Journal: EuroIntervention

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Abstract

Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, ... Schmidt T, Lansky AJ
Background
Stroke remains a feared complication associated with TAVI. Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction.
Aims
The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients.
Methods
Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data.
Results
Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion.
Conclusions
The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).



EuroIntervention: 24 May 2022; epub ahead of print
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, ... Schmidt T, Lansky AJ
EuroIntervention: 24 May 2022; epub ahead of print | PMID: 35608032
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Abstract

Temporal patterns, characteristics, and predictors of clinical outcomes in patients undergoing percutaneous coronary intervention for stent thrombosis.

Mohamed MO, Sirker A, Chieffo A, Avanzas P, ... Kinnaird T, Mamas MA
Background
There are limited data on the outcomes of percutaneous coronary intervention (PCI) following stent thrombosis (ST) and differences exist based on timing.
Aims
Our aim was to study the rates of PCI procedures for an ST indication among all patients admitted for PCI at a national level and to compare their characteristics and procedural outcomes based on ST timing.
Methods
All PCI procedures in England and Wales (2014-2020) were retrospectively analysed and stratified by the presence of ST into four groups: non-ST, early ST (0-30 days), late ST (>30-360 days), very late ST (>360 days). Multivariable logistic regression models were performed to assess the odds ratios (OR) of in-hospital MACCE (major adverse cardiovascular and cerebrovascular events, a composite of mortality, acute stroke and reinfarction) and mortality.
Results
Overall, 7,923 (1.4%) procedures were for ST indication, most commonly for early ST (n=4,171; 52.6%), followed by very late ST (n=2,801; 35.4%) and late ST (n=951; 12.0%). The rate of PCI for ST declined between 2014 and 2020 (1.7 to 1.4%; p<0.001). Early ST was the only subgroup associated with increased odds of MACCE (OR 1.22, 95% CI: 1.05-1.41), all-cause mortality (OR 1.21, 95% CI: 1.07-1.36) and reinfarction (OR 2.48, 95% CI: 1.48-4.14), compared with non-ST indication. The odds of mortality were significantly reduced in ST patients with the use of intravascular imaging (OR 0.66, 95% CI: 0.48-0.92) and newer P2Y12 inhibitors (ticagrelor: OR 0.69, 95% CI: 0.49-0.95; prasugrel: OR 0.54, 95% CI: 0.30-0.96).
Conclusions
PCI for ST has declined in frequency over a 7-year period, with most procedures performed for early ST. Among the different times of ST onset, only early ST is associated with worse clinical outcomes after PCI. Routine use of intravascular imaging and newer P2Y12 inhibitors could further improve outcomes in this high-risk procedural group.



EuroIntervention: 23 May 2022; epub ahead of print
Mohamed MO, Sirker A, Chieffo A, Avanzas P, ... Kinnaird T, Mamas MA
EuroIntervention: 23 May 2022; epub ahead of print | PMID: 35599596
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Abstract

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

Lunardi M, Louvard Y, Lefèvre T, Stankovic G, ... Serruys PW, Onuma Y
The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.



EuroIntervention: 18 May 2022; epub ahead of print
Lunardi M, Louvard Y, Lefèvre T, Stankovic G, ... Serruys PW, Onuma Y
EuroIntervention: 18 May 2022; epub ahead of print | PMID: 35583108
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Abstract

Treatment of coronary bifurcation lesions, part I: implanting the first stent in the provisional pathway. The 16th expert consensus document of the European Bifurcation Club.

Albiero R, Burzotta F, Lassen JF, Lefèvre T, ... Louvard Y, Stankovic G
Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term \"stepwise layered\" emphasises the versatility of this approach that allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16th European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.



EuroIntervention: 15 May 2022; epub ahead of print
Albiero R, Burzotta F, Lassen JF, Lefèvre T, ... Louvard Y, Stankovic G
EuroIntervention: 15 May 2022; epub ahead of print | PMID: 35570748
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Abstract

Treatment of coronary bifurcation lesions, part II: implanting two stents. The 16th expert consensus document of the European Bifurcation Club.

Lassen JF, Albiero R, Johnson TW, Burzotta F, ... Louvard Y, Stankovic G
The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The recent focus of meetings and consensus statements has been on the technical issues in bifurcation stenting, recognising that the final result of a bifurcation procedure and the long-term outcome for our patients are strongly influenced by factors, including preprocedural strategy, stenting technique selection, performance of optimal procedural steps, the ability to identify and correct complications and finally, and most important, the overall performance of the operator. Continuous refinement of bifurcation stenting techniques and the promotion of education and training in bifurcation stenting techniques represent a major clinical need. Accordingly, the consensus from the latest EBC meeting in Brussels, October 2021, was to promote education and training in bifurcation stenting based on the EBC principle. Part II of this 16th EBC consensus document aims to provide a step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the second stent either in the provisional stenting (PS) strategy or in upfront 2-stent techniques (e.g., 2-stent PS pathway and double kissing crush stenting). Finally, a detailed overview and discussion of the numerous modalities available to provide continuous education and technical training in bifurcation stenting techniques are discussed, with consideration of their future application in enhancing training and practice in coronary bifurcation lesion treatment.



EuroIntervention: 15 May 2022; epub ahead of print
Lassen JF, Albiero R, Johnson TW, Burzotta F, ... Louvard Y, Stankovic G
EuroIntervention: 15 May 2022; epub ahead of print | PMID: 35570753
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Abstract

Impact of right ventricular-pulmonary arterial coupling on clinical outcomes of tricuspid regurgitation.

