Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study
In: CardioVascular and Interventional Radiology, Jg. 45 (2022-07-21), S. 1276-1287
Online
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Zugriff:
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.
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Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study
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Autor/in / Beteiligte Person: | Marianne, Brodmann ; Wouter, Lansink ; Katharina, Guetl ; Antonio, Micari ; Jeremiah, Menk ; Thomas, Zeller |
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Zeitschrift: | CardioVascular and Interventional Radiology, Jg. 45 (2022-07-21), S. 1276-1287 |
Veröffentlichung: | Springer Science and Business Media LLC, 2022 |
Medientyp: | unknown |
ISSN: | 1432-086X (print) ; 0174-1551 (print) |
DOI: | 10.1007/s00270-022-03214-y |
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