Drug-coated balloon (DCB) treatment in the infrapopliteal arteries was associated with favorable angiographic efficacy at 1-year follow-up compared with treatments with uncoated balloons or drug- eluting stents (DES), according to recent data published in JACC: Cardiovascular Interventions.

The role of DCB in revascularization of stenotic or occluded infrapopliteal arteries is controversial among clinicians. Therefore, researchers conducted a meta-analysis of randomized trials to investigate the outcomes of patients undergoing percutaneous revascularization with DCB compared with standard methods of treatment for atherosclerotic disease of infrapopliteal arteries.

Researchers selected 641 patients enrolled in 5 trials who had received DCB (n=378) or the control therapy of either an uncoated balloon or DES (n=263) to be included in the study. The patients were followed for a median of 12 months.


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Rates of target lesion revascularization (TLR) and amputation were measured as primary efficacy and safety outcomes, respectively. Secondary outcomes included death, major adverse events, Rutherford class between 5 and 6, and late lumen loss.

Compared with patients treated with uncoated balloon or DES therapy, patients treated with DCB had a risk of TLR (risk ratio: 0.71; 95% confidence interval [CI]: 0.47-1.09; P=.12), amputation (risk ratio: 1.01; 95% CI: 0.65-1.58; P=0.95), death (risk ratio: 1.14; 95% CI: 0.71-1.82; P=.59), major adverse events (risk ratio: 0.92; 95% CI: 0.59-1.43; P=.70), and Rutherford class between 5 and 6 (risk ratio: 0.87; 95% CI: 0.46-1.62; P=.65).

“The large majority of trials included in this report contained only sufficient power for angiographic or composite clinical outcomes, thus supporting the necessity of a meta-analysis to investigate the risk of TLR after DCB angioplasty,” the authors wrote.

“We display for the first time that even after pooling >600 patients suffering from infrapopliteal artery disease, the impact of TLR of DCB needs to be further studied, since the available sample size accounts for <50% of that required to address a measurable effect of DCB for this end point.”

Results also showed that lesions treated with DCB had a lower late lumen loss compared with patients treated with uncoated balloon or DES therapy (weighted mean difference: -0.41; 95% CI: -0.79 to -0.03; P=.04).

The authors of the study also noted that while initial data display favorable outcomes with DCB compared with uncoated balloons in this setting, 2 subsequenttrials2,3 did not confirm these results.

In fact, 1 of the trials3 revealed potential harm associated with a DCB device, which was subsequently withdrawn from the market. Additional trials should be conducted to investigate developments in DCB technology.

“Further studies, in larger number of patients receiving a standardized wound care management and a longer follow-up are still required to disclose the role of DCB for atherosclerotic disease of infrapopliteal arteries,” they concluded.

References

  1. Cassese S, Ndrepepa G, Liistro F, et al. Drug-coated balloon for revascularization of infrapopliteal arteries: A meta-analysis of randomized trials. JACC Cardiovasc Interv. 2016. doi: 10.1016/j.jcin.2016.02.011
  2. Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-First Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8(12):1614-1622. doi: 10.1016/j.jcin.2015.07.011
  3. Zeller T, Baumgartner I, Scheinert D, et al. Drug-eluting balloon vs standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64(15):1568-1576. doi: 10.1016/j.jacc.2014.06.1198.