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

Circulation

Volumn 133, Issue 1, 2016, Pages 39-47

  Alexander, Karen P ^a   Weisz, Giora ^b,c   Prather, Kristi ^a   James, Stefan ^d   Mark, Daniel B ^a   Anstrom, Kevin J ^a   Davidson Ray, Linda ^a   Witkowski, Adam ^e   Mulkay, Angel J ^f   Osmukhina, Anna ^g   Farzaneh Far, Ramin ^g   Ben Yehuda, Ori ^c,h   Stone, Gregg W ^h   Ohman, E Magnus ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b SHAARE ZEDEK MEDICAL CENTER   (Israel)

^c CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

^d UPPSALA UNIVERSITY   (Sweden)

^e INSTITUTE OF CARDIOLOGY   (Poland)

^f Holy Name Medical Center   (United States)

^g GILEAD SCIENCES   (United States)

^h Department of Medicine   (United States)

Author keywords

angina; angioplasty; revascularization

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PLACEBO; RANOLAZINE; CARDIOVASCULAR AGENT;

ADULT; AGED; ANGINA PECTORIS; ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; FEMALE; HEART MUSCLE REVASCULARIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; CLINICAL TRIAL; MIDDLE AGED; PROCEDURES; RADIOGRAPHY; TREATMENT OUTCOME; TRENDS; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANGINA PECTORIS; CARDIOVASCULAR AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL REVASCULARIZATION; PERCUTANEOUS CORONARY INTERVENTION; QUALITY OF LIFE; RANOLAZINE; TREATMENT OUTCOME;

EID: 84953838061     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.115.019768     Document Type: Article

References (41)

1. Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ, American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation 2013 127 2233 2249. doi: 10.1161/CIR.0b013e3182949a2e.
2. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB, American Heart Association Statistics Committee and Stroke Statistics Subcommittee Heart disease and stroke statistics-2015 update: a report from the American Heart Association. Circulation 2015 131 e29 322. doi: 10.1161/CIR.0000000000000152.
3. Spertus JA, Jones P, McDonell M, Fan V, Fihn SD., Health status predicts long-Term outcome in outpatients with coronary disease. Circulation 2002 106 43 49
4. Arnold SV, Morrow DA, Lei Y, Cohen DJ, Mahoney EM, Braunwald E, Chan PS., Economic impact of angina after an acute coronary syndrome: insights from the MERLIN-TIMI 36 trial. Circ Cardiovasc Qual Outcomes 2009 2 344 353. doi: 10.1161/CIRCOUTCOMES.108.829523.
5. Alexander KP, Cowper PA, Kempf JA, Lytle BL, Peterson ED., Profile of chronic and recurrent angina pectoris in a referral population. Am J Cardiol 2008 102 1301 1306. doi: 10.1016/j.amjcard.2008.07.006.
6. Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE, Mancini GB, COURAGE Trial Research Group Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med 2008 359 677 687. doi: 10.1056/NEJMoa072771.
7. Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, Leadley K, Dawkins KD, Kappetein AP, Synergy between PCI with Taxus and Cardiac Surgery Investigators Quality of life after PCI with drug-Eluting stents or coronary-Artery bypass surgery. N Engl J Med 2011 364 1016 1026. doi: 10.1056/NEJMoa1001508.
8. Zhang Z, Mahoney EM, Stables RH, Booth J, Nugara F, Spertus JA, Weintraub WS., Disease-specific health status after stent-Assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent or Surgery trial. Circulation 2003 108 1694 1700. doi: 10.1161/01.CIR.0000087600.83707.FD.
9. Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES., Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-Analysis of 89. 883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol 2013 62 1421 1431. doi: 10.1016/j.jacc.2013.05.033.
10. Head SJ, Mack MJ, Holmes DR Jr, Mohr FW, Morice MC, Serruys PW, Kappetein AP., Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data. Eur J Cardiothorac Surg 2012 41 535 541. doi: 10.1093/ejcts/ezr105.
11. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW, SYNTAX Investigators Percutaneous coronary intervention versus coronary-Artery bypass grafting for severe coronary artery disease. N Engl J Med 2009 360 961 972. doi: 10.1056/NEJMoa0804626.
12. Husted SE, Ohman EM., Pharmacological and emerging therapies in the treatment of chronic angina. Lancet 2015 386 691 701. doi: 10.1016/S0140-6736(15)61283-1.
13. Chaitman BR, Pepine CJ, Parker JO, Skopal J, Chumakova G, Kuch J, Wang W, Skettino SL, Wolff AA, Combination Assessment of Ranolazine In Stable Angina (CARISA) Investigators Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial. JAMA 2004 291 309 316. doi: 10.1001/jama.291.3.309.
14. Kosiborod M, Arnold SV, Spertus JA, McGuire DK, Li Y, Yue P, Ben-Yehuda O, Katz A, Jones PG, Olmsted A, Belardinelli L, Chaitman BR., Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). J Am Coll Cardiol 2013 61 2038 2045. doi: 10.1016/j.jacc.2013.02.011.
15. Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L, ERICA Investigators Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol 2006 48 566 575. doi: 10.1016/j.jacc.2006.05.044.
16. Wilson SR, Scirica BM, Braunwald E, Murphy SA, Karwatowska-Prokopczuk E, Buros JL, Chaitman BR, Morrow DA., Efficacy of ranolazine in patients with chronic angina observations from the randomized, double-blind, placebo-controlled MERLIN-TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Segment Elevation Acute Coronary Syndromes) 36 Trial. J Am Coll Cardiol 2009 53 1510 1516. doi: 10.1016/j.jacc.2009.01.037.
17. Weisz G GP, Iniquez A, Zurakowski A, Schechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW., Ranolazine in patients with incomplete revascularization after percutaneous coronary intervention (RIVER-PCI): a randomized, double-blind, placebo-controlled, multi-center trial. Lancet 2015
18. Weisz G, Farzaneh-Far R, Ben-Yehuda O, Debruyne B, Montalescot G, Lerman A, Mahmud E, Alexander KP, Ohman EM, White HD, Olmsted A, Walker GA, Stone GW., 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. Am Heart J 2013 166 953 959.e3. doi: 10.1016/j.ahj.2013.08.004.
19. Arnold SV, Kosiborod M, Li Y, Jones PG, Yue P, Belardinelli L, Spertus JA., Comparison of the Seattle Angina Questionnaire With Daily Angina Diary in the TERISA Clinical Trial. Circ Cardiovasc Qual Outcomes 2014 7 844 850. doi: 10.1161/CIRCOUTCOMES.113.000752.
20. Arnold SV, Morrow DA, Wang K, Lei Y, Mahoney EM, Scirica BM, Braunwald E, Cohen DJ, MERLIN-TIMI 36 Investigators Effects of ranolazine on disease-specific health status and quality of life among patients with acute coronary syndromes: results from the MERLIN-TIMI 36 randomized trial. Circ Cardiovasc Qual Outcomes 2008 1 107 115. doi: 10.1161/CIRCOUTCOMES.108.798009.
21. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD., Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 1994 74 1240 1244
22. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD., Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995 25 333 341
23. Spertus JA, Salisbury AC, Jones PG, Conaway DG, Thompson RC., Predictors of quality-of-life benefit after percutaneous coronary intervention. Circulation 2004 110 3789 3794. doi: 10.1161/01.CIR.0000150392.70749.C7.
24. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB., A brief self-Administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 1989 64 651 654
25. EuroQol Group EuroQol-A new facility for the measurement of health-related quality of life. Health Policy 1990 16 199 208
26. Rose GA, Blackburn H., Cardiovascular survey methods. Monogr Ser World Health Organ 1968 56 1 188
27. Ware JE Jr, Sherbourne CD., The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992 30 473 483
28. Raudenbush SW, Bryk AS., Hierarchical Linear Models: Applications and Data Analysis Methods 1992 Newbury Park, CA SAGE Publications, Inc.
29. Schafer J., Analysis of Incomplete Multivariable Data 1997 New York, NY Chapman and Hall/CRC
30. Abdallah MS, Wang K, Magnuson EA, Spertus JA, Farkouh ME, Fuster V, Cohen DJ, FREEDOM Trial Investigators Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA 2013 310 1581 1590. doi: 10.1001/jama.2013.279208.
31. Venkitachalam L, Kip KE, Mulukutla SR, Selzer F, Laskey W, Slater J, Cohen HA, Wilensky RL, Williams DO, Marroquin OC, Sutton-Tyrrell K, Bunker CH, Kelsey SF, NHLBI-Sponsored Dynamic Registry Investigators Temporal trends in patient-reported angina at 1 year after percutaneous coronary revascularization in the stent era: a report from the National Heart, Lung, and Blood Institute-sponsored 1997-2006 dynamic registry. Circ Cardiovasc Qual Outcomes 2009 2 607 615. doi: 10.1161/CIRCOUTCOMES.109.869131.
32. Dagenais GR, Lu J, Faxon DP, Kent K, Lago RM, Lezama C, Hueb W, Weiss M, Slater J, Frye RL, Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Study Group Effects of optimal medical treatment with or without coronary revascularization on angina and subsequent revascularizations in patients with type 2 diabetes mellitus and stable ischemic heart disease. Circulation 2011 123 1492 1500. doi: 10.1161/CIRCULATIONAHA.110.978247.
33. Arnold SV, Kosiborod M, McGuire DK, Li Y, Yue P, Ben-Yehuda O, Spertus JA., Effects of ranolazine on quality of life among patients with diabetes mellitus and stable angina. JAMA Intern Med 2014 174 1403 1405. doi: 10.1001/jamainternmed.2014.2120.
34. Gehi AK, Rumsfeld JS, Liu H, Schiller NB, Whooley MA., Relation of self-reported angina pectoris to inducible myocardial ischemia in patients with known coronary artery disease: the Heart and Soul Study. Am J Cardiol 2003 92 705 707
35. Chan PS, Patel MR, Klein LW, Krone RJ, Dehmer GJ, Kennedy K, Nallamothu BK, Weaver WD, Masoudi FA, Rumsfeld JS, Brindis RG, Spertus JA., Appropriateness of percutaneous coronary intervention. JAMA 2011 306 53 61. doi: 10.1001/jama.2011.916.
36. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA., Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA 2011 305 1882 1889. doi: 10.1001/jama.2011.601.
37. Steg PG, Greenlaw N, Tendera M, Tardif JC, Ferrari R, Al-Zaibag M, Dorian P, Hu D, Shalnova S, Sokn FJ, Ford I, Fox KM, Prospective Observational Longitudinal Registry of Patients With Stable Coronary Artery Disease (CLARIFY) Investigators Prevalence of anginal symptoms and myocardial ischemia and their effect on clinical outcomes in outpatients with stable coronary artery disease: data from the International Observational CLARIFY Registry. JAMA Intern Med 2014 174 1651 1659. doi: 10.1001/jamainternmed.2014.3773.
38. Gössl M, Faxon DP, Bell MR, Holmes DR, Gersh BJ., Complete versus incomplete revascularization with coronary artery bypass graft or percutaneous intervention in stable coronary artery disease. Circ Cardiovasc Interv 2012 5 597 604. doi: 10.1161/CIRCINTERVENTIONS.111.965509.
39. Rosner GF, Kirtane AJ, Genereux P, Lansky AJ, Cristea E, Gersh BJ, Weisz G, Parise H, Fahy M, Mehran R, Stone GW., Impact of the presence and extent of incomplete angiographic revascularization after percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circulation 2012 125 2613 2620. doi: 10.1161/CIRCULATIONAHA.111.069237.
40. Gutierrez JA, Karwatowska-Prokopczuk E, Murphy SA, Belardinelli L, Farzaneh-Far R, Walker G, Morrow DA, Scirica BM., Effects of Ranolazine in Patients With Chronic Angina in Patients With and Without Percutaneous Coronary Intervention for Acute Coronary Syndrome: Observations From the MERLIN-TIMI 36 Trial. Clin Cardiol 2015 38 469 475. doi: 10.1002/clc.22425.
41. Morrow DA, Scirica BM, Chaitman BR, McGuire DK, Murphy SA, Karwatowska-Prokopczuk E, McCabe CH, Braunwald E, MERLIN-TIMI 36 Investigators Evaluation of the glycometabolic effects of ranolazine in patients with and without diabetes mellitus in the MERLIN-TIMI 36 randomized controlled trial. Circulation 2009 119 2032 2039. doi: 10.1161/CIRCULATIONAHA.107.763912.