Jones Robert H, Velazquez Eric J, Michler Robert E, Sopko George, Oh Jae K, O'Connor Christopher M, Hill James A, Menicanti Lorenzo, Sadowski Zygmunt, Desvigne-Nickens Patrice, Rouleau Jean-Lucien, Lee Kerry L
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27710, USA.
N Engl J Med. 2009 Apr 23;360(17):1705-17. doi: 10.1056/NEJMoa0900559. Epub 2009 Mar 29.
Surgical ventricular reconstruction is a specific procedure designed to reduce left ventricular volume in patients with heart failure caused by coronary artery disease. We conducted a trial to address the question of whether surgical ventricular reconstruction added to coronary-artery bypass grafting (CABG) would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone.
Between September 2002 and January 2006, a total of 1000 patients with an ejection fraction of 35% or less, coronary artery disease that was amenable to CABG, and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction were randomly assigned to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow-up was 48 months.
Surgical ventricular reconstruction reduced the end-systolic volume index by 19%, as compared with a reduction of 6% with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups. However, no significant difference was observed in the primary outcome, which occurred in 292 patients (59%) who were assigned to undergo CABG alone and in 289 patients (58%) who were assigned to undergo CABG with surgical ventricular reconstruction (hazard ratio for the combined approach, 0.99; 95% confidence interval, 0.84 to 1.17; P=0.90).
Adding surgical ventricular reconstruction to CABG reduced the left ventricular volume, as compared with CABG alone. However, this anatomical change was not associated with a greater improvement in symptoms or exercise tolerance or with a reduction in the rate of death or hospitalization for cardiac causes. (ClinicalTrials.gov number, NCT00023595.)
外科心室重建是一种特定的手术方法,旨在减少由冠状动脉疾病引起的心力衰竭患者的左心室容积。我们进行了一项试验,以探讨与单纯冠状动脉旁路移植术(CABG)相比,在CABG基础上加用外科心室重建术是否会降低心脏原因导致的死亡或住院率。
在2002年9月至2006年1月期间,共有1000例射血分数为35%或更低、适合CABG的冠状动脉疾病以及适合外科心室重建的左心室优势前壁功能障碍患者被随机分配接受单纯CABG(499例患者)或CABG联合外科心室重建术(501例患者)。主要结局是任何原因导致的死亡和心脏原因导致的住院的复合结局。中位随访时间为48个月。
与单纯CABG使收缩末期容积指数降低6%相比,外科心室重建术使其降低了19%。两个研究组的心脏症状和运动耐量从基线到相似程度均有所改善。然而,在主要结局方面未观察到显著差异,接受单纯CABG的292例患者(59%)和接受CABG联合外科心室重建术的289例患者(58%)出现了主要结局(联合治疗方法的风险比为0.99;95%置信区间为0.84至1.17;P = 0.90)。
与单纯CABG相比,在CABG基础上加用外科心室重建术可减少左心室容积。然而,这种解剖学变化并未带来症状或运动耐量的更大改善,也未降低心脏原因导致的死亡或住院率。(ClinicalTrials.gov编号,NCT00023595。)