P2771Effects of ticagrelor vs. clopidogrel on neointimal proliferation in paclitaxel-eluting stents implanted in the femoropopliteal district: a randomized pilot study using optical coherence tomography

Abstract

Background/Introduction: The optimal antithrombotic regimen for management of patients with peripheral artery disease after revascularization is poorly defined especially in the current era of invasive treatment approaches with advanced techniques and availability of more intensive antiplatelet agents with pleiotropic effects such as Ticagrelor. Purpose: To evaluate, in a nested, single‐blind, single‐center, prospective, randomized study, the effects of Ticagrelor as compared to Clopidogrel on neointimal proliferation assessed by frequency‐domain optical coherence tomography (FD‐OCT) in patients with symptomatic femoropopliteal disease treated with angioplasty (PTA) and implantation of paclitaxel‐eluting stent (PES). Methods: Forty patients treated with PTA and PES of the femoropopliteal district were randomized in a 1:1 manner to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing T alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing C alone for 9 months. At 12 months control angiography and FD‐OCT along the entire stented segment were performed. Evaluation of the effectiveness of the P2Y12 receptor inhibition by the VerifyNow system was performed before procedure and at follow‐up. The primary endpoint was the net percentage volume obstruction as assessed by FD‐OCT; co‐primary endpoint was the percentage of uncovered stent struts. Results: The median age of the patients was 72±19 years, and 65% were men and 55% had a critical limb ischemia. During the follow‐up 3 patients died (1 in T group and 2 in C group), 4 had early in‐stent restenosis (1 in T group and 3 in C group), and 5 patients refused to perform repeat angiography (3 in T group and 2 in C group). Of the remaining 28 patients who performed control angiography, FD‐OCT was not suitable for analysis in 2 patients. Overall there was an impressive high number of uncovered stent struts (20%±26%). No significant difference between T and C groups was found as concerning the net percentage volume obstruction [29.7%±17.6% vs 31.2%±10.7% (p=0.78)] and the percentage of uncovered stent struts [24.2%±32.8% vs 15.3%±15.8%; (p=0.4)]. A significant different platelet reactivity (PR) was found between the 2 groups (PR Units: 81±72 in the T group vs 200±61 in the C group (p<0.001). Conclusion(s): A large amount of uncovered stent struts at 12 month follow‐up was found in patients treated with PES in the femoropopliteal district regardless of the antiplatelet treatment assumed. Ticagrelor does not reduce neointimal proliferation in these patient. These findings highlight the need for future studies to better understand the optimal antiplatelet medication regimen after revascularization for PAD.