The RIVER-PCI study, which was presented at TCT today, shows that ranolazine did not reduce the composite rate of ischemia-driven revascularisation or hospitalisation in patients with a history of chronic angina who had residual unrevascularised coronary artery disease after percutaneous coronary intervention (PCI). The study has also been published in The Lancet.
RIVER-PCI was a multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial conducted at 245 centres in 15 countries. In the study, 2,604 qualifying patients with a history of chronic angina and incomplete revascularisation were randomised to ranolazine (n=1,317) or placebo (n=1,287). The primary efficacy endpoint was the time from randomisation to the first occurrence of ischemia-driven revascularisation or ischemia-driven hospitalisation without revascularisation.
Incomplete revascularisation was associated with high event rates. After a median follow-up of 643 days, the composite primary endpoint occurred in 345 patients assigned to ranolazine and 364 assigned to placebo (Kaplan-Meier estimates 26.2% vs. 28.3% respectively; HR 0.95; 95% CI 0.82 to 1.10; p=0.48). The results were consistent across multiple subgroups. There were no significant differences between the two groups in the incidence of the components of the primary endpoint or major secondary endpoints including sudden cardiac death, cardiovascular death, and myocardial infarction.
Lead investigator Giora Weisz (Chairman of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel), says: “The results of RIVER-PCI show that the routine use of ranolazine does not reduce the composite rate of ischemia-driven revascularisation or hospitalisation in patients with a history of chronic angina who had incomplete revascularisation after PCI.”