Infrapopliteal Sirolimus-Eluting Versus Bare Metal Stents for Critical Limb Ischemia: Long-Term Angiographic and Clinical Outcome in >100 Patients Dimitris Karnabatidis, MD Ass. Prof. of Interventional Radiology Department of Diagnostic and Interventional Radiology Patras University Hospital, Rion, Greece Head: Prof. Dimitris Siablis

Critical Limb Ischemia (CLI) CLI: “chronic ischemic rest pain requiring regular analgesia or non-healing ulcers, or gangrene attributable to objectively proven arterial occlusive disease” Estimated incidence = /1,000,000 population per annum ≈ 45% cardiovascular disease mortality rate at 5 years Up to 25% amputation rate despite revascularization attempts Recommendation 73 (TASC SVS 2000) Dormandy JA et al, Saunders, 1998:11-26 Soder HK et al, J Vasc Interv Radiol 2000;11:

CLI Epidemic  Costs $10-20 billion/year in the US  amputations/year in the US - EU  Someone, somewhere loses a leg due to DIABETES every 30 sec

Leg Amputations

Surgical Options To date, surgical bypass has been the mainstream therapy for infrapopliteal occlusive disease CLI patients are high-risk surgical candidates with multiple co-morbidities (diabetes mellitus, coronary disease, ischemic nephropathy e.t.c.) 30-50% of CLI patients are not suitable candidates for bypass surgery Peri-operative mortality rate between 1.8 to 6% Siablis D et al. J Endovasc Ther 2005Tsetis D et al, Br J Radiol 2004

Interventional Radiology  Low-profile interventional instruments  Expanding worldwide endovascular experience  Reduced peri-interventional morbidity and mortality rates  Shorter procedural time periods  Does not preclude surgical options  First-line therapy of critical leg ischemia Siablis D et al. J Endovasc Ther 2005Tsetis D et al, Br J Radiol 2004 Soder HK et al, J Vasc Interv Radiol 2000Kandarpa K et al, J Vasc Interv Radiol 2001

 Suboptimal angioplasty outcome is a well recognized adverse predictor of vessel patency  Balloon angioplasty & bare metal stents: almost equivalent results in the BTK arena  Re-obstruction rate of 41-66% at 1 year according to prospective angiographic studies  Vigorous clinical surveillance is required and frequent re-do procedures Endovascular points Siablis D et al. J Endovasc Ther 2007Feiring AJ et al. JACC 2004 Rand T et al. Cardiovasc Interv Radiol 2006

Sirolimus-eluting stents 2 controlled trials and 2 cohort studies Significant inhibition of in-stent restenosis Significant reduction of re-do angioplasty procedures Drug-eluting Stents: BTK Evidence Bosiers M, et al. J Cardiovasc Surg (Torino) 2006 Commeau P, et al. Catheter Cardiovasc Interv 2006 Siablis D, et al. J Endovasc Ther 2007 Siablis D, et al. J Endovasc Ther 2005 Scheinert D, et al. Eurointervention 2006

Interim published results

Siablis D, Karnabatidis D, Katsanos K, et al. Under peer review 2008

p=0.205, log rank testp=0.507, log rank test Siablis D, Karnabatidis D, Katsanos K, et al. Under peer review 2008 Patient survival & limb salvage

Angiographic results: Primary patency Cox proportional hazards regression analysis HR: 4.8, CI: , p<0.001 Siablis D, Karnabatidis D, Katsanos K, et al. Under peer review 2008 x5

Siablis D, Karnabatidis D, Katsanos K, et al. Under peer review 2008 HR: 0.38, CI: , p<0.001 Angiographic results In-stent restenosis Cox proportional hazards regression analysis x0.4

Siablis D, Karnabatidis D, Katsanos K, et al. Under peer review 2008 HR: 2.5, CI: , p=0.006 Re-do procedures Cox proportional hazards regression analysis x2.5

BaselineImmediate2-year

Conclusions Compared to bare metal stents, application of sirolimus-eluting stents in below-the-knee arteries significantly inhibits restenosis, improves long-term angiographic patency and reduces the need for repeat procedures due to clinical relapse

The Amputation, Thomas Rowlandson ( )