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

Drug-coated Balloons for the Treatment of Coronary In-stent Restenosis: A Multicentre, Randomised Controlled Clinical Study

DOI: 10.4244/EIJ-D-19-00051

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

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, 6-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 1 year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (P>0.99), target lesion revascularisation 7.7% vs. 10.0% (P=0.89), and stent thrombosis 0% vs. 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 6 months.

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