Coronary interventions

Clopidogrel monotherapy in patients with and without on-treatment high platelet reactivity: a SMART-CHOICE substudy

EuroIntervention 2021;17:e888-e897. DOI: 10.4244/EIJ-D-21-00223

Seung Hun Lee
Seung Hun Lee1,2, MD, PhD; Sang Yeub Lee3, MD, PhD; Woo Jung Chun4, MD, PhD; Young Bin Song1, MD, PhD; Seung-Hyuk Choi1, MD, PhD; Jin-Ok Jeong5, MD, PhD; Seok Kyu Oh6, MD, PhD; Kyeong Ho Yun6, MD, PhD; Young-Youp Koh7, MD, PhD; Jang-Whan Bae3, MD, PhD; Jae Woong Choi8, MD, PhD; Hyeon-Cheol Gwon1, MD, PhD; Joo-Yong Hahn1, MD, PhD
1. Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 2. Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea; 3. Chungbuk Regional Cardiovascular Disease Center, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea; 4. Department of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea; 5. Chungnam National University Hospital, Daejeon, Republic of Korea; 6. Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Republic of Korea; 7. Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea; 8. Eulji General Hospital, Seoul, Republic of Korea

Background: Although P2Y12 inhibitor monotherapy has emerged as a promising alternative for dual antiplatelet therapy (DAPT), there remains concern regarding the safety of clopidogrel monotherapy.

Aims: We sought to investigate clinical outcomes of clopidogrel monotherapy in patients with and without on-treatment high platelet reactivity (HPR).

Methods: In the SMART-CHOICE study, three-month DAPT followed by P2Y12 inhibitor monotherapy was compared with 12-month DAPT in patients undergoing percutaneous coronary intervention. A platelet function test was performed for 833 patients with clopidogrel-based therapy. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE: a composite of all-cause death, myocardial infarction, or stroke) at 12 months.

Results: Overall, 108 (13.0%) patients had HPR on clopidogrel. Patients with HPR had a significantly higher rate of MACCE than patients without HPR (8.7% vs 1.5%, adjusted HR 3.036, 95% CI: 1.060-8.693, p=0.038). The treatment effect of clopidogrel monotherapy for the 12-month MACCE was not significantly different compared with DAPT among patients with HPR (8.0% vs 9.4%, adjusted HR 0.718, 95% CI: 0.189-2.737, p=0.628) and without HPR (2.2% vs 0.9%, adjusted HR 2.587, 95% CI: 0.684-9.779, p=0.161; adjusted p for interaction=0.170).

Conclusions: Clopidogrel monotherapy showed treatment effects comparable to DAPT for MACCE in patients with or without HPR. However, HPR was significantly associated with an increased risk of MACCE in clopidogrel-treated patients regardless of maintenance of aspirin. Clinical Trial Registration: Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES (SMART-CHOICE) ( NCT02079194).

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