Journal: EuroIntervention

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<div><h4>Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study.</h4><i>van der Sangen NMR, Claessen BEPM, Küçük IT, den Hartog AW, ... Appelman Y, Henriques JPS</i><br /><b>Background</b><br />Early P2Y<sub>12</sub> inhibitor monotherapy has emerged as a promising alternative to 12 months of dual antiplatelet therapy following percutaneous coronary intervention (PCI).<br /><b>Aims</b><br />In this single-arm pilot study, we evaluated the feasibility and safety of ticagrelor or prasugrel monotherapy directly following PCI in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).<br /><b>Methods</b><br />Patients received a loading dose of ticagrelor or prasugrel before undergoing platelet function testing and subsequent PCI using new-generation drug-eluting stents. The stent result was adjudicated with optical coherence tomography in the first 35 patients. Ticagrelor or prasugrel monotherapy was continued for 12 months. The primary ischaemic endpoint was the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis or stroke within 6 months. The primary bleeding endpoint was Bleeding Academic Research Consortium type 2, 3 or 5 bleeding within 6 months.<br /><b>Results</b><br />From March 2021 to March 2022, 125 patients were enrolled, of whom 75 ultimately met all in- and exclusion criteria (mean age 64.5 years, 29.3% women). Overall, 70 out of 75 (93.3%) patients were treated with ticagrelor or prasugrel monotherapy directly following PCI. The primary ischaemic endpoint occurred in 3 (4.0%) patients within 6 months. No cases of stent thrombosis or spontaneous myocardial infarction occurred. The primary bleeding endpoint occurred in 7 (9.3%) patients within 6 months.<br /><b>Conclusions</b><br />This study provides first-in-human evidence that P2Y<sub>12</sub> inhibitor monotherapy directly following PCI for NSTE-ACS is feasible, without any overt safety concerns, and highlights the need for randomised controlled trials comparing direct P2Y<sub>12</sub> inhibitor monotherapy with the current standard of care.<br /><br /><br /><br /><small>EuroIntervention: 03 Feb 2023; epub ahead of print</small></div>
van der Sangen NMR, Claessen BEPM, Küçük IT, den Hartog AW, ... Appelman Y, Henriques JPS
EuroIntervention: 03 Feb 2023; epub ahead of print | PMID: 36734020
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<div><h4>Changes in absolute flow, myocardial resistance and FFR after chronic total occlusion percutaneous coronary intervention.</h4><i>Khan SA, Alsanjari O, Keulards DCJ, Vlaar PJ, ... Karamasis GV, Davies JR</i><br /><b>Background</b><br />Randomised studies of percutaneous coronary intervention (PCI) in patients with chronic total occlusion (CTO) have shown inconsistent outcomes, suggesting incomplete understanding of this cohort and their coronary physiology. To address this shortcoming, we designed a prospective observational study to measure the recovery of absolute coronary blood flow following successful CTO PCI Aims: We sought to identify patient and procedural characteristics associated with a favourable physiological outcome after CTO PCI.<br /><b>Methods</b><br />Consecutive patients with a CTO subtending viable myocardium underwent PCI utilising contemporary techniques and the hybrid algorithm. Immediately after PCI, and at 3-month follow-up, physiological measurements were performed utilising continuous thermodilution.<br /><b>Results</b><br />A total of 81 patients were included with a mean age 63.6±8.9 years, and 66 (81.5%) were male. Physiological measurements of absolute coronary blood flow in the CTO vessel increased by 30% (p<0.001) and microvascular resistance reduced by 16% (p<0.001) from immediately post-CTO PCI to follow-up assessment. Fractional flow reserve increased by 0.02 (p=0.015) in the same period. Prior coronary artery bypass graft (CABG) and a higher estimated glomerular filtration rate (eGFR) were associated with a larger change in absolute flow. An extraplaque strategy was associated with a smaller change in absolute flow.<br /><b>Conclusions</b><br />Post-CTO PCI, there is a continued augmentation in absolute coronary blood flow and reduction in microvascular resistance from baseline to follow-up at 3 months. Prior CABG and a higher baseline eGFR were predictors of a larger change in absolute coronary flow, whilst an extraplaque final wire path strategy predicted a smaller change. Lastly, the patient characteristics and comorbidities had a larger influence than procedural factors on the observed change in absolute flow.<br /><br /><br /><br /><small>EuroIntervention: 01 Feb 2023; epub ahead of print</small></div>
Khan SA, Alsanjari O, Keulards DCJ, Vlaar PJ, ... Karamasis GV, Davies JR
EuroIntervention: 01 Feb 2023; epub ahead of print | PMID: 36722201
