Ticagrelor monotherapy noninferior to DAPT following PCI
Ticagrelor monotherapy after 1 month of dual antiplatelet therapy (DAPT) was noninferior to standard 1-year DAPT among patients who had undergone percutaneous coronary intervention (PCI) with drug-eluting stents, according to results of the GLASSY* trial presented at ACC.19.
“Ticagrelor monotherapy after 1-month DAPT was noninferior to conventional DAPT in the prevention of all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke, or urgent target-vessel revascularization (TVR) at 2 years,” said study author Dr Marco Valgimigli from the Swiss Cardiovascular Center Bern in Bern, Switzerland.
Study participants comprised patients undergoing PCI with biolimus-eluting stents. Participants in the intervention arm received ticagrelor (90 mg BID) plus aspirin (75–100 mg/day) for 1 month followed by ticagrelor monotherapy for 23 months, while those in the control arm received aspirin (75–100 mg/day) plus either ticagrelor 90 mg BID (patients with acute coronary syndrome**) or clopidogrel 75 mg/day (patients with stable coronary artery disease) for 12 months followed by aspirin monotherapy for 12 months. Total number of participants was 15,991 recruited from 130 centres worldwide (GLOBAL LEADERS cohort), of whom 7,585 (from the 20 top-enrolling sites) made up the GLASSY cohort.
Ticagrelor monotherapy was noninferior to standard DAPT pertaining to the risk of all-cause death, nonfatal MI, nonfatal stroke, or urgent TVR (7.14 percent vs 8.41 percent; pnoninferiority<0.001). [ACC.19, abstract 408-16]
Secondary efficacy outcomes were comparable between patients in the intervention and control arms with regard to all-cause death (2.93 percent vs 3.6 percent; p=0.11), cardiac death (1.82 percent vs 2.32 percent; p=0.13), cardiac death or MI (4.51 percent vs 5.41 percent; p=0.081), MI (2.85 percent vs 3.56 percent; p=0.085), stroke (1.16 percent each; p=0.99), and definite stent thrombosis (0.71 percent vs 1 percent; p=0.17). However, patients in the intervention arm experienced a significant reduction in urgent TVR (1.87 percent vs 2.72 percent; p=0.015).
A landmark analysis in the second year of treatment showed that compared with those in the control arm, patients in the intervention arm had significant reductions in MI (0.69 percent vs 1.27 percent; p=0.062) and definite stent thrombosis (0.05 percent vs 0.38 percent; p=0.007).
The primary safety endpoint, defined as Bleeding Academic Research Consortium (BARC) score 3 or 5 bleeding, occurred in 2.46 percent of patients in both the intervention and control arms.
“Even when you compare ticagrelor monotherapy and aspirin monotherapy in the second year, the bleeding rate was almost identical,” Valgimigli pointed out. “If you factor in the [lack of] difference in bleeding, ticagrelor monotherapy starts to become a very interesting and appealing approach to mitigate ischaemic risk without increasing bleeding risk,” he added.
“Our results provide new evidence that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischaemic risk as compared to a standard DAPT for 1 year and may reduce the rates of MI and stent thrombosis as compared to aspirin alone … [without increasing] the risk of major bleeding,” he said.
While the results of this study are “appealing and promising”, results of other ongoing studies in this area of research may provide clinicians with more information on which drug is preferable, noted Valgimigli.