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Background: Percutaneous coronary intervention (PCI) of calcified lesions remains challenging for interventionalists., Aims: We aimed to investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon angioplasty (RA+NCBA)., Methods: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days., Results: The mean age was 71.1±9.4 years, and 22% were women. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm 2 vs 6.9±1.8 mm 2 ; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare, and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group., Conclusions: Combining RA with CBA resulted in a similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

Competing Interests: Declaration of Competing Interest Dr. Christiansen has received research grants from OrbusNeich to his institution. Dr. de Winter has received educational grants from OrbusNeich to his institution. Dr. Jakobsen has received research grants from OrbusNeich to his institution. Dr. Okkels Jensen has received an unrestricted grant to her institution from Biotronik and Biosensors. Dr. Dangas reports personal fees from Biosensors and Philips. Dr. Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe AG, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from ACC, Boston Scientific, California Institute for Regenerative Medicine, Cine-Med Research, Janssen, from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; has <1% equity in Applied Therapeutics, Elixir Medical, and STEL; and has served on the Scientific Advisory Board for AMA. Dr. Spirito received a research grant from the Swiss National Science Foundation. The remaining authors have no competing interests to declare.

Background: Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results., Aims: The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy., Methods: Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization., Results: A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450-1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25-1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25-0.75, p = 0.002)., Conclusions: Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

There is limited data on new-generation stent outcomes in patients with previous coronary artery bypass graft (CABG) and the associated risk of gender and race/ethnicity is unclear. We investigated 1-year outcomes after platinum chromium everolimus-eluting stent implantation in a diverse population of men, women, and minorities with previous CABG pooled from the PLATINUM Diversity (NCT02240810) and PROMUS Element Plus (NCT01589978) registries. Our primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1-year post percutaneous coronary intervention (PCI). Secondary end points included all-cause death, MI, TVR, target vessel failure, and stent thrombosis. A total of 4,175 patients were included in the analysis, including 1,858 women (44.5%), 1,057 minorities (25.3%), and 662 (15.9%) with previous CABG. Patients with previous CABG were older, included more men and White patients, and had more co-morbidities compared with patients without previous CABG. At 1 year, patients with previous CABG had a higher risk of MACE (12.6% vs 7.5%, hazard ratio 1.70, 95% confidence interval 1.32 to 2.19, p <0.001) and end points, including death/MI, TVR, and target vessel failure. After multivariate adjustment, no differences were observed in MACE (adjusted hazard ratio 1.11, 95% confidence interval 0.82 to 1.49, p = 0.506) or any secondary end points. No interaction was observed between previous CABG and gender or minority status. In conclusion, in a contemporary PCI population, patients with previous CABG remain at high risk for PCI because of their elevated risk profile. Previous CABG status was however not independently associated with worse outcomes after adjustment, nor was any interaction observed with gender or race/ethnicity., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Aspirin is the only antiplatelet agent with a Class I recommendation for long-term prevention of cardiovascular events in patients with coronary artery disease (CAD). There is inconsistent evidence on how it compares with alternative antiplatelet agents., Objectives: This study compared P2Y 12 inhibitor monotherapy vs aspirin in patients with CAD., Methods: We conducted a patient-level meta-analysis of randomized trials comparing P2Y 12 inhibitor monotherapy vs aspirin monotherapy for the prevention of cardiovascular events in patients with established CAD. The primary outcome was the composite of cardiovascular death, myocardial infarction, and stroke. Prespecified key secondary outcomes were major bleeding and net adverse clinical events (the composite of the primary outcome and major bleeding). Data were pooled in a 1-step meta-analysis., Results: Patient-level data were obtained from 7 trials. Overall, 24,325 participants were available for analysis, including 12,178 patients assigned to receive P2Y 12 inhibitor monotherapy (clopidogrel in 7,545 [62.0%], ticagrelor in 4,633 [38.0%]) and 12,147 assigned to receive aspirin. Risk of the primary outcome was lower with P2Y 12 inhibitor monotherapy compared with aspirin over 2 years (HR: 0.88; 95% CI: 0.79-0.97; P = 0.012), mainly owing to less myocardial infarction (HR: 0.77; 95% CI: 0.66-0.90; P < 0.001). Major bleeding was similar (HR: 0.87; 95% CI: 0.70-1.09; P = 0.23) and net adverse clinical events were lower (HR: 0.89; 95% CI: 0.81-0.98; P = 0.020) with P2Y 12 inhibitors. The treatment effect was consistent across prespecified subgroups and types of P2Y 12 inhibitors., Conclusions: Given its superior efficacy and similar overall safety, P2Y 12 inhibitor monotherapy might be preferred over aspirin monotherapy for long-term secondary prevention in patients with established CAD. (P2Y 12 Inhibitor or Aspirin Monotherapy as Secondary Prevention in Patients With Coronary Artery Disease: An Individual Patient Data Meta-Analysis of Randomized Trials [PANTHER collaborative initiative]; CRD42021290774)., Competing Interests: Funding Support and Author Disclosures This study was funded by institutional support of the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, and the Department of Cardiology at Bern University Hospital, which had no role in the data analysis, interpretation, or writing of the report. There was no industry involvement in the design, analysis, or funding of this study. Dr Valgimigli has received personal fees from AstraZeneca; has received grants and personal fees from Terumo; and has received personal fees from Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals Ltd, Departement Klinische Forschung of Universität Basel, Bristol Myers Squibb SA, Medscape, Biotronik, and Novartis, outside the submitted work. Dr Windecker has received research and 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 Swiss, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an unpaid advisory board member and/or unpaid 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 but has not received personal payments by pharmaceutical companies or device manufacturers; 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; is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee; is a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the Advisory Board of the Australian Victorian Heart Institute; and is chairperson of the ESC Congress Program Committee and Deputy Editor of JACC: Cardiovascular Interventions. Dr Mehran has served on the scientific advisory boards of the American Medical Association, the American College of Cardiology (Board of Trustees Member), the Society for Cardiovascular Angiography & Interventions (Women in Innovations Committee Member), JAMA Cardiology (Associate Editor), and the Cardiovascular Research Foundation (Faculty) (no fee). Dr Woodward is a consultant for Freeline; and has recently been a consultant to Amgen. Dr Schunkert has received personal fees from Amgen, AstraZeneca, Bayer Vital GmbH, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Merck Sharp & Dohme, Novartis, Sanofi, Servier, and SYNLAB. Dr Franzone has received payment or honoraria for lectures, presentations, Speaker Bureaus, manuscript writing, or educational events from Edwards Lifesciences and Boehringer Ingelheim. 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, and 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, and TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; consultant: Broadview Ventures; 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 National Institutes of Health–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), 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), and 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 Dr Bhatt nor Brigham and Women’s Hospital receive any income from this patent); research funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, 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, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 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, and Vascular Solutions; trustee: American College of Cardiology; and unfunded research: FlowCo and Takeda. Dr Steg has received grants, personal fees, and nonfinancial support from Sanofi; has received grants and personal fees from Amarin, Servier, and Bayer; has received personal fees from Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Idorsia, Pfizer, and Novartis; and has a patent on the use of alirocumab to reduce risk after acute coronary syndrome (royalties to Sanofi) pending. Dr Szarek has served as a consultant or on advisory boards (or both) for CiVi, Resverlogix, Baxter, Esperion, Sanofi, and Regeneron Pharmaceuticals, Inc. 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.)

