This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A retrospective case series compared 335 matched pairs of patients undergoing percutaneous coronary intervention (PCI) with either angiographic guidance alone or a combination of angiographic and frequency-domain optical coherence tomography (FD OCT) guidance. Cardiac death or myocardial infarction (MI) were less frequent in patients treated by PCI with a combination of angiographic and FD OCT guidance than in those treated by PCI with angiographic guidance alone over a follow-up period of 1 year. There were 15 cardiac deaths and 29 MIs in the angiography-only group, and 4 cardiac deaths and 18 MIs in the combined angiography and FD-OCT group; odds ratio 0.49; 95% confidence interval 0.25 to 0.96, p=0.037.
4.2 A randomised controlled trial comparing FD OCT against intravascular ultrasound for PCI optimisation in 70 patients reported that there was inferior stent expansion, both focal (65% versus 80%, p=0.002) and diffuse (84% versus 99%, p=0.003), when FD OCT had been used for guidance. PCI guided by FD OCT also showed a significant increase in residual stent-edge plaque burden (51% versus 42%, p<0.001). There were no significant differences in stent apposition.
4.3 In the retrospective case series comparing 335 matched pairs of patients undergoing PCI with either angiographic guidance or a combination of angiographic and FD OCT guidance, FD OCT led to additional interventions (further stenting and additional balloon dilation) in 116 patients (35%).
4.4 In a case series of 40 patients in whom OCT was performed to evaluate ambiguous or intermediate lesions, 60% (24/40) were treated by PCI and 40% (16/40) had PCI deferred. None of the patients for whom PCI was deferred had a coronary event within an average follow-up of 4.6 months.
4.5 The specialist advisers listed a key efficacy outcome as a change in diagnosis or management due to OCT imaging results. They cited as examples identifying culprit or non-culprit plaques in acute coronary syndromes, identifying intracoronary or intra-stent thrombus, identifying dissections and complications after stenting, examining stent deformation and conformation, identifying modes of stent failure including neoatherogenesis, and documenting stent tissue coverage.