Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Tepe, G; Laird, J; Schneider, P; Brodmann, M; Krishnan, P; Micari, A; Metzger, C; Scheinert, D; Zeller, T; Cohen, DJ; Snead, DB; Alexander, B; Landini, M; Jaff, MR; IN.PACT SFA Trial Investigators.
Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.
Circulation. 2015; 131(5): 495-502.
Doi: 10.1161/CIRCULATIONAHA.114.011004
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations. In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461. © 2014 The Authors.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angioplasty - methods Angioplasty - trends
- Angioplasty, Balloon - methods Angioplasty, Balloon - trends
- Female -
- Femoral Artery - pathology
- Humans -
- Internationality -
- Male -
- Middle Aged -
- Peripheral Arterial Disease - diagnosis Peripheral Arterial Disease - therapy
- Popliteal Artery - pathology
- Prospective Studies -
- Single-Blind Method -
- Time Factors -
- Treatment Outcome -
- Vascular Access Devices - trends
- Find related publications in this database (Keywords)
- drug-eluting balloons
- peripheral arterial disease
- peripheral vascular diseases