Coronary stents have revolutionized the treatment of coronary artery disease. Compared with balloon angioplasty, bare-metal stents (BMSs) effectively prevented abrupt vessel closure but were limited by in-stent restenosis (ISR) due to smooth muscle cell proliferation and neointimal hyperplasia. The first-generation drug-eluting stent (DES), with its antiproliferative drug coating, offered substantial advantages over BMSs as it mitigated the risk of ISR. Nonetheless, they had several design limitations that increased the risk of late stent thrombosis. Significant advances in stent design, including thinner struts, enhanced polymers' formulation, and more potent antiproliferative agents, have led to the introduction of new-generation DES with a superior safety profile. Cardiologists have over 20 different DES types to choose from, each with its unique features and characteristics. This review highlights the evolution of stent design and summarizes the clinical data on the different stent types. We conclude by discussing the clinical implications of stent design in high-risk subsets of patients., Competing Interests: Conflict of interest: R.M. reports institutional research payments from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, Philips, RenalPro, Vivasure, and Zoll; personal fees from Cine-Med Research, and WebMD; consulting fees paid to the institution from Abbott, Janssen, Medtronic, Novartis; Equity <1% in Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); Scientific Advisory Board for AMA, ACC (BOT Member), SCAI (Women in Innovations Committee Member), and JAMA Associate Editor; Faculty CRF (no fee). The other authors have nothing to disclose., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR)., Background: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact., Methods: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure., Results: Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding)., Conclusion: CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD., (© 2023 Wiley Periodicals LLC.)

