Aspirin-Free DAPT Regimen Associated With Reduced Risk for Bleeding in Patients Undergoing SPCI for ACS

Delay between PCI and antiplatelet therapy linked to improved coronary reperfusion.
Delay between PCI and antiplatelet therapy linked to improved coronary reperfusion.
A novel vs reference DAPT regimen after staged PCI was found to reduce the risk for bleeding in patients with acute coronary syndrome.

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 ( 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