Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study
| Autor: | John R. Laird, Mahmood K. Razavi, Karl-Ludwig Schulte, Robert M. Bersin, Michael R. Jaff, Andrew Holden, David Mego, Erin Moore, Scott Kujath, Robert Beasley, Silviu Marica, Alexandra J. Lansky, Dierk Scheinert, Richard A Settlage, Robert Mendes, Thomas Zeller, William Robinson, Fakhir Elmasri, Jörg Teßarek, Rainer Schmiedel |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Prosthesis Design Iliac Artery 030218 nuclear medicine & medical imaging 03 medical and health sciences Peripheral Arterial Disease 0302 clinical medicine Angioplasty medicine Clinical endpoint Vascular Patency Humans Radiology Nuclear Medicine and imaging Myocardial infarction Prospective Studies Adverse effect Prospective cohort study Aged business.industry Middle Aged medicine.disease Confidence interval United States Surgery Clinical trial Europe Treatment Outcome 030220 oncology & carcinogenesis Female Stents Cardiology and Cardiovascular Medicine business Angioplasty Balloon New Zealand |
| Zdroj: | Journal of vascular and interventional radiology : JVIR. 30(6) |
| ISSN: | 1535-7732 |
| Popis: | Purpose This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. Methods A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). Results At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%–23.2%), primary patency was 89.1% (95% CI: 82.6%–93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%–94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure. Conclusions The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries. |
| Databáze: | OpenAIRE |
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