Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions

24-Month Results of IN.PACT SFA

John R. Laird, Peter A. Schneider, Gunnar Tepe, Marianne Brodmann, Thomas Zeller, Christopher Metzger, Prakash Krishnan, Dierk Scheinert, Antonio Micari, David J. Cohen, Hong Wang, Melissa S. Hasenbank, Michael R. Jaff

Research output: Contribution to journalArticle

180 Citations (Scopus)

Abstract

Background 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. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods 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. Results 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. Conclusions 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)

Original languageEnglish (US)
Pages (from-to)2329-2338
Number of pages10
JournalJournal of the American College of Cardiology
Volume66
Issue number21
DOIs
StatePublished - 2015

Fingerprint

Femoral Artery
Angioplasty
Pharmaceutical Preparations
Therapeutics
Quality of Life
Popliteal Artery
Balloon Angioplasty
Peripheral Arterial Disease
Paclitaxel
Amputation
Walking
Thrombosis

Keywords

  • angioplasty
  • femoropopliteal artery
  • peripheral arterial disease
  • target lesion revascularization

ASJC Scopus subject areas

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine

Cite this

Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions : 24-Month Results of IN.PACT SFA. / Laird, John R.; Schneider, Peter A.; Tepe, Gunnar; Brodmann, Marianne; Zeller, Thomas; Metzger, Christopher; Krishnan, Prakash; Scheinert, Dierk; Micari, Antonio; Cohen, David J.; Wang, Hong; Hasenbank, Melissa S.; Jaff, Michael R.

In: Journal of the American College of Cardiology, Vol. 66, No. 21, 2015, p. 2329-2338.

Research output: Contribution to journalArticle

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 2015, 'Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA', Journal of the American College of Cardiology, vol. 66, no. 21, pp. 2329-2338. https://doi.org/10.1016/j.jacc.2015.09.063
Laird, John R. ; Schneider, Peter A. ; Tepe, Gunnar ; Brodmann, Marianne ; Zeller, Thomas ; Metzger, Christopher ; Krishnan, Prakash ; Scheinert, Dierk ; Micari, Antonio ; Cohen, David J. ; Wang, Hong ; Hasenbank, Melissa S. ; Jaff, Michael R. / Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions : 24-Month Results of IN.PACT SFA. In: Journal of the American College of Cardiology. 2015 ; Vol. 66, No. 21. pp. 2329-2338.
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title = "Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA",
abstract = "Background 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. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods 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. Results 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. Conclusions 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)",
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author = "Laird, {John R.} and Schneider, {Peter A.} and Gunnar Tepe and Marianne Brodmann and Thomas Zeller and Christopher Metzger and Prakash Krishnan and Dierk Scheinert and Antonio Micari and Cohen, {David J.} and Hong Wang and Hasenbank, {Melissa S.} and Jaff, {Michael R.}",
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T1 - Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions

T2 - 24-Month Results of IN.PACT SFA

AU - Laird, John R.

AU - Schneider, Peter A.

AU - Tepe, Gunnar

AU - Brodmann, Marianne

AU - Zeller, Thomas

AU - Metzger, Christopher

AU - Krishnan, Prakash

AU - Scheinert, Dierk

AU - Micari, Antonio

AU - Cohen, David J.

AU - Wang, Hong

AU - Hasenbank, Melissa S.

AU - Jaff, Michael R.

PY - 2015

Y1 - 2015

N2 - Background 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. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods 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. Results 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. Conclusions 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)

AB - Background 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. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods 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. Results 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. Conclusions 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)

KW - angioplasty

KW - femoropopliteal artery

KW - peripheral arterial disease

KW - target lesion revascularization

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