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
| Autor: | Raymond C.K. Chan, Frankie C.C. Tam, Shun-Ling Kong, Kelvin K.W. Chan, Stephen W.L. Lee, Roxana Mehran, Arthur Yung, Hung-Fat Tse, Anthony Y.T. Wong, Simon C.C. Lam, Catherine P. Shea, Michael Haude, Gary S. Mintz, Lei-Wei Zhang, Akiko Maehara, Karl K.Y. Wu |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Coronary Artery Disease 030204 cardiovascular system & hematology Coronary Angiography Prosthesis Design Endothelial progenitor cell Coronary Restenosis 03 medical and health sciences 0302 clinical medicine Percutaneous Coronary Intervention Restenosis Optical coherence tomography Predictive Value of Tests Risk Factors Neointima medicine Humans 030212 general & internal medicine Prospective Studies Dual therapy Aged Endothelial Progenitor Cells Sirolimus Wound Healing medicine.diagnostic_test business.industry Stent Cardiovascular Agents Drug-Eluting Stents Middle Aged medicine.disease Combined Modality Therapy Coronary Vessels Surgery Clinical trial Treatment Outcome Quartile Female Cardiology and Cardiovascular Medicine Nuclear medicine business Tomography Optical Coherence medicine.drug |
| Zdroj: | Circulation. Cardiovascular interventions. 9(7) |
| ISSN: | 1941-7632 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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