Myocardial Infarction Clinical Trial
— REALITYOfficial title:
Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.
Verified date | March 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial. The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.
Status | Completed |
Enrollment | 668 |
Est. completion date | September 10, 2020 |
Est. primary completion date | October 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged = 18 years - Recent acute myocardial infarction, with or without ST- segment elevation, with a combination of ischemic symptoms occurring in the past 48 hours,before the MI related admission, and elevation of biomarkers of myocardial injury (troponin) - Anemia Hb = 10g / dL but > 7 g/dL on Hb, measured at any time during the index hospital admission for MI. - Written informed consent - Coverage for medical insurance. Exclusion Criteria: - Shock (SBP < 90 mmHg with clinical signs of low output or patients requiring inotropic agents) - MI occurring post-percutaneous coronary intervention (PCI) or post-coronary artery bypass graft (CABG) (i.e. type IV or V Acute MI according to the 2012 Universal Definition of MI - Life-threatening or massive ongoing bleeding (as judged by the investigator) - Any blood transfusion in the previous 30-days - any known malignant hematologic disease Note: Sickle cell disease, thalassemia and anemia due to chronic renal failure (even under EPO) are not an exclusion criteria |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bichat | Paris | |
Spain | Hospital Clinic of Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France, Spain,
Bernard AC, Davenport DL, Chang PK, Vaughan TB, Zwischenberger JB. Intraoperative transfusion of 1 U to 2 U packed red blood cells is associated with increased 30-day mortality, surgical-site infection, pneumonia, and sepsis in general surgery patients. J Am Coll Surg. 2009 May;208(5):931-7, 937.e1-2; discussion 938-9. doi: 10.1016/j.jamcollsurg.2008.11.019. Epub 2009 Mar 26. — View Citation
Briggs AH, O'Brien BJ. The death of cost-minimization analysis? Health Econ. 2001 Mar;10(2):179-84. Review. — View Citation
Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8. — View Citation
Carson JL, Carless PA, Hébert PC. Outcomes using lower vs higher hemoglobin thresholds for red blood cell transfusion. JAMA. 2013 Jan 2;309(1):83-4. doi: 10.1001/jama.2012.50429. — View Citation
Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA, Weinstein R, Swinton McLaughlin LG, Djulbegovic B; Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guideline from the AABB*. Ann Intern Med. 2012 Jul 3;157(1):49-58. doi: 10.7326/0003-4819-157-1-201206190-00429. Review. — View Citation
Caruba T, Katsahian S, Schramm C, Charles Nelson A, Durieux P, Bégué D, Juillière Y, Dubourg O, Danchin N, Sabatier B. Treatment for stable coronary artery disease: a network meta-analysis of cost-effectiveness studies. PLoS One. 2014 Jun 4;9(6):e98371. doi: 10.1371/journal.pone.0098371. eCollection 2014. — View Citation
Chatterjee S, Wetterslev J, Sharma A, Lichstein E, Mukherjee D. Association of blood transfusion with increased mortality in myocardial infarction: a meta-analysis and diversity-adjusted study sequential analysis. JAMA Intern Med. 2013 Jan 28;173(2):132-9. doi: 10.1001/2013.jamainternmed.1001. — View Citation
Cooper HA, Rao SV, Greenberg MD, Rumsey MP, McKenzie M, Alcorn KW, Panza JA. Conservative versus liberal red cell transfusion in acute myocardial infarction (the CRIT Randomized Pilot Study). Am J Cardiol. 2011 Oct 15;108(8):1108-11. doi: 10.1016/j.amjcard.2011.06.014. Epub 2011 Jul 24. — View Citation
Ducrocq G, Calvo G, González-Juanatey JR, Durand-Zaleski I, Avendano-Sola C, Puymirat E, Lemesle G, Arnaiz JA, Martínez-Sellés M, Rousseau A, Cachanado M, Vicaut E, Silvain J, Karam C, Danchin N, Simon T, Steg PG; REALITY investigators. Restrictive vs lib — View Citation
Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, Cachanado M, Durand-Zaleski I, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, Ferrari E, Calvo G, Danchin N, Avendaño-Solá C, Frenkiel J, Rousseau A, Vicaut E, Simon T, Steg PG; REALITY Inves — View Citation
Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Jüni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14. — View Citation
