Preliminary results at six-month follow-up, presented by Marc Bosiers at the VEITHsymposium showed that drug-eluting stents had a higher primary patency rate in below-the-knee critical limb ischaemia lesions in comparison with bare metal stents
The question now is whether the awaited 12-month angiographic results will confirm the benefits of drug-eluting stents or there will be a setback as seen in the STRIDES and SIROCCOtrials for the superficial femoral artery
The preliminary, six-month results of the DESTINY trial indicate a trend in favour of drug-eluting stents for treatment of short, below-the-knee lesions.
Marc Bosiers, Dendermonde, Belgium, who presented the data at the VEITHsymposium, New York, USA, told delegates that the investigators were awaiting the final 12-month angiographic results, but at six months with duplex scanning, drug-eluting stents had a primary patency of 92.4% vs. bare metal stents which had a 78.1% primary patency. “This difference also needs to be higher in order to justify the high price for drug-eluting stents,” he added.
The DESTINY (Drug-eluting stents in the critically ischaemic lower leg) trial is a physician-initiated prospective, randomised, multicentre trial comparing the implant of a drug-eluting stent (Xience V, Abbott Vascular) vs. a bare metal stent (Multilink Vision, Abbott Vascular) in the critically ischaemic lower leg.
The study was designed to include critical limb ischaemia patients with lesions classified as category Rutherford four or five. Patients who had lesion lengths less than or equal to 40mm were included. Also, patients with a maximum of two below-the-knee stenoses greater than 50% were included, and the study restricted the number of stents to two per patient.
Bosiers said, “The primary endpoint is primary patency at 12 months, defined as no binary in-stent restenosis (>50%) and no target lesion revascularisation performed within 12 months.”
With the 140 patients included in total, 66 were randomised to the bare metal stent group and 74 to the drug-eluting stent group. Sixty seven per cent of the group receiving bare metal stents, and 61% of patients receiving the drug-eluting stents were male. The two groups were similar in terms of mean age.
“For proximal lesions, the six-month primary patency was 92.2% for drug-eluting stents, vs.77.9% for bare metal stents. For more distal lesions, primary patency at six months was 92.9% with drug-eluting stents and 80% for bare metal stents. Also, six-month limb salvage for patients in the drug-eluting stents group was 100%, while it was 97.8% for the bare metal stent group,” Bosiers told delegates.
“Of course, we need to obtain the 12-month results with angiogram, before we draw any firm conclusions,” added Bosiers.