Disclosures: Mehran reports she received grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo, Medtronic, Novartis Pharmaceuticals and OrbusNeich; personal fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medtelligence, Medscape/WebMD, PLx Opco dba PLx Pharma, Roivant Sciences, Sanofi and Siemens Medical Solutions; other compensation from Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano and Watermark Research Partners; and nonfinancial support and other compensation from and Idorsia Pharmaceuticals and Regeneron Pharmaceuticals. Sharma reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
July 13, 2021
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TWILIGHT: Ticagrelor monotherapy 3 months post-PCI decreases bleeding regardless of age

Disclosures: Mehran reports she received grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo, Medtronic, Novartis Pharmaceuticals and OrbusNeich; personal fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medtelligence, Medscape/WebMD, PLx Opco dba PLx Pharma, Roivant Sciences, Sanofi and Siemens Medical Solutions; other compensation from Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano and Watermark Research Partners; and nonfinancial support and other compensation from and Idorsia Pharmaceuticals and Regeneron Pharmaceuticals. Sharma reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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Regardless of patient age, switching from dual antiplatelet therapy to ticagrelor monotherapy after 3 months of ticagrelor plus aspirin reduces bleeding without increasing ischemic events, according to new data from the TWILIGHT trial.

“We are very careful about selecting our DAPT regimens in elderly patients and we might ration care to them because we are worried about bleeding. [Ticagrelor monotherapy] is a novel strategy for them,” Roxana Mehran, MD, professor of medicine and director of interventional cardiovascular research and clinical trials at Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, said in an interview with Healio. “You can give them a potent agent and still reduce bleeding events.”

Roxana Mehran, MD, professor of medicine and director of interventional cardiovascular research and clinical trials at Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai.

As Healio previously reported, the TWILIGHT trial included high-risk patients undergoing PCI with drug-eluting stents. Patients had at least one clinical and one angiographic high-risk criterion, with age 65 years or older serving as a clinical entry criterion. After 3 months of DAPT with ticagrelor (Brilinta, AstraZeneca), event-free patients were randomly assigned to ticagrelor plus placebo or ticagrelor plus aspirin for 12 additional months.

Mehran, Dominick J. Angiolillo, MD, PhD, professor of medicine at the University of Florida College of Medicine, Jacksonville, and colleagues defined Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding as the primary endpoint, and the composite of all-cause death, MI or stroke as the key secondary endpoint.

Among the cohort of 6,532 patients, 47.7% were aged at least 65 years.

Benefit regardless of age

In patients aged 65 years or older, ticagrelor monotherapy lowered the primary endpoint vs. ticagrelor plus aspirin (4.5% vs. 8.2%; HR = 0.53; 95% CI, 0.4-0.71; P < .001) without increasing ischemic events (monotherapy, 4.2%; DAPT, 4.4%; HR = 0.96; 95% CI, 0.68-1.35; P = .798). The researchers observed consistent findings in patients younger than 65 years in the primary (P for interaction = 0.62) and key secondary (P for interaction = 0.77) endpoints and across various age categories.

“The magnitude of benefit [with ticagrelor monotherapy] is larger for the elderly, but it is still important for the younger patients,” Mehran told Healio, noting that this finding came as a surprise to her. “I had thought all of the benefit would be in the elderly patients, but that’s not the case. It’s all of them, whether you are old or young. This tells us how important it is, especially in the elderly population, to think about withdrawing aspirin.”

Improvements in patient safety

Garima Sharma

In an accompanying editorial, Garima Sharma, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, and colleagues wrote that the movement away from DAPT and toward antiplatelet monotherapy potentially joins a small number of significant changes in the history of antithrombotic therapy that have led to improvements in patient safety.

“Although no other agent can replace the convenience, low cost or COX-1-selective platelet-inhibitory effects of aspirin, and no clinical trials of antiplatelet monotherapy have gone completely aspirin-free, we conclude that a short course of DAPT should be considered to optimize the ischemia benefit and bleeding risk in older individuals who have increased risk for bleeding with aspirin,” Sharma and colleagues wrote.

Reference:

For more information:

Roxana Mehran, MD, can be reached at roxana.mehran@mountsinai.org; Twitter: @drroxmehran.