Søndergaard Lars, Popma Jeffrey J, Reardon Michael J, Van Mieghem Nicolas M, Deeb G Michael, Kodali Susheel, George Isaac, Williams Mathew R, Yakubov Steven J, Kappetein Arie P, Serruys Patrick W, Grube Eberhard, Schiltgen Molly B, Chang Yanping, Engstrøm Thomas
Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (L.S., T.E.).
Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.).
Circulation. 2019 Oct 15;140(16):1296-1305. doi: 10.1161/CIRCULATIONAHA.118.039564. Epub 2019 Sep 3.
For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach.
The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years.
Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; <0.01) and were more likely to be male (65.1% versus 54.2%; <0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1-22.9 versus 14.0%; 95% CI, 9.2-21.1; =0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5-14.7 versus 12.3%; 95% CI, 9.8-15.4; =0.76).
For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting.
URL: https://www.
gov. Unique identifier: NCT01586910.
对于患有严重主动脉瓣狭窄和冠状动脉疾病的患者，完全经皮主动脉瓣置换和血运重建方法尚未与标准手术方法进行比较。
前瞻性SURTAVI试验（美敦力CoreValve系统治疗需要主动脉瓣置换的中度风险严重症状性主动脉瓣狭窄患者的安全性和有效性研究）于2012年6月至2016年6月在美国、加拿大和欧洲的87个中心招募了中度风险的严重主动脉瓣狭窄患者。SYNTAX评分（紫杉醇药物洗脱支架与心脏外科手术协同试验）>22的复杂冠状动脉疾病为排除标准。根据血运重建需求对患者进行分层，然后随机分配接受经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）治疗。TAVR组中分配进行血运重建的患者接受经皮冠状动脉介入治疗，而SAVR组中的患者则进行冠状动脉旁路移植术。主要终点是2年时全因死亡率或致残性卒中的发生率。
在1660例尝试进行主动脉瓣植入的受试者中，332例（20%）被分配进行血运重建。与未分配进行血运重建的1328例患者相比，他们的胸外科医师协会死亡风险评分更高（4.8±1.7%对4.4±1.5%；P<0.01），且更可能为男性（65.1%对54.2%；P<0.01）。随机分组接受治疗后，有169例患者接受TAVR和经皮冠状动脉介入治疗，163例患者接受SAVR和冠状动脉旁路移植术，695例患者接受TAVR，633例患者接受SAVR。在TAVR和经皮冠状动脉介入治疗与SAVR和冠状动脉旁路移植术之间，主要终点发生率无显著差异（16.0%；95%CI，11.1 - 22.9对14.0%；95%CI，9.2 - 21.1；P = 0.62），TAVR和SAVR之间也无显著差异（11.9%；95%CI，9.5 - 14.7对12.3%；95%CI，9.8 - 15.4；P = 0.76）。
对于具有严重主动脉瓣狭窄和非复杂冠状动脉疾病（SYNTAX评分≤22）的中度手术风险患者，TAVR和经皮冠状动脉介入治疗的完全经皮方法是SAVR和冠状动脉旁路移植术的合理替代方案。
网址：https://www.
gov。唯一标识符：NCT01586910。
