Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study.

Ueki, Yasushi; Räber, Lorenz; Otsuka, Tatsuhiko; Rai, Himanshu; Losdat, Sylvain; Windecker, Stephan; Garcia-Garcia, Hector M; Landmesser, Ulf; Koolen, Jacques; Byrne, Robert; Haude, Michael; Joner, Michael (2020). Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study. Circulation. Cardiovascular interventions, 13(3), e008657. American Heart Association 10.1161/CIRCINTERVENTIONS.119.008657

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BACKGROUND

The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia.

METHODS

Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or ≥0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography.

RESULTS

Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL ≥0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53±0.68 mm2) compared with those with LLL ≥0.5 mm (1.48±1.20 mm2; P<0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47±0.33 mm2) compared with patients with LLL ≥0.5 mm (1.68±0.34 mm2; P=0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63±1.23 mm2; calcified: 0.81±1.44 mm2; and fibrous: 1.20±1.52 mm2; P <0.001), while there was no difference with regards to neointimal hyperplasia area (P=0.132).

CONCLUSIONS

In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504.

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