NEJM:经导管主动脉瓣置换术治疗无法手术的重度主动脉瓣狭窄患者

　　背景  对于有重度主动脉瓣狭窄、并且不适宜手术治疗的患者，经导管主动脉瓣置换术（TAVR）是推荐的治疗。这类患者在1 年后的转归尚不清楚。

　　方法  我们将患者随机分为接受经股动脉TAVR或接受标准治疗（通常包括球囊主动脉瓣膜成形术）。我们对2年转归的数据进行分析。

　　结果  在21家医疗中心，共358例患者接受随机分组。2 年时，TAVR 组的死亡率为43.3% ，标准治疗组为68.0%（P＜0.001），相应的心源性死亡率分别为31.0%和62.4%（P<0.001）。在生存超过1年的患者中，1年时所见的与TAVR 相关的生存优势仍然具有显著性[风险比为0.58，95%可信区间（CI）为0.36～0.92，采用时序检验的P 值为0.02]。TAVR 后的卒中发生率高于标准治疗组（13.8%对5.5%，P=0.01），因为在前30 天内，在TAVR 组发生较多的缺血事件（6.7%对1.7%，P=0.02），在30天后，TAVR组发生较多的出血性卒中（2.2% 对0.6% ，P=0.16）。2 年时，TAVR 组再次住院率为35.0%，标准治疗组为72.5%（P＜0.001）。与标准治疗相比，TAVR 也与功能状况改善相关（P＜0.001）。数据表明，TAVR 后的死亡率获益可能限于没有广泛的共存病况的患者。超声心动图分析显示，主动脉瓣面积的增加持续维持，主动脉瓣压力梯度降低，不伴有瓣周主动脉瓣反流的加重。

　　结论  在经过恰当选择的、有重度主动脉瓣狭窄并且不是合适的手术候选者的患者中，TAVR降低了死亡率和住院率，在随访2 年时，症状的减少和瓣膜血流动力学的改善仍然得以维持。存在广泛的共存病况有可能减少TAVR的生存获益。

Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis

BACKGROUND

Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.

METHODS

We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed..

RESULTS

A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation..

CONCLUSIONS

Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)