医学界心血管频道经导管主动脉瓣置换术是一种适用于严重主动脉瓣狭窄高危患者的、侵入性较小的手术方式，NEJM用简短的视频对新研究成果进行了汇总。 视频来源：NEJM 制作：医学界心血管频道 Transcatheter aortic-valve replacement, or TAVR, is a less invasive alternative to open aortic-valve surgery for patients with severe aortic stenosis. 对于重度主动脉瓣狭窄而言，经导管主动脉瓣置换术（TAVR）比开放手术创伤小。 Clinical trials initially tested TAVR in patients for whom open cardic surgery would be high risk. 在临床研究中，TAVR最初应用于开放性心脏手术高危患者。 The PARTNER 2 Trial enrolled 2032 patients with severe aortic stenosis and intermediate surgical risk, PARTNER 2研究包含了2032例患者，均存在严重的主动脉瓣狭窄和开放手术中等风险， with 1011 patients assigned to TAVR, and 1021 assigned to open surgery. 其中TAVR组（患者）1011例，开放手术组1021例。 The primary end point was a composite of death from any cause or disabling stroke at 2 years, 主要复合终点是2年内出现的任何原因所致死亡或致残性卒中， with the hypothesis of the TAVR was non-inferior to surgery 假设TAVR不劣于开放手术 with the prespecified noninferiority margin of 1.2 for the upper bond of the hazard ratio. （危险比上限1.2为预设非劣效性界值）。 At 2 years primary end point was met by 19.3% of the patients in TAVR group, and 21.1% of those in surgery group 2年时，TAVR组主要终点发生率为19.3%，而开放手术组为21.1% For hazard ratio of 0.89, and 95% confidence interval of 0.73-1.09， （危险比0.89, 95%可信区间0.73-1.09）， which met the prespecified noninferiority criteria. 达到了预设的非劣性标准。 At 30 days major vascular complications were more frequent in TAVR patients, TAVR组30天内严重血管并发症发生率较高， but life-threatening bleeding, acute kidney injury, and new-onset atrial fibrilation were more common in the surgery patients； 而致命性出血、急性肾损伤和新发房颤在开放手术组更常见； improvement in aortic-valve area in gradients was significantly greater in the TAVR group at both 30 days and 2 years, TAVR在术后30天和术后2年的主动脉瓣口面积改善更明显， however, the frequency in severity of paravalvular aortic regurgitation was greater after TAVR than after surgery. 但同时TAVR术后主动脉瓣关闭不全发生率也更高。 Thus this trial established that TAVR is non-inferior to open aortic surgery for patients at intermediate risk. 因此，这项研究得出结论，对于中危患者而言，TAVR的治疗效果不劣于开放手术。 Intermediate-risk patients hoping to avoid open surgery can be safely referred to TAVR evaluation. 中危患者不愿行开放手术者，可建议其行TAVR治疗， and may even have fewer adverse events such as major bleeding or kidney injury. 除创伤小外，TAVR还可以减少一些不良事件，如严重出血、肾损伤等。 参考资料： http://www./do/10.1056/NEJMdo005062/full |
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