Sugiura A, Kavsur R, Spieker M, Iliadis C, ... Pfister R, Becher MU
Background
In terms of pathophysiology, tricuspid regurgitation (TR) and right ventricular (RV) function are linked to each other.
Aims
This study sought to evaluate RV-pulmonary artery (PA) coupling and its impact on clinical outcomes of TR in patients undergoing mitral transcatheter edge-to-edge repair (TEER).
Methods
We calculated RV-PA coupling ratios in patients undergoing mitral TEER from August 2010 to March 2019 by dividing the tricuspid annular plane systolic excursion (TAPSE) by the echocardiographic estimated PA systolic pressure (PASP). TR was graded as none/trace, mild, moderate, or severe. The primary outcome was all-cause mortality or rehospitalisation within 12 months.
Results
Among 744 patients analysed, severe TR was documented in 22.3% of patients and the mean TAPSE/PASP was 0.43±0.25. Technical success of TEER was achieved in 97.2% of participants. Severe TR vs TR ≤moderate (adjusted HR 1.92, 95% CI: 1.39-2.66) and TAPSE/PASP (adjusted HR 0.45, 95% CI: 0.22-0.93) were associated with the outcome. Patients were divided according to the TAPSE/PASP tertile. Compared to patients with TR ≤moderate, patients with severe TR had a higher event rate (TAPSE/PASP <0.30: 32.9% vs 45.1%; 0.30≤ TAPSE/PASP <0.44: 27.8% vs 41.8%; TAPSE/PASP ≥0.44: 16.0% vs 40.4%), whereas the prognostic significance of TR was attenuated in patients with reduced TAPSE/PASP (i.e., RV-PA uncoupling; interaction term p=0.03). The trends were consistent in the multivariable regression models, spline curves, and sensitivity analysis using post-interventional parameters.
Conclusions
RV-PA coupling affects the outcome correlation of TR in patients undergoing mitral TEER. The prognostic impact of TR is attenuated in patients with RV-PA uncoupling.



EuroIntervention: 13 May 2022; epub ahead of print
Sugiura A, Kavsur R, Spieker M, Iliadis C, ... Pfister R, Becher MU
EuroIntervention: 13 May 2022; epub ahead of print | PMID: 35550286
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Abstract

Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial.

Lee YJ, Cho JY, Yun KH, Lee SJ, ... Jang Y, Kim JS
Background
The impact of 1-month dual antiplatelet therapy (DAPT) followed by aspirin monotherapy according to clinical presentation has not been elucidated.
Aims
This study aimed to compare the impact of 1-month DAPT followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation (1-month DAPT after PF-DCS) vs 6-12-month DAPT followed by aspirin monotherapy after biodegradable polymer drug-eluting stent (BP-DES) implantation (6-12-month DAPT after BP-DES) according to clinical presentation.
Methods
This is a post hoc analysis of the One-Month DAPT trial. The primary outcome was the composite of major adverse cardiac and cerebrovascular events (MACCE; a composite of cardiac death, non-fatal myocardial infarction, target vessel revascularisation, and stroke) and major bleeding.
Results
Among 1,828 patients with stable coronary artery disease (CAD), 1-month DAPT after PF-DCS resulted in lower rates of the primary outcome than 6-12-month DAPT after BP-DES (3.9% vs 6.5%; hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.39-0.90; p=0.012). However, among 1,192 patients with acute coronary syndrome (ACS), the rates of primary outcome were not significantly different between the two therapy groups (5.6% vs 3.6%; HR 1.57, 95% CI: 0.91-2.70; p=0.102) and a significant interaction was observed between therapy and clinical presentation regarding primary outcome (Pint=0.005). A significant interaction was observed in MACCE (Pint=0.016), but not in major bleeding (Pint=0.276).
Conclusions
In patients undergoing drug-eluting stent implantation for non-complex lesions, the benefits of 1-month DAPT followed by aspirin monotherapy for a composite of ischaemic and bleeding outcomes were found in patients with stable CAD, but not in those with ACS.
Clinicaltrials
gov: NCT02513810.



EuroIntervention: 26 Apr 2022; epub ahead of print
Lee YJ, Cho JY, Yun KH, Lee SJ, ... Jang Y, Kim JS
EuroIntervention: 26 Apr 2022; epub ahead of print | PMID: 35470799
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Impact:
Abstract

Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2.

Garot P, Neylon A, Morice MC, Tamburino C, ... Hengstenberg C, Capodanno D
Background
The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding.
Aims
We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR).
Methods
Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients.
Results
Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72-6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications.
Conclusions
The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.



EuroIntervention: 22 Apr 2022; epub ahead of print
Garot P, Neylon A, Morice MC, Tamburino C, ... Hengstenberg C, Capodanno D
EuroIntervention: 22 Apr 2022; epub ahead of print | PMID: 35450838
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Abstract

Device-related thrombus following left atrial appendage occlusion.

Simard TJ, Hibbert B, Alkhouli MA, Abraham NS, Holmes DR
Thrombus formation on intracardiac devices remains a subject of importance, with rates in the 2-5% range. Device-related thrombus (DRT) following left atrial appendage occlusion is an area of particular concern considering its association with embolic events. DRT continues to present numerous questions, including the optimal definition, incidence, risk factors, monitoring, therapy, and clinical outcomes - all subjects of ongoing assessment. Herein, we discuss these considerations, building upon the relevant historical context and pathophysiologic insights while discussing the future considerations in this rapidly evolving field.



EuroIntervention: 20 Apr 2022; epub ahead of print
Simard TJ, Hibbert B, Alkhouli MA, Abraham NS, Holmes DR
EuroIntervention: 20 Apr 2022; epub ahead of print | PMID: 35440430
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Impact:
Abstract

Intravascular ultrasound guidance for lower extremity arterial and venous interventions.

