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

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/).

Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R).

AIMS: The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). METHODS AND RESULTS: A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. CONCLUSIONS: GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R.

AIMS: The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R). METHODS AND RESULTS: Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001. CONCLUSIONS: cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.