This article is more than 5 years old. Information may no longer be current.
PRAGUE-18: Prasugrel, ticagrelor confer similar outcomes in patients with STEMI undergoing PCI
Click Here to Manage Email Alerts
In the first randomized, head-to-head comparison of prasugrel and ticagrelor, the drugs were associated with similar short-term outcomes in patients with STEMI who received them before PCI.
In the PRAGUE-18 trial, 1,230 patients with STEMI (mean age, 62 years; 24% women) were randomly assigned upon arrival to a PCI center to prasugrel (Effient, Daiichi Sankyo/Eli Lilly) 60 mg orally followed by 10 mg per day for 1 year (5 mg per day for patients aged 75 years or older or weighing less than 60 kg) or ticagrelor (Brilinta, AstraZeneca) 180 mg orally followed by 90 mg twice daily for 1 year.
After discharge, patients had to cover the cost of prasugrel or ticagrelor, so some switched to clopidogrel, which is generic, Petr Widimsky, MD, DrSc, from Cardiocenter, Charles University, Prague, Czech Republic, said during a presentation at the European Society of Cardiology Congress.
Petr Widimsky
The primary endpoint was a composite of death, reinfarction, urgent target vessel revascularization, stroke, serious bleeding leading to transfusion and prolonged hospitalization at 7 days. The key secondary endpoint was CV death, nonfatal MI or stroke at 30 days.
The trial was scheduled to enroll 2,500 patients, but was stopped early for futility after an interim analysis showed no difference in the primary endpoint (prasugrel group, 4%; ticagrelor group, 4.1%; P = .939; log-rank P = .935) or the key secondary endpoint (prasugrel group, 2.7%; ticagrelor group, 2.5%; P = .864; log-rank P = .665), according to Widimsky.
“Our findings confirm previous indirect, nonrandomized comparisons of these two drugs, based on analyses of various registries,” Widimsky said in a press release. “Thus, both drugs are very effective and safe and significantly contribute to the excellent outcomes of patients with acute [MI] in modern cardiology. These study results offer more freedom to clinicians to select the antiplatelet agent added on top of aspirin for patients with STEMI who receive dual antiplatelet therapy.”
Patients will be followed for 1 year and final follow-up will be completed in 2017, according to the release. – by Erik Swain
References:
Widimsky P, et al. Hot Line: Coronary artery disease and stenting. Presented at: European Society of Cardiology Congress; Aug. 27-31, 2016; Rome.
Motovska Z, et al. Circulation. 2016;doi:10.1161/CIRCULATIONAHA.116.024823.
Disclosure: Widimsky reports no relevant financial disclosures.
Perspective
Back to Top
Sripal Bangalore, MD, MHA
This is an important study because, prior to this, it was either a guess or an indirect comparison as to whether prasugrel or ticagrelor were superior. In that setting, it’s valuable information, and it’s good to see that there are no differences between the two treatment strategies.
That being said, there are a number of limitations, including the small sample size, which means the study is likely underpowered. There were also patients who crossed over. The short 7-day and 30-day endpoints are somewhat troublesome. I would like to see longer-term outcomes. There are some strengths, but many weaknesses we need to consider.
In terms of clinical practice, the findings somewhat reassure clinicians that choosing either of the two drugs means that patients are not worse off.
We definitely need longer-term, well-powered studies to determine if there are differences between prasugrel and ticagrelor. For 7-day endpoints, you need a lot more patients, especially when event rates are very low.
Click Here to Manage Email Alerts