Abstract
Background: 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. Methods and Results: 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 procedurerelated deaths and no major amputations. Conclusions: 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. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and
| Original language | English (US) |
|---|---|
| Pages (from-to) | 495-502 |
| Number of pages | 8 |
| Journal | Circulation |
| Volume | 131 |
| Issue number | 5 |
| DOIs | |
| State | Published - Feb 3 2015 |
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Keywords
- Drug-eluting balloons
- Peripheral arterial disease
- Peripheral vascular diseases
ASJC Scopus subject areas
- Physiology (medical)
- Cardiology and Cardiovascular Medicine
Cite this
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. / Tepe, Gunnar; Laird, John; Schneider, Peter; Brodmann, Marianne; Krishnan, Prakash; Micari, Antonio; Metzger, Christopher; Scheinert, Dierk; Zeller, Thomas; Cohen, David J.; Snead, David B.; Alexander, Beaux; Landini, Mario; Jaff, Michael R.
In: Circulation, Vol. 131, No. 5, 03.02.2015, p. 495-502.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 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
AU - Tepe, Gunnar
AU - Laird, John
AU - Schneider, Peter
AU - Brodmann, Marianne
AU - Krishnan, Prakash
AU - Micari, Antonio
AU - Metzger, Christopher
AU - Scheinert, Dierk
AU - Zeller, Thomas
AU - Cohen, David J.
AU - Snead, David B.
AU - Alexander, Beaux
AU - Landini, Mario
AU - Jaff, Michael R.
PY - 2015/2/3
Y1 - 2015/2/3
N2 - Background: 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. Methods and Results: 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 procedurerelated deaths and no major amputations. Conclusions: 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. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and
AB - Background: 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. Methods and Results: 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 procedurerelated deaths and no major amputations. Conclusions: 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. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and
KW - Drug-eluting balloons
KW - Peripheral arterial disease
KW - Peripheral vascular diseases
UR - http://www.scopus.com/inward/record.url?scp=84923684095&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84923684095&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.114.011004
DO - 10.1161/CIRCULATIONAHA.114.011004
M3 - Article
C2 - 25472980
AN - SCOPUS:84923684095
VL - 131
SP - 495
EP - 502
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 5
ER -