Leave No Stent Behind
Are Drug-Coated Balloons Enough for Femoropopliteal Disease?
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Endovascular revascularization is recommended for patients who fail medical and exercise therapy for lifestyle-limiting claudication secondary to peripheral arterial disease.1 The cornerstone of endovascular intervention has been percutaneous transluminal angioplasty (PTA) since the advent of the procedure over 50 years ago.2 However, restenosis rates for PTA in the femoropopliteal circulation remain up to 50% at 2 years, resulting in the development of alternate techniques to improve postintervention patency.3,4 Stenting with nitinol self-expanding stents and drug-eluting nitinol self-expanding stents has reduced restenosis in the femoropopliteal artery compared with PTA; however, long-term patency even with stents remains suboptimal.3–5 In theory, stents may not maintain long-term patency because of the mechanical strain exerted from torsion, flexion, and extension of the femoropopliteal artery. Consequently, enormous resources have been devoted to the development of drug-coated balloons (DCBs) which deliver an antiproliferative drug to mitigate neointimal hyperplasia after PTA while also avoiding the continuous hazard of a chronic indwelling metallic endoprosthesis.
See Article by Schneider et al
DCBs which deliver paclitaxel have now been studied for over a decade as one potential option of facilitating antirestenotic drug delivery while avoiding the implantation of a stent.6 To date, long-term data on patency after DCB angioplasty have been lacking. The IN.PACT SFA trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) randomized 331 patients in a 2:1 fashion to DCB versus standard PTA.7,8 The patient demographics were consistent with other studies with an average age of 68 years, 65% men and 45% with diabetes mellitus. The average lesion length was just under 9 cm with almost 60% of the lesions calcified. The …