Search

Accurate sizing of vessel diameter is important for understanding the physiology of blood vessels as well as the treatment of coronary and peripheral artery disease. The objective of this study was to validate a novel catheter-based system [the LumenRECON (LR) system] for the real-time reconstruction of lumen cross-sectional area (CSA) along the length of a vessel segment. A total of 22 swine (20 Yorkshire and 2 atherosclerotic Ossabaw swine) were used to evaluate the accuracy, reproducibility, and safety of the system compared with intravascular ultrasound (IVUS). The CSA of the right coronary artery, left anterior descending coronary artery, and left circumflex artery were determined by IVUS and the LR system over a 3- to 4-cm segment in 12 Yorkshire and 2 atherosclerotic Ossabaw swine and 2 postmortem atherosclerotic human hearts. In eight chronic animals, the effect of the LR catheter on the vessel wall was evaluated at 1 day and 2 wk (4 animals each) after the intervention. A Bland-Altman plot of the LR and IVUS data showed a mean difference between the two measurements of 0.055 mm in diameter, which was not statistically significant from zero, indicating a lack of bias in the comparison of the LR system with IVUS. The root mean square error of the two measurements was 10.2% of the mean IVUS diameter. The repeatability of the LR system was assessed using duplicate measurements. The mean of the difference between the two measurements was nearly zero, and the repeatability coefficient was within 4.5% of the mean of the two measurements. No injury or intimal hyperplasia was found acutely or chronically after the use of the LR system. This study establishes the accuracy, reproducibility, and safety of a nonimaging 2.7-Fr catheter for lumen sizing of coronary arteries. The system provides a continuous quantitative axial profile of the mean vessel lumen in real time and may have significant utility in vascular research and clinically in the catheterization laboratory. [ABSTRACT FROM AUTHOR]

The Therapeutic Angiogenesis With Recombinant Fibroblast Growth Factor-2 for Intermittent Claudication (TRAFFIC) is a large, randomized, placebo-controlled, regimen-finding trial of intra-arterial recombinant fibroblast growth factor-2 in patients with intermittent claudication. This report describes the major design considerations and end points in TRAFFIC. [ABSTRACT FROM AUTHOR]

The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent. [ABSTRACT FROM AUTHOR]

The cumulative experience of 4 clinical trials using the MULTI-LINK coronary stent design was analyzed. Multivariable logistic regression identified postprocedure in-stent minimum lumen diameter (p = 0.0001), stent length (p = 0.0038), smoking (p = 0.0105). and diabetes (p = 0.0803) as the most important predictors of in-stent restenosis at late (6- to 9-month) angiographic follow-up. [ABSTRACT FROM AUTHOR]

Abciximab, an Fab monoclonal antibody fragment that blocks the platelet glycoprotein IIb/IIIa receptor, is increasingly used as an adjunct to coronary intervention. Little is known, however, about the efficacy and safety of readministration of abciximab. This study examined and characterized outcomes of patients receiving abciximab for a second time. From April 1995 to June 1997, 164 consecutive patients were readministered abciximab at our 3 institutions. We retrospectively examined and analyzed in-hospital outcomes in this cohort. The median time to readministration was 95 days. The angiographic success rate of percutaneous intervention was 99.5%. Rates and 95% confidence intervals of in-hospital events were death 2% (0.7% to 6.1%), myocardial infarction 3% (1% to 7%), coronary bypass surgery 0% (0% to 2.2%), and intracranial hemorrhage 2% (0.4% to 5.3%). Severe thrombocytopenia was observed in 4% of patients (1.4% to 7.8%) after readministration. Allergic or anaphylactic reactions were not observed. Major bleeding was associated with excessive concomitant antithrombotic therapy. Patients undergoing readministration of abciximab within 2 weeks of first administration experienced a higher incidence of severe thrombocytopenia (12% vs. 2%, p = 0.046). Thus, abciximab remains clinically efficacious when readministered as an adjunct to percutaneous coronary intervention. However, concomitant heparin administration must be carefully monitored and warfarin therapy should be avoided. Vigilant surveillance for thrombocytopenia should be employed. Reduced dosing may be necessary when abciximab is readministered within days of the initial administration. [ABSTRACT FROM AUTHOR]

