Drug-eluting stents as opposed to bare metal stents should be used in below-the-knee lesions, if stenting is unavoidable, suggest one-year results of the PES-BTK-70 study, which is investigating the below-the-knee arterial use of self-expanding paclitaxel-coated stents.
Patrick Peeters, Imelda Hospital, Bonheiden, Belgium, also told delegates at the 2016 Leipzig Interventional Course (LINC; 26–29 January, Leipzig, Germany), that they should “try to avoid stenting with bare metal stents in below-the-knee lesions”.
Peeters told the audience about three previous studies looking at drug-eluting stents in below-the-knee lesions: the sirolimus-eluting Yukon stent (Translumina) versus bare metal stenting; the everolimus-eluting Xience stent (DESTINY trial, Abbott) versus bare metal stenting; and the sirolimus-eluting Cypher stent (ACHILLES study, Cordis) versus plain balloon angioplasty. The three trials reported an overall improvement of ±20% in patency rate at one year after treatment with a sirolimus-eluting stent when compared with a bare metal stent or plain balloon angioplasty. Peeters said that the results indicated that, as there is no difference in outcomes between plain balloon angioplasty and bare metal stenting, balloon angioplasty should be used as it is an easier procedure and is less expensive. However, he said, “These results are not significant and the patient cohort was too small”.
In the PES-BTK-70 study, Peeters and colleagues examined the use of self-expanding paclitaxel-eluting stents, using the Stentys stent system (Stentys). The prospective, non-randomised, multicentre study is evaluating the immediate- and long-term (12 months) outcome of the stent in <50mm lesions. The study enrolled 70 patients (45 male, average age 74.64 years) with Rutherford classification IV (37) and V (33) with de novo or restenotic lesions after plain balloon angioplasty in the infrapopliteal arteries and a total target lesion length of ≤50mm. The patient cohort characteristics were “what you would expect” for a below-the-knee study. Lesion length was 19.7mm on average and procedure success was 97%.
The primary endpoint was primary patency at six and 12 months, defined as the absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography and verified by core lab.
Peeters reported a 72.6% 12-month primary patency, a 79.1% 12-month rate of freedom from target lesion revascularisation and a limb salvage rate of 98.5%. At baseline, 33 patients were in Rutherford class 5, but by 12 months this number had fallen to 11. Thirty-seven patients were in class 4 at baseline, while 2 remained at 4 at 12 months. There were no patients in class 0 at baseline compared with 35 at 12 months. “All patients are now in a lower Rutherford class than at baseline,” Peeters noted.
No stent fractures were reported. Peeters suggested that surgeons “Avoid balloon-expandable stents due to risks of crushing and stent fractures”.
The one-year patency rates (72.6%) were comparable to the three previously-mentioned trials (all ranging from 75–82.5%), as was device performance when measuring limb salvage rates, freedom from target lesion revascularisation and primary patency, Peeters told the audience.