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<div><h4>Prevalence and patterns of in-stent neoatherosclerosis in lower extremity artery disease.</h4><i>Müller A, Bradaric C, Kafka A, Joner M, ... Ibrahim T, Koppara T</i><br /><b>Background</b><br />In-stent restenosis (ISR) is responsible for a rapid decline of vessel patency after stenting. To date, little is known about the role of in-stent neoatherosclerosis (NA) in stent failure in lower limb arteries.<br /><b>Aims</b><br />This study aimed to determine the prevalence and patterns of in-stent NA in patients with symptomatic ISR of the lower extremity vasculature using intravascular optical coherence tomography (OCT) imaging.<br /><b>Methods</b><br />Patients underwent endovascular revascularisation for ISR including angiography and OCT imaging. NA was defined as the presence of at least 1 fibroatheroma or fibrocalcific plaque within the neointima of a stented segment.<br /><b>Results</b><br />Using OCT, we imaged 24 symptomatic patients with lower extremity artery disease (LEAD), with a total of 30 ISR in the lower limbs, prior to their scheduled endovascular interventions. NA formation was observed in 23 (76.7%) lesions, while all stents with an implant duration >5 years (n=8) showed signs of NA. The time from stent implantation to OCT was significantly increased in lesions with NA (p=0.002). Lesions without NA had a significantly shorter duration from index procedure to OCT than those with ≥50 percent (n=9; p=0.003) or <50 percent (n=14; p=0.015) of frames exhibiting signs of NA. NA was predominantly characterised by fibroatheroma with thick fibrous caps with or without calcification.<br /><b>Conclusions</b><br />In-stent NA is frequently identified by OCT imaging after endovascular therapy in lower limb arteries; this increased both in frequency and extent the longer the duration since implantation. Our findings indicate an active atherosclerotic process that may need tailored mitigation strategies.<br /><br /><br /><br /><small>EuroIntervention: 30 Jan 2023; epub ahead of print</small></div>
Müller A, Bradaric C, Kafka A, Joner M, ... Ibrahim T, Koppara T
EuroIntervention: 30 Jan 2023; epub ahead of print | PMID: 36714952
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<div><h4>Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.</h4><i>Kharbanda RK, Perkins AD, Kennedy J, Banning AP, ... Stables R, Clayton T</i><br /><AbstractText>Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.</AbstractText><br /><br /><br /><br /><small>EuroIntervention: 26 Jan 2023; epub ahead of print</small></div>
Kharbanda RK, Perkins AD, Kennedy J, Banning AP, ... Stables R, Clayton T
EuroIntervention: 26 Jan 2023; epub ahead of print | PMID: 36706009
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<div><h4>Mitral valve transcatheter edge-to-edge repair.</h4><i>Hausleiter J, Stocker TJ, Adamo M, Karam N, Swaans MJ, Praz F</i><br /><AbstractText>Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, results in reduced quality of life, heart failure, and increased mortality. Mitral valve transcatheter edge-to-edge repair (M-TEER) has matured considerably as a non-surgical treatment option since its commercial introduction in Europe in 2008. As a result of major device and interventional improvements, as well as the accumulation of experience by the interventional cardiologists, M-TEER has emerged as an important therapeutic strategy for patients with severe and symptomatic MR in the current European and American guidelines. Herein, we provide a comprehensive up-do-date overview of M-TEER. We define preprocedural patient evaluation and highlight key aspects for decision-making. We describe the currently available M-TEER systems and summarise the evidence for M-TEER in both primary mitral regurgitation (PMR) and secondary mitral regurgitation (SMR). In addition, we provide recommendations for device selection, intraprocedural imaging and guiding, M-TEER optimisation and management of recurrent MR. Finally, we provide information on major unsolved questions and \"grey areas\" in M-TEER.</AbstractText><br /><br /><br /><br /><small>EuroIntervention: 23 Jan 2023; 18:957-976</small></div>
Hausleiter J, Stocker TJ, Adamo M, Karam N, Swaans MJ, Praz F
EuroIntervention: 23 Jan 2023; 18:957-976 | PMID: 36688459
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<div><h4>Ticagrelor or prasugrel versus clopidogrel in patients undergoing percutaneous coronary intervention for chronic coronary syndromes.</h4><i>Koshy AN, Giustino G, Sartori S, Hooda A, ... Mehran R, Sharma SK</i><br /><b>Background</b><br />Potent P2Y<sub>12</sub> inhibitors such as ticagrelor and prasugrel are superior to clopidogrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI). Whether this benefit extends to a patient population with chronic coronary syndromes (CCS) is unclear.<br /><b>Aims</b><br />We sought to compare the safety and efficacy of prasugrel and ticagrelor versus clopidogrel in patients undergoing PCI for CCS.<br /><b>Methods</b><br />Consecutive patients undergoing PCI for CCS at a tertiary centre between 2014 and 2019 who were discharged on prasugrel or ticagrelor were compared with those on clopidogrel. The primary endpoint was the composite of death and myocardial infarction (MI), with secondary outcomes including rates of bleeding, stroke, and target vessel revascularisation at 1 year.<br /><b>Results</b><br />Overall, 11,508 patients were included in the study (ticagrelor/prasugrel n=2,860 [24.9%], clopidogrel n=8,648 [75.1%]) with an increasing frequency of potent P2Y<sub>12</sub> inhibitor use over the study period (p<sub>trend</sub><0.001). Clopidogrel was used more frequently in patients with multimorbid risk factors, whereas anatomical or procedural complexity was associated with ticagrelor/prasugrel use (left main PCI, bifurcation PCI, number of lesions, rotational atherectomy). No difference in the incidence of death or MI was noted across the groups (ticagrelor/prasugrel vs clopidogrel: 2.7% vs 3.1%, adjusted hazard ratio [adjHR] 0.86, 95% confidence interval [CI]: 0.62-1.17; p=0.33) or secondary outcomes including bleeding (adjHR 0.75, 95% CI: 0.46-1.21; p=0.23) on propensity score stratification analysis. Additionally, no difference in the primary outcome was observed across subgroups, including those undergoing complex PCI.<br /><b>Conclusions</b><br />Ticagrelor and prasugrel are increasingly used in patients with CCS undergoing PCI with similar 1-year efficacy and safety when compared to clopidogrel. Whether use of these agents can be beneficial in patients undergoing PCI for CCS with a high thrombotic and low bleeding risk warrants further study.<br /><br /><br /><br /><small>EuroIntervention: 19 Jan 2023; epub ahead of print</small></div>