Left main coronary artery (LMA) disease jeopardizes a large area of myocardium and increases the risk of major adverse cardiovascular events. LMCA disease is found in 5% to 7% of all diagnostic coronary angiographies, and more than 80% of the patients enrolled in recent large randomized controlled left main trials had distal left main bifurcation or trifurcation disease. Emerging clinical evidence from prospective all-comer registries and randomized trials has provided a solid basis for percutaneous coronary intervention as a treatment option in selected patients with unprotected LMCA disease; however, to date, no uniform recommendations as to optimal stenting strategy for LMCA bifurcation lesions exist. This review provides an overview of provisional stenting technique and escalation to 2-stent strategies in LMCA bifurcation lesions. Data from randomized controlled trials and registries are reviewed. Technical characteristics of optimal provisional LMCA stenting technique and angiographic and intravascular determinants of escalation are also summarized., Competing Interests: Funding Support and Author Disclosures Dr Paradies has received speaker fee/consultancy for Abbott/Boston Scientific and Abbott research grant to the Institution. Dr Chieffo has received speaker fee/consultancy for Abiomed, Boston Scientific, Biosensor, Menarini, and Shock Wave Medical. Prof Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck; in addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; has received consulting fees from IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Prof van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, PulseCath BV, Daiichi Sankyo, AstraZeneca; and has received advisory/consultancy fees from Amgen, Anteris, JenaValve, Abbott Vascular, Boston Scientific, Biotronik, Medtronic, Abiomed, Amgen, PulseCath BV, Daiichi Sankyo, and AstraZeneca., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

A universal definition to identify patients at higher risk of complications after percutaneous coronary intervention (PCI) is lacking. We aimed to validate a recently developed score to identify patients at increased risk of all-cause death after PCI. All consecutive patients from a large PCI registry not presenting with ST-elevation myocardial infarction or cardiogenic shock were included. Each patient was assigned a score obtained by summing the points associated with the following variables: age >80 years (3 points), dialysis (6 points), left ventricular ejection fraction <30% (2 points), and multivessel PCI (2 points). Patients were stratified in 3 groups: low risk (score 0), intermediate risk (score 2 to 3), or high risk (score ≥4). The primary outcome was all-cause death, and the secondary outcomes were major adverse cardiovascular events and major bleeding. Events were assessed at 1 year after PCI. Between January 2014 and December 2019, 12,689 patients underwent PCI. Compared with the 9,884 patients at low risk, those at intermediate and high risk had a fourfold (hazard ratio 3.99, 95% confidence interval 2.95 to 5.38) and ninefold (hazard ratio 9.55, 95% confidence interval 6.89 to 13.2) higher hazard for all-cause death at 1 year, respectively. The score had a good predictive value for all-cause death at 1 year (area under the curve 0.70). The risk of major adverse cardiovascular events and major bleeding increased consistently from the low- to the high-risk group. In conclusion, in patients who underwent PCI for stable ischemic heart disease or non-ST-elevation acute coronary syndrome, a score based on 4 variables well predicted the risk of all-cause death at 1 year., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Patients with chronic kidney disease (CKD) are at higher risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). Complex PCI (CPCI) is associated with higher rates of ischemic complications. Whether CPCI confers an additive risk of adverse events in CKD patients is unclear., Methods: Patients who underwent PCI at a single tertiary-care-center between 2012 and 2019 were stratified by CKD status and CPCI. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1-year follow-up. Secondary outcomes included the individual components of the primary outcome and major bleeding., Results: Out of 15,071 patients, 4537 (30.1%) had CKD and 10,534 (69.9%) had no CKD. Patients undergoing CPCI were 1151 (25.4%) and 2983 (28.3%) in the two cohorts, respectively. At one year, CPCI compared with no CPCI was associated with higher risk of MACE in both CKD (Adj. HR 1.72, 95% confidence interval [CI] 1.45-2.06, p < 0.001) and no-CKD patients (Adj. hazard ratios [HR] 2.19, 95% CI 1.91-2.51, p < 0.001; p of interaction 0.057), determined by an excess of death, MI and TVR in CKD patients and of TVR and MI only in no-CKD. CPCI was related with a consistent increase of major bleeding in the CKD (Adj. HR 1.49, 95% CI 1.18-1.87, p < 0.001) and no-CKD group (Adj. HR 1.23, 95% CI 0.98-1.54, p = 0.071, p of interaction 0.206)., Conclusion: At 1-year follow-up, CPCI was associated with higher risk of MACE and major bleeding irrespective of concomitant CKD. CPCI predicted mortality in CKD patients only., (© 2023 Wiley Periodicals LLC.)

