Search

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.)

Background: In the drug-eluting stent era, the best strategy to treat Medina 001 lesion remains unestablished. This is the first prospective registry assessing the efficacy and safety of the second-generation drug-coated balloon in patients with side-branch ostial lesion., Methods: Forty-nine patients with de novo Medina 001 lesion and associated myocardial ischemia were treated with second-generation drug-coated balloon-Dior balloon catheter (Eurocor GmbH, Bonn Germany), and prospectively included in this study. After mandatory pre-dilatation, a paclitaxel-eluting balloon was inflated for a minimum of 45 seconds. Left main bifurcation, severely calcified lesions and cardiogenic shock, were the only exclusion criteria., Results: The inclusion period was 2.7 years. Mean age was 62 ± 12 years old, 41% diabetic, 65% presented with acute coronary syndrome. The most common vessel treated was the first diagonal (50%). Pre-dilatation with a cutting balloon was used in 59%. Angiographic success was 86% (in 14% a bare metal stent was implanted because of acute recoil [n = 5] or coronary dissection more than type B [n = 2]). At a mean of 12.2 ± 2.2 months, major cardiac adverse events rate was 14.3% (1 myocardial infarction, 0 cardiac deaths, 7 target lesion revascularization). There was no thrombosis or occlusion. At a mean of 7.2 ± 1.1 months, binary restenosis was 22.5% (n = 7) with a late loss of 0.32 ± 0.73 mm., Conclusion: Medina 001 lesion is an infrequent type of coronary lesion. Drug-coated balloon-Dior is a safe and technically easy therapeutic option, associated with acceptable mid-term clinical outcomes. (J Interven Cardiol 2016;29:285-292)., (© 2016, Wiley Periodicals, Inc.)

Iatrogenic coronary ostial stenosis after aortic valve replacement is a rare, life-threatening complication, which may follow implantation of either a mechanical or a biological prosthesis. Historically, this condition has been treated by urgent coronary bypass surgery but is associated with high morbidity and mortality, due to the hazards of early repeat sternotomy. We report a case of iatrogenic coronary ostial stenosis successfully treated with stenting and discuss the advantages of percutaneous intervention over coronary bypass surgery., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Objectives: To determine the 3 year safety and efficacy of crush-stenting with paclitaxel-eluting stents., Background: The optimum two-stent strategy for treatment of coronary bifurcation lesions is undetermined. Crush-stenting is advocated to minimize restenosis through complete circumferential stent coverage; long-term follow-up data are lacking., Methods and Results: In a single center prospective registry, 100 consecutive patients with bifurcation lesions were treated with the Crush technique. The vast majority (93%) were true bifurcations, predominantly involving the left anterior descending and diagonal arteries. Technical success was 98%. Final kissing balloon dilatation, which became standard practice during the study, was attempted in 68 patients and successful in 51. Abciximab was used in all cases. There were no peri-procedural stent thromboses. Follow-up was 100% at 3 years. Symptom-driven target lesion revascularisation was 8% at 3 years. Cumulative 3-year major adverse cardiac events was 28% (7 cardiac deaths, 15 myocardial infarctions, 11 target vessel revascularisations). Absence of a final kissing inflation predicted repeat revascularisation but not death, infarction or stent thrombosis. Three probable stent thromboses occurred, of which two were very late., Conclusion: Where a two-stent bifurcation strategy is required, Crush-stenting with paclitaxel-eluting stents is safe and effective in the long-term. Failure to perform a final kissing dilatation increases the likelihood of revascularisation but not other adverse events.

Aims: The long-term impact of treating bifurcation lesions on the overall outcome of patients with multivessel coronary disease treated percutaneously with drug-eluting stents is unknown. This analysis determined the influence of bifurcation treatment using sirolimus-eluting stents on 3-year clinical outcomes., Methods and Results: Of the 607 patients (2,160 lesions) in the ARTS II study, 324 patients underwent revascularisation procedures involving treatment of at least one bifurcation (465 lesions). Three-year outcomes were compared to those without bifurcations. Despite more diffuse and complex disease in the bifurcation group, survival free of adverse events was equivalent in the two groups. At 3-years, there was no difference in rate of overall MACCE (20.2% vs. 18.5%, p=NS) or any of the component events between the bifurcation and the non-bifurcation group. There was a trend for a higher rate of definite stent thrombosis in the bifurcation group (4.6 vs 2.1%, p=0.1), but in multivariate analysis the CK value post-procedure served as the only independent predictor of definite stent thrombosis (p=0.015), with the presence of a bifurcation lesion of borderline significance (p=0.056)., Conclusions: In multivessel disease treated by PCI with DES, the presence of bifurcation disease had no adverse influence on 3-year clinical outcomes.

