P2Y12i monotherapy reduces ischemic outcomes in patients undergoing multivessel PCI
Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI
Introduction and methods
Monotherapy with the P2Y12 inhibitor ticagrelor following 1- month dual antiplatelet therapy (DAPT) did not result in a reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction (MI) compared with aspirin monotherapy following 12-month DAPT in the GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) . Two more recent trials, the STOPDAPT-2 (ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study) and SMART-CHOICE (Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES) demonstrated superiority of a regimen of 1- or 3-month DAPT followed by P2Y12 monotherapy compared to 12-month DAPT with regard to bleeding outcomes and noninferiority for a composite end point of ischemic events [2,3]. Data on optimal antiplatelet regimen in patients undergoing multivessel percutaneous coronary intervention (PCI) are limited.
This study compared 1-month DAPT followed by 23-month ticagrelor monotherapy with standard DAPT regimen with regard to bleeding and ischemic outcomes in 3576 patients undergoing multivessel PCI. Data of the GLOBAL LEADERS trial was used for this non pre-specified analysis. The GLOBAL LEADERS trial enrolled patients with an indication for PCI, who were randomized to receive 1-month DAPT (aspirin plus ticagrelor) followed by 23-month ticagrelor monotherapy or standard DAPT regimen for 12 months (aspirin plus ticagrelor for ACS or clopidogrel for CAD) followed by 12-month aspirin monotherapy. Primary endpoint was composite of all-cause death or new Q-wave MI at two years. Key secondary end point was BARC bleeding type 3 or 5 at two years.
- Ticagrelor monotherapy resulted in a lower risk of the primary end point compared to standard DAPT regimen (3.06% vs. 4.85%; HR: 0.62; 95% CI: 0.44 to 0.88; P=0.006). Individual end points of all-cause mortality and any revascularization were also reduced in those receiving ticagrelor monotherapy compared to standard DAPT regimen (HR: 0.63, 95%CI: 0.42-0.93, P=0.019 and HR: 0.79, 95%CI: 0.65-0.97, P=0.022).
- Risk of BARC type 3 or 5 bleeding was similar between the two regimen groups.
- In a subgroup of ACS patients with multivessel PCI, ticagrelor monotherapy resulted in a lower risk of the primary end point compared to standard DAPT regimen (HR: 0.55, 95%CI: 0.35-0.89, P=0.14), driven by a reduction in all-cause mortality (HR: 0.51, 95%CI: 0.30-0.87, P=0.013). Risk of bleeding was similar in the two groups in this subgroup of ACS patients
In this post-hoc analysis of the GLOBAL LEADERS trial in patients with multivessel PCI, ticagrelor monotherapy reduced the composite of all-cause death or MI after two years compared to standard DAPT regimen without any difference in BARC type 3 or 5 bleeding.