Background: COMBO (OrbusNeich Medical, Hong Kong) is a dual-therapy coronary stent featuring sirolimus as antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collaboration aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI)., Methods: Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry and MASCOT studies were pooled together. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI) or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes were the individual components of the primary endpoint and stent thrombosis (ST). Endpoints were evaluated against performance goals based on the EAPCI (the European Association of Percutaneous Coronary Intervention) recommendations for new drug-eluting stents., Results: A total of 6753 patients (mean age 63.7 ± 11.4 years, 23% women) were included. At 1-year follow-up, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and CD-TLR were 1.3%, 1.8%, and 2.5%, respectively. The rate of definite/probable ST was 0.73%, early ST (<1 month) was 0.48%, while late ST (1-12 months) was 0.26%. The performance goals were met for all of the evaluated endpoints., Conclusions: This large patient-level pooled analysis provides a comprehensive outline of the performance of the dual-therapy COMBO stent. The low rates of primary and secondary endpoints suggest that this stent technology may be a good alternative to other contemporary drug eluting coronary stent platforms., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Biological and sociocultural differences between men and women are complex and likely account for most of the variations in the epidemiology and treatment outcomes of coronary artery disease (CAD) between the 2 sexes. Worse outcomes in women have been described following both conservative and invasive treatments of CAD. For example, increased levels of residual platelet reactivity during treatment with antiplatelet drugs, higher rates of adverse cardiovascular outcomes following percutaneous coronary revascularization, and higher operative and long-term mortality after coronary bypass surgery have been reported in women compared with in men. Despite the growing recognition of sex-specific determinants of outcomes, representation of women in clinical studies remains low and sex-specific management strategies are generally not provided in guidelines. This review summarizes the current evidence on sex-related differences in patients with CAD, focusing on the differential outcomes following medical therapy, percutaneous coronary interventions, and coronary artery bypass surgery., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the prevalence and prognostic impact of high bleeding risk (HBR), as determined by the Academic Research Consortium HBR criteria, in real-world patients undergoing left main (LM) percutaneous coronary intervention (PCI)., Background: LM PCI is often reserved for patients at increased risk for periprocedural adverse events. Patients at HBR represent a relevant percentage of this cohort, but their outcomes after LM PCI are still poorly investigated., Methods: All patients undergoing LM PCI between 2014 and 2017 at a tertiary care center were prospectively enrolled. Patients were defined as having HBR if they met at least 1 major or 2 minor Academic Research Consortium HBR criteria. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months., Results: Among 619 enrolled patients, 55.3% were at HBR. The rate of the primary endpoint was 4-fold higher in patients at HBR compared with those without HBR (20.5% vs 4.9%; HR: 4.43; 95% CI: 2.31-8.48), driven by an increased risk for all-cause death (HR: 3.88; 95% CI: 1.88-8.02) and MI (HR: 6.18; 95% CI: 1.83-20.9). Rates of target vessel or lesion revascularization and stent thrombosis were comparable in the 2 groups. Bleeding occurred more frequently in patients at HBR (HR: 3.77; 95% CI: 1.83-7.76). Consistent findings were observed after Cox multivariable regression adjustment., Conclusions: Among patients undergoing LM PCI, those with HBR are at increased risk for all-cause death, MI, and bleeding. Conversely, rates of repeat revascularization and stent thrombosis were comparable, suggesting frailty and comorbidities as primary causes of worse outcomes in patients at HBR., Competing Interests: Funding Support and Author Disclosures Dr Stefanini has received a research grant from Boston Scientific; and speaker or consulting fees from B. Braun, Biosensors, and Boston Scientific. Dr Baber has received honoraria from AstraZeneca and Boston Scientific. Dr Sharma has received fees for Speaker Bureau from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr Mehran has received grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo Company, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; personal fees from Abbott Laboratories, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, PLx Opco d/b/a PLx Pharma, Roivant Sciences, Sanofi, Medtelligence (Janssen Scientific Affairs), and Janssen Scientific Affairs; other compensation from Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano, and Watermark Research Partners; and nonfinancial support and other compensation from Regeneron Pharmaceuticals and Idorsia Pharmaceuticals. Dr Dangas has received consulting fees and advisory board fees from AstraZeneca; consulting fees from Biosensors; and previously held stock in Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents., Background: Second-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications., Methods: DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up., Results: A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not., Conclusions: Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes., (© 2020 Wiley Periodicals LLC.)

Objectives: To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery., Background: Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown., Methods: We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI., Results: Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components., Conclusions: Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials., (© 2021 Wiley Periodicals LLC.)

