The Risk/Benefit Tradeoff of Extending Dual Antiplatelet Therapy More than 12 Months in TWILIGHT-Like High-Risk Patients After Complex Percutaneous Coronary Intervention
Haoyu Wang1, Dong Yin2, Kefei Dou2
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China1, Fuwai Hospital, China2
Patients undergoing complex percutaneous coronary intervention (PCI) are known to be at high-risk for both ischemic and bleeding complications. The risk/benefit tradeoff of extending dual antiplatelet therapy (DAPT)>12 months with clopidogrel and aspirin for TWILIGHT-like patients who are at high risk of bleeding or ischemic events and undergo complex PCI is unclear.
8358 consecutive patients fulﬁlling the “TWILIGHT-like” criteria undergoing PCI between January 2013 and December 2013 were prospectively enrolled in Fuwai PCI Registry. We identified 2677 of "TWILIGHT-like" complex PCI patients who were events free at 1 year after the index procedure. "TWILIGHT-like" patients were identified based on at least one clinical and one angiographic feature. PCI was defined as complex PCI when at least one of the following features were met: ≥3 lesions treated, ≥3 stents implanted, 3 coronary vessels treated, total stent length >60 mm, bifurcation with 2 stents implanted, chronic total occlusion (CTO) as target lesion, left main as target vessel, use of any atherectomy device, or surgical bypass graft. Median follow-up was 29 months.
Risk of primary efficacy outcome, major adverse cardiac and cerebrovascular events (composite of all-cause death, myocardial infarction, or stroke), was reduced with DAPT>12-month vs. DAPT≤12-month (hazard ratio [HR]adj: 0.374, 95% CI: 0.235-0.595; HRmatched: 0.292 [0.151-0.561]; HRIPTW: 0.356 [0.225-0.562]), with directional consistency for cardiovascular death and definite/probable stent thrombosis. In contrast, >12-month DAPT was comparable to ≤12-month DAPT for the risk of clinically relevant bleeding ([HR]adj: 1.189, 95% CI: 0.474-2.984; HRmatched: 1.577 [0.577-4.312]; HRIPTW: 1.239 [0.502-3.059]). Importantly, there was also a significant net benefit in favor of prolonged DAPT treatment.
Among high-risk "TWILIGHT-like" patients who underwent complex PCI and who remained free from major ischemic and bleeding events 12 months after coronary stenting, continuation of DAPT with clopidogrel and aspirin beyond 12 months was associated with a positive net clinical benefit, as it was associated with a reduction in the incidence of ischemic events without trade-off in the risk of clinically relevant bleeding.