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Drug-eluting stents, bare-metal stents, or balloon-only angioplasty for below-the-knee disease. Giuseppe Biondi Zoccai Division of Cardiology, University of Turin, Turin, Italy. Learning goals. Scope of the problem Systematic review Case study Take home messages. Scope of the problem.
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Drug-eluting stents, bare-metal stents, or balloon-only angioplasty for below-the-knee disease Giuseppe Biondi Zoccai Division of Cardiology, University of Turin, Turin, Italy
Learning goals • Scope of the problem • Systematic review • Case study • Take home messages
Scope of the problem ASYMPTOMATIC ATHEROSCLEROSIS: 3-15% PREVALENCE <2% AMPUTATION RISK AT 5 YEARS CLAUDICATION: 1-6% PREVALENCE <5% AMPUTATION RISK AT 5 YEARS CHRONIC CRITICAL LIMB ISCHEMIA: <0.5% PREVALENCE 10-20% AMPUTATION RISK AT 5 YEARS ACUTE LIMB ISCHEMIA: <0.1% PREVALENCE >50% AMPUTATION RISK AT 5 YEARS Biondi Zoccai et al, G ItalCardiol 2009
Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues
Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues BMS
Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues DES
Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues ABS
Explosion of data on stents for PAD PubMed queried on 16 June 2010: stent* AND (femoral OR popliteal OR femoropopliteal OR "femoro-popliteal" OR tibial OR "infra-popliteal" OR infrapopliteal OR (critical AND limb AND ischemia)) NOT (vein OR venous)
Iliac stenting: just in bail-out? DutchIliacStent Trial: randomized trial of stenting vs balloon-only PTA (withstentifcomplications or meangradient >10 mm Hg)* *stentingfinallyperformed in 40% ofptsrandomizedto PTA Routine stenting PTA with selective stenting Klein et al, Radiology 2006
The RESILIENT II trial: LifeStent12-month results after SFA stenting Laird et al, CirculationIntevention 2010
The PaRADISE trial Feiring et al, J Am CollCardiol 2010
The PaRADISE trial FIRST TRIAL EVER TO EMPLOY PRIMARY (I.E. DEFAULT) DRUG-ELUTING STENTING FOR BTK DISEASE Feiring et al, J Am CollCardiol 2010
The PaRADISE trial Feiring et al, J Am CollCardiol 2010
What about absorbable stents? 6-month angiographic patency rate: 31.8% for AMS vs. 58.0% for PTA (p=0.013) Bosiers et al, CardiovascInterventRadiol 2009
Learning goals • Scope of the problem • Systematic review • Case study • Take home messages
Systematic review of BTK stenting Biondi-Zoccai et al, J EndovascTher 2009
Background and Methods • The purpose of this work was to perform a systematic review of the literature published on the outcomes of stenting for below-the-knee (BTK) disease in patients with critical limb ischemia (CLI). • Potentially relevant studies of stent implantation in the infragenicular arteries in >5 patients with >1-month follow-up were systematically sought. Data were abstracted and pooled with a random-effect model to generate risk estimates with 95% confidence intervals (CI). Biondi-Zoccai et al, J EndovascTher 2009
Included studies Biondi-Zoccai et al, J EndovascTher 2009
Results • Eighteen nonrandomized studies were retrieved (640 pts). • After 12 months, binary restenosis occurred in 25.7% (95% CI 11.6% to 40.0%) and primary patency in 78.9% (95% CI 71.8% to 86.0%). • Accordingly, improvement in Rutherford class occcurred in 91.3% (95% CI 85.5% to 97.1%), with TVR in 10.1% (95% CI 6.2% to 13.9%), and limb salvage in 96.4% (95% CI 94.7% to 98.1%). Biondi-Zoccai et al, J EndovascTher 2009
