Journal: Circ Cardiovasc Interv

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Abstract

Prognostic Value of Measuring Fractional Flow Reserve after Percutaneous Coronary Intervention in patients with Complex Coronary Artery Disease: Insights from the FAME 3 Trial.

Piroth Z, Otsuki H, Zimmermann FM, Ferenci T, ... Fearon WF, FAME 3 Investigators
Background: We evaluate the prognostic value of measuring fractional flow reserve (FFR) after percutaneous coronary intervention (post-PCI FFR) and intravascular imaging in patients undergoing PCI for three-vessel coronary artery disease (CAD) in the FAME 3 trial.
Methods:
The FAME 3 trial is a multicenter, international, randomized study comparing FFR-guided PCI with coronary artery bypass grafting (CABG) in patients with multivessel CAD. PCI was not non-inferior with respect to the primary endpoint of death, myocardial infarction (MI), stroke or repeat revascularization at 1 year. Post-PCI FFR data were acquired on a patient and vessel-related basis. Intravascular imaging guidance was tracked. The primary end point is a comparison of target vessel failure (TVF) defined as a composite of cardiac death, target vessel MI and target vessel revascularization at one year based on post-PCI FFR values. Cox regression with robust standard errors was used for analysis.
Results:
Of the 757 patients randomized to PCI, 461 (61%) had post-PCI FFR measurement and 11.1% had intravascular imaging performed. The median post-PCI FFR was 0.89 [IQR 0.85-0.94]. On a vessel-level, post-PCI FFR was found to be a significant predictor of TVF univariately (HR=0.67 [95% CI:0.48-0.93] for 0.1 unit increase, p=0.0165). On a patient-level, the single lowest post-PCI FFR value was also found to be a significant predictor of TVF univariately (HR=0.65 [95% CI:0.48-0.89] for 0.1 unit increase, p=0.0074). Post-PCI FFR was an independent predictor of TVF in multivariable analysis adjusted for key clinical parameters. Outcomes were similar between patients who had intravascular imaging guidance and those who did not. Conclusions: Post-PCI FFR measurement was a significant predictor of TVF on a vessel and patient level and an independent predictor of outcomes in a population with complex three-vessel CAD eligible for CABG. The limited use of intravascular imaging did not affect outcomes.




Circ Cardiovasc Interv: 19 Sep 2022; epub ahead of print
Piroth Z, Otsuki H, Zimmermann FM, Ferenci T, ... Fearon WF, FAME 3 Investigators
Circ Cardiovasc Interv: 19 Sep 2022; epub ahead of print | PMID: 36121706
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Abstract

Instantaneous Wave Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations with FFR/IVUS and Prognostic Implications: The iLITRO - EPIC07 Study.

Rodriguez-Leor O, de la Torre Hernandez JM, García Camarero T, García Del Blanco B, ... Pérez de Prado A, iLITRO-EPIC07 Study Investigators
Background: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in non-left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS.
Methods:
Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area (MLA) measurements. Primary clinical endpoint was a composite of cardiovascular death, LMCA lesion-related non-fatal myocardial infarction or unplanned LMCA revascularization.
Results:
FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+ / iFR - and 29 FFR - / iFR+) MLA was ≥ 6mm2 in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, MACE incidence was 8.3% in the defer group and 13.3% in the revascularization group (HR 0.71, 95% CI [0.30-1.72], p=0.45). Conclusions: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of MACE.




Circ Cardiovasc Interv: 16 Sep 2022; epub ahead of print
Rodriguez-Leor O, de la Torre Hernandez JM, García Camarero T, García Del Blanco B, ... Pérez de Prado A, iLITRO-EPIC07 Study Investigators
Circ Cardiovasc Interv: 16 Sep 2022; epub ahead of print | PMID: 36111801
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Abstract

Atrial Functional Tricuspid Regurgitation: Novel Definition and Impact on Prognosis.

