Early healing after treatment of coronary lesions by thin strut everolimus, or thicker strut biolimus eluting bioabsorbable polymer stents: The SORT-OUT VIII OCT study.

ABSTRACT

AIMS: Early healing after drug-eluting stent (DES) implantation may reduce the risk of stent thrombosis. The aim of this study was to compare patterns of early healing after implantation of the thin strut everolimus-eluting Synergy DES (Boston Scientific) or the biolimus-eluting Biomatix Neoflex DES (Biosensors). METHODS AND RESULTS: A total of 160 patients with the chronic or acute coronary syndrome were randomized 11 to Synergy or Biomatrix DES. Optical coherence tomography (OCT) was performed at baseline and at either 1- or 3-month follow-up. The primary endpoint was a coronary stent healing index (CSHI), a weighted index of strut coverage, neointimal hyperplasia, malapposition, and extrastent lumen. A total of 133 cases had OCT follow-up and 119 qualified for matched OCT analysis. The median CSHI score did neither differ significantly between the groups at 1 month Synergy 8.0 (interquartile range [IQR] 3.0; 14.0) versus Biomatrix 8.5 (IQR 4.0; 15.0) (p = 0.47) nor at 3 months Synergy 6.5 (IQR 2.0; 13.0) versus Biomatrix 6.0 (IQR 4.0; 11.0) (p = 0.83). Strut coverage was 84.6% (IQR 72.0; 97.9) for Synergy versus 77.6% (IQR 70.1; 90.3) for Biomatrix (p = 0.15) at 1 month and 90.3% (IQR 79.0; 98.8) (Synergy) versus 83.9% (IQR 77.5; 92.6) (Biomatrix) (p = 0.068) at 3 months. Pooled 1- and 3-month coverage was 88.6% (IQR 74.4; 98.4) for Synergy compared with 80.7% (IQR 73.2; 90.8) for Biomatrix (p = 0.02). CONCLUSIONS: The early healing response after treatment with the Synergy or Biomatrix DES did not differ significantly as determined by a healing index. The Synergy DES showed overall better early stent strut coverage.