Six-Year Outcomes After Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

Annual follow-up is planned for 10 years, evaluating the composite of all-cause mortality or disabling stroke and key secondary endpoints.

计划进行10年的年度随访，评估全因死亡或致残性中风的复合终点以及关键次要终点。

Our prespecified objective was to report the 6-year clinical outcomes of transcatheter aortic valve replacement (TAVR) vs surgery from the Evolut Low Risk trial. Given an increase in reintervention rates at 6 years, we performed additional analyses in available 7-year data.

我们预先设定的目标是报告从Evolut Low Risk试验中得出的经导管主动脉瓣置换术（TAVR）与手术的6年临床结果。鉴于6年时再干预率的增加，我们在可用的7年数据中进行了额外的分析。

Methods

Low-risk patients with severe symptomatic aortic stenosis were randomized to TAVR or surgery from 2016-2019.

从2016年到2019年，低危患者中有严重症状的主动脉瓣狭窄被随机分配到TAVR或手术。

Prespecified analyses at 6 years included annual follow-up of clinical outcomes reported as Kaplan-Meier estimates with log-rank test.

6年的预设分析包括每年对临床结果的随访，以Kaplan-Meier估计报告，并用对数秩检验进行比较。

Because the trial enrolled patients over several years, at the time of data lock, a majority of patients had completed 7-year follow-up.

由于该试验在数年内招募了患者，因此在数据锁定时，大多数患者已经完成了7年的随访。

Given an increased reintervention rate at 6 years in the TAVR arm, we performed additional analysis of 7-year data available at the time of the database lock.

鉴于TAVR组在6年时的再干预率增加，我们在数据库锁定时对当时可用的7年数据进行了额外分析。

Reintervention rates are reported as cumulative incidence.

再干预率以累积发生率报告。

Results

A total of 1,414 patients underwent an attempted implantation (730 TAVR, 684 surgery).

共有1,414名患者尝试进行了植入手术（730例TAVR，684例手术）。

At 6 years, the composite endpoint of all-cause mortality or disabling stroke was 23.3% for TAVR and 20.4% for surgery (difference: 2.8% [95% CI: -1.9% to 7.6%]; P = 0.43).

在6年时，全因死亡或致残性中风的复合终点事件发生率为TAVR组23.3%，手术组20.4%（差异：2.8% [95% 置信区间：-1.9% 至 7.6%]；P = 0.43）。

All-cause mortality with vital status sweep at 6 years was 23.3% (95% CI: 20.6%-26.4%) for TAVR and 20.2% (95% CI: 17.4%-23.3%) for surgery (P = 0.24).

在6年的随访中，经导管主动脉瓣置换术（TAVR）组的全因死亡率为23.3%（95%置信区间：20.6%-26.4%），而手术组为20.2%（95%置信区间：17.4%-23.3%）（P = 0.24）。

The reintervention rate at 6 years was 5.5% for TAVR and 3.3% for surgery (sHR: 1.66 [95% CI: 0.96-2.86]; P = 0.07).

6年时，经导管主动脉瓣置换术（TAVR）的再次干预率为5.5%，而手术组为3.3%（sHR: 1.66 [95%置信区间：0.96-2.86]; P = 0.07）。

Using available 7-year follow-up (555 TAVR and 480 surgery), the reintervention rate for TAVR was 9.8% and for surgery was 6.0% (sHR: 1.68 [95% CI: 1.10-2.58]; P = 0.02).

利用现有的7年随访数据（555例经导管主动脉瓣置换术（TAVR）和480例手术），TAVR的再次干预率为9.8%，手术的再次干预率为6.0%（校正风险比：1.68 [95% 置信区间：1.10-2.58]；P = 0.02）。

In the TAVR and surgery groups, the rate of reintervention for regurgitation was 5.6% vs 1.6% (sHR: 3.39 [95% CI: 1.62-7.07]; P < 0.001) and the rate of reintervention for stenosis was 3.6% vs 3.5% (sHR: 1.14 [95% CI: 0.61-2.15]; P = 0.70).

在TAVR组和手术组中，因反流导致的再次干预率分别为5.6%和1.6%（校正风险比：3.39 [95% 置信区间：1.62-7.07]；P < 0.001），因狭窄导致的再次干预率分别为3.6%和3.5%（校正风险比：1.14 [95% 置信区间：0.61-2.15]；P = 0.70）。

Conclusions

The 6-year results from the Evolut Low Risk trial show no significant difference in the composite endpoint of all-cause mortality or disabling stroke.

Evolut Low Risk试验的6年结果显示，在全因死亡或致残性中风的复合终点上没有显著差异。

At 6 and 7 years, the TAVR arm had a higher reintervention rate compared with surgery, driven by an increased incidenceof aortic regurgitation.

在6年和7年时，与手术相比，TAVR组的再次干预率更高，这是由于主动脉瓣返流发生率的增加所驱动的。

(Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

(Medtronic Evolut 经导管主动脉瓣置换术在低风险患者中的应用; NCT02701283).