Koshy AN, Giustino G, Sartori S, Hooda A, ... Mehran R, Sharma SK
EuroIntervention: 19 Jan 2023; epub ahead of print | PMID: 36660810
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<div><h4>Quantitative flow ratio versus fractional flow reserve for guiding percutaneous coronary intervention: design and rationale of the randomised FAVOR III Europe Japan trial.</h4><i>Andersen BK, Sejr-Hansen M, Westra J, Campo G, ... Christiansen EH, Holm NR</i><br /><AbstractText>Quantitative flow ratio (QFR) is a computation of fractional flow reserve (FFR) based on invasive coronary angiographic images. Calculating QFR is less invasive than measuring FFR and may be associated with lower costs. Current evidence supports the call for an adequately powered randomised comparison of QFR and FFR for the evaluation of intermediate coronary stenosis. The aim of the FAVOR III Europe Japan trial is to investigate if a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with a standard FFR-guided strategy in the evaluation of patients with intermediary coronary stenosis. FAVOR III Europe Japan is an investigator-initiated, randomised, clinical outcome, non-inferiority trial scheduled to randomise 2,000 patients with either 1) stable angina pectoris and intermediate coronary stenosis, or 2) indications for functional assessment of at least 1 non-culprit lesion after acute myocardial infarction. Up to 40 international centres will randomise patients to either a QFR-based or a standard FFR-based diagnostic strategy. The primary endpoint of major adverse cardiovascular events is a composite of all-cause mortality, any myocardial infarction, and any unplanned coronary revascularisation at 12 months. QFR could emerge as an adenosine- and wire-free alternative to FFR, making the functional evaluation of intermediary coronary stenosis less invasive and more cost-effective.</AbstractText><br /><br /><br /><br /><small>EuroIntervention: 17 Jan 2023; epub ahead of print</small></div>
Andersen BK, Sejr-Hansen M, Westra J, Campo G, ... Christiansen EH, Holm NR
EuroIntervention: 17 Jan 2023; epub ahead of print | PMID: 36648404
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<div><h4>Preclinical evaluation of the degradation kinetics of third-generation resorbable magnesium scaffolds.</h4><i>Seguchi M, Baumann-Zumstein P, Fubel A, Waksman R, ... Galli S, Joner M</i><br /><b>Background</b><br />The novel sirolimus-eluting resorbable scaffold DREAMS 3G was designed as a third-generation development of its predecessor, the Magmaris scaffold.<br /><b>Aims</b><br />This preclinical study aimed to examine the qualitative and temporal course of the degradation of the DREAMS 3G relative to the Magmaris scaffold.<br /><b>Methods</b><br />Forty-nine DREAMS 3G and 24 Magmaris scaffolds were implanted into 48 mini swine for degradation kinetics analysis. Another DREAMS 3G was implanted into one mini swine for crystallinity analysis of the degradation end product after 730 days. Degradation kinetics were determined at 28, 90, 120, 180, and 365 days.<br /><b>Results</b><br />Discontinuity density in DREAMS 3G was significantly lower than that in Magmaris scaffolds for the follow-up timepoints of 90 and 120 days. Planimetric analysis indicated 99.6% backbone degradation for DREAMS 3G at 12 months. Compared to the Magmaris scaffold, individual strut degradation in DREAMS 3G showed less variability and the remaining backbone core was more homogeneous. The degradation end product of DREAMS 3G manifested as calcium phosphate with a minor share of aluminium phosphate.<br /><b>Conclusions</b><br />DREAMS 3G showed almost complete degradation after one year, with amorphous calcium and aluminium phosphate as the end products of degradation. Despite its thinner struts, scaffold discontinuity was significantly lower in the DREAMS 3G than in the Magmaris scaffold, likely providing a longer scaffolding time. DELETE: delete.<br /><br /><br /><br /><small>EuroIntervention: 13 Jan 2023; epub ahead of print</small></div>
Seguchi M, Baumann-Zumstein P, Fubel A, Waksman R, ... Galli S, Joner M
EuroIntervention: 13 Jan 2023; epub ahead of print | PMID: 36636768