Secemsky EA, Parikh SA, Kohi M, Lichtenberg M, ... Hawkins B, Rosenfield K
This review details the utility of intravascular ultrasound (IVUS) for the management of peripheral artery and venous disease. The purpose of this document is to provide an update in the use of IVUS in peripheral arterial and venous pathology and demonstrate the use of IVUS as a practical diagnostic imaging procedure to evaluate and treat peripheral vascular disorders. IVUS, a diagnostic tool that relies on sound waves to produce precise images of the vessel being evaluated, was originally introduced to the medical community for the purposes of peripheral artery imaging, though it was quickly adapted for coronary interventions with positive outcomes. The utility of IVUS includes vessel measurement, pre- and post-procedural planning, treatment optimisation, and detection of thrombus, dissection or calcium severity. While angiography remains the standard imaging approach during peripheral intervention, multiple observational studies and small prospective trials have shown that in comparison, IVUS provides more accurate imaging detail that may improve procedural outcomes. IVUS can also address limitations of angiography, including the need to administer contrast medium, and eliminate the ambiguity associated with other forms of imaging. This review provides contemporary examples of where IVUS is being used during peripheral intervention, as well as representative imaging to serve as a resource for the practising clinician.



EuroIntervention: 19 Apr 2022; epub ahead of print
Secemsky EA, Parikh SA, Kohi M, Lichtenberg M, ... Hawkins B, Rosenfield K
EuroIntervention: 19 Apr 2022; epub ahead of print | PMID: 35438078
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Abstract

Prevalence and outcomes of stent thrombosis with in-stent calcified nodules: substudy from the REAL-ST registry.

Takahashi Y, Otake H, Kuramitsu S, Ohya M, ... Saito S, Kimura T
Background
The relationship between in-stent calcified nodules (IS-CN) and second-generation drug-eluting stent (G2-DES) stent thrombosis (ST) remains uncertain.
Aims
We aimed to evaluate the prevalence, clinical demographic and long-term clinical outcomes after G2-DES ST with IS-CN.
Methods
The prespecified substudy of the REAL-ST registry (a retrospective, multicentre registry of patients with definite ST after first- and G2-DES implantation) enrolled patients who experienced definite G2-DES ST and who underwent pre-intervention intravascular ultrasound imaging at index ST events.
Results
IS-CN was observed in 15 out of 118 (13%) definite G2-DES ST cases. The multiple logistic regression model demonstrated that haemodialysis (odds ratio [OR] 12.27, 95% confidence interval [CI]: 1.56-94.54; p=0.02), proximal or mid-right coronary artery lesions (OR 12.79, 95% CI: 1.78-92.13; p=0.01) and severe calcification (OR 13.01, 95% CI: 1.18-142.94; p=0.04) were independently associated with ST with IS-CN. The cumulative 5-year incidence of target lesion revascularisation (TLR) after ST was significantly higher in the IS-CN group than in the non-IS-CN group (p=0.02). Independent predictors of TLR after the index ST events were female sex (hazard ratio [HR] 3.05, 95% CI: 1.20-7.74; p=0.02), diabetes mellitus (HR 3.26, 95% CI: 1.26-8.41; p=0.01) and IS-CN (HR 3.07, 95% CI: 1.16-8.14; p=0.02).
Conclusions
IS-CN may be one of the underlying mechanisms of G2-DES ST. Notably, IS-CN was associated with a higher TLR rate after the index ST events, suggesting the need for careful clinical follow-up of ST patients with IS-CN.



EuroIntervention: 08 Apr 2022; epub ahead of print
Takahashi Y, Otake H, Kuramitsu S, Ohya M, ... Saito S, Kimura T
EuroIntervention: 08 Apr 2022; epub ahead of print | PMID: 35389345
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Impact:
Abstract

Phoenix atherectomy for patients with peripheral artery disease.

Giusca S, Hagstotz S, Lichtenberg M, Heinrich U, ... Andrassy M, Korosoglou G
Background
Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD).
Aims
We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients.
Methods
Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed.
Results
A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK; 32%) segments. Complex TASC C/D lesions and moderate to severe calcifications (PACSS score ≥2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (HR 3.7; p<0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03).
Conclusions
The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates.
German clinical trials register
DRKS00016708.



EuroIntervention: 07 Apr 2022; epub ahead of print
Giusca S, Hagstotz S, Lichtenberg M, Heinrich U, ... Andrassy M, Korosoglou G
EuroIntervention: 07 Apr 2022; epub ahead of print | PMID: 35389346
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Abstract

Dual versus triple antithrombotic therapy after percutaneous coronary intervention: the prospective multicentre WOEST 2 Study.

Bor WL, de Veer AJW, Olie RH, Rikken SAOF, ... Dewilde WJM, Ten Berg JM
Background
For patients with oral anticoagulants (OAC) undergoing percutaneous coronary intervention (PCI), European guidelines have recently changed their recommendations to dual antithrombotic therapy (DAT; P2Y12 inhibitor and OAC) without aspirin.
Aims
The prospective WOEST 2 registry was designed to obtain contemporary real-world data on antithrombotic regimens and related outcomes after PCI in patients with an indication for OAC.
Methods
In this analysis, we compare DAT (P2Y12 inhibitor and OAC) to triple antithrombotic therapy (TAT; aspirin, P2Y12 inhibitor, and OAC) on thrombotic and bleeding outcomes after one year. Clinically relevant bleeding was defined as Bleeding Academic Research Consortium classification (BARC) grade 2, 3, or 5; major bleeding as BARC grade 3 or 5. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause mortality, myocardial infarction, stent thrombosis, ischaemic stroke, and transient ischaemic attack.
Results
A total of 1,075 patients were included between 2014 and 2021. Patients used OAC for atrial fibrillation (93.6%) or mechanical heart valve prosthesis (4.7%). Non-vitamin K oral anticoagulant (NOAC) was prescribed in 53.1% and vitamin K antagonists in 46.9% of patients. At discharge, 60.9% received DAT, and 39.1% TAT. DAT was associated with less clinically relevant and similar major bleeding (16.8% vs 23.4%; p<0.01 and 7.6% vs 7.7%, not significant), compared to TAT. MACCE was not statistically significant different (12.4% vs 9.7%; p=0.17). Multivariable adjustment and propensity score matching confirmed these results.
Conclusions
Dual antithrombotic therapy is associated with a substantially lower risk of clinically relevant bleeding without a statistically significant penalty in ischaemic events.



