title: First report of a novel polymer-free dual-drug eluting stent in de novo coronary artery disease: results of the first in human BICARE trial.
abstract: BACKGROUND
  Persistence of stent polymer coating has been associated with incomplete endothelialization, expansive vessel remodeling, neoatherosclerosis, and delayed healing associated with inflammation that may contribute to late adverse events.
  
  
  METHODS
  The BICARE (Lepu Medical, Beijing, China) stent is a novel polymer-free, nanotechnology-based stent eluting sirolimus and probucol. As a first in human feasibility study, patients with a single de novo native coronary stenosis <30 mm in length and with reference vessel diameter from 2.5 to 4.0 mm underwent revascularization with the BICARE stent. The primary endpoint of target lesion failure (TLF) was assessed at 30 days. Secondary endpoints included in-stent late lumen loss and proportion of uncovered or malapposed stent struts by optical coherence tomography at 4-month angiographic surveillance.
  
  
  RESULTS
  Among 32 consecutive patients (age, 55.7 ± 8.7 years; men, 62.5%; diabetes, 18.8%), the average baseline reference vessel diameter and lesion length were 2.85 ± 0.48 mm and 15.0 ± 5.6 mm, respectively. At 30 days there was no occurrence of TLF. At 4 months (angiographic follow-up, N=32), angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1%. Complete strut coverage was 98.2% with 0.2% malapposition among 16,751 analyzed struts. At 18 months, TLF occurred in 3 (9.4%) patients related to repeat revascularization with no adverse safety events identified.
  
  
  CONCLUSIONS
  The preliminary feasibility and safety of a polymer-free, dual-drug eluting stent are demonstrated by absence of early adverse safety events and favorable angiographic suppression of neointimal hyperplasia. Stent imaging suggests favorable healing with extensive stent strut coverage and very low malapposition. These findings further inform comparison with biopermanent polymer DES.
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, People's Republic of China.
authors.forename: Mengyue
authors.initials: M
authors.lastname: Yu
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: Yongjian
authors.initials: Y
authors.lastname: Wu
authors.forename: Hongbing
authors.initials: H
authors.lastname: Yan
authors.forename: Jue
authors.initials: J
authors.lastname: Chen
authors.forename: Jie
authors.initials: J
authors.lastname: Qian
authors.forename: Shubin
authors.initials: S
authors.lastname: Qiao
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.forename: Run-Lin
authors.initials: RL
authors.lastname: Gao
mesh_terms: D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D004338:Drug Combinations; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011341:Probucol / Q000008:administration & dosage*; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D004338:Drug Combinations; D011341:Probucol; D020123:Sirolimus
keywords: drug-eluting stent; first in human trial; polymer; probucol; sirolimus