PMID- 21073365 OWN - NLM STAT- MEDLINE DCOM- 20101221 LR - 20220409 IS - 1533-4406 (Electronic) IS - 0028-4793 (Linking) VI - 363 IP - 25 DP - 2010 Dec 16 TI - Cardiac-resynchronization therapy for mild-to-moderate heart failure. PG - 2385-95 LID - 10.1056/NEJMoa1009540 [doi] AB - 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.). FAU - Tang, Anthony S L AU - Tang AS AD - Island Medical Program, University of British Columbia, Vancouver, Canada. atang@westerncardiology.ca FAU - Wells, George A AU - Wells GA FAU - Talajic, Mario AU - Talajic M FAU - Arnold, Malcolm O AU - Arnold MO FAU - Sheldon, Robert AU - Sheldon R FAU - Connolly, Stuart AU - Connolly S FAU - Hohnloser, Stefan H AU - Hohnloser SH FAU - Nichol, Graham AU - Nichol G FAU - Birnie, David H AU - Birnie DH FAU - Sapp, John L AU - Sapp JL FAU - Yee, Raymond AU - Yee R FAU - Healey, Jeffrey S AU - Healey JS FAU - Rouleau, Jean L AU - Rouleau JL CN - Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators LA - eng SI - ClinicalTrials.gov/NCT00251251 GR - Canadian Institutes of Health Research/Canada PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20101114 PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 SB - IM CIN - N Engl J Med. 2010 Dec 16;363(25):2456-7. PMID: 21073362 CIN - Curr Heart Fail Rep. 2011 Mar;8(1):4-6. PMID: 21125356 CIN - Nat Rev Cardiol. 2011 Jan;8(1):4. PMID: 21218557 CIN - Evid Based Med. 2011 Oct;16(5):138-9. PMID: 21436182 CIN - N Engl J Med. 2011 Mar 31;364(13):1277; author reply 1277-8. PMID: 21449793 CIN - Expert Rev Med Devices. 2011 May;8(3):313-7. PMID: 21542704 MH - Aged MH - *Cardiac Pacing, Artificial/adverse effects MH - *Defibrillators, Implantable/adverse effects MH - Double-Blind Method MH - Electrocardiography MH - Female MH - Heart Failure/classification/mortality/*therapy MH - Hospitalization/statistics & numerical data MH - Humans MH - Intention to Treat Analysis MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Ventricular Dysfunction, Left/therapy FIR - Tang, Anthony S IR - Tang AS FIR - Wells, George A IR - Wells GA FIR - Talajic, Mario IR - Talajic M FIR - Arnold, Malcolm IR - Arnold M FIR - Sheldon, Robert IR - Sheldon R FIR - Connolly, Stuart IR - Connolly S FIR - Hohnloser, Stefan IR - Hohnloser S FIR - Rouleau, Graham Nichol Jean L IR - Rouleau GN FIR - Tang, Anthony S IR - Tang AS FIR - Wells, George A IR - Wells GA FIR - Talajic, Mario IR - Talajic M FIR - Arnold, Malcolm IR - Arnold M FIR - Sheldon, Robert IR - Sheldon R FIR - Connolly, Stuart IR - Connolly S FIR - Hohnloser, Stefan IR - Hohnloser S FIR - Nichol, Graham IR - Nichol G FIR - Rouleau, Jean L IR - Rouleau JL FIR - Yee, Raymond IR - Yee R FIR - Ignaszewski, Andrew IR - Ignaszewski A FIR - Dorian, Paul IR - Dorian P FIR - Haddad, Haissam IR - Haddad H FIR - Newman, David IR - Newman D FIR - Howlett, Jonathan IR - Howlett J FIR - Mitchell, L B IR - Mitchell LB FIR - Roberts, Robin IR - Roberts R FIR - Teo, Koon IR - Teo K FIR - Gillis, Anne IR - Gillis A FIR - Newton, Gary IR - Newton G FIR - Kerr, Francois Philippon Charles IR - Kerr FP FIR - Healey, Jeff IR - Healey J FIR - Sapp, John IR - Sapp J FIR - Gula, Lorne IR - Gula L FIR - Tung, Stanley IR - Tung S FIR - Froeschl, Michael IR - Froeschl M FIR - Froeschl, Sandra IR - Froeschl S FIR - Swiggum, Elizabeth IR - Swiggum E FIR - Mielniczuk, Lisa IR - Mielniczuk L FIR - Smith, S IR - Smith S FIR - Hessian, R IR - Hessian R FIR - Fodor, George IR - Fodor G FIR - Vuurmas, Tycho IR - Vuurmas T FIR - Sterns, Larry IR - Sterns L FIR - Sapp, John IR - Sapp J FIR - 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Vanhaecke J FIR - Droogne, W IR - Droogne W FIR - Ramdat Misier, A R IR - Ramdat Misier AR FIR - Beukema, W P IR - Beukema WP FIR - Delnoy, P P H M IR - Delnoy PP FIR - Elvan, A IR - Elvan A FIR - Smit, J J J IR - Smit JJ FIR - Toal, S IR - Toal S FIR - Douglas, G IR - Douglas G FIR - Searles, G IR - Searles G FIR - Fitzgerald, F IR - Fitzgerald F FIR - Collings, E IR - Collings E FIR - Seidl, K IR - Seidl K FIR - Kleemann, T IR - Kleemann T FIR - Strauss, U IR - Strauss U FIR - Geller, J C IR - Geller JC FIR - Can, L H IR - Can LH FIR - Hasdemir, C IR - Hasdemir C FIR - Labonte, R IR - Labonte R FIR - Juma, Z IR - Juma Z FIR - Peterson, T IR - Peterson T FIR - Beausoleil, B IR - Beausoleil B FIR - Lai, C IR - Lai C FIR - Nigro, F IR - Nigro F FIR - Maguire, B IR - Maguire B FIR - Fox, G IR - Fox G EDAT- 2010/11/16 06:00 MHDA- 2010/12/22 06:00 CRDT- 2010/11/16 06:00 PHST- 2010/11/16 06:00 [entrez] PHST- 2010/11/16 06:00 [pubmed] PHST- 2010/12/22 06:00 [medline] AID - 10.1056/NEJMoa1009540 [doi] PST - ppublish SO - N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.