| Autor: |
Schulte, Karl-Ludwig, Kralj, Ivan, Gissler, Hans Martin, Bagnaschino, Luis Alberto, Buschmann, Ivo, Pernès, Jean-Marc, Haage, Patrick, Goverde, Peter, Beregi, Jean-Paul, Válka, Martin, Boudny, Jaroslav, Geibel, Thomas, Velkoborsky, Marek, Zähringer, Markus, Paetzel, Christian, Fanelli, Fabrizio, Müller-Hülsbeck, Stefan, Zeller, Thomas, Langhoff, Ralf |
| Zdroj: |
Journal of Endovascular Therapy; Dec2012, Vol. 19 Issue 6, p774-784, 11p |
| Abstrakt: |
Purpose: To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). Methods: Between April and October 2008, the registry enrolled 744 patients (496 men; 69±10 years) who had symptomatic >70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. Results: In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by >0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. Conclusion: The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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