Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Essen, Germany.
Ann Thorac Surg. 2013 Feb;95(2):599-605. doi: 10.1016/j.athoracsur.2012.07.075. Epub 2012 Sep 26.
Aortic valve replacement with coronary artery bypass graft surgery is currently the standard therapy for patients with aortic stenosis and concomitant coronary artery disease. We sought to determine whether transcatheter aortic valve implantation combined with percutaneous coronary intervention might be an equivalent strategy.
A total of 243 high-risk patients (Society of Thoracic Surgeons [STS] score >10% and/or European System for Cardiac Operative Risk Evaluation [EuroSCORE] >15%) presenting with aortic stenosis with concomitant coronary artery disease were studied. Patients were treated either by surgical aortic valve replacement combined with coronary artery bypass graft (group 1, n = 184) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (group 2, n = 59). A propensity score adjusted regression analysis was used to compare 30-day mortality as the primary study endpoint between the groups.
Group 1 mean age (75 ± 6 years), EuroSCORE (18.1% ± 13.8%), and STS score (13.1% ± 8.7%) were significantly different from group 2 (mean age 80 ± 6 years, EuroSCORE 27.5% ± 16.3%, and STS score 16.7% ± 10.5%; p < 0.001). Thirty-day mortality was 12.5% in group 1 compared with 11.9% in group 2 (odds ratio 0.94, 95% confidence interval: 0.38 to 2.32, p = 0.89). Univariate analysis revealed left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and previous cardiac surgery as predictors for 30-day mortality (p < 0.05). Risk-adjusted multivariate regression analysis showed only left ventricular ejection fraction to be strongly associated with 30-day mortality and confirmed no significant difference between the groups (p = 0.44). To further control for study bias, a 10-layer propensity score model based on the univariate analysis again indicated equivalence regarding the primary endpoint (p = 0.33).
The present study demonstrates that transcatheter aortic valve implantation in combination with prior percutaneous coronary intervention within 12 months produces similar results in a propensity score matched high-risk patient population.
主动脉瓣置换术联合冠状动脉旁路移植术是目前治疗主动脉瓣狭窄合并冠状动脉疾病患者的标准治疗方法。我们试图确定经导管主动脉瓣植入术联合经皮冠状动脉介入术是否是一种等效策略。
共纳入 243 例高危患者(胸外科医师学会评分>10%和/或欧洲心脏手术风险评估系统评分>15%),主动脉瓣狭窄合并冠状动脉疾病。患者接受外科主动脉瓣置换术联合冠状动脉旁路移植术(组 1,n=184)或经皮冠状动脉介入术治疗,在经心尖或经股动脉经导管主动脉瓣植入术(组 2,n=59)前 12 个月内进行。采用倾向评分调整回归分析比较两组 30 天死亡率作为主要研究终点。
组 1 的平均年龄(75±6 岁)、欧洲心脏手术风险评估系统评分(18.1%±13.8%)和胸外科医师学会评分(13.1%±8.7%)与组 2 (平均年龄 80±6 岁,欧洲心脏手术风险评估系统评分 27.5%±16.3%,胸外科医师学会评分 16.7%±10.5%)有显著差异(p<0.001)。组 1 的 30 天死亡率为 12.5%,组 2 为 11.9%(比值比 0.94,95%置信区间:0.38 至 2.32,p=0.89)。单因素分析显示左心室射血分数、肺动脉高压、肾功能不全、胸外科医师学会评分、欧洲心脏手术风险评估系统评分和既往心脏手术是 30 天死亡率的预测因素(p<0.05)。风险调整多因素回归分析显示,只有左心室射血分数与 30 天死亡率密切相关,且两组间差异无统计学意义(p=0.44)。为了进一步控制研究偏倚,基于单因素分析的 10 层倾向评分模型再次表明主要终点等效(p=0.33)。
本研究表明,在倾向评分匹配的高危患者人群中,经导管主动脉瓣植入术联合 12 个月内先前经皮冠状动脉介入术的治疗效果相似。