ORLANDO, Fla. — The addition of ranolazine to standard medical therapy in patients with incomplete revascularization after percutaneous coronary intervention (PCI) did not reduce angina frequency or improve quality of life (QOL) compared with placebo.
E. Magnus Ohman, MD, of the Duke Clinical Research Institute in Durham, North Carolina, presented the results of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization After Percutaneous Coronary Intervention) trial at the American Heart Association Scientific Sessions.
The study included 2604 patients with a history of chronic angina who had incomplete revascularization after PCI, meaning “not every significant vessel was targeted for a PCI,” Ohman said during a press conference. “In this setting, patients who have angina typically continue to have angina after the procedure based on historical data.”
Ohman and colleagues randomly assigned patients 1:1 to either oral ranolazine (Gilead Sciences, Foster City, CA) (n=1317), an inhibitor of the late sodium current, or placebo (n=1287).
Researchers collected angina and QOL questionnaires from patients at baseline, as well as 1 month, 6 months and 12 months after index PCI.
In the QOL analyses, which included 2389 or 92% of the randomized patients, both ranolazine and placebo groups experienced improvements in the primary QOL outcome—defined as Seattle Angina Questionnaire (SAQ) angina frequency score—after PCI. Specifically, SAQ scores improved from baseline (ranolazine, 67.3 vs. placebo, 69.7; P=.03) to 1 month (ranolazine, 86.6 vs placebo, 85.8; P=.62) and 12 months (ranolazine, 88.4 ± 17.8 vs placebo, 88.5; P=.6).
In adjusted analysis, SAQ angina frequency did not significantly differ between groups after baseline (P=.11). Although there was an improvement at 6 months in SAQ angina frequency among ranolazine patients who were diabetic and had more angina (P=.02 for both), this benefit was not sustained at 12 months.
“Despite incomplete revascularization following PCI, there was no incremental benefit in angina or quality of life measures by adding ranolazine in this angiographically identified population,” Ohman concluded. “We saw significant and sustained improvements in angina in both arms following PCI, with most patients having rare or no angina by 1 month.”
Ohman noted that more research in patients with incomplete revascularization is needed because there is a disconnect between the frequency of hospitalization for ischemia and revascularization and angina frequency.
He added, “We really need to start developing better anti-angina agents to improve the tolerability and use of these agents.”
Disclosures: Dr Ohman has received research grants from Gilead Sciences and also serves as a consultant/on the advisory board.
- Alexander KP, Weisz G, Prather K, et al. Effects of ranolazine on angina and quality of life after percutaneous coronary intervention with incomplete revascularization. Circulation. 2016;doi:10.1161/circulationaha.115.019768.
- Ohman EM et al. LBCT.03: ACS and PCI: The Continuum of Care. Angina and Quality of Life Following PCI With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Presented at: American Heart Association Scientific Sessions; November 7-11, 2015; Orlando, FL.