Purpose: To investigate the safety and efficacy of ticagrelor in patients with critical limb ischemia (CLI) and high on-clopidogrel platelet reactivity (HCPR) undergoing complex, limb-salvage, peripheral endovascular procedures (PEP).
Materials and methods: The study included consecutive patients with HCPR undergoing PEP for CLI. HCPR was defined as platelet reaction units (PRU) >234 as assessed by the VerifyNow P2Y12 assay. Patients with HCPR were prescribed ticagrelor, 180/90 mg twice daily, and aspirin, 100 mg daily, for 6 months and ticagrelor, 180/90 mg twice daily, thereafter. Primary safety outcome was total major bleeding, and primary efficacy outcome was the composite of cardiovascular death and major amputation. Secondary outcomes included the level of platelet inhibition achieved and target limb revascularization (TLR)-free survival rate.
Results: In total, 37 CLI patients with 40 limbs were investigated. Mean follow-up period was 11.3 ± 5.0 months (range 6-21). The mean treated lesion length was 229.2 ± 71.4 mm in the femoropopliteal axis and 179.3 ± 83.9 mm in the infrapopliteal arteries. No major or minor bleeding was detected. There were four periprocedural minor adverse events (10.8%), and in two cases (5.6%) ticagrelor was discontinued. In all patients, ticagrelor achieved platelet inhibition lower than the cut-off value. Mean PRU during clopidogrel therapy was 308.4 ± 41.8 (range 257-422) versus 67.0 ± 52.8 (range 2-189) when switched to ticagrelor; p < 0.0001. Kaplan-Meier estimated primary efficacy outcome and TLR-free survival rates were 92.0 and 67.3% at 12 months, respectively.
Conclusion: In this series of CLI patients with HCPR undergoing complex PEP, initial experience with ticagrelor was proven safe and efficient because it resulted in sufficient platelet inhibition and satisfactory clinical results without major complications.