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<div><h4>Impact of periprocedural major adverse events on 10-year mortality after revascularisation.</h4><i>Kotoku N, Serruys PW, Ninomiya K, Soo A, ... Garg S, Onuma Y</i><br /><b>Background</b><br />The long-term prognostic impact of a composite of periprocedural major adverse events (PMAE) following revascularisation for patients with complex coronary artery disease (CAD) has not yet been established.<br /><b>Aims</b><br />This study aimed to assess the impact on 10-year mortality of non-fatal PMAE following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Other objectives were to evaluate 1) whether PMAE affect mortality predicted by the SYNTAX score II 2020 (SSII-2020) and 2) whether optimal medical therapy (OMT) positively affects the prognosis of patients with non-fatal PMAE.<br /><b>Methods</b><br />The association between 10-year mortality and non-fatal PMAE occurring within 30 days of PCI or CABG in patients with three-vessel disease and/or left main disease enrolled in the SYNTAXES study was investigated.<br /><b>Results</b><br />The main findings are that non-fatal PMAE occurred less frequently following PCI than CABG (11.2% vs 28.2%; p<0.001) and that non-fatal PMAE were an independent predictor of all-cause mortality in the first year post-procedure, but not at 5 or 10 years, in both treatment modalities. PMAE substantially alter the individual predictions of 10-year mortality by the SSII-2020. In patients with non-fatal PMAE, OMT may provide survival benefits during the first year post-procedure as well as in the long term.<br /><b>Conclusions</b><br />In patients with complex CAD, non-fatal PMAE were more common following CABG than PCI, but their prognostic impact was similar, being significant in the first year and then diminishing out to 10 years. Patients with non-fatal PMAE may therefore require more careful follow-up and additional preventive treatment in the first year post-procedure.<br /><br /><br /><br /><small>EuroIntervention: 12 Jan 2023; epub ahead of print</small></div>
Kotoku N, Serruys PW, Ninomiya K, Soo A, ... Garg S, Onuma Y
EuroIntervention: 12 Jan 2023; epub ahead of print | PMID: 36632743
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<div><h4>A bench study of balloon-expandable valves for the treatment of self-expanding valve failure.</h4><i>Akodad M, Meier D, Sellers S, De Backer O, ... Webb JG, Sathananthan J</i><br /><b>Background</b><br />Coronary obstruction and access are concerns in patients undergoing redo transcatheter aortic valve implantation (TAVI).<br /><b>Aims</b><br />We sought to assess the neo-skirt height, leaflet overhang, leaflet deflection,and transcatheter heart valve (THV) expansion and performance, at 2 different implant depths, of the SAPIEN 3 Ultra (S3U) within the ACURATE neo2 (ACn2) THV.<br /><b>Methods</b><br />An in vitro study was performed with a 23 mm S3U deployed within a small (S) ACn2 and a 26 mm S3U deployed within a medium (M) and a large (L) ACn2. The S3U outflow was positioned at the top of the ACn2 crown (low implant) and at the base of the commissural post of the ACn2 (high implant). Testing was performed under physiological conditions as per ISO-5840-3 standard.<br /><b>Results</b><br />The neo-skirt height was shorter when the S3U outflow was positioned at a low implantation depth (S: 9.6 mm, M: 12.2 mm, L: 13.8 mm vs S: 15.2 mm, M: 15.1 mm, L: 17.8 mm ACn2 for high implants). Hydrodynamic performance was acceptable for all configurations. Leaflet overhang was <50% for all configurations except the low implant of the 26 mm S3U in the L ACn2 (77.6%). There was a gap from the side of the neo-skirt to the outer border of the THV frame which was >2 mm for all configurations. The S3U was underexpanded for all configurations, and the achieved area was 77.9%-92.9% of the expected nominal area.<br /><b>Conclusions</b><br />Redo TAVI with an S3U within an ACn2 has favourable hydrodynamics and moderate leaflet overhang. Importantly, the design of the ACn2 results in a neo-skirt that is not deflected all the way to the outer dimensions of the THV, hence creating a space that facilitates coronary flow and access.<br /><br /><br /><br /><small>EuroIntervention: 09 Jan 2023; epub ahead of print</small></div>
Akodad M, Meier D, Sellers S, De Backer O, ... Webb JG, Sathananthan J
EuroIntervention: 09 Jan 2023; epub ahead of print | PMID: 36621917
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<div><h4>Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.</h4><i>Durand E, Sabatier R, Smits PC, Verheye S, Pereira B, Fajadet J</i><br /><b>Background</b><br />R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI.<br /><b>Aims</b><br />We aimed to evaluate the safety and efficacy of the R-One system for PCI.<br /><b>Methods</b><br />The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured.<br /><b>Results</b><br />Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table.<br /><b>Conclusions</b><br />This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).<br /><br /><br /><br /><small>EuroIntervention: 05 Jan 2023; epub ahead of print</small></div>
Durand E, Sabatier R, Smits PC, Verheye S, Pereira B, Fajadet J
EuroIntervention: 05 Jan 2023; epub ahead of print | PMID: 36602883
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<div><h4>Impact of evolocumab on the pharmacodynamic profiles of clopidogrel in patients with atherosclerotic cardiovascular disease: a randomised, double-blind, placebo-controlled study.</h4><i>Franchi F, Ortega-Paz L, Rollini F, Been L, ... Zenni M, Angiolillo DJ</i><br /><b>Background</b><br />The impact of intense low-density lipoprotein cholesterol (LDL-C) reduction using a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor on profiles of platelet reactivity has yet to be explored.<br /><b>Aims</b><br />Our aim was to investigate the effects of the PCSK9 inhibitor, evolocumab, on platelet reactivity in patients with atherosclerotic cardiovascular disease (ASCVD) on clopidogrel treatment.<br /><b>Methods</b><br />This was a prospective, randomised, double-blind, placebo-controlled pharmacodynamic study in patients with ASCVD on clopidogrel treatment and with LDL-C levels ≥70 mg/dL despite a maximally tolerated statin dose. Patients were stratified according to levels of platelet reactivity using VerifyNow P2Y<sub>12</sub> reactivity units (PRU) into high platelet reactivity (HPR; PRU >208) or normal platelet reactivity (NPR; PRU >85 and ≤208). Each cohort was randomised to receive evolocumab 420 mg or placebo. The primary endpoint was the difference in PRU at 30 days.