EuroIntervention: 04 Apr 2022; epub ahead of print
Bor WL, de Veer AJW, Olie RH, Rikken SAOF, ... Dewilde WJM, Ten Berg JM
EuroIntervention: 04 Apr 2022; epub ahead of print | PMID: 35370126
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Impact:
Abstract

Safety and prognostic relevance of acetylcholine testing in patients with stable myocardial ischaemia or myocardial infarction and non-obstructive coronary arteries.

Montone RA, Rinaldi R, Del Buono MG, Gurgoglione F, ... Niccoli G, Crea F
Background
Intracoronary provocation testing with acetylcholine (ACh) is crucial for the diagnosis of functional coronary alterations in patients with suspected myocardial ischaemia and non-obstructive coronary arteries.
Aims
Our intention was to assess the safety and predictive value for major adverse cardiovascular and cerebrovascular events (MACCE) in patients presenting with ischaemia with non-obstructive coronary arteries (INOCA) or with myocardial infarction with non-obstructive coronary arteries (MINOCA).
Methods
We prospectively enrolled consecutive INOCA or MINOCA patients undergoing intracoronary ACh provocation testing.
Results
A total of 317 patients were enrolled: 174 (54.9%) with INOCA and 143 (45.1%) with MINOCA. Of these, 185 patients (58.4%) had a positive response to the ACh test. Complications during ACh provocative testing were all mild and transient and occurred in 29 (9.1%) patients, with no difference between patients with positive or negative responses to ACh testing, nor between INOCA and MINOCA patients. A history of paroxysmal atrial fibrillation, moderate/severe diastolic dysfunction and a higher QT dispersion at baseline electrocardiogram were independent predictors of complications. MACCE occurred in 30 patients (9.5%) during a median follow-up of 22 months. The incidence of MACCE was higher among patients with a positive ACh test (24 [13.0%] vs 6 [4.5%], p=0.017), and a positive ACh test was an independent predictor of MACCE.
Conclusions
ACh provocation testing is associated with a low risk of mild and transient complications, with a similar prevalence in both INOCA and MINOCA patients. Importantly, ACh provocation testing can help to identify patients at higher risk of future clinical events, suggesting a net clinical benefit derived from its use in this clinical setting.



EuroIntervention: 04 Apr 2022; epub ahead of print
Montone RA, Rinaldi R, Del Buono MG, Gurgoglione F, ... Niccoli G, Crea F
EuroIntervention: 04 Apr 2022; epub ahead of print | PMID: 35377315
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Impact:
Abstract

Antiplatelet therapy after percutaneous coronary intervention.

Angiolillo DJ, Galli M, Collet JP, Kastrati A, O\'Donoghue ML
Antiplatelet therapy is key to reducing local thrombotic complications and systemic ischaemic events among patients undergoing percutaneous coronary interventions (PCI), but it is inevitably associated with increased bleeding. The continuous refinement in stent technologies, together with the high incidence of ischaemic recurrences after PCI and the understanding of prognostic implications associated with bleeding, have led to a substantial evolution in antiplatelet treatment regimens over the past decades. Numerous investigations have been conducted to better stratify patients undergoing PCI according to their ischaemic and bleeding risks and to implement antithrombotic regimens accordingly. Evidence from these investigations have resulted in a number of antithrombotic treatment options as recommended by recent guidelines. In this State-of-the-Art review we provide the rationale, summarise the evidence, and discuss current and future directions of antiplatelet treatment regimens after PCI.



EuroIntervention: 01 Apr 2022; 17:e1371-e1396
Angiolillo DJ, Galli M, Collet JP, Kastrati A, O'Donoghue ML
EuroIntervention: 01 Apr 2022; 17:e1371-e1396 | PMID: 35354550
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Impact:
Abstract

Timing of coronary angiography in patients with non-ST-elevation acute coronary syndrome: long-term clinical outcomes from the nationwide SWEDEHEART registry.

Eggers KM, James SK, Jernberg T, Lindahl B
Background
Current guidelines stress the importance of early invasive assessment of patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), in particular those at high risk. However, supporting scientific evidence is limited.
Aims
We aimed to investigate the prognostic impact of the timing of coronary angiography in a large cohort of NSTE-ACS patients.
Methods
We performed a retrospective analysis including 34,666 NSTE-ACS patients registered from 2013 to 2018 in the SWEDEHEART registry. The prognostic implications of the timing of coronary angiography on a continuous scale and within <24 vs 24-72 hours were assessed using Cox regression analyses.
Results
The median time interval from admission to invasive assessment was 32.8 (25th, 75th percentiles 20.4-63.8) hours. There was no apparent time window within 96 hours from admission that provided prognostic benefit. Coronary angiography within 24-72 hours (vs <24 hours) was not associated with worse outcome overall (all-cause mortality: hazard ratio 1.01, 95% confidence interval [CI] 0.92-1.11; major adverse events: hazard ratio 1.04, 95% CI: 0.98-1.12). Interaction analyses indicated a greater relative benefit of coronary angiography <24 hours in some lower-risk groups (women, non-diabetics, patients with minor troponin elevation) but neutral effects in higher-risk groups (defined by age or the GRACE 2.0 score).
Conclusions
These Swedish data do not provide support for an early invasive strategy in NSTE-ACS, especially in high-risk patients. Our results suggest that the timing of invasive assessment should rather be based on individualised decisions integrating symptoms and risk panorama than on strictly defined time intervals.