Background: Although the number of complex percutaneous coronary intervention (CPCI) procedures is increasing, data regarding sex-related outcomes following CPCI are scarce., Methods: We retrospectively analyzed data of patients enrolled in a single-center registry between 2009 and 2017. Patients were divided into two groups (CPCI and non-CPCI) stratified by sex. CPCI was defined as any PCI procedure with ≥1 of the following characteristics: ≥3 target vessels/lesions, ≥3 stents implanted, bifurcation with ≥2 stents, stent length > 60 mm, or chronic total occlusion. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization, at oneon-year follow-up., Results: Among 20,419 patients, 5004 (24.5%) underwent CPCI of whom 25.6% (n = 1281) women and 74.4% (n = 3723) men. Women presented with more comorbidities yet less complex coronary anatomy than men (syntax score: 19.5 ± 10.3 vs. 20.6 ± 10.7, p = 0.009). Moreover, women were more likely to fulfill a single rather than multiple CPCI criteria. At one year, a higher rate of MACE occurred in women (14.0% vs. 11.6%, p = 0.02). After multivariable adjustment for confounders, the risk of MACE at one year was similar among both sexes (HR:1.04, 95% CI [0.85-1.26], p = 0.71), without significant interaction between the complexity of the procedure and sex (p-interaction = 0.96). Nonetheless, the risk of MI was significantly higher in women than men undergoing CPCI (HR:1.63, 95% CI [1.12-2.38], p = 0.01)., Conclusions: Despite presenting with less challenging lesions than men, women had a higher rate of MI at one year following CPCI, even after adjusting for potential confounders., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Since its introduction in 1977, percutaneous coronary intervention has become one of the most commonly performed therapeutic procedures worldwide. Such widespread diffusion, however, would have not been possible without a concomitant evolution of the pharmacotherapies associated with this intervention. Antithrombotic agents are fundamental throughout the management of patients undergoing coronary stent implantation, starting from the procedure itself to the long-term prevention of cardiovascular events. The last 40 years of interventional cardiology have seen remarkable improvements in both drug therapies and device technologies, which largely reflected a progressive understanding of the pathophysiological mechanisms of coronary artery disease, as well as procedure- and device-related adverse events. The purpose of this article is to provide an overview of the important milestones in antithrombotic pharmacology that have shaped clinical practice of today while also providing insights into knowledge gaps and future directions., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Perioperative cardiovascular complications are important causes of morbidity and mortality associated with non-cardiac surgery, particularly in patients with coronary artery disease (CAD). Although preoperative cardiac risk assessment can facilitate the identification of vulnerable patients and implementation of adequate preventive measures, excessive evaluation might lead to undue resource utilization and surgical delay. Owing to conflicting data, there remains some uncertainty regarding the most beneficial perioperative strategy for patients with CAD. Antithrombotic agents are the cornerstone of secondary prevention of ischaemic events but substantially increase the risk of bleeding. Given that 5-25% of patients undergoing coronary stent implantation require non-cardiac surgery within 2 years, surgery is the most common reason for premature cessation of dual antiplatelet therapy. Perioperative management of antiplatelet therapy, which necessitates concomitant evaluation of the individual thrombotic and bleeding risks related to both clinical and procedural factors, poses a recurring dilemma in clinical practice. Current guidelines do not provide detailed recommendations on this topic, and the optimal approach in these patients is yet to be determined. This Review summarizes the current data guiding preoperative risk stratification as well as periprocedural management of patients with CAD undergoing non-cardiac surgery, including those treated with stents.

Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in epidemiologic studies. Evidence regarding its role in patients who underwent percutaneous coronary intervention (PCI) is scarce. We evaluated consecutive patients who underwent PCI with drug-eluting stents from 2012 to 2017, excluding those with unavailable baseline HDL, age <18 years, presentation with ST-segment elevation myocardial infarction (MI) or shock, and coexisting neoplastic disease. The final population was stratified according to baseline HDL levels into reduced and nonreduced HDL cohorts, with cut-off value 40 mg/dl in males and 50 mg/dl in females. The primary end point was 1-year major adverse cardiovascular events (MACE), defined as the composite of death, MI, or target vessel revascularization (TVR). Among 10,843 patients included, 6,511 (60%) had reduced HDL, and 4,332 (40%) nonreduced HDL. The rate of 1-year MACE was similar between the 2 groups (7.5% vs 6.6%; p = 0.14). Although mortality and MI rates were comparable, reduced HDL was associated with significantly higher TVR 5.2% vs 4.0%; p = 0.02, a finding that attenuated after multivariable adjustment (adjusted hazard ratio 1.18, p = 0.14). Sex subgroup analysis included 7,718 (71.2%) males and 3,125 (28.8%) females. Among men, there was a trend toward higher MACE in those with reduced HDL (7.4% vs 6.0%; p = 0.08) mostly driven by TVR (5.4% vs 3.7%; p = 0.005). No association between HDL and 1-year outcomes was evident in females. Assessment for interaction between sex and reduced HDL did not reach statistical significance. In conclusion, reduced baseline HDL was not associated with increased risk of MACE in a contemporary PCI population., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Women have been associated with higher rates of recurrent events after percutaneous coronary intervention than men, possibly attributable to advanced age at presentation and greater comorbidities. These factors also put women at higher risk of bleeding, which may influence therapeutic strategies and clinical outcomes. Methods and Results We performed a patient-level pooled analysis of 4 postapproval registries to evaluate sex-related differences in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. HBR required fulfillment of at least 1 major or 2 minor criteria of the Academic Research Consortium definition. Outcomes of interest were major bleeding and major adverse cardiac events (composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis). Of the total 10 502 patients, 2832 (27.0%) were women. The prevalence of HBR was higher in women compared with men (29.0% versus 20.5%, P <0.0001). Women at HBR were older and had more comorbidities, while men at HBR were more often smokers, with prior myocardial infarction and more complex coronary lesions. At 4 years, women at HBR had significantly higher major bleeding compared with men at HBR (10.8% versus 6.2%, P <0.0001); however, this difference was attenuated after multivariable adjustment (hazard ratio, 0.92; 95% CI, 0.41-2.08). Major adverse cardiac event rates between groups were similar (12.2% versus 12.6%, P =0.82) and remained consistent after adjustment (hazard ratio, 0.64; 95% CI, 0.32-1.28). Conclusions The prevalence of HBR was higher in women compared with men, with considerable differences in the distribution of criteria. Women at HBR experienced higher rates of major bleeding but similar major adverse cardiac event rates compared with men at HBR at 4 years.

Introduction : The increasing complexity of patients undergoing percutaneous coronary intervention (PCI) regarding both coronary anatomy and comorbidities requires dedicated devices. The Resolute Onyx (R-Onyx, Medtronic, CA, USA) stent is a novel durable polymer zotarolimus-eluting stent (ZES) promising better deliverability, increased radiopacity and lower thrombogenicity. Areas covered : In this review, we discuss device features, preclinical evidence, and clinical studies including patients treated with R-Onyx. The BIONYX and Onyx ONE studies were two major landmark trials demonstrating non-inferiority of R-Onyx as compared to other latest generation devices. We also elaborate on alternative innovations in drug-eluting stent (DES) technology and how R-Onyx fits into this field. Expert opinion : R-Onyx is designed to address the challenges of contemporary PCI, but evidence on its clinical performance is largely derived from studies on older generation devices from the ZES family. Nonetheless, all clinical studies on R-Onyx consistently show excellent outcomes, with particularly low rates of stent thrombosis, making it a promising candidate for short dual antiplatelet regimens. In addition, R-Onyx is available with a wide range of stent diameters allowing accurate sizing for both very small and very large coronary vessels.

