Author + information
- Ling tao1,
- Zhanquan LI2,
- Zhiyong Yin3,
- Wenhua Lin4,
- Yin Liu5,
- Hui Li6,
- Bo Yu7,
- Wei Li8,
- helen lau9 and
- Bo Xu10
- 1The First Affiliated Hospital of The Fourth Military Medical University, Xian, Shanxi, China
- 2The People's Hospital of Liaoning Province, Shenyang, China
- 3The First Affiliated Hospital of The Fourth Military Medical University, Xi'an, Shanxi, China
- 4Teda International Cardiovascular Hospital, Tianjin, Tianjin, China
- 5Tianjin Chest Hospital, Tianjin, China
- 6Daqing Oilfields General Hospital, Daqing, Heilongjiang, China
- 7The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
- 8Medical Research & Biometrics Center of National Center for Cardiovascular Disease, Beijing, Beijing, China
- 9OrbusNeich Medical Co. Ltd., Hong Kong, Hong Kong, China
- 10Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China, Beijing, Beijing, China
We sought to evaluate the angiographic efficacy and clinical safety and effectiveness of the combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) in a randomized trial designed to enable its approval by the China Food and Drug Administration.
RECOVERY is a multicenter randomized controlled trial comparing the Combo bio-engineered stent with the polymer-free sirolimus-eluting Nano stent (PF-SES) (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary artery lesions [NCT02542007]. The primary endpoint is 9-month angiographic in-segment late loss, powered for non-inferiority testing. Secondary endpoints include the 1-year rates of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization, TLF components, and ARC defined definite/probable stent thrombosis.
A total of 433 patients were randomly assigned in a 1:1 ratio to the treatment with Combo stent or the treatment with PF-SES between May, 2015 and May, 2016 at 16 centers in China. Compliance rates for clinical follow-ups were 100% at 30 days, 99.8% at 6 months, and 100% at 1 year, and 88% for angiographic follow-up at 9 months. The baseline clinical, angiographic, and procedural characteristics were well balanced. The primary and secondary endpoint data will be presented at TCT2017.
RECOVERY is the first randomized trial to evaluate the safety and efficacy of Combo bio-engineered stent vs. the PF-SES, both based on 316L stainless steel platforms and abluminally coated with sirolimus. Combo features a unique bio-engineered double coating consisting of an abluminal biodegradable polymer for the delivery of sirolimus, combined with a circumferentially immobilized EPC capturing antibody, whereas the SES comparator is polymer-free.
CORONARY: Stents: Drug-Eluting