Dataset Information

Efficacy and Safety of Ticagrelor in Comparison to Clopidogrel in Elderly Patients With ST-Segment-Elevation Myocardial Infarctions.

ABSTRACT: Background Current guidelines recommend the new-generation P2Y12-inhibitor ticagrelor for patients with acute ST-segment-elevation myocardial infarctions (STEMIs). The aim of the present study was to assess efficacy and safety of ticagrelor for elderly patients with STEMI (?75 years) in an all-comers STEMI registry. Methods and Results Patients with STEMI, aged ?75 years, treated with primary percutaneous coronary intervention and documented in the Bremen STEMI Registry between 2006 and 2017 entered analysis. The primary efficacy outcome, major adverse cardiac and cerebrovascular events, was defined as a composite of death, myocardial reinfarction, and stroke. The safety outcome was defined as any significant bleeding event within 1 year. To estimate benefit/risk ratio, net adverse clinical events (major adverse cardiac and cerebrovascular events+bleedings) were calculated. Outcomes were estimated in propensity score-matched cohorts to adjust for possible confounders. Of a total of 7466 patients with STEMI, 1087, aged ?75 years, were selected, of which 552 (51%) received clopidogrel and 535 (49%) received ticagrelor, with similar age (80.9±4.6 versus 80.9±4.6 years) and sex (51% versus 50% female) distributions between treatment arms. The primary efficacy outcome occurred in 32.4% of patients treated with clopidogrel versus 25.5% treated with ticagrelor (P=0.015), with the 1-year mortality rate at 26.8% versus 21.1% (P=0.035). Because there was no difference in the safety outcome (clopidogrel versus ticagrelor, 4.9% versus 5.1%; not significant), net adverse clinical events were higher for clopidogrel than for ticagrelor: 37.3% versus 30.6% (P=0.028). In a propensity score-matched model, the advantage for ticagrelor on major adverse cardiac and cerebrovascular events remained significant (hazard ratio, 0.69; 95% CI, 0.49-0.97; P=0.03), whereas 1-year-mortality (hazard ratio, 0.89; 95% CI, 0.67-1.27; P=0.5) and 1-year bleeding events (hazard ratio, 1.1; 95% CI, 0.4-2.3; P=0.8) did not differ. Conclusions These results from propensity score-matched registry data show that for elderly patients with STEMI, ticagrelor compared with clopidogrel was associated with a reduction in major adverse cardiac and cerebrovascular events without a significant increase in bleeding events within 1 year.

SUBMITTER: Schmucker J

PROVIDER: S-EPMC6818018 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Ticagrelor in Comparison to Clopidogrel in Elderly Patients With ST-Segment-Elevation Myocardial Infarctions.

Schmucker Johannes J Fach Andreas A Mata Marin Luis Alberto LA Retzlaff Tina T Osteresch Rico R Kollhorst Bianca B Hambrecht Rainer R Pohlabeln Hermann H Wienbergen Harm H

Journal of the American Heart Association 20190905 18

Background Current guidelines recommend the new-generation P2Y12-inhibitor ticagrelor for patients with acute ST-segment-elevation myocardial infarctions (STEMIs). The aim of the present study was to assess efficacy and safety of ticagrelor for elderly patients with STEMI (≥75 years) in an <i>all-comers</i> STEMI registry. Methods and Results Patients with STEMI, aged ≥75 years, treated with primary percutaneous coronary intervention and documented in the Bremen STEMI Registry between 2006 and 2 ...[more]

PMID: 31538856

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Project description:Importance:The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective:To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants:We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017. The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0%. Interventions:Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). Patients were randomized with a median of 11.4 hours after fibrinolysis, and 90% were pretreated with clopidogrel. Main Outcomes and Measures:The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. Results:The mean (SD) age was 58.0 (9.5) years, 2928 of 3799 patients (77.1%) were men, and 2177 of 3799 patients (57.3%) were white. At 30 days, TIMI major bleeding had occurred in 14 of 1913 patients (0.73%) receiving ticagrelor and in 13 of 1886 patients (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI, -0.49% to 0.58%; P < .001 for noninferiority). Major bleeding defined by the Platelet Inhibition and Patient Outcomes criteria and by the Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 23 patients (1.20%) in the ticagrelor group and in 26 patients (1.38%) in the clopidogrel group (absolute difference, -0.18%; 95% CI, -0.89% to 0.54; P = .001 for noninferiority). The rates of fatal (0.16% vs 0.11%; P = .67) and intracranial bleeding (0.42% vs 0.37%; P = .82) were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel (hazard ratio, 0.91; 95% CI, 0.67-1.25; P = .57). Conclusions and Relevance:In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days. Trial Registration:clinicaltrials.gov Identifier: NCT02298088.

Project description:BackgroundEuropean guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population.MethodsTo compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in the Cardio-STEMI Sanremo registry between February 2011 and June 2013. Cases and controls were defined according to P2Y12 inhibitors, correcting the bias due to lack of randomization by propensity score analysis. Ticagrelor was introduced in 2012 in both in-hospital and pre-hospital settings independently of this study.ResultsOf the 416 patients enrolled in the Cardio-STEMI registry, 401 with a definite diagnosis of STEMI were included in this study. One hundred forty-two patients received ticagrelor and 259 received clopidogrel. Regarding clinical presentation and procedural data, those in the ticagrelor group had lower CRUSADE scores (23 [14-36] vs 27 [18-38]; p = 0.015] but a higher proportion of radial access (33% vs 14%; p < 0.001), percutaneous coronary intervention (PCI; 92% vs 81 %; p = 0.002) and primary PCI ≤ 12 h (82% vs 66%; p = 0.001). The patients in the ticagrelor group had a higher procedural success rate (100% vs. 96%; p = 0.044). There was no difference in Bleeding Academic Research Consortium bleeding and in unadjusted incidence of hospital major adverse cardiovascular events (MACE; cardiac death, myocardial infarction, or stroke) but there was a significant reduction in unadjusted cardiac hospital death in the ticagrelor group (0.7% vs 5.4%; p = 0.024). After correcting for propensity score, hospital death (p = 0.22) and hospital MACE (p = 0.96) did not differ in both groups. The unadjusted survival at 1 year after STEMI was higher in the ticagrelor group (97.8% vs 87.8%; p = 0.024), and this result was confirmed by propensity score analysis (hazard ratio = 0.29 [0.08-0.99]; p = 0.048).ConclusionsIn this real-word propensity score analysis, ticagrelor did not affect the risk of MACE during the hospital phase, or the incidence of hospital bleeding in patients with STEMI. However, in this mono-centric experience, ticagrelor resulted in improved 1-year survival, even after correction by propensity score.

Dataset Information

Efficacy and Safety of Ticagrelor in Comparison to Clopidogrel in Elderly Patients With ST-Segment-Elevation Myocardial Infarctions.

Publications

Efficacy and Safety of Ticagrelor in Comparison to Clopidogrel in Elderly Patients With ST-Segment-Elevation Myocardial Infarctions.

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