Department of Diagnostic and Interventional Cardiology Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital Massa Italy.
Department of Clinical and Interventional Cardiology IRCCS Policlinico San Donato Milan Italy.
J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24.
Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99]; =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58-0.98]; =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow-up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72-1.10]; =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short-term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov; Unique identifier: NCT02713932.
背景 经导管主动脉瓣置换术（TAVR）需要大口径入路，这与出血和血管并发症有关。ProGlide 和 Prostar XL 是广泛应用于临床实践的血管闭合装置，但由于发表的研究结果存在冲突，它们在 TAVR 中的疗效和安全性比较仍存在争议。我们旨在比较 TAVR 后使用 ProGlide 与 Prostar XL 血管闭合装置的结果。
方法和结果 本大规模分析使用了 RISPEVA，这是一个多中心国家前瞻性数据库，纳入了接受经股 TAVR 治疗的患者，分为使用 ProGlide 与 Prostar XL 血管闭合装置的两组。均进行了多变量和倾向评分调整。共入选 2583 例患者，其中 1361 例使用 ProGlide，1222 例使用 Prostar XL。主要终点是心血管死亡率、出血和血管并发症的复合终点，在 30 天和 1 年随访时评估。30 天时，ProGlide 组的主要终点显著低于 Prostar XL 组（分别为 13.8%和 20.5%；多变量调整后的比值比，0.80 [95%CI，0.65-0.99]；=0.043），这主要归因于出血并发症的减少（分别为 9.1%和 11.7%；多变量调整后的比值比，0.76 [95%CI，0.58-0.98]；=0.046）。倾向评分分析证实，ProGlide 可显著降低主要不良心血管事件和出血风险。在 1 年随访时，两种血管闭合装置的主要终点无显著差异（多变量调整后的危险比，0.88 [95%CI，0.72-1.10]；=0.902）。倾向评分分析也得到了类似的结果。在手术过程中，与 Prostar XL 相比，ProGlide 显著提高了器械成功率（分别为 99.2%和 97.5%；=0.001）。
结论 ProGlide 在 TAVR 中优于 Prostar XL，可显著降低短期复合不良事件发生率，这主要归因于出血并发症减少。
注册信息 URL：clinicaltrials.gov；唯一标识符：NCT02713932。
