Original title: Drug-Eluting Balloons for the Treatment of the Superficial Femoral Artery In-Stent Restenosis. 2-Year Follow-Up. Reference: Vittorio Virga et al. J Am Coll Cardiol Intv 2014;7:411–5.
Although the use of the self-expanding nitinol stent has improved angioplasty outcomes in femoropopliteal territory, restenosis remains a challenge still affecting at least 25% of the population in the first year. The purpose of this prospective registry was to evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR) at 2 years.
Studies evaluating the use of DEB for the treatment of restenosis had already been published, but only at 1 year follow up. However, when DEBs were used to treat SFA de novo lesions the occurrence of restenosis increased by 50% between the first and the second years follow-up, which calls for further research on longer follow up.
This registry included 39 consecutive patients with superficial femoral artery ISR between December 2009 and December 2010. All patients underwent conventional angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota).
During follow up, one patient died of heart failure and another for sudden death. At 2 years follow up, cardiovascular mortality rate was 5.12%. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up).
ISR lesions classes II and III (+50 mm or total occlusions) showed worse results compared to class I restenosis (33.3 % and 36.3 % vs. 12.5%; p = 0.05).
Secondary patency by Doppler reached 87%; Rutherford class was 0.6 ± 0.7 (baseline, 2.9 ± 0.7; p<0.05)and an ankle-brachial index of 0.94 ± 0.09 (baseline 0.77 ± 0.09; p< 0.05).
Conclusions
The data suggest that the use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.
Editorial Comment
The value of long term follow up to evaluate drug eluting devices (either stents or balloons) for the treatment of restenosis is based on the need to understand whether this is a late catch up phenomenon or it is simply the natural history of restenosis.
This is why the Zilver-PTX study was the first to publish 2 year outcomes with the paclitaxel eluting stent for the treatment of restenosis in this territory, showing a 60.8% rate of freedom from target lesion revascularization. The Zilver-PTX, as well as this study with paclitaxel IN.PACT DEB, have not yet identified predictors for recurrent restenosis.
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