Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry

Abstract

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]; P=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]; P=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]; P=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; P=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: clini​caltr​ials.gov; Unique identifier: NCT02713932.

Keywords: ProGlide; Prostar; transcatheter aortic valve replacement; vascular closure devices.

Conflict of interest statement

Dr Berti was a proctor for Abbott. Dr Navarese reports consulting fees/honoraria from Abbott, Astra‐Zeneca, Amgen, Bayer, and Sanofi‐Aventis; and grants from Abbott, and Amgen, outside the submitted work. Dr Giordano was a proctor for Abbott. The remaining authors have no disclosures to report.

Figures

Figure 1. Flowchart of the RISPEVA study.

VCD indicates vascular closure device.

Figure 2. Primary end point (cardiovascular death, bleeding and vascular complications) risk at 30‐day and 1‐year follow‐up unadjusted and adjusted with multivariate and propensity score methods.

Univariate, multivariate and propensity score–adjusted analyses are presented. The variables included in the multivariate model are age, surgical risk estimated with the Society of Thoracic Surgery score, coronary artery disease, frailty status, anticoagulant therapy, hemoglobin level, platelet count, diabetes mellitus, chronic kidney disease, obesity, New York Heart Association class at admission, hypertension, peripheral artery disease, sheath size, transcatheter aortic valve replacement device, and vascular calcifications. The list of covariates included in the propensity score are listed in Table S2. HR, hazard ratio; n, clinical events in the ProGlide and Prostar XL cohorts; and OR, odds ratio.

Figure 3. Primary end point (cardiovascular death, bleeding and vascular complications) risk at 30‐day follow‐up with ProGlide vs Prostar XL in prespecified subgroups.

CFA indicates common femoral artery; CKD, chronic kidney; N, number of events in each group; OR, odds ratio; and SFAR, sheath‐to‐femoral artery ratio.

Figure 4. Procedural vascular and bleeding complications with ProGlide vs Prostar XL.

Figure 5. Bleeding outcomes at 30 days among studies with ≥100 patients comparing ProGlide vs Prostar XL.

The size of the marker is proportional to the statistical weight of the study. Individual and pooled odds ratios (ORs) are reported.