Objectives: This study compared clinical outcomes and revascularization strategies among patients presenting with low ejection fraction, low-gradient (LEF-LG) severe aortic stenosis (AS) according to the assigned treatment modality., Background: The optimal treatment modality for patients with LEF-LG severe AS and concomitant coronary artery disease (CAD) requiring revascularization is unknown., Methods: Of 1,551 patients, 204 with LEF-LG severe AS (aortic valve area <1.0 cm(2), ejection fraction <50%, and mean gradient <40 mm Hg) were allocated to medical therapy (MT) (n = 44), surgical aortic valve replacement (SAVR) (n = 52), or transcatheter aortic valve replacement (TAVR) (n = 108). CAD complexity was assessed using the SYNTAX score (SS) in 187 of 204 patients (92%). The primary endpoint was mortality at 1 year., Results: LEF-LG severe AS patients undergoing SAVR were more likely to undergo complete revascularization (17 of 52, 35%) compared with TAVR (8 of 108, 8%) and MT (0 of 44, 0%) patients (p < 0.001). Compared with MT, both SAVR (adjusted hazard ratio [adj HR]: 0.16; 95% confidence interval [CI]: 0.07 to 0.38; p < 0.001) and TAVR (adj HR: 0.30; 95% CI: 0.18 to 0.52; p < 0.001) improved survival at 1 year. In TAVR and SAVR patients, CAD severity was associated with higher rates of cardiovascular death (no CAD: 12.2% vs. low SS [0 to 22], 15.3% vs. high SS [>22], 31.5%; p = 0.037) at 1 year. Compared with no CAD/complete revascularization, TAVR and SAVR patients undergoing incomplete revascularization had significantly higher 1-year cardiovascular death rates (adj HR: 2.80; 95% CI: 1.07 to 7.36; p = 0.037)., Conclusions: Among LEF-LG severe AS patients, SAVR and TAVR improved survival compared with MT. CAD severity was associated with worse outcomes and incomplete revascularization predicted 1-year cardiovascular mortality among TAVR and SAVR patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: The aim of this study was to evaluate whether coronary artery disease (CAD) severity exerts a gradient of risk in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI)., Methods and Results: A total of 445 patients with severe AS undergoing TAVI were included into a prospective registry between 2007 and 2012. The preoperative SYNTAX score (SS) was determined from baseline coronary angiograms. In case of revascularization prior to TAVI, residual SS (rSS) was also determined. Clinical outcomes were compared between patients without CAD (n = 158), patients with low SS (0-22, n = 207), and patients with high SS (SS > 22, n = 80). The pre-specified primary endpoint was the composite of cardiovascular death, stroke, or myocardial infarction (MI). At 1 year, CAD severity was associated with higher rates of the primary endpoint (no CAD: 12.5%, low SS: 16.1%, high SS: 29.6%; P = 0.016). This was driven by differences in cardiovascular mortality (no CAD: 8.6%, low SS: 13.6%, high SS: 20.4%; P = 0.029), whereas the risk of stroke (no CAD: 5.1%, low SS: 3.3%, high SS: 6.7%; P = 0.79) and MI (no CAD: 1.5%, low SS: 1.1%, high SS: 4.0%; P = 0.54) was similar across the three groups. Patients with high SS received less complete revascularization as indicated by a higher rSS (21.2 ± 12.0 vs. 4.0 ± 4.4, P < 0.001) compared with patients with low SS. High rSS tertile (> 14) was associated with higher rates of the primary endpoint at 1 year (no CAD:12.5%, low rSS: 16.5%, high rSS: 26.3%, P = 0.043)., Conclusions: Severity of CAD appears to be associated with impaired clinical outcomes at 1 year after TAVI. Patients with SS > 22 receive less complete revascularization and have a higher risk of cardiovascular death, stroke, or MI than patients without CAD or low SS., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

The key role played by platelets in the atherosclerosis physiopathology, especially in the acute setting, is ascertained: they are the main actors during thrombus formation and, thus, one of the major investigated elements related to atherothrombotic process involving coronary arteries. Platelets have been studied from different points of view, according with the technology advances and the improvement in the hemostasis knowledge achieved in the last years. Morphology and reactivity constitute the first aspects investigated related to platelets with a significant body of evidence published linking a number of their values and markers to coronary artery disease and cardiovascular events. Recently, the impact of genetics on platelet activation has been explored with promising findings as additional instrument for patient risk stratification; however, this deserves further confirmations. Moreover, the interplay between immune system and platelets has been partially elucidated in the last years, providing intriguing elements that will be basic components for future research to better understand platelet regulation and improve cardiovascular outcome of patients. [ABSTRACT FROM AUTHOR]

Cardiovascular disease still represents the main cause of mortality worldwide. Despite huge improvements, atherosclerosis persists as the principal pathological condition, both in stable and acute presentation. Specifically, acute coronary syndromes have received substantial research and clinical attention in recent years, contributing to improve overall patients' outcome. The identification of different evolution patterns of the atherosclerotic plaque and coronary artery disease has suggested the potential need of different treatment approaches, according to the mechanisms and molecular elements involved. In addition to traditional risk factors, the finer portrayal of other metabolic and lipid-related mediators has led to higher and deep knowledge of atherosclerosis, providing potential new targets for clinical management of the patients. Finally, the impressive advances in genetics and non-coding RNAs have opened a wide field of research both on pathophysiology and the therapeutic side that are extensively under investigation. [ABSTRACT FROM AUTHOR]

