Switch to ticagrelor monotherapy after 3-month DAPT safely reduces bleeding after PCI
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Key takeaways:
- Ticagrelor monotherapy after 3-month dual antiplatelet therapy reduced 1-year major bleeding vs. prolonged DAPT.
- The risk for adverse ischemic outcomes was similarly low in both arms.
SAN FRANCISCO — In a new meta-analysis, researchers reaffirmed safety and efficacy of ticagrelor monotherapy to reduce major bleeding after 3-month dual antiplatelet therapy among patients who underwent PCI for ACS.
The results of the individual patient data meta-analysis of the TWILIGHT and TICO randomized trials were presented at TCT 2023 and simultaneously published in Circulation.
“These novel and compelling data challenge the conventional paradigm of using dual antiplatelet therapy in all patients after an acute coronary syndrome. The net clinical benefit provided by ticagrelor monotherapy offers clinicians a reassuring alternative to long-term dual antiplatelet therapy in these high-risk patients,” Usman Baber, MD, associate professor of medicine at the University of Oklahoma Health Sciences Center, said in a press release.
For this meta-analysis, Baber and colleagues included 7,529 patients (mean age, 63 years; 23% women), from the TICO and TWILIGHT randomized trials, of whom, after 3 months of DAPT following PCI, 49.5% were randomly assigned to ticagrelor monotherapy (Brilinta, AstraZeneca) and the remainder received ticagrelor plus aspirin.
In the TICO trial, 3,056 patients with ACS (mean age, 61 years; 80% men) who underwent PCI with a sirolimus-eluting stent were assigned to ticagrelor monotherapy or prolonged DAPT.
As Healio previously reported, among patients with ACS who underwent PCI with a sirolimus-eluting stent (Orsiro, Biotronik), ticagrelor monotherapy after 3 months was superior at preventing net adverse clinical events compared with prolonged DAPT at 1 year.
For the TWILIGHT trial, 7,119 patients underwent randomization 3 months after PCI to continued DAPT or were switched to ticagrelor monotherapy.
As Healio previously reported, switching from DAPT to ticagrelor monotherapy after 3 months following PCI was associated with lower bleeding risk without raising ischemic risk.
For the present study, the prespecified primary endpoint was major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding and the key secondary ischemic endpoint was the composite of all-cause death, MI or stroke.
After 3 months, researchers observed that ticagrelor monotherapy was associated with reduced risk for BARC 3 or 5 bleeding compared with DAPT (0.8% vs. 2.1%; HR = 0.37; 95% CI, 0.24-0.56; P < .001).
Moreover, the rates of all-cause death, MI or stroke did not significantly differ between the two groups (ticagrelor monotherapy, 2.4%; DAPT, 2.7%; HR = 0.91; 95% CI, 0.68-1.21; P = .515).
“We are very honored to have collaborated with our colleagues in Korea, to pool individual patient data on two similar trials, and now have some definitive answers in how to treat patients with acute coronary syndromes. This strategy of short (3 months) dual antiplatelet therapy (ticagrelor plus aspirin) followed by ticagrelor monotherapy is associated with less bleeding without any compromise in ischemic events,” Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai, said in a press release.
References:
- Baber U, et al. Circulation. 2023;doi:10.1161/CIRCULATIONAHA.123.067283.
- Mount Sinai. Eliminating long-term aspirin for acute coronary syndrome patients is safe, effective, and reduces bleeding complications. Published Oct. 23, 2023. Accessed Nov. 2, 2023.