Abstract
Purpose
The authors compared the immediate, mid-term and long-term effectiveness of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients.
Materials and methods
From October 2006 to November 2009, 48 patients with non-insulin-dependent diabetes mellitus (DM) and an indication for percutaneous revascularisation of the femoropopliteal arteries were randomly assigned to treatment with angioplasty or cryoplasty. The following parameters were analysed and compared between the two groups: immediate technical success (residual stenosis <30%) and distal run-off as assessed on postprocedural angiography, and degree of restenosis and distal run-off at 6 and 12 months, as assessed with either colour Doppler ultrasound (CDUS) or digital subtraction angiography (DSA).
Results
Treatment with angioplasty revealed a significant superiority in procedural technical success (p=0.04), a significant reduction in the degree of restenosis at 6 months (p=0.02) and a significant increase in the distal run-off at 6 (p=0.005) and 12 (p=0.01) months.
Conclusions
Conventional angioplasty is more effective than cryoplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients and provides better immediate, mid-term and long-term results.
Riassunto
Obiettivo
Scopo del nostro lavoro è stato confrontare l’efficacia immediata e a medio e lungo termine della crioplastica e dell’angioplastica nel trattamento delle lesioni steno-ostruttive del distretto femoro-popliteo in pazienti diabetici.
Materiali e metodi
Da ottobre 2006 a novembre 2009, 48 pazienti affetti da diabete mellito con indicazione ad intervento di rivascolarizzazione percutanea dell’asse femoro-popliteo sono stati assegnati in maniera randomizzata al trattamento mediante crioplastica ed angioplastica. I parametri analizzati e confrontati tra i due gruppi di trattamento sono stati: successo tecnico (stenosi residua <30%) e run-off distale al termine della procedura, valutati angiograficamente, grado di restenosi e run-off distale a 6 e 12 mesi, valutati mediante eco-color Doppler o angiografia.
Risultati
Nel gruppo trattato con angioplastica si è riscontrato un incremento significativo di successo tecnico post-procedurale (p=0,04), una riduzione significativa del grado di restenosi a 6 mesi (p=0,02) ed un significativo incremento del run-off distale a 6 (p=0,005) e 12 mesi (p=0,01) rispetto al gruppo trattato con crioplastica.
Conclusioni
L’angioplastica convenzionale risulta più efficace della crioplastica nel trattamento delle lesioni steno-ostruttive del distretto femoro-popliteo in pazienti diabetici, con migliori risultati immediati ed a medio e lungo termine.
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References/Bibliografia
King H, Aubert RE, Herman WH (1998) Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections. Diabetes Care 21:1414–1431
Melliere D, Berrahal D, Desgranges P et al (1999) Influence of diabetes on revascularisation procedures of the aorta and lower limb arteries: early results. Eur J Vasc Endovasc Surg 17:438–441
Siablis D, Karnabatidis D, Katsanos K et al (2007) Infrapopliteal application of paclitaxel-eluting stents for critical limb ischemia: midterm angiographic and clinical results. J Vasc Interv Radiol 18:1351–1361
DeRubertis BG, Pierce M, Ryer EJ et al (2008) Reduced primary patency rate in diabetic patients after percutaneous intervention results from more frequent presentation with limb-threatening ischemia. J Vasc Surg 47:101–108
Rutherford RB, Jones DN, Bergentz SE et al (1988) Factors affecting the patency of infrainguinal bypass. J Vasc Surg 8:236–246
Pozzi Mucelli F, Fisicaro M, Calderan L et al (2003) Percutaneous revascularization of femoropopliteal artery disease: PTA and PTA plus stent. Results after six years’ follow-up. Radiol Med 105:339–349
Schillinger M, Sabeti S, Loewe C et al (2006) Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 354:1879–1888
Muradin GS, Bosch JL, Stijnen T et al (2001) Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: metaanalysis. Radiology 221:137–145
Rogers JH, Laird JR (2007) Overview of new technologies for lower extremity revascularization. Circulation 116:2072–2085
Lumsden AB, Davies MG, Peden EK (2009) Medical and endovascular management of critical limb ischemia. J Endovasc Ther 16:II31–II62
Zeller T, Sixt S, Rastan A (2009) New techniques for endovascular treatment of peripheral artery disease with focus on chronic critical limb ischemia. Vasa 38:3–12
Peeters P, Keirse K, Verbist J et al (2009) Other endovascular methods of treating the diabetic foot. J Cardiovasc Surg (Torino) 50:313–321
McCaslin JE, Macdonald S, Stansby G (2007) Cryoplasty for peripheral vascular disease. Cochrane Database Syst Rev 17:CD005507
Laird JR, Dawson DLJ (2009) The role for cryoplasty in the treatment of infrainguinal artery disease: case studies. J Endovasc Ther 16:II116–II128
Yiu WK, Cheng SW, Sumpio BE (2007) Direct comparison of endothelial cell and smooth muscle cell response to supercooling and rewarming. J Vasc Surg 46:557–564
Wildgruber MG, Berger HJ (2008) Cryoplasty for the prevention of arterial restenosis. Cardiovasc Intervent Radiol 31:1050–1058
McCaslin JE, Macdonald S, Stansby G (2007) Cryoplasty for peripheral vascular disease. Cochrane Database Syst Rev 4:CD005507
Schmieder GC, Carroll M, Panneton JM (2010) Poor outcomes with cryoplasty for lower extremity arterial occlusive disease. J Vasc Surg 52:362–368
Diaz ML, Urtasun F, Barberena J et al (2011) Cryoplasty versus conventional angioplasty in femoropopliteal arterial recanalization: 3-year analysis of reintervention-free survival by treatment received. Cardiovasc Intervent Radiol 34:911–917
Spiliopoulos S, Katsanos K, Karnabatidis D et al (2010) Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc Intervent Radiol 33:929–938
Jahnke T, Mueller-Huelsbeck S, Charalambous N et al (2010) Prospective, randomized singlecenter trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study. J Vasc Interv Radiol 21:186–194
Thomsen HS (2006) European Society of Urogenital Radiology (ESUR) guidelines on the safe use of iodinated contrast media. Eur J Radiol 60:307–313
Grassl ED, Bischof JC (2005) In vitro model systems for evaluation of smooth muscle cell response to cryoplasty. Cryobiology 50:162–173
Bennett MR (1999) Apoptosis of vascular smooth muscle cells in vascular remodelling and atherosclerotic plaque rupture. Cardiovasc Res 41:361–368
Tatsutani KN, Joye JD, Virmani R et al (2005) In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in response to hypothermia and freezing. Cryo Lett 26:55–64
Selvin E, Marinopoulos S, Berkenblit G et al (2004) Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 141:421–431
Muntner P, Wildman RP, Reynolds K et al (2005) Relationship between HbA1c level and peripheral arterial disease. Diabetes Care 28:1981–1987
Norgren L, Hiatt WR, Dormandy JA et al (2007) Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg 33(Suppl 1):S1–S75
Armstrong DG, Lavery LA (1998) Diabetic foot ulcers: prevention, diagnosis and classification. Am Fam Physician 57:1325–1332
Cotroneo AR, Pascali D, Santoro M et al (2008) Endovascular treatment of femoropopliteal steno-obstructive disease with percutaneous transluminal angioplasty: midterm results. Radiol Med 113:1043–1055
Samson RH, Showalter DP, Lepore MRJr (2006) Cryoplasty therapy of the superficial femoral and popliteal arteries: a single center experience. Vasc Endovascular Surg 40:446–450
Samson RH, Showalter DP, Lepore MJr (2008) Cryoplasty therapy of the superficial femoral and popliteal arteries: a reappraisal after 44 months’ experience. J Vasc Surg 48:634–637
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Fossaceca, R., Guzzardi, G., Di Terlizzi, M. et al. Comparison of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients: immediate, mid-term and long-term results. Radiol med 117, 1176–1189 (2012). https://doi.org/10.1007/s11547-012-0793-7
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DOI: https://doi.org/10.1007/s11547-012-0793-7