Polisena Julie, Forster Alan J, Cimon Karen, Rabb Danielle
Canadian Agency for Drugs and Technologies in Health, 600-865 Carling Ave, Ottawa, Ontario, K1S 5S8, Canada.
Syst Rev. 2013 Oct 10;2:94. doi: 10.1186/2046-4053-2-94.
Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published.
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature.
This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting.
Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.
上市后监测（PMS）可能会识别出因长期使用医疗器械而导致的罕见严重事件或不良事件，这些事件在上市前的过程中未被发现。经皮冠状动脉腔内血管成形术（PTCA）是一种非手术 procedure，它使用球囊导管来扩张狭窄的动脉。2011年，制造商向美国食品药品监督管理局（FDA）提交了1942份与使用PTCA导管相关的不良事件报告，较2008年报告的883份有所增加。主要研究目标是对2007年至2012年期间发表的已发表文献和灰色文献进行系统综述，以了解冠状动脉疾病（CAD）患者使用PTCA导管相关的事件、不良事件和故障发生频率。灰色文献未进行商业出版。
我们检索了MEDLINE、EMBASE、Cochrane对照试验中央注册库和PubMed，以查找2007年1月至2012年7月期间发表的关于CAD患者PTCA导管PMS的医学文献。我们还检索了灰色文献。
本综述纳入了11项研究。报告的院内不良事件为心肌梗死和血肿的个别病例。在冠状动脉穿孔患者的研究中，与需要支架置入的患者相比，发现更多接受球囊血管成形术的患者。
我们的系统综述表明，已发表文献和灰色文献中与CAD患者使用PTCA导管相关的PMS研究的数量和质量较低，可能不是安全决策的有用信息来源。在大多数研究中，目标不是监测PTCA导管在临床实践中使用的长期安全性。未来的研究可以探索监管机构管理的PMS数据库的优势和局限性。
