Department of Cardiology, Affiliated Drum Tower Hospital, Nanjing University School of Medicine, Nanjing, China.
Department of Endocrinology, Affiliated Drum Tower Hospital, Nanjing University School of Medicine, Nanjing, China.
Ann Surg. 2021 Mar 1;273(3):459-466. doi: 10.1097/SLA.0000000000003906.
To determine the 5-year and temporal performance of TAVR versus SAVR.
TAVR has become a valuable treatment for severe aortic stenosis but the long-term safety and efficacy remain unclear.
Databases were searched until October 6, 2019 for randomized trials with ≥5 years' follow-up. Primary outcome was all-cause mortality. Odds ratios (ORs) with 95% confidence intervals (CIs) were pooled with random-effects models.
We included 4 trials with 3,758 patients. TAVR was associated with a significantly higher 5-year all-cause mortality than SAVR (OR, 1.19; 95% CI, 1.03-1.37; P = 0.02). Landmark analysis showed no significant difference within 2 years (OR, 0.92; 95% CI, 0.79-1.08; P = 0.33) but a statistically higher mortality in TAVR between 2 and 5 years (OR, 1.32; 95% CI, 1.14-1.52; P = 0.0002), with significant difference between these 2 temporal phases (P for interaction = 0.001). Similar interaction was found for cardiovascular mortality and several other outcomes. Rates of all-cause mortality or disabling stroke, permanent pacemaker implantation, aortic-valve rehospitalization, and reintervention were higher, but rates of major bleeding and new-onset fibrillation were lower in TAVR at 5 years. The incidences of myocardial infarction, stroke, and transient ischemic attack were not statistically different between TAVR and SAVR.
TAVR was associated with a significantly higher all-cause mortality at 5 years compared with SAVR. Of note, all-cause mortality presented a characteristic temporal pattern showing increased risk between 2 and 5 years but not within 2 years. Longer-term follow-up data are warranted.
比较 TAVR 与 SAVR 的 5 年及时间表现。
TAVR 已成为严重主动脉瓣狭窄的一种有价值的治疗方法，但长期安全性和疗效尚不清楚。
数据库检索至 2019 年 10 月 6 日，以获取随访时间≥5 年的随机试验。主要结局为全因死亡率。采用随机效应模型汇总比值比（OR）及其 95%置信区间（CI）。
共纳入 4 项随访时间≥5 年的试验，共纳入 3758 例患者。TAVR 5 年全因死亡率显著高于 SAVR（OR，1.19；95%CI，1.03-1.37；P=0.02）。里程碑分析显示，2 年内无显著差异（OR，0.92；95%CI，0.79-1.08；P=0.33），但 2 至 5 年内 TAVR 死亡率较高（OR，1.32；95%CI，1.14-1.52；P=0.0002），这两个时间阶段之间存在显著差异（P 交互=0.001）。心血管死亡率和其他几个结局也存在类似的交互作用。TAVR 组 5 年时全因死亡率或致残性卒中、永久性起搏器植入、主动脉瓣再入院和再次介入治疗的发生率较高，而全因死亡率或致残性卒中、永久性起搏器植入、主动脉瓣再入院和再次介入治疗的发生率较高，但 5 年时主要出血和新发房颤的发生率较低。TAVR 与 SAVR 组心肌梗死、卒中和短暂性脑缺血发作的发生率无统计学差异。
与 SAVR 相比，TAVR 5 年时全因死亡率显著升高。值得注意的是，全因死亡率呈现出一种特征性的时间模式，即 2 至 5 年内风险增加，但 2 年内无风险增加。需要进行更长期的随访研究。
