open access
P2Y12 inhibitor monotherapy in complex percutaneous coronary intervention: A post-hoc analysis of SMART-CHOICE randomized clinical trial
Affiliations- Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, Korea, Republic Of
- Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic Of
- Division of Cardiology, Samsung Changwon Hospital, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Ewha Womans University Medical Center Seoul Hospital, Seoul, Korea, Republic Of
- Division of Cardiology, Dongsuwon General Hospital, Suwon, Korea, Republic Of
- Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea, Republic Of
- Division of Cardiology, Kangwon National University Hospital, Chuncheon, Korea, Republic Of
- Department of Cardiology, Wonkwang University School of Medicine, Iksan, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea, Republic Of
- Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea, Republic Of
- Department of Cardiology, Seoul Eulji Hospital, Eulji University College of Medicine, Seoul, Korea, Republic Of
- Department of Internal Medicine, College of Medicine, Chung-Ang University, Seoul, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea, Republic Of
- Division of Cardiology, Kwangju Christian Hospital, Gwangju, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Saint Carollo Hospital, Suncheon, Korea, Republic Of
- Division of Cardiology, Department of Internal Medicine, Konkuk University Chungju Hospital, Konkuk University College of Medicine, Chungju, Korea, Republic Of
- Department of Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea, Republic Of
open access
Abstract
Background: It remains unclear whether P2Y12 monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y12 inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT.
Methods: The post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5.
Results: Complex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05–2.89, p = 0.033) and a similar risk of BARC types 2–5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56–1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y12 inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38–2.21, p = 0.853).
Conclusions: P2Y12 inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.
Abstract
Background: It remains unclear whether P2Y12 monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y12 inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT.
Methods: The post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5.
Results: Complex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05–2.89, p = 0.033) and a similar risk of BARC types 2–5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56–1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y12 inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38–2.21, p = 0.853).
Conclusions: P2Y12 inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.
Keywords
clopidogrel, high-risk, percutaneous coronary intervention
Supp./Additional Files (1)
About this articleTitle
P2Y12 inhibitor monotherapy in complex percutaneous coronary intervention: A post-hoc analysis of SMART-CHOICE randomized clinical trial
Journal
Issue
Article type
Original Article
Pages
855-863
Published online
2021-09-08
Page views
6481
Article views/downloads
1070
DOI
10.5603/CJ.a2021.0101
Pubmed
Bibliographic record
Cardiol J 2021;28(6):855-863.
Keywords
clopidogrel
high-risk
percutaneous coronary intervention
Authors
Ji Woong Roh
Joo-Yong Hahn
Ju-Hyeon Oh
Woo Jung Chun
Yong Hwan Park
Woo Jin Jang
Eul-Soon Im
Jin-Ok Jeong
Byung Ryul Cho
Seok Kyu Oh
Kyeong Ho Yun
Deok-Kyu Cho
Jong-Young Lee
Young-Youp Koh
Jang-Whan Bae
Jae Woong Choi
Wang Soo Lee
Hyuck Jun Yoon
Seung Uk Lee
Jang Hyun Cho
Woong Gil Choi
Seung-Woon Rha
Hee-Yeol Kim
Joo Myung Lee
Taek Kyu Park
Jeong Hoon Yang
Jin-Ho Choi
Seung-Hyuck Choi
Sang Hoon Lee
Hyeon-Cheol Gwon
Dong-Bin Kim
Young Bin Song
References (18)- Vranckx P, Valgimigli M, Jüni P, et al. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018; 392(10151): 940–949.
- Hahn JY, Song YB, Oh JH, et al. SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019; 321(24): 2428–2437.
- Mehran R, Baber U, Sharma SK, et al. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019; 381(21): 2032–2042.
- Kim BK, Hong SJ, Cho YH, et al. TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020; 323(23): 2407–2416.
- Kirtane AJ, Doshi D, Leon MB, et al. Treatment of higher-risk patients with an indication for revascularization: evolution within the field of contemporary percutaneous coronary intervention. Circulation. 2016; 134(5): 422–431.
- Dangas G, Baber U, Sharma S, et al. Ticagrelor with or without aspirin after complex PCI. J Am Coll Cardiol. 2020; 75(19): 2414–2424.
- Piccolo R, Giustino G, Mehran R, et al. Stable coronary artery disease: revascularisation and invasive strategies. Lancet. 2015; 386(9994): 702–713.
- Stefanini GG, Serruys PW, Silber S, et al. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011; 57(22): 2221–2232.
- Giustino G, Baber U, Sartori S, et al. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2015; 65(13): 1298–1310.
- Serruys PW, Takahashi K, Chichareon P, et al. Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial. Eur Heart J. 2019; 40(31): 2595–2604.
- Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011; 123(23): 2736–2747.
- Watanabe H, Domei T, Morimoto T, et al. STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019; 321(24): 2414–2427.
- Giustino G, Chieffo A, Palmerini T, et al. Efficacy and safety of dual antiplatelet therapy after complex PCI. J Am Coll Cardiol. 2016; 68(17): 1851–1864.
- CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996; 348(9038): 1329–1339.
- Costa F, van Klaveren D, James S, et al. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017; 389(10073): 1025–1034.
- Costa F, van Klaveren D, Feres F, et al. PRECISE-DAPT Study Investigators. Dual antiplatelet therapy duration based on ischemic and bleeding risks after coronary stenting. J Am Coll Cardiol. 2019; 73(7): 741–754.
- Zimarino M, Angiolillo DJ, Dangas G, et al. Antithrombotic therapy after percutaneous coronary intervention of bifurcation lesions. EuroIntervention. 2021; 17(1): 59–66.
