Duration of DAPT Based on Bleeding and Ischemic Risk

Quick Takes

  • When comparing ≤6 months to 1 year of DAPT using clopidogrel after DES, there appears to be no advantage of longer-duration DAPT regardless of risk strata including ACS.
  • Longer-duration DAPT with clopidogrel was associated with increased bleeding among patients with high bleeding risk.

Study Questions:

What are the risks and benefits of 1 year versus ≤6 months of dual antiplatelet therapy (DAPT) with clopidogrel after drug-eluting stenting (DES) when patients are stratified based on risk of bleeding and ischemic events?

Methods:

Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, “all-comers” registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year versus ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of seven randomized trials that enrolled 15,083 patients treated with DES.

Results:

In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (hazard ratio, 2.80; 95% confidence interval, 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes (ACS). These results were consistent in a network meta-analysis.

Conclusions:

In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including ACS), but was associated with greater bleeding in patients at increased risk of bleeding.

Perspective:

Findings from this complex analysis conclude the following: 1) When comparing ≤6 months to 1 year of DAPT using clopidogrel, there appears to be no differences in ischemic or bleeding outcomes regardless of stable disease or in the setting of ACS. 2) Longer-duration DAPT using clopidogrel was associated with increased bleeding risk among patients with high bleeding risk. 3) The authors introduce the ADAPT-DES ischemic and bleeding scores.

There have been increasing data to support shorter-duration DAPT after DES for chronic stable coronary disease. The current analysis brings into question the need and benefit of standard 12 months of DAPT with clopidogrel after DES for ACS. Whether there remains a benefit in a subset of patients or with alternative P2Y12 inhibitors remains to be determined.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Prevention, Interventions and ACS

Keywords: Acute Coronary Syndrome, Clopidogrel, Coronary Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Ischemia, Pharmaceutical Preparations, Platelet Aggregation Inhibitors, Risk Assessment, Risk Factors, Secondary Prevention


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