FABOLUS-FASTER Phase IV trial of Aggrastat in acute coronary syndrome published in Circulation.- Medicure

Medicure announced that results from the investigator sponsored FABOLUS-FASTER Phase IV clinical trial, using Aggrastat (tirofiban) in acute coronary syndrome, have been published in Circulation, a peer-reviewed journal of the American Heart Association. FABOLUS-FASTER studied different regimens of intravenous platelet inhibitors, notably Aggrastat (tirofiban hydrochloride) injection (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The FABOLUS-FASTER study randomized 122 P2Y12-naive STEMI patients to receive tirofiban (n=40), cangrelor (n=40), or a 60 mg loading dose of prasugrel (n=42). Those randomized to prasugrel were sub-randomized to chewed (n=21) or integral (n=21) tablet administration. The study was powered to test the noninferiority of cangrelor compared with tirofiban, the superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel compared with integral prasugrel for the primary endpoint of 30-minute inhibition of platelet aggregation (IPA) after stimulation with (20 µmol/L) ADP.

The results from the FABOLUS-FASTER trial showed cangrelor did not reach non-inferiority with tirofiban; in fact, tirofiban achieved superior IPA over cangrelor at 30 minutes (95.0%+/-9.0% vs 34.1%+/-22.5%; P <0.001). Cangrelor and tirofiban were both superior to chewed prasugrel (10.5% +/- 11.0%, P<0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3%+/-11.4%; P=0.47). Results from FABOLUS-FASTER were recently presented virtually at the PCR e-Course Scientific Sessions, due to the cancellation of EuroPCR 2020. Complete results from this study were published on June 27, 2020 in Circulation, a peer-reviewed journal of the American Heart Association.

See: “Cangrelor, Tirofiban and Chewed or Standard Prasugrel Regimens in Patients with ST-Segment Elevation Myocardial Infarction: Primary Results of the FABOLUS FASTER Trial.” Gargiulo G, Esposito G, Avvedimento M, et al. Circulation. 2020. doi :10.1161/circulationaha.120.046928