TY - JOUR
T1 - Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention
T2 - Insight From the STOPDAPT-2 Trial
AU - Yamamoto, Ko
AU - Watanabe, Hirotoshi
AU - Morimoto, Takeshi
AU - Domei, Takenori
AU - Ohya, Masanobu
AU - Ogita, Manabu
AU - Takagi, Kensuke
AU - Suzuki, Hirohiko
AU - Nikaido, Akira
AU - Ishii, Mitsuru
AU - Fujii, Shinya
AU - Natsuaki, Masahiro
AU - Yasuda, Satoshi
AU - Kaneko, Takeo
AU - Tamura, Takashi
AU - Tamura, Toshihiro
AU - Abe, Mitsuru
AU - Kawai, Kazuya
AU - Nakao, Koichi
AU - Ando, Kenji
AU - Tanabe, Kengo
AU - Ikari, Yuji
AU - Igarashi Hanaoka, Keiichi
AU - Morino, Yoshihiro
AU - Kozuma, Ken
AU - Kadota, Kazushige
AU - Furukawa, Yutaka
AU - Nakagawa, Yoshihisa
AU - Kimura, Takeshi
N1 - Funding Information:
STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy-2) was funded by Abbott Vascular Japan. The study sponsor is not involved in the implementation of the study, data collection, event fixation, and statistical analysis. However, approval of the study sponsor should be obtained for presentation in scientific meetings and submission of papers.
Funding Information:
Dr Watanabe reports honoraria from Abbott, Daiichi Sankyo, Otsuka, Kowa, Bayer, Pfizer, Ono Pharmaceutical, and Boehringer Ingelheim. Dr Morimoto reports hono- raria from Bayer, Daiichi Sankyo, Japan Lifeline, Kyocera, Mitsubishi Tanabe, Novartis, Toray, Bristol-Myers Squibb, and Kowa and expert witness from Asahi Kasei, Boston Scientific, Bristol-Myers Squibb, and Sanofi. Dr Natsuaki reports honoraria from Abbott. Dr Tanabe reports honoraria from Abbott, Daiichi Sankyo, and Sanofi. Dr K. Ko-zuma reports research grants and honoraria from Abbott. Dr Furukawa reports honoraria from Daiichi Sankyo, Bayer, Sanofi, Kowa, Pfizer, Bristol-Myers Squibb, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma, Takeda, and Ono Pharmaceutical. Dr T. Kimura reports honoraria from Abbott, Abiomed, Astellas, Astellas Amgen Bio-pharma, AstraZeneca, Bayer, Boston Scientific, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Edwards Lifescience, Eisai, Daiichi Sankyo, Interscience, Japan Society for the Promotion of Science, Kowa, Kowa Pharmaceutical, Lifescience, Medical Review, MSD, MSD Life Science Foundation, Mitsubishi Tanabe Pharma, Novartis Pharma, Ono Pharmaceutical, OrbusNeich, Otsuka Pharmaceutical, Pharmaceuticals and Medical Devices Agency, Philips, Public Health Research Foundation, Sanofi, Sumitomo Dainippon Pharma, Takeda Pharmaceutical, Terumo, Toray, and Tsumura. The other authors report no conflicts.
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10-0.92], P=0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47-1.20], P=0.23; Pinteraction=0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16-1.79], P=0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50-1.47], P=0.58; Pinteraction=0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P=0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P=0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02619760.
AB - Background: Safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) is uncertain in patients undergoing complex percutaneous coronary intervention (PCI). Methods: We conducted a post hoc subgroup analysis based on the complexity of PCI in the STOPDAPT-2 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-2), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after cobalt-chromium everolimus-eluting stent implantation. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents, >60 mm total stent lengths, and target of chronic total occlusion. The primary end point was the composite of cardiovascular (cardiovascular death/myocardial infarction/definite stent thrombosis/stroke) and bleeding (TIMI [Thrombolysis in Myocardial Infarction] major/minor) end points. The major secondary end points were the cardiovascular and bleeding end points. Results: Among the 3009 study patients, there were 509 patients (16.9%) with complex PCI (1-month DAPT: N=245, and 12-month DAPT: N=264) and 2500 patients (83.1%) without complex PCI (1-month DAPT: N=1255, and 12-month DAPT: N=1245). There were no significant interactions between the complexity of PCI and the effects of 1-month DAPT versus 12-month DAPT on the primary end point (complex PCI: 1.67% versus 5.32%, hazard ratio, 0.30 [95% CI, 0.10-0.92], P=0.04, and noncomplex PCI: 2.50% versus 3.35%, hazard ratio, 0.75 [95% CI, 0.47-1.20], P=0.23; Pinteraction=0.14), and on the major secondary cardiovascular end point (complex PCI: 1.67% versus 3.04%, hazard ratio, 0.54 [95% CI, 0.16-1.79], P=0.31, and noncomplex PCI: 2.02% versus 2.39%, hazard ratio, 0.86 [95% CI, 0.50-1.47], P=0.58; Pinteraction=0.49). The cumulative 1-year incidence of the major secondary bleeding end point was significantly lower in the 1-month DAPT group than in the 12-month DAPT group regardless of the complexity of PCI (complex PCI: 0% versus 2.29%, log-rank P=0.02, and noncomplex PCI: 0.48% versus 1.38%, log-rank P=0.02). Conclusions: The effects of clopidogrel monotherapy after 1-month DAPT relative to 12-month DAPT for the primary and major secondary end points were comparable in complex PCI and noncomplex PCI without significant interactions. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02619760.
KW - clopidogrel
KW - drug-eluting stent
KW - percutaneous coronary intervention
KW - stent
KW - thrombosis
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UR - http://www.scopus.com/inward/citedby.url?scp=85106185965&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.120.010384
DO - 10.1161/CIRCINTERVENTIONS.120.010384
M3 - Article
C2 - 34003662
AN - SCOPUS:85106185965
SN - 1941-7640
VL - 14
SP - E010384
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 5
ER -