The MULTI-LINK DUET is the next generation MULTI-LINK stent with modified strut geometry. Safety and efficacy of the MULTI-LINK DUET were evaluated in a prospective multicenter registry and were compared with prior MULTI-LINK stent experience from the ASCENT randomized trial. A total of 270 patients received 302 MULTI-LINK DUET stents and were evaluated using a composite primary end point of major cardiac events (death, Q-wave and non-Q-wave myocardial infarction, and requirement for coronary revascularization) attributable to the target stenosis cumulative to 30 days following enrollment. Quantitative coronary angiography was performed at a mean follow-up of 6 +/- 2 (+/-SD) months. No difference in primary end point or in angiographic restenosis to 6 months was observed between MULTI-LINK DUET and MULTI-LINK experiences. The MULTI-LINK DUET demonstrated improved device and procedural success, less postprocedural in-stent stenosis, larger postprocedural minimal lumen diameter, and fewer postprocedural marginal dissections compared with the MULTI-LINK stent. Multivariate regression modeling identified stent length, diabetes mellitus, poststent minimal lumen diameter, lesion eccentricity, and current smoking as independent predictors of in-stent restenosis. Thus, the MULTI-LINK DUET Registry demonstrates enhanced procedural performance with clinical and angiographic outcomes similar to those previously observed for the MULTI-LINK stent in the ASCENT randomized trial. [ABSTRACT FROM AUTHOR]

Angiographic studies have demonstrated that perfusion balloon percutaneous transluminal coronary angioplasty (PTCA) may result in modestly improved luminal gains and fewer major dissections than conventional balloon PTCA. However, intracoronary ultrasound (ICUS), which is more sensitive than angiography in evaluating the incidence, extent, and severity of dissection, was not used. We randomized 48 patients with 54 coronary stenoses to conventional or perfusion balloon PTCA. Four 2-minute inflations were permitted with conventional balloon PTCA. Two 10-minute inflations were allowed with perfusion balloon PTCA. Quantitative coronary angiography and ICUS were performed before and after treatment. In-hospital clinical events were recorded. Conventional and perfusion balloon PTCA achieved similar improvements in lumen diameter (1.25+/-0.51 vs 1.28+/-0.51 mm) and reductions in percent stenosis (-45+/-21% vs -44+/-15%) by quantitative coronary angiography. Comparable gains in lumen diameter (0.62+/-0.39 vs 0.50+/-0.38 mm) and lumen area (2.70+/-1.96 vs 2.05+/-1.52 mm2) were observed on ICUS. Angiography demonstrated similar rates of any dissection (36% vs 21%) and major dissection (12% vs 7%). ICUS identified a similar incidence of any dissection (60% vs 76%) and type II dissection (52% vs 62%). The relative dissection area was also similar (9.2+/-5.6% vs 7.8+/-5.8%). One conventional balloon patient experienced postprocedural chest pain. No patient in either group died, or had myocardial infarction, abrupt closure, or urgent revascularization. [ABSTRACT FROM AUTHOR]

Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific)., Objectives: This analysis presents the 5-year results from the trial comparing the 2 devices head to head., Methods: Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years., Results: A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n = 917, Amulet occluder; and n = 916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (P = 0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; P = 0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; P = 0.666), major bleeding (20.1% vs 20.0%; P = 0.882), cardiovascular (CV) death (14.3% vs 15.4%; P = 0.429), and all-cause death (28.7% vs 31.1%; P = 0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n = 38, nondisabling; n = 11, disabling; n = 11, fatal; n = 12, unknown) than strokes in patients with the Watchman device (n = 19, nondisabling; n = 22, disabling; n = 17, fatal; n = 10, unknown). Moreover, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n = 63) compared with patients with the Amulet occluder (n = 31)., Conclusions: The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation-related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448)., Competing Interests: Funding Support and Author Disclosures Abbott funded the Amulet IDE trial. No funding was provided for this analysis. Dr Lakkireddy has received institutional research and educational grants from Abbott, Atricure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Ellis has received institutional research grants from Boehringer Ingelheim, Medtronic, and Boston Scientific; and has served as a consultant or in an advisory capacity to Medtronic, Abbott Medical, Boston Scientific, and Atricure. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific; and has received speaker honoraria from Boston Scientific. Dr Hermiller has served as a consultant to Abbott, Edwards, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has served as a consultant and proctor to Edwards Lifesciences and Abbott; and has held shares in Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; has served on the advisory board of and as a consultant to Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; and has received honoraria from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio. Dr Schmidt has received speaker honoraria and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton has served as a consultant to Boston Scientific, Biosense Webster, St Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Anderson is an employee of Abbott. