TY - JOUR
T1 - Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures
T2 - A meta-analysis
AU - Nikolsky, Eugenia
AU - Mehran, Roxana
AU - Halkin, Amir
AU - Aymong, Eve D.
AU - Mintz, Gary S.
AU - Lasic, Zoran
AU - Negoita, Manuela
AU - Fahy, Martin
AU - Krieger, Shoshana
AU - Moussa, Issam
AU - Moses, Jeffrey W.
AU - Stone, Gregg W.
AU - Leon, Martin B.
AU - Pocock, Stuart J.
AU - Dangas, George
N1 - Funding Information:
The research fellowship program of the Cardiovascular Research Foundation is a recipient of an educational grant from St. Jude Medical Inc.
PY - 2004/9/15
Y1 - 2004/9/15
N2 - This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
AB - This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
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U2 - 10.1016/j.jacc.2004.06.048
DO - 10.1016/j.jacc.2004.06.048
M3 - Article
C2 - 15364320
AN - SCOPUS:4444370081
SN - 0735-1097
VL - 44
SP - 1200
EP - 1209
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -