New data from a large, real-world study support the use of drug-eluting devices to reduce amputations, readmissions, and healthcare costs in the treatment of peripheral arterial disease (PAD), Marianne Brodmann (Medical University of Graz, Graz, Austria) informed attendees at the Leipzig Interventional Course (LINC 2025; 28–30 January, Leipzig, Germany).
Brodmann was, for the first time, sharing the results of TRUE-PTX. This study sought to evaluate the use of paclitaxel drug-eluting versus non-drug-eluting devices for the treatment of PAD in a large patient population, focusing specifically on above-ankle amputation, hospital readmission, and mortality rates at 12 months.
Several studies have demonstrated the benefits of drug-eluting therapy for femoropopliteal lesions, Brodmann noted, including sustained vessel patency, clinical improvement, and fewer reinterventions. The question of whether these benefits transfer to real-world practice, however, remains unanswered.
In order to address to address this gap in the literature, Brodmann and colleagues identified 10,000 patients on the Truveta platform who had undergone either drug-eluting therapy (5,000 patients) or non-drug-eluting therapy (5,000 patients) for PAD and analysed their outcomes.
Regarding patient characteristics, Brodmann shared that 40% were female and 82% were white. The presenter also pointed out that race and ethnicity distributions varied between the treatment groups. “Drug-eluting devices were used more frequently for white and Hispanic patients, and less frequently for Black patients,” the presenter noted.
On comorbidities, Brodmann detailed that approximately 32% of patients across the two groups had chronic limb-threatening ischaemia (CLTI), and that other comorbidities were far more prevalent in those patients treated with drug-eluting devices.
Brodmann reported that, before matching, 12-month amputation and readmission “occurred significantly less frequently for patients receiving drug-eluting treatment”. The presenter added that there was no significant difference between the two groups regarding mortality. “So, once again, a severe hint that drug-eluting technology, paclitaxel-coated technology, is not relevant for mortality,” she remarked.
After propensity-score matching, there were around 4,000 patients remaining in the drug-eluting device group and around 3,700 in the non-drug-eluting device group, Brodmann relayed. The proportion of patients with CLTI stayed broadly the same, at close to 30%.
Patients in this matched cohort treated with non-drug-eluting treatment were more likely to have above-ankle amputation, any readmission, and readmission associated with a repeat procedure, Brodmann communicated.
The presenter summarised that, in a contemporary, real-world patient cohort with a high prevalence of CLTI, above-ankle amputation and readmission within 12 months occurred more frequently with non-drug-eluting therapy versus paclitaxel drug-eluting devices in propensity-score-matched patients.
“This large study of real-world evidence parallels the results of formal randomised controlled trials,” Brodmann said in her concluding remarks. “The TRUE-PTX results support the use of drug-eluting devices to reduce amputations and readmissions, and the results have implications for reducing healthcare costs.”
“It’s not only about patient satisfaction, about patient quality of life; it’s also about expense,” Brodmann continued, elaborating on this final point. “Major amputation is expensive and avoiding amputation has the potential for substantial cost savings.”
Based on these conclusions, Brodmann shared her take-home message from the presentation: “Drug-eluting technologies should be the de facto standard of care for PAD.”
