Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary intervention: the TAILORED-CHIP randomized clinical trial
Do‐Yoon Kang, Seong-Bong Wee, Jung‐Min Ahn, Hanbit Park, Sung-Cheol Yun, Kyoung‐Ha Park, Se Hun Kang, Jon Suh, Jang-Whan Bae, Sangwoo Park, Jang Hyun Cho, Jung‐Won Suh, Bong‐Ki Lee, Seung‐Woon Rha, Hoyoun Won, Jae‐Sik Jang, Young-Rak Cho, Cheol Hyun Lee, Young Keun Ahn, Jun‐Hyok Oh, Jae Seok Bae, Chul Soo Park, Jin Bae Lee, Jae Woong Choi, Se-Whan Lee, Sung‐Ho Her, Osung Kwon, Seung‐Jung Park, Duk‐Woo Park, Seung‐Jung Park, Duk‐Woo Park
Abstract
BACKGROUND AND AIMS: Limited data exist on optimal antiplatelet strategies for high-risk patients undergoing complex percutaneous coronary intervention (PCI). This study aimed to investigate the efficacy and safety of tailored antiplatelet treatment with temporal modulation of the intensity of platelet inhibition in patients undergoing complex high-risk PCI. METHODS: We randomly assigned 2018 patients with high-risk anatomical or clinical characteristics undergoing complex PCI to a tailored antiplatelet strategy with early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin <6 months) and late de-escalation (clopidogrel monotherapy >6 months) or dual antiplatelet therapy (clopidogrel plus aspirin for 12 months). The primary outcome was a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularization, and clinically relevant bleeding (Bleeding Academic Research Consortium Type 2, 3, or 5) at 12 months. RESULTS: The mean age was 64.0 years, 22.6% had left main PCI, 19.5% had complex bifurcation PCI, 84.1% had diffuse long lesions, 93.7% had multivessel PCI, and 36.7% had medically treated diabetes. At 12 months, a primary outcome event occurred in 105 patients (10.5%) assigned to tailored antiplatelet therapy and in 89 patients (8.8%) assigned to dual antiplatelet therapy [hazard ratio, 1.19; 95% confidence interval (CI), 0.90-1.58; P = .21]. The incidence of major ischaemic events appeared to be similar in both groups. The incidence of clinically relevant bleeding at 12 months was 7.2% in the tailored-therapy group and 4.8% in the dual-therapy group (difference, 2.45% points; 95% CI, 0.37-4.53). CONCLUSIONS: Among high-risk patients undergoing complex PCI, tailored antiplatelet strategy with early escalation and late de-escalation, as compared with dual antiplatelet therapy, did not decrease the incidence of primary net adverse events at 12 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT03465644.