Author + information
- Received August 25, 2015
- Revision received September 25, 2015
- Accepted September 25, 2015
- Published online December 1, 2015.
- John R. Laird, MD∗∗ (, )
- Peter A. Schneider, MD†,
- Gunnar Tepe, MD‡,
- Marianne Brodmann, MD§,
- Thomas Zeller, MD‖,
- Christopher Metzger, MD¶,
- Prakash Krishnan, MD#,
- Dierk Scheinert, MD∗∗,
- Antonio Micari, MD, PhD††,
- David J. Cohen, MD, MSc‡‡,
- Hong Wang, MD, MPH§§,
- Melissa S. Hasenbank, PhD§§,
- Michael R. Jaff, DO‖‖,
- IN.PACT SFA Trial Investigators
- ∗UC Davis, Sacramento, California
- †Kaiser Permanente–Moanalua Medical Center and Clinic, Honolulu, Hawaii
- ‡RodMed Klinikum, Rosenheim, Germany
- §Medical University, Graz, Austria
- ‖Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany
- ¶Wellmont Holston Valley Medical Center, Kingsport, Tennessee
- #Mount Sinai Medical Center, New York, New York
- ∗∗Park-Krankenhaus and Universitätsklinikum Leipzig, Leipzig, Germany
- ††GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy
- ‡‡Saint Luke’s Mid America Heart Institute, Kansas City, Missouri
- §§Medtronic, Santa Rosa, California
- ‖‖Massachusetts General Hospital, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. John R. Laird, UC Davis Vascular Center, Lawrence J. Ellison Ambulatory Care Center, 4860 Y Street, Suite 3400, Sacramento, California 95817.
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)
This study was funded by Medtronic, Santa Rosa, California. Dr. Laird has received research grants from W.L Gore and Medtronic; and has served as a compensated consultant/advisory board member for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, and Medtronic. Dr. Schneider is chief medical officer for Intact Vascular; has received modest royalties from Cook Medical; and has served on the scientific advisory boards without compensation of Medtronic, Abbott Vascular, and Cardinal. Dr. Tepe has received research grants from and is a compensated advisory board member for Medtronic and B. Braun; and has received support from Biotronik. Dr. Zeller has received speaking honorarium from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, Veryan, and Viva Physicians; is an advisory board member for Medtronic, Spectranetics, Boston Scientific, Bard, Cook, and Gore & Associates; and is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, and ReCor. Dr. Metzger has received hands on proctor fees from Abbott Vascular and TriVascular; has served as a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, and TriVascular; and has received symposium honoraria from Abbott Vascular, Bard, Boston Scientific, and CSI. Dr. Krishnan has served as a compensated consultant for Abbott Vascular, Bard Peripheral Vascular, and Medtronic. Dr. Scheinert has served as a compensated consultant for Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Hemoteq, Medtronic/Covidien, Ostial Inc., TriReme Medical, TriVascular, and Upstream Peripheral Technologies. Dr. Micari has served as a compensated consultant for Medtronic. Dr. Cohen has received research grants from and served as a compensated consultant for Medtronic. Drs. Wang and Hasenbank are full-time salaried employees of Medtronic. Dr. Jaff has served as a noncompensated advisor for Medtronic; has served as a compensated board member of VIVA Physicians, a 501 c 3 not-for-profit education and research organization; and is an equity investor of PQ Bypass and Vascular Therapies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Mehdi H. Shishehbor, DO, MPH, served as Guest Editor for this paper.
- Received August 25, 2015.
- Revision received September 25, 2015.
- Accepted September 25, 2015.
- 2015 American College of Cardiology Foundation