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CLINICAL STUDY

Vascular closure devices in patients treated with anticoagulation and iib/iiia receptor inhibitors during percutaneous revascularization

Robert J. Applegate, MD, FACC^*,*, Mark A. Grabarczyk, MD^*, William C. Little, MD, FACC^*, Timothy Craven, MSPH, Michael Walkup, MS, Frederic R. Kahl, MD, FACC^*, Gregory A. Braden, MD, FACC, Kevin M. Rankin, MD, FACC and Michael A. Kutcher, MD, FACC^*

^* Section of CardiologyWinston-Salem, North Carolina, USA
Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina,USA
Cardiology Specialists of North Carolina, Winston-Salem, North Carolina, USA
Mid-State Cardiology, Nashville, Tennessee, USA

Manuscript received November 26, 2001; revised manuscript received March 20, 2002, accepted April 5, 2002.

^* Reprint requests and correspondence: Dr. Robert J. Applegate, Section of Cardiology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, North Carolina 27157-1045USA.
bapplega{at}wfubmc.edu

OBJECTIVES: The study assessed clinical outcomes of closure device use following percutaneous coronary revascularization using current standards of anticoagulation and antiplatelet therapy.

BACKGROUND: Evaluation of the outcomes of patients by use of vascular closure devices during coronary interventions employing current standards of anticoagulation and glycoprotein (GP) IIb/IIIa inhibitor therapy is limited.

METHODS: We evaluated outcomes of 4,525 consecutive patients who underwent percutaneous coronary intervention between July 1997 and April 2000. All patients received anticoagulation with heparin and GP IIb/IIIa inhibitor therapy with abciximab. The closure method was manual in 1,824 patients, Angioseal in 524 patients and Perclose in 2,177 patients. Procedural and hospital vascular outcomes were evaluated.

RESULTS: Closure device success was 97.1% Angioseal and 94.1% Perclose (p < 0.05). Minor vascular complications occurred in 1.8% of manual patients, 1.1% of Angioseal patients and 1.2% of Perclose patients (p = NS); major complications occurred in 1.3% of manual patients, 1.1% of Angioseal patients and 1.0% of Perclose patients (p = NS). Multivariate logistic regression identified only closure device failure as an independent predictor of a vascular complication. In patients with successful closure with a device, minor complications (0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs. 2.5%, p < 0.05) were reduced compared to manual compression.

CONCLUSIONS: Arterial closure following coronary interventions using anticoagulation and GP IIb/IIIa inhibitor therapy can be safely and effectively performed, with vascular complication rates similar to or lower than with manual pressure. Additionally, vascular complication rates using GP IIb/IIIa inhibitor therapy regardless of the method of arterial closure are equivalent to or lower than previously published rates of vascular complications.

Abbreviations and Acronyms   ACT   activated clotting time   GEE   generalized estimating equation   GP   glycoprotein   IV   intravenous   OR   odds ratio   PCI   percutaneous coronary intervention

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