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Ticagrelor or Prasugrel in Patients With Acute Coronary Syndrome and High Bleeding Risk
Shqipdona Lahu1,2, Antonia Presch1, Gjin Ndrepepa1
1Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Germany (S.L., A.P., G.N., M.J., E.X., S.K., N.R., H.B.S., K.M., T.K., H.S., A.K., S.C.).
Insights
Ticagrelor and prasugrel showed similar efficacy and safety in acute coronary syndrome patients with high bleeding risk undergoing percutaneous coronary intervention. High bleeding risk increased both ischemic and bleeding events but did not alter the relative treatment effects.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) often have high bleeding risk (HBR).
- The comparative effectiveness and safety of potent P2Y12 inhibitors, ticagrelor and prasugrel, in this HBR population remain incompletely understood.
- This study addresses the uncertainty surrounding optimal antiplatelet therapy for ACS patients with HBR undergoing PCI.
Purpose of the Study:
- To evaluate the relative efficacy and safety of ticagrelor versus prasugrel in patients with ACS and HBR undergoing PCI.
- To assess the impact of HBR status on treatment outcomes in patients receiving ticagrelor or prasugrel.
- To determine if HBR modifies the comparative effectiveness and safety of these P2Y12 inhibitors.
Main Methods:
- A post hoc analysis of the ISAR-REACT 5 trial (NCT01944800) involving ACS patients randomized to ticagrelor or prasugrel.
- HBR was defined using Academic Research Consortium (ARC) criteria.
- Primary endpoint: composite of all-cause death, myocardial infarction, or stroke. Secondary endpoint: Bleeding Academic Research Consortium (BARC) type 3-5 bleeding, assessed at 12 months.
Main Results:
- Out of 3239 patients, 486 met ARC-HBR criteria. HBR patients had significantly higher risks for both primary (HR=3.57) and secondary (HR=2.94) endpoints compared to non-HBR patients.
- In the HBR group, no significant differences in primary (HR=1.09) or secondary (HR=1.18) endpoints were observed between ticagrelor and prasugrel.
- In the non-HBR group, ticagrelor was associated with a higher risk of the primary endpoint (HR=1.62) versus prasugrel, with similar safety.
Conclusions:
- High bleeding risk in ACS patients undergoing PCI increases both ischemic and bleeding event risks.
- Ticagrelor and prasugrel demonstrated comparable efficacy and safety profiles in the HBR subgroup.
- The findings suggest that HBR status does not significantly alter the relative treatment effects of ticagrelor and prasugrel, though larger cohort confirmation is warranted.
Background:
The relative efficacy and safety of more potent P2Y12 inhibitors in patients with acute coronary syndrome and high bleeding risk (HBR) undergoing percutaneous coronary intervention remains unclear. We aimed to study the treatment effect of ticagrelor and prasugrel in percutaneous coronary intervention patients presenting with acute coronary syndrome and HBR.
Methods:
This post hoc analysis of the ISAR-REACT 5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) included patients with acute coronary syndrome undergoing percutaneous coronary intervention, randomized to ticagrelor or prasugrel, in whom HBR was defined as per Academic Research Consortium criteria. The primary (efficacy) end point was the composite of all-cause death, myocardial infarction, or stroke. The secondary (safety) end point was Bleeding Academic Research Consortium type 3 to 5 bleeding. Outcomes were assessed 12 months after randomization.
Results:
Out of the 3239 patients included in this analysis, 486 fulfilled the criteria for Academic Research Consortium-HBR definition (HBR group; ticagrelor, n=230 and prasugrel, n=256), while 2753 did not (non-HBR group; ticagrelor, n=1375 and prasugrel, n=1378). Compared with the non-HBR group, the HBR group had a higher risk for the primary (hazard ratio [HR]=3.57 [95% CI, 2.79-4.57]; P<0.001) and secondary end point (HR=2.94 [2.17-3.99]; P<0.001). In the HBR group, the primary (HR=1.09 [0.73-1.62]) and secondary (HR=1.18 [0.67-2.08]) end points were not significantly different between patients assigned to ticagrelor and prasugrel. In the non-HBR group, the primary end point (HR=1.62 [1.19-2.20]) occurred more frequently in patients assigned to ticagrelor as compared to patients assigned to prasugrel, without difference in safety (HR=1.08 [0.74-1.58]). There was no significant treatment allocation-by-HBR status interaction with respect to the primary (P for interaction=0.12) or secondary (P for interaction=0.80) end points.
Conclusions:
In patients with acute coronary syndrome undergoing percutaneous coronary intervention, HBR status increased both ischemic and bleeding risk without significant impact on the relative efficacy and safety of either ticagrelor or prasugrel. These results warrant confirmation in larger cohorts.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT01944800.
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