CLI-randomized study CLI-OPCI (n = 670, 1:1) evaluated the impact of stent implantation guided by angiography and optical coherence tomography (OCT), versus angioplasty guided alone by angiography. All patients who had been subjected to stent placement were then evaluated by angiography.
Arm OCT, after an optimal angiographic result, an intracoronary OCT evaluation was performed. In the event of OCT suboptimal results, an intervention was indicated (post-dilation or additional stent implantation).
The definition of suboptimal results was based on 5 parameters:
1) Edge dissection > 200 microns and longer than 600 microns.
2) Poor stent apposition.
3) Sub-expanding stent (<90% compared with reference segment proximal and distal).
4) Presence of thrombus.
5) Significant residual stenosis (in-stent minimum luminal area
The primary endpoint was based on a combined rate of cardiac death or non-fatal MI at 12 months follow up. In the OCT group, after an acceptable angiographic result, use of OCT identified one of the 5 parameters in 34.7% of cases -“indicating” an intervention- (post-dilation or additional stent implantation). At 12 months, the combined rate of cardiac death and myocardial infarction was lower in the OCT group (6.6 vs. 13%, p = 0.006), at the expense of a lower rate of death in this group (1.2 vs. 4.5%, p = 0.01). No difference in reoperation rates of target vessel and definite stent thrombosis was observed.
These findings suggest: