Primary Nitinol Stenting in Femoropopliteal Occlusive Disease: A Meta-Analysis of Randomized Controlled Trials
- 1 October 2012
- journal article
- research article
- Published by International Society of Endovascular Specialists in Journal of Endovascular Therapy
- Vol. 19 (5), 585-595
- https://doi.org/10.1583/jevt-12-3898r.1
Abstract
Purpose To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials. Methods A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI). Results The study population was made up of 627 patients (416 men; mean age 67 ± 10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6 ± 45.7 mm in the stenting group vs. 66.7 ± 41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, pConclusion This meta-analysis supports the use of the primary stenting, mainly for long lesions, as a first-line endovascular treatment for symptomatic disease in the femoropopliteal segment, contrary to indications for use in current clinical guidelines.Keywords
This publication has 27 references indexed in Scilit:
- Nitinol Stent Implantation Versus Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in LengthCirculation, 2007
- Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)Journal of Vascular Surgery, 2007
- Balloon Angioplasty versus Implantation of Nitinol Stents in the Superficial Femoral ArteryNew England Journal of Medicine, 2006
- ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): Executive Summary A Collaborative Report From the American Association for Vascular Surgery/Society for Vascular Surgery,⁎⁎AAVS/SVS when Guideline initiated, now merged into SVSSociety for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease)Journal of the American College of Cardiology, 2006
- Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trialThe Lancet, 2005
- Randomized Study to Compare PTA Alone versus PTA with Palmaz Stent Placement for Femoropopliteal LesionsJournal of Vascular and Interventional Radiology, 2001
- PTA versus Palmaz Stent Placement in Femoropopliteal Artery Obstructions: A Multicenter Prospective Randomized StudyJournal of Vascular and Interventional Radiology, 2001
- Outcome and influence of age after infrainguinal revascularisation in critical limb ischaemiaEuropean Journal of Vascular and Endovascular Surgery, 1998
- Balloon Angioplasty Combined with Primary Stenting Versus Balloon Angioplasty Alone in Femoropopliteal Obstructions: A Comparative Randomized StudyCardioVascular and Interventional Radiology, 1997
- Assessing the quality of reports of randomized clinical trials: Is blinding necessary?Controlled Clinical Trials, 1996