Frank SM, Abazyan B, Ono M, Hogue CW, Cohen DB, Berkowitz DE, Ness PM, Barodka VM. Decreased erythrocyte deformability after transfusion and the effects of erythrocyte storage duration. Anesth Analg. 2013 May;116(5):975-981. doi: 10.1213/ANE.0b013e31828843e6. Epub 2013 Feb 28. — View Citation
Greiner W, Weijnen T, Nieuwenhuizen M, Oppe S, Badia X, Busschbach J, Buxton M, Dolan P, Kind P, Krabbe P, Ohinmaa A, Parkin D, Roset M, Sintonen H, Tsuchiya A, de Charro F. A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ. 2003 Sep;4(3):222-31. — View Citation
Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. — View Citation
Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700. — View Citation
Hébert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056. — View Citation
Hébert PC, Yetisir E, Martin C, Blajchman MA, Wells G, Marshall J, Tweeddale M, Pagliarello G, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases? Crit Care Med. 2001 Feb;29(2):227-34. — View Citation
Hollingworth W, McKell-Redwood D, Hampson L, Metcalfe C. Cost-utility analysis conducted alongside randomized controlled trials: are economic end points considered in sample size calculations and does it matter? Clin Trials. 2013 Feb;10(1):43-53. doi: 10.1177/1740774512465358. Epub 2012 Dec 11. — View Citation
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E; CHEERS Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013 Mar 25;346:f1049. doi: 10.1136/bmj.f1049. — View Citation
Kaiser C, Brunner-La Rocca HP, Buser PT, Bonetti PO, Osswald S, Linka A, Bernheim A, Zutter A, Zellweger M, Grize L, Pfisterer ME; BASKET Investigators. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET). Lancet. 2005 Sep 10-16;366(9489):921-9. Erratum in: Lancet. 2005 Dec 17;366(9503):2086. — View Citation
Magnuson EA, Farkouh ME, Fuster V, Wang K, Vilain K, Li H, Appelwick J, Muratov V, Sleeper LA, Boineau R, Abdallah M, Cohen DJ; FREEDOM Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation. 2013 Feb 19;127(7):820-31. doi: 10.1161/CIRCULATIONAHA.112.147488. Epub 2012 Dec 31. — View Citation
Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis. Value Health. 2007 Sep-Oct;10(5):336-47. — View Citation
Murray CJ, Richards MA, Newton JN, Fenton KA, Anderson HR, Atkinson C, Bennett D, Bernabé E, Blencowe H, Bourne R, Braithwaite T, Brayne C, Bruce NG, Brugha TS, Burney P, Dherani M, Dolk H, Edmond K, Ezzati M, Flaxman AD, Fleming TD, Freedman G, Gunnell D, Hay RJ, Hutchings SJ, Ohno SL, Lozano R, Lyons RA, Marcenes W, Naghavi M, Newton CR, Pearce N, Pope D, Rushton L, Salomon JA, Shibuya K, Vos T, Wang H, Williams HC, Woolf AD, Lopez AD, Davis A. UK health performance: findings of the Global Burden of Disease Study 2010. Lancet. 2013 Mar 23;381(9871):997-1020. doi: 10.1016/S0140-6736(13)60355-4. Epub 2013 Mar 5. — View Citation
Perkins HA, Busch MP. Transfusion-associated infections: 50 years of relentless challenges and remarkable progress. Transfusion. 2010 Oct;50(10):2080-99. doi: 10.1111/j.1537-2995.2010.02851.x. Review. — View Citation
Raikou M, Briggs A, Gray A, McGuire A. Centre-specific or average unit costs in multi-centre studies? Some theory and simulation. Health Econ. 2000 Apr;9(3):191-8. — View Citation
Rao SV, Sherwood MW. Isn't it about time we learned how to use blood transfusion in patients with ischemic heart disease? J Am Coll Cardiol. 2014 Apr 8;63(13):1297-1299. doi: 10.1016/j.jacc.2013.11.028. Epub 2013 Dec 18. — View Citation
Robinson SD, Janssen C, Fretz EB, Berry B, Chase AJ, Siega AD, Carere RG, Fung A, Simkus G, Klinke WP, Hilton JD. Red blood cell storage duration and mortality in patients undergoing percutaneous coronary intervention. Am Heart J. 2010 May;159(5):876-81. doi: 10.1016/j.ahj.2010.02.018. — View Citation
Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. Epub 2005 Apr 11. — View Citation
Salisbury AC, Reid KJ, Marso SP, Amin AP, Alexander KP, Wang TY, Spertus JA, Kosiborod M. Blood transfusion during acute myocardial infarction: association with mortality and variability across hospitals. J Am Coll Cardiol. 2014 Aug 26;64(8):811-9. doi: 10.1016/j.jacc.2014.05.040. — View Citation