Schlotter F, Dietz MF, Stolz L, Kresoja KP, ... Bax JJ, Lurz P
Background
Atrial functional tricuspid regurgitation (atrial TR) has received growing recognition as a TR entity with a distinct cause owing to its independence from valvular tethering as the predominant mechanism underlying TR. However, characterization of atrial TR varies, and a universal definition is lacking.
Methods
In total, 651 patients with significant functional TR were analyzed, including 438 conservatively treated individuals and 213 patients who received transcatheter tricuspid valve repair (TTVR). Based on a clustering approach, we defined atrial TR as tricuspid valve (TV) tenting height ≤10 mm, midventricular right ventricular diameter ≤38 mm, and left ventricular ejection fraction ≥50%.
Results
Patients with atrial TR were more often females, had higher right ventricular fractional area change, higher left ventricular ejection fraction, and lower LV end-diastolic diameter, TV tenting area and height, lower right ventricular and tricuspid annular size, enlarged, but lower right atrial area and lower TV effective regurgitant orifice area (all P<0.05). Patients with atrial TR had significantly better long-term survival than non-atrial TR in the conservatively treated TR cohort (P<0.01, n=438). Atrial TR was independently associated with a lower rate of the combined end point of mortality and heart failure hospitalization at 1-year follow-up in the TTVR cohort (hazard ratio, 0.39; P<0.05, n=213). TR degree was significantly reduced after TTVR in non-atrial and atrial TR (P<0.01). Functional parameters significantly improved following TTVR independent of TR cause (P<0.05).
Conclusions
An echocardiography-based atrial TR definition is associated with prognostic relevance in patients with functional TR in conservatively treated TR and after TTVR.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e011958
Schlotter F, Dietz MF, Stolz L, Kresoja KP, ... Bax JJ, Lurz P
Circ Cardiovasc Interv: 01 Sep 2022; 15:e011958 | PMID: 36126130
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Abstract

Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Kaneko T, Hirji SA, Yazdchi F, Sun YP, ... Shah PB, O\'Gara P
Background
In some patients, the alternative access route for transcatheter aortic valve replacement (TAVR) is utilized because the conventional transfemoral approach is not felt to be either feasible or optimal. However, accurate prognostication of patient risks is not well established. This study examines the associations between peripheral (transsubclavian/transaxillary, and transcarotid) versus central access (transapical and transaortic) in alternative access TAVR and 30-day and 1-year end points of mortality and stroke for all valve platforms.
Methods
Using data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry with linkage to Medicare claims, patients who underwent alternative access TAVR from June 1, 2015 to June 30, 2018 were identified. Adjusted and unadjusted Cox proportional hazards modeling were performed to determine the association between alternate access TAVR site and 30-day and 1-year end points of mortality and stroke.
Results
Of 7187 alternative access TAVR patients, 3725 (52%) had peripheral access and 3462 (48%) had central access. All-cause mortality was significantly lower in peripheral access versus central access group at in-hospital and 1 year (2.9% versus 6.3% and 20.3% versus 26.6%, respectively), but stroke rates were higher (5.0% versus 2.8% and 7.3% versus 5.5%, respectively; all P<0.001). These results persisted after 1-year adjustment (death adjusted hazard ratio, 0.72 [95% CI, 0.62-0.85] and stroke adjusted hazard ratio, 2.92 [95% CI, 2.21-3.85]). When broken down by individual subtypes, compared with transaxillary/subclavian access patients, transapical, and transaortic access patients had higher all-cause mortality but less stroke (P<0.05).
Conclusions
In this real-world, contemporary, nationally representative benchmarking study of alternate access TAVR sites, peripheral access was associated with favorable mortality and morbidity outcomes compared with central access, at the expense of higher stroke. These findings may allow for accurate prognostication of risk for patient counseling and decision-making for the heart team with regard to alternative access TAVR.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e011756
Kaneko T, Hirji SA, Yazdchi F, Sun YP, ... Shah PB, O'Gara P
Circ Cardiovasc Interv: 01 Sep 2022; 15:e011756 | PMID: 36126131
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Abstract

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, ... Schnorr B, Mohd Ali R
Background
Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis.
Methods
One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
Results
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups.
Conclusions
This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT02996318, NCT03242096.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e012305
Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, ... Schnorr B, Mohd Ali R
Circ Cardiovasc Interv: 01 Sep 2022; 15:e012305 | PMID: 36126132
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Abstract

Impact of Serial Coronary Stenoses on Various Coronary Physiologic Indices.

