The use of vascular closure devices significantly reduced complications and the need for transfusions in obese and overweight patients undergoing transfemoral percutaneous coronary intervention (PCI), but the benefit over manual closure was not seen in lean and normal-weight patients or in those treated with a glycoprotein IIb/IIIa inhibitor, researchers reported.
The benefit was also counterbalanced by a small increase in risk of retroperitoneal bleeding, Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center in Ann Arbor, and colleagues, wrote online in the Annals of Internal Medicine.
Vascular closure devices (VCDs) are designed to prevent arterial bleeding, especially after PCI performed by the transfemoral route, which is still the most common route in the U.S.
The devices permit closure of the arteriotomy site using sutures, plugs, or metallic clips, but the role of these devices in preventing vascular complications remains controversial, the researchers noted.
"Most randomized trials evaluating VCDs have been small and underpowered, and the largest meta-analysis on the subject raised concerns that these devices may be associated with an increase in vascular complications," they wrote. "These devices are commonly used in clinical practice, and a recent large observational study suggested that they may be associated with a reduction in bleeding complications."
The newly published study is among the first to compare the efficacy of VCDs to manual closure in the real-world PCI practice setting, with the focus on specific subgroups with the highest risk for complications.
Researchers collected data on 92,000 patients who had PCI procedures at 32 Michigan hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2007 and 2009.
Of the 85,048 PCIs that met study inclusion criteria, 28,528 (37%) used VCDs.
A main study endpoint was vascular complications, including acute thrombosis, loss of limb, retroperitoneal bleeding, need for surgical repair, pseudoaneurysm, or hematoma requiring transfusion or arteriovenous fistula. Other endpoints included transfusion or in-hospital death.
Using propensity score-matched analysis, the use of VCDs was found to be associated with reductions in vascular complications (OR 0.78, 95% CI 0.67-0.90, P=0.001) and post-procedure transfusions (OR 0.85 CI 0.74-0.96, P=0.011).
"These findings were consistent across many prespecified subgroups except for patients with a BMI less than 25 kg/m2 and those treated with platelet glycoprotein IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated," the researchers wrote.
When specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR 0.69 CI 0.58-0.83, P<0 .001="" 0.38-0.76="" 0.54="" 1.12-2.20="" 1.57="" also="" an="" associated="" bleeding="" but="" ci="" in="" increase="" odds="" of="" or="" p="0.009).</span" pseudoaneurysms="" retroperitoneal="" the="" they="" were="" with="">
"Our sudy supports the conclusion that VCDs are associated with reduced vascular complications and transfusions," Gurm and colleagues wrote, adding that the benefit of these devices was evident only in obese and overweight patients in whom manual control of access site is usually difficult.
The study also confirmed that VCD use is particularly beneficial in patients treated with bivalirudin and that its use was associated with a significantly increased risk for retroperitoneal bleeding, which negated any benefit in patients who received GP IIb/IIIa.
"Our data suggest that physicians contemplating VCD use should carefully weigh this increased risk for retroperitoneal bleeding against the expected reduction in pseudoaneurysms and hematomas," the researchers wrote. "The decision to use these devices needs to be individualized for each patient."
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