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

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

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.

Original languageEnglish (US)
JournalAmerican Heart Journal
Volume166
Issue number6
DOIs
StatePublished - Dec 2013

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Percutaneous Coronary Intervention
Placebos
Hospitalization
Ischemia
Mortality
Ranolazine
Sudden Cardiac Death
Transient Ischemic Attack
Controlled Clinical Trials
Cost-Benefit Analysis
Heart Failure
Sodium
Stroke
Myocardial Infarction
Quality of Life
Clinical Trials
Safety
Drug Therapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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, Bernard; Montalescot, Gilles; Lerman, Amir; Mahmud, Ehtisham; Alexander, Karen P.; Ohman, E. Magnus; White, Harvey D.; Olmsted, Ann; Walker, Gennyne A.; Stone, Gregg W.

In: American Heart Journal, Vol. 166, No. 6, 12.2013.

Research output: Contribution to journalArticle

Weisz, Giora ; Farzaneh-Far, Ramin ; Ben-Yehuda, Ori ; Debruyne, Bernard ; Montalescot, Gilles ; Lerman, Amir ; Mahmud, Ehtisham ; Alexander, Karen P. ; Ohman, E. Magnus ; White, Harvey D. ; Olmsted, Ann ; Walker, Gennyne A. ; Stone, Gregg W. / 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. In: American Heart Journal. 2013 ; Vol. 166, No. 6.
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abstract = "Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.",
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T1 - Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention

T2 - Design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial

AU - Weisz, Giora

AU - Farzaneh-Far, Ramin

AU - Ben-Yehuda, Ori

AU - Debruyne, Bernard

AU - Montalescot, Gilles

AU - Lerman, Amir

AU - Mahmud, Ehtisham

AU - Alexander, Karen P.

AU - Ohman, E. Magnus

AU - White, Harvey D.

AU - Olmsted, Ann

AU - Walker, Gennyne A.

AU - Stone, Gregg W.

PY - 2013/12

Y1 - 2013/12

N2 - Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.

AB - Background Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR. Trial Design RIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013. Conclusions RIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.

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