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Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI
Marco Valgimigli1, Davide Cao2, Dominick J Angiolillo3
1Cardiocentro Ticino Institue, Ente Ospedaliero Cantonale, Lugano and Bern University Hospital, Bern, Switzerland.
Insights
For high bleeding risk patients undergoing percutaneous coronary intervention, one month of dual antiplatelet therapy (DAPT) showed similar ischemic outcomes and reduced bleeding compared to three months of DAPT.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients remains unclear.
- Current guidelines lack definitive recommendations for DAPT duration in HBR patients post-PCI.
- Balancing ischemic event prevention and bleeding risk is critical in HBR patients.
Purpose of the Study:
- To compare the efficacy and safety of 1-month versus 3-month DAPT regimens in HBR patients undergoing PCI with drug-eluting stents.
- To evaluate ischemic and bleeding outcomes in HBR patients treated with different DAPT durations.
- To inform clinical decision-making regarding DAPT duration in HBR populations.
Main Methods:
- Exploratory analysis of the XIENCE Short DAPT program, including three prospective, single-arm studies.
- Propensity score stratification was used to compare patients receiving 1-month DAPT (XIENCE 28 USA and Global) versus 3-month DAPT (XIENCE 90).
- Assessment of ischemic (all-cause mortality, myocardial infarction) and bleeding (BARC types 2-5, 3-5) outcomes up to 12 months post-PCI.
Main Results:
- The primary endpoint of all-cause mortality or myocardial infarction was similar between the 1-month and 3-month DAPT groups (7.3% vs 7.5%).
- The key secondary endpoint of BARC type 2-5 bleeding was significantly lower in the 1-month DAPT group compared to the 3-month DAPT group (7.6% vs 10.0%, P=0.012).
- While major BARC type 3-5 bleeding did not differ significantly at 12 months, it was lower at 90 days with 1-month DAPT (1.0% vs 2.1%, P=0.015).
Conclusions:
- One month of DAPT in HBR patients undergoing PCI with everolimus-eluting stents is associated with similar ischemic event rates compared to three months of DAPT.
- A shorter DAPT duration of 1 month significantly reduces bleeding risk in HBR patients post-PCI.
- These findings suggest that a 1-month DAPT regimen may be a viable option for HBR patients, warranting further investigation.
Background:
The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.
Objectives:
The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.
Methods:
The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.
Results:
A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).
Conclusions:
Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).
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