<br /><b>Results</b><br />A total of 84 patients (HPR, n=37 [19 evolocumab vs 18 placebo]; NPR, n=47 [22 evolocumab vs 25 placebo]) were included. Evolocumab significantly reduced LDL-C compared to placebo at 14 (p<0.001) and 30 (p=0.001) days. At 14 days, PRU levels were significantly lower with evolocumab compared to placebo in the HPR (218.2±29.7 vs 246.6±35.2; p=0.017), but not in the NPR cohort (141.2±42.8 vs 148.2±41.7; p=0.578). At 30 days, there were no significant differences in PRU in the HPR (219.3±38.3 vs 240.9±51.8; p=0.161) or NPR (141.5±54.3 vs 158.6±40.8; p=0.229) cohorts.<br /><b>Conclusions</b><br />Compared to placebo, evolocumab in adjunct to statin therapy did not significantly reduce platelet reactivity at 30 days in ASCVD patients on clopidogrel treatment despite intense LDL-C reduction. ClinicalTrials.gov: NCT03096288.<br /><br /><br /><br /><small>EuroIntervention: 03 Jan 2023; epub ahead of print</small></div>
Franchi F, Ortega-Paz L, Rollini F, Been L, ... Zenni M, Angiolillo DJ
EuroIntervention: 03 Jan 2023; epub ahead of print | PMID: 36602868
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<div><h4>Validation of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in patients undergoing peripheral endovascular interventions.</h4><i>Tomoi Y, Kuramitsu S, Shinozaki T, Soga Y, ... Hiramori S, Ando K</i><br /><b>Background</b><br />It remains unclear whether the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria could apply to peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT).<br /><b>Aims</b><br />We sought to evaluate the application of the ARC-HBR criteria to PAD patients undergoing EVT with contemporary drug-coated devices (DCD) for femoropopliteal artery lesions.<br /><b>Methods</b><br />Between May 2012 and December 2019, 542 consecutive patients undergoing EVT with DCD for femoropopliteal artery lesions were retrospectively analysed. The primary study endpoint was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5.<br /><b>Results</b><br />Of 542 patients, 435 (80.3%) were stratified into the HBR group. The cumulative 5-year incidence of major bleeding events was significantly higher in the HBR group than in the no-HBR group (31.9% vs 2.3%; p<0.001). The 5-year major bleeding event rate gradually increased with the number of ARC-HBR criteria (≥2 major criteria: 48.6%, 1 major: 33.1%, ≥2 minor: 12.9%, and non-HBR: 2.3%; p<0.001). Major bleeding events were associated with a 5.4-fold increased risk of mortality (adjusted hazard ratio: 5.42, 95% confidence interval: 2.91-10.1; p<0.001). Severe chronic kidney disease, heart failure, and severe anaemia were predictors of major bleeding events.<br /><b>Conclusions</b><br />80.3% of PAD patients undergoing EVT for femoropopliteal artery lesions with contemporary drug-coated devices met the ARC-HBR criteria. Given that major bleeding events remarkably increased the risk of mortality after EVT, the ARC-HBR criteria might be helpful for the risk stratification of PAD patients who undergo EVT with contemporary DCD.<br /><br /><br /><br /><small>EuroIntervention: 29 Dec 2022; epub ahead of print</small></div>
Tomoi Y, Kuramitsu S, Shinozaki T, Soga Y, ... Hiramori S, Ando K
EuroIntervention: 29 Dec 2022; epub ahead of print | PMID: 36579610
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<div><h4>Timing of bioprosthetic valve fracture in transcatheter valve-in-valve intervention: impact on valve durability and leaflet integrity.</h4><i>Meier D, Payne GW, Mostaço-Guidolin LB, Bouchareb R, ... Sathananthan J, Sellers SL</i><br /><b>Background</b><br />Bioprosthetic valve fracture (BVF) can be used to improve transcatheter heart valve (THV) haemodynamics following a valve-in-valve (ViV) intervention. However, whether BVF should be performed before or after THV deployment and the implications on durability are unknown.  Aims: We sought to assess the impact of BVF timing on long-term THV durability.<br /><b>Methods</b><br />The impact of BVF timing was assessed using small ACURATE neo (ACn) or 23 mm SAPIEN 3 (S3) THV deployed in 21 mm Mitroflow valves compared to no-BVF controls. Valves underwent accelerated wear testing up to 200 million (M) cycles (equivalent to 5 years). At 200M cycles, THV were evaluated by hydrodynamic testing, second-harmonic generation (SHG) microscopy, scanning electron microscopy (SEM) and histology.<br /><b>Results</b><br />At 200M cycles, the regurgitant fraction (RF) and effective orifice area (EOA) for the ACn were 8.03±0.30%/1.74±0.01 cm<sup>2</sup> (no BVF), 12.48±0.70%/1.97±0.02 cm<sup>2</sup> (BVF before ViV) and 9.29±0.38%/2.21±0.0 cm<sup>2</sup> (BVF after ViV), respectively. For the S3 these values were 2.63±0.51%/1.26±0.01 cm<sup>2</sup>, 2.03±0.42%/1.65±0.01 cm<sup>2</sup>, and 1.62±0.38%/2.22±0.01 cm<sup>2</sup>, respectively. Further, SHG and SEM revealed a higher degree of superficial leaflet damage when BVF was performed after ViV for the ACn and S3. However, the histological analysis revealed significantly less damage, as determined by matrix density analysis, through the entire leaflet thickness when BVF was performed after ViV with the S3 and a similar but non-significant trend with the ACn.  Conclusions: BVF performed after ViV appears to offer superior long-term EOA without increased RF. Ultrastructure leaflet analysis reveals that the timing of BVF can differentially impact leaflets, with more superficial damage but greater preservation of overall leaflet structure when BVF is performed after ViV.<br /><br /><br /><br /><small>EuroIntervention: 19 Dec 2022; epub ahead of print</small></div>
