PARTNER试验（主动脉经导管瓣膜置入）中经导管主动脉瓣置换术后卒中及短暂性脑缺血发作的时间、危险因素及结局分析
Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves).
作者信息
Kapadia Samir, Agarwal Shikhar, Miller D Craig, Webb John G, Mack Michael, Ellis Stephen, Herrmann Howard C, Pichard Augusto D, Tuzcu E Murat, Svensson Lars G, Smith Craig R, Rajeswaran Jeevanantham, Ehrlinger John, Kodali Susheel, Makkar Raj, Thourani Vinod H, Blackstone Eugene H, Leon Martin B
机构信息
From the Cleveland Clinic, OH (S. Kapadia, S.A., S.E., E.M.T., L.G.S., J.R., J.E., E.H.B.); Stanford University Medical School, CA (D.C.M.); St. Paul's Hospital, University of British Columbia, Vancouver (J.G.W.); Baylor Scott and White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H.); MedStar Washington Hospital Center, DC (A.D.P.); Columbia University Medical Center/New York-Presbyterian Hospital (C.R.S., S. Kodali, M.B.L.); Cedars Sinai Medical Center, Los Angeles, CA (R.M.); and Emory University, Atlanta, GA (V.H.T.).
出版信息
Circ Cardiovasc Interv. 2016 Sep;9(9). doi: 10.1161/CIRCINTERVENTIONS.115.002981.
BACKGROUND
Prior studies of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) are limited by reporting and follow-up variability. This is a comprehensive analysis of time-related incidence, risk factors, and outcomes of these events.
METHODS AND RESULTS
From April 2007 to February 2012, 2621 patients, aged 84±7.2 years, underwent transfemoral (TF; 1521) or transapical (TA; 1100) TAVR in the PARTNER trial (Placement of Aortic Transcatheter Valves; as-treated), including the continued access registry. Stroke and TIA were identified by protocol and adjudicated by a Clinical Events Committee. Within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF 58 [3.8%]; TA 29 [2.7%]; P=0.09), 85% within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.50%) patients experienced a TIA (TF 10 [0.67%]; TA 3 [0.27%]; P>0.17). Stroke and TIA were associated with lower 1-year survival than expected (TF 47% after stroke versus 82%, and 64% after TIA versus 83%; TA 53% after stroke versus 80%, and 64% after TIA versus 83%). Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual antiplatelet therapy; high pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR.
CONCLUSIONS
Risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli-prevention devices, and better intraprocedural pharmacological protection may mitigate this risk.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
背景
既往关于经导管主动脉瓣置换术（TAVR）后卒中及短暂性脑缺血发作（TIA）的研究受报告及随访差异的限制。本文对这些事件的时间相关发病率、危险因素及转归进行了全面分析。
方法与结果
在2007年4月至2012年2月期间，2621例年龄为84±7.2岁的患者在PARTNER试验（主动脉经导管瓣膜置入；实际治疗）中接受了经股动脉（TF；1521例）或经心尖（TA；1100例）TAVR，包括持续入组登记。卒中及TIA通过方案确定，并由临床事件委员会判定。在TAVR后30天内，87例（3.3%）患者发生卒中（TF组58例[3.8%]；TA组29例[2.7%]；P = 0.09），85%发生在1周内。即刻卒中风险在第2天达到峰值，然后在1至2周时降至0.8%的低水平并持续存在。在30天内，13例（0.50%）患者发生TIA（TF组10例[0.67%]；TA组3例[0.27%]；P>0.17）。卒中和TIA与1年生存率低于预期相关（TF组卒中后为47%，而预期为82%，TIA后为64%，而预期为83%；TA组卒中后为53%，而预期为80%，TIA后为64%，而预期为83%）。TA-TAVR后早期卒中的危险因素包括更多的后扩张、无反流的单纯主动脉瓣狭窄，可能还有更多的起搏次数、手术日期较早以及未接受双联抗血小板治疗；TAVR前较高的主动脉峰值梯度是TF-TAVR后早期卒中的危险因素。
结论
TAVR后早期卒中或TIA风险最高，且与1年死亡率增加相关。对TAVR进行改良、使用栓子预防装置以及更好的术中药物保护可能会降低这种风险。
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