Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months.

AIMS: The aim of this study was to investigate the impact of dual antiplatelet therapy (DAPT) termination on late and very late scaffold thrombosis (ScT) in patients treated with the Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: Data from the registries of three centres were pooled (808 patients). To investigate the effect of DAPT termination on ScT after a minimum of six months, we selected a subgroup ("DAPT study cohort" with 685 patients) with known DAPT status >6 months and excluded the use of oral anticoagulants and early ScT. In this cohort, definite/probable ScT incidence for the period on DAPT was compared to ScT incidence after DAPT termination. ScT incidence was 0.83 ScT/100 py with 95% confidence interval (CI): 0.34-1.98. After DAPT termination, the incidence was higher (1.77/100 py; 95% CI: 0.66-4.72), compared to the incidence on DAPT (0.26/100 py, 95% CI: 0.04-1.86; p=0.12) and increased within the month after DAPT termination (6.57/100 py, 95% CI: 2.12-20.38; p=0.01). No very late ScT occurred in patients who continued on DAPT for a minimum of 18 months. CONCLUSIONS: The incidence of late and very late definite/probable ScT was acceptable. The incidence was low while on DAPT but potentially higher when DAPT was terminated before 18 months.

Integrated Biomarker and Imaging Study 3 (IBIS-3) to assess the ability of rosuvastatin to decrease necrotic core in coronary arteries.

AIMS: Statins are highly effective in reducing major adverse clinical events, but the direct effects on coronary plaque composition remain debatable. Our aim was to mechanistically evaluate the treatment effect of high-intensity statin therapy on compositional coronary plaque changes. METHODS AND RESULTS: The third Integrated Biomarker and Imaging Study (IBIS-3) was a prospective, investigator-initiated, single-centre study. Serial radiofrequency intravascular ultrasound (RF-IVUS) measurements of a predefined non-stenotic segment in a non-culprit coronary artery were performed to evaluate the effect of rosuvastatin (intended dose: 40 mg daily) on necrotic core (NC) volume in patients with stable angina or acute coronary syndrome. Changes in lipid core burden index (LCBI) were evaluated through serial near-infrared spectroscopy (NIRS) imaging in a subset. Serial RF-IVUS (and NIRS) data of a median segment of 41 mm (interquartile range: 32 to 49 mm) were complete in 164 (103) patients. Follow-up measurements were performed at six and 12 months in 30 (26) and 134 (77) patients, respectively. Mean levels of low-density lipoprotein cholesterol decreased by 30%, from 2.49 mmol/l to 1.73 mmol/l at the end of follow-up. High-dose rosuvastatin therapy resulted in a non-significant change of -1.4 mm3 (95% CI: -3.0, 0.1) in NC volume during follow-up (p=0.074). The change in NC percentage of total plaque volume was -1.4% (95% CI: -2.4 to -0.4; p=0.006). A neutral effect was also observed on LCBI. Indications of significant regression of NC volume and LCBI in the highest baseline quartiles were observed, which should cautiously be regarded as hypothesis-generating. CONCLUSIONS: High-intensity rosuvastatin therapy during one year resulted in a neutral effect on NC and LCBI within non-stenotic, non-culprit coronary segments with a relatively low atheroma burden. This study has been registered in The Netherlands Trial Register (NTR) nr. 2872.