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N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.

Cardiac-resynchronization therapy for mild-to-moderate heart failure.

Collaborators (321)

Tang AS, Wells GA, Talajic M, Arnold M, Sheldon R, Connolly S, Hohnloser S, Rouleau GN, Tang AS, Wells GA, Talajic M, Arnold M, Sheldon R, Connolly S, Hohnloser S, Nichol G, Rouleau JL, Yee R, Ignaszewski A, Dorian P, Haddad H, Newman D, Howlett J, Mitchell LB, Roberts R, Teo K, Gillis A, Newton G, Kerr FP, Healey J, Sapp J, Gula L, Tung S, Froeschl M, Froeschl S, Swiggum E, Mielniczuk L, Smith S, Hessian R, Fodor G, Vuurmas T, Sterns L, Sapp J, Healey J, Gardner M, Thibault B, Parkash R, Basta M, Birnie D, Sivakumaran S, Dorian P, Green M, Nery P, Essebag V, Tang AS, Talajic M, Higginson L, Sidhu K, McKee G, Ha A, Tang AS, Wells GA, Talajic M, Arnold M, Theoret-Patrick P, Yetisir E, Luce M, Morin C, Tran ML, Ryan J, Williams K, Gagne L, Birnie D, Tang A, Green M, Lemery R, Gollob M, Nery P, Posan E, Keren A, Redpath C, Davis D, Haddad H, Higginson L, Melniczuk L, Carlin L, Ewart G, Baker A, Gagne L, MacDonald K, Dunne R, Fleming R, Arnold JM, Yee R, Skanes AC, Klein GJ, Krahn AD, Sapp J, Parkash R, Basta M, Gardner M, Gray C, Jackson S, Rajda M, Giddens K, Carroll L, Fearon A, Exner DV, Kavanagh KM, Gillis AM, Sheldon RS, Duff HJ, Isaac DL, Wyse DG, Schroeder K, Ramadan D, Cassidy P, Ellis L, Dorestijn P, Sorensen S, Koshman M, Doucet A, Healey JS, Connolly SJ, Morillo CA, Nair GM, Long L, Malcolm V, Meyer W, Carroll S, Long J, Sivakumaran S, Kimber S, Pantano A, Cujec B, Gulamhusein S, Chan M, Jones A, Paradon K, Mulcahey C, Haykowsky L, van Schaik A, Scott I, Thibault B, Dubuc M, Gagné P, Guerra PG, Khairy P, Macle L, Roy D, Talajic M, Aubin D, Lemarbre F, Simard E, Sterns L, Leather R, Novak P, Tang A, McNish H, Green A, Bastell M, Topham P, Goethe JW, Hohnloser S, Duray G, Israel C, Coutu B, Costi P, De Guise M, Greiss I, Lacombe P, Laramee P, Raymond JM, Bergeron M, Denis I, Roby N, Kerr C, Tung S, Yeung-Lai-Wah J, Ignaszewski A, Honeyman C, Shepherd S, Simpson C, Abdollah H, Redfearn D, Barnachuk A, Veenhuyzen G, McCans J, Fair S, Staples P, Philippon F, O'Hara G, Molin F, Champagne J, Blier L, Gilbert M, Nault I, Sarrazin JF, Charbonneau L, Wulffhart Z, Khaykin Y, Verma A, Tsang B, Chun R, Symmes J, Srivamadevan M, Thangaroopan M, Hacker P, Patterson S, Nath A, Winger K, Beardsall M, Kus T, Frenette M, Hadjis T, Essebag V, Sturmer M, Becker G, Langlois A, Fortier C, Sami M, Giannetti N, Essebag V, Hadjis T, Coutu I, Barber C, Rinne C, Smith S, Lowery D, Janzen I, Williams J, Stobie P, Anderson H, Di Camillo C, Ferguson L, Jenkinson L, Crystal E, Lashevsky I, Lau C, Daoulah A, Calton R, Pekar A, Letvin E, Vecchio J, Lukomsky M, Yuen V, Lakhanpal M, Connors S, Furey M, Fagan S, Matthews J, Constantine M, Power K, Dorian P, Mangat I, Pinter A, Korley V, Ahmad K, O'Donnell S, Allan K, Kowalewski M, Darling D, Erdogan A, Franzen W, Greiss H, Steen-Müller MK, Sanders P, Young G, Stiles M, John B, Leong D, Cehic D, Shashidhar, Dimitri H, Mitchell AM, Maxwell V, Nicholls V, Ayala Parades F, Roux JF, Jean C, Lavallee L, Cameron D, Parker J, Hill A, Abraham L, Weiss C, Himmrich E, Hink HU, Mollnau H, Willems R, Heidbüchel H, Huybrechts W, Nuyens D, Rossenbacker T, Van Cleemput J, Vanhaecke J, Droogné W, Ramdat Misier AR, Beukema WP, Delnoy PP, Elvan A, Smit JJ, Toal S, Douglas G, Searles G, Fitzgerald F, Collings E, Seidl K, Kleemann T, Strauss U, Geller JC, Can LH, Hasdemir C, Labonté R, Juma Z, Peterson T, Beausoleil B, Lai C, Nigro F, Maguire B, Fox G.

Author information

1
Island Medical Program, University of British Columbia, Vancouver, Canada. atang@westerncardiology.ca

Abstract

BACKGROUND:

Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients.

METHODS:

We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure.

RESULTS:

We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD-CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD-CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD-CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P = 0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001).

CONCLUSIONS:

Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.).

PMID:
21073365
DOI:
10.1056/NEJMoa1009540
[Indexed for MEDLINE]
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