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Drug-coated balloons safely, effectively delay restenosis in femoropopliteal lesions
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Treatment of long, complex femoropopliteal lesions with a drug-coated balloon yielded a high rate of primary patency at 1-year follow-up, researchers reported in a recent retrospective analysis.
However, a significant decline in patency observed at 2 years suggest that the treatment effectively delays but does not prevent restenosis in these lesions.
Researchers evaluated outcomes from the use of DCBs to treat complex femoropopliteal lesions in 288 limbs among 260 patients (mean age, 68 years; 63% men). All patients were treated between May 2009 and January 2012 at a single tertiary center.
Vessel patency, defined as freedom from more than 50% restenosis, was the primary endpoint. Secondary endpoints included freedom from target lesion revascularization, improvement to Rutherford class and ankle-brachial index, and safety endpoints including rates of mortality and amputation. All patients were treated with the IN.PACT Pacific or Admiral DCB (Medtronic), with follow-up conducted before discharge and at 6, 12 and 24 months after treatment.
Primary patency occurred in an estimated 79.2% of lesions at 1 year and 53.7% at 2 years, with freedom from TLR observed in 85.4% and 68.6% of cases, respectively. Among patients with in-stent restenosis, specifically, primary patency occurred in 76.6% at 1 year and 48.6% at 2 years, with freedom from TLR in 83% and 58.7%, respectively. Primary patency was more common among men (P = .002), patients without diabetes (P = .027), smokers (P = .027), those with no, mild or moderate calcification (P = .023), and nonobese patients (P = .016).
The mortality rate was 4.6% at 1 year and 10.4% at 2 years, with one death occurring within 30 days of treatment. Patients were free from TLR in 85.4% of cases at 1 year and 68.6% at 2 years. Freedom from TLR was more common among men (P = .001), those with residual stenosis of less than 30% (P = .013) and nonobese patients (P = .017).
Rutherford category improved in a majority of limbs at both 1 year (73.3% of limbs) and 2 years (66.4%), with a decrease from a median of 3.3 at baseline to 1.2 at 1 year and 1.1 at 2 years. The 2-year major amputation rate was 2.1%. Mean ankle-brachial index improved from a mean of 0.56 at baseline to 0.88 at 1 year and 0.8 at 2 years. No adverse events related to the balloon coating were observed.
Results from binary logistic regression analysis indicated that severe calcification (OR = 2.15; 95% CI, 1.018-4.54) and obesity (OR = 1.825; 95% CI, 1.069-3.116) were significantly predictive of restenosis at 2 years, whereas male sex was associated with significantly lower restenosis risk (OR = 0.491; 95% CI, 0.288-0.839).
“The treatment of long and complex femoropopliteal lesions with DCBs is associated with impressive patency results comparing favorably to historical, uncoated balloon angioplasty at 1 year,” the researchers wrote. “However, patency rates drop off significantly after the first year, which may represent a late catch-up phenomenon. ... Our results suggest that DCBs are safe and effective in delaying rather than preventing restenosis in [this patient population].” – by Adam Taliercio
Disclosure: The researchers report financial relationships with Abbott Vascular, Boston Scientific, Biotronik, C.R. Bard, Cook Medical, Cordis, Covidien, Gardia Medical, Gore, Hemoteq, IDEV Technologies, Medtronic, Spectranetics, TriReme Medical, Trivascular and Upstream Peripheral.
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