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Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI)., Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR., Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022., Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups., Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB)., Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI., Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events., Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.

Background: Percutaneous coronary intervention (PCI) for bifurcation lesions can be technically challenging and is associated with higher risk. There is little data on sex-based differences in strategy and outcomes in bifurcation PCI., Aims: We sought to assess whether differences exist between women and men in the treatment and outcomes of bifurcation PCI., Methods: We collected data on 4006 patients undergoing bifurcation PCI, from the e-ULTIMASTER study, a prospective, multicentre study enrolling patients from 2014 to 2018. We divided the bifurcation cohort according to sex, with 1-year follow-up of outcomes (target lesion failure [TLF], target vessel failure [TVF], and patient-oriented composite endpoint [POCE])., Findings: Women were older (69.2 ± 10.9 years vs. 64.4 ± 11.0 years), with a greater burden of cardiovascular comorbidities. For true and non-true bifurcation lesions, women and men were equally likely to undergo a single stent approach (true: 63.2% vs. 63.6%, p = 0.79, non-true: 95.4% vs. 94.3%, p = 0.32), with similar rates of final kissing balloon (FKB) (37.2% vs. 35.5%, p = 0.36) and proximal optimization (POT) (34.4% vs. 34.2%, p = 0.93) in cases where two stents were used. Lastly, after propensity score matching, there was no difference between women and men in the incidence of the composite endpoints of TLF (5.5% vs. 5.2%, RR 1.05 [95% CI 0.77-1.44], p = 0.75), TVF (6.2% vs. 6.3%, RR 0.99 [95% CI 0.74-1.32], p = 0.96), and POCE (9.9% vs. 9.5%, RR 1.05 [95% CI 0.83-1.31], p = 0.70)., Conclusion: In this contemporary, real-world study of bifurcation PCI, we report no difference in stent strategy between women and men, with similar outcomes at 1-year., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background Coronary bifurcation lesions (CBLs) are frequently encountered in clinical practice and are associated with worse outcomes after percutaneous coronary intervention. However, there are limited data around the prognostic impact of different CBL distributions. Methods and Results All CBL percutaneous coronary intervention procedures from the prospective e-Ultimaster (Prospective, Single-Arm, Multi Centre Observations Ultimaster Des Registry) multicenter international registry were analyzed according to CBL distribution as defined by the Medina classification. Cox proportional hazards models were used to compare the hazard ratio (HR) of the primary outcome, 1-year target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization), and its individual components between Medina subtypes using Medina 1.0.0 as the reference category. A total of 4003 CBL procedures were included. The most prevalent Medina subtypes were 1.1.1 (35.5%) and 1.1.0 (26.8%), whereas the least prevalent was 0.0.1 (3.5%). Overall, there were no significant differences in patient and procedural characteristics among Medina subtypes. Only Medina 1.1.1 and 0.0.1 subtypes were associated with increased target lesion failure (HR, 2.6 [95% CI, 1.3-5.5] and HR, 4.0 [95% CI, 1.6-9.0], respectively) at 1 year, compared with Medina 1.0.0, prompted by clinically driven target lesion revascularization (HR, 3.1 [95% CI, 1.1-8.6] and HR, 4.6 [95% CI, 1.3-16.0], respectively) as well as cardiac death in Medina 0.0.1 (HR, 4.7 [95% CI, 1.0-21.6]). No differences in secondary outcomes were observed between Medina subtypes. Conclusions In a large multicenter registry analysis of coronary bifurcation percutaneous coronary intervention procedures, we demonstrate prognostic differences in 1-year outcomes between different CBL distributions, with Medina 1.1.1 and 0.0.1 subtypes associated with an increased risk of target lesion failure.

Background and Aims: Patients with peripheral artery disease (PAD) represent a high risk group, and have an increased risk of cardiovascular events and worse cardiovascular outcomes. Our aim was to study the impact of PAD among patients undergoing percutaneous coronary intervention (PCI) with a newer-generation thin-strut DES., Methods: In this analysis of the e-ULTIMASTER registry, patients with and without known PAD undergoing PCI were compared. A propensity-score was used to adjust for differences between the groups. The primary outcome was target lesion failure (TLF): a composite of cardiac death, target-vessel related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up., Results: Of 33,880 patients included in the analysis, PAD was present in 2255 (6.7%). Patients with PAD were older (69.0 ± 10.0 vs. 63.8 ± 11.3 years) with a higher burden of comorbidities. Patients with PAD were less likely to present with STEMI (9.6% vs. 21%), and more likely to undergo complex PCI (left main 5.5% vs. 3.0% ostial lesions 10.4% vs. 7.0%, bifurcations 14.5% vs. 12.3% and calcification 26.8% vs. 17.8%). PAD was found to be independently associated with 41% increased risk for TLF. The risk for all cause death and for cardiac death was 75% and 103% higher, respectably. No difference was found in the rates of stent thrombosis, clinically driven target lesion revascularization, or myocardial infarction (MI)., Conclusions: Patients with PAD are at higher risk for (cardiac) death post PCI, but not target vessel or lesion repeat revascularizations. The PAD cohort represents a population with a higher risk clinical profile. Further research combining medical and device therapies is needed to further improve the outcomes in this high-risk population., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice., Methods: A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events., Results: The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43)., Conclusions: These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Aim To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). Methods and results In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n  = 1707; standard DAPT, n  = 1676) and 1196 complex (abbreviated DAPT, n  = 588; standard DAPT, n  = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69–1.52, and HR: 1.24, 95% CI: 0.79–1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71–1.15, and HR: 0.91, 95% CI: 0.69–1.21; P interaction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42–0.98, and HR: 0.70; 95% CI: 0.55–0.89; P interaction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. Conclusion In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. Clinical Trial Registration This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed. [ABSTRACT FROM AUTHOR]