Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

Silber, Sigmund; Kirtane, Ajay J.; Belardi, Jorge; Liu, Minglei; Brar, Sandeep; Rothman, Martin T.; Windecker, Stephan

doi:10.1093/eurheartj/ehu026

Cited by 109 publications

(54 citation statements)

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“…[31][32][33] In fact, favorable outcomes related to premature discontinuation of dual-antiplatelet therapy have been reported with both R-ZES and EES. 34,35 The consistency between findings from preclinical investigations, intracoronary imaging studies, and clinical trials further supports the equivalent safety and efficacy profile of R-ZES and EES.…”

Section: Discussionmentioning

confidence: 59%

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

Piccolo

Stefanini

Franzone

et al. 2015

Circ: Cardiovascular Interventions

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Background-Although new-generation drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention, there remains debate about differences in efficacy and the risk of stent thrombosis between the Resolute zotarolimus-eluting stent (R-ZES) and the everolimus-eluting stent (EES). The aim of this study was to evaluate the safety and efficacy of the R-ZES compared with EES in patients undergoing percutaneous coronary intervention. Methods and Results-A systematic literature search of electronic resources was performed using specific search terms until September 2014. Random-effects meta-analysis was performed comparing clinical outcomes between patients treated with R-ZES and EES up to maximum available follow-up. The primary efficacy end point was targetvessel revascularization.

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Section: Discussionmentioning

confidence: 59%

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

Piccolo

Stefanini

Franzone

et al. 2015

Circ: Cardiovascular Interventions

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“…This study assessed the incidence, reasons, and clinical impact of early prasugrel cessation in a sizable, contemporary cohort of patients with STEMI treated with PCI by current standards. Prasugrel cessation before 1 year was not uncommon (≈14%), but was less frequent compared with previous studies focusing on any DAPT cessation post‐PCI in more stable clinical settings 6, 7, 8, 9, 10. Crossover to another P2Y 12 ‐inhibitor, mainly clopidogrel, was more frequent compared with physician‐recommended discontinuation or disruption (because of bleeding, side effects, or noncompliance).…”

Section: Discussionmentioning

confidence: 78%

“…This finding likely reflects appreciation of the persistently elevated ischemic risk following acute STEMI. Previous investigations reported higher rates of early DAPT cessation within 1 year post PCI, ranging between 18.5% and 24%,6, 7, 8, 9, 10 but this needs to be interpreted in view of different study populations (primarily stable patients with CAD) and antiplatelet treatments (mostly clopidogrel) as well as varying definitions of treatment cessation across studies.…”

Section: Discussionmentioning

confidence: 88%

“…Several reports found no adverse impact of DAPT interruptions after 30 days post PCI with new‐generation DES9, 10; these studies, however, pooled all DAPT interruptions between 30 days and 12 months, thereby not accounting for the possibly differing ischemic risk throughout the entire period following the first month post‐PCI. Other studies applying time‐dependent analyses reported higher risk of ischemic events following early DAPT cessation7, 8 and importantly showed that the clinical sequelae depend on the underlying reason and mode of cessation 6.…”

Section: Discussionmentioning

confidence: 99%

“…Notably, different modes of DAPT cessation (either driven by physician recommendation, patient noncompliance, or interventions necessitating temporary treatment withdrawal) appear to have varying effects on patient outcomes 6. Previous studies assessing premature cessation of antiplatelet therapy focused primarily on more stable clinical settings and clopidogrel rather than novel, potent P2Y 12 ‐inhibitors, and they often did not account for the temporal relation between treatment cessation and subsequent outcomes 9, 10. While STEMI is characterized by elevated ischemic risk compared with stable coronary artery disease (CAD) and is an independent predictor of stent thrombosis,11 there are limited data on the adherence to guideline‐recommended antiplatelet treatment following primary PCI.…”

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confidence: 99%

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Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST‐Elevation Myocardial Infarction

