Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization

Abstract

Background-Angina often persists or returns in populations following percutaneous coronary intervention (PCI). We hypothesized that ranolazine would be effective in reducing angina and improving quality of life (QOL) in incomplete revascularization (ICR) post-PCI patients. Methods and Results-In RIVER-PCI, 2604 patients with a history of chronic angina who had ICR post-PCI were randomized 1:1 to oral ranolazine versus placebo; QOL analyses included 2389 randomized subjects. Angina and QOL questionnaires were collected at baseline and months 1, 6, and 12. Ranolazine patients were more likely than placebo to discontinue study drug by month 6 (20. P=0.11). Improvement in SAQ angina frequency was observed with ranolazine at month 6 among diabetics (mean difference 3.3; 95% CI 0.6, 6.1; P=0.02) and those with more angina (baseline SAQ angina frequency ≤60; mean difference 3.4; 95% CI 0.6, 6.2; P=0.02), but was not maintained at month 12. Conclusions-Despite ICR following PCI, there was no incremental benefit in angina or QOL measures by adding ranolazine in this angiographically-identified population. These measures markedly improved within 1 month of PCI and persisted up to 1 year in both treatment arms. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01442038.

Refractory angina: new drugs on the block

“…A meta-analysis showed that the addition of ranolazine to either beta blockers or calcium channel blockers results in significant improvement of angina symptoms [22]. However, the recent ranolazine in patients with incomplete revascularization after percutaneous coronary intervention trial failed to show incremental benefit of ranolazine in reducing angina or improving quality of life in patients with incomplete percutaneous revascularization [23]. In a nonrandomized trial involving purely refractory angina patients, ranolazine was shown to be an effective antianginal regimen; albeit with a number of side effects that resulted in discontinuation of the drug 1 year after the initiation of treatment [24].…”

Ranolazine following percutaneous coronary intervention: For whom? For what?

“…This enthusiasm has been curbed now that two large-scale, multicenter, randomized controlled trials have failed to show superiority of ranolazine over placebo in regard to clinical outcomes for patients with acute coronary syndromes [6] or stable coronary artery disease (CAD) [7]. Furthermore, ranolazine's lack of effect on angina scores or quality of life (QoL) in the recent Ranolazine in Patients With Incomplete Revascularization After Percutaneous Coronary Intervention (RIVER-PCI) trial sheds doubt on ranolazine's place among evidence-based treatment alternatives for IHD [8]. Similarly, a smaller trial detected no effect of ranolazine treatment on angina scores in patients with coronary microvascular dysfunction in the absence of obstructive coronary artery disease [9].…”

Report of the American Heart Association (AHA) Scientific Sessions 2015, Orlando

“…There was no incremental benefit in angina or the QOL measures from additional ranolazine in this angiographically-identified population ( Figure 3C). 9 …”