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Revised Scientific Summary of Trials in Intravascular Imaging-Guided PCI

HOME DES IVUS (2010)

Methods

The HOME DES IVUS trial was a randomized controlled trial (RCT) evaluating intravascular ultrasound (IVUS)-guided versus angiography-guided percutaneous coronary intervention (PCI) for drug-eluting stent (DES) implantation. Patients with coronary artery disease requiring PCI were randomized to IVUS-guided (n=105) or angiography-guided (n=105) groups to optimize stent deployment and assess clinical outcomes.

Results

  • Primary Endpoint (Target Lesion Failure, TLF): TLF, defined as a composite of cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR), occurred in 11 patients in the IVUS-guided group and 12 in the angiography-guided group (relative risk [RR] 0.92, 95% confidence interval [CI] 0.42–1.98).
  • Statistical Analysis: No significant difference was observed between groups (p > 0.05).

Conclusion

The HOME DES IVUS trial showed comparable TLF rates between IVUS-guided and angiography-guided PCI for DES implantation.

AVIO (2013)

Methods

The AVIO trial was a prospective RCT comparing IVUS-guided versus angiography-guided PCI in patients with complex coronary lesions. A total of 284 patients were randomized equally (n=142 per group) to assess the impact of IVUS on procedural optimization and clinical outcomes.

Results

  • Primary Endpoint (TLF): TLF occurred in 23 patients in the IVUS-guided group and 29 in the angiography-guided group (RR 0.79, 95% CI 0.48–1.30).
  • Statistical Analysis: The difference was not statistically significant, but a trend toward reduced TLF was noted in the IVUS group.

Conclusion

The AVIO trial demonstrated a non-significant trend toward reduced TLF with IVUS-guided PCI compared to angiography-guided PCI in complex coronary lesions.

RESET (2013)

Methods

The RESET trial was an RCT investigating IVUS-guided versus angiography-guided PCI with DES implantation. Patients (n=543) were randomized to IVUS-guided (n=269) or angiography-guided (n=274) groups, focusing on clinical outcomes in a broad PCI population.

Results

  • Primary Endpoint (TLF): TLF occurred in 12 patients in the IVUS-guided group and 20 in the angiography-guided group (RR 0.61, 95% CI 0.30–1.23).
  • Statistical Analysis: The reduction in TLF was not statistically significant but suggested a favorable trend for IVUS guidance.

Conclusion

The RESET trial showed a non-significant trend toward reduced TLF with IVUS-guided PCI compared to angiography-guided PCI for DES implantation.

AIR-CTO (2015)

Methods

The AIR-CTO trial was an RCT evaluating IVUS-guided versus angiography-guided PCI in patients with chronic total occlusion (CTO) lesions. A total of 230 patients were randomized equally (n=115 per group) to assess the impact of IVUS on procedural success and clinical outcomes in CTO interventions.

Results

  • Primary Endpoint (TLF): TLF occurred in 21 patients in the IVUS-guided group and 26 in the angiography-guided group (RR 0.81, 95% CI 0.48–1.35).
  • Statistical Analysis: The difference was not statistically significant.

Conclusion

The AIR-CTO trial indicated a non-significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI in CTO lesions.

Kim et al (2015)

Methods

This RCT compared optical coherence tomography (OCT)-guided versus angiography-guided PCI, focusing on stent strut coverage and clinical outcomes. Patients (n=117) were randomized to OCT-guided (n=58) or angiography-guided (n=59) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 2 patients in the OCT-guided group and 3 in the angiography-guided group (RR 0.68, 95% CI 0.12–3.91).
  • Statistical Analysis: The low event rate and wide CI indicate no significant difference between groups.

Conclusion

The trial by Kim et al showed comparable TLF rates between OCT-guided and angiography-guided PCI, with low event rates in both groups.

Tan et al (2015)

Methods

This RCT investigated IVUS-guided versus angiography-guided PCI in elderly patients with unprotected left main coronary artery (LMCA) lesions. A total of 123 patients were randomized to IVUS-guided (n=61) or angiography-guided (n=62) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 8 patients in the IVUS-guided group and 17 in the angiography-guided group (RR 0.48, 95% CI 0.22–1.03).
  • Statistical Analysis: The reduction in TLF approached statistical significance.

Conclusion

The trial by Tan et al demonstrated a notable, near-significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI in elderly patients with LMCA lesions.

CTO-IVUS (2015)

Methods

The CTO-IVUS trial was an RCT assessing IVUS-guided versus angiography-guided PCI in CTO lesions with various DES types. A total of 402 patients were randomized equally (n=201 per group).