Results (continued) • Head-to-head comparisons showed that sirolimus-eluting stents were superior to balloon-expandable bare metal stents in preventing restenosis and increasing primary patency (both p<0.001). • Sirolimus-eluting stents were also better than paclitaxel-eluting stents in terms of primary patency (p<0.001) and repeat revascularizations (p=0.014). Biondi-Zoccai et al, J EndovascTher 2009
Detailed outcomes Biondi-Zoccai et al, J EndovascTher 2009
Repeat PTA after BTK stenting Biondi-Zoccai et al, J EndovascTher 2009
Learning goals • Scope of the problem • Systematic review • Case study • Take home messages
68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: ANTEGRADE PUNCTURE COMMON FEMORAL PROFUNDA FEMORAL SUPERFICIAL FEMORAL
68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: POPLITEAL AND TIBIAL DISEASE POPLITEAL POSTERIOR TIBIAL? ANTERIOR TIBIAL? ANTERIOR TIBIAL POSTERIOR TIBIAL? PERONEAL PERONEAL
68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: FOOT DISEASE PERONEAL POSTERIOR TIBIAL ANTERIOR TIBIAL
STEP 1: SUBINTIMAL ANGIOPLASTY LEADING TO EXTENSIVE DISSECTION COVERING POSTERIOR TIBIAL ARTERY OSTIUM POPLITEAL ANTERIOR TIBIAL POSTERIOR TIBIAL? PERONEAL
STEP 2: POSTERIOR TIBIAL ARTERY ACCESS TO GAID RETROGRADE ACCESS AND INTRALUMINAL RE-ENTRY IN THE POPLITEAL POSTERIOR TIBIAL POSTERIOR TIBIAL 19G NEEDLE V18 0.018” WIRE
STEP 3: RESIDUAL DISSECTIONS AFTER EXTENSIVE BALLOON-ONLY ANGIOPLASTY WITH 2.5 TO 5.0 MM BALLOONS AT 14 ATM POPLITEAL POSTERIOR TIBIAL PERONEAL POSTERIOR TIBIAL PLANTAR
STEP 3: RESIDUAL DISSECTIONS AFTER EXTENSIVE BALLOON-ONLY ANGIOPLASTY WITH 2.5 TO 5.0 MM BALLOONS AT 14 ATM POPLITEAL POSTERIOR TIBIAL WOULD YOU IMPLANT ANY STENT? PERONEAL POSTERIOR TIBIAL PLANTAR
STEP 3: RESIDUAL DISSECTIONS AFTER EXTENSIVE BALLOON-ONLY ANGIOPLASTY WITH 2.5 TO 5.0 MM BALLOONS AT 14 ATM POPLITEAL POSTERIOR TIBIAL WOULD YOU IMPLANT ANY STENT? IF SO, WHICH TYPE, SIZE AND HOW MANY? PERONEAL POSTERIOR TIBIAL PLANTAR
STEP 3: RESIDUAL DISSECTIONS AFTER EXTENSIVE BALLOON-ONLY ANGIOPLASTY WITH 2.5 TO 5.0 MM BALLOONS AT 14 ATM POPLITEAL POSTERIOR TIBIAL NO STENT WAS ACTUALLY IMPLANTED IN THIS PATIENT, GIVEN LIMITATIONS IN DESIGN OF CURRENTLY AVAILABLE STENTS (SHORT LENGTH, LOW FLEXIBILITY, UNTAPERED DESIGN) NONETHELESS, HE REMAINED FREE OF MAJOR AMPUTATION AND REPEAT REVASCULARIZATION UP TO 8 MONTHS AFTER PTA PERONEAL POSTERIOR TIBIAL PLANTAR
Learning goals • Scope of the problem • Systematic review • Case study • Take home messages
Take home messages • BTK implantation of bare-metal stents should be reserved to patients intolerant to clopidogrel, as restenosis rates are similar to those of balloon-only angioplasty • Conversely, bail-out drug-eluting stenting is beneficial for infra-popliteal lesions, but drawbacks in design of current stents limit their suitability for BTK disease • Primary (i.e. default) drug-eluting stent implantation in BTK lesions has been recently proposed, but further studies are needed to confirm this approach
ThankyouforyourattentionForanycorrespondence: gbiondizoccai@gmail.comForthese and furtherslides on thesetopicsfeel free tovisit the metcardio.org website:http://www.metcardio.org/slides.html