New information from the TWILIGHT trial showed that ticagrelor monotherapy after three months of ticagrelor plus aspirin was associated with similar rates of recurrent coronary revascularization, major cardiac and cerebrovascular adverse events (MACCE), and a higher risk low net adverse clinical events (NACE) compared to dual antiplatelet therapy (DAPT). The results of the randomized controlled trial of more than 7,000 patients were presented today as late-breaking clinical research at the 2023 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions (SCAI).
Despite advances in percutaneous coronary intervention (PCI) techniques, devices, and secondary prevention, repeat revascularization remains a concern and is associated with increased morbidity, hospitalizations, and healthcare costs.
In the TWILIGHT trial, high-risk patients who experienced no events and adhered to a ticagrelor-based DAPT for three months after PCI were randomized to receive ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. The primary endpoint was repeated revascularization due to recurrent or persistent symptomatic myocardial ischemia. Secondary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac and cerebrovascular events (MACCE) and net adverse clinical events (NACE). All endpoints were judged and assessed 12 months after randomization in the per-protocol population.
Among 7039 patients, ticagrelor monotherapy and ticagrelor plus aspirin were associated with a similar risk of repeat revascularization (7.1% versus 6.6%, HR 1.09, 95% CI 0.90-1.30 ), TLR, TVR, and MACCE, while NACE was lower with ticagrelor monotherapy. The results also showed that clinically motivated revascularization was associated with an excess risk of subsequent death, myocardial infarction or stroke (aHR 2.92, 95% CI 1.82 – 4.67) .
In patients at high risk of PCI, it is essential to reduce the frequency of repeat revascularizations. Results from the TWILIGHT trial presented today provide insight into the impact of DAPT and ticagrelor monotherapy after PCI for the clinical community. »
Usman Baber, MD, associate professor of medicine at the University of Oklahoma Health Sciences Center and lead study author
Source:
Society of Angiography and Cardiovascular Procedures