RIVER-PCI: No Benefit of Ranolazine on QOL and Angina Frequency Following PCI With Incomplete Revascularization
In chronic angina patients with incomplete revascularization following percutaneous coronary intervention (PCI), quality of life (QOL) and angina frequency over time were no different with ranolazine compared to placebo, according to results from the RIVER-PCI trial presented Nov. 10 during AHA 2015 in Orlando and published simultaneously in Circulation.
The trial looked at 2,604 patients with a history of chronic angina who had incomplete revascularization post-PCI, who were randomized to ranolazine or placebo. The analyses included 2,389 patients, who were given angina frequency and QOL questionnaires at baseline, one month, six months and 12 months.
Results showed that the ranolazine group was more likely to discontinue the drug than placebo group by six months (20.4 percent vs. 14.1 percent) and 12 months (27.2 percent vs. 21.3 percent). Further, QOL "improved markedly, but similarly," in the ranolazine and placebo groups, respectively, from baseline to one month and 12 months. The angina frequency did not differ in adjusted analysis between groups after the baseline assessment.
The investigators conclude that their findings "highlight the difficulty in assessing the clinical significance of incomplete revascularization, since patient-reported angina and QOL markedly improved within one month after PCI." However, they add that the study "clarifies that prescribing ranolazine based on angiographic determinations alone is unsupported, despite a high rate of recurrent events in this population over time."
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