Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the AngiosealÃ¢ÂÂ¢ Vascular Closure Device: A Prospective Single-Center Cohort StudyMarco Albanese*, Gregor Stappert, Konstantin Chondros and Wolfgang Schoels
Klinik für Kardiologie und Angiologie, Herzzentrum Duisburg, Gerrickstr 21, 47137 Duisburg, Germany
- *Corresponding Author:
- Marco Albanese
Klinik für Kardiologie und Angiologie, Herzzentrum Duisburg
Gerrickstr 21, 47137 Duisburg, Germany
Tel: + 41 81 925 5145
E-mail: [email protected]
Received date: March 27, 2017; Accepted date: April 17, 2017; Published date: April 22, 2017
Citation: Albanese M, Stappert G, Chondros K, Schoels W (2017) Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the Angioseal™ Vascular Closure Device: A Prospective Single-Center Cohort Study. J Clin Trials 7:306. doi:10.4172/2167-0870.1000306
Copyright: © 2017 Albanese M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Objective: Particularly with the transfemoral access, potential complications at the puncture site with early exercise are a major concern. The purpose of this study was to compare femoral artery access site complications after percutaneous coronary interventions (PCI) in 1) patients following a standard care procedure and 2) performing treadmill electrocardiographic (ECG) stress testing within 24 h after application of the Angioseal™ vascular closure device.
Methods: This is a prospective, randomised, single-center cohort study conducted in a high-volume tertiary interventional heart centre in Duisburg, Germany. 221 patients were included and 200 entered analysis. Patients were randomly assigned to treadmill testing within 24 h after transfemoral seven French (F) PCI or discharged with the recommendation of limited exercise for two weeks. Clinical examination and Duplex ultrasound (DUS) of the inguinal region was obtained within 24 h after PCI in both groups and repeated immediately after the treadmill test in the exercise group. Two-weeks clinical follow-up was obtained in both groups.
Results: Early treadmill testing could be performed without any major limitations or acute complications in all assigned patients. DUS showed no new pseudoaneurysm (PSA) or arteriovenous fistula (AVF) after treadmill testing. At follow-up, there were 1) no differences regarding pain or physical limitations between the two groups and 2) four patients (4%) in the exercise group and seven patients (7%) in the standard care group developed major hematoma (>6 cm)/minor bleeding, which were clinically uneventful.
Conclusions: Treadmill ECG stress testing within 24 h of PCI with the femoral access site closed by the Angioseal device was not associated with a higher complication rate compared to standard care.