Abstract

Aim: This study aimed to understand if intracoronary imaging-guided optimization is useful for improving the acute success of scaffold deployment versus angiography-guided optimization. Methods: The 162 patients randomized to bioresorbable scaffold implant were allocated 1:1 to either an imaging-guided or angiography-guided optimization strategy, with each arm having a final optical coherence tomography acquisition, performed blind to the operator in the angiography arm. Further optimization was guided by prespecified criteria (underexpansion, presence of significant malapposition, edge dissection and any residual stenosis) in the imaging-guided arm. Minimal scaffolding area was the primary end-point. Scaffold expansion, malapposition, an optimal-result composite and target lesion failure at 12 months were secondary endpoints. Results: The minimal scaffold area was larger with imaging guidance (7.18 versus 6.37 mm2, mean difference 0.81, 95% CI 0.39 to 1.24; p<0.001), and the scaffold expansion index was higher (0.84 versus 0.77; p<0.001). There were increases in imaging guidance-use post-dilatation (75 versus 33%), and in absence of significant acute malapposition (11 versus 43%), as well as in the achievement of optimal-result composite (53 versus 26%) (all p<0.001). Although numerically fewer failed with imaging guidance over 12 months, there was no difference between two groups (imaging guidance, 7.4% vs. 14.8%; p = 0.21). Conclusion: In addition to finding scaffold dimensions larger by intracoronary imaging, there was less malapposition and a higher rate of an optimal acute result with intracoronary imaging than with angiography. There was no powering for clinical outcomes in the study. These data advance the use of intracoronary imaging to improve the use of bioresorbable scaffolding.

Keywords: Bioresorbable scaffold, Optical coherence tomography, Intracoronary imaging, Percutaneous coronary intervention, Malapposition