Arora Sameer, Ramm Cassandra J, Misenheimer Jacob A, Vavalle John P
Division of Cardiology, University of North Carolina at Chapel Hill, North Carolina, USA. Electronic correspondence:
Division of Cardiology, University of North Carolina at Chapel Hill, North Carolina, USA.
J Heart Valve Dis. 2016 Nov;25(6):653-656.
Following publication of the results of the PARTNER trial, the American College of Cardiology/American Heart Association recognized the success of transcatheter aortic valve replacement (TAVR) by incorporating it as a feasible option in high-surgical risk patients, and recommending it as the standard of care for patients at prohibitive risk of surgery. Although this was recognized as a major success in the field of percutaneous valve replacement, surgical aortic valve replacement (SAVR) continued to be realized as the procedure of choice for low and intermediate surgical risk patients. Meanwhile, observational studies - predominantly from Europe - showed encouraging results for TAVR in lower-risk populations. With a lack of any large randomized controlled clinical trial, however, the advantages of TAVR continued to be limited to only a minority of patients with severe, symptomatic aortic stenosis.
Between December 2011 and November 2013, the PARTNER 2 investigators enrolled a total of 2,032 intermediate-risk patients with severe symptomatic aortic stenosis at 57 centers in the United States and Canada. Patients were randomized 1:1 to undergo either TAVR or SAVR. The primary end point was death and neurological events after two years.
The study results showed similar rates for death and neurological events in the TAVR and SAVR groups. The TAVR group was found to have a larger valve area and a lower incidence of acute kidney injury, bleeding events, and atrial fibrillation. Conversely, the SAVR group experienced fewer vascular complications and lower rates of paravalvular regurgitation.
The results of the PARTNER 2 trial are reviewed, and its implications for the future discussed.
在“经导管主动脉瓣置换术（TAVR）对比外科主动脉瓣置换术（SAVR）治疗有症状的主动脉瓣狭窄患者”（PARTNER）试验结果公布后，美国心脏病学会/美国心脏协会认可了经导管主动脉瓣置换术的成功，并将其纳入高手术风险患者的可行选择，同时推荐其作为手术风险极高患者的治疗标准。尽管这被认为是经皮瓣膜置换领域的一项重大成功，但外科主动脉瓣置换术仍是低和中度手术风险患者的首选手术方式。与此同时，主要来自欧洲的观察性研究显示，经导管主动脉瓣置换术在低风险人群中也取得了令人鼓舞的结果。然而，由于缺乏大型随机对照临床试验，经导管主动脉瓣置换术的优势仍仅限于少数有严重症状性主动脉瓣狭窄的患者。
2011年12月至2013年11月期间，PARTNER 2研究的研究者在美国和加拿大的57个中心共招募了2032例有严重症状性主动脉瓣狭窄的中度风险患者。患者按1:1随机分组，分别接受经导管主动脉瓣置换术或外科主动脉瓣置换术。主要终点是两年后的死亡和神经系统事件。
研究结果显示，经导管主动脉瓣置换术组和外科主动脉瓣置换术组的死亡和神经系统事件发生率相似。经导管主动脉瓣置换术组的瓣膜面积更大，急性肾损伤、出血事件和房颤的发生率更低。相反，外科主动脉瓣置换术组的血管并发症较少，瓣周反流发生率较低。
回顾了PARTNER 2试验的结果，并讨论了其对未来的影响。
