Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study
© 2022. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:45 |
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| Enthalten in: |
Cardiovascular and interventional radiology - 45(2022), 9 vom: 21. Sept., Seite 1276-1287 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Brodmann, Marianne [VerfasserIn] |
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| Links: |
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| Themen: |
Cardiovascular Agents |
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| Anmerkungen: |
Date Completed 12.09.2022 Date Revised 01.11.2022 published: Print-Electronic ClinicalTrials.gov: NCT01609296 Citation Status MEDLINE |
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| doi: |
10.1007/s00270-022-03214-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM343842025 |
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| 245 | 1 | 0 | |a Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study |
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| 500 | |a ClinicalTrials.gov: NCT01609296 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CLINICALTRIALS: gov identifier: NCT01609296 | ||
| 520 | |a LEVEL OF EVIDENCE: Level 3, Cohort Study | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Femoropopliteal | |
| 650 | 4 | |a Long lesions | |
| 650 | 4 | |a Peripheral artery disease | |
| 650 | 4 | |a Target lesion revascularization | |
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| 700 | 1 | |a Micari, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Menk, Jeremiah |e verfasserin |4 aut | |
| 700 | 1 | |a Zeller, Thomas |e verfasserin |4 aut | |
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