Ahn JM, Nakayoshi T, Hashikata T, Kashiyama K, ... Lyons J, Fearon WF
Background
Determining the functional significance of each individual coronary lesion in patients with serial coronary stenoses is challenging. It has been proposed that nonhyperemic pressure ratios, such as the instantaneous wave free ratio (iFR) and the ratio of resting distal to proximal coronary pressure (Pd/Pa) are more accurate than fractional flow reserve (FFR) because autoregulation should maintain stable resting coronary flow and avoid hemodynamic interdependence (cross-talk) that occurs during hyperemia. This study aimed to measure the degree of hemodynamic interdependence of iFR, resting Pd/Pa, and FFR in a porcine model of serial coronary stenosis.
Methods
In 6 anesthetized female swine, 381 serial coronary stenoses were created in the left anterior descending artery using 2 balloon catheters. The degree of hemodynamic interdependence was calculated by measuring the absolute changes in iFR, resting Pd/Pa, and FFR across the fixed stenosis as the severity of the other stenosis varied.
Results
The hemodynamic interdependence of iFR, resting Pd/Pa, and FFR was 0.039±0.048, 0.021±0.026, and 0.034±0.034, respectively (all P<0.001). When the functional significance of serial stenoses was less severe (0.70-0.90 for each index), the hemodynamic interdependence was 0.009±0.020, 0.007±0.013, and 0.017±0.022 for iFR, resting Pd/Pa, and FFR, respectively (all P<0.001). However, in more severe serial coronary stenoses (<0.60 for each index), hemodynamic interdependence was 0.060±0.050, 0.037±0.030, and 0.051±0.037 for iFR, resting Pd/Pa, and FFR, respectively (all P<0.001).
Conclusions
When assessing serial coronary stenoses, nonhyperemic pressure ratios are affected by hemodynamic interdependence. When the functional significance of serial coronary stenoses is severe, the effect is similar to that which is seen with FFR.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e012134
Ahn JM, Nakayoshi T, Hashikata T, Kashiyama K, ... Lyons J, Fearon WF
Circ Cardiovasc Interv: 01 Sep 2022; 15:e012134 | PMID: 36126133
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Abstract

Balloon Interrogation of Intervening Tissue: A Novel Method to Decide Strategy for Closing Multiple Atrial Septal Defects.

Dalvi B, Bhalgat P
Background
Two separate ostium secundum atrial septal defects are a challenging substrate for device closure due to lack of a well-described strategy or an adequately evaluated protocol.
Methods
This is a prospective study comprising 20 patients with 2 atrial septal defects who underwent device closure. All of them underwent balloon interrogation (BI) of the intervening tissue to decide 1- versus 2-device strategy. During BI, if the flow through both the defects could be stopped completely implying adequate mobility of the separating tissue, a single device strategy was used. The size of the device in this subset was determined by BI diameter. In case the flow persisted, 2 devices were used to close the defects separately.
Results
The mean age was 24±17 years. The main defect size was (mean 14.5 mm±SD 2.69 mm), whereas the second defect measured (mean 8.5±SD 3.02 mm). The tissue separating the 2 defects was measured (mean 6.1±SD 2.6 mm). In 15 of them, based on the BI results, a single device was used successfully to close both the defects without a residual shunt. In the remaining 5 patients, 2 devices were used. There were no complications during the procedure or at follow-up period of 41.9±16.9 months.
Conclusions
BI in patients with 2 atrial septal defects is helpful in defining 1- versus 2-device strategies and in choosing the size of the device to be used. Nearly 3/4 of the patients may get away with a single device for closing both the defects successfully thereby decreasing the cost and complexity of the procedure.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e012048
Dalvi B, Bhalgat P
Circ Cardiovasc Interv: 01 Sep 2022; 15:e012048 | PMID: 36126135
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Abstract

Definition of Optimal Optical Coherence Tomography-Based Stent Expansion Criteria: In-Stent Minimum Lumen Area Versus Residual Stent Underexpansion.

