Risk/Benefit Tradeoff of Prolonging Dual Antiplatelet Therapy More Than 12 Months in TWILIGHT-Like High-Risk Patients After Complex Percutaneous Coronary Intervention

Am J Cardiol. 2020 Oct 15:133:61-70. doi: 10.1016/j.amjcard.2020.07.033. Epub 2020 Jul 24.

Abstract

Patients who underwent 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. Eight thousand three hundred and fifty-eight consecutive patients fulfilling the "TWILIGHT-like" criteria who underwent PCI from January 2013 to December 2013 were prospectively enrolled in Fuwai PCI Registry. We identified 2,677 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 1 clinical and 1 angiographic feature. 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 months versus DAPT≤ 12 months (hazard ratio [HR]adj 0.374, 95% confidence interval [CI] 0.235 to 0.595; HRmatched 0.292 [0.151 to 0.561]; HRIPTW 0.356 [0.225 to 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 to 2.984; HRmatched 1.577 [0.577 to 4.312]; HRIPTW 1.239 [0.502 to 3.059]). Importantly, there was also a significant net benefit in favor of prolonged DAPT treatment. In conclusion, among "TWILIGHT-like" patients after complex PCI, continuing duration of DAPT> 12 months was associated with a net clinical benefit and lower rates of ischemic events without increasing the risk of clinically relevant bleeding than DAPT≤ 12 months, suggesting that long-term DAPT may have a favorable risk-benefit ratio in this high-risk population.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aspirin / administration & dosage
  • Aspirin / adverse effects
  • China
  • Clopidogrel / administration & dosage
  • Clopidogrel / adverse effects
  • Cohort Studies
  • Coronary Artery Disease / therapy*
  • Drug Administration Schedule
  • Drug-Eluting Stents
  • Dual Anti-Platelet Therapy / adverse effects*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention*
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / adverse effects*
  • Registries
  • Risk Assessment
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Aspirin