Three trials presented recently have found that drug-eluting stents score over angioplasty, or bare metal stents, in the periphery. ACHILLES has shown better primary patency for Cordis’ Cypher stent in the infrapopliteal region over angioplasty, YUKON has shown a similar benefit for Translumina’s Yukon BTX stent below the knee over a bare metal stent, and Abbott Vascular has used the results of the DESTINY trial to obtain the CE mark for Xience V. Interventional News does a round-up.
Angiographic 12-month results with Cordis’ sirolimus-eluting stent are “very promising and have the potential to be considered a first-line therapy option for suitable infrapopliteal lesions.” Investigators say that Cypher Select is also suitable for use in diabetic patients.
ACHILLES is the first multicentre, randomised comparison of Cordis’ sirolimus-eluting stent to angioplasty in patients with claudication and critical limb ischaemia. The results were presented by Dierk Scheinert, Leipzig, Germany at the annual LINC meeting.
The 200-patient study compared the performance of the Cypher Select Plus sirolimus-eluting stent to balloon angioplasty in de novo and restenotic native infrapopliteal arterial lesions with follow-up at six weeks, six months and 12 months. The primary endpoint is in-segment binary restenosis at 12 months by quality assurance. Ninety nine patients received the Cypher Select Plus stent. Mean number of stents implanted were 1.8 and number of lesions was 113. Seventy four (74.7%) patients were available for 12 months follow-up. A hundred and one patients were scheduled for balloon angioplasty only. Of these, 93 received percutaneous balloon angioplasty alone. Eight patients crossed-over to the stent group. Eighty (79.2%) patients were available for 12 months follow-up.
“What is of note [in the patient demographics] is that 64% in both treatment arms were diabetic patients, which underlines the relevance of this for diabetes mellitus,” said Scheinert.
Referring to lesion characteristics, he noted, “The large number of patients were in Rutherford 4 and 5 (46% in the stent group and 42% in the angioplasty group) respectively. One-third of the patients in both groups had Rutherford 3 lesions.”
Pre-procedure stenosis was 68.8±19.3% in patients treated with Cypher and 74±19% in patients who received angioplasty (p=0.056). Post-procedure stenosis was 13.3±14.3% in the stent group and 25.9±15.2% in the angioplasty group (p
“One year results with Cypher are promising in focal lesions. Complete one-year follow-up data including clinical endpoints and wound healing assessments will be presented at a later time point once analyses are complete,” he concluded.
YUKON-BTX final results
A polymer-free sirolimus-eluting stent achieved significantly higher primary and secondary patency rates at one year compared to bare metal stents, the final results of the YUKON-BTK have shown. Data of the randomised, double-blind study were presented by Thomas Zeller, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany, at the annual LINC meeting.
Zeller told delegates that the purpose of the study was to compare the effectiveness of the treatment with balloon-expandable Yukon-BTX drug-eluting stent over the treatment with Yukon-BTX uncoated stent in patients with ischaemic infrapopliteal arterial disease. Primary endpoint was one-year primary patency rate, defined as freedom from in-stent restenosis (≥50%) detected with angiography or, if appropriate, with duplex ultrasound. “We enrolled not only critical limb ischaemia patients but also claudicants with moderate to severe claudication. The lesion length was somewhat longer as compared to the DESTINY trial,” said Zeller.
One hundred and sixty one patients were enrolled and randomised to the sirolimus-eluting stent (82) or the bare metal stent (79). In the drug-eluting stent group, 12-month follow-up data were available for 62 patients, and, in the bare metal stent group, 12-month follow-up data were available for 63 patients.
The results showed that, at one year, the bare metal stent group had primary patency rate of 55.6% and secondary patency rate of 71.4%. The sirolimus-eluting stent group had primary patency rate of 80.6% (p=0.004) and secondary patency rate of 91.9% (p=0.005). A comparison of patients in each treatment group who were Rutherford class ≤2 (moderate or no claudication) at baseline, six and 12 months showed a significant difference in favour of the sirolimus-eluting stent. At baseline, the percentage of Rutherford class ≤2 patients was 9.9% for the sirolimus-eluting stent and 15.5% for the bare metal; at six months, it was 71.4% for drug-eluting stent and 66.1% for the bare metal stent; and at 12 months it was 78.8% for the sirolimus-eluting stent 63.9% for the bare metal stent (p=0.04).
Xience Prime update
Abbott has received the CE mark for its Xience Prime everolimus-eluting coronary stent system for the treatment of critical limb ischaemia or severe claudication of the lower leg. Data generated on Xience V drug-eluting stent from the DESTINY trial supported the CE mark application. DESTINY’s multicentre trial compared Xience to Abbott’s bare metal Multi-link Vision stent, in 140 patients with claudication of the lower leg, with lesion lengths less than 40mm.
The 12-month results from DESTINY demonstrated that Xience V had better patency compared to the bare metal stent at 12 months (85.2% Xience V versus 54.4% Multi-link Vision; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50% while the rate for Xience V remained above 85%.
“The DESTINY trial demonstrates that everolimus eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischaemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients,” said Marc Bosiers, head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial.