Key result
ProGlide cuts vascular complications ~46% vs. Prostar XL after TAVR.
Why the study?
The impact of Prostar XL and ProGlide vascular closure devices on vascular and bleeding complications after transfemoral TAVR remains unclear.
RCT (n=746)
Odds Ratio: 0.54 (95% CI 0.37–0.8)
p-value: p=<0.01
ProGlide was associated with fewer vascular complications and AKI than Prostar XL after TAVR; leaves open whether device selection should change practice pending randomized data.
BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.
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Power et al. (2019) conducted an RCT in Transfemoral TAVR (n=746). ProGlide (PG) vascular closure device vs. Prostar XL (PS) vascular closure device was evaluated on 30-day incidence of major or minor vascular complications (OR 0.54, 95% CI 0.37-0.80, p=<0.01). Compared to Prostar XL, the ProGlide vascular closure device significantly reduced major or minor vascular complications after TAVR (adjusted OR 0.54; 95% CI 0.37-0.80; p<0.01).
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