Table 3.
Study/Journal/Year/Design | Sample size | Primary end point | Stent sizing criteria in OCT guidance | Result | Conclusion |
---|---|---|---|---|---|
Habara et al. (21)/Circulation: Cardiovascular interventions/2012/ RCT, single center |
• N = 70 • OCT group n = 35 IVUS group n = 35 |
Stent expansion analyzed by IVUS | Lumen diameter | - Focal and diffuse stent expansion were smaller (64.7 vs. 80.3%, 84.2 vs. 98.8%, P < 0.05, respectively), in OCT vs IVUS group - Minimum and Mean stent area was smaller (6.1 vs. 7.1 mm2 & 7.5 ± 2.5 vs. 8.7 ± 2.4 mm) under OCT vs. IVUS |
OCT guidance for stent implantation was associated with smaller stent expansion compared with conventional IVUS guidance |
OPUS-CLASS (22)/JACC: Cardiovascular Imaging/2013/ Prospective, multicenter |
• N = 100 • Angiography performed in all • Followed by OCT and IVUS in - Pre-PCI−20 - Pre-& Post PCI-60 - Post PCI follow-up −20 |
Comparison of lumen dimensions measurement with OCT vs. IVUS vs. angiography (QCA) in patient and in phantom model | Lumen diameter | - Mean minimum lumen diameter measured by QCA was significantly smaller than that measured by FD-OCT (1.81 mm2 vs. 1.91 mm; p < 0.001) - The minimum lumen area measured by IVUS was significantly greater than that by FD-OCT (3.68 vs. 3.27 mm2; p < 0.001) - In a phantom model, the mean lumen area according to OCT was equal to the actual lumen area of the phantom model; IVUS overestimated the lumen area |
• OCT provided accurate measurements of coronary lumen with excellent intra-observer reproducibility • OCT is much more sensitive in detecting intrastent tissue protrusion, incomplete stent apposition, stent edge dissection, and intrastent thrombus compared with IVUS |
ILUMIEN II (23)/JACC: Cardiovascular interventions/2015/ Post-hoc analysis of 2 prospective studies |
OCT-guided stenting in patients in the ILUMIEN I, N = 354 vs. IVUS-guided stenting in the ADAPT-DES, N = 586 | Post-PCI stent expansion (%) defined as the MSA divided by the mean reference lumen area | Lumen diameter | Degree of stent expansion was not significantly different between OCT and IVUS guidance 72.8 vs. 70.6%, respectively, p−0.29 | OCT and IVUS guidance resulted in a comparable degree of stent expansion |
OPINION (24)/European Heart Journal/2017/RCT, multicenter, non-inferiority trial | • N = 829 • OCT guided PCI = 414 • IVUS guided PCI n = 415 |
Target vessel failure (TVF) defined as a composite of cardiac death, MI, and ischemia-driven target vessel revascularization until 12 months after the PCI | Lumen diameter | - TVF occurred in 21 (5.2%) undergoing OCT-guided PCI and 19 (4.9%) undergoing IVUS-guided PCI (non-inferiority = 0.042) - Rate of binary restenosis was comparable between OCT-guided PCI and IVUS-guided PCI (in-stent: 1.6 vs. 1.6%, P = 1.00; and in-segment: 6.2 vs. 6.0%, P = 1.00) |
OCT-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI Stent sizes were smaller in the OCT arm compared with the IVUS arm (2.92 vs. 2.99 mm; p = 0.005) |
ILUMIEN III/(17)/Lancet/2016/ RCT, multicenter |
• N = 450 • 158 [35%] in OCT • 146 [32%] in IVUS • 146 [32%] angiographic guidance |
Post-PCI MSA as assessed by OCT | Proximal or distal normal segment EEL diameter (whichever is lesser) rounded down to the nearest 0.25mm | - Final median MSA was 5.79 mm2 with OCT and 5.89 mm2 with IVUS guidance - OCT guidance was non-inferior to IVUS guidance (p = 0.001), but not superior (p = 0.42) - Untreated dissections and major malapposition were significantly less frequent in OCT group compared with IVUS group |
OCT-guided PCI using reference segment EEL-based stent optimization strategy was safe and resulted in similar MSA to that of IVUS-guided PCI |
MISTIC-1 (25)/Circulation: Cardiovascular Interventions/2020/ RCT, multicenter, non-inferiority trial |
• N = 109 • OCT- 54 patients with 62 lesions • IVUS-55 patients with 64 lesions |
In-segment MLA assessed using OCT at the 8-month follow-up | Lumen up-size for OCT guidance (10% or 0.25-mm larger than mean lumen diameter at reference sites) | • Post-procedural minimum stent area was 6.31 mm2 and 6.72 ± 2.08 mm2 in OCT and IVUS group, respectively (P = 0.26) • 8-month follow-up, in-segment MLA was 4.56 & 4.13 mm2 in OCT and IVUS group, respectively (non-inferiority <0.001) |
OCT-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment MLA at 8 months Clinical outcomes at 3 years follow-up did not differ between the two groups |
iSIGHT (19)/Circulation: Cardiovascular Interventions/2021/ RCT |
• N = 156 lesions • OCT [51 lesions (32.7%)] • IVUS [52 lesions (33.3%)] Angiography [53 lesions (34.0%)] |
Stent expansion (MSA ≥ 90% of the average reference lumen area) | • When EEL was visible in ≥180° of the vessel circumference, the reference was sized to the mean EEL diameter • Otherwise, the largest lumen diameter was used |
Stent expansion with OCT guidance (98.01 ± 16.14%) was noninferior to IVUS (91.69 ± 15.75%, non-inferiority <0.001) | Stent expansion with OCT guidance using a dedicated EEL–based sizing strategy was non-inferior to that achieved with IVUS |