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Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter
Bernard Chevalier1, Bernard Lancelin, Rene Koning
1Centre Cardiologique du Nord, Saint-Denis, France. bchevali@aol.com
Insights
Arterial sealing devices like Angio-Seal significantly reduce access site complications after coronary angioplasty in high-risk patients. This method offers faster hemostasis and fewer bleeding events compared to traditional compression techniques.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Access Management
Background:
- Coronary stenting procedures carry a high risk of access site complications.
- Arterial sealing devices offer potential benefits like immediate hemostasis and improved patient comfort.
Purpose of the Study:
- To compare the efficacy of Angio-Seal versus traditional compression methods in reducing access site complications after coronary angioplasty.
- To evaluate outcomes in 612 high-risk patients undergoing coronary angioplasty.
Main Methods:
- A multicenter, randomized study comparing Angio-Seal (Group A) with compression hemostasis (Group B).
- High-risk criteria included age > 70, previous puncture, hypertension, specific medications, and sheath size.
- Patients were monitored for 7 days with duplex sonography to assess complications.
Main Results:
- Angio-Seal achieved 87% immediate hemostasis with a mean time of 5 minutes versus 52 minutes for compression (P < 0.001).
- Early ambulation was significantly reduced in Group A (438 min) vs. Group B (952 min) (P < 0.001).
- The 7-day cumulative complication rate was 5.9% for Angio-Seal versus 18% for compression (P < 0.001), primarily due to reduced prolonged bleeding.
Conclusions:
- Angio-Seal implantation effectively reduces access site complications in high-risk patients undergoing coronary angioplasty.
- The device enables immediate sheath removal and hemostasis, leading to fewer bleeding events compared to compression methods.
Abstract:
Clinical trials have shown that coronary stenting is associated with a high level of complications at the access site. Arterial sealing devices have proven their efficacy in obtaining immediate hemostasis after sheath removal, in allowing early ambulation, and in improving patient comfort. However, there is no report showing a reduction of local complications related to their use. The purpose of this multicenter study was to compare randomly the efficacy of Angio-Seal versus compression methods of hemostasis in reducing the rate of access site complications after coronary angioplasty in 612 selected patients with higher risk of local events satisfying at least one of the following high-risk criteria: age > 70, previous puncture at the same site, history of hypertension, treatment with ticlopidine at least 2 days before the procedure, use of abciximab, 8 Fr access, prolonged heparin treatment after the angioplasty, and use of lytics if fibrinogen > 1 g/l. Group A (n = 306) had immediate sheath removal, Angio-Seal implantation, and cessation of bed rest 4 hr after the intervention. Group B (n = 306) had sheath removal according to local practice and cessation of bed rest 6-18 hr after the hemostasis procedure, also according to local practice. Clinical follow-up was done at 1 hr, 4 hr, 24 hr, discharge, and 7 days and a systematic color flow duplex sonography was performed to confirm diagnosis of access site complication. In group A, device deployment and immediate hemostasis were obtained in, respectively, 96.8% and 87% of patients. Time to hemostasis was shorter in group A: 5 vs. 52 min (P < 0.001). Cessation of bed rest was dramatically reduced in group A (438 +/- 450 min) vs. group B (952 +/- 308 min; P < 0.001). The cumulative rate of complications, using a composite primary endpoint, at 7 days was significantly different between the two groups: 5.9% of group A patients and 18% of group B patients (P < 0.001). This difference was mainly due to the dramatic reduction of prolonged bleeding in group A patients. Angio-Seal device use in high-local-risk patients allows immediate sheath removal and hemostasis with a reduction of local event rate despite a higher level of anticoagulation, compared to regular compression techniques, directly related to a dramatic decrease of prolonged bleeding.