Meier D, Payne GW, Mostaço-Guidolin LB, Bouchareb R, ... Sathananthan J, Sellers SL
EuroIntervention: 19 Dec 2022; epub ahead of print | PMID: 36534495
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<div><h4>Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries.</h4><i>Mejía-Rentería H, Wang L, Chipayo-Gonzales D, van de Hoef TP, ... Gonzalo N, Escaned J</i><br /><b>Background</b><br />Myocardial ischaemia with non-obstructive coronary arteries (INOCA) represents a challenging and frequent, but largely underdiagnosed, condition.<br /><b>Aims</b><br />We aimed to investigate the feasibility and diagnostic value of angiography-derived coronary microcirculatory resistance in patients with INOCA syndrome.<br /><b>Methods</b><br />This is an investigator-driven, prospective and blinded study. The diagnostic yield of angiography-derived index of coronary microcirculatory resistance (angio-IMR) was investigated against thermodilution-derived IMR (thermo-IMR) in patients with clinically indicated coronary angiography due to suspected myocardial ischaemia and angiographically normal or non-obstructive coronary arteries. The angio-IMR was derived from resting angiograms (contrast-flow angio-IMR [cAngio-IMR]) by an expert analyst blinded to the thermo-IMR. An independent, blinded, physiology core laboratory analysed the raw intracoronary physiology data and provided the final thermo-IMR values.<br /><b>Results</b><br />A total of 104 patients (108 coronary vessels) were analysed after fulfilling predefined inclusion criteria. Most patients were female (67%). Obstructive epicardial disease was angiographically (percent diameter stenosis <50%) and physiologically (fractional flow reserve>0.80) ruled out in all cases. Median thermo-IMR and cAngio-IMR were 16.6 (12.7, 23.0) and 16.8 (12.8, 23.1) units, respectively (median difference <span lang=\"EN-GB\" style=\"font-size:12.0pt\"><span style=\"font-family:\"Times New Roman\",serif\">-</span></span>0.31, 95% confidence interval: <span lang=\"EN-GB\" style=\"font-size:12.0pt\"><span style=\"font-family:\"Times New Roman\",serif\">-</span></span>1.53 to 1.00; p=0.654). cAngio-IMR showed good correlation (Pearson coefficient 0.76; p<0.001), agreement (mean bias 0.4), discriminatory power (area under the curve from the receiver operator characteristics 0.865; p<0.001) and accuracy (85%), compared to thermo-IMR (≥25 U).<br /><b>Conclusions</b><br />Evaluating coronary microcirculatory resistance in patients with INOCA syndrome using cAngio-IMR is feasible and accurate. By circumventing the need of coronary instrumentation and hyperaemic drugs, this method may facilitate the assessment of coronary microcirculatory resistance in patients with suspected INOCA.<br /><b>Clinicaltrials</b><br />gov: NCT04827498.<br /><br /><br /><br /><small>EuroIntervention: 16 Dec 2022; epub ahead of print</small></div>
Mejía-Rentería H, Wang L, Chipayo-Gonzales D, van de Hoef TP, ... Gonzalo N, Escaned J
EuroIntervention: 16 Dec 2022; epub ahead of print | PMID: 36534493
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Abstract
<div><h4>A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.</h4><i>Wintzer-Wehekind J, Lefèvre T, Benamer H, Monsegu J, ... Dumonteil N, Abdellaoui M</i><br /><b>Background</b><br />Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker.<br /><b>Aims</b><br />This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI.<br /><b>Methods</b><br />This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes.<br /><b>Results</b><br />Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported.<br /><b>Conclusions</b><br />This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.<br /><br /><br /><br /><small>EuroIntervention: 08 Dec 2022; epub ahead of print</small></div>
Wintzer-Wehekind J, Lefèvre T, Benamer H, Monsegu J, ... Dumonteil N, Abdellaoui M
EuroIntervention: 08 Dec 2022; epub ahead of print | PMID: 36484703
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Abstract
<div><h4>Ten-year clinical outcomes of drug-eluting stents with different polymer coating strategies by degree of coronary calcification: a pooled analysis of the ISAR-TEST 4 and 5 randomised trials.</h4><i>Rheude T, Koch T, Joner M, Lenz T, ... Kastrati A, Kufner S</i><br /><b>Background</b><br />Long-term data concerning the efficacy of different polymer-coating strategies of new-generation drug-eluting stents (DES) in patients with coronary artery calcification (CAC) are scant.<br /><b>Aims</b><br />We aimed to investigate 10-year outcomes by degree of CAC after new-generation DES implantation with different polymer-coating strategies.<br /><b>Methods</b><br />We analysed individual patient and lesion characteristics of patients randomised to treatment with polymer-free sirolimus-eluting, biodegradable-polymer sirolimus-eluting and permanent-polymer zotarolimus- or everolimus-eluting stents. Endpoints of interest at 10 years were all-cause mortality, myocardial infarction (MI), target lesion revascularisation (TLR) and definite or probable stent thrombosis (ST) according to the degree of CAC (no, mild, moderate or severe) and coating strategy (polymer-free vs biodegradable-polymer vs permanent-polymer).