infrapopliteal sirolimus-eluting versus bare metal stents for critical limb ischemia: long-term...
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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
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
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
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