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbot, and CVRx. Dr Zhao is an employee of Abbott. Dr Alkhouli has served as a consultant to Boston Scientific and Abbott. Dr Windecker has received institutional research, travel, or educational grants from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, B Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cleerly, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, GE Medical Systems, Gebro Pharma, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Neucomed, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Technologies, Pfizer, Philips, Polares, Regeneron, Sanofi-Aventis, Servier, Siemens Healthcare, Sinomed, SMT Sahajanand Medical Technologies, Terumo, Vifor, V-Wave, and Zoll Medical; has served as an advisory board member of and/or member of the steering or executive committee group for trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave, with payments to the institution but no personal payments; and has served as a member of the steering or executive committee group for several investigator-initiated trials that receive funding by industry without impact on his personal remuneration., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain., Aims: We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS., Methods: This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification., Results: Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT., Conclusions: Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.

Aims: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients., Methods and Results: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population., Conclusions: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial., (© 2024 European Society of Cardiology.)

This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients with high bleeding risk successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary end point was all-cause death or myocardial infarction (MI). The key secondary end point was Bleeding Academic Research Consortium type 2 to 5 bleeding. The outcomes were assessed from 1 to 12 months after index PCI. Of 3,364 patients, 2,241 (66.6%) were aged ≥75 years. The risk of death or MI was similar with 1- versus 3-month DAPT in patients aged ≥75 (8.5% vs 8.0%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69 to 1.30) and <75 years (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60 to 1.57, interaction p = 0.478). Bleeding Academic Research Consortium type 2 to 5 bleeding was consistently lower with 1- than with 3-month DAPT in patients aged ≥75 years (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48 to 0.91) and <75 years (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57 to 1.29, interaction p = 0.737). In conclusion, in patients at high bleeding risk who underwent PCI, patients older and younger than 75 years derived a consistent benefit from 1- compared with 3-month DAPT in terms of bleeding reduction, with no increase in all-cause death or MI at 1 year., Competing Interests: Declaration of competing interest Dr. Spirito received a research grant for the Swiss National Science Foundation. Dr. Angiolillo declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, Sanofi and Ventura, outside the present work. D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and Scott R. MacKenzie Foundation. Dr Bangalore received consulting fees or been on the advisory board for Abbott Vascular, Boston Scientific, Biotronik, Amgen, Pfizer,Merck, Viatris, and REATA. Dr. Vranckx received personal fees from Daichii Sankyo, Bayer AG, Pfizer-Bristol Meyers Squibb alliance, Novartis, CSL Behring not related to this research. Dr. Bhatt discloses the following relationships - Advisory Board: Angiowave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: Angiowave (stock options), Boston VA Research Institute, Bristol-Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Consultant: Broadview Ventures, Hims; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio; Royalties: Elsevier (Editor, Braunwald's Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. Dr Campo received institutional research grants from SMT, Siemens, GE Healthcare, GADA and Abbott Vascular outside the present work. Dr. Neumann received grants or fees from Amgen, Bayer Health Care, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, GlaxoSmithKline, Abbott Vascular, and Medtronic. Dr. Toelg received speaker honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr. Valgimigli reports personal fees from Astra Zeneca, grants and personal fees from Terumo, personal fees from Alvimedica/CID, personal fees from Abbott Vascular, personal fees from Daiichi Sankyo, personal fees from Opsens, personal fees from Bayer, personal fees from CoreFLOW, personal fees from IDORSIA PHARMACEUTICALS LTD, personal fees from Universität Basel | Dept. Klinische Forschung, personal fees from Vifor, personal fees from Bristol-Myers Squib SA, personal fees from iVascular, personal fees from Medscape, outside the submitted work. Dr. Varenne received lectures fees by AV and Biotronik. Dr. Windecker reports research, travel or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc. Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. Dr Windecker served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol-Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Mehran reports institutional research payments from Abbott, Abiomed, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, Atricure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Element Science, Faraday, Humacyte, Idorsia Pharmaceuticals, Janssen, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, Pi-Cardia, PLx Pharma, RenalPro, RM Global, Shockwave, Vivasure, Zoll; personal fees from Cine-Med Research, Novartis, WebMD; equity <1% in Applied Therapeutics, Elixir Medical, Stel, ControlRad (spouse); scientific advisory board for AMA, ACC (BOT Member), SCAI (Women in Innovations Committee Member), JAMA associate editor; faculty CRF (no fee). The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy., Objectives: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry., Methods: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee., Results: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline)., Conclusions: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy., Competing Interests: Funding Support and Author Disclosures Dr Smith is on the CLASP IID Trial leadership team and has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and honoraria for speaking from Artivion and Medtronic. Dr Lim is a consultant for Opus, Nyra, Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, V Wave, and WL Gore. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she receives no direct compensation. Dr Zahr is a consultant and has received research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman consults in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling has received clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on a scientific advisory board and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; has received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR Trial and EXPAND registry and co-national principal investigator for the PINNACLE FLX Trial and CHAMPION Trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF Trial. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; has received speaker honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor for Edwards Lifesciences and Medtronic; and serves as a lecturer for Edwards Lifesciences and Boston Scientific. Dr Baldus has received research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott, and Medtronic. Dr Szerlip is a proctor for Edwards Lifesciences and Abbott; is a speaker for Edwards Lifesciences and Boston Scientific; serves as a national principal investigator for an early feasibility study for Edwards Lifesciences; serves on the advisory board for Abbott; and is part of a steering committee for Medtronic. Dr Kliger is a consultant for and has received speaker honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Webb is a consultant and national principal investigator for Edwards Lifesciences–sponsored clinical studies; and has received speaking honoraria, travel support, or grant support from Edwards Lifesciences. Dr von Bardeleben is a principal investigator for Phase 3, post-market clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR and other registries) for Abbott, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Neochord, Philips and Siemens. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Guerrero has received grant support, and consulting and proctoring fees from Edwards Lifesciences. Dr McCabe is a consultant and has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and holds equity in Excision Medical. Dr Davidson is a consultant and has received research grant support from Edwards Lifesciences. Dr Shah has received grant support, consulting, and proctoring fees from Edwards Lifesciences. Dr Yadav is a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Hausleiter is a consultant, and receives speaker honoraria and institutional research support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR)., Objectives: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial., Methods: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort., Results: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline)., Conclusions: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR., Competing Interests: Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Zahr has served as a consultant for and received research and educational grants from Edwards Lifesciences and Medtronic. Dr Smith has served on the CLASP IID trial leadership team; received institutional grant and travel support for device evaluation from Edwards Lifesciences; received institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Gillam has served as a consultant for Philips, Bracco, and Edwards Lifesciences; and directed an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic for which she has received no direct compensation. Dr Chadderdon has served as an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar has served as a consultant for and received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr von Bardeleben has served as a principal investigator for phase 3, postmarket clinical trials and investigator-initiated trials (Reshape II HF, TENDER, EuroSMR and other registries) for Abbott, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Neochord, Philips, and Siemens. Dr Szerlip has served as a proctor and speaker for Edwards