EuroIntervention: 31 Mar 2022; epub ahead of print
Eggers KM, James SK, Jernberg T, Lindahl B
EuroIntervention: 31 Mar 2022; epub ahead of print | PMID: 35352681
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Impact:
Abstract

Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study.

Medranda GA, Soria Jimenez CE, Torguson R, Case BC, ... Waksman R, Rogers T
Background
Given enough time, transcatheter heart valves (THVs) will degenerate and may require reintervention. Redo transcatheter aortic valve implantation (TAVI) is an attractive strategy but carries a risk of coronary obstruction.
Aims
We sought to predict how many TAVIs patients could undergo in their lifetime using computed tomography (CT) simulation.
Methods
We analysed paired CT scans (baseline and 30 days post-TAVI) from patients in the LRT trials and EPROMPT registry. We implanted virtual THVs on baseline CTs, comparing predicted valve-to-coronary (VTC) distances to 30-day CT VTC distances to evaluate the accuracy of CT simulation. We then simulated implantation of a second virtual THV within the first to estimate the risk of coronary obstruction due to sinus sequestration and the need for leaflet modification.
Results
We included 213 patients with evaluable paired CTs. There was good agreement between virtual (baseline) and actual (30 days) CT measurements. CT simulation of TAVI followed by redo TAVI predicted low coronary obstruction risk in 25.4% of patients and high risk, likely necessitating leaflet modification, in 27.7%, regardless of THV type. The remaining 46.9% could undergo redo TAVI so long as the first THV was balloon-expandable but would likely require leaflet modification if the first THV was self-expanding.
Conclusions
Using cardiac CT simulation, it is possible to predict whether a patient can undergo multiple TAVI procedures in their lifetime. Those who cannot may prefer to undergo surgery first. CT simulation could provide a personalised lifetime management strategy for younger patients with symptomatic severe aortic stenosis and inform decision-making.
Clinicaltrial
gov: NCT02628899; ClinicalTrial.gov: NCT03557242; ClinicalTrial.gov: NCT03423459.



EuroIntervention: 25 Mar 2022; epub ahead of print
Medranda GA, Soria Jimenez CE, Torguson R, Case BC, ... Waksman R, Rogers T
EuroIntervention: 25 Mar 2022; epub ahead of print | PMID: 35321859
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Impact:
Abstract

Transcatheter versus surgical aortic valve replacement in patients with morbid obesity: a multicentre propensity score-matched analysis.

McInerney A, Rodes-Cabau J, Veiga G, Lopez-Otero D, ... Escaned J, Nombela-Franco L
Background
Morbidly obese (MO) patients are increasingly undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS). However, the best therapeutic strategy for these patients remains a matter for debate.
Aims
Our aim was to compare the periprocedural and mid-term outcomes in MO patients undergoing TAVR versus SAVR.
Methods
A multicentre retrospective study including consecutive MO patients (body mass index ≥40 kg/m2, or ≥35 kg/m2 with obesity-related comorbidities) from 18 centres undergoing either TAVR (n=860) or biological SAVR (n=696) for severe AS was performed. Propensity score matching resulted in 362 pairs.
Results
After matching, periprocedural complications, including blood transfusion (14.1% versus 48.1%; p<0.001), stage 2-3 acute kidney injury (3.99% versus 10.1%; p=0.002), hospital-acquired pneumonia (1.7% versus 5.8%; p=0.005) and access site infection (1.5% versus 5.5%; p=0.013), were more common in the SAVR group, as was moderate to severe patient-prosthesis mismatch (PPM; 9.9% versus 39.4%; p<0.001). TAVR patients more frequently required permanent pacemaker implantation (14.4% versus 5.6%; p<0.001) and had higher rates of ≥moderate residual aortic regurgitation (3.3% versus 0%; p=0.001). SAVR was an independent predictor of moderate to severe PPM (hazard ratio [HR] 1.80, 95% confidence interval [CI]: 1.25-2.59; p=0.002), while TAVR was not. In-hospital mortality was not different between groups (3.9% for TAVR versus 6.1% for SAVR; p=0.171). Two-year outcomes (including all-cause and cardiovascular mortality, and readmissions) were similar in both groups (log-rank p>0.05 for all comparisons). Predictors of all-cause 2-year mortality differed between the groups; moderate to severe PPM was a predictor following SAVR (HR 1.78, 95% CI: 1.10-2.88; p=0.018) but not following TAVR (p=0.737).
Conclusions
SAVR and TAVR offer similar mid-term outcomes in MO patients with severe AS, however, TAVR offers some advantages in terms of periprocedural morbidity.



EuroIntervention: 24 Mar 2022; epub ahead of print
McInerney A, Rodes-Cabau J, Veiga G, Lopez-Otero D, ... Escaned J, Nombela-Franco L
EuroIntervention: 24 Mar 2022; epub ahead of print | PMID: 35321860
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Impact:
Abstract

Coronary lithotripsy for the treatment of underexpanded stents; the international multicentre CRUNCH registry.

