Optimal Pre-dilatation Treatment before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis. The OPTIMIS trial

Abstract

Introduction: Bioresorbable scaffolds (BRS) have been developed to overcome limitations related to late stent failures of drug-eluting-stents, but previous studies have observed lumen reduction over time after implantation of BRS. The aim of the study was to investigate if lesion preparation with a scoring balloon compared to a standard non-compliant balloon minimizes lumen reduction after implantation of a Magmaris BRS (MgBRS) assessed with optical coherence tomography (OCT) and intravascular ultrasound (IVUS). Method: Eighty-two patients with stable angina pectoris were included and randomized in a ratio 1:1 to lesion preparation with either a scoring balloon or a standard non-compliant balloon prior to implantation of a MgBRS. The primary endpoint was minimal lumen area (MLA) 6 months after MgBRS implantation. Results: Following MgBRS implantation, MLA (6.4 ± 1.6 mm2 vs. 6.3 ± 1.5 mm2, p=0.65), mean scaffold area (7.8 ± 1.5 mm2 vs. 7.5 ± 1.7 mm2, p=0.37), and mean lumen area (8.0 ± 1.6 mm2 vs. 7.7 ± 2.1 mm2, p=0.41) did not differ significantly in patients where the lesions were prepared with scoring vs. standard non-compliant balloon respectively. Six-month angiographic follow-up with OCT and IVUS was available in seventy-four patients. The primary endpoint, 6-months MLA, was significantly larger in lesions prepared with a scoring balloon compared to a standard non-compliant balloon (4.7 ± 1.4 mm2 vs. 3.9 ± 1.9 mm2, p=0.04), whereas mean lumen area (7.2 ± 1.4 mm3 vs. 6.8 ± 2.2, p=0.35) did not differ significantly. IVUS findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8 ± 2.9 mm2 vs. 17.0 ± 3.6 mm2, p=0.62), whereas mean vessel area (17.1 ± 4.4 mm2 vs. 15.7 ± 4.9 mm2, p<0.001) was smaller in lesions prepared with a standard non-compliant balloon due to negative remodeling. Conclusion: Lesion preparation with a scoring balloon prior to implantation of a MgBRS resulted in significantly larger MLA after 6 months due to less negative remodeling compared to lesion preparation with a standard non-compliant balloon. Registration: URL: https://www.clinicaltrials.gov; Unique identifier:NCT04666584.