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Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis

Supplemental Digital Content is available in the text. 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.