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DCB bests plain balloon angioplasty for TLR risk reduction in patients with femoropopliteal artery disease
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In patients with femoropopliteal artery disease, treatment with a drug-coated balloon yielded a significantly reduced risk for target lesion revascularization at 12 months compared with conventional plain balloon angioplasty, with no effect on all-cause mortality, according to a systematic review and meta-analysis.
Researchers identified eight randomized trials that assessed the efficacy of drug-coated balloons (DCB) vs. plain balloon (PB) angioplasty for treatment of femoropopliteal artery disease through Dec. 1, 2015. The eight trials were Biolux P-I, FAIR, FemPac, In.PACT SFA, LEVANT 1, LEVANT 2, PACIFIER and THUNDER.
Risk for TLR at 12 months was reduced by 67% with DCB vs. PB angioplasty (RR = 0.33; 95% CI, 0.19-0.57). Both treatment groups had similar risk for all-cause mortality (RR = 0.96; 95% CI, 0.47-1.95). Assessment of long-term outcomes (mean follow-up, 1.9 years) yielded similar results: a reduced incidence of TLR with DCB (RR = 0.35; 95% CI, 0.24-0.51) and similar incidence of all-cause mortality (incidence rate ratio = 1.13; 95% CI, 0.6-2.15).
“Additional trials to confirm the superior antirestenotic efficacy of currently available DCB vs. PB angioplasty in a general clinical and angiographic subset of patients with femoropopliteal artery disease are not required. Future trials should focus on the comparison between DCB and potentially more effective comparators such as drug-eluting stents,” the researchers wrote.
Konstantinos Katsanos, MD, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust, London, discussed the findings in a related editorial. According to Katsanos, the antirestenotic effects demonstrated by DCB in this analysis supports their use for treatment of femoropopliteal artery disease.
“DCB should be considered the new standard of care for the treatment of noncomplex lesions in a claudicant population,” Katsanos wrote. “However, current DCB devices have no class effect and more randomized studies are needed to expand our knowledge into the role of paclitaxel pharmacokinetics, application in more complex lesions, combination with stenting and treatment of critical limb ischemia for limb salvage.” – by Jennifer Byrne
Disclosure: One researcher reports submission of patent applications in relation to drug-eluting stent technology. Another researcher reports receiving lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific and institutional research grants from Boston Scientific and Heartflow. Please see the full study for a list of the researchers’ relevant financial disclosures. Katsanos reports consulting for Medtronic and receiving travel/sponsorship support from Boston Scientific.
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