ProGlide Comes Out Ahead of Prostar in Vascular Closure After Transfemoral TAVR: BRAVO 3

Still, as many as one in four patients are afflicted by vascular complications following TAVR, experts note.

ProGlide Comes Out Ahead of Prostar in Vascular Closure After Transfemoral TAVR: BRAVO 3

LAS VEGAS, NV—Vascular closure complications occur in about one-quarter of patients undergoing transfemoral TAVR, according to post hoc analysis of the BRAVO 3 trial, but not all closure devices appear to be created equal.

“Given that TAVR is continuously developing—the practice is moving faster than the science—continuous improvement of these vascular closure devices [is necessary],” David Power, MBBCh (Icahn School of Medicine at Mount Sinai, New York, NY), who presented the data in a featured clinical research session at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI), told TCTMD.

“Now that these devices have become more used and there's more competition between devices, it's difficult for us to say with certainty which of these vascular closure devices are better than another,” he said during his presentation.

Lately, a number of newer vascular closure devices have been coming down the pipeline, but as Power pointed out, limited head-to-head comparison data exist.

30-Day Outcomes

In a subanalysis of the BRAVO 3 randomized trial, Power and colleagues analyzed data from 746 patients who received either the Prostar XL or Perclose ProGlide (both Abbott Vascular), which are suture-mediated devices, at the discretion of the operator. Baseline characteristics between those who received Prostar (47%) and ProGlide (53%) were similar, with the exception that those who received ProGlide were more likely than those given Prostar to have chronic obstructive pulmonary disease or prior CAD (P < 0.01 for both).

Sheath sizes less than 18 mm were more often used in patients undergoing vascular closure with ProGlide, but distribution of valve types and success of closure-device implantation were similar between the groups. Compared with Prostar, ProGlide was associated with a shorter hospital length of stay (mean 7.3 vs 9.2 days; P < 0.001) and shorter procedural time (mean 37.6 vs 42.9 minutes; P < 0.003).

The rate of major or minor vascular complications (primary endpoint) at 30 days was 20%, with patients in the Prostar arm being more likely to report these events compared with the ProGlide cohort in both unadjusted and adjusted analyses.

“This difference seemed to be driven by differences in minor vascular complications, which was mainly related to blood transfusions—between 2 to 4 units of blood—and also nonroutine compression of the vascular access site,” Power explained. Additionally, “there was a strong signal toward increased [acute kidney injury (AKI)] with the Prostar device and decreased AKI with the ProGlide device, which was robust after multivariate analysis.”

30-Day Outcomes

 

ProGlide

Prostar

Adjusted OR

(95% CI)

Major or Minor Vascular Complications

15%

24%

0.54

(0.37-0.80)

Major Vascular Complications

7%

12%

0.62

(0.37-1.04)

Minor Vascular Complications

8%

13%

0.55

(0.34-0.90)

Major Bleeding (BARC ≥ 3b)

8%

11%

0.74

(0.45-1.22)

Any BARC Bleeding

49%

47%

1.10

(0.82-1.49)

Acute Kidney Injury

17%

25%

0.61

(0.40-0.90)

MACCE

8%

8%

1.09

(0.64-1.88)

Death

4%

6%

0.80

(0.41-1.59)

 

There were no significant differences in bleeding between the vascular closure devices, which “indicates that the majority of vascular complications within our study have mostly consisted of nonroutine postprocedural compression or nonroutine vascular interventions,” Power and colleagues write. “Notwithstanding, these events should not be considered unimportant as they may have been a cause for the increased length of in-hospital stay as we observed in the Prostar group. Additionally, they may have led to more pronounced or prolonged hypotension during the procedure contributing to the higher rate of AKI seen with Prostar.”

Predictably, there were also no differences in MACCE and mortality rates.

‘A Ways to Go’

“It appears that the preponderance of data is moving away from the use of Prostar. ProGlide appears to be coming out on top,” Power told TCTMD.

Typically, he said, operators are “more comfortable” with ProGlide over Prostar since it’s often used in smaller femoral access, as well. The routine technique in using ProGlide is inserting two devices into the femoral artery via a guidewire, “so if one of the devices misfires, there's some procedural redundancy in this. The vascular access site may be closed using the second ProGlide device,” he continued. Comparatively, “the Prostar device is typically used on its own, so if there's some type of mistake made or it's not perfect in that position, that may lead to . . . increased bleeding, increased vascular complications.”

In a panel discussion following the presentation of the findings, Connie N. Hess, MD (University of Colorado School of Medicine, Aurora), asked about the potential mechanism behind the differences observed in acute kidney injury.

“It’s difficult to know,” Power responded. “Some prior nonrandomized data has shown a trend toward [more] AKI with the Prostar device. . . . We posit that it may be related to increased contrast loads, which may be required as a concern for incomplete closure of the vascular access site or even hypotension related [to] further interventions required to stop that bleeding.”

“But it could be selection bias as well?” asked session co-moderator Rajiv Gulati, MD, PhD (Mayo Clinic, Rochester, MN).

“Yes, this was a nonrandomized study,” Power said.

During the press conference, Timothy Henry, MD (Lindner Research Center at the Christ Hospital, Cincinnati, OH), called the subanalysis “a really nice study” that points out a substantial proportion of TAVR patients are still having vascular complications. “This is a nice step, but it shows that we still have a ways to go. This area hasn’t had as much attention as it needs.”

Note: Study co-authors Roxana Mehran, MD, and George Dangas, MD, PhD, are faculty members of the Cardiovascular Research Foundation, the publisher of TCTMD.

Sources
Disclosures
  • The BRAVO-3 randomized trial was supported by The Medicines Company.
  • Power reports no relevant conflicts of interest.

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