Karen P Alexander1, Giora Weisz2, Kristi Prather2, Stefan James2, Daniel B Mark2, Kevin J Anstrom2, Linda Davidson-Ray2, Adam Witkowski2, Angel J Mulkay2, Anna Osmukhina2, Ramin Farzaneh-Far2, Ori Ben-Yehuda2, Gregg W Stone2, E Magnus Ohman2. 1. From Duke Clinical Research Institute and Duke University, Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala University, Sweden (S.J.); Department of Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.). karen.alexander@duke.edu. 2. From Duke Clinical Research Institute and Duke University, Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala University, Sweden (S.J.); Department of Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.).
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; QOLanalyses 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 (20.4% versus 14.1%, P<0.001) and 12 (27.2% versus 21.3%, P<0.001). Following qualifying index PCI, the primary QOL outcome (Seattle Angina Questionnaire [SAQ] angina frequency score) improved markedly, but similarly, in the ranolazine and placebo groups, respectively, from baseline (67.3±24.5 versus 69.7±24.0, P=0.01) to month 1 (86.6±18.1 versus 85.8±18.5, P=0.27) and month 12 (88.4±17.8 versus 88.5±17.8, P=0.94). SAQ angina frequency repeated measures did not differ in adjusted analysis between groups post baseline (mean difference 1.0; 95% CI -0.2, 2.2; 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.
RCT Entities:
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. Ranolazinepatients were more likely than placebo to discontinue study drug by month 6 (20.4% versus 14.1%, P<0.001) and 12 (27.2% versus 21.3%, P<0.001). Following qualifying index PCI, the primary QOL outcome (Seattle Angina Questionnaire [SAQ] angina frequency score) improved markedly, but similarly, in the ranolazine and placebo groups, respectively, from baseline (67.3±24.5 versus 69.7±24.0, P=0.01) to month 1 (86.6±18.1 versus 85.8±18.5, P=0.27) and month 12 (88.4±17.8 versus 88.5±17.8, P=0.94). SAQangina frequency repeated measures did not differ in adjusted analysis between groups post baseline (mean difference 1.0; 95% CI -0.2, 2.2; P=0.11). Improvement in SAQangina 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 SAQangina 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.
Authors: Mohammed Qintar; Taishi Hirai; Suzanne V Arnold; Justin Sheehy; James Sapontis; Phil Jones; Yuanyuan Tang; William Lombardi; Dimitri Karmpaliotis; Jeffery Moses; Christian Patterson; William J Nicholson; David J Cohen; John A Spertus; J Aaron Grantham; Adam C Salisbury Journal: Am Heart J Date: 2019-04-26 Impact factor: 4.749
Authors: Alexander C Fanaroff; Stefan K James; Giora Weisz; Kristi Prather; Kevin J Anstrom; Daniel B Mark; Ori Ben-Yehuda; Karen P Alexander; Gregg W Stone; E Magnus Ohman Journal: J Am Coll Cardiol Date: 2017-05-09 Impact factor: 24.094
Authors: Carlos A Salazar; Juan E Basilio Flores; Liz E Veramendi Espinoza; Jhon W Mejia Dolores; Diego E Rey Rodriguez; César Loza Munárriz Journal: Cochrane Database Syst Rev Date: 2017-02-08
Authors: Xin Zheng; Rachel P Dreyer; Jeptha P Curtis; Shuling Liu; Xiao Xu; Xueke Bai; Xi Li; Haibo Zhang; Siming Wang; Frederick A Masoudi; John A Spertus; Jing Li; Harlan M Krumholz Journal: J Am Heart Assoc Date: 2020-03-05 Impact factor: 5.501