Author + information
- Received September 13, 2017
- Revision received February 2, 2018
- Accepted February 13, 2018
- Published online May 21, 2018.
- Antonio Micari, MD, PhDa,∗ (, )
- Marianne Brodmann, MDb,
- Koen Keirse, MDc,
- Patrick Peeters, MDd,
- Gunnar Tepe, MDe,
- Martin Frost, PhDf,
- Hong Wang, MD, MPHg,
- Thomas Zeller, MDh,
- for the IN.PACT Global Study Investigators
- aGVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy
- bDepartment of Internal Medicine, Division of Angiology, Medical University, Graz, Austria
- cDepartment of Vascular Surgery, Regional Hospital Heilig Hart Tienen, Tienen, Belgium
- dImelda Hospital, Bonheiden, Belgium
- eRoMed Klinikum, Department of Diagnostic and Interventional Radiology, Rosenheim, Germany
- fMedtronic, Bakken Research Center BV, Maastricht, the Netherlands
- gMedtronic, Santa Rosa, California
- hUniversitäts-Herzzentrum Freiburg – Bad Krozingen, Bad Krozingen, Germany
- ↵∗Address for correspondence:
Dr. Antonio Micari, Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, Via Corriera 1, 48033 Cotignola (Ravenna), Italy.
Objectives The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials.
Background Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions.
Methods The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months.
Results Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months.
Conclusions This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)
- drug-coated balloon
- femoropopliteal artery
- peripheral artery disease
- target lesion revascularization
This research was supported by Medtronic. Prof. Micari is a compensated consultant for Medtronic and Boston Scientific. Prof. Brodmann has received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and Viva Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Prof. Tepe has received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr. Frost and Dr. Wang are full-time employees of Medtronic. Prof. Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, W.L. Gore & Associates, Medtronic, and Spectranetics; and his clinic has received study funds or funds 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., W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 13, 2017.
- Revision received February 2, 2018.
- Accepted February 13, 2018.
- 2018 The Authors
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.