Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction: From the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration (original) (raw)
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Objectives: To investigate the safety and efficacy of new-generation drug eluting stents (DES), compared with early-generation DES, in women undergoing complex percutaneous coronary intervention (CPCI). Background: Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unclear. Methods: We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized based on the presence or absence of CPCI, which was defined as the composite of total stent length > 30mm, ≥ 2 stents implanted, ≥ 2 lesions treated or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction or target lesion revascularization at three years of follow-up. Results: Out of 10,241 women included in the pooled database, 4629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI ...
Circulation. Cardiovascular interventions, 2016
The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-...
The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women.
Journal of Cardiovascular Medicine, 2015
Aims The randomized comparison of titanium-nitrideoxide-coated bioactive stent with everolimus-eluting stent in acute coronary syndrome (BASE-ACS) trial demonstrated an outcome of the titanium-nitride-oxide coated bioactive stents (BASs) that was statistically noninferior to that of the everolimus-eluting stents (EESs) at 12-month follow-up, in patients presenting with acute coronary syndrome (ACS) who underwent early percutaneous coronary intervention. We performed a post-hoc gender-based analysis of the BASE-ACS trial at 24-month follow-up.
Gender Impact on Prognosis of Acute Coronary Syndrome Patients Treated With Drug-Eluting Stents
The American Journal of Cardiology, 2012
Women have a higher risk of adverse outcomes after percutaneous coronary intervention (PCI) than men. However, in acute coronary syndrome (ACS), long-term outcomes after contemporary PCI with drug-eluting stent (DES) have not been fully investigated. We aimed to test the impact of gender on outcomes in patients with ACS after PCI with DES. We analyzed all patients with ACS from the prospective NOBORI-2 trial who underwent PCI with a Nobori DES from 2008 through 2009 in 125 centers worldwide. End points of the study were target lesion failure, cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization, and major adverse cardiac events (composite of cardiac death, MI, and target vessel revascularization) at 1 year and yearly up to 5 years. There were 1,640 patients with ACS, 1,268 men (77%) and 372 women (23%). Compared to men, women were 5 years older and more frequently had co-morbidities such as diabetes mellitus and hypertension. There were no gender differences for cardiac death (1.3% vs 2.7%), MI (2.1% vs 3.2%), or target lesion revascularization (2.6% vs 3.8%) at 1 year after the procedure for men and women, respectively. The trend was the same at 2 years (cardiac death 2.0% vs 2.3%, MI 2.5% vs 3.5%, target lesion revascularization 3.2% vs 4.6%). Target lesion failure rates were 4.5% and 5.9% at 1 year and 5.7% and 7.3% at 2 years in men and women, respectively (p ؍ NS). Multivariate analysis, which included age, hypertension, diabetes mellitus, and number of diseased vessels, showed that gender was not a predictor for outcome. There were no differences in bleeding or stent thrombosis rates. Relief from anginal symptoms was similar. The same rate of adherence to dual antiplatelet therapy was observed and reached 73% at 1 year and 31% at 2 years after the ACS event and PCI. In conclusion, although women had worse baseline characteristics, no differences in outcomes were observed between men and women treated for ACS with contemporary DES. Published by Elsevier Inc.
Catheterization and Cardiovascular Interventions, 2015
for the MIDAS 23 Study Group Objective: We examined gender disparity in the use of drug-eluting stents (DES) versus bare metal stents (BMS) during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), and gender disparity in all-cause mortality after coronary stent implantation for AMI. Background: Gender disparities in AMI managements have been well documented, but it is unclear whether these disparities are seen in the type of coronary stent implantation for AMI and outcomes. Methods: Hospital discharge data from January 1, 2003 through December 31, 2010 in New Jersey from the Myocardial Infarction Data Acquisition System were used to identify 40,215 patients (12,878 women and 27,337 men) with coronary stent implantation for AMI. The in-hospital, short term (30 days) and long term (1 and 5 year) all-cause mortality rates, unadjusted and adjusted for demographics and comorbidities, were determined. Results: Women were older than men and had a higher prevalence of co-morbidities. Men had higher prevalence of prior coronary revascularizations. After adjustment for co-morbidities, there was no significant gender difference in the use of DES versus BMS for AMI, except in 2003 and 2006 where women were found to be more likely to receive a DES versus a BMS. After adjustment, women had higher odds of in-hospital deaths but no difference in short and long-term all-cause mortality rates. Conclusions: There was no significant gender difference in the proportion of DES implantation versus BMS for AMI in contemporary years. Women treated with either BMS or DES for AMI had higher inhospital death than men. V
Revista Española de Cardiología (English Edition), 2014
Introduction and objectives: The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. Methods: This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. Results: Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio = 0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio = 2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio = 0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. Conclusions: Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men.
Catheterization and Cardiovascular Interventions, 2013
Background: Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drugeluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents. Methods: Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint. Results: Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n 5 192) and Xience V (n 5 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P 5 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P 5 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P 5 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P 5 0.50). Conclusions: This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute-and Xience V-treated females. V
2022
This record contains raw data related to the article: Gender-associated outcomes following percutaneous coronary intervention with a third-generation, ultrathin-strut drug-eluting stent: a real-world, single-center experience. ABSTRACT <strong>Introduction.</strong> In recent years the new third-generation, ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60-80 µm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). Aim of the present study was to assess different clinical outcomes and safety of this drug-eluting stent in male and female patients in a real-world setting. <strong>Methods. </strong>The present study is a retrospective analysis including all patients treated with BP-SES between January 2017 and December 2019 at a single, high-volume center. Follow-up was performed by outpatient visit or...
The American Journal of Cardiology, 2016
The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p [ 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p [ 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender. Ó 2016 Elsevier Inc. All rights reserved. (Am J Cardiol 2016;118:1178e1186) Recently, a meta-analysis of randomized trials of patients who underwent percutaneous coronary intervention (PCI) showed that the use of newer generation drug-eluting stent (DES) is effective and safe in women during 3-year follow-up. 1 However, the modifying effect of gender on clinical outcome after DES implantation, including stent thrombosis (ST), was not analyzed. Consequently, the interplay between gender, established risk factors for ST, dual antiplatelet therapy (DAPT) use, and patient outcome remains unclear. Against this background, we explored the data of the large (8,709 patients) Patient Related Outcomes With Endeavor Versus Cypher Stenting Trial (PROTECT) 2e4 to evaluate the influence of gender on the incidence of ST (among other clinical end points) and on the relation between DES stent type and these end points during 5-year follow-up. Methods PROTECT is a prospective, open-label, multicenter, randomized, superiority trial, powered to study differences in long-term clinical effectiveness and safety in a broad group of coronary artery disease (CAD) patients with an indication for PCI. Details of the trial design and the main results have been published previously (ClinicalTrials.gov, number NCT00476957). 2e4 In short, 8,709 patients from 196 centers in 36 countries were randomized 1:1 to receive either an Endeavor zotarolimus-eluting stent (E