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Volumetric imaging finds less neointimal tissue, lower late lumen loss with PES for SFA lesions
Implantation of a paclitaxel-eluting nitinol stent for superficial femoral artery lesions appears to be associated with significantly smaller amounts of neointimal tissue and lower late lumen loss vs. bare-metal stents based on serial volumetric optical frequency domain imaging, according to recent findings.
In the subanalysis of a prospective, randomized study comparing strut coverage between BMS (S.M.A.R.T. Control, Cordis) and PES (Zilver PTX, Cook Medical) implantation at 6 months in patients with superficial femoral artery (SFA) disease, researchers evaluated 30 of 40 randomized de novo lesions (15 treated with BMS and 15 with PES) that were prespecified as a serial optical frequency domain imaging subanalysis group at enrollment.
Patients underwent primary stent implantation via the contralateral femoral approach.
Quantitative vascular angiography was performed before and after stent implantation and at 6-month follow-up.
The primary endpoint was late lumen area loss at 6-month follow-up. Late lumen area loss was defined as lumen volume index after stent implantation minus lumen volume index at 6-month follow-up. Axial distribution of neointimal tissue through the stented segment was assessed by dividing each stent into eight segments along the longitudinal axis, with average neointimal volume index of each segment then determined.
The researchers found that, at 6 months, there was a lower percent diameter stenosis in patients treated with PES vs. BMS (28.5% vs. 39.7%; P = .04). The PES group also had smaller angiographic late lumen diameter loss vs. the BMS group (0.83 mm vs. 1.4 mm; P = .03). During the follow-up period, BMS increased stent volume index by 33.8%, whereas PES increased stent volume index by 32.1%. The BMS group had neointimal volume index of 10.5 mm3/mm, and the PES group had neointimal volume index of 7.4 mm3/mm (P < .01). There was a reduction in lumen volume index during follow-up in both the BMS group (from 22.9 mm3/mm to 17.2 mm3/mm; P < .001) and in the PES group (from 20.8 mm3/mm to 17.9 mm3/mm; P < .001). The PES group had smaller late lumen area loss vs. the BMS group (2.9 mm3/mm vs. 5.6 mm3/mm; P < .01) because of a lesser extent of neointima.
“Our data suggest that PES in the SFA may improve patency by suppression of neointimal proliferation without an increase of abnormal neointimal findings compared with BMS,” the researchers wrote. “No adjunctive intervention might be required for abnormal findings, which were identified on [optical frequency domain imaging] post-stent implantation.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.