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. 2022 May 11;9:854554. doi: 10.3389/fcvm.2022.854554

Table 2.

Studies performed for a comparison between OCT and angiography for percutaneous coronary intervention (PCI) optimization.

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