Nitinol Stent Implantation in TASC A and B Superficial Femoral Artery Lesions: The Femoral Artery Conformexx Trial (FACT)

Abstract

Purpose:

To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST).

Methods:

Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68±9 years) with a single de novo >70% SFA lesion <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received (“on treatment” analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study.

Results:

Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75±0.79 to 0.94±1.38 (p<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62±0.15 to 0.85±0.20 (p<0.0001).

Conclusion:

This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.

Keywords

peripheral vascular disease angioplasty stent restenosis superficial femoral artery

Get full access to this article

View all access options for this article.

References

Schillinger

Sabeti

Loewe

. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006; 354: 1879–1888.

Schillinger

Sabeti

Dick

. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007; 115: 2745–2749.

Krankenberg

Schlüter

Steinkamp

. Nitinol stent implantation vs. percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: The Femoral Artery Stenting Trial (FAST). Circulation. 2007; 116: 285–292.

Scheinert

Sax

. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005; 45: 312–315.

Norgren

Hiatt

Dormandy

. Intersociety consensus for the management of peripheral arterial disease. Int Angiol. 2007; 26: 81–157.

Rutherford

Baker

Ernst

. Recommended standards for reports dealing with lower extremity ischemia: Revised version. J Vasc Surg. 1997; 26: 517–538.

Ranke

Creutzig

Alexander

. Duplex scanning of the peripheral arteries: Correlation of the peak velocity ratio with angiographic diameter reduction. Ultrasound Med Biol. 1992; 18: 433–440.

Sabeti

Schillinger

Amighi

. Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: Propensity score-adjusted analysis. Radiology. 2004; 232: 516–521.

Hirsch

Haskal

Hertzer

. 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, Society 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) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006; 47: 1239–1312.

10.

Duda

Bosiers

Lammer

. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: Long-term results from the SIROCCO trial. J Endovasc Ther. 2006; 13: 701–710.

11.

Kandarpa

Becker

Hunink

. Transcatheter interventions for the treatment of peripheral atherosclerotic lesions: Part I. J Vasc Interv Radiol. 2001; 12: 683–695.

12.

Oliva

. Drug eluting stents for superficial femoral artery disease. Oral presentation at the 53^rd Annual Scientific Session of the American College of Cardiology; New Orleans, Louisiana, USA; March 7–10, 2004.

13.

Mewissen

. Self-expanding nitinol stents in the femoropopliteal segment: Technique and intermediate-term results. Tech Vasc Interv Radiol. 2004; 7: 2–5.

14.

Edwards' Resilient trial demonstrates statistically superior results for treating peripheral arterial disease in the leg. Medical News Today. October 24, 2007; available at: http://www.medicalnewstoday.com/articles/86441.php

15.

Zeller

Rastan

Schwarzwälder

. Long-term results after directional atherecto-my of femoropopliteal lesions. J Am Coll Cardiol. 2006; 48: 1573–1578.