Lifesciences; as a national principal investigator for an early feasibility study; on the advisory board and as a proctor for Abbott; as part of the steering committee for Medtronic; and as a speaker for Boston Scientific. Dr Goldman has been involved in minimally invasive mitral valve observation for Edwards Lifesciences. Dr Inglessis-Azuaje has served as a proctor and lecturer for Edwards Lifesciences; a consultant and proctor for Medtronic; and a lecturer for Boston Scientific. Dr Yadav has served as a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Lurz has received institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr Davidson has served as a consultant and received research grant support from Edwards Lifesciences. Dr Mumtaz has served as a consultant and proctor for and received honoraria and research support from Edwards Lifesciences, Abbott, Medtronic, JOMDD, Teleflex, and Atricure. Dr Gada has served as a consultant for Medtronic, Boston Scientific, Abbott, and Becton Dickinson. Dr Kar has served as a consultant for Abbott, Medtronic, Boston Scientific, W.L. Gore, Laminar, Intershunt, and V wave; received institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; served as co-national principal investigator for the REPAIR MR trial and EXPAND registry; served as co-national principal investigator for the PINNACLE FLX trial and CHAMPION trial; served on the steering committee for the Triluminate trial; and served on the executive committee for the RELIEVE HF trial. Dr Kodali has served as a consultant for and received honoraria from Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; received institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and served on the scientific advisory board and has received equity for Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Laham has served as a speaker for and received compensation from Abbott, Edwards Lifesciences, and Medtronic. Dr Fam has served as a consultant for Edwards Lifesciences and Abbott. Dr Kessler has received speaking honoraria for Edwards Lifesciences and Abbott. Dr O’Neill has served as a consultant for Abiomed, BSCI, and Abbott; and a consultant (expired) for Edwards Lifesciences. Dr Whisenant has served as a consultant for Edwards Lifesciences and Abbott. Dr Kliger has served as a consultant for and received speaking honoraria from Edwards Lifesciences, Medtronic, and Siemens. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller has served as a consultant and proctor for Edwards Lifesciences. Dr Morse has served as a consultant for Edwards Lifesciences. Dr Schofer has received travel support from Edwards Lifesciences and Abbott/St. Jude Medical; and speaking honoraria from Edwards Lifesciences and Boston Scientific. Dr Latib has served as a consultant and on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Mahoney has received grant support, consulting, and/or proctoring fees from Edwards Lifesciences. Dr Kaneko has served on the advisory board of Edwards Lifesciences, Abbott, and Johnson & Johnson; and as a consultant for Medtronic. Dr Shah has received grant support, consulting, and/or proctoring fees from Edwards Lifesciences. Dr Price has received consulting and/or speaking honoraria from Alleviant Medical, Medtronic, Boston Scientific, Abbott, W.L. Gore, Philips Medical, Shockwave, and InnovHeart. Dr Muhammad is a consultant and proctor for Edwards Lifesciences and Medtronic. Dr Praz received personal fees from Edwards Lifesciences during the conduct of the study. Dr Koulogiannis has served as a consultant and advisory board member for Edwards Lifesciences; and a speaker for Abbott. Dr Marcoff has served as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Hausleiter has served as a consultant for, received speaker honoraria from, and institutional research support from Edwards Lifesciences. Dr Lim has served as a consultant for LagunaTech, Nyra Medical, Opus Medical, Philips, Venus, and Valgen; and on his behalf his institution has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Trisol. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain., Objectives: The aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program., Methods: The XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI., Results: Among 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS)., Conclusions: Between 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment., Competing Interests: Funding Support and Author Disclosures The study was sponsored by Abbott. Dr Valgimigli has received personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Opsens, Bayer, CoreFlow, Idorsia Pharmaceuticals, Universität Basel | Departement Klinische Forschung, Vifor, Bristol Myers Squibb, iVascular, and Medscape; and has received grants and personal fees from Terumo, outside the submitted work. Dr Spirito has received a research grant from the Swiss National Science Foundation. Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, Sanofi, and Ventura, outside the submitted work; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Bangalore has received consulting fees or has been an advisory board member for Abbott Vascular, Boston Scientific, Biotronik, Amgen, Pfizer, Merck, Viatris, and REATA. Dr Vranckx has received personal fees from Daiichi Sankyo, Bayer, Pfizer/Bristol Myers Squibb, Novartis, and CSL Behring, not related to this research. Dr Bhatt has served on advisory boards for AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; has served on boards of directors for AngioWave, the Boston VA Research Institute, Bristol Myers Squibb, DRS.LINQ, High Enroll, the Society of Cardiovascular Patient Care, and TobeSoft; has stock or stock options with AngioWave, Bristol Myers Squibb, and DRS.LINQ; has served as inaugural chair of the American Heart Association Quality Oversight Committee; has been a consultant for Broadview Ventures; has served on data monitoring committees for Acesion Pharma, Assistance Publique–Hôpitaux de Paris, the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (chair, PEITHO trial), the Cleveland Clinic (including for the ExCEED trial, funded by Edwards Lifesciences), Contego Medical (chair, PERFORMANCE 2 trial), the Duke Clinical Research Institute, the Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo, and for the ABILITY-DM trial, funded by Concept Medical), Novartis, the Population Health Research Institute, and Rutgers University (for the National Institutes of Health–funded MINT trial); has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org, and chair of the American College of Cardiology Accreditation Oversight Committee), the law firm of Arnold and Porter (work related to Sanofi/Bristol Myers Squibb clopidogrel litigation), the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee, funded by Boehringer Ingelheim; AEGIS-II executive committee, funded by CSL Boehringer), Belvoir Publications (editor-in-chief, Harvard Heart Letter), the Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen & Company, the Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (editor-in-chief, Journal of Invasive Cardiology), the Journal of the American College of Cardiology (guest editor, associate editor), K2P (cochair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (continuing medical education steering committees), MJH Life Sciences, Oakstone CME (course director, Comprehensive Review of Interventional Cardiology), Piper Sandler, the Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and U.S. national coleader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (secretary and treasurer), WebMD (continuing medical education steering committees), and John Wiley (steering committee); has other relationships with Clinical Cardiology (deputy editor), the NCDR-ACTION Registry Steering Committee (chair), and the VA CART Research and Publications Committee (chair); has been named on a patent for sotagliflozin, assigned to Brigham and Women’s Hospital, which assigned to Lexicon (neither Dr Bhatt nor Brigham and Women’s Hospital receives any income from this patent); has received research funding from 89Bio, Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, Myo-Kardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, the Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, and Youngene; has received royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has been a site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; has been a trustee for the American College of Cardiology; and has performed unfunded research for FlowCo andTakeda. Dr Campo has received institutional research grants outside the submitted work. Dr Neumann has received grants or fees from Amgen, Bayer Health Care, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, GlaxoSmithKline, Abbott Vascular, and Medtronic. Dr Toelg has received speaker honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an advisory board member and/or a member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis, with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry, without impact on his personal remuneration. Dr Mehran has received institutional research payments from Abbott, Abiomed, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, Atricure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Element Science, Faraday, Humacyte, Idorsia Pharmaceuticals, Janssen, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, Pi-Cardia, PLx Pharma, RenalPro, RM Global, Shockwave, Vivasure, and Zoll; has received personal fees from Cine-Med Research, Novartis, and WebMD; holds equity (<1%) in Applied Therapeutics, Elixir Medical, Stel, and ControlRad (spouse); is a scientific advisory board member for the American Medical Association, the American College of Cardiology (Board of Trustees member), and the Society for Cardiovascular Angiography and Interventions (Women in Innovations Committee member); is an associate editor for JAMA; and is a faculty member for the Cardiovascular Research Foundation (no fee). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Real-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT., Objectives: The COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR)., Methods: COAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The 1-year outcomes from the COAPT-PAS full cohort and the COAPT-like and MITRA-FR-like subgroups who met RCT inclusion/exclusion criteria are reported., Results: Patients in the COAPT-PAS had more comorbidities, more severe HF and functional limitations, and less guideline-directed medical therapy than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR-like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, a similar and durable reduction of mitral regurgitation to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), a large improvement in quality of life at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR-like), faster procedure times, similar or lower clinical event rates compared with the RCTs' MitraClip arms, and lower clinical event rates than the RCTs' guideline-directed medical therapy only arms. One-year heart failure hospitalizations was 18.9% in COAPT-PAS, 19.7% in COAPT-like compared with 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR-like compared with 47.4% in MITRA-FR-RCT., Conclusions: This large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott. Dr Goel has served as a consultant and proctor for Edwards Lifesciences; and has served as a consultant for Abbott outside the submitted work. Dr Makkar has received grants from Edwards Lifesciences and Abbott; and has served as a consultant for Cordis and Medtronic. Dr Naik has served as a consultant for Abbott and Edwards Lifesciences. Dr Mahoney has served as consultant and proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; has served as a consultant for Abbott; and has received research support from Edwards, Medtronic, Abbott, and Boston Scientific. Dr Morse has served as a consultant for Edwards Lifesciences. Dr Thourani has served as a consultant for or done research with Abbott Vascular, Artivion, Atricure, Boston Scientific, Dasi Simulations, Edwards Lifesciences, Medtronic, and Shockwave. Dr Yadav has served as a consultant and speaker for Edwards Lifesciences, Abbott, Dasi Simulations, and Shockwave Medical. Dr Batchelor has served as a consultant for, is on the Speakers Bureau of, and has received research grant support from Abbott; has served as a consultant for and received research grant support from Boston Scientific; and has served as a consultant for V-Wave and Medtronic. Dr Rogers has received research grant support from Abbott and Boston Scientific; and has served as a consultant for Abbott, Baylis, and Boston Scientific. Dr Whisenant has served as a consultant for Edwards Lifesciences and Abbott. Dr Rinaldi has received advisory board fees from Boston Scientific; has received teaching-course fees from Abbott and Edwards Lifesciences; has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences; has received research support and grants from Boston Scientific; and has received proctor fees from Abbott and Edwards Lifesciences. Dr Hermiller has served as a consultant for Abbott, Edwards Lifesciences, and Medtronic; and has served as a proctor for Abbott and Edwards Lifesciences. Dr Lindenfeld has received research grant support from AstraZeneca; and has received consulting fees from Abbott Vascular, AstraZeneca, CVRx, Edwards Lifesciences, Impulse Dynamics, Boehringer Ingelheim, VoluMetrix, and V-Wave. Dr Lindman has served as a consultant for and received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years., Objectives: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial., Methods: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death., Results: A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients., Conclusions: The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial [Amulet IDE]; NCT02879448)., Competing Interests: Funding Support and Author Disclosures Abbott funded the Amulet IDE Trial. No funding was provided for this analysis. Dr Lakkireddy has received research and educational grants to the institution from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honorarium from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Ellis has received institutional research grants from Boehringer-Ingelheim Inc, Medtronic, and Boston Scientific; and has received consulting/advisory fees from, Abbott Medical Inc, Boston Scientific, and AtriCure Inc. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific, and speaker honorarium from Boston Scientific. Dr Hermiller serves as a consultant to Abbott, Edwards Lifesciences, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has performed consultancy and proctoring for Edwards Lifesciences and Abbott; and is a shareholder for Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is on the advisory board for Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is a consultant for Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; and has received honoraria from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio. Dr Schmidt has received speaker honorarium and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton is a consultant for Boston Scientific, Biosense Webster, St. Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbott, and CVRx Inc. Dr Anderson is an employee of Abbott. Mr Gage is an employee of Abbott. Dr Alkhouli serves as a consultant to Boston Scientific and Abbott. Dr Windecker reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis with payments to the institution but no personal payments; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)