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DEBATE-ISR: DEB for femoropopliteal in-stent restenosis yields similar outcomes to balloon angioplasty
In patients with symptomatic diabetes and femoropopliteal in-stent restenosis, the use of drug-eluting balloons yielded results similar to those achieved by balloon angioplasty in terms of freedom from target lesion revascularization at 3 years, according to findings from the DEBATE-ISR study.
In the single-center, prospective registry, researchers evaluated 44 consecutive patients with diabetes who had claudication or critical limb ischemia (CLI). The mean age of the patients was 74 ± 11 years and 32 were men. Patients were successfully treated for femoropopliteal in-stent restenosis using drug-eluting balloons (DEB) between 2010 and 2011. A historical control group consisting of 42 consecutive patients with diabetes (mean age, 76 ± 7 years; 23 men) also was evaluated. These patients underwent conventional balloon angioplasty for the same indication between 2008 and 2009. Patients were seen for follow-up at 1, 6, 12, 24 and 36 months for clinical evaluation and duplex ultrasound testing.
The study’s primary endpoint was the 3-year incidence of TLR, which was performed only if clinically warranted by symptom recurrence or by the presence of a 50% or more target lesion stenosis.
At 3-year follow-up, there were nine patient deaths per group and one major amputation per group. The DEB group had a 40% incidence of TLR vs. a 43% incidence in the balloon angioplasty group (P = .8).
In most patients, CLI was present. More than half of the patients had Tosaka class III in-stent restenosis. The DEB group had a mean lesion length of 132 ± 86 mm and the balloon angioplasty group had a mean lesion length of 137 ± 82 mm (P = .7)
At 3 years, no significant differences were revealed by Kaplan-Meier analysis between the groups in freedom from TLR (P = .59). In both groups, the presence of a Tosaka class III in-stent restenosis at the index procedure was independently correlated with recurring events (OR = 3.96; 95% CI, 1.55-10.1). Late lumen loss or arterial aneurysm was not observed in any of the patients.
The researchers noted that recent data have suggested a less effective longer-term performance by DEBs when treating restenotic lesions, especially after stenting.
“Notwithstanding the suboptimal results seen in the longer period, the midterm benefit provided by DEBs in terms of reduction of restenosis and TLR is still of value since it represents a key factor in the management of femoropopliteal [in-stent restenosis],” the researchers wrote. “Because continued patency favors [wound] healing, the antiproliferative effects of DEBs may translate into consistent improvement in clinical outcome, particularly in patients with CLI.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.