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Meta-analysis: DCB effective for infrapopliteal artery revascularization
Patients with atherosclerotic disease in infrapopliteal arteries experienced comparable clinical outcomes and improved angiographic outcomes when treated with drug-coated balloons compared with other therapies, according to results from a recent meta-analysis.
However, in a related editorial, Thomas Zeller, MD, Universitats-Herzzentrum Freiburg-Bad Krozingen, Germany, and Michael R. Jaff, DO, Massachusetts General Hospital in Boston, wrote that the findings “must be interpreted with caution,” citing concerns about the clinical benefit of the treatment and the ability to generalize the findings to other DCBs not included in the analysis.
The researchers evaluated data collected from five randomized trials (n = 641) assessing the use of DCBs compared with control therapies for the revascularization of infrapopliteal arteries. Target lesion revascularization was the primary efficacy outcome of the current analysis, and amputation was the primary safety outcome. Secondary outcomes included death, major adverse events, class of 5 or 6 and late lumen loss.
Across the included studies, 378 patients with 527 lesions received DCBs and 263 patients with 365 lesions were treated with a drug-eluting stent or an uncoated balloon. Of these patients, 614 had evaluable follow-up data, with a median duration of 12 months.
TLR occurred in 23.6% of evaluable patients. Patients who received DCBs were at similar risk for TLR (18.3% vs. 29.1% vs. controls; RR = 0.71; 95% CI, 0.47-1.09). Amputation occurred in 14.6% of patients, with similar risk observed regardless of treatment type (13.3% with DCBs vs. 14.9% with control therapy; RR = 1.04; 95% CI, 0.7-1.54).
The mortality rate was 11.5%, with no difference in mortality risk between those treated with DCBs (11.4%) and control therapies (10.6%; RR = 1.14; 95% CI, 0.71-1.82). Across four trials, 37.2% of evaluable patients experienced major adverse events, with no significant risk difference between groups (29.9% with DCBs vs. 38.5% with control therapy; RR = 0.92; 95% CI, 0.59-1.43). Risk for persistent class 5 or 6 after treatment, observed in 62% of patients overall in three evaluable trials, also did not differ significantly according to treatment (66% vs. 55.6%; RR = 0.87; 95% CI, 0.46-1.22).
Among 482 lesions with evaluable angiographic data, those treated using DCBs exhibited significantly lower late lumen loss at 12 months (weighted mean difference, –0.41 vs. control therapy; P = .04).
The researchers called for analysis of a larger patient population with longer-term follow-up, but concluded, “in patients with infrapopliteal artery disease, percutaneous intervention with DCBs as compared to uncoated balloon or DES displays similar clinical efficacy and a favorable angiographic outcome at 1-year follow-up.”
Zeller and Jaff noted that four of the five included trials used a DCB that had been removed from the market after negative outcomes in a large trial assessing its use to treat infrapopliteal arterial disease. Only 72 patients had been treated with a device that remains commercially available, and this device “did not show any technical or clinical benefit over [control therapies].”
Zeller and Jaff also wrote that the improved outcomes related to late lumen loss with the use of DCBs were only observed in three uncontrolled trials. Results from the remaining two studies, which were independently controlled, yielded identical results between treatment types, “suggesting a lack of biological efficacy of ... the DCB brands examined in those two studies,” they wrote.
“Despite the superior angiographic outcome defined as [late lumen loss] in this meta-analysis, the performance of DCB in infrapopliteal lesions remains controversial,” Zeller and Jaff concluded. “The results ... cannot be generalized to other commercially available DCBs without published clinical study data or to those DCBs still under clinical evaluation.” – by Adam Taliercio
Disclosure: The researchers report no relevant financial disclosures. Zeller reports financial relationships with Boston Scientific, Cook, Medtronic, Spectranetics, Terumo, Trireme, W.L. Gore and Veryan. Jaff is a board member for VIVA Physicians, an equity investor of PQ Bypass and a noncompensated adviser for Medtronic.