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. 2019 Jun;26(3):305-315.
doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Michel M P J Reijnen  1 , Iris van Wijck  1 , Thomas Zeller  2 , Antonio Micari  3 , Pierfrancesco Veroux  4 , Koen Keirse  5 , Seung-Whan Lee  6 , Pei Li  7 , Despina Voulgaraki  8 , Suzanne Holewijn  1
Affiliations

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Michel M P J Reijnen et al. J Endovasc Ther. 2019 Jun.

Abstract

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296).

Materials and methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI).

Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups.

Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

Keywords: amputation; claudication; critical limb ischemia; drug-coated balloon; femoropopliteal segment; limb salvage; peripheral artery disease; popliteal artery; stenosis; superficial femoral artery; target lesion revascularization.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Michel M. P. J. Reijnen is a consultant for Endologix, Terumo Aortic, and Bentley Innomed and received research and clinical trial funds from Endologix, Terumo Aortic, Bentley Innomed, Medtronic, and W.L. Gore & Associates. Thomas Zeller declares honoraria received from Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp, Cook Medical, W.L. Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, and Shockwave; he is a consultant for Boston Scientific Corp., Cook Medical, W.L. Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, B. Braun, Shockwave, and Bayer; he received research, clinical trial, or drug study funds from 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, W.L. Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun; he owns common stock in Veryan and QT Medical. Antonio Micari is a consultant and board member for Medtronic. Pierfrancesco Veroux is a consultant for CvrX and Endologix and received research and clinical trial funds and honoraria from Medtronic, Abbott, Terumo, Cook, W.L. Gore & Associates, and Boston Scientific. Pei Li and Despina Voulgaraki are full-time employees of Medtronic.

Figures

Figure 1.
Figure 1.
Flowchart of the study population through 1-year follow-up. DCB, drug-coated balloon; RC, Rutherford category.
Figure 2.
Figure 2.
Kaplan-Meier estimate of freedom from major target limb amputation through 12 months in patients with Rutherford category (RC) 2,3 claudication and RC 4,5 critical limb ischemia. SE, standard error.
Figure 3.
Figure 3.
Kaplan-Meier estimate for freedom from death through 12 months in patients with Rutherford category (RC) 2,3 claudication and RC 4,5 critical limb ischemia. SE, standard error.
Figure 4.
Figure 4.
Kaplan-Meier estimate for freedom from clinically-driven target lesion revascularization (CD-TLR) through 12 months in patients with Rutherford category (RC) 2,3 claudication and RC 4,5 critical limb ischemia. All TLR events were adjudicated by the independent and blinded Clinical Events Committee. SE, standard error.
Figure 5.
Figure 5.
Changes in Rutherford category (RC) through 12 months for patients with critical limb ischemia. The changes from baseline to 6 months and baseline to 12 months were both statistically significant (p<0.001).
Figure 6.
Figure 6.
Changes in the EuroQol 5 Dimensions questionnaire results through 12 months for patients with critical limb ischemia.
See this image and copyright information in PMC

References

    1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67. - PubMed
    1. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e686–e725. - PMC - PubMed
    1. European Stroke Organisation, Tendera M, Aboyans V, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–2906. - PubMed
    1. Bosma J, Vahl A, Wisselink W. Systematic review on health-related quality of life after revascularization and primary amputation in patients with critical limb ischemia. Ann Vasc Surg. 2013;27:1105–1114. - PubMed
    1. Dua A, Lee CJ. Epidemiology of peripheral arterial disease and critical limb ischemia. Tech Vasc Interv Radiol. 2016;19:91–95. - PubMed

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