Majithia Arjun, Matheny Michael E, Paulus Jessica K, Marinac-Dabic Danica, Robbins Susan, Ssemaganda Henry, Hewitt Kathleen, Ponirakis Angelo, Loyo-Berrios Nilsa, Moussa Issam, Drozda Joseph, Normand Sharon-Lise, Resnic Frederic S
Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington, MA (A.M., S.R., H.S., F.S.R.).
Tufts School of Medicine, Boston, MA (A.M., F.S.R.).
Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e004666. doi: 10.1161/CIRCOUTCOMES.118.004666.
Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11% to 5.32% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78% to 10.18%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.
背景 当前确保医疗器械上市后安全性的策略受到样本量小以及依赖不良事件自愿报告的限制。对临床登记处进行前瞻性、主动监测可能会在医疗器械安全性的上市后评估中提供早期预警，但尚未在国家临床数据登记处得到证实。
方法与结果 CathPCI DELTA（数据提取与纵向趋势分析）研究旨在评估在国家心血管登记处内对医疗器械进行前瞻性、主动安全性监测的可行性。我们试图通过使用国家心血管数据登记处CathPCI登记处的数据对抽吸血栓切除术导管进行主动安全性监测研究，来评估我们的监测策略避免虚假安全警报的能力，在该登记处，对于主要的院内安全结局死亡和主要不良心血管事件（MACE），预计安全性结果无差异。我们对2011年1月1日至2013年9月30日期间95925例ST段抬高型心肌梗死患者在经皮冠状动脉介入治疗期间使用的5种抽吸血栓切除术导管装置进行了倾向匹配分析。经过33个月的监测，未触发关于死亡或MACE主要安全终点的安全警报，未观察到导管间差异。在最常用的抽吸血栓切除术导管装置中，急性住院期间死亡的绝对风险范围为5.11%至5.32%，死亡的相对风险范围为0.96至1.03。MACE的绝对风险范围为9.78%至10.18%，MACE的相对风险范围为0.99至1.02。所分析的任何抽吸血栓切除术导管装置之间的死亡或MACE发生率均无统计学显著差异。
结论 CathPCI DELTA研究表明，对国家临床登记处进行前瞻性、主动安全性监测对于提供新医疗器械的近实时安全性评估是可行的。
