Dataset Information

One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study.

ABSTRACT:

Objective

To investigate 1?year outcomes with routine prasugrel treatment after acute coronary syndrome (ACS) in a large-scale registry.

Methods

The Rijnmond Collective Cardiology Research registry is a prospective, observational study that enrolled 4,258 consecutive ACS patients treated with percutaneous coronary intervention (PCI) with 1?year follow-up. Patients received prasugrel as first-choice antiplatelet agent, except for increased bleeding risk patients in which clopidogrel was recommended. Events were validated by an independent clinical endpoint committee.

Results

A total number of 2,677 patients received prasugrel at discharge after the index event. Eighty-one percent of the target population was on prasugrel treatment at hospital discharge. At 1 year, the primary endpoint, a composite of all-cause mortality and myocardial infarction, occurred in 2.4% of patients receiving prasugrel. All-cause mortality occurred in 1.0%, myocardial infarction in 1.5%, target-vessel revascularisation in 3.1%, stent thrombosis in 0.6%, and stroke in 0.5% of the patients treated with prasugrel. Thrombolysis in Myocardial Infarction defined major bleeding episodes not related to coronary artery bypass grafting were observed in 1.4% of patients receiving prasugrel.

Conclusions

In routine practice, a tailored approach of prasugrel prescription in ACS patients undergoing PCI, resulted in low ischaemic and low bleeding rates up to 1 year post PCI.

SUBMITTER: Yetgin T

PROVIDER: S-EPMC6046662 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study.

Yetgin T T Boersma E E Smits P C PC de Vries A G AG Huijskens E E Zijlstra F F van der Linden M M J M MMJM van Geuns R J M RJM

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 20180801 7-8

<h4>Objective</h4>To investigate 1‑year outcomes with routine prasugrel treatment after acute coronary syndrome (ACS) in a large-scale registry.<h4>Methods</h4>The Rijnmond Collective Cardiology Research registry is a prospective, observational study that enrolled 4,258 consecutive ACS patients treated with percutaneous coronary intervention (PCI) with 1‑year follow-up. Patients received prasugrel as first-choice antiplatelet agent, except for increased bleeding risk patients in which clopidogre ...[more]

PMID: 29931649

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Project description:BackgroundPrasugrel and ticagrelor have demonstrated higher efficacy than clopidogrel in their main clinical trials for patients with acute coronary syndrome (ACS). However, the long-term prognosis and different clinical characteristics related to the type of antiplatelet prescription in current clinical practice ACS patients have not been analysed in depth. The objective of this study was to analyse the clinical profile of ACS and the efficacy and safety of novel oral P2Y12 inhibitors in current clinical practice patients discharged afterACS.MethodsWe collected data from the ACHILLES registry, and an observational, prospective and multicentre registry of patients discharged after ACS. We analysed baseline characteristics, clinical profile and therapy during ACS admission and compared with the different treatments at discharge. After 1 year of follow-up, ischaemic and major bleeding events were analysed. Multivariate Cox regression analysis and Kaplan Meier curves were also plotted.ResultsOf 1717 consecutive patients, 1294 (75.4%) were discharged with a P2Y12 inhibitor without oral anticoagulation. Novel oral P2Y12 inhibitors were indicated in 47%. Patients treated with clopidogrel were elderly (69.1 ± 13.4 vs 60.4 ± 11.5 years; P < .001) and had a higher prevalence of cardiovascular risk factors. GRACE and CRUSADE scores were higher in the clopidogrel than in novel oral P2Y12 inhibitors group (P < .001). After 1 year of follow-up, 64(5.0%/year) patients had a new myocardial infarction, 127(10.0%/year) had a major adverse cardiovascular event (MACE) and 78(6.1%/year) died. Patients treated with clopidogrel had a significantly higher annual rate of cardiovascular mortality, MACE and all-cause mortality (allP < .001) without differences in major bleeding (P = .587) compared with novel oral P2Y12 inhibitors. After multivariate adjustment for the main clinical variables related to adverse prognosis in ACS patients, the discharge with novel oral P2Y12 inhibitors therapy was independently associated with lower risk of all-cause mortality (HR0.49, 95% CI [0.24-0.98], P = .044) and lower risk of MACE (HR0.64, 95% CI [0.41-0.98], P = .044).ConclusionsIn this prospective, observational and current clinical practice ACS registry, the use of novel oral P2Y12 inhibitors was associated with a reduction in adverse events compared with clopidogrel in patients with ACS. Novel oral P2Y12 inhibitors prescription at discharge was independently associated with lower all-cause mortality and MACE without differences in bleeding events. However, clopidogrel remained the most common P2Y12 inhibitor employed for ACS, especially in older and high-risk patients.

Project description:ImportanceIt is unclear whether ticagrelor or prasugrel hydrochloride is superior for patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).ObjectiveTo assess the safety and efficacy of ticagrelor vs prasugrel for patients with ACS treated with PCI.Design, setting, and participantsA prespecified analysis was performed of a postrandomization subgroup of 3377 patients who presented with ACS and were treated with PCI in the investigator-initiated, multicenter, phase 4, open-label Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5 randomized clinical trial, conducted from September 1, 2013, to February 28, 2018. Statistical analysis was performed from September 1, 2020, to January 30, 2021. Analysis was performed according to the intention-to-treat principle.InterventionsPatients were randomly assigned to a ticagrelor-based or prasugrel-based strategy. This analysis focuses on the subgroup of patients who underwent PCI that was formed after randomization.Main outcomes and measuresThe primary end point was a composite consisting of all-cause death, myocardial infarction, or stroke at 12 months. The safety end point was Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding.ResultsThe ticagrelor group comprised 1676 patients (1323 men [78.9%]; mean [SD] age, 64.4 [12.0] years), and the prasugrel group comprised 1701 patients (1341 men [78.8%]; mean [SD] age, 64.7 [12.0] years). The primary end point occurred for 162 patients (9.8%) in the ticagrelor group and 120 patients (7.1%) in the prasugrel group (hazard ratio [HR], 1.41; 95% CI, 1.11-1.78; P = .005). Myocardial infarction occurred in 88 patients (5.3%) in the ticagrelor group compared with 55 patients (3.8%) in the prasugrel group (HR, 1.67; 95% CI, 1.19-2.34; P = .003). The safety end point, BARC type 3 to 5 bleeding, occurred in 84 of 1672 patients (5.3%) in the ticagrelor group and 78 of 1680 patients (4.9%) in the prasugrel group (HR; 1.10; 95% CI, 0.81-1.50; P = .54).Conclusions and relevanceAmong patients presenting with ACS who were treated with PCI, the incidence of the primary composite end point occurred less frequently for patients who received prasugrel compared with those who received ticagrelor. The incidence of bleeding events was comparable between the 2 groups. These results suggest that, for patients presenting with ACS who undergo PCI, a prasugrel-based strategy is superior to a ticagrelor-based strategy. However, because these observations are based on a postrandomization subgroup, these findings should be regarded as hypothesis generating and dedicated randomized clinical trials may be warranted to confirm these findings.Trial registrationClinicalTrials.gov Identifier: NCT01944800.

Project description:The 30-day clinical outcomes with prasugrel or ticagrelor were compared using a US payer database in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).Prasugrel and ticagrelor demonstrated superior efficacy with increased non-coronary artery bypass graft major bleeding compared with clopidogrel in randomized clinical trials. No direct randomized or observational studies have compared clinical outcomes between prasugrel and ticagrelor.Patients hospitalized for ACS-PCI between August 1, 2011 and April 30, 2013 and prescribed prasugrel or ticagrelor were selected. Drug treatment cohorts were propensity matched based upon demographic and clinical characteristics. The primary objective compared 30-day net adverse clinical events (NACE) in prasugrel- and ticagrelor-treated patients using a prespecified 20% noninferiority margin. Secondary objectives included comparisons of major adverse cardiovascular events (MACE) and major bleeding.Data were available for 16,098 patients (prasugrel, n?=?13,134; ticagrelor, n?=?2,964). In unmatched cohorts, prasugrel-treated patients were younger with fewer comorbidities than ticagrelor-treated patients, and 30-day NACE rates were 5.6 and 9.3%, respectively (P?<?0.001). Following propensity matching, NACE was noninferior (P?<?0.001) and 22% lower in prasugrel-treated than in ticagrelor-treated patients (RR, 0.78; 95% CI, 0.64-0.94). A 30-day adjusted MACE (RR, 0.80; 95% CI, 0.64-0.98) and major bleeding (RR, 0.65; 95% CI, 0.45-0.95) were also lower in prasugrel-treated patients compared with ticagrelor-treated patients.In this "real-world," retrospective, observational study, physicians appear to preferentially use prasugrel in younger patients with lower risk of bleeding or comorbidities compared with ticagrelor. Following adjustment, clinical outcomes associated with prasugrel use appear as good, if not better, than those associated with ticagrelor in ACS-PCI patients. © 2015 Wiley Periodicals, Inc.

Dataset Information

One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study.

Objective

Methods

Results

Conclusions

Publications

One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study.

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