At the recent VEITHsymposium, New York, Dr Koen Deloose, Belgium, presented the 12-month results from the MELOPEE trial, a European, prospective, multi-centre study that aimed to evaluate clinical performance and primary patency of the LifeStent (Bard) in symptomatic lesions of the popliteal artery.
According to Deloose, the main inclusion criteria involved 64 patients with stenotic (>50%) or occlusive atherosclerotic disease of the popliteal artery, lesions <15cm in length, and at least a single vessel run-off until the ankle. Patients were at least 50 years in age, with life-altering claudication or critical limb ischaemia (CLI). Clinical evaluations and Rutherford categorisation occurred at 30 days, six and 12 months, as did colour flow duplex ultrasound (CFDU) evaluations, and X-rays occurred at six months.
The primary endpoints of the study were performance and safety. For performance, 12-month patency was defined as the absence of: any reintervention to restore blood flow; amputation due to restenosis or occlusion; conversion to bypass surgery to restore blood flow; and untreated significant restenosis/occlusion on duplex. Safety included death or major amputations at 30 days.
The study’s secondary endpoints were procedure angiographic success, periprocedural complications at one and 30 days, Rutherford evolution, limb-salvage rate, and survival rate.
It was noted that 22 of the 64 patients (34.4%) had diabetes. Forty-seven (73.4%) had arterial hypertension, 32 (50%) had hypercholesterolemia, 25 (39.1%) were nicotine dependent, and 7 (10.9%) suffered from coronary artery disease. It is also noteworthy that 40.7% of the included patients were critical limb ischaemia-patients.
According to Deloose, “The immediate procedural success rate was 100% and the post-procedural stenosis was 5.6%. There was one distal embolization and one acute thrombosis, both successfully treated in an endovascular way.” He added that at 12 months, primary patency was achieved in 70.2% of patients. The limb salvage rate was 96.9% and survival was 87.4%. The Rutherford distribution is shown in Figure 1.
Deloose reported that X-ray sub-study (at six months) results revealed that there was no fracture observed in 84.2% of patients (n=19). A mild fracture was observed in 5.3% and a moderate fracture was seen in 10.5% of subjects.
In his concluding remarks, Deloose said that the 12-month patency of 70% in a popliteal segment was “very promising”. He also stated that the triple helical structure of the LifeStent “proves to be fracture resistant in a challenging anatomy, although we need more data to determine superiority”.