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

2024; Oxford University Press; Volume: 45; Issue: 43 Linguagem: Inglês

10.1093/eurheartj/ehae521

1522-9645

Ulf Landmesser, Ziad A. Ali, Akiko Maehara, Mitsuaki Matsumura, Richard Shlofmitz, Giulio Guagliumi, Matthew J. Price, Jonathan Hill, Takashi Akasaka, Francesco Prati, Hiram G Bezerra, William Wijns, David M. Leistner, Paolo Canova, F Alfonso, Franco Fabbiocchi, Giuseppe Calligaris, Rohit M. Oemrawsingh, Stephan Achenbach, Carlo Trani, Balbir Singh, Robert McGreevy, Robert W. McNutt, Shih‐Wa Ying, Jana Buccola, Gregg W. Stone,

Aortic aneurysm repair treatments

Abstract 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.