Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Eur Heart J. 2015 Dec 14;36(47):3370-9. doi: 10.1093/eurheartj/ehv417. Epub 2015 Aug 26.
The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear.
To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy.
The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.
Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007).
Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.
大多数经导管主动脉瓣植入术（TAVI）目前通过经皮股动脉入路进行。血管闭合装置的类型对血管并发症发生率的潜在影响尚不清楚。
比较 Prostar XL 与 Perclose ProGlide 血管闭合策略的疗效。
ClOsure device iN TRansfemoral aOrtic vaLve implantation（CONTROL）多中心研究纳入了 3138 例连续经皮股动脉 TAVI 患者，根据血管闭合策略进行分类：Prostar XL（Prostar 组）与 Perclose ProGlide 血管闭合策略（ProGlide 组）。采用倾向评分匹配法组建基线特征相似的患者队列。
倾向评分匹配后，共纳入 944 例匹配良好的患者（472 对患者）。Prostar 组复合主要血管并发症或住院期间死亡率高于 ProGlide 组（9.5%比 5.1%，P=0.016），主要血管并发症发生率较高（7.4%比 1.9%，P<0.001）是主要原因。然而，两组住院期间死亡率相似（4.9%比 3.5%，P=0.2）。Prostar 组股动脉狭窄发生率较低（3.4%比 0.5%，P=0.004），但总体而言，Prostar 组主要出血发生率较高（16.7%比 3.2%，P<0.001）、急性肾损伤发生率较高（17.6%比 4.4%，P<0.001），住院时间较长（中位数 6 天比 5 天，P=0.007）。
与 ProGlide 相比，经股动脉 TAVI 中 Prostar XL 血管闭合与较高的主要血管并发症发生率相关，但两种器械的住院期间死亡率相似。
