Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial

Takashi Muramatsu, Yukio Ozaki, Mamoru Nanasato, Masato Ishikawa, Ryo Nagasaka, Masaya Ohota, Yosuke Hashimoto, Yu Yoshiki, Hidemaro Takatsu, Katsuyoshi Ito, Hiroki Kamiya, Yukihiko Yoshida, Toyoaki Murohara, Hideo Izawa, MISTIC-1 Investigators, Takashi Muramatsu, Yukio Ozaki, Mamoru Nanasato, Masato Ishikawa, Ryo Nagasaka, Masaya Ohota, Yosuke Hashimoto, Yu Yoshiki, Hidemaro Takatsu, Katsuyoshi Ito, Hiroki Kamiya, Yukihiko Yoshida, Toyoaki Murohara, Hideo Izawa, MISTIC-1 Investigators

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 mm2 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 mm2 in OFDI and IVUS group, respectively (Pnon-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.

Keywords: coronary artery disease; drug-eluting stent; intravascular ultrasound; optical coherence tomography; percutaneous coronary intervention.

Conflict of interest statement

None.

Figures

Figure 1.
Figure 1.
Study flow diagram of the MISTIC-1 trial (The Multimodality Imaging Study in Cardiology cohort 1). *The patient underwent optical frequency domain imaging (OFDI) of 2 lesions at the 8-mo follow-up. IVUS indicates intravascular ultrasound; and PCI, percutaneous coronary intervention.
Figure 2.
Figure 2.
Neointimal healing score at the 8-mo follow-up.A, Box plot and (B) cumulative frequency distribution curve. IVUS indicates intravascular ultrasound; OFDI, optical frequency domain imaging; and PCI, percutaneous coronary intervention.
Figure 3.
Figure 3.
In-segment minimum lumen area at the 8-mo follow-up.A, Box plot and (B) cumulative frequency distribution curve. IVUS indicates intravascular ultrasound; MLA, minimum lumen area; OFDI, optical frequency domain imaging; and PCI, percutaneous coronary intervention.
Figure 4.
Figure 4.
Kaplan-Meier curves.A, Device-oriented composite end point (DoCE) and (B) patient-oriented composite end point (PoCE). DoCE is a composite of cardiovascular mortality, target-vessel myocardial infarction, or clinically driven target-lesion revascularization, whereas PoCE is a composite of all-cause mortality, all myocardial infarction, or all revascularization. IVUS indicates intravascular ultrasound; MI, myocardial infarction; OFDI, optical frequency domain imaging; and PCI, percutaneous coronary intervention.

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