Paclitaxel DCB safe for long-term in femoropopliteal PAD:IN.PACT Global Study

Written By : Medha Baranwal |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2022-06-10T19:30:19+05:30 | Updated On 10 Jun 2022 7:30 PM IST

Germany: A paclitaxel-based drug-coated balloon (DCB) showed safe and durable outcomes in real-world patients with femoropopliteal peripheral arterial disease (PAD), according to 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study.

Numerous randomized controlled trials (RCTs) have shown paclitaxel drug-coated balloons (DCBs) to be superior to non-coated angioplasty balloons for treating femoropopliteal peripheral arterial disease. However, there is a lack of clinical evidence in more complex patients who are often excluded from RCTs. Also, there is very limited long-term data up to 5 years in PAD revascularisation studies.

Thomas Zeller, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany, and colleagues in their study, published in the EuroIntervention report on the 5-year outcomes from the IN.PACT Global Study. The evaluation of IN.PACT Admiral DCB was done for the treatment of femoropopliteal atherosclerotic diseasein a real-world patient population.

A total of 1,535 patients were enrolled at 64 international sites. The prespecified clinical cohort included 1,406 patients with claudication or rest pain. Evaluation of the patients for the occurrence of adverse events and clinically driven target lesion revascularisations (CD-TLR) was done for up to 5 years.

Salient findings include:

The mean lesion length was 12.1±9.5 cm in 1,774 lesions, 18.0% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified.
Per independent clinical events committee adjudication, the Kaplan-Meier estimate of freedom from CD-TLR up to 5 years was 69.4%, and the restricted mean survival time to first CD-TLR was 1,470.1 days.
Outcomes were similar for males and females; freedom from CD-TLR was 69.1% in females and 69.6% in males.
The cumulative incidence of major adverse events for the clinical cohort was 45.9% and freedom from all-cause mortality with the vital status update was 78.9% up to 5 years.

"The IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease," the researchers concluded.

Reference:

Zeller T, Brodmann M, Ansel GM, et al. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022;Epub ahead of print.

EuroInterventionPaclitaxel-coated balloonsfemoropopliteal peripheral arterial disease

Source : EuroIntervention

Medha Baranwal

MSc. Biotechnology

Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751