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Risk-Benefit of 1-Year DAPT After DES Implantation in Patients Stratified by Bleeding and Ischemic Risk
Tullio Palmerini1, Antonio Giulio Bruno1, Björn Redfors2
1Division of Cardiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Insights
One year of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation did not reduce ischemic events but increased bleeding risk in high-risk patients. Shorter DAPT durations may be safer for select patient groups.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The optimal duration of dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) implantation remains uncertain, despite common practice of 1-year treatment.
- Risk stratification for ischemic and bleeding events is crucial for tailoring DAPT duration.
Purpose of the Study:
- To evaluate the risk-benefit profile of 1-year versus 6-month or shorter DAPT after DES implantation.
- To develop and validate novel risk scores for stratifying ischemic and bleeding events.
Main Methods:
- Development of ischemic and bleeding risk scores using the ADAPT-DES registry (8,665 patients).
- Investigation of the risk-benefit profile across risk strata using a pooled dataset from 7 randomized trials (15,083 patients).
- Validation of findings through network meta-analysis.
Main Results:
- Novel risk scores demonstrated good calibration and discriminatory power (c-indexes 0.76 for ischemic, 0.66 for bleeding).
- No significant difference in ischemic events between 1-year and ≤6-month DAPT across all risk strata.
- Increased bleeding risk observed with 1-year DAPT compared to ≤6-month DAPT in patients at high bleeding risk (HR: 2.80), without a reduction in ischemic events.
Conclusions:
- A 1-year DAPT duration following DES implantation is not associated with reduced ischemic events in any risk stratum.
- Longer DAPT duration increases bleeding risk in patients identified as high bleeding risk.
- Individualized DAPT duration based on risk stratification is warranted to optimize patient outcomes.
Background:
Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain.
Objectives:
The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify 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 vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 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 (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. 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 acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.
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