真实世界人群中行经股动脉的经导管主动脉瓣置换术与外科主动脉瓣置换术的 5 年结果。

Five-Year Outcomes of Transfemoral Transcatheter Aortic Valve Replacement or Surgical Aortic Valve Replacement in a Real World Population.

机构信息

Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Italy (M.B., C.T.).

National Centre for Global Health-Istituto Superiore di Sanità, Rome, Italy (P.D., S.R., F.S.).

出版信息

Circ Cardiovasc Interv. 2019 Jul;12(7):e007825. doi: 10.1161/CIRCINTERVENTIONS.119.007825. Epub 2019 Jul 9.

DOI:10.1161/CIRCINTERVENTIONS.119.007825

PMID:31284737

Abstract

BACKGROUND

The OBSERVANT study (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study.

METHODS AND RESULTS

The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12-1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11-1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years.

CONCLUSIONS

The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

摘要

背景

OBSERVANT 研究（严重主动脉瓣狭窄治疗中经股动脉 TAVR 与 SAVR 效果的观察性研究）表明，对于低危和中危真实世界倾向性匹配的主动脉瓣狭窄患者，经股 TAVR 与 SAVR 的 1 年死亡率相似。我们报告了意大利 OBSERVANT 研究的 5 年结果。

方法和结果

2010 年 12 月至 2012 年 6 月间，未经调整的入组人群（N=7618）包括 5707 例 SAVR 患者和 1911 例 TAVR 患者。采用倾向评分法选择两组基线特征相似的患者。所有结果均通过与行政数据库的链接进行裁决。本分析的主要终点是 5 年时的任何原因死亡和主要心脏不良事件和脑血管事件。匹配人群共 1300 例（每组 650 例）。倾向评分法生成了低危和中危人群（平均 logistic EuroSCORE2：5.1±6.2%对 4.9±5.1%，SAVR 对经股 TAVR；P=0.485）。5 年时，手术组的任何原因死亡率为 35.8%，经导管组为 48.3%（风险比，1.38；95%CI，1.12-1.69；P=0.002）。同样，与 SAVR 相比，TAVR 与主要心脏不良事件和脑血管事件的风险增加相关（42.5%对 54.0%；风险比，1.35；95%CI，1.11-1.63；P=0.003）。5 年时，两组的脑血管事件、心肌梗死和冠状动脉血运重建的累积发生率相似。