<br /><b>Results</b><br />A total of 4,953 patients with 6,924 lesions were included. No, mild, moderate or severe CAC was present in 24.5%, 41.8%, 25.8% and 8.0% of patients, respectively. At 10-year follow-up, overall event rates were high, with an incremental increase according to the degree of CAC (all-cause mortality: no 25.3%, mild 32.1%, moderate 41.7%, severe CAC 46.5%; adjusted [adj.] p=0.004; TLR: no 17.4%, mild 16.5%, moderate 19.8%, severe CAC 28.7%; adj. p=0.001; MI: no 4.9%, mild 5.9%, moderate 6.0%, severe CAC 10.5%; adj. p=0.02; and ST: no 1.3%, mild 1.4%, moderate 1.8%, severe CAC 3.6%; adj. p=0.57). In patients with moderate-severe CAC, event rates were comparable, regardless of the DES polymer-coating strategy.<br /><b>Conclusions</b><br />At 10 years after PCI with new-generation DES, there was an incremental increase in adverse events by degree of coronary calcification. These detrimental effects do not seem to be impacted by different polymer-coating strategies.<br /><br /><br /><br /><small>EuroIntervention: 01 Dec 2022; epub ahead of print</small></div>
Rheude T, Koch T, Joner M, Lenz T, ... Kastrati A, Kufner S
EuroIntervention: 01 Dec 2022; epub ahead of print | PMID: 36453826
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Abstract
<div><h4>Early vascular responses to abluminal biodegradable polymer-coated versus circumferential durable polymer-coated newer-generation drug-eluting stents in humans: a pathological study.</h4><i>Kawagoe Y, Otsuka F, Onozuka D, Ishibashi-Ueda H, ... Hatakeyama K, Yasuda S</i><br /><b>Background</b><br />Recent clinical studies are testing strategies for short (1-3 months) dual antiplatelet therapy following newer-generation drug-eluting stent (DES) placement. However, detailed biological responses to newer-generation DES remain unknown in humans.<br /><b>Aims</b><br />We sought to evaluate early pathologic responses to abluminal biodegradable polymer-coated (BP-) DES compared with circumferential durable polymer-coated (DP-) DES in human autopsy cases.<br /><b>Methods</b><br />The study included 38 coronary lesions with newer-generation DES implanted for <90 days (DP-DES=24, BP-DES=14) in 26 autopsy cases. The degree of strut coverage was defined as follows: grade 0 (bare), grade 1 (with fibrin or tissues/cells without endothelium), grade 2 (with single-layered endothelium), and grade 3 (with endothelium and underlying smooth muscle cell layers).<br /><b>Results</b><br /> The duration following implantation was similar in DP- and BP-DES (median=20 vs 17 days). A total of 2,022 struts (DP-DES=1,297, BP-DES=725) were pathologically analysed. Focal grade 2 coverage was observed as early as 5 days after the implantation in both stents. The multilevel mixed-effects ordered logistic regression model demonstrated that BP-DES exhibited greater strut coverage compared with DP-DES (odds ratio [OR]: 3.64, 95% confidence interval [CI]: 1.37-9.67; p=0.009), which remained significant after adjustment for the duration following implantation and underlying tissue characteristics (OR: 2.74, 95% CI: 1.10-6.80; p=0.030). The predictive probability of grade 2 and 3 coverage was comparably limited at 30 days (DP-DES=17.1%, BP-DES=28.7%) and increased at 90 days (DP-DES=76.5%, BP-DES=86.6%). Both stents showed low inflammation and a similar degree of fibrin deposition.<br /><b>Conclusions</b><br />Single-layered endothelial coverage begins in the days after newer-generation DES placement, and BP-DES potentially exhibit faster strut coverage with smooth muscle cell infiltration than DP-DES in humans. Nevertheless, vessel healing remains suboptimal in both stents at 30 days.<br /><br /><br /><br /><small>EuroIntervention: 30 Nov 2022; epub ahead of print</small></div>
Kawagoe Y, Otsuka F, Onozuka D, Ishibashi-Ueda H, ... Hatakeyama K, Yasuda S
EuroIntervention: 30 Nov 2022; epub ahead of print | PMID: 36448921
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Abstract
<div><h4>Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.</h4><i>Mangner N, Brinkert M, Keller LS, Moriyama N, ... Toggweiler S, Linke A</i><br /><b>Background</b><br />One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC).<br /><b>Aims</b><br />We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective.  <br /><b>Methods:</b><br/>Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days.<br /><b>Results</b><br />In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results.<br /><b>Conclusions</b><br />Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.<br /><br /><br /><br /><small>EuroIntervention: 28 Nov 2022; epub ahead of print</small></div>
Mangner N, Brinkert M, Keller LS, Moriyama N, ... Toggweiler S, Linke A
EuroIntervention: 28 Nov 2022; epub ahead of print | PMID: 36440479
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Abstract
<div><h4>Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.</h4><i>Kim WK, Tamburino C, Möllmann H, Montorfano M, ... Allocco DJ, Sondergaard L</i><br /><b>Background</b><br />The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device.<br /><b>Aims</b><br />To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS).<br /><b>Methods</b><br />ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography.<br /><b>Results</b><br />The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%.<br /><b>Conclusions</b><br />The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.<br /><br /><br /><br /><small>EuroIntervention: 27 Nov 2022; epub ahead of print</small></div>
