News | Antiplatelet and Anticoagulation Therapies | October 23, 2015

Ranolazine Does Not Reduce Adverse Events Related to Incomplete Revascularization Post-PCI

International trial reported at TCT finds medication did not significantly change composite rates of ischemia-driven revascularization or hospitalization

RIVER-PCI trial, ranolazine, incomplete revascularization, ICR, post-PCI, TCT 2015

October 23, 2015 — A randomized trial found that ranolazine did not reduce the composite rate of ischemia-driven revascularization or hospitalization in patients with a history of chronic angina who had residual unrevascularized coronary artery disease after percutaneous coronary intervention (PCI).

Findings from the RIVER-PCI trial were reported at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), and published in The Lancet.

Incomplete revascularization (ICR) after PCI is associated with increased mortality and adverse cardiovascular events. Whether intensive anti-anginal medical therapy can reduce the rates of adverse events among patients with ICR is unknown. Ranolazine, a piperazine derivative, is a late sodium current blocker that reduces intracellular calcium overload during ischemia, and is indicated for the treatment of angina.

RIVER-PCI was a multicenter, randomized, parallel-group, double-blind, placebo-controlled, event-driven trial conducted at 245 centers in 15 countries. In the study, 2,604 qualifying patients with a history of chronic angina and ICR (residual unrevascularized coronary artery disease) were randomized to ranolazine (n=1,317) or placebo (n=1,287). The primary efficacy endpoint was the time from randomization to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

Incomplete revascularization was associated with high event rates. After a median follow-up of 643 days, the composite primary endpoint occurred in 345 patients assigned to ranolazine and 364 assigned to placebo (Kaplan-Meier estimates 26.2 percent vs. 28.3 percent respectively; HR 0.95; 95 percent CI 0.82 to 1.10; p=0.48). The results were consistent across multiple subgroups. There were no significant differences between the two groups in the incidence of the components of the primary endpoint or major secondary endpoints including sudden cardiac death, cardiovascular death and myocardial infarction.

“The results of RIVER-PCI show that the routine use of ranolazine does not reduce the composite rate of ischemia-driven revascularization or hospitalization in patients with a history of chronic angina who had ICR after PCI,” said lead investigator Giora Weisz, M.D. Weisz is chairman of cardiology at Shaare Zedek Medical Center in Jerusalem, Israel. He is also an associate professor of medicine at Columbia University Medical Center in New York.

“RIVER-PCI is the first trial to have prospectively studied patients with incomplete revascularization after PCI, and to examine the potential role of adjunctive anti-ischemic pharmacotherapy,” he said.

The RIVER-PCI trial was sponsored and funded by Gilead Sciences Inc. and The Menarini Group. Weisz reported being a member of the medical advisory boards of AngioSlide, AstraZeneca, Calore, Corindus, Medtronic, Medivisor and M.I. Medical Incentives. He also reported institutional research grants from AngioSlide and Corindus.

Study investigators Ori Ben-Yehuda, M.D., and Philippe Généreux, M.D., are employees of CRF, which received a grant from Gilead Sciences Inc. for study management.

For more information:

Related Content

Videos | TCT | October 03, 2018
DAIC Editor Dave Fornell takes a tour of some of the most innovative new cardiovascular technology he found on the ex
cardiologist Ted Feldman, M.D., at TCT 2017. #TCT2018 #TCT #TCT18 TCT Late breaking trials, studies.
Feature | TCT | September 21, 2018
October 4, 2018 – The Cardiovascular Research Foundation (CRF) had 15 late-breaking trials and 12 late-breaking clini
Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics. #TCT #TCT18 #TCT2018
Feature | TCT | September 14, 2018 | Dave Fornell, Editor
The volume of information attendees receive at the annual...
Videos | TCT | November 15, 2017
DAIC Editor Dave Fornell shows some of the innovations displayed on the expo floor at the 2017 Transcatheter Cardiova
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | TCT | November 09, 2017
November 9, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has select
Key Interventional Cardiology and structural heart Technologies to Prepare for TCT 2017.
Feature | TCT | October 26, 2017 | Dave Fornell
Here is an aggregation of DAIC content for all major cardiovascular technology news and advances this past year. These...
Videos | TCT | November 18, 2016
DAIC Editor Dave Fornell takes a video tour of some of the most innovative new interventional cardiology technologies
Videos | TCT | November 05, 2015
DAIC Editor Dave Fornell offers his choices for the most innovative new interventional cardiovascular technologies pr
Videos | TCT | November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
Amaranth Fortitute Bioresorbable stent

The Amaranth Fortitute bioresorbable stent was among several fully bioresorbing platforms discussed in sessions, late breaking trial data presentations and on the expo floor at TCT 2015.

Feature | TCT | October 19, 2015 | Tom Watson, BS, RCVT, Clinical Analyst, MD Buyline
There were several overarching technology trends seen at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) ann
Overlay Init