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Drug-eluting stents, bare-metal stents, or balloon-only angioplasty for below-the-knee disease

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

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  1. 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

  2. Learning goals • Scope of the problem • Systematic review • Case study • Take home messages

  3. 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

  4. Scope of the problem - II

  5. Scope of the problem - III

  6. TASC II 2007 vs. TASC 2000

  7. Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues

  8. Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues BMS

  9. Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues DES

  10. Why stents? • Balloon-only angioplasty is fraught with: • Elastic recoil • Flow-limiting dissection • Constrictive remodeling • Neointimal hyperplasia • Biocompatibility • Stents may address these issues ABS

  11. 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)

  12. 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

  13. The RESILIENT II trial: LifeStent12-month results after SFA stenting Laird et al, CirculationIntevention 2010

  14. The PaRADISE trial Feiring et al, J Am CollCardiol 2010

  15. 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

  16. The PaRADISE trial Feiring et al, J Am CollCardiol 2010

  17. 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

  18. Learning goals • Scope of the problem • Systematic review • Case study • Take home messages

  19. Systematic review of BTK stenting Biondi-Zoccai et al, J EndovascTher 2009

  20. 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

  21. Included studies Biondi-Zoccai et al, J EndovascTher 2009

  22. 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

  23. 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

  24. Detailed outcomes Biondi-Zoccai et al, J EndovascTher 2009

  25. Repeat PTA after BTK stenting Biondi-Zoccai et al, J EndovascTher 2009

  26. Learning goals • Scope of the problem • Systematic review • Case study • Take home messages

  27. 68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: ANTEGRADE PUNCTURE COMMON FEMORAL PROFUNDA FEMORAL SUPERFICIAL FEMORAL

  28. 68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: POPLITEAL AND TIBIAL DISEASE POPLITEAL POSTERIOR TIBIAL? ANTERIOR TIBIAL? ANTERIOR TIBIAL POSTERIOR TIBIAL? PERONEAL PERONEAL

  29. 68-YEAR-OLD MAN WITH LEFT 5TH TOE GANGRENE: FOOT DISEASE PERONEAL POSTERIOR TIBIAL ANTERIOR TIBIAL

  30. STEP 1: SUBINTIMAL ANGIOPLASTY LEADING TO EXTENSIVE DISSECTION COVERING POSTERIOR TIBIAL ARTERY OSTIUM POPLITEAL ANTERIOR TIBIAL POSTERIOR TIBIAL? PERONEAL

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. Learning goals • Scope of the problem • Systematic review • Case study • Take home messages

  37. 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

  38. ThankyouforyourattentionForanycorrespondence: gbiondizoccai@gmail.comForthese and furtherslides on thesetopicsfeel free tovisit the metcardio.org website:http://www.metcardio.org/slides.html

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