Ticagrelor alone non-inferior after one month post drug eluting stent placement

1. In this pre-specified ancillary study of a randomized control trial, ticagrelor alone after one month was found non-inferior, but not superior, to dual antiplatelet therapy in preventing ischemic events after drug eluting coronary stenting.

2. Ticagrelor did not decrease bleeding risk compared with dual antiplatelet therapy.

Evidence Rating Level: 2 (Good)

Study Rundown: Dual antiplatelet therapy is standard of care after implantation of drug eluting coronary stents to reduce risk of stent thrombosis and ischemic events. This was an ancillary study using approximately 50% of patients enrolled in the parent randomized controlled trial, GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation). It found that compared with standard of care (aspirin and clopidogrel/ticagrelor for 1 year after drug eluting stent implantation followed by aspirin alone), aspirin and ticagrelor for 1 month followed by ticagrelor alone for 23 months was non-inferior, but not superior, in reducing a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, or urgent target vessel revascularization. There were similar rates of bleeding between the two groups.

The size and multi-center nature of the study are the major strengths of this study.
More studies are required to further elucidate the value of ticagrelor versus aspirin alone in reducing rates of urgent revascularization, and if this may translate into improved outcomes for select patients.

Click to read the study in JACC

Relevant Reading: Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention The SMART-CHOICE Randomized Clinical Trial

In-Depth [randomized controlled trial]: This was an ancillary study designed after study recruitment began (but before the 2 year recruitment period was completed) for the GLOBAL LEADERS study (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation). Sample size was 7,585 patients undergoing percutaneous coronary intervention with drug eluting stent implantation. The intervention group received one month of 75-100 mg of aspirin and 90 mg of ticagrelor twice daily, followed by 23 months of ticagrelor alone. The control group received 12 months of dual antiplatelet therapy (DAPT) with 75-100 mg of aspirin plus one of 75-100 mg of clopidogrel (if stable coronary artery disease) or ticagrelor 90 mg twice daily (if acute coronary syndrome) followed by aspirin alone for 12 months. After 2 years, the composite outcome of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, or urgent target vessel revascularization occurred in 271 patients in the intervention group (7.1%) vs 319 patients in the control group (8.4%) (RR 0.85, 95% CI 0.72 – 0.99, p < 0.001 demonstrating non-inferiority, but p=0.0465 for superiority hence not achieving superiority based on the study methodology). Rates of serious bleeding were similar between both groups (2.48% BARC 3 or 5 bleeding in both groups). There was a 31% relative risk reduction in urgent target vessel revascularization which persisted for over 1 year of follow up.

Image: PD

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