Tovar Forero MN, Sardella G, Salvi N, Cortese B, ... Van Mieghem NM, Daemen J
Background
Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy.
Aims
To evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification.
Methods
This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE).
Results
Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain.
Conclusions
Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.



EuroIntervention: 23 Mar 2022; epub ahead of print
Tovar Forero MN, Sardella G, Salvi N, Cortese B, ... Van Mieghem NM, Daemen J
EuroIntervention: 23 Mar 2022; epub ahead of print | PMID: 35318955
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Impact:
Abstract

How to set up regional STEMI networks: a \"Stent - Save a life!\" initiative.

Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber C
Clinical guidelines recommend the development of ST-elevation myocardial infarction (STEMI) networks at community, regional and/or national level to ideally offer primary coronary angioplasty, or at least the best available STEMI care to all patients. However, there is a discrepancy between this clinical recommendation and daily practice, with no coordinated care for STEMI patients in many regions of the world. While this can be a consequence of lack of resources, in reality it is more frequently a lack of organisational power. In this paper, the Stent - Save a Life! Initiative (www.stentsavealife.com) proposes a practical methodology to set up a STEMI network effectively in any region of the world with existing resources, and to develop the STEMI network continuously once it has been established.



EuroIntervention: 18 Mar 2022; 17:1313-1317
Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber C
EuroIntervention: 18 Mar 2022; 17:1313-1317 | PMID: 34387547
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Impact:
Abstract

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
Background
The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing.
Aims
The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old.
Methods
All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (</>70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups.
Results
Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715).
Conclusions
Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).



EuroIntervention: 18 Mar 2022; 17:1289-1297
Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
EuroIntervention: 18 Mar 2022; 17:1289-1297 | PMID: 34673502
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Impact:
Abstract

Temporal trends in clinical outcomes after percutaneous coronary intervention: a systematic review of 66,327 patients from 25 all-comers trials.

Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
Background
With the improvements of percutaneous coronary intervention (PCI) technology and post-PCI patient management, several registry studies reported temporal trends in post-PCI clinical outcomes. However, their results are inconclusive, potentially reflecting region-specific trends, based on site-reported events without external validity.
Aims
This study aimed to investigate temporal trends in post-PCI clinical outcomes in all-comers randomised controlled trials (RCTs) involving coronary stents.
Methods
We performed a systematic review identifying RCTs comparing a clinical outcome as a primary endpoint among different coronary stents with an all-comers design and independent clinical event adjudication, extracting the study start year, patient baseline characteristics, and one- and five-year clinical outcomes. Temporal trends in clinical outcomes (cardiac death, myocardial infarction [MI], target lesion revascularisation [TLR], stent thrombosis [ST]) were assessed using random-effects meta-regression analyses, estimating the relationship between clinical outcomes and study start year.
Results
Overall, 25 all-comers trials (51 device arms, 66,327 patients) conducted between 2003 and 2018 fulfilled the eligibility criteria. Random-effects meta-regression analysis revealed significant decreasing trends in one- and five-year cardiac death, one-year TLR, and five-year ST incidences (relative risk per 10-year increase: 0.69 [0.51-0.92], 0.66 [0.44-0.98], 0.60 [0.41-0.88], and 0.18 [0.07-0.44], respectively). There was no significant trend in myocardial infarction incidences.
Conclusions
This is the first attempt to clarify and quantify the temporal trends of post-PCI outcome incidence. The 15-year improvements in PCI therapy and post-therapeutic patient management are associated with reduced incidences of cardiac death and PCI-related adverse events.



EuroIntervention: 18 Mar 2022; 17:1318-1329
Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
EuroIntervention: 18 Mar 2022; 17:1318-1329 | PMID: 34602385
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Impact:
Abstract

Prevalence, predictors, and outcomes of in-stent restenosis with calcified nodules.

Tada T, Miura K, Ikuta A, Ohya M, ... Fuku Y, Kadota K
Background
Calcified nodules (CN) have been reported as being associated with stent failure including in-stent restenosis (ISR). However, there is no systematic study of this condition.
Aims
We aimed to clarify the prevalence, predictors, and midterm results of ISR lesions with CN.
Methods
We examined the clinical characteristics of 651 ISR lesions in patients who underwent percutaneous coronary intervention (PCI) with optical coherence tomography (OCT) between October 2008 and July 2016, and their 6- to 8-month follow-up angiography results. CN was defined as a high backscattering mass with small nodular calcium depositions which protruded into the vessel lumen.
Results
Thirty-two ISR lesions (4.9%) had CN. Multivariable analysis showed that calcified lesion (odds ratio [OR] 12.441, p<0.001), incomplete stent apposition (OR 3.228, p=0.005), haemodialysis (OR 3.633, p=0.024), and female gender (OR 3.212, p=0.036) were independently associated with ISR lesions with CN. Midterm follow-up was performed on 612 ISR lesions. Both ISR and target lesion revascularisation (TLR) rates were significantly higher in lesions with CN compared with those without CN (43.8% vs 25.0%, p=0.023; 37.5% vs 18.8%, p=0.020, respectively). However, multivariate analysis did not show the presence of CN as an independent predictor of re-TLR (OR 1.690, p=0.286).
Conclusions
The prevalence of ISR lesions with CN was 4.9%. Calcified lesions, incomplete stent apposition, haemodialysis, and female gender are probably associated with CN formation. ISR lesions with CN may have poor midterm outcomes compared with ISR lesions without CN.



EuroIntervention: 18 Mar 2022; 17:1352-1361
Tada T, Miura K, Ikuta A, Ohya M, ... Fuku Y, Kadota K
EuroIntervention: 18 Mar 2022; 17:1352-1361 | PMID: 34483090
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Impact:
Abstract

Transcatheter edge-to-edge mitral valve repair in patients with mitral annulus calcification.

Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
Background
MAC is commonly found in patients affected with MR, and it is associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge repair could be an alternative treatment, although there is little evidence in this population.
Aims
The aim of this study was to analyse the safety, efficacy and durability of MitraClip implantation in patients affected with mitral regurgitation (MR) and mitral annulus calcification (MAC).
Methods
We analysed the outcomes of 61 suitable patients affected with severe MR and moderate or severe MAC (the \"MAC\" group) and 791 patients with no or mild MAC (the \"NoMAC\" group) treated with the MitraClip device.
Results
Procedural success was similar (91.8% vs 95.1%, p=0.268, in MAC and NoMAC, respectively), with a very low rate of complications. At one-year follow-up, 90.6% of MAC and 79.5% of NoMAC patients had MR grade ≤2 (p=0.129), 80% in both groups remained in NYHA Functional Class ≤II, and a significant reduction in cardiac readmissions was observed (65% vs 78% in MAC vs NoMAC, p=0.145). One-year mortality tended to be higher in MAC patients (19.7% vs 11.3%, p=0.050), with no difference in cardiovascular mortality (15.3% vs 9.2%, p=0.129).
Conclusions
MitraClip use in selected patients with moderate or severe MAC is safe, feasible and achieves good clinical and echocardiographic results at one-year follow-up.



EuroIntervention: 18 Mar 2022; 17:1300-1309
Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
EuroIntervention: 18 Mar 2022; 17:1300-1309 | PMID: 34483091
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Impact:
Abstract

Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial.

Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
Background
Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce.
Aims
This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group.
Methods
AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT.
Results
Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86).
Conclusions
The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical
Trial registration:
ClinicalTrials.gov: NCT01858077.



EuroIntervention: 18 Mar 2022; 17:1340-1347
Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
EuroIntervention: 18 Mar 2022; 17:1340-1347 | PMID: 34483094
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Impact:
Abstract

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

Dangas G, Baber U, Sharma S, Giustino G, ... Gibson CM, Mehran R
Background
In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
Aims
The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type.
Methods
In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation.
Results
Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications.
Conclusions
As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.



EuroIntervention: 18 Mar 2022; 17:1330-1339
Dangas G, Baber U, Sharma S, Giustino G, ... Gibson CM, Mehran R
EuroIntervention: 18 Mar 2022; 17:1330-1339 | PMID: 34881696
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Impact:
Abstract

Clinical outcomes of no stenting in patients with ST-segment elevation myocardial infarction undergoing deferred primary percutaneous coronary intervention.

Madsen JM, Kelbæk H, Nepper-Christensen L, Jacobsen MR, ... Engstrøm T, Lønborg JT
Background
ST-segment elevation myocardial infarction (STEMI) is treated with stenting, but the underlying stenosis is often not severe, and stenting may potentially be omitted.
Aims
The aim of the study was to investigate outcomes of patients with STEMI treated with percutaneous coronary intervention (PCI) without stenting.
Methods
Patients were identified through the DANAMI-3-DEFER study. Stenting was omitted in the patients with stable flow after initial PCI and no significant residual stenosis on the deferral procedure, who were randomised to deferred stenting. These patients were compared to patients randomised to conventional PCI treated with immediate stenting. The primary endpoint was a composite of all-cause mortality, recurrent myocardial infarction (MI), and target vessel revascularisation (TVR).
Results
Of 603 patients randomised to deferred stenting, 84 were treated without stenting, and in patients randomised to conventional PCI (n=612), 590 were treated with immediate stenting. Patients treated with no stenting had a median stenosis of 40%, median vessel diameter of 2.9 mm, and median lesion length of 11.4 mm. During a median follow-up of 3.4 years, the composite endpoint occurred in 14% and 16% in the no and immediate stenting group, respectively (unadjusted hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.48-1.60; p=0.66). The association remained non-significant after adjusting for confounders (adjusted HR 0.53, 95% CI: 0.22-1.24; p=0.14). The rate of TVR and recurrent MI were 2% vs 4% (p=0.70) and 4% vs 6% (p=0.43), respectively.
Conclusions
Patients with STEMI, with no significant residual stenosis and stable flow after initial PCI, treated without stenting, had comparable event rates to patients treated with immediate stenting.



EuroIntervention: 15 Mar 2022; epub ahead of print
Madsen JM, Kelbæk H, Nepper-Christensen L, Jacobsen MR, ... Engstrøm T, Lønborg JT
EuroIntervention: 15 Mar 2022; epub ahead of print | PMID: 35289303
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Impact:
Abstract

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial.

de Winter RJ, Zaman A, Hara H, Gao C, ... Onuma Y, Serruys PW
Background
In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target-vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months.
Aims
This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent.
Methods
The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years.
Results
The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES.
Conclusions
At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population.
Clinicaltrials
gov: NCT02870140.



EuroIntervention: 14 Mar 2022; epub ahead of print
de Winter RJ, Zaman A, Hara H, Gao C, ... Onuma Y, Serruys PW
EuroIntervention: 14 Mar 2022; epub ahead of print | PMID: 35285804
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Impact:
Abstract

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

van Geuns RJ, Chun-Chin C, McEntegart MB, Merkulov E, ... Onuma Y, Oldroyd KG
Background
Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).
Aims
The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease.
Methods
This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI of LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years.
Results
Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02).
Conclusions
In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.



EuroIntervention: 13 Mar 2022; epub ahead of print
van Geuns RJ, Chun-Chin C, McEntegart MB, Merkulov E, ... Onuma Y, Oldroyd KG
EuroIntervention: 13 Mar 2022; epub ahead of print | PMID: 35285803
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Impact:
Abstract

Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.

