Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis: The OPTIMIS Trial

BACKGROUND: Bioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound. METHODS: Eighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up. RESULTS: Following Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm2; P=0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm2; P=0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm2; P=0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm2; P=0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm2; P=0.35) did not differ significantly. Intravascular ultrasound 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 versus 17.0±3.6 mm2; P=0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm2; P<0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling. CONCLUSIONS: Lesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.