Romagnoli E, Ramazzotti V, Burzotta F, Gatto L, ... Prati F, CLI-OPCI Project Investigators*
Background
The mismatch between in-stent minimum lumen area (sMLA) and reference vessel lumen area, defined as stent underexpansion (SU), could be an important determinant of stent failure. We tested the clinical predictive value of absolute sMLA in comparison to relative SU in the context of the CLI-OPCI (Centro Per La Lotta Contro L\'Infarto-Optimisation of Percutaneous Coronary Intervention) project registry.
Methods
We retrospectively analyzed end procedural optical coherence tomography findings in 1211 patients (1422 lesions) undergoing percutaneous coronary intervention, assessing the prevalence and magnitude of residual SU and exploring correlation with outcome in comparison with sMLA.
Results
In our series, both sMLA and SU were related to vessel size and anatomic lesion complexity. When compared with patients without adverse event at follow-up, those experiencing device-oriented cardiovascular events (composite of cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis) showed a lower sMLA (5.6±2.1 versus 6.1±2.1 mm2; P=0.011) but a comparable degree of SU (11.6±14.1% versus 11.2±13.3%; P=0.734). The prespecified cutoff value of sMLA <4.5 mm2, documented in 23.8% of cases, was confirmed as independent outcome predictor for device-oriented cardiovascular events (hazard ratio [HR], 2.05 [95% CI, 1.5-2.9]) including target lesion revascularization (HR, 2.43 [95% CI, 1.7-3.5]) and stent thrombosis (HR, 3.23 [95% CI, 1.7-6.3]). A residual SU of 10%, 20%, and 30% was observed in 38.0%, 18.2%, and 7.6% of cases, respectively. No grade of residual SU significantly increased the risk of stent failure, unless if an SU >20% was associated with an sMLA <4.5 mm2 (HR, 3.11 [95% CI, 1.7-5.6]). Finally, an association between stent overexpansion (ie, >110%) and device-oriented cardiovascular events was also observed (HR, 1.60 [95% CI, 1.1-2.3]).
Conclusions
Final absolute sMLA and not relative SU was associated with an increased risk of stent failure. A variable grade of SU was common, but it resulted in being clinically relevant only when associated with an sMLA <4.5 mm2.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e011496
Romagnoli E, Ramazzotti V, Burzotta F, Gatto L, ... Prati F, CLI-OPCI Project Investigators*
Circ Cardiovasc Interv: 01 Sep 2022; 15:e011496 | PMID: 36126136
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Abstract

Prevalence and Impact of Neoatherosclerosis on Clinical Outcomes After Percutaneous Treatment of Second-Generation Drug-Eluting Stent Restenosis.

Chen Z, Matsumura M, Mintz GS, Noguchi M, ... Shlofmitz RA, Maehara A
Background
Clinical and morphological factors associated with lipidic versus calcified neoatherosclerosis within second-generation drug-eluting stents and the impact of lipidic versus calcified neoatherosclerosis on long-term outcomes after repeat intervention have not been well studied.
Methods
A total of 512 patients undergoing optical coherence tomography before percutaneous coronary intervention for second-generation drug-eluting stents in-stent restenosis were included. Neoatherosclerosis was defined as lipidic or calcified neointimal hyperplasia in ≥3 consecutive frames or ruptured lipidic neointimal hyperplasia. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, or clinically driven target lesion revascularization).
Results
The overall prevalence of neoatherosclerosis was 28.5% (146/512): 56.8% lipidic, 30.8% calcified, and 12.3% both lipidic and calcific. The prevalence increased as a function of time from stent implantation: 20% at 1 to 3 years, 30% at 3 to 7 years, and 75% >7 years. Renal insufficiency, poor lipid profile, and time from stent implantation were associated with lipidic neoatherosclerosis, whereas severe renal insufficiency, female sex, and time from stent implantation were associated with calcified neoatherosclerosis. Multivariable Cox regression revealed that female sex and lipidic neoatherosclerosis were associated with more target lesion failure, whereas stent age and final minimum lumen diameter after reintervention were related to lower target lesion failure. Calcified neoatherosclerosis was not related to adverse events after reintervention for in-stent restenosis given a large enough minimum lumen diameter was achieved.
Conclusions
Lipidic but not calcified neoatherosclerosis was associated with poor subsequent outcomes after repeat revascularization if optimal stent expansion was achieved in lesions with calcified neoatherosclerosis.



