Primary Use of Sirolimus-Eluting Stents in the Infrapopliteal Arteries

Abstract

Purpose:

To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia.

Methods:

A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73±9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%±5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing ≥70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification.

Results:

Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6±0.4 at baseline to 0.8±0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3±0.8 at baseline to 0.9±1.1 (p<0.0001) after 1 year.

Conclusion:

Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.

Keywords

peripheral vascular occlusive disease infrapopliteal arteries sirolimus-eluting stent balloon angioplasty critical limb ischemia intermittent claudication

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References

Hirsch

Haskal

Hertzer

. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): A Collaborative Report from the American Associations 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)–Summary of Recommendations. J Vasc Interv Radiol. 2006;17:1383–1398.

Dormandy

Rutherford

. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg. 2000;31:S1–S296.

Weitz

Byrne

Clagett

. Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: a critical review. Circulation. 1996;94:3026–3069.

The European Working Group on Critical Leg Ischemia. Second European consensus document on chronic critical leg ischemia. Circulation. 1991;84(Suppl IV):IV-1–IV-26.

McDaniel

Cronenwett

. Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989;3:273–277.

Laird

. Limitations of percutaneous transluminal angioplasty and stenting for the treatment of disease of the superficial femoral and popliteal arteries. J Endovasc Ther. 2006; 13 Suppl 2:II30–40.

Dorros

Jaff

Dorros

. Tibioperoneal (outflow lesion) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia: five year follow-up. Circulation. 2001;104:2057–2062.

Krankenberg

Sorge

Zeller

. Percutaneous transluminal angioplasty of infrapopliteal arteries in patients with intermittent claudication: acute and one-year results. Catheter Cardiovasc Interv. 2005;64:12–17.

Biondi-Zoccai

Sangiorgi

Lotrionte

. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009;16:251–260.

10.

Siablis

Karnabatidis

Katsanos

. Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: enduring 1-year angiographic and clinical benefit. J Endovasc Ther. 2007;14: 241–250.

11.

Ranke

Rieder

Creutzig

. A normogram of duplex ultrasound quantification of peripheral arterial stenoses. Studies of the cardiovascular model and in angiography patients. Med Klin (Munich). 1995;90: 72–77.

12.

Mousa

Rhee

Trocciola

. Percutaneous endovascular treatment for chronic limb ischemia. Ann Vasc Surg. 2005;19:186–191.

13.

Whittemore

Belkin

. Infrainguinal bypass. In: Rutherford

, ed. Vascular Surgery 2000. Philadelphia, PA: W.B. Saunders Co.; 2000:998–1018.

14.

Bakal

Sprayregen

Schleinbaum

. Percutaneous transluminal angioplasty of infrapopliteal arteries: results in 53 patients. AJR Am J Roentgenol. 1990;154:171–174.

15.

Faglia

Dalla Paola

Clerici

. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg. 2005;29:620–627.

16.

Rand

Basile

Cejna

. PTA versus carbofilm-coated stents in infrapopliteal arteries: pilot study. Cardiovasc Intervent Radiol. 2006;29:29–38.

17.

Feiring

Wesolowski

Lade

. Primary stent-supported angioplasty for treatment of below-knee critical limb ischemia and severe claudication. J Am Coll Cardiol. 2004;44: 2307–2314.

18.

Commeau

Barragan

Roquebert

. Sirolimus for below the knee lesions: mid-term results of Siro BTK Study. Catheter Cardiovasc Interv. 2006;68:793–798.

19.

Scheinert

Ulrich

Scheinert

. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions. Eurointervention. 2006;2:169–174.

20.

Siablis

Kraniotis

Karnabatidis

. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study. J Endovasc Ther. 2005;12: 685–695.

21.

Cossman

Ellison

Wagner

. Comparison of contrast arteriography to arterial mapping with color-flow duplex imaging in the lower extremities. J Vasc Surg. 1989;10: 522–529.

22.

Marti Mestre

Cairols Castellote

Vila Coll

. Arterial mapping with duplex ultrasound: diagnostic-therapeutic strategy in patients with critical lower-limb ischemia. Int Angiol. 2009;28:209–214.