Leave No Stent Behind

Abstract

E ndovascular 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][4][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 alDCBs 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 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 study sponsor and subjects remained blinded for 1 year, whereas the clinical events committee and the core laboratories remained blinded for 3 years. In this issue of Circulation: Cardiovascular Interventions, the investigators report the 3-year results of the study.9 Primary patency adjudicated by duplex Doppler ultrasound was superior in the DCB group (69.5%) compared with the PTA group (45.1%). It is notable that there has been a loss of primary patency from 1 (82%) to 2 years (78%) and now to 3 years. 7-9 Over 3 years, primary patency rates after PTA hovered around 50% suggesting that after the first year, PTA patients that remained patent had a similar trajectory when compared with the DCB group. Similarly, 85% of patients in the DCB group remained free from clinically driven target lesion revascularization (TLR) at 3 years compared with 69% in the PTA group. Again, this difference seems to occur in the first 6 months to 1 year and remains sustained out to 3 years. There is no late catch-up effect. Observations from preclinical models indicate that paclitaxel remains resident in the artery for up to 180 days after the index procedure, providing a plausible mechanistic explanation for why the peak biological benefits of DCBs occur in the first 6 months. 10Despite the clear sustained improvement in primary patency and a decrease ...