Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial

Weisz, Giora; Farzaneh‐Far, Ramin; Ben‐Yehuda, Ori; Debruyne, B.; Montalescot, Gilles; Lerman, Amir; Mahmud, Ehtisham; Alexander, Karen P.; Ohman, E. Magnus; White, Harvey D.; Olmsted, Ann; Walker, Gennyne; Stone, Gregg W.

doi:10.1016/j.ahj.2013.08.004

Cited by 22 publications

(15 citation statements)

References 40 publications

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“…The recent RIVER-PCI trial 63 enrolled patients with chronic stable angina and incomplete revascularization after percutaneous coro nary intervention. Ranolazine did not improve the primary end point of death, myocardial infarction, or recurrent chronic stable angina requiring further revascularization.…”

Section: Key Points For Ranolazinementioning

confidence: 99%

A 'diamond' approach to personalized treatment of angina

et al. 2017

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Chronic stable angina pectoris is the most prevalent symptomatic manifestation of ischaemic heart disease, and its management is a priority (BOX 1). Current clinical guidelines recommend antianginal therapy to control symptoms, before considering coronary artery revasculariza tion [1][2][3][4] . However, revascularization by either percutaneous coronary angioplasty or CABG surgery is indicated in patients who have significant artery steno sis (50% left main narrowing or proximal three-vessel disease) to reduce myocardial ischaemia and its adverse clinical manifestation. Antianginal agents are approved by documenting that they improve total exercise duration, together with a reduction in daily frequency of chronic stable angina compared with placebo and/or equivalence to an active comparator. Cardiovascular outcomes, although highly advocated, are not a pre requisite for regulatory approval. None of the antianginal drugs has been proved to reduce cardiovascular mortality or the rate of myocardial infarction. When patients are optimally treated, mortality for chronic stable angina is low, which might explain why all trials designed to improve prognosis have been negative. Guidelines recom mend a first-choice and a second-choice approach, based more on tradition and expert opinion, rather than evidence. This categorical approach has been questioned in the past couple of years 5-8 . Newer antianginal drugs, which are classified as second choice, have more evidence-based clinical data that are more contemporary to support their use than is available for the traditional first-choice drugs. Equally, the often-needed combin ation of double or triple therapy is based on expert opinion and not related to the underlying pathophysio logy. What constitutes optimal antianginal treatment, therefore, varies considerably between countries, and the majority of doctors treat their patients according to their own preconceptions.A group of experts with experience and interest in chronic stable angina met at the University of Ferrara, Italy, to discuss an individualized approach to medical treatment of chronic stable angina, on the basis E X P E RT C O N S E N S U S D O C U M E N TA 'diamond' approach to personalized treatment of angina Abstract | In clinical guidelines, drugs for symptomatic angina are classified as being first choice (β-blockers, calcium-channel blockers, short-acting nitrates) or second choice (ivabradine, nicorandil, ranolazine, trimetazidine), with the recommendation to reserve second-choice medications for patients who have contraindications to first-choice agents, do not tolerate them, or remain symptomatic. No direct comparisons between first-choice and second-choice treatments have demonstrated the superiority of one group of drugs over the other. Meta-analyses show that all antianginal drugs have similar efficacy in reducing symptoms, but provide no evidence for improvement in survival. The newer, second-choice drugs have more evidence-based clinical data that are more contemporary than is available for tr...

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Section: Key Points For Ranolazinementioning

confidence: 99%

A 'diamond' approach to personalized treatment of angina

et al. 2017

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“…The design and rationale of the RIVER-PCI trial have been previously reported. 18 Briefly, participants with a history of chronic angina who underwent PCI with consequent ICR were randomized to 1000 mg of ranolazine twice a day, or matching placebo. ICR was defined as the presence of at least one lesion with visually estimated ≥50% diameter stenosis in a coronary artery with reference vessel diameter ≥2.0 mm, whether in a PCI-treated target vessel or in a nontreated nontarget vessel.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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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.

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“…RIVER-PCI was a multicenter, randomized, double-blind, placebo-controlled trial conducted in 245 centers in 15 countries; the design and primary results have been published, as have the effects on angina burden and quality of life (6, 9, 10). Briefly, patients with a history of chronic angina who had undergone PCI with resultant incomplete revascularization were randomized to receive ranolazine 1000 mg twice daily or placebo.…”

Section: Methodsmentioning

confidence: 99%

Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus

Wang

James

Weisz

et al. 2017

Journal of the American College of Cardiology

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BACKGROUND Chronic angina is more common in diabetes mellitus (DM) patients with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES This study sought to examine ranolazine’s antianginal effect in relation to glucose control. METHODS We performed a secondary analysis of RIVER-PCI, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention (PCI) were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on hemoglobin A1c (HbA1c) at 6 and 12 months of follow-up. Interaction between baseline HbA1c and ranolazine’s effect on Seattle Angina Questionnaire (SAQ) angina frequency at 6 and 12 months was tested. RESULTS Overall, 961 (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42±0.08% (adjusted mean difference ± standard error) and 0.44±0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19±0.02% and 0.20±0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced SAQ angina frequency at 6 months among DM patients, but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA1c ≥7.5% than those with HbA1c <7.5% (interaction p=0.07). CONCLUSIONS In patients with DM and chronic angina with incomplete revascularization after PCI, ranolazine’s effect on glucose control and angina at 6 months was proportionate to baseline HbA1C, but the effect on angina dissipated by 12 months.

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Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post–Percutaneous Coronary Intervention (RIVER-PCI) trial

Cited by 22 publications

References 40 publications

A 'diamond' approach to personalized treatment of angina

A 'diamond' approach to personalized treatment of angina

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

Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus

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