Ticagrelor versus clopidogrel in patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district: A randomized pilot study using frequency-domain optical coherence tomography.

Objectives: Aim of this study was to evaluate different response in platelet reactivity and vessel healing using high-resolution frequency-domain optical coherence tomography (FD-OCT) in patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES), and randomly assigned to clopidogrel or ticagrelor for 12 months.

Background: The optimal antithrombotic regimen for long-term management of patients with peripheral artery disease (PAD) after revascularization is poorly defined and often extrapolated from trials performed on patients undergoing percutaneous coronary intervention.

Methods: In this single center randomized trial 40 patients with femoropopliteal artery disease treated with ZILVER PTX DES stents, were randomized to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing Ticagrelor alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing Clopidogrel alone for 9 months. Platelet reactivity via the P2Y12 pathway was evaluated at baseline and at 3 months follow-up, angiographic and FD-OCT follow-up along the entire stented segment was performed at 12 months.

Results: No significant difference between T and C group was found concerning net percentage volume obstruction (29.7% ± 17.6% vs. 31.2% ± 10.7%; p = 0.78). FD-OCT at 12 months showed a high percentage of uncovered stent struts in both groups: 24.2% ± 32.8% in the T group vs 15.3% ± 15.8% in the C group (p = 0.4). Mean values of platelet reactivity units (PRU) at 3 month follow-up were 81 ± 72 in the T group and 200 ± 61 in the C group (p < 0.001).

Conclusions: Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation. Ticagrelor does not reduce neointimal proliferation in patients treated with DES in the femoropopliteal district as compared with clopidogrel. A large amount of uncovered stent struts at 12-month follow-up was found in these patients regardless of the antiplatelet treatment assumed.