Infrapopliteal Sirolimus-Eluting Infrapopliteal Sirolimus-Eluting Versus Bare Metal Stents for Critical Versus Bare Metal Stents for Critical

Limb Ischemia:Limb Ischemia:Long-Term Angiographic and Clinical Long-Term Angiographic and Clinical

Outcome in >100 PatientsOutcome in >100 Patients

Dimitris Karnabatidis, MDDimitris Karnabatidis, MDAss. Prof. of Interventional Radiology

Department of Diagnostic and Interventional RadiologyPatras University Hospital, Rion, Greece

Head: Prof. Dimitris SiablisHead: Prof. Dimitris Siablis

Critical Limb Ischemia Critical Limb Ischemia (CLI)(CLI)

CLI: “chronic ischemic rest pain requiring regular analgesia or non-healing ulcers, or gangrene attributable to objectively proven arterial occlusive disease”

Estimated incidence = 400-1000/1,000,000 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, 1998:11-26Soder HK et al, J Vasc Interv Radiol 2000;11:1021-1031

CLI EpidemicCLI Epidemic

Costs $10-20 billion/year in the US

220000-240000 amputations/year in the US - EU

Someone, somewhere loses a leg due to DIABETES every 30 sec

www.cxvascular.com

www.ILEGX.com

Leg AmputationsLeg Amputations

Surgical OptionsSurgical 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 2005 Tsetis D et al, Br J Radiol 2004

Interventional RadiologyInterventional 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 2005 Tsetis D et al, Br J Radiol 2004Soder HK et al, J Vasc Interv Radiol 2000 Kandarpa 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 pointsEndovascular points

Siablis D et al. J Endovasc Ther 2007 Feiring AJ et al. JACC 2004Rand 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:Drug-eluting Stents: BTK Evidence BTK Evidence

Bosiers M, et al. J Cardiovasc Surg (Torino) 2006Commeau P, et al. Catheter Cardiovasc Interv 2006

Siablis D, et al. J Endovasc Ther 2007

Siablis D, et al. J Endovasc Ther 2005Scheinert D, et al. Eurointervention 2006

Interim published resultsInterim published results

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

p=0.205, log rank test p=0.507, log rank test

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

Patient survival &Patient survival &limb salvagelimb salvage

Angiographic results: Angiographic results: Primary patencyPrimary patency

Cox proportional hazards regression analysisCox proportional hazards regression analysis

HR: 4.8, CI: 2.9-7.9, 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: 0.25-0.58, p<0.001

Angiographic resultsAngiographic resultsIn-stent restenosisIn-stent restenosis

Cox proportional hazards regression analysisCox proportional hazards regression analysis

x0.4

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

HR: 2.5, CI: 1.3-5.0, p=0.006

Re-do proceduresRe-do proceduresCox proportional hazards regression analysisCox proportional hazards regression analysis

x2.5

Baseline Immediate 2-year

ConclusionsConclusions

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 (1756-1827)