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Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial.
POISE Study Group, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Málaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P.Collaborators (366)
Devereaux PJ, Yang H, Yusuf S, Guyatt G, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Chrolavicius S, Pogue J, Leslie K, Villar JC, Xavier D, Greenspan L, Lisheng L, Xu S, Málaga G, Avezum A, Jacka M, Choi P, Guyatt G, Berwanger O, Chan M, Chauret D, Faroughi N, Fodor G, Gilbert K, Hudson RJ, Held C, Ibarra P, Kashfi A, Keltai M, Laine M, Lanthier L, Montori VM, Panju A, Gallacher L, Lawrence M, Mead A, Rodrigues T, Dagenais G, Cheng D, Lowenstein E, Roberts RS, Ciapponi A, Garcia Dieguez M, Leslie K, Avezum A, Berwanger O, Hudson RJ, Jacka M, Schricker T, Warriner B, Liu L, Xu S, Villar JC, Tristan M, Baidel Y, Salazar A, Espinel M, Zevallos JC, Keltai M, Faller J, Pais P, Xavier D, Andrade SI, Raeder J, Málaga G, Alonso-Coello P, Urrutia G, Gannedahl P, Phrommintikul A, Foëx P, Giles J, Sear J, Goldman L, Caccavo RA, Ferrari A, Nicolosi LN, Sierra F, Tesolin P, Barratt S, Beilby D, Bolsin S, Boyd D, Bugler S, Cope L, Douglas J, Fatovich S, Grant J, Halliwell R, Kerridge RK, Leslie K, Love J, March S, McCulloch TJ, Myles PS, Paech M, Peyton P, Poole C, Poustie S, Priestly M, Reeves M, Wallace S, Weitkamp B, Wolfers D, Baptista M, do Amara Baruzzi AC, Blacher C, Bodanese LC, Campos de Albuquerque D, Esteves JP, França Neto OR, Guiselli Gallina LE, Izukawa NM, Kallas FC, Kerr Saraiva JF, Marin-Neto JA, Nigro Maia L, Penha Rosateli PH, Rabello R, Schammass Ducatti T, Aggarwala R, Argibay-Poliquin E, Badner N, Baer C, Beattie WS, Bednarowski M, Bertozzi HA, Boisvenu G, Boulton A, Brunet D, Bryson GL, Burlingham J, Campeau J, Chauret D, Choi P, Cook D, Cook DR, Cossette P, Crossan M, Davies B, Devereaux PJ, DeWolfe J, Doig G, Duffy P, Eng MS, Finlay S, Finlayson A, Gallacher J, Ghali W, Gilbert K, Hughes D, Hunter L, Jacka MJ, Kamra C, Khurana M, Kinsella C, Lanthier L, Lee TW, Lovell M, MacDonald C, MacDonald P, Marquis M, Marti J, Martinek R, Merchant RN, Misterski J, Mizera R, Moor R, Morin J, O'Reilly M, Ostrander J, Parlow JL, Paul J, Pettit S, Pilon D, Pruneau G, Rammohan S, Schricker T, Sivakumaran S, Sonnema L, Stoger S, Thompson C, Tod D, Toner S, Turabian M, Twist D, Urbanowicz C, van Vlymen JM, Warriner B, Wijeysundera DN, Wong DT, Yang H, Zarnke K, Chang J, Chen KK, Chen W, Chen WZ, Cui JY, Deng LL, Ge XL, Hu WJ, Li HY, Li XS, Li Z, Liu HL, Liu LH, Liu X, Liu XY, Liu YD, Lv BN, Ren FX, Suo XX, Tang L, Wang H, Wang QY, Wei GW, Wu SB, Wu XM, Wu ZD, Xiao R, Xu YF, Xu X, Zan ZX, Zhang L, Zhang WH, Zhao SH, Zhao WD, Zou YC, Zuo MZ, R A, Alvarez S, Arrieta M, Barrera JG, Cáceres LE, Cañón W, Castellanos H, Chaparro MS, Chaves A, Chona J, Duarte E, Garcia HF, Guevara C, Ibarra P, Manrique J, Martinez LX, Mateus L, Parra SB, Pava LF, Perafán PE, Plata R, Rangel GW, Rojas M, Romero MF, Romero T, Ruiz J, Torres GF, Mellada Herrera JA, Palomino Cabrera E, Caballero H, Sanchez Velez M, Cruz T, Rodriguez V, Hynynen M, Leino K, Chan MT, Choi GY, Gin T, Yu SC, Darvas K, Entz L, Hajdu Z, Keleti G, Nagy A, Peter S, Regoly-Merei J, Abraham V, Afzal L, Agarwal S, Panwar RB, Bharani A, Chidambaram N, Desai S, Girija KR, Gupta R, Kaur SG, Haridas KK, Jerry N, Kerkar P, Kilpadi K, Mohanan PP, Naik S, Swamy AG, Parakh R, Paul SK, Pinjala R, Panwar VR, Kumar PR, Raju VA, Ramakrishna P, Ramana PV, Ramanathan M, Devi TR, Ramdas EK, Saraf JK, Sigamani A, Singh R, Srivastava OP, Suresh KR, Swami A, Varma S, Xavier F, Yadav A, Noor MY, Hassan J, Hian NS, Pilus I, Wang CY, Islas-Andrade S, Mora Martinez JM, Orta Flores R, Tamez Perez HE, Chan B, McAllister-Sim D, Vinnell T, Walker S, Young Y, Aasbø V, Mellin-Olsen J, Raeder J, Aguirre R, Aphang-Lam M, Arrunategui B, Baca L, Botazzi Alvarez R, Calmett D, Coloma E, Malaga G, Ponce de Leon D, Rojas Pareja JG, Sihuayro Ancco AM, Soto Tarazona A, Tupayachi G, Kelly RP, Alvarez Zurro C, Blanc Saizar G, Cruz Pardos P, de Nadal Clanchet M, Fernandez Riveira C, Martiez Borja M, Mases Fernández A, Moral Garcia V, Toran Garcia L, Unceta-Barrenechea Orue B, Hörnquist R, Hörnquist R, Malmstedt J, Rosell J, Vimláti L, Kuanprasert S, Rerkkasem K, Foëx P, Giles J, Howard-Alpe G, Sear J.
McMaster University, Faculty of Health Sciences, Clinical Epidemiology and Biostatistics, Room 2C8, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada. philipj@mcmaster.ca
BACKGROUND: Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers. METHODS: We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2-4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00182039. FINDINGS: All 8351 patients were included in analyses; 8331 (99.8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5.8%] patients in the metoprolol group vs 290 [6.9%] in the placebo group; hazard ratio 0.84, 95% CI 0.70-0.99; p=0.0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4.2%] vs 239 [5.7%] patients; 0.73, 0.60-0.89; p=0.0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3.1%] vs 97 [2.3%] patients; 1.33, 1.03-1.74; p=0.0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1.0%] vs 19 [0.5%] patients; 2.17, 1.26-3.74; p=0.0053). INTERPRETATION: Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol.
PMID: 18479744 [PubMed - indexed for MEDLINE]