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Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial
Cheol Whan Lee1, Jung-Min Ahn, Duk-Woo Park
1From The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul (C.W.L., J.-M.A., D.-W.P., S.-J.K., S.-W.L., Y.-H.K., S.-W.P., S.-J.P.); Division of Biostatistics, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul (S.H.); Ulsan University Hospital, Ulsan (S.-G.L.); Chungnam National University Hospital, Daejeon (I.-W. Seong); Korea University Guro Hospitals, Seoul (S.-W.R.); Chonnam National University Hospital, Gwangju (M.-H.J.); Korea University Anam Hospitals, Seoul (D.-S.L.); Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju (J.-H.Y.); Keimyung University Dongsan Medical Center, Daegu (S.-H.H.); Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul (Y.-S.C.); National Health Insurance Corp, Ilsan Hospital, Ilsan (J.-Y.Y.); Soon Chun Hyang University Hospital Bucheon, Bucheon (N.-H.L.); Hallym University Sacred Heart Hospital, Anyang (H.-S.K.); Kangwon National University Hospital, Chuncheon (B.-K.L.); Daegu Catholic University Medical Center, Daegu (K.-S.K.); Kwangju Christian Hospital, Kwangju (S.-U.L.); Chonbuk National University Hospital, Jeonju (J.-K.C.); GangNeung Asan Medical Center, Gangneung (S.-S.C.); Sam Anyang Hospital, Anyang (I.-W. Suh); Kyungpook National University Hospital, Daegu (H.-S.P.); Dongguk University Gyeongju Hospital, Gyeongju (D.-Y.N.); Catholic University of Korea, Incheon St. Mary's Hospital, Incheon (D.-S.J.); Catholic University of Korea, Seoul St. Mary's Hospital, Seoul (K.-B.S.); Veterans Hospital Service Medical Center, Seoul (K.L.); and Inje University College of Medicine, Busan Paik Hospital, Busan (J.-S.J.), South Korea.
Insights
For patients with drug-eluting stents, extending dual antiplatelet therapy beyond 12 months did not significantly lower the risk of major cardiovascular events compared to aspirin alone.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Long-term dual antiplatelet therapy (DAPT) risks and benefits are not well-established.
- Patients with drug-eluting stents (DES) often receive DAPT for extended periods.
- Understanding optimal DAPT duration is crucial for cardiovascular event prevention.
Purpose of the Study:
- To evaluate the efficacy and safety of extending DAPT beyond 12 months in patients with DES.
- To compare aspirin monotherapy with continued DAPT in preventing major adverse cardiovascular events (MACE).
- To assess the impact on bleeding events in patients post-DES implantation.
Main Methods:
- Prospective, multicenter, open-label, randomized trial involving 5045 patients.
- Patients received DAPT for at least 12 months post-DES, then randomized to aspirin alone or aspirin plus clopidogrel.
- Primary endpoint: composite of cardiac death, myocardial infarction, or stroke at 24 months post-randomization.
Main Results:
- No significant difference in the primary endpoint between aspirin alone and DAPT groups (2.4% vs. 2.6%, P=0.75).
- Individual risks of cardiac death, MI, stent thrombosis, and stroke were similar between groups.
- Major bleeding rates were comparable: 1.1% for aspirin alone vs. 1.4% for DAPT (P=0.20).
Conclusions:
- Extended DAPT beyond 12 months did not reduce MACE in patients with DES who completed 12 months without complications.
- Aspirin monotherapy is a viable alternative to DAPT for selected patients after the initial 12-month period.
- The study provides evidence for de-escalating antiplatelet therapy in specific patient populations.
Background:
The risks and benefits of long-term dual antiplatelet therapy remain unclear.
Methods And Results:
This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20).
Conclusions:
Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke.
Clinical Trial Registration Url:
http://www.clinicaltrials.gov. Unique identifier: NCT01186146.
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