Evaluation of Early Healing Profile and Neointimal Transformation Over 24 Months Using Longitudinal Sequential Optical Coherence Tomography Assessments and 3-Year Clinical Results of the New Dual-Therapy Endothelial Progenitor Cell Capturing Sirolimus-Eluting Combo Stent: The EGO-Combo Study. (July 2016)

• Record Type: Journal Article
• Authors: Lee, Stephen W.L.; Lam, Simon C.C.; Tam, Frankie C.C.; Chan, Kelvin K.W.; Shea, Catherine P.; Kong, Shun-Ling; Wong, Anthony Y.T.; Yung, Arthur; Zhang, Lei-Wei; Tse, Hung-Fat; Wu, Karl K.Y.; Chan, Raymond; Haude, Michael; Mehran, Roxana; Mintz, Gary S.; Maehara, Akiko
• Is Part Of: Circulation. Volume 9:Number 7(2016)
• Publication Date: 2016-07
• Subjects: coronary disease -- drug-eluting stents -- optical coherence tomography -- sirolimus -- stents; Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.115.003469
• Languages: English
• ISSNs: 1941-7640

Abstract

Abstract : Background—: Current monotherapy drug-eluting stents are associated with impaired healing, neoatherosclerosis, and late stent thrombosis. The healing profile and neointimal transformation of the first dual-therapy endothelial progenitor cell–capturing sirolimus-eluting stent are unknown. Methods and Results—: In this prospective, single-center study, 61 patients treated with the Combo stent had optical coherence tomography at baseline, early follow-up (4 monthly groups in a 1:2:2:1 ratio from 2 to 5 months), 9 months, and 24 months. Optical coherence tomography early strut coverage increased from 77.1% to 92.5% to 92.7% to 94.9% between 2 and 5 months. At 9 months, the major adverse cardiac event rate was 1.64%, and angiographic in-stent late loss was 0.24 mm (0.08–0.40). The 36-month major adverse cardiac event rate was 3.3%. From 9 to 24 months, neointimal regression was confirmed by optical coherence tomography: neointimal thickness (median [first quartile and third quartile]), 0.14 mm (0.08 and 0.21) versus 0.12 mm (0.07 and 0.19), P <0.001; neointimal volume, 29.9 mm 3 (22.1 and 43.2) versus 26.2 mm 3 (19.6 and 35.8), P =0.003; and percent neointimal volume, 17.8% (12.2 and 21.2) versus 15.7% (11.2 and 19.4), P =0.01. No definite or probable late stent thrombosis was recorded. Conclusions—: With additional endothelial progenitor cell–capturing technology, the Combo stent exhibits a unique late neointimal regression (from 9 to 24 months) that has not been reported in any drug-eluting stents, translating into good 36-month clinical results with minimal restenosis and no late stent thrombosis. This is the first study testing the concept of using a longitudinal sequential optical coherence tomography protocol to continuously document early healing profile and late neointimal transformation, predicting long-term outcomes of a new novel stent platform. Clinical Trial Registration—: URL:http://www.clinicaltrials.gov . Unique identifiers: NCT01274234, NCT01756807, and NCT02263313. Abstract : Supplemental Digital Content is available in the text.