Drug-Coated Balloons for PAD Revascularization

Quick Takes

  • Patients with high-risk peripheral artery disease (PAD) lesions including in-stent restenosis, long lesions, and chronic total occlusion (CTO) are at high risk for adverse outcomes.
  • Use of drug-coated balloons for high-risk PAD lesions is generally associated with good outcomes, especially for long lesions and CTO.
  • Further investigation is needed to identify highly effective and safe therapies for in-stent restenosis of PAD lesions.

Study Questions:

What are the 5-year safety and effectiveness outcomes of a paclitaxel drug-coated balloon (DCB) for the treatment of de novo in-stent restenosis (ISR), long lesions, or chronic total occlusions (CTOs) in patients with peripheral artery disease (PAD)?


The IN.PACT Global Study was a prospective, international, single-arm study of patients with PAD who had undergone revascularization with a DCB for one of three high-risk characteristics: 1) de novo ISR, 2) long lesions of ≥15 cm, and/or 3) CTO (occlusion length ≥5 cm). The authors report on 5-year outcomes of the prespecified imaging cohort from the IN.PACT Global Study. Included patients had intermittent claudication and/or rest pain along with angiographic evidence of an occlusion or stenosis in the superficial femoral artery and/or popliteal artery. Dual antiplatelet therapy was required for 1 month along with indefinite aspirin therapy. The primary endpoint was patency at 12 months with key secondary endpoints of clinically driven target vessel revascularization and a composite safety endpoint of freedom from device- and procedure-related death through 30 days and freedom from major limb amputation or target vessel revascularization through 5 years. All images were independently adjudicated by a core lab.


The overall IN.PACT Global Study enrolled 1,535 patients at 64 global centers. This analysis reports on 417 patients in the imaging cohort, 132 with de novo ISR, 158 with long lesions, and 127 with CTO. Five-year follow-up was completed for 256 patients with median follow-up of 1,800 days (interquartile range, 1,002-1,835 days). Freedom from all-cause mortality was 81.4% in the ISR group, 75.2% in the long lesion group, and 78.2% in the CTO group. Freedom from clinically driven target vessel revascularization was 58.0% in the ISR group, 67.3% in the long lesion group, and 69.8% in the CTO group at 5 years. The cumulative incidence of the composite safety outcome was 56.0% in the ISR group, 65.7% in the long lesion group, and 75.2% in the CTO group.


The authors conclude that long-term safety and effectiveness of DCB therapy in three high-risk cohorts demonstrated low reintervention rates and no safety issues for the long lesion and CTO groups. Rates of de novo ISR and composite safety outcomes were modest in the ISR cohort.


Patients with PAD who require revascularization can be challenging, especially when they present with high-risk features (e.g., ISR, long lesions, and CTO). The safety and efficacy of DCB therapy in these high-risk patients with PAD has been debated. The results of this 5-year imaging subcohort study provide reassurance that DCB has high effectiveness and a good safety profile, particularly for patients with long lesions and/or CTO. Outcomes were less favorable for patients with ISR, potentially due to differences in plaque characteristics between de novo and restenotic plaque. Furthermore, all patients in this study used dual antiplatelet therapy, so the impact of dual pathway inhibition (rivaroxaban 2.5 mg twice daily plus aspirin ≤100 mg daily) remains unknown.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and SIHD, Interventions and Imaging, Interventions and Vascular Medicine, Chronic Angina

Keywords: Angioplasty, Balloon, Balloon Occlusion, Diagnostic Imaging, Coronary Occlusion, Coronary Restenosis, Intermittent Claudication, Platelet Aggregation Inhibitors, Myocardial Revascularization, Peripheral Arterial Disease, Stents, Vascular Diseases

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