Results

  • Primary Endpoint (TLF): TLF occurred in 5 patients in the IVUS-guided group and 14 in the angiography-guided group (RR 0.36, 95% CI 0.13–0.97).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.05).

Conclusion

The CTO-IVUS trial showed a significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI in CTO lesions.

OCTACS (2015)

Methods

The OCTACS trial was an RCT evaluating OCT-guided versus angiography-guided PCI with Nobori stent implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI). Patients (n=85) were randomized to OCT-guided (n=40) or angiography-guided (n=45) groups.

Results

  • Primary Endpoint (TLF): No TLF events occurred in the OCT-guided group, compared to 2 in the angiography-guided group (RR 0.22, 95% CI 0.01–4.54).
  • Statistical Analysis: The low event rate precluded definitive conclusions, but a trend favored OCT guidance.

Conclusion

The OCTACS trial showed no TLF events with OCT-guided PCI and a low event rate with angiography-guided PCI in NSTEMI patients, suggesting a favorable trend for OCT.

DOCTORS (2016)

Methods

The DOCTORS trial was an RCT assessing OCT-guided versus angiography-guided PCI in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). A total of 240 patients were randomized equally (n=120 per group).

Results

  • Primary Endpoint (TLF): TLF occurred in 3 patients in the OCT-guided group and 2 in the angiography-guided group (RR 1.50, 95% CI 0.26–8.82).
  • Statistical Analysis: No significant difference was observed due to low event rates.

Conclusion

The DOCTORS trial demonstrated comparable TLF rates between OCT-guided and angiography-guided PCI in NSTE-ACS patients.

ROBUST (2018)

Methods

The ROBUST trial was a multicenter RCT evaluating OCT-guided versus angiography-guided PCI in primary PCI settings. Patients (n=201) were randomized to OCT-guided (n=105) or angiography-guided (n=96) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 5 patients in the OCT-guided group and 1 in the angiography-guided group (RR 4.57, 95% CI 0.64–38.43).
  • Statistical Analysis: The higher TLF rate in the OCT group was not statistically significant.

Conclusion

The ROBUST trial showed a non-significant increase in TLF with OCT-guided PCI compared to angiography-guided PCI in primary PCI settings.

Liu et al (2019)

Methods

This single-center RCT evaluated IVUS-guided versus angiography-guided DES implantation in patients with unprotected LMCA lesions. A total of 336 patients were randomized to IVUS-guided (n=167) or angiography-guided (n=169) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 22 patients in the IVUS-guided group and 37 in the angiography-guided group (RR 0.60, 95% CI 0.37–0.97).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.05).

Conclusion

The trial by Liu et al demonstrated a significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI in patients with LMCA lesions.

IVUS-XPL (2020)

Methods

The IVUS-XPL trial was an RCT providing 5-year follow-up data on IVUS-guided versus angiography-guided DES implantation. A total of 1400 patients were randomized equally (n=700 per group).

Results

  • Primary Endpoint (TLF): TLF occurred in 36 patients in the IVUS-guided group and 70 in the angiography-guided group (RR 0.51, 95% CI 0.35–0.76).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.001).

Conclusion

The IVUS-XPL trial showed a significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI over 5 years.

ILUMIEN III (2021)

Methods

The ILUMIEN III trial was an RCT comparing OCT-guided, IVUS-guided, and angiography-guided PCI. Patients (n=431) were randomized to imaging-guided (OCT/IVUS, n=289) or angiography-guided (n=142) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 8 patients in the imaging-guided group and 2 in the angiography-guided group (RR 1.97, 95% CI 0.42–9.13).
  • Statistical Analysis: No significant difference was observed, with wide CIs indicating limited power.

Conclusion

The ILUMIEN III trial showed comparable TLF rates between imaging-guided (OCT/IVUS) and angiography-guided PCI, with no significant difference.

ULTIMATE (2021)

Methods

The ULTIMATE trial was an RCT providing 3-year outcomes for IVUS-guided versus angiography-guided DES implantation. A total of 1423 patients were randomized to IVUS-guided (n=714) or angiography-guided (n=709) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 47 patients in the IVUS-guided group and 76 in the angiography-guided group (RR 0.61, 95% CI 0.43–0.87).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.01).

Conclusion

The ULTIMATE trial demonstrated a significant reduction in TLF with IVUS-guided PCI compared to angiography-guided PCI over 3 years.

ISIGHT (2021)

Methods

The ISIGHT trial was an RCT comparing OCT-guided or IVUS-guided PCI versus angiography-guided PCI. Patients (n=150) were randomized to imaging-guided (n=101) or angiography-guided (n=49) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 6 patients in the imaging-guided group and 3 in the angiography-guided group (RR 0.97, 95% CI 0.25–3.72).
  • Statistical Analysis: No significant difference was observed due to low event rates and small sample size.

