title: Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.
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.
  
  
  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 (20.4% 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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01442038.
authors.affiliation: 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.
authors.forename: Karen P
authors.initials: KP
authors.lastname: Alexander
authors.affiliation: 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.).
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.affiliation: 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.).
authors.forename: Kristi
authors.initials: K
authors.lastname: Prather
authors.affiliation: 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.).
authors.forename: Stefan
authors.initials: S
authors.lastname: James
authors.affiliation: 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.).
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.affiliation: 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.).
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.affiliation: 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.).
authors.forename: Linda
authors.initials: L
authors.lastname: Davidson-Ray
authors.affiliation: 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.).
authors.forename: Adam
authors.initials: A
authors.lastname: Witkowski
authors.affiliation: 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.).
authors.forename: Angel J
authors.initials: AJ
authors.lastname: Mulkay
authors.affiliation: 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.).
authors.forename: Anna
authors.initials: A
authors.lastname: Osmukhina
authors.affiliation: 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.).
authors.forename: Ramin
authors.initials: R
authors.lastname: Farzaneh-Far
authors.affiliation: 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.).
authors.forename: Ori
authors.initials: O
authors.lastname: Ben-Yehuda
authors.affiliation: 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.).
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: 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.).
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods / Q000639:trends; D062645:Percutaneous Coronary Intervention / Q000379:methods / Q000639:trends*; D011788:Quality of Life; D011859:Radiography; D000069458:Ranolazine / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000069458:Ranolazine
keywords: angina; angioplasty; revascularization