Objective To investigate the effects of antithrombotic therapy on target lesion revascularisation (TLR) and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months after femoropopliteal intervention with second-generation bare metal nitinol stents. Methods A total of 277 lesions in 258 limbs of 248 patients with de novo atherosclerosis in the above-the-knee femoropopliteal segment were analysed from the Japan multicentre postmarketing surveillance. Results At discharge, dual antiplatelet therapy (DAPT) was prescribed in 68.5% and cilostazol in 30.2% of patients. At 12 months of follow-up, prescriptions of DAPT significantly (p=0.0001) decreased to 51.2% and prescription of cilostazol remained unchanged (p=0.592) at 28.0%. Prescription of warfarin also remained unchanged (14.5% at discharge, 13.3% at 12 months, p=0.70). At 12 months, freedoms from TLR and MACCE were 89.4% and 89.7%, respectively. In a multivariate Cox proportional hazards model, neither DAPT nor cilostazol at discharge was associated with both TLR and MACCE at 12 months. However, warfarin at discharge was only independently associated with TLR at 12 months. Kaplan-Meier estimates demonstrated that warfarin at discharge yielded a significantly (p=0.013) lower freedom from TLR at 12 months than no warfarin at discharge. Freedom from TLR at 12 months by the Kaplan-Meier estimates was 77.8% (95% CI 59.0% to 88.8%) in patients with warfarin at discharge and 91.2% (95% CI 86.3% to 94.3%) in those without warfarin at discharge. Conclusions Clinical benefits of DAPT or cilostazol might be small in terms of TLR and MACCE at 12 months. Anticoagulation with warfarin at discharge might increase TLR at 12 months.
- femoropopliteal artery disease
- medical treatment
- peripheral artery disease