Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.

Background and aims

Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial.

Methods

ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions.

Results

A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion.

Conclusions

In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.

CommentIn

doi: 10.1093/eurheartj/ehae626

References:

• Maehara A, Matsumura M, Ali ZA, Mintz GS, Stone GW. IVUS-guided versus OCT-guided coronary stent implantation: a critical appraisal. JACC Cardiovasc Imaging 2017;10:1487–503. 10.1016/j.jcmg.2017.09.008
• Räber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, et al. . Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39:3281–300. 10.1093/eurheartj/ehy285
• Araki M, Park SJ, Dauerman HL, Uemura S, Kim JS, Di Mario C, et al. . Optical coherence tomography in coronary atherosclerosis assessment and intervention. Nat Rev Cardiol 2022;19:684–703. 10.1038/s41569-022-00687-9
• Romagnoli E, Burzotta F, Vergallo R, Gatto L, Biondi-Zoccai G, Ramazzotti V, et al. . Clinical impact of OCT-derived suboptimal stent implantation parameters and definitions. Eur Heart J Cardiovasc Imaging 2023;25:48–57. 10.1093/ehjci/jead172
• Kim BG, Kachel M, Kim JS, Guagliumi G, Kim C, Kim IS, et al. . Clinical implications of poststent optical coherence tomographic findings: severe malapposition and cardiac events. JACC Cardiovasc Imaging 2022;15:126–37. 10.1016/j.jcmg.2021.03.008