Table 2.
Study/Journal/Year/Design | Sample size | Primary end point | Result | Conclusion |
---|---|---|---|---|
CLI-OPCI (12)/Euro-Intervention/2012/ Retrospective, multicenter |
• N = 670 • 335 in the OCT group • 335 in the Angio group |
1-year rate of cardiac death or MI | • OCT group vs. angio group- - Cardiac death (1.2 vs. 4.5%, p = 0.010) - Cardiac death or MI (6.6 vs. 13.0%, p = 0.006) - Composite of cardiac death, MI, or repeat revascularization (9.6 vs. 14.8%, p = 0.044) - Post PCI OCT in the OCT group revealed adverse features requiring further interventions in 34.7% patients (1/3rd) |
OCT guided optimization can improve clinical outcomes of patients undergoing PCI |
CLI-OPCI II (13) (JACC Cardiovasc Imaging)/2015/ Retrospective analysis, multicenter |
1,002 lesions (832 patients) | • 1-year MACE (composite of all-cause mortality, MI and TLR) • Association of sub-optimal stent deployment as assessed by offline OCT with MACE at 1 yr |
• Sub-optimal stent deployment required the presence of at least 1 of the OCT findings- 1. Edge dissection: Presence of a linear rim of tissue with clear separation and a width >200 mm, (<5 mm) to a stent edge 2. Malapposition: stent-adjacent vessel lumen distance >200 mm 3. In-stent minimum lumen area (MLA) <4.5 mm2 4. In-stent MLA <70% of the average reference lumen area 5. Intrastent plaque/thrombus protrusion >500 mm in thickness • Suboptimal stent seen in 31.0% patients • Independent predictors of MACE were In-stent MLA <4.5 mm2 (p−0.040), dissection >200 mm at the distal stent edge (p−0.004), and reference lumen area <4.5 mm2 at either distal (p < 0.001) or proximal (p < 0.001) stent edges |
- Suboptimal stent deployment was associated with an increased risk of MACE - Presence of at least 1 significant criterion for suboptimal OCT stent deployment was confirmed as an independent predictor of MACE (HR: 3.53, p < 0.001) - MACE group had significantly more findings of sub-optimal stent deployment (59.2 vs. 26.9%; p < 0.001) |
OCTACS study (14)/Circulation: Cardiovascular interventions/2015/RCT, Single center | • 100 patients • 1:1 • OCT-guided vs angio-guided Nobori biolimus-eluting DES implantation |
Difference in percentage of uncovered struts in the OCT-guided vs. the angio-guided group at 6-months | OCT-guided PCI resulted in a lower proportion of uncovered struts (4.3 vs. 9.0%, P < 0.01) and more number of completely covered stents (17.5 vs. 2.2%, P = 0.02) | OCT-guided optimization of DES improves strut coverage in comparison with angiographic guidance alone |
ILUMIEN I (15)/European Heart Journal/2015/Prospective, non-randomized, observational | 418 patients (467 stenosis) | • Impact of OCT on physician decision-making • MACE at 30 days (cardiac death, MI and target lesion revascularization) |
• Pre-PCI OCT - Altered strategy in 55% of patients (57% stenosis) - Selecting different stent lengths shorter in 25%, longer in 43% • Post PCI OCT - Unsatisfactory result in 25% of patients (27% stenosis) - 14.5% malapposition - 7.6% under-expansion - 2.7% edge dissection |
- Decision-making was affected by OCT imaging prior to PCI in 55% and post-PCI in 25% patients - MACE events at 30 days were low: death 0.25%, MI 7.7%, repeat PCI 1.7%, and stent thrombosis 0.25% |
DOCTORS (16)/Circulation/2016/ RCT, multicenter |
• N = 240 (NSTEMI-ACS) • 120 in the OCT group • 120 in the Angio group |
FFR post PCI | • Significantly higher FFR in OCT group (0.94 ± 0.04 vs. 0.92 ± 0.05, P = 0.005) compared to angiographic guided group • OCT led to altered procedural strategy in 55% patients • Post-PCI OCT revealed - Stent under-expansion 42% - Stent malapposition 32% - Incomplete lesion coverage in 20% - Edge dissection in 37.5% • Led to the more frequent use of poststent dilation in the OCT-guided group vs. the angiography-guided group (43 vs. 12.5%, P < 0.0001) with lower residual stenosis (7.0 vs. 8.7%, P = 0.01) |
• OCT-guided PCI is associated with higher post procedure FFR • No significant difference in the rate of procedural MI or complications |
ILUMIEN III (17)/Lancet/2016/RCT, multicenter | • N = 450 • 158 [35%] in OCT • 146 [32%] in IVUS • 146 [32%] angiographic guidance • Exclusion—LM or ostial RCA, bypass graft stenosis, CTO, planned two-stent bifurcations, and ISR |
• Post-PCI MSA as assessed by OCT • Tested- - Non-inferiority of OCT guidance to IVUS guidance -Superiority of OCT guidance to angiography guidance - Superiority of OCT guidance to IVUS guidance |
- Final median MSA was 5.79 mm2 with OCT and 5.49 mm2 with angiography guidance. OCT guidance was not superior to angiography guidance (p = 0.12) - Minimum and mean stent expansion was significantly improved by OCT [87.6% and 105.8%] as compared with angiography (82.9%, P = 0.02 and 101.4%, P = 0.001, respectively) - Untreated major dissections at end of procedure and major malapposition were significantly less in OCT guided group (28 and 11%) compared with angiography group (44%, P = 0.006 and 31%, P < 0.0001) |
• OCT guided stent placement was not superior to angiography-guided stent placement in terms of MSA • Minimum and mean stent expansion were significantly greater while untreated major dissections and major malapposition were significantly less in OCT than with angiography-guided PCI |
LONDON PCI COHORT (18)/JACC: Cardiovascular interventions/2018/ Registry (Observational) |
OCT in 1,149 (1.3%) patients, IVUS in 10,971 (12.6%) patients Angiography alone in 75,046 patients | All-cause mortality at a median of 4.8 years | OCT-guided PCI was associated with significantly reduced mortality rates when compared with angiography alone (9.60 vs. 16.80%; p < 0.0001) | OCT-guided PCI was associated with improved MACE and long-term survival compared with angiography-guided PCI |
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) | Stent expansion with OCT guidance (98.01 ± 16.14%) was superior to angiography (90.53 ± 14.84%, P = 0.041) | Stent expansion with OCT guidance was superior to an optimized angiographic strategy |