Combination treatment involving laser debulking followed by drug-eluting balloon angioplasty is associated with superior outcomes when compared to the use of drug-eluting balloon angioplasty alone in critical limb ischaemia patients with superficial femoral artery stent occlusions, a randomised study from Italy finds.
Speaking on the background to the study that was carried out by Roberto Gandini and co-workers, Constantino Del Giudice, IRCCS Policlinico di Tor Vergata, Rome, Italy, presented the study at EuroPCR 2014 congress (20–23 May 2014, Paris, France) and explained that stenting is a good alternative to surgical bypass to treat superficial femoral artery disease.
“Several trials have demonstrated that primary stenting may improve immediate angiographic results and long-term patency. However, notwithstanding the improvements in devices, neointimal hyperplasia still remains the biggest Achilles’ heel of this approach, resulting in a restenosis rate of 14–50% at one-year follow-up, of which 33% can be occlusions,” Del Giudice said.
He made the point that even the use of drug-eluting stents that have recently been introduced into clinical practice for the treatment of femoral artery disease, have a rate of restenosis/occlusion of about 17%.
“The treatment of in-stent restenosis and occluded stents is a challenging condition for interventionists who have no clear guidelines on the approach to adopt. Debulking of the neointimal hyperplasia is a good option to obtain complete recanalisation. Laser ablation, which uses ultraviolet light emitted from catheter containing optical fibres, vaporises the different components of plaque without eliciting an inflammatory response and may be particularly useful. The use of laser atherectomy may also improve the outcomes achieved with drug-eluting balloon angioplasty,” Del Giudice said.
The investigators randomised 56 patients (of 558 critical limb ischaemia patients) who underwent endovascular treatment of a superficial femoral artery chronic stent occlusion from December 2009 to March 2013. The patients were randomly assigned to one of two groups: Group 1 underwent laser debulking followed by drug-eluting balloon angioplasty (n=28) and Group 2 patients were treated with drug-eluting balloon angioplasty alone (n=28). The clinicians defined the patency rate at 12-month follow-up as the primary endpoint. Secondary endpoints were target lesion revascularisation and clinical success at 12-month follow-up.
In Group 1, the patency rate was significantly higher than in Group 2 at six- and 12-month follow-up stages (91.7% and 66.7% in Group 1 and 58.3% and 37.5% in Group 2, respectively, p=0.01). Target lesion revascularisation at 12-month follow-up was 16.7% in Group 1 and 50% in Group 2 (p=0.01). Two patients (7.6%) needed major amputations in Group 1 while 11 patients (42.3%) needed major amputations in Group 2 at the 12-month follow-up (p=0.003).