The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss. (April 2018)

• Record Type: Journal Article
• Authors: Lee, Stephen W.L.; Tam, Frankie C.C.; Lam, Simon C.C.; Kong, Shun-Ling; Shea, Catherine P.; Chan, Kelvin K.W.; Wong, Michael K.L.; Chan, Michael P.H.; Wong, Anthony Y.T.; Yung, Arthur S.Y.; Lam, Yui-Ming; Zhang, Lei-Wei; Wu, Karl K.Y.; Mintz, Gary S.; Maehara, Akiko
• Is Part Of: Circulation. Volume 11:Number 4(2018)
• Publication Date: 2018-04
• Subjects: drug-eluting stents -- myocardial infarction -- polymers -- sirolimus -- zotarolimus; Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.117.006034
• Languages: English
• ISSNs: 1941-7640

Abstract

Abstract : Background—: Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer. Methods and Results—: Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9–eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9–eluting stent at 2 to 6 months ( P <0.001) and less variance of percent coverage at 9 months, 99.7% (interquartile range, 99.1–100) versus 99.6% (interquartile range, 96.8–99.9; difference, 0.10; 95% confidence interval, 0.00–1.05; P <0.001). No significant difference was observed in major adverse cardiac events or angiographic end points. Conclusions—: Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9–eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small sample size. Clinical Trial Registration—: URL:https://www.clinicaltrials.gov . Unique identifier: NCT01742507. Abstract : Supplemental Digital Content is available in the text.