The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Coronary interventions

A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis

EuroIntervention 2020;16:e328-e334. DOI: 10.4244/EIJ-D-19-00051

1. Universität Giessen, Giessen, Germany; 2. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; 3. German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Bad Nauheim, Germany; 4. Universitätsklinikum, Ulm, Germany; 5. Charité Campus Virchow Klinikum, Universitätsmedizin, Berlin, Germany; 6. Universitätsklinikum Rostock, Rostock, Germany; 7. Universitätsklinikum Düsseldorf, Düsseldorf, Germany; 8. Clinique Saint Hilaire, Rouen, France; 9. Clinique du Millénaire, Montpellier, France; 10. PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France; 11. Hemoteq AG, Würselen, Germany; 12. Boston Scientific Corporation, Marlborough, MA, USA

Aims: Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please).

Methods and results: AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [−0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups.

Conclusions: In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. Clinical Trials Registration: NCT02151812 (http://clinicaltrials.gov/)

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