Effects of Ranolazine on Angina and Quality of Life Following PCI with Incomplete Revascularization -- The Ranolazine for Incomplete Vessel Revascularization.

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Presentation transcript:

Effects of Ranolazine on Angina and Quality of Life Following PCI with Incomplete Revascularization -- The Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial Karen P. Alexander, Giora Weisz, Kristi Prather, Stefan James, Daniel B. Mark, Kevin J. Anstrom, Linda Davidson-Ray, Adam Witkowski, Angel J. Mulkay, Anna Osmukhina, Ramin Farzaneh-Far, Ori Ben-Yehuda, Gregg W. Stone, E. Magnus Ohman For the RIVER-PCI Investigators For the RIVER-PCI Investigators ClinicalTrials.gov NCT Embargoed Until 10:45 a.m. ET, Tuesday, Nov. 10, 2015

Weisz G et al. Am Heart J 2013;166: sites 15 countries 1:1 Randomization Strata: ACS vs. non-ACS, DM vs. non-DM Primary Endpoint Ischemia-driven revascularization or Ischemia-driven hospitalization Primary Endpoint Ischemia-driven revascularization or Ischemia-driven hospitalization Event driven Minimum 1 Year Follow-up Event driven Minimum 1 Year Follow-up Ranolazine 1000 mg BID Ranolazine 1000 mg BID Placebo Patients with History of Chronic Angina AND Incomplete Revascularization After PCI N=2600 N=2600 Standard Medical Therapy Study Design

Primary Endpoint No. at risk Ranolazine Placebo Ischemia-driven revascularization or ischemia-driven hospitalization 100 Months since randomization Freedom from primary endpoint event (%) HR [95%CI] = 0.95 [0.82, 1.10] p-value = 0.48 Ranolazine Placebo Weisz G et al. Lancet epub ahead of print Oct 15, 2015

QOL Population Overall Trial Population (2,604) 97 questionnaires invalid 8 questionnaires not done 92% QOL Population (2,389) 78% (1,864) complete data at all time points 1,317 to ranolazine 1,207 in QOL population 1,287 to placebo 103 questionnaires invalid 7 questionnaires not done 1,182 in QOL population

SAQ Angina Frequency P = 0.60 P = 0.62 P = P = 0.23

SAQ Angina Frequency P = 0.06 P = 0.51 P = 0.17 Mean Treatment Difference (Ranolazine – Placebo) – Adjusted for baseline

SAQ Angina Frequency – Diabetes and Baseline Angina Ranolazine – Placebo (Adjusted for Baseline Score) Diabetes No Diabetes Daily/Weekly Angina at Baseline (≤60) Monthly/None Angina at Baseline (>60) Interaction P=0.02 * Interaction P=0.02 *

Conclusions  Despite incomplete revascularization following PCI, there was no incremental benefit in angina or QOL measures by adding ranolazine in this angiographically-identified population  Significant and sustained improvements in angina were observed in both arms following PCI, with most patients having rare or no angina by one month  Additional research is needed to understand the relationship between patient-reported angina and ischemia-driven events

November 10, 2015 in Circulation