RIVER-PCI Subanalysis: No Impact of Ranolazine on Quality of Life
Routine use of ranolazine does not improve angina or quality of life (QoL) measures in patients with incomplete revascularization after PCI, according to a substudy of the RIVER-PCI trial presented at the American Heart Association 2015 Scientific Sessions in Orlando, FL, and simultaneously published in Circulation.
The main RIVER-PCI trial included 2,619 patients with post-PCI evidence of incomplete revascularization (at least 50% stenosis) and a history of chronic angina who were randomized to receive ranolazine (Ranexa, Gilead; 1,000 mg twice a day; n = 1,322) or placebo (n = 1,297). At a median follow up of 643 days, there was no difference between the 2 arms for the combined primary endpoint of ischemia-driven revascularization or hospitalization, or its individual components.
For the QoL substudy, Karen P. Alexander, MD, of Duke Clinical Research Institute (Durham, NC), and colleagues looked at the 2,604 RIVER-PCI patients with a qualifying PCI who received at least 1 dose of study drug and were included in the full efficacy analysis.
Compared with placebo patients, those treated with ranolazine had higher rates of drug discontinuation at 6 months (20.4% vs 14.1%, P < .001) and 1 year (27.2% vs 21.3%, P < .001). Patients in both groups had marked but similar post-PCI improvements in angina frequency score as assessed by the Seattle Angina Questionnaire (SAQ) from baseline to 1 month and to 1 year.
In patients with diabetes and in those with more frequent angina at baseline (SAQ score ≤ 60) an improvement was seen at 6 months compared with placebo, but the difference was not maintained at 12 months.
No Support for Routine Use
Study co-author Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), told TCTMD that the findings from the subanalysis are consistent with those of the main trial as well as with ranolazine’s mechanism of action and results from prior studies.
“Thus, ranolazine should not be used routinely after PCI, but may have a role in patients who still have moderate or greater angina despite revascularization to improve symptoms,” he noted.
In a press conference with the media, E. Magnus Ohman, MD, of Duke University School of Medicine (Durham, NC), another of the study’s co-authors, said more research is needed in patients with incomplete revascularization and in the area of antianginal drugs “to improve the tolerability of these agents.”
Also commenting on the study, John A. Spertus, MD, MPH, of St. Luke’s Mid America Heart Institute (Kansas City, MO), observed that “prophylactic ranolazine is not necessary, and we shouldn’t presume that every patient undergoing angioplasty with a residual [stenosis] ought to be treated with this drug.”
Note: Stone is a faculty member
of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Alexander KP, Weisz G, Prather K, et al. Effects of ranolazine on angina and quality of life after percutaneous coronary intervention with incomplete revascularization: results from the ranolazine for incomplete vessel revascularization (RIVER-PCI) trial. Circulation. 2015;Epub ahead of print.
- The trial was sponsored by Gilead Sciences, Inc, and cofunded by The Menarini Group.
- Alexander reports consulting and research grants to her institution from Gilead Sciences.
- Ohman reports research funding from Daiichi Sankyo, Eli Lilly, and Gilead Sciences; and consulting fees from WebMD and multiple pharmaceutical companies.
- Spertus reports owning the copyright to the Kansas City Cardiomyopathy Questionnaire.
- Stone reports no relevant conflicts of interest.