Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation

Abstract

Background: Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary. Methods: MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure. Results: A total of 109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled. Postprocedural minimum stent area was 6.31±1.89 and 6.72±2.08 mm 2 in OFDI and IVUS group, respectively ( P =0.26). At the 8-month follow-up, in-segment minimum lumen area was 4.56±1.94 and 4.13±1.86 mm 2 in OFDI and IVUS group, respectively ( P non-inferiority <0.001). Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00–3.14] versus 0.90 [0.00–3.30], respectively; P =0.43). The incidence rate of device-oriented composite end point at 3 years was 7.4% and 7.3% in OFDI and IVUS group, respectively (hazard ratio, 1.05 [95% CI, 0.26–4.18]; P =0.95). Conclusions: OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03292081.

Outcomes of intravascular ultrasound versus optical coherence tomography guided percutaneous coronary angiography: A meta regression‐based analysis

“…Finally, after screening 298 full-text articles, a total of seven studies with 5917 participants were included (2075 patients in the OCT guidance group and 3842 patients in the IVUS guidance group). [18][19][20][21][22][23][24] The quality of the studies included was moderate. Among the seven studies included, half were observational studies with matched cohorts, increasing the potential risk of selection bias.…”

“…[22][23][24] The remaining four were RCTs. [18][19][20][21] Quality assessment findings of the included studies are summarized in Section S3, Figures S1 and S2.…”

“…To our knowledge, this is the first comprehensive meta-analysis that compared clinical outcomes of IVUS-guided PCI with OCT-guided PCI, including the results of the recent MISTIC-1, ILUMIEN III: OPTI-PCI and iSIGHT trials. [19][20][21] Previous meta-analyses have explored the impact of IVUS and OCT but were underpowered because of the limited number of studies present. 25,26 Extending the role of intracoronary imaging, the current meta-analysis provides convincing evidence that OCT and IVUS guided PCI have equivalent clinical cardiovascular outcomes.…”

“…Six out of seven studies reported data on MACE 18,[20][21][22][23][24] and MI. [18][19][20][21]23,24 Cardiac mortality was assessed in four out of seven studies. 18,19,21,24 Six out of seven studies assessed all-cause mortality during short-term follow-up (in-hospital to 30 days) among the OCT and IVUS groups.…”

“…[18][19][20][21]23,24 Cardiac mortality was assessed in four out of seven studies. 18,19,21,24 Six out of seven studies assessed all-cause mortality during short-term follow-up (in-hospital to 30 days) among the OCT and IVUS groups. 18,19,[21][22][23][24] TLR was reported in four studies, 18,20,21,24 ST in three studies, 18,20,24 and stroke was reported in only two studies.…”