Forrest John K, Deeb G Michael, Yakubov Steven J, Gada Hemal, Mumtaz Mubashir A, Ramlawi Basel, Bajwa Tanvir, Teirstein Paul S, DeFrain Michael, Muppala Murali, Rutkin Bruce J, Chawla Atul, Jenson Bart, Chetcuti Stanley J, Stoler Robert C, Poulin Marie-France, Khabbaz Kamal, Levack Melissa, Goel Kashish, Tchétché Didier, Lam Ka Yan, Tonino Pim A L, Ito Saki, Oh Jae K, Huang Jian, Popma Jeffrey J, Kleiman Neal, Reardon Michael J
Yale University School of Medicine, New Haven, Connecticut, USA.
University of Michigan Health Systems University Hospital, Ann Arbor, Michigan, USA.
J Am Coll Cardiol. 2023 May 2;81(17):1663-1674. doi: 10.1016/j.jacc.2023.02.017. Epub 2023 Mar 5.
Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process.
The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.
Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years.
There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years.
Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
关于低手术风险患者经导管主动脉瓣置换术（TAVR）与外科手术在2年以上时间点的疗效比较的随机数据有限。这给努力在共同决策过程中对患者进行教育的医生带来了未知因素。
作者评估了Evolut低风险试验的3年临床和超声心动图结果。
低风险患者被随机分为接受自膨胀、瓣环上瓣膜的TAVR或外科手术。在3年时评估全因死亡或致残性卒中的主要终点以及几个次要终点。
共进行了1414例植入尝试（730例TAVR；684例外科手术）。患者平均年龄为74岁，35%为女性。3年时，TAVR组7.4%的患者和外科手术组10.4%的患者发生了主要终点事件（风险比：0.70；95%置信区间：0.49 - 1.00；P = 0.051）。全因死亡或致残性卒中治疗组间的差异随时间大致保持一致：第1年为-1.8%；第2年为-2.0%；第3年为-2.9%。外科手术组轻度瓣周反流的发生率（TAVR组为20.3%，外科手术组为2.5%）和起搏器植入率（TAVR组为23.2%，外科手术组为9.1%；P < 0.001）较低。两组中度或更严重瓣周反流的发生率均<1%，且无显著差异。接受TAVR的患者在3年时瓣膜血流动力学有显著改善（TAVR组平均压差为9.1 mmHg，外科手术组为12.1 mmHg；P < 0.001）。
在Evolut低风险研究中，就全因死亡或致残性卒中而言，3年时TAVR与外科手术相比显示出持久的益处。（低风险患者的美敦力Evolut经导管主动脉瓣置换术；NCT02701283）