Circ Cardiovasc Interv: 01 Sep 2022; 15:e011693
Chen Z, Matsumura M, Mintz GS, Noguchi M, ... Shlofmitz RA, Maehara A
Circ Cardiovasc Interv: 01 Sep 2022; 15:e011693 | PMID: 36126137
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Abstract

Sex-Based Differences in Periprocedural Complications Following Lower Extremity Peripheral Vascular Intervention.

Altin SE, Gitto M, Secemsky EA, Rao SV, Hess CN
Background
Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI.
Methods
Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications.
Results
Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003).
Conclusions
In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.



Circ Cardiovasc Interv: 08 Aug 2022:CIRCINTERVENTIONS121011768; epub ahead of print
Altin SE, Gitto M, Secemsky EA, Rao SV, Hess CN
Circ Cardiovasc Interv: 08 Aug 2022:CIRCINTERVENTIONS121011768; epub ahead of print | PMID: 35938403
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Abstract

Cardiovascular and Renal Implications of Myocardial Infarction in the ISCHEMIA-CKD Trial.

Chaitman BR, Cyr DD, Alexander KP, Pracoń R, ... Hochman JS, Bangalore S
Background
ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease) reported an initial invasive treatment strategy did not reduce the risk of death or nonfatal myocardial infarction (MI) compared with a conservative treatment strategy in patients with advanced chronic kidney disease, stable coronary disease, and moderate or severe myocardial ischemia. The cumulative frequency of different MI type after randomization and subsequent prognosis have not been reported.
Methods
MI classification was based on the Third Universal Definition for MI. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary MI definition used cTn (cardiac troponin); both definitions included elevated biomarker-only events with higher thresholds than nonprocedural MIs. The cumulative frequency of MI type according to treatment strategy was determined. The association of MI with subsequent all-cause death and new dialysis initiation was assessed by treating MI as a time-dependent covariate.
Results
The 3-year incidence of type 1 or 2 MI with the primary MI definition was 11.2% in invasive treatment strategy and 13.6% in conservative treatment strategy (hazard ratio [HR], 0.66 [95% CI, 0.42-1.02]). Procedural MIs were more frequent in invasive treatment strategy and accounted for 9.8% and 28.3% of all MIs with the primary and secondary MI definitions, respectively. Patients had an increased risk of all-cause death after type 1 MI (adjusted HR, 4.35 [95% CI, 2.73-6.93]) and after procedural MI with the primary (adjusted HR, 2.75 [95% CI, 0.99-7.60]) and secondary MI definitions (adjusted HR, 2.91 [95% CI, 1.73-4.88]). Dialysis initiation was increased after a type 1 MI (HR, 6.45 [95% CI, 2.59-16.08]) compared with patients without an MI.
Conclusions
In ISCHEMIA-CKD, the invasive treatment strategy had higher rates of procedural MIs, particularly with the secondary MI definition, and lower rates of type 1 and 2 MIs. Procedural MIs, type 1 MIs, and type 2 MIs were associated with increased risk of subsequent death. Type 1 MI increased the risk of dialysis initiation.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT01985360.



Circ Cardiovasc Interv: 01 Aug 2022; 15:e012103
Chaitman BR, Cyr DD, Alexander KP, Pracoń R, ... Hochman JS, Bangalore S
Circ Cardiovasc Interv: 01 Aug 2022; 15:e012103 | PMID: 35973009
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Abstract

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort.

Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, ... Kimura T, STOPDAPT-2 and STOPDAPT-2 ACS Investigators
Background
The benefit of clopidogrel monotherapy after 1-month dual antiplatelet therapy (DAPT) compared with 12-month DAPT with aspirin and clopidogrel was demonstrated in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), but not in the STOPDAPT-2 acute coronary syndrome (ACS); however, both trials were underpowered based on the actual event rates.
Methods
We obtained the prespecified pooled population of 5997 patients as the STOPDAPT-2 total cohort (STOPDAPT-2: N=3009/STOPDAPT-2 ACS: N=2988; ACS: N=4136/chronic coronary syndrome [CCS]: N=1861), comprising 2993 patients assigned to 1-month DAPT followed by clopidogrel monotherapy, and 3004 patients assigned to 12-month DAPT with aspirin and clopidogrel after percutaneous coronary intervention. The primary end point was the composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or any stroke) or bleeding (Thrombolysis in Myocardial Infarction major/minor) end points at 1 year.
Results
One-month DAPT was noninferior to 12-month DAPT for the primary end point (2.84% versus 3.04%; hazard ratio [HR], 0.94 [95% CI, 0.70-1.27]; Pnoninferiority=0.001; Psuperiority=0.68). There was no significant risk-difference for the cardiovascular end point between the 1- and 12-month DAPT groups (2.40% versus 1.97%; HR, 1.24 [95% CI, 0.88-1.75]; Pnoninferiority=0.14; Psuperiority=0.23). There was a lower risk of the bleeding end point with 1-month DAPT relative to 12-month DAPT (0.50% versus 1.31%; HR, 0.38 [95% CI, 0.21-0.70]; Psuperiority=0.002). One-month DAPT relative to 12-month DAPT was associated with a lower risk for major bleeding regardless of ACS or CCS (ACS: HR, 0.46 [95% CI, 0.23-0.94]; P=0.03, and CCS: HR, 0.26 [95% CI, 0.09-0.79]; P=0.02; Pinteraction=0.40), while it was associated with a numerical increase in cardiovascular events in ACS patients, but not in CCS patients, although not statistically significant and without interaction (ACS: HR, 1.50 [95% CI, 0.99-2.27]; P=0.053, and CCS: HR, 0.74 [95% CI, 0.38-1.45]; P=0.39; Pinteraction=0.08).
Conclusions
Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT with aspirin and clopidogrel had a benefit in reducing major bleeding events without being associated with increase in cardiovascular events.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifiers: NCT02619760, NCT03462498.



Circ Cardiovasc Interv: 01 Aug 2022:CIRCINTERVENTIONS122012004; epub ahead of print
Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, ... Kimura T, STOPDAPT-2 and STOPDAPT-2 ACS Investigators
Circ Cardiovasc Interv: 01 Aug 2022:CIRCINTERVENTIONS122012004; epub ahead of print | PMID: 35912647
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Abstract

Presence of Coronary Endothelial Dysfunction, Coronary Vasospasm, and Adenosine-Mediated Vasodilatory Disorders in Patients With Ischemia and Nonobstructive Coronary Arteries.

Feenstra RGT, Boerhout CKM, Woudstra J, Vink CEM, ... van de Hoef TP, Piek JJ
Background
Coronary function testing in patients with ischemia and nonobstructive coronary arteries (INOCA) commonly includes assessment of adenosine-mediated vasodilation and acetylcholine spasm provocation. The purpose of this study was to evaluate the diagnostic value of additional endothelial function testing for the diagnosis of vasomotor dysfunction in patients with INOCA.
Methods
In this retrospective cohort study, we included patients with INOCA who underwent clinically indicated comprehensive coronary function testing. Endothelial dysfunction was defined as a <50% increase in coronary blood flow, determined by Doppler flow, and/or epicardial vasoconstriction compared to baseline, in response to low-dose acetylcholine. Coronary artery spasm (CAS) was defined as vasospastic angina or microvascular angina in response to coronary high-dose acetylcholine. An impaired adenosine-mediated vasodilation was defined as a coronary flow reserve <2.5 and/or hyperemic microvascular resistance ≥2.5.
Results
Among all 110 patients, 79% had endothelial dysfunction, 62% had CAS, and 29% had an impaired adenosine-mediated vasodilation. Endothelial dysfunction was present in 80% of patients who tested positively for CAS and/or an impaired adenosine-mediated vasodilation. Endothelial function testing increases the diagnostic yield of coronary function testing that only incorporates adenosine testing and spasm provocation by 17% to 92%. Of patients with normal adenosine-mediated vasodilation and no inducible CAS, 68% had endothelial dysfunction.
Conclusions
Concomitant endothelial dysfunction was prevalent in the vast majority of patients with INOCA with inducible CAS and/or an impaired adenosine-mediated vasodilation. In patients with INOCA without inducible CAS and normal adenosine-mediated vasodilation, two-thirds had endothelial dysfunction. These results indicate the relevance to perform endothelial function testing in patients with INOCA in view of its therapeutic implication.



