Author + information
- Received June 15, 2018
- Revision received November 15, 2018
- Accepted December 4, 2018
- Published online March 4, 2019.
- Gunnar Tepe, MDa,∗ (, )
- Antonio Micari, MD, PhDb,
- Koen Keirse, MDc,
- Thomas Zeller, MDd,
- Dierk Scheinert, MDe,
- Pei Li, PhDf,
- Randy Schmahl, MScg,
- Michael R. Jaff, DOh,
- on behalf of the IN.PACT Global Study Investigators
- aDepartment of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany
- bDepartment of Cardiology, Humanitas Gavazzeni, Bergamo, Italy
- cDepartment of Vascular Surgery, Regional Hospital Heilig Hart Tienen, Tienen, Belgium
- dUniversitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany
- eDivision of Interventional Angiology, University Hospital Leipzig, Leipzig, Germany
- fMedtronic, Minneapolis, Minnesota
- gBakken Research Center, Medtronic, Maastricht, the Netherlands
- hNewton-Wellesley Hospital, Newton, Massachusetts
- ↵∗Address for correspondence:
Dr. Gunnar Tepe, Klinikum Rosenheim, Institut für Diagnostische und Interventionelle, Radiologie Pettenkoferstraße 10, 83022 Rosenheim, Germany.
Objectives This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO).
Background CTOs are difficult to treat, and the optimal intervention remains to be determined.
Methods The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis.
Results The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. Provisional stenting was performed in 46.8% of lesions. The primary safety composite endpoint was achieved by 88.7% of subjects. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months.
Conclusions The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. (IN.PACT Global Clinical Study; NCT01609296)
Funding support was provided by Medtronic. Dr. Tepe received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr. Micari is a compensated consultant for Medtronic. Dr. Keirse has reported that he has no relationships relevant to the contents of this paper to disclose. Dr. Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; has served as a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, and Spectranetics; and has received institutional research support for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, Cardiovascular Systems, Inc., Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. Prof. Scheinert is a compensated consultant for Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Hemoteq, Medtronic, Ostial Inc., TriReme, Medical, and Trivascular. Dr. Li and Mr. Schmahl are full-time employees of Medtronic. Dr. Jaff has served as a noncompensated advisor for Medtronic and Boston Scientific; is an equity investor in PQ Bypass; and is a consultant for Philips/Volcano.
- Received June 15, 2018.
- Revision received November 15, 2018.
- Accepted December 4, 2018.
- 2019 The Authors