CLOSE-UP: Vascular Closure Tops Manual Compression

PARIS, France—Use of a vascular closure device during coronary angiography not only shortens the time to hemostasis but also reduces the risk of in-hospital hematoma compared with manual compression, according to late-breaking clinical trial results released Tuesday, May 17 at EuroPCR 2011.

For the CLOSE-UP trial, Niels Ramsing Holm, MD, of the Aarhus University Hospital (Aarhus, Denmark), and colleagues evaluated FemoSeal (St. Jude Medical, St. Paul, MN), a semi-automatic vascular closure device that is fully resorbable and employs sandwich-type seal discs, at a single high-volume center. Patients undergoing angiography via femoral access and using a 6-Fr sheath were randomized to receive either FemoSeal (n = 501) or manual compression (n = 500) during their procedure.

The FemoSeal device “was proven very safe in the Swedish SCAAR registry in 2007,” Dr. Holm noted. “To confirm this finding, the aim of the CLOSE-UP study was to compare the safety and efficacy of FemoSeal and manual compression in a randomized trial.”

Fewer In-Hospital Hematomas, Faster Closure

At baseline, patients treated with FemoSeal were more likely to be receiving statins and to have hypertension, prior PCI, and greater BMI than those treated with manual compression.

Antithrombotic use and procedural characteristics were largely similar regardless of randomized treatment. Although overall total angiography time excluding closure was 7.0 minutes in both groups, the median time to hemostasis was significantly lower with FemoSeal than with manual compression (1 vs. 8 min; P < 0.0001). The rate of technical/deployment failure in the FemoSeal group was 6.4%.

In-hospital hematoma greater than 5 cm, the study's primary endpoint, was less common with FemoSeal use (2.2% vs. 6.7% with manual compression; P = 0.002). At 14 days, access-site related major adverse vascular events (MAVE) and other outcomes were equivalent between groups (table 1).

Table 1. Outcomes at 14-Day Follow-Up

Discussant Pierfrancesco Agostoni, MD, PhD, of the University Medical Center (Utrecht, the Netherlands), was quick to point out that he has not yet tried FemoSeal but discovered through background research that it resembles the Angio-Seal vascular closure device, also manufactured by St. Jude Medical.

Dr. Agostoni praised the CLOSE-UP trial for its expert operators and focus on endpoints rarely considered in other trials, including in-hospital need for new compression, post-discharge medical evaluation, and self-assessed large hematoma at 15 days. However, he noted that the patient cohort was low-risk and only underwent angiography without intervention. Another weakness was lack of clarity on whether there was independent clinical events assessment.

Importantly, Dr. Agostini asked, “[i]s it worthwhile to pay for a device to gain on average only 7 minutes compression time and to reduce the acute incidence of large hematomas without any impact on time to ambulation [or] on major vascular complications?”

And while the low incidence of infection is “reassuring,” Dr. Agostini said, he questioned the fate of patients who experienced device failure and why the incidence of hematomas showed a “suspicious increase” between hospital discharge and 14-day follow-up in the FemoSeal group.

Study Details

Manual compression involved immediate sheath removal and compression to hemostasis (≥ 5 min). In standard care, sandbag use was discouraged and no bandage or compression system was employed.

One hour of bed rest was recommended in both groups.

 

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Source:
Holm NR. Randomised comparison of manual compression and use of FemoSeal vascular closure device for closure after femoral artery access coronary angiography: The closure devices used in everyday practice (CLOSE-UP) study. Presented at: EuroPCR; May 17, 2011; Paris, France.

 

 

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