Background: Cardiac surgery is the reference treatment for patients with left main (LM) disease, although percutaneous coronary intervention with drug-eluting stents is emerging as a possible alternative. The objective of this registry was to evaluate the 2-year outcome of elective percutaneous coronary intervention for unprotected LM disease with paclitaxel-eluting stents., Methods and Results: A total of 291 patients were prospectively included from 4 centers. Acute myocardial infarction and cardiogenic shock were the only exclusion criteria. Patients were 69+/-11 years old, 29% were diabetic, and 25% had 3-vessel disease. For distal LM lesions (78%), the provisional side-branch T-stenting approach was used in 92% of cases and final kissing balloon inflation in 97%. Angiographic success was obtained in 99.7% of cases. At 2-year follow-up, the total cardiac death rate was 5.4% (1 EuroSCORE point was associated with a 15% [95% confidence interval 2.9% to 28.2%, P=0.013] higher risk of cardiac death), target-lesion revascularization was 8.7%, and incidence of Q-wave or non-Q-wave myocardial infarction was 0.9% and 3.1%, respectively. The combined end point occurred in 15.8% of cases and stroke in 0.7%. The incidence of definite and probable LM stent thrombosis was 0.7%, whereas the incidence of any stent thrombosis was 3.8%, with a higher risk in patients with side-branch stenting in the presence of LM bifurcation lesions (hazard ratio 9.6, 95% confidence interval 1.2 to 77.7, P=0.035)., Conclusions: Unprotected LM stenting with paclitaxel-eluting stents, with a strategy of provisional side-branch T-stenting for distal lesions, provides excellent acute angiographic results and good mid-term clinical outcomes, with a 15.8% rate of major adverse cardiac events at 2-year follow-up.

Spontaneous coronary artery dissection is a rare but occasionally lethal condition that is more common in the peri- and post-partum periods. Recommendations for its management are derived from the literature only in the form of single case reports and few small case series in which successful outcomes were obtained. No consensus of opinion or guideline for optimal treatment exists. We present a case of post-partum coronary artery dissection initially treated with drug-eluting stents, but complicated by the extension of intramural hematoma and further dissection. After consideration of surgical revascularization, medical management with dual-antiplatelet therapy resulted in complete healing of the dissection and spontaneous gradual resolution of intramural hematoma after three weeks. Unfortunately development of in-stent restenosis necessitated reintervention with further coronary stenting 2 months later.

Objectives: Our goal was to determine whether the deployment of drug-eluting stents (DES) in bifurcation lesions, according to a uniform provisional side-branch T-stenting strategy (PTS), is a safe and effective treatment in the immediate and long term., Background: In comparison with simple stenoses, successful percutaneous intervention for coronary bifurcation lesions is limited by a higher incidence of procedural complications and need for repeat revascularization. The ideal strategy to overcome these limitations remains to be demonstrated while recent controversy surrounds the long-term safety of DES in bifurcations., Methods: Consecutive patients treated for bifurcation lesions using DES were studied in a prospective single-center registry. Between 2003 to 2005, 477 procedures were performed. The PTS strategy was used in 92%, with a side-branch stent in 28% and final kissing balloon inflation in 95%., Results: Angiographic success was achieved in 99% with 2.5% in-hospital major adverse cardiac events. The cumulative rate of major adverse cardiac events was 10.7% at 1 year and 13.6% at 2 years, including 6.9% and 8.9% target vessel revascularization. Deviation from the PTS strategy independently predicted 2-year mortality (odds ratio: 5.5 [95% confidence interval: 1.63 to 18.3], p < 0.01). The rate of definite or probable stent thrombosis at 2 years was 2.5% with half of all events occurring before hospital discharge., Conclusions: The PTS strategy for the treatment of bifurcation lesions is applicable to over 90% of patients in the real world. With DES, both safety and efficacy have been demonstrated in the long-term with <10% need for repeat revascularization in the first 2 years and a low incidence of late stent thrombosis.

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]