Koskinas

Zanchin

Klingenberg

et al. 2018

JAHA

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BackgroundEarly withdrawal of recommended antiplatelet treatment with clopidogrel adversely affects prognosis following percutaneous coronary interventions. Optimal antiplatelet treatment is essential following ST‐segment elevation myocardial infarction (STEMI) given the increased risk of thrombotic complications. This study assessed the frequency, predictors, and clinical impact of early prasugrel cessation in patients with STEMI undergoing primary percutaneous coronary interventions.Methods and ResultsWe pooled patients with STEMI discharged on prasugrel in 2 prospective registries (Bern PCI Registry [NCT02241291] and SPUM‐ACS (Inflammation and Acute Coronary Syndromes) [NCT01000701]) and 1 STEMI trial (COMFORTABLE‐AMI (Comparison of Biomatrix Versus Gazelle in ST‐Elevation Myocardial Infarction) [NCT00962416]). Prasugrel treatment status at 1 year was categorized as no cessation; crossover to another P2Y12‐inhibitor; physician‐recommended discontinuation; and disruption because of bleeding, side effects, or patient noncompliance. In time‐dependent analyses, we assessed the impact of prasugrel cessation on the primary end point, a composite of cardiac death, myocardial infarction, and stroke. Of all 1830 included patients (17% women, mean age 59 years), 83% were treated with new‐generation drug‐eluting stents. At 1 year, any prasugrel cessation had occurred in 13.8% of patients including crossover (7.2%), discontinuation (3.7%), and disruption (2.9%). Independent predictors of any prasugrel cessation included female sex, age, and history of cerebrovascular event. The primary end point occurred in 5.2% of patients and was more frequent following disruption (hazard ratio 3.04, 95% confidence interval,1.34–6.91; P=0.008), without significant impact of crossover or discontinuation. Consistent findings were observed for all‐cause death, myocardial infarction, and stent thrombosis following prasugrel disruption.ConclusionsIn this contemporary study of patients with STEMI, early prasugrel cessation was not uncommon and primarily involved change to another P2Y12‐inhibitor. Disruption was the only type of early prasugrel cessation associated with statistically significant excess in ischemic risk within 1 year following primary percutaneous coronary interventions.

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Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy

et al. 2020

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IMPORTANCE Female sex has been identified as a risk factor for bleeding after percutaneous coronary intervention (PCI) and may have contributed to the underuse of drug-eluting stents in women. This risk may be further enhanced among patients with a high bleeding risk.OBJECTIVE To assess the 2-year outcomes by sex in patients with a high bleeding risk who were enrolled in the LEADERS FREE trial. DESIGN, SETTING, AND PARTICIPANTSThis cohort study is a prespecified, sex-based secondary analysis of the LEADERS FREE double-blind, randomized clinical trial that was conducted at 68 sites in 20 countries from December 2012 to May 2014. Patients with a high bleeding risk who underwent PCI and met the trial eligibility criteria were enrolled at the participating sites and followed up for up to 2 years.INTERVENTIONS Patients were randomized 1:1 to either a bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy. MAIN OUTCOMES AND MEASURESThe primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target lesion revascularization. Bleeding was assessed using the Bleeding Academic Research Consortium (BARC) scale, and the source of bleeding was recorded.RESULTS A total of 2432 patients with a high bleeding risk were included in the study. Of these patients, the mean (SD) age was 75 (9) years, and 1694 (69.7%) were men and 738 (30.3%) were women. Women and men had similar incidence of the 2-year primary safety (14.7% vs 13.6%; P = .37) and efficacy (9.2% vs 9.5%; P = .70) end points. The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization (women: 6.3% vs 12.1%; men: 7.0% vs 12.0%; P for interaction = .70) and similar rates of the primary safety end point (women: 12.4% vs 17.0%; men: 12.6% vs 14.5%; P for interaction = .40). Overall, 2-year BARC types 3 to 5 major bleeding (10.2% vs 8.6%; P = .14) was not statistically different between the sexes, but women experienced greater BARC types 3 to 5 major bleeding within the first 30 days (5.1% vs 2.4%; P = .007) and greater vascular access site major bleeding than men (2.2% vs 0.5%; P < .001). In both sexes, vascular (women: hazard ratio [HR], 3.45 [95% CI, 1.51-7.87]; men: HR, 4.14 [95% CI, 1.33-12.95]) and nonvascular major bleeding (women: HR, 3.76 [95% CI, 2.17-6.53]; men: HR, 4.62 [95% CI, 3.23-6.61]) were associated with greater 2-year mortality.CONCLUSIONS AND RELEVANCE This study found no sex differences in the ischemic outcomes of patients with a high bleeding risk after PCI, but women appeared to demonstrate greater early bleeding and major bleeding from the vascular access site. Both women and men with major bleeding seemed to experience worse 2-year mortality, suggesting that bleeding avoidance strategies should be uniformly adopted for all patients, with close attention dedicated to women to avoid denying them the benefits of PCI.

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Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

Cited by 109 publications

References 54 publications

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST‐Elevation Myocardial Infarction

Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy

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