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SHR Neuro Cancer Cardio Lipid Metab Microb

Brodmann, M; Lansink, W; Guetl, K; Micari, A; Menk, J; Zeller, T.
Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study.
Cardiovasc Intervent Radiol. 2022; 45(9): 1276-1287. Doi: 10.1007/s00270-022-03214-y [OPEN ACCESS]
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Leading authors Med Uni Graz

Brodmann Marianne

Co-authors Med Uni Graz

Kurzmann-Gütl Katharina

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Abstract:

PURPOSE: Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB. RESULTS: Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively. CONCLUSIONS: The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. CLINICALTRIALS: gov identifier: NCT01609296. LEVEL OF EVIDENCE: Level 3, Cohort Study.

Find related publications in this database (using NLM MeSH Indexing)

Angioplasty, Balloon - administration & dosage

Cardiovascular Agents - administration & dosage

Coated Materials, Biocompatible - administration & dosage

Cohort Studies - administration & dosage

Femoral Artery - diagnostic imaging

Humans - administration & dosage

Paclitaxel - administration & dosage

Peripheral Arterial Disease - diagnostic imaging, therapy

Popliteal Artery - diagnostic imaging

Prospective Studies - administration & dosage

Time Factors - administration & dosage

Vascular Access Devices - administration & dosage

Vascular Patency - administration & dosage

Find related publications in this database (Keywords)

Drug-coated balloon

Target lesion revascularization

Femoropopliteal

Peripheral artery disease

Long lesions

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