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Randomized Controlled Trial
. 2024 Sep 2;20(17):e1086-e1097.
doi: 10.4244/EIJ-D-24-00314.

Optical frequency domain imaging-guided versus intravascular ultrasound-guided percutaneous coronary intervention for acute coronary syndromes: the OPINION ACS randomised trial

Hiromasa Otake  1 , Takashi Kubo  2 , Kiyoshi Hibi  3 , Makoto Natsumeda  4 , Masaru Ishida  5 , Toru Kataoka  6 , Tomofumi Takaya  7 , Masamichi Iwasaki  8 , Shinjo Sonoda  9 , Toshiro Shinke  10 , Gaku Nakazawa  11 , Yu Takahashi  1 , Tetsuya Ioji  12 , Takashi Akasaka  13 , Opinion Acs Investigators
Affiliations
Randomized Controlled Trial

Optical frequency domain imaging-guided versus intravascular ultrasound-guided percutaneous coronary intervention for acute coronary syndromes: the OPINION ACS randomised trial

Hiromasa Otake et al. EuroIntervention. .

Abstract

Background: The clinical benefits of optical frequency domain imaging (OFDI)-guided percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remain unclear.

Aims: We sought to compare intravascular ultrasound (IVUS)- and OFDI-guided PCI in patients with ACS.

Methods: OPINION ACS is a multicentre, prospective, randomised, non-inferiority trial that compared OFDI-guided PCI with IVUS-guided PCI using current-generation drug-eluting stents in ACS patients (n=158). The primary endpoint was in-stent minimum lumen area (MLA), assessed using 8-month follow-up OFDI.

Results: Patients presented with ST-segment elevation myocardial infarction (55%), non-ST-segment elevation myocardial infarction (29%), or unstable angina pectoris (16%). PCI procedural success was achieved in all patients, with comparably low periprocedural complications rates in both groups. Immediately after PCI, the minimum stent area (p=0.096) tended to be smaller for OFDI versus IVUS guidance. Proximal stent edge dissection (p=0.012) and irregular protrusion (p=0.03) were significantly less frequent in OFDI-guided procedures than in IVUS-guided procedures. Post-PCI coronary flow, assessed using corrected Thrombolysis in Myocardial Infarction frame counts, was significantly better in the OFDI-guided group than in the IVUS-guided group (p<0.001). The least squares mean (95% confidence interval [CI]) in-stent MLA at 8 months was 4.91 (95% CI: 4.53-5.30) mm2 and 4.76 (95% CI: 4.35-5.17) mm2 in the OFDI- and IVUS-guided groups, respectively, demonstrating the non-inferiority of OFDI guidance (pnon-inferiority<0.001). The average neointima area tended to be smaller in the OFDI-guided group. The frequency of major adverse cardiac events was similar.

Conclusions: Among ACS patients, OFDI-guided PCI and IVUS-guided PCI were equally safe and feasible, with comparable in-stent MLA at 8 months. OFDI guidance may be a potential option in ACS patients. This study was registered in the Japan Registry of Clinical Trials (jrct.niph.go.jp: jRCTs052190093).

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Conflict of interest statement

T. Akasaka is a medical advisor of Terumo Corporation (employee). The other authors have no conflicts of interest relevant to the contents of this paper to declare.Impact on daily practiceAmong patients with acute coronary syndrome (ACS), optical frequency domain imaging (OFDI)- and intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) were equally safe and feasible, with comparable in-stent minimum lumen areas at 8 months. IVUS-guided PCI may facilitate larger stent sizing than OFDI-guided PCI, whereas OFDI-guided PCI may reduce the risk of stent edge dissection and a final Thrombolysis in Myocardial Infarction flow of <3 following PCI. Our results indicate that given the post-PCI findings, OFDI guidance might be an option for PCI in ACS patients.

Figures

Figure 1
Figure 1. Trial profile of the OPINION ACS study.
ACS: acute coronary syndrome; IVUS: intravascular ultrasound; OFDI: optical frequency domain imaging; PCI: percutaneous coronary intervention; mITT: modified intention-to-treat; PPS: per protocol set
Figure 2
Figure 2. TIMI flow analysis.
A) TIMI flow grade 3. B) Corrected TIMI frame count. C) Correlation between irregular protrusion volume and corrected TIMI frame count. IVUS: intravascular ultrasound; OFDI: optical frequency domain imaging; PCI: percutaneous coronary intervention; TIMI: Thrombolysis in Myocardial Infarction
Central illustration
Central illustration. OFDI versus IVUS in percutaneous coronary intervention for acute coronary syndrome.
A) OPINION ACS: study design and features of OFDI-guided PCI. B) Primary endpoint result. ACS: acute coronary syndrome; IVUS: intravascular ultrasound; MLA: minimum lumen area; NSTEMI: non-ST-segment elevation myocardial infarction; OFDI: optical frequency domain imaging; PCI: percutaneous coronary intervention; STEMI: ST-segment elevation myocardial infarction; TIMI: Thrombolysis in Myocardial Infarction
See this image and copyright information in PMC

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