van Nieuwkerk Astrid C, Santos Raquel B, Andraka Leire, Tchetche Didier, de Brito Fabio S, Barbanti Marco, Kornowski Ran, Latib Azeem, D'Onofrio Augusto, Ribichini Flavio, Ten Francisco, Dumonteil Nicolas, Baan Jan, Piek Jan J, Abizaid Alexandre, Sartori Samantha, D'Errigo Paola, Tarantini Giuseppe, Lunardi Mattia, Orvin Katia, Pagnesi Matteo, Nogales-Asensio Juan Manuel, Ghattas Angie, Dangas George, Mehran Roxana, Delewi Ronak
Heart Center, Amsterdam UMC, Department of Cardiology, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
Department of Cardiology, Centro Hospitalar Universitário do Porto, Largo Prof. Abel Salazar, 4099-001 Porto, Portugal.
J Clin Med. 2021 Sep 4;10(17):4005. doi: 10.3390/jcm10174005.
Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking.
The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve ( = 4096) were compared to patients undergoing TAVI with an SE-valve ( = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed.
In the matched population of = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0-12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02-1.21, = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86-1.37, = 0.48).
This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.
用于经导管主动脉瓣植入术（TAVI）的球囊扩张式（BE）瓣膜和自膨式（SE）瓣膜在临床实践中均被广泛应用。然而，缺乏足够样本量的随机对照试验来比较这两种瓣膜设计。
CENTER研究纳入了12381例行经股动脉TAVI的患者。在倾向评分匹配后，将接受BE瓣膜TAVI的患者（n = 4096）与接受SE瓣膜TAVI的患者（n = 4096）进行比较。评估包括一年死亡率和卒中发生率在内的临床结局。
在匹配的5410例患者群体中，平均年龄为81±3岁，60%为女性，胸外科医师协会预测的30天死亡率为6.2%（四分位间距4.0 - 12.4）。接受BE瓣膜或SE瓣膜治疗的患者一年死亡率无差异（BE：16.4% 对SE：17.0%，相对风险1.04，95%置信区间0.02 - 1.21，P = 0.57）。一年卒中发生率也相当（BE：4.9% 对SE：5.3%，RR 1.09，95%置信区间0.86 - 1.37，P = 0.48）。
本研究表明，在接受TAVI的严重主动脉瓣狭窄患者中，使用BE瓣膜或SE瓣膜的一年死亡率和卒中发生率相当。
