Brandon M Jones MD Interventional Cardiology Providence Heart and Vascular Institute Portland Oregon Disclosures None Case 60 yo M with ho HTN HLD and Type 2 Diabetes Right heel ulcer has now been present for 1 year ID: 1039551
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1. Should I Use a DCB (Drug Coated Balloon) Here?Brandon M. Jones, MDInterventional CardiologyProvidence Heart and Vascular InstitutePortland, Oregon
2. DisclosuresNone
3. Case:60 y/o M with h/o HTN, HLD, and Type 2 Diabetes.Right heel ulcer has now been present for ~1 year.ABI 6 months ago were non-compressible, TBI 0.6.Vascular surgery had initially advised conservative therapy.Now referred to Vascular Medicine by Podiatry.Duplex ultrasound shows the following:50-74% stenosis right mid superficial femoral artery (SFA)>75% stenosis right mid poplitealDiffuse tibial disease
4. Artifact from Hip ProsthesisModerate Iliac Disease~60% Mid SFA~80% Mid PoplitealOccluded Posterior TibialPeroneal is the single Vessel to the ankle but does not reach the footOccluded Anterior Tibial
5. How to Approach?Balloon Angioplasty alone: Plagued by high rates of restenosis or re-occlusion.Atherectomy: Good for plaque modification or debulking.Stents (bare metal, interwoven, covered, or drug eluting).Lithotripsy.Drug Coated Balloons.
6. What is a Drug Coated Balloon?A balloon coated with Paclitaxal (an agent that prevents cell growth) that is bound to a delivery molecule (excipient). When inflated, the drug molecule is taken up into the vessel wall and delivers anti-proliferative therapy for a prolonged period of time.Lutonix (BD): Polysorbate and sorbitol with 2 μg/mm2 paclitaxel.IN.PACT (Medtronic): Urea with 3.5 μg/mm2 paclitaxelStellarex (Phillips): Polyethylene glycol with 2 µg/mm2 paclitaxel.Ranger (Boston Scientific) investigational, not FDA approved
7. Potential Benefits of DCBSimplify treatment of restenotic lesions (no stent/scaffolding to prevent endovascular or surgical approaches).No risk of stent fracture (especially concerning at areas of flexion (CFA or popliteal).
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9. IN.PACT-SFADCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001)
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11. Ranger II SFAPresented at VIVA 2019.Primary patency vs. PTA at 12 months: 89.2% vs. 72.9% P = 0.0022
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13. PlanTreat the SFA and popliteal with DCBs.PTA of the AT and PT.Conservative treatment of the moderate iliac disease.
14. 1 month later:
15. But 2 months after that:Wounds healing has stalled. Pulses diminished. New ulcer on the right great toe.SFA and popliteal are still widely patent, no restenosis.The proximal AT has re-narrowed but is patent.The PT has re-occludedPTAT
16. Re-treatment?4mm DCBs in both the AT and PT
17. Below Knee Disease?
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19. Lutonix BTKInitially showed benefit at 6 months in freedom from composite endpoint of above-ankle amputation, target-lesion occlusion, and clinically driven target lesion revascularization (85.8% vs. 71.4%, p<0.001).1-year data showed no difference in composite endpoint (60.3% vs. 60.9%, p = 0.54) and no difference in wound healing.
20. Below the Knee?Reasonable to consider in lesions that have failed primary PTA or wound healing.Illuminate BTK (Stellarex) trial underway.
21. Off Label: 74F severe buttock claudication, left internal iliac occluded.Severe ISR External Iliac90% Internal IliacLesion Won’t YieldTreated both with 6mm Shockwave Balloon followed by 6mm Inpact DCBs
22. Other Uses:Small series published for use in Common Femoral Artery.Coronary artery applications for treating in-stent restenosis (under investigation in the US).IN.PACT DCB FDA approved for treating failed AV access for dialysis patients.
23. The ControversyDecember, 2018: Meta-analysis, Katsanos et al. JAHA. Increased all-cause mortality at 2 years for patients treated with paclitaxel vs. balloon angioplasty alone.January, 2019: FDA releases a warning letter in response.June, 2019: FDA Advisory Committee determined a late mortality signal was present, recommended additional clinical study, and supported continued use with increased focus on shared decision making with patients during the informed consent process.The topic remains controversial.
24. Thank Youbrandon.jones@providence.org