Paclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment.
- 1 November 2015
- journal article
- review article
- Vol. 15 (20), 1-62
Abstract
Peripheral arterial disease is a condition in which atherosclerotic plaques partially or completely block blood flow to the legs. Although percutaneous transluminal angioplasty and metallic stenting have high immediate success rates in treating peripheral arterial disease, long-term patency and restenosis rates in long and complex lesions remain unsatisfactory. The objective of this analysis was to evaluate the clinical effectiveness, safety, cost-effectiveness and budget impact of Zilver paclitaxel self-expanding drug-eluting stents for the treatment of de novo or restenotic lesions in above-the-knee peripheral arterial disease. Literature searches were performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid Embase, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews. For the economic review, a search filter was applied to limit search results to economics-related literature. Data sources for the budget impact analysis included expert opinion, published literature, and Ontario administrative data. Systematic reviews, meta-analyses, randomized controlled trials, and observational studies were included in the clinical effectiveness review, and full economic evaluations were included in the economic literature review. Studies were included if they examined the effect of Zilver paclitaxel drug-eluting stents in de novo or restenotic lesions in above-the-knee arteries. For the budget impact analysis, 3 scenarios were constructed based on different assumptions. One randomized controlled trial reported a significantly higher patency rate with Zilver paclitaxel drug-eluting stents for lesions ≤ 14 cm than with angioplasty or bare metal stents. One observational study showed no difference in patency rates between Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. Zilver paclitaxel drug-eluting stents were associated with a significantly higher event-free survival rate than angioplasty, but the event-free survival rate was similar for Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. No economic evaluations compared Zilver paclitaxel drug-eluting stents with bare metal stents or angioplasty for peripheral arterial disease. A budget impact analysis showed that the cost savings associated with funding of Zilver paclitaxel drug-eluting stents would be $470,000 to $640,000 per year, assuming that the use of the Zilver paclitaxel drug-eluting stent was associated with a lower risk of subsequent revascularization. Based on evidence of low to moderate quality, Zilver paclitaxel drug-eluting stents were associated with a higher patency rate than angioplasty or bare metal stents, and with fewer adverse events than angioplasty. The effectiveness and safety of Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons were similar.This publication has 38 references indexed in Scilit:
- Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic PatientsCardioVascular and Interventional Radiology, 2013
- Measurement and Interpretation of the Ankle-Brachial IndexCirculation, 2012
- A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in FranceCardioVascular and Interventional Radiology, 2012
- Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal DiseaseCirculation: Cardiovascular Interventions, 2011
- Nitinol Stents With Polymer-Free Paclitaxel Coating for Lesions in the Superficial Femoral and Popliteal Arteries Above the Knee:Twelve-Month Safety and Effectiveness Results From the Zilver PTX Single-Arm Clinical StudyJournal of Endovascular Therapy, 2011
- ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries * The Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC)European Heart Journal, 2011
- Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)Journal of Vascular Surgery, 2007
- Prevalence and clinical impact of stent fractures after femoropopliteal stentingJournal of the American College of Cardiology, 2005
- Report from The Swedish Council on Technology Assessment in Health Care (SBU)International Journal of Technology Assessment in Health Care, 1994