Circ Cardiovasc Interv: 29 Jul 2022:CIRCINTERVENTIONS122012017; epub ahead of print
Feenstra RGT, Boerhout CKM, Woudstra J, Vink CEM, ... van de Hoef TP, Piek JJ
Circ Cardiovasc Interv: 29 Jul 2022:CIRCINTERVENTIONS122012017; epub ahead of print | PMID: 35904014
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Abstract

Diffusion of Percutaneous Ventricular Assist Devices in US Markets.

Bjarnason TA, Mentias A, Panaich S, Vaughan Sarrazin M, ... Desai NR, Girotra S
Background
Percutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost.
Methods
Using the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost.
Results
A total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%-85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91-2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost.
Conclusions
Although utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost.



Circ Cardiovasc Interv: 29 Jul 2022:101161CIRCINTERVENTIONS121011778; epub ahead of print
Bjarnason TA, Mentias A, Panaich S, Vaughan Sarrazin M, ... Desai NR, Girotra S
Circ Cardiovasc Interv: 29 Jul 2022:101161CIRCINTERVENTIONS121011778; epub ahead of print | PMID: 35904015
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Abstract

Comparison of Unguided De-Escalation Versus Guided Selection of Dual Antiplatelet Therapy After Acute Coronary Syndrome: A Systematic Review and Network Meta-Analysis.

Kuno T, Fujisaki T, Shoji S, Sahashi Y, ... Kohsaka S, Bhatt DL
Background
The benefit of dual antiplatelet therapy (DAPT) for reducing ischemic events is greatest in the early period of acute coronary syndrome, and recent randomized controlled trials have investigated the unguided de-escalation strategy of changing potent P2Y12 inhibitors to less potent or reduced-dose P2Y12 inhibitors 1 month after acute coronary syndrome. However, it remains unclear which strategy is more effective and safer: the uniform unguided de-escalation strategy versus the personalized guided selection of DAPT with genotype or platelet function tests.
Methods
PubMed, EMBASE, and Cochrane Central were searched for articles published from database inception to September 10, 2021. Randomized controlled trials investigating DAPT using clopidogrel, low-dose prasugrel, standard-dose prasugrel, ticagrelor, unguided de-escalation strategy, and guided selection strategy for patients with acute coronary syndrome were included. Hazard ratios and relative risk estimates were extracted from each study. The estimates were pooled using a random-effects network meta-analysis. The primary efficacy outcome was major adverse cardiovascular events, defined as a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major or minor bleeding. Secondary outcomes were all-cause death, cardiovascular death, myocardial infarction, stroke, stent thrombosis, and major bleeding.
Results
This study included 19 randomized controlled trials with 69 746 patients. Compared with guided selection of DAPT, unguided de-escalation of DAPT was associated with a decreased risk of the primary safety outcome (hazard ratio, 0.48 [95% CI, 0.33-0.72]) without increased risks of major adverse cardiovascular events (hazard ratio, 0.82 [95% CI, 0.53-1.28]) or any secondary outcomes. The results were similar when the guided selection strategy was divided into platelet function-guided and genotype-guided strategies.
Conclusions
Compared with guided selection of DAPT, unguided de-escalation of DAPT decreased bleeding without increasing ischemic events in patients after acute coronary syndrome. If a strategy of de-escalation is chosen, these findings do not support the routine use of personalized guiding tests.
Registration
URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42021273082.



Circ Cardiovasc Interv: 28 Jul 2022:101161CIRCINTERVENTIONS122011990; epub ahead of print
Kuno T, Fujisaki T, Shoji S, Sahashi Y, ... Kohsaka S, Bhatt DL
Circ Cardiovasc Interv: 28 Jul 2022:101161CIRCINTERVENTIONS122011990; epub ahead of print | PMID: 35899618
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This program is still in alpha version.