ISAR-CLOSURE: Vascular Closure Devices Noninferior to Manual Compression in Transfemoral Angiography

New data presented Saturday at TCT 2014 show that, in patients undergoing transfemoral coronary angiography, vascular closure devices match manual compression in terms of vascular access site complications and time to hemostasis. However, results varied by the type of closure device used.  

sat.schulz.headStefanie Schüpke Schulz, MD, of the Deutsches Herzzentrum München in Munich, Germany, and colleagues randomly assigned 3,015 patients to vascular closure with either the Femoseal device (St. Jude Medical; n=1,509) or the Exoseal device (Cordis; n=1,506) and 1,509 patients to manual compression.

Use of vascular closure devices proved noninferior to manual compression for the primary endpoint of vascular access site complications at 30 days (hematoma ≥5 cm, arteriovenous fistula, psuedoaneurysm, access-site-related bleeding, acute ipsilateral leg ischemia, need for vascular surgical or interventional treatment or local infection). For both groups, the majority of events were hematomas, followed by psuedoaneurysm. Other adverse events were rare and comparable between both groups (see Figure).

The vascular closure devices also fell within the margin of noninferiority compared with manual compression (Pnoninferiority<.001). Time to hemostasis was 1 minute (range, 0.5-2.0 minutes) for vascular closure and 10 minutes (range, 10-15 minutes) for manual compression (P<.001). Repeat manual compression was required in 1.8% of patients in the device group and 0.7% of patients in the manual compression group (P=.003).

sat.schulz.figure“In patients undergoing transfemoral coronary angiography, vascular closure devices are noninferior to manual compression in terms of vascular access site complications and reduced time-to-hemostasis,” Schulz said. “The increase in efficacy … with no trade-off in safety provides a sound rationale for the use of vascular closure devices over manual compression in daily routine.”

Femoseal vs. Exoseal closure devices

Additional results indicated that vascular access site complications were less common in patients who received Femoseal compared with Exoseal (6% vs. 7.8%; P=.043).

The Femoseal device demonstrated shorter time-to-hemostasis than did Exoseal at 0.5 minutes (range, 0.2-1.0 minutes) vs. 2 minutes (range, 1.0-2.0; P<.001).  Device deployment failure also was less frequent in the Femoseal group compared with the Exoseal group (5.3% vs. 12.2%, P<.001), though need for repeat manual compression was similar between the two closure device types.The study included patients undergoing coronary angiography with a 6F sheath via the common femoral artery with a diameter of >5 mm.

Antithrombotic medication use was comparable between the two groups and almost half of the cohort had multivessel disease, Schulz said.

 Disclosures:

  • Schulz reports no relevant conflicts of interest.

 

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