Comparison between optical frequency domain imaging and intravascular ultrasound in PCI guidance for Biolimus A9 eluting stent implantation

Abstract

Background It has been reported that intravascular ultrasound (IVUS) guided PCI reduced a risk of major adverse cardiac event compared to conventional angiography guided PCI, while comparison between IVUS-guided and optical frequency domain imaging (OFDI)-guided PCI specifically in long-term clinical outcomes (>1 year) has been unexplored. Purpose We sought to compare imaging surrogates at 8 months and clinical outcomes beyond 1 year after drug-eluting stent implantation between IVUS and OFDI guidance. Methods The MISTIC-1 is a prospective, multi-centre, single-blinded, randomised-controlled, non-inferiority trial comparing OFDI-guided and IVUS-guided PCI using Biolimus A9 eluting Nobori stent. We enrolled patients with stable coronary artery disease who have symptoms or clinically relevant myocardial ischemia. Stent landing zones were selected in the most normal looking sites with largest lumen and without percentage plaque area >50% in IVUS group while without lipidic plaque of >2 quadrants or suggestive thin-cap fibroatheroma in OFDI group. Stent sizing was based on external elastic lamina (EEL) in IVUS group, while by taking 10% or 0.25mm larger than mean lumen diameter at reference sites in OFDI group. Stent optimisation with in-stent minimum lumen area ≥80% of the average lumen area at proximal and distal reference sites was encouraged in both groups. Primary efficacy endpoint is in-segment minimum lumen area (MLA) assessed by OFDI at 8 months. Secondary safety endpoint is a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation. Based on the assumption that mean in-segment MLA at follow-up was 4.5mm2 with a standard deviation of 2.0mm2 in the control (IVUS) group and a non-inferiority limit of 1.2mm2 for OFDI group, sample size was estimated as 48 cases in each group with 5% type I error and 90% statistical power. Results Since June-2014 and August-2016, we prospectively enrolled 109 patients (mean age 70 years, male 78%) with 126 lesions. Baseline patient and lesion characteristics were well balanced and average nominal size and length of stent used did not differ between OFDI-guided and IVUS-guided PCI (3.0 and 19.1mm vs. 3.1 and 19.3mm, respectively). Post-procedural minimum stent area was 6.24mm2 in OFDI group and 6.72mm2 in IVUS group (p=0.20). At 8-month follow-up, in-segment MLA was 4.56mm2 in OFDI group and 4.13mm2 in IVUS group (P for non-inferiority <0.001). During the follow-up (median 4.5 years [1654 days]), incidence rates of major adverse cardiac event were comparable between the two groups (7.4% in OFDI group and 7.3% in IVUS group, hazard ratio 0.96, 95% CI 0.24–3.83, p=0.95). No definite or probable stent thrombosis were documented in both groups. Conclusion OFDI-guided PCI demonstrated comparable results in achieving satisfactory imaging surrogates as well as long-term clinical outcomes after newer generation DES implantation as compared to IVUS-guided PCI. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Suzuken Memorial Foundation