Sherwood MW, Rao SV. Acute coronary syndromes: Blood transfusion in patients with acute MI and anaemia. Nat Rev Cardiol. 2013 Apr;10(4):186-7. doi: 10.1038/nrcardio.2013.14. Epub 2013 Feb 5. — View Citation
Silvain J, Abtan J, Kerneis M, Martin R, Finzi J, Vignalou JB, Barthélémy O, O'Connor SA, Luyt CE, Brechot N, Mercadier A, Brugier D, Galier S, Collet JP, Chastre J, Montalescot G. Impact of red blood cell transfusion on platelet aggregation and inflammatory response in anemic coronary and noncoronary patients: the TRANSFUSION-2 study (impact of transfusion of red blood cell on platelet activation and aggregation studied with flow cytometry use and light transmission aggregometry). J Am Coll Cardiol. 2014 Apr 8;63(13):1289-1296. doi: 10.1016/j.jacc.2013.11.029. Epub 2013 Dec 18. — View Citation
Silvain J, Pena A, Cayla G, Brieger D, Bellemain-Appaix A, Chastre T, Vignalou JB, Beygui F, Barthelemy O, Collet JP, Montalescot G. Impact of red blood cell transfusion on platelet activation and aggregation in healthy volunteers: results of the TRANSFUSION study. Eur Heart J. 2010 Nov;31(22):2816-21. doi: 10.1093/eurheartj/ehq209. Epub 2010 Jun 29. — View Citation
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. — View Citation
Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2. Review. — View Citation
Villanueva C, Colomo A, Bosch A, Concepción M, Hernandez-Gea V, Aracil C, Graupera I, Poca M, Alvarez-Urturi C, Gordillo J, Guarner-Argente C, Santaló M, Muñiz E, Guarner C. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013 Jan 3;368(1):11-21. doi: 10.1056/NEJMoa1211801. Erratum in: N Engl J Med. 2013 Jun 13;368(24):2341. — View Citation
Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, Meier-Hellmann A, Nollet G, Peres-Bota D; ABC (Anemia and Blood Transfusion in Critical Care) Investigators. Anemia and blood transfusion in critically ill patients. JAMA. 2002 Sep 25;288(12):1499-507. — View Citation
Wijeysundera HC, Tomlinson G, Ko DT, Dzavik V, Krahn MD. Medical therapy v. PCI in stable coronary artery disease: a cost-effectiveness analysis. Med Decis Making. 2013 Oct;33(7):891-905. doi: 10.1177/0272989X13497262. Epub 2013 Jul 25. — View Citation
Williamson LM, Devine DV. Challenges in the management of the blood supply. Lancet. 2013 May 25;381(9880):1866-75. doi: 10.1016/S0140-6736(13)60631-5. Review. — View Citation
Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM. Blood transfusion in elderly patients with acute myocardial infarction. N Engl J Med. 2001 Oct 25;345(17):1230-6. — View Citation
Yeh RW, Wimmer NJ. Blood transfusion in myocardial infarction: opening old wounds for comparative-effectiveness research. J Am Coll Cardiol. 2014 Aug 26;64(8):820-2. doi: 10.1016/j.jacc.2014.05.041. — View Citation
* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cost-effectiveness ratio at 30 days | The primary endpoint is the incremental cost-effectiveness ratio (ICER) at 30-days, using the composite endpoint (30-day composite of all-cause death, non fatal stroke, nonfatal recurrent MI, and emergency revascularization prompted by ischemia) as the effectiveness criterion | 30 days | |
Secondary | Cost-effectiveness ratio at 1 year | Incremental cost-effectiveness ratio (ICER) at 1 year, using the composite endpoint (1-year composite of all-cause death, non fatal stroke, nonfatal recurrent MI, and emergency revascularization prompted by ischemia) as the effectiveness criterion | 1 year | |
Secondary | Clinically non inferiority at 30 days | The main clinical endpoint is Major Adverse Cardiac Events (MACE) at 30-days defined as the 30-day composite of all-cause death, non-fatal recurrent MI, non-fatal stroke and emergency revascularization prompted by ischemia, (all of the components of this composite clinical outcome will be analyzed separately as secondary endpoints of their own) | 30 days | |
Secondary | Clinically non inferiority at 1 year | The main clinical endpoint is Major Adverse Cardiac Events (MACE) at 30-days defined as the 30-day composite of all-cause death, non-fatal recurrent MI, non-fatal stroke and emergency revascularization prompted by ischemia, (all of the components of this composite clinical outcome will be analyzed separately as secondary endpoints of their own) | 1 year |
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