A novel 1-month regimen of dual antiplatelet therapy (DAPT) combined with aspirin followed by a 23-month regimen of DAPT alone after staged percutaneous coronary intervention (SPCI) was found to reduce the risk for bleeding in patients with acute coronary syndrome (ACS), compared with a standard DAPT treatment, according to a study published in The American Journal of Cardiology.
In this prospective, open-label, randomized controlled trial, GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation (ClinicalTrials.gov Identifier: NCT01813435), 15,968 patients with ACS were recruited at 130 hospitals in 18 countries between 2013 and 2015 and randomized. Of those patients, 1651 underwent SPCI (n=847 receiving the experimental regimen: ticagrelor and aspirin for 1 month followed by 23 months of ticagrelor monotherapy; n=804 receiving the reference regimen: 12 months clopidogrel or ticagrelor followed by 12 months of aspirin). Participants were assessed for mortality, new Q-wave myocardial infarction, or major bleeding events over a 2-year period.
In this cohort, mean age was 64.5±10.3 years, 76.7% were men, 25.3% had comorbid diabetes, 73.6% had hypertension, 69.9% had hypercholesterolemia, and 32.7% had previously received PCI. Among patients undergoing SPCI vs nonstaged PCI rates of hypercholesterolemia were lower (P =.041), and rates of previous myocardial infarction (P <.001), previous PCI (P <.001), previous coronary artery bypass grafting (P <.001), bifurcation or trifurcation (P <.001), and multivessel treatment (P <.001) were higher.
After adjusting for all confounders, patients with vs without SPCI had higher risks for: all-cause mortality (hazard ratio [HR], 1.437; 95% CI, 1.020-2.025; P =.038), revascularization (HR, 1.515; 95% CI, 1.263-1.817; P <.001), and bleeding academic research consortium (BARC) scores of 2, 3, or 5 (HR, 1.261; 95% CI, 1.006-1.581; P =.044) at 2 years.
Net adverse events were lower in patients receiving the experimental vs reference regimen (15.0% vs 20.4%, respectively; HR, 0.707; 95% CI, 0.526-0.951; P =.022), which was primarily driven by reduced frequency of BARC 3 and 5 bleeding events (1.8% vs 4.5%, respectively; HR, 0.496; 95% CI, 0.317-0.776; P =.002).
This study may have been limited by the reliance on site-reported statistics for adverse events.
”In patients [with ACS] undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT,” concluded the study authors.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Kawashima H, Tomaniak M, Ono M, et al. Safety and efficacy of 1-month dual antiplatelet therapy (ticagrelor + aspirin) followed by 23-month ticagrelor monotherapy in patients undergoing staged percutaneous coronary intervention (A sub-study from GLOBAL LEADERS). Am J Cardiol. 2021;138:1-10. doi:10.1016/j.amjcard.2020.09.057