Ono M, Hara H, Kawashima H, Gao C, ... Onuma Y, Serruys PW
Background
The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear.
Aims
We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes beyond 1 year post-PCI.
Methods
This post hoc subanalysis of the open-label, all-comers, randomised GLOBAL LEADERS trial, which compared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT), with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events, and adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy.
Results
The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank p=0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005).
Conclusions
Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI.
Clinicaltrials
gov: NCT01813435.



EuroIntervention: 08 Mar 2022; epub ahead of print
Ono M, Hara H, Kawashima H, Gao C, ... Onuma Y, Serruys PW
EuroIntervention: 08 Mar 2022; epub ahead of print | PMID: 35260381
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Abstract

Assessment of arterial stiffness to predict blood pressure response to renal sympathetic denervation.

Fengler K, Rommel KP, Kriese W, Kresoja KP, ... Thiele H, Lurz P
Background
Recent trials support the efficacy of renal sympathetic denervation (RDN) to reduce blood pressure (BP). Nevertheless, about one third of patients are considered non-responders to RDN. Previous retrospective analyses suggest arterial stiffness could predict BP response to RDN.
Aims
We prospectively assessed the potential of invasive pulse wave velocity (iPWV) to predict BP response to RDN. Additionally, we aimed to establish non-invasive models based on arterial stiffness to predict BP response to RDN.
Methods
IPWV, magnetic resonance imaging-based markers of arterial stiffness and the carotid-femoral pulse wave velocity were recorded prior to RDN in patients with treatment resistant hypertension. Changes in daytime BP after 3 months were analysed according to the prespecified iPWV cut-off (14.4 m/s). Regression analyses were used to establish models for non-invasive prediction of BP response. Results were compared to iPWV as reference and were then validated in an external patient cohort.
Results
Eighty patients underwent stiffness assessment before RDN. After 3 months, systolic 24h and daytime BP were reduced by 13.6±9.8 mmHg and 14.7±10.6 mmHg in patients with low iPWV, versus 6.2±13.3 mmHg and 6.3±12.8 mmHg in those with high iPWV (p<0.001 for both). Upon regression analysis, logarithmic ascending aortic distensibility and systolic baseline BP independently predicted BP change at follow-up. Both were confirmed in the validation cohort.
Conclusions
IPWV is an independent predictor for BP response after RDN. In addition, BP change prediction following RDN using non-invasive measures is feasible. This could facilitate patient selection for RDN treatment.



EuroIntervention: 06 Mar 2022; epub ahead of print
Fengler K, Rommel KP, Kriese W, Kresoja KP, ... Thiele H, Lurz P
EuroIntervention: 06 Mar 2022; epub ahead of print | PMID: 35244604
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Abstract

Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

Ortega-Paz L, Brugaletta S, Gomez-Lara J, Alfonso F, ... Gómez-Hospital JA, Sabaté M
Background
Long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain.
Aims
To report the 3-year clinical outcomes of the MAGSTEMI trial.
Methods
This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee.
Results
Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000).
Conclusions
At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.



EuroIntervention: 27 Feb 2022; epub ahead of print
Ortega-Paz L, Brugaletta S, Gomez-Lara J, Alfonso F, ... Gómez-Hospital JA, Sabaté M
EuroIntervention: 27 Feb 2022; epub ahead of print | PMID: 35225793
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Abstract

Leaflet-to-annulus index and residual tricuspid regurgitation following tricuspid transcatheter edge-to-edge repair.

Tanaka T, Sugiura A, Kavsur R, Vogelhuber J, ... Nickenig G, Weber M
Background
A mismatch between tricuspid leaflet size and annular dilation is one of the morphological features tied to the development of tricuspid regurgitation (TR).
Aims
We assessed the association of the leaflet-to-annulus index (LAI) with residual TR after transcatheter edge-to-edge repair (TEER).
Methods
Consecutive patients who underwent TEER for TR were enrolled. Significant residual TR was defined as a post-procedural TR ≥3+, and patients were divided into two groups according to the amount of residual TR. The LAI was retrospectively calculated using procedural transoesophageal echocardiography and was defined as follows: (anterior leaflet length+septal leaflet length)/septolateral tricuspid annulus diameter.
Results
Of 140 patients, 43 patients had residual TR ≥3+ after TEER. The patients with residual TR ≥3+ had a lower LAI compared to those with residual TR <3+ (1.04±0.10 vs 1.13±0.09; p=0.001). In multivariable analysis, the LAI was associated with residual TR ≥3+ (odds ratio [OR] [per 0.1 increase]: 0.57; 95% confidence interval [95% CI]: 0.35-0.94; p=0.02), independent of baseline TR severity or coaptation gap size. Patients with residual TR ≥3+ had a higher incidence of the composite outcome, consisting of all-cause mortality and heart failure hospitalisation within one year after TEER (47.1% vs 26.6%, p=0.02). Residual TR ≥3+ was an independent predictor of the composite outcome within one year (hazard ratio: 2.04; 95% CI: 1.01-4.11; p=0.04).
Conclusions
The leaflet-to-annulus mismatch (i.e., LAI) is associated with residual TR ≥3+ after TEER for TR. A detailed echocardiographic analysis of the tricuspid valve will be conducive to identifing suitable subjects for TEER.



EuroIntervention: 22 Feb 2022; epub ahead of print
Tanaka T, Sugiura A, Kavsur R, Vogelhuber J, ... Nickenig G, Weber M
EuroIntervention: 22 Feb 2022; epub ahead of print | PMID: 35193837
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This program is still in alpha version.