title: Comparison of Aspirin and Naoxintong Capsule () with Adjusted-Dose Warfarin in Elderly Patients with High-Risk of Non-Valvular Atrial Fibrillation and Genetic Variants of Vitamin K Epoxide Reductase.
abstract: OBJECTIVE
  To compared the therapeutic effect of a Chinese patent medicine Naoxintong Capsule (, NXT) and aspirin with adjusted-dose warfarin in Chinese elderly patients (over 65 years) with nonvalvular atrial fibrillation (NVAF) and genetic variants of vitamin K epoxide reductase (VKORC1), who are at high-risk of thromboembolism.
  
  
  METHODS
  A total of 151 patients, with NVAF and AA genotype of VKORC1-1639 (a sensitive genotype to warfarin) and a CHA2DS2-VASc clinical risk score of 2 or above, were chosen for this study. Patients were randomized into two groups and orally treated with a combination of aspirin (100 mg/day) and NXT (1.6 g thrice a day) or adjusted-dose warfarin [international normalized ratio 2.0-3.0). The primary end points including ischemic stroke and death as well as the secondary end points including hemorrhage events were followed up for at least 1 year.
  
  
  RESULTS
  Baseline clinical data and the rates of primary end points were similar between groups. However, the rate of serious bleeding (secondary event) in the combination therapy group was lower than that in the adjusted-dose warfarin group (0% vs. 7.9%, odds ratio: 0.921, 95% confidence interval: 0.862-0.984, P=0.028).
  
  
  CONCLUSIONS
  Aspirin combined with NXT and warfarin displayed comparable rates of primary end point including ischemic stroke and all-cause death during the 1-year follow-up. However, as compared with warfarin, the combination therapy reduced the rate of serious bleeding. Therefore, aspirin combined with NXT might provide an alternative pharmacotherapy in preventing ischemic stroke for elderly patients with NAVF who cannot tolerate warfarin. (No. ChiCTR-TRC-13003596).
authors.affiliation: Department of Internal Medicine, Fujian Provincial Cardiovascular Disease Institute, Provincial Clinical College of Fujian Medical University, Fuzhou, 350001, China.
authors.forename: Huan
authors.initials: H
authors.lastname: Wang
authors.affiliation: Cardiovascular Internal Medicine, Quzhou People's Hospital of Zhejiang Province, Quzhou, Zhejiang Province, 324000, China.
authors.forename: Xiao-Kai
authors.initials: XK
authors.lastname: Zhou
authors.affiliation: Cardiovascular Internal Medicine, the Affiliated Hospital in Putian College of Fujian Province, Putian, Fujian Province, 351100, China.
authors.forename: Li-Fan
authors.initials: LF
authors.lastname: Zheng
authors.affiliation: Department of Internal Medicine, Fujian Provincial Cardiovascular Disease Institute, Provincial Clinical College of Fujian Medical University, Fuzhou, 350001, China.
authors.forename: Xiao-Ying
authors.initials: XY
authors.lastname: Wu
authors.affiliation: Department of Internal Medicine, Fujian Provincial Cardiovascular Disease Institute, Provincial Clinical College of Fujian Medical University, Fuzhou, 350001, China. chenhuiwyd@sina.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Chen
mesh_terms: D000368:Aged; D001241:Aspirin / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000201:enzymology* / Q000235:genetics; D001483:Base Sequence; D002214:Capsules; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D023381:Endpoint Determination; D005260:Female; D014644:Genetic Variation; D006801:Humans; D008297:Male; D012307:Risk Factors; D016896:Treatment Outcome; D064417:Vitamin K Epoxide Reductases / Q000235:genetics*; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; C571443:naoxintong; D014859:Warfarin; D064417:Vitamin K Epoxide Reductases; D001241:Aspirin
keywords: Chinese medicine; alternative medicine; antithrombotic therapy; aspirin combined with Naoxintong; atrial fibrillation; genetic variants; warfarin