Worldwide Epidemiology, GlaxoSmithKline Research and Development, 709 Swedeland Road, King of Prussia, PA 19406, USA.
Metabolic Pathways and Cardiovascular Unit, GlaxoSmithKline Research and Development, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK.
Eur Heart J Cardiovasc Pharmacother. 2017 Oct 1;3(4):214-220. doi: 10.1093/ehjcvp/pvx007.
This retrospective chart review was designed to evaluate physician adherence to the prescribing information for fondaparinux regarding adjunctive anticoagulant use during percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome (ACS).
Medical record abstractors at each site obtained information regarding the use of fondaparinux and adjunctive anticoagulants during PCI. Physician adherence to fondaparinux prescribing information regarding the administration of an adjunctive anticoagulant during PCI was estimated using generalized estimating equations. This retrospective study, conducted in 2008-2010, included a total of 1056 patient records from 27 sites across 6 countries (Canada, France, Germany, Greece, Poland, and Sweden). Over 98% of patients had been treated with fondaparinux at the recommended 2.5 mg dose. Use of adjunctive anticoagulant during PCI was 97.5%, giving an adjusted adherence rate of 98.8% (95% confidence interval: 0.97-0.99), with 86.3% of patients receiving unfractionated heparin. Although the sub-group of patients with ST-elevation myocardial infarction who underwent primary PCI was too small to make a definitive conclusion, 70.4% of the 159 patients did not receive fondaparinux immediately prior to (<24 h) or during primary PCI, suggesting that their treating physicians may have been adherent to the prescribing information.
Physician adherence to the prescribing information for adjunctive anticoagulation during PCI in patients with an ACS receiving fondaparinux was high. The results were consistent in each of the six countries and across patient sub-groups.
本回顾性图表分析旨在评估医生在急性冠脉综合征(ACS)患者行经皮冠状动脉介入治疗(PCI)时,是否遵循了磺达肝癸钠的说明书中关于联合使用抗凝剂的建议。
每个研究中心的病历记录员均获取了磺达肝癸钠和 PCI 期间联合使用抗凝剂的相关信息。采用广义估计方程评估了医生在 PCI 期间联合使用磺达肝癸钠时,是否遵循了磺达肝癸钠说明书的建议。这项 2008-2010 年进行的回顾性研究共纳入了来自 6 个国家(加拿大、法国、德国、希腊、波兰和瑞典)27 个中心的 1056 例患者的记录。超过 98%的患者接受了推荐剂量 2.5mg 的磺达肝癸钠治疗。97.5%的患者在 PCI 期间联合使用了抗凝剂,因此调整后的依从率为 98.8%(95%置信区间:0.97-0.99),其中 86.3%的患者接受了普通肝素。尽管接受直接 PCI 的 ST 段抬高型心肌梗死患者亚组人数太少,无法得出明确结论,但 159 例患者中有 70.4%在直接 PCI 前 24 小时内(<24 小时)或直接 PCI 期间没有使用磺达肝癸钠,这表明他们的治疗医生可能遵循了说明书的建议。
ACS 患者接受磺达肝癸钠治疗时,医生在 PCI 期间联合使用抗凝剂的依从性较高。该结果在六个国家和不同患者亚组中均一致。