Medizinische Universität Graz - Research portal
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SHR Neuro Cancer Cardio Lipid Metab Microb
Laird, JR; Schneider, PA; Tepe, G; Brodmann, M; Zeller, T; Metzger, C; Krishnan, P; Scheinert, D; Micari, A; Cohen, DJ; Wang, H; Hasenbank, MS; Jaff, MR; IN.PACT SFA Trial Investigators.
Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA.
J Am Coll Cardiol. 2015; 66(21):2329-2338
Doi: 10.1016/j.jacc.2015.09.063
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angioplasty - standards
- Angioplasty - trends
- Angioplasty, Balloon - standards
- Angioplasty, Balloon - trends
- Female -
- Femoral Artery - diagnostic imaging
- Follow-Up Studies -
- Humans -
- Internationality -
- Male -
- Middle Aged -
- Paclitaxel - administration & dosage
- Popliteal Artery - diagnostic imaging
- Prospective Studies -
- Single-Blind Method -
- Time Factors -
- Treatment Outcome -
- Ultrasonography -
- Find related publications in this database (Keywords)
- angioplasty
- femoropopliteal artery
- peripheral arterial disease
- target lesion revascularization