Conclusion

The ISIGHT trial showed comparable TLF rates between imaging-guided (OCT/IVUS) and angiography-guided PCI.

RENOVATE-COMPLEX-PCI (2023)

Methods

The RENOVATE-COMPLEX-PCI trial was an RCT evaluating imaging-guided (IVUS/OCT) versus angiography-guided PCI in complex coronary lesions. A total of 1639 patients were randomized to imaging-guided (n=1092) or angiography-guided (n=547) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 76 patients in the imaging-guided group and 60 in the angiography-guided group (RR 0.63, 95% CI 0.46–0.88).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.01).

Conclusion

The RENOVATE-COMPLEX-PCI trial demonstrated a significant reduction in TLF with imaging-guided (IVUS/OCT) PCI compared to angiography-guided PCI in complex coronary lesions.

ILUMIEN IV (2023)

Methods

The ILUMIEN IV trial was an RCT comparing OCT-guided versus angiography-guided PCI. A total of 2487 patients were randomized to OCT-guided (n=1233) or angiography-guided (n=1254) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 76 patients in the OCT-guided group and 86 in the angiography-guided group (RR 0.90, 95% CI 0.67–1.21).
  • Statistical Analysis: No significant difference was observed, but a trend favored OCT guidance.

Conclusion

The ILUMIEN IV trial showed a non-significant trend toward reduced TLF with OCT-guided PCI compared to angiography-guided PCI.

OCTOBER (2023)

Methods

The OCTOBER trial was an RCT comparing OCT-guided versus angiography-guided PCI in complex bifurcation lesions. A total of 1201 patients were randomized to OCT-guided (n=600) or angiography-guided (n=601) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 59 patients in the OCT-guided group and 83 in the angiography-guided group (RR 0.71, 95% CI 0.52–0.97).
  • Statistical Analysis: The reduction in TLF was statistically significant (p < 0.05).

Conclusion

The OCTOBER trial demonstrated a significant reduction in TLF with OCT-guided PCI compared to angiography-guided PCI in complex bifurcation lesions.

GUIDE DES (2023)

Methods

The GUIDE DES trial was an RCT comparing IVUS-guided versus angiography-guided PCI. A total of 1528 patients were randomized to IVUS-guided (n=765) or angiography-guided (n=763) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 29 patients in each group (RR 1.00, 95% CI 0.60–1.65).
  • Statistical Analysis: No difference was observed between groups.

Conclusion

The GUIDE DES trial showed comparable TLF rates between IVUS-guided and angiography-guided PCI.

MISTIC (2020)

Methods

The MISTIC trial was a randomized non-inferiority trial comparing optical frequency domain imaging (OFDI)-guided versus IVUS-guided PCI with biolimus A9-eluting stents in patients with coronary artery disease. A total of 109 patients were randomized to OFDI-guided (n=54) or IVUS-guided (n=55) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 3 patients in the OFDI-guided group and 4 in the IVUS-guided group (RR 0.76, 95% CI 0.18–3.27).
  • Statistical Analysis: No significant difference was observed due to low event rates and small sample size.

Conclusion

The MISTIC trial showed comparable TLF rates between OFDI-guided and IVUS-guided PCI with biolimus A9-eluting stents.

OPINION (2017)

Methods

The OPINION trial was an RCT comparing OFDI-guided versus IVUS-guided PCI in patients with coronary artery disease. A total of 829 patients were randomized to OFDI-guided (n=414) or IVUS-guided (n=415) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 21 patients in the OFDI-guided group and 19 in the IVUS-guided group (RR 1.11, 95% CI 0.61–2.02).
  • Statistical Analysis: No significant difference was observed between groups.

Conclusion

The OPINION trial demonstrated comparable TLF rates between OFDI-guided and IVUS-guided PCI in patients with coronary artery disease.

OCTIVUS (2023)

Methods

The OCTIVUS trial was an RCT comparing OCT-guided versus IVUS-guided PCI in patients with coronary artery disease requiring DES implantation. A total of 2008 patients were randomized to OCT-guided (n=1005) or IVUS-guided (n=1003) groups.

Results

  • Primary Endpoint (TLF): TLF occurred in 61 patients in the OCT-guided group and 59 in the IVUS-guided group (RR 1.03, 95% CI 0.73–1.46).
  • Statistical Analysis: No significant difference was observed between groups.

Conclusion

The OCTIVUS trial showed comparable TLF rates between OCT-guided and IVUS-guided PCI in patients with coronary artery disease.