Paclitaxel effect was witnessed in tissue specimens of a minority of chronic limb-threatening ischemia (CLTI) patients treated with drug-coated balloons (DCBs)—but was not dependent on DCB type, nor the dose level of the drug administered, and was not associated with major adverse limb or clinical events, a new single-center analysis of debrided and amputated tissue found. Researchers behind the study said the evidence supports the safety of using DCBs in patients with CLTI.
Rabih Chaer, MD, from the University of Pittsburgh Medical Center Presbyterian, Pittsburgh, and colleagues worked on the hypothesis that “the paclitaxel dose administered might play a role in the pathogenesis of any possible side effects associated with its use,” looking at the impact on wound healing.
They prospectively enrolled 50 patients with Rutherford class 5 and 6 ischemia who received angioplasty with either an IN.PACT Admiral (27) or Lutonix (23) DCB in the superficial femoral or popliteal arteries and who also had planned minor amputation or debridement within 90 days.
Collected tissue samples were analyzed for medial necrosis, medial arterial wall inflammation, foreign-body reaction, emboli and paclitaxel crystals, Chaer said.
Results showed that 66.7% of patients healed or improved their wounds; 29 underwent planned minor amputations, with 20 improving, four worsening, and six eventually requiring major amputation due to non-reconstructable tibial disease or infection, Chaer revealed during the 2022 Annual Symposium of the Society for Clinical Vascular Surgery (SCVS) in Las Vegas (March 19–23). Some 18 patients underwent wound debridement—11 improving, one worsening, and six eventually undergoing major amputation, Chaer continued.
“Major amputation-free survival at six months was 71.4%,” he told SCVS 2022. “Evidence of medial necrosis was observed in 10 specimens, with no difference among DCB type. There was no correlation between paclitaxel and major amputation or wound healing, and between DCB type and wound healing.”
Primary patency was 97.1% at six months, Chaer noted, with overall survival nearly 88% at six months and 63.7% at one year.
“What was interesting to note was that the total paclitaxel dose was actually higher in the patients who did not have any downstream paclitaxel effect on histology,” he added