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Published on: May 14, 2013
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.
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.
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