Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta‐analysis and critical examination of current methodologies

The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.

[1]  D. Scheinert,et al.  The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). , 2013, Journal of vascular surgery.

[2]  P. Fitzgerald,et al.  Duplex criteria for in‐stent restenosis in the superficial femoral artery , 2013, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[3]  J. de Haro,et al.  Primary Nitinol Stenting in Femoropopliteal Occlusive Disease: A Meta-Analysis of Randomized Controlled Trials , 2012, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[4]  D. Mozaffarian,et al.  Heart disease and stroke statistics--2012 update: a report from the American Heart Association. , 2012, Circulation.

[5]  M. Bosiers,et al.  Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. , 2011, Journal of vascular surgery.

[6]  M. Dake,et al.  Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease: Twelve-Month Zilver PTX Randomized Study Results , 2011, Circulation. Cardiovascular interventions.

[7]  M. Nobuyoshi,et al.  Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. , 2010, Journal of vascular surgery.

[8]  Maurice Buchbinder,et al.  Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery: Twelve-Month Results From the RESILIENT Randomized Trial , 2010, Circulation. Cardiovascular interventions.

[9]  P. Holt,et al.  Role of Superficial Femoral Artery Stents in the Management of Arterial Occlusive Disease: Review of Current Evidence , 2010, Vascular.

[10]  Johannes Lammer,et al.  Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[11]  Andrew Thomas,et al.  The BUGS project: Evolution, critique and future directions , 2009, Statistics in medicine.

[12]  Thomas Jahnke,et al.  Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-Month Results of the DURABILITY I Study , 2009, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[13]  M. Schlüter,et al.  Nitinol Stent Implantation in TASC A and B Superficial Femoral Artery Lesions: The Femoral Artery Conformexx Trial (FACT) , 2008, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[14]  S. Pocock,et al.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. , 2007, Preventive medicine.

[15]  D. Scheinert,et al.  Nitinol Stent Implantation Versus Percutaneous Transluminal Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in Length: The Femoral Artery Stenting Trial (FAST) , 2007, Circulation.

[16]  L. Norgren,et al.  Inter-society consensus for the management of peripheral arterial disease. , 2007, International angiology : a journal of the International Union of Angiology.

[17]  Bram D. Zuckerman,et al.  FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[18]  D. Bloch,et al.  Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[19]  Y. Ostchega,et al.  Prevalence of Peripheral Arterial Disease and Risk Factors in Persons Aged 60 and Older: Data from the National Health and Nutrition Examination Survey 1999–2004 , 2007, Journal of the American Geriatrics Society.

[20]  F. Vermassen,et al.  A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. , 2007, European heart journal.

[21]  Marie Gerhard-Herman,et al.  Guidelines for noninvasive vascular laboratory testing: a report from the American Society of Echocardiography and the Society for Vascular Medicine and Biology , 2006, Vascular medicine.

[22]  J. Gardin,et al.  Guidelines for noninvasive vascular laboratory testing: a report from the American Society of Echocardiography and the Society of Vascular Medicine and Biology. , 2006, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[23]  Johannes Lammer,et al.  Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. , 2006, The New England journal of medicine.

[24]  Rodney A. White,et al.  ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography , 2006, Circulation.

[25]  J. Murabito,et al.  Temporal trends in the incidence of intermittent claudication from 1950 to 1999. , 2005, American journal of epidemiology.

[26]  Thomas Zeller,et al.  Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. , 2005, Journal of vascular and interventional radiology : JVIR.

[27]  E. Minar,et al.  Primary Patency of Long-Segment Self-Expanding Nitinol Stents in the Femoropopliteal Arteries , 2005, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[28]  T. Murphy,et al.  Aortoiliac insufficiency: long-term experience with stent placement for treatment. , 2004, Radiology.

[29]  Gerhard Ziemer,et al.  Sirolimus-Eluting Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Six-Month Results , 2002, Circulation.

[30]  J. Brossmann,et al.  Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease. , 2002, Journal of vascular and interventional radiology : JVIR.

[31]  S L Normand,et al.  Meta-analysis: formulating, evaluating, combining, and reporting. , 1999, Statistics in medicine.

[32]  R B D'Agostino,et al.  Intermittent claudication. A risk profile from The Framingham Heart Study. , 1997, Circulation.

[33]  J. Higgins.  Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration , 2011 .

[34]  L. Norgren,et al.  Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). , 2007, Journal of vascular surgery.

[35]  A. Auterith,et al.  Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral and popliteal arteries: a midterm follow-up. , 2002, Radiology.