There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories. The aim of this study was to investigate bleeding and ischemic outcomes according to BMI in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial. The TWILIGHT trial randomized high-risk patients to ticagrelor plus aspirin or ticagrelor plus placebo at 3 months after percutaneous coronary intervention. In this secondary analysis, patients were stratified by standard BMI categories, as recommended by the European Society of Cardiology Working Group on Thrombosis (normal weight [BMI 18.5-24.99 kg/m2], overweight [BMI 25-29.99 kg/m2], and obese [BMI ≥30 kg/m2]) and by median BMI, as prespecified in the protocol. Among 7,038 patients randomized and with available BMI, 1,807 (25.7%) were normal weight, 2,927 (41.6%) were overweight, and 2,304 (32.7%) were obese. In normal-weight, overweight, and obese patients, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced the primary endpoint of Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (normal weight: HR: 0.48 [95% CI: 0.32-0.73]; overweight: HR: 0.57 [95% CI: 0.41-0.78]; obese: HR: 0.63 [95% CI: 0.44-0.91]; P for interaction = 0.627), without any increase in the composite ischemic endpoint of all-cause death, myocardial infarction, or stroke (normal weight: HR: 1.36 [95% CI: 0.84-2.19]; overweight: HR: 0.92 [95% CI: 0.63-1.35]; obese: HR: 0.84 [95% CI: 0.56-1.25]; P for interaction = 0.290). These findings were consistent with the prespecified analysis by median BMI. Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Bleeding following percutaneous coronary intervention has important prognostic implications. The Academic Research Consortium (ARC) recently proposed a list of clinical criteria to define patients at high bleeding risk (HBR).Objectives: This study sought to validate the ARC definition for HBR patients in a contemporary real-world cohort.Methods: Patients undergoing coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they met at least 1 major or 2 minor ARC-HBR criteria. To account for the presence of multiple criteria, patients were further stratified by the number of times they fulfilled the ARC-HBR definition. The primary endpoint was a composite of peri-procedural in-hospital or post-discharge bleeding at 1 year. Secondary endpoints included individual components of the primary bleeding endpoint, myocardial infarction, and all-cause mortality.Results: Among 9,623 patients, 4,278 (44.4%) qualified as HBR. Moderate or severe anemia was the most common major criterion (33.2%); age ≥75 years was the most frequent minor criterion and the most common overall (46.8%). The rate of the primary bleeding endpoint at 1 year was 9.1% in HBR patients compared with 3.2% in non-HBR patients (p < 0.001), with a stepwise increase in bleeding risk corresponding to the number of times the ARC-HBR definition was fulfilled. HBR patients also experienced significantly higher rates of all secondary endpoints.Conclusions: This study validates the ARC-HBR definition in a contemporary group of patients who underwent percutaneous coronary intervention. The ARC-HBR definition identified patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria showed additive prognostic value. [ABSTRACT FROM AUTHOR]

Objectives This study compared clinical outcomes and revascularization strategies among patients presenting with low ejection fraction, low-gradient (LEF-LG) severe aortic stenosis (AS) according to the assigned treatment modality. Background The optimal treatment modality for patients with LEF-LG severe AS and concomitant coronary artery disease (CAD) requiring revascularization is unknown. Methods Of 1,551 patients, 204 with LEF-LG severe AS (aortic valve area <1.0 cm 2 , ejection fraction <50%, and mean gradient <40 mm Hg) were allocated to medical therapy (MT) (n = 44), surgical aortic valve replacement (SAVR) (n = 52), or transcatheter aortic valve replacement (TAVR) (n = 108). CAD complexity was assessed using the SYNTAX score (SS) in 187 of 204 patients (92%). The primary endpoint was mortality at 1 year. Results LEF-LG severe AS patients undergoing SAVR were more likely to undergo complete revascularization (17 of 52, 35%) compared with TAVR (8 of 108, 8%) and MT (0 of 44, 0%) patients (p < 0.001). Compared with MT, both SAVR (adjusted hazard ratio [adj HR]: 0.16; 95% confidence interval [CI]: 0.07 to 0.38; p < 0.001) and TAVR (adj HR: 0.30; 95% CI: 0.18 to 0.52; p < 0.001) improved survival at 1 year. In TAVR and SAVR patients, CAD severity was associated with higher rates of cardiovascular death (no CAD: 12.2% vs. low SS [0 to 22], 15.3% vs. high SS [>22], 31.5%; p = 0.037) at 1 year. Compared with no CAD/complete revascularization, TAVR and SAVR patients undergoing incomplete revascularization had significantly higher 1-year cardiovascular death rates (adj HR: 2.80; 95% CI: 1.07 to 7.36; p = 0.037). Conclusions Among LEF-LG severe AS patients, SAVR and TAVR improved survival compared with MT. CAD severity was associated with worse outcomes and incomplete revascularization predicted 1-year cardiovascular mortality among TAVR and SAVR patients. [ABSTRACT FROM AUTHOR]