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JAMA Cardiol., Nov 27 2024, | https://doi.org/10.1001/jamacardio.2024.4030
Long-Term Aspirin vs Clopidogrel After Coronary Stenting by Bleeding Risk and Procedural Complexity
Jeehoon Kang 1, Jaewook Chung 1, Kyung Woo Park 1, Jang-Whan Bae 2, Huijin Lee 1, Doyeon Hwang 1, Han-Mo Yang 1, Kyoo-Rok Han 3, Keon-Woong Moon 4, Ung Kim 5, Moo-Yong Rhee 6, Doo-Il Kim 7, Song-Yi Kim 8, Sung-Yun Lee 9, Seung Uk Lee 10, Sang-Wook Kim 11, Seok Yeon Kim 9, Jung-Kyu Han 1, Eun-Seok Shin 12, Bon-Kwon Koo 1, Hyo-Soo Kim 1
1Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.
2Chungbuk National University, Cheongju, Korea.
3Kangdong Sacred Heart Hospital, Hallym University, Seoul, Korea.
4St Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.
5Yeungnam University Hospital, Daegu, Korea.
6Dongguk University Ilsan Hospital, Goyang, Korea.
7Haeundae Paik Hospital, Inje University, Busan, Korea.
8Jeju National University, Jeju, Korea.
9Seoul Medical Center, Seoul, Korea.
10Kwangju Christian Hospital, Gwangju, Korea.
11Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si, Korea.
12Ulsan University Hospital, Ulsan, Korea.
Corresponding author : Kyung Woo Park
1Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.
2Chungbuk National University, Cheongju, Korea.
3Kangdong Sacred Heart Hospital, Hallym University, Seoul, Korea.
4St Vincent's Hospital, The Catholic University of Korea, Seoul, Korea.
5Yeungnam University Hospital, Daegu, Korea.
6Dongguk University Ilsan Hospital, Goyang, Korea.
7Haeundae Paik Hospital, Inje University, Busan, Korea.
8Jeju National University, Jeju, Korea.
9Seoul Medical Center, Seoul, Korea.
10Kwangju Christian Hospital, Gwangju, Korea.
11Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si, Korea.
12Ulsan University Hospital, Ulsan, Korea.
Corresponding author : Kyung Woo Park
Abstract
Importance: Antiplatelet monotherapy in the chronic maintenance period for patients with high bleeding risk (HBR) and those who have undergone complex percutaneous coronary intervention (PCI) has not yet been explored.
Objective: To compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.
Design, setting, and participants: This post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up. The analysis was conducted from February to November 2023. Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.
Interventions: Patients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio. Those with sufficient data to assess HBR or complex PCI were analyzed.
Main outcomes and measures: Coprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).
Results: Of 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%). Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity. For the thrombotic composite end point, the hazard ratio (HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12). The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).
Conclusions and relevance: In this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.
Objective: To compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.
Design, setting, and participants: This post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up. The analysis was conducted from February to November 2023. Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.
Interventions: Patients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio. Those with sufficient data to assess HBR or complex PCI were analyzed.
Main outcomes and measures: Coprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).
Results: Of 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%). Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity. For the thrombotic composite end point, the hazard ratio (HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12). The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).
Conclusions and relevance: In this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.
논문정보
- Research article
- 2024년 11월 (BRIC 등록일 2024-11-28)
- 국내 연구진
- 의약학 > 응용의학
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