Kim WK, Tamburino C, Möllmann H, Montorfano M, ... Allocco DJ, Sondergaard L
EuroIntervention: 27 Nov 2022; epub ahead of print | PMID: 36440588
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<div><h4>Radiation protection for healthcare professionals working in catheterisation laboratories during pregnancy: an EAPCI position statement in collaboration with EHRA, EACVI, the ESC Regulatory Affairs Committee and Women as One.</h4><i>Manzo-Silberman S, Velázquez M, Burgess S, Sahni S, ... Dudek D, Chieffo A</i><br /><AbstractText>: The European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Heart Rhythm Association (EHRA), the European Association of Cardiovascular Imaging (EACVI), the European Society of Cardiology (ESC) Regulatory Affairs Committee and Women as One support continuous review and improvement, not only in the practice of assuring patients a high quality of care but also in providing health professionals with support documents to help them in their career and enhance gender equity. Recent surveys have revealed that radiation exposure is commonly reported as the primary barrier for women pursuing a career in interventional cardiology or cardiac electrophysiology (EP). The fear of foetal exposure to radiation during pregnancy may lead to a prolonged interruption in their career. Accordingly, this joint statement aims to provide a clear statement on radiation risk and the existing data on the experience of radiation-exposed cardiologists who continue to work in catheterisation laboratories (cath labs) throughout their pregnancies. In order to reduce the barrier preventing women from accessing these careers, increased knowledge in the community is warranted. Finally, by going beyond simple observations and review of the literature, our document suggests proposals for improving workplace safety and for encouraging equity.</AbstractText><br /><br /><br /><br /><small>EuroIntervention: 22 Nov 2022; epub ahead of print</small></div>
Manzo-Silberman S, Velázquez M, Burgess S, Sahni S, ... Dudek D, Chieffo A
EuroIntervention: 22 Nov 2022; epub ahead of print | PMID: 36411964
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<div><h4>Long-term outcomes of peripheral atherectomy for femoropopliteal endovascular interventions.</h4><i>Krawisz AK, Raja A, Jones WS, Schneider P, ... Schermerhorn M, Secemsky EA</i><br /><b>Background</b><br />The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking.<br /><b>Aims</b><br />This study sought to determine the long-term safety of atherectomy in contemporary practice.<br /><b>Methods</b><br />Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes.<br /><b>Results</b><br />Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01).<br /><b>Conclusions</b><br />The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.<br /><br /><br /><br /><small>EuroIntervention: 14 Nov 2022; epub ahead of print</small></div>
Krawisz AK, Raja A, Jones WS, Schneider P, ... Schermerhorn M, Secemsky EA
EuroIntervention: 14 Nov 2022; epub ahead of print | PMID: 36373386
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<div><h4>Safety and efficiency of percutaneous coronary intervention using a standardised optical coherence tomography workflow.</h4><i>Osborn EA, Johnson M, Maksoud A, Spoon D, ... West NEJ, Rauch J</i><br /><b>Background</b><br />While intravascular imaging guidance during percutaneous coronary intervention (PCI) improves outcomes, routine intravascular imaging usage remains low, in part due to perceived inefficiency and safety concerns.<br /><b>Aims</b><br />The LightLab (LL) Initiative was designed to evaluate whether implementing a standardised optical coherence tomography (OCT) workflow impacts PCI safety metrics and procedural efficiency.<br /><b>Methods</b><br />In this multicentre, prospective, observational study, PCI procedural data were collected over 2 years from 45 physicians at 17 US centres. OCT-guided PCI incorporating the LL workflow (N=264), a structured algorithm using routine pre- and post-PCI OCT imaging, was compared with baseline angiography-only PCI (angio) (N=428). Propensity score analysis identified 207 matched procedures. Outcomes included procedure time, radiation exposure, contrast volume, device utilisation, and treatment strategy.<br /><b>Results</b><br />Compared with angiography alone, LL workflow OCT-guided PCI increased the median procedural time by 9 minutes but reduced vessel preparation time (2 min LL workflow vs 3 min angio; p<0.001) and resulted in less unplanned additional treatment (4% LL workflow vs 10% angio; p=0.01). With LL workflow OCT guidance, fewer cineangiography views were needed compared to angiography guidance, leading to decreased radiation exposure (1,133 mGy LL workflow vs 1,269 mGy angio; p=0.02), with no difference in contrast utilisation between groups (p=0.28). Furthermore, LL workflow OCT guidance resulted in fewer predilatation balloons and stents being used, more direct stent placement, and greater stent post-dilatation than angiography-guided PCI.<br /><b>Conclusions</b><br />The incorporation of a standardised pre- and post-PCI OCT imaging workflow improves procedural efficiency and safety metrics, at a cost of a modestly longer procedure time.<br /><br /><br /><br /><small>EuroIntervention: 08 Nov 2022; epub ahead of print</small></div>
Osborn EA, Johnson M, Maksoud A, Spoon D, ... West NEJ, Rauch J
EuroIntervention: 08 Nov 2022; epub ahead of print | PMID: 36373421
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This program is still in alpha version.