Department of Vascular and Endovascular Surgery, Royal Free Hospital, London, United Kingdom.
Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
J Vasc Surg. 2019 Aug;70(2):607-614.e3. doi: 10.1016/j.jvs.2019.01.052. Epub 2019 Mar 14.
Randomized controlled trials (RCTs) constitute level I evidence and are used as the backbone of guidelines and recommendations for treatment. Although RCTs are theoretically the studies of choice for the assessment of the effectiveness of health care interventions, these trials (and their interpretation) may sometimes result in erroneous conclusions, erroneous therapeutic decisions, and incorrect recommendations. We aimed to check the applicability of the results of RCTs to everyday practice.
We reviewed the literature for studies comparing the results of RCTs with observational or population-based studies in the field of vascular surgery, focusing on two specific topics: the results of carotid artery stenting vs carotid endarterectomy for the management of carotid artery stenosis; and the results of open surgical repair vs endovascular aneurysm repair for the management of ruptured abdominal aortic aneurysms.
We found considerable discrepancy in the results of RCTs with real-life registries and observational studies in both topics. In the management of carotid artery stenosis, observational studies reported worse outcomes after carotid artery stenting compared with carotid endarterectomy. Regarding ruptured abdominal aortic aneurysms, population-based studies reported better results for endovascular aneurysm repair compared with open repair. In contrast, RCTs in both topics reported similar results for the two procedures.
There is evidence that RCTs sometimes do not reflect clinical reality and are therefore potentially misleading to the reader. Every RCT has to be interpreted and applied carefully using complete available evidence and good clinical judgment.
随机对照试验（RCT）构成了一级证据，被用作治疗指南和建议的基础。尽管 RCT 从理论上讲是评估医疗干预措施有效性的首选研究，但这些试验（及其解释）有时可能导致错误的结论、错误的治疗决策和不正确的建议。我们旨在检查 RCT 结果在日常实践中的适用性。
我们检索了血管外科学领域中比较 RCT 结果与观察性或基于人群的研究的文献，重点关注两个特定主题：颈动脉支架置入术与颈动脉内膜切除术治疗颈动脉狭窄的结果比较；开放手术修复与血管内动脉瘤修复治疗破裂性腹主动脉瘤的结果比较。
我们在这两个主题中发现，RCT 与真实世界的注册研究和观察性研究的结果存在相当大的差异。在颈动脉狭窄的治疗中，观察性研究报告颈动脉支架置入术的结果比颈动脉内膜切除术差。关于破裂性腹主动脉瘤，基于人群的研究报告血管内动脉瘤修复的结果优于开放修复。相比之下，这两个主题的 RCT 报告了两种手术相似的结果。
有证据表明，RCT 有时并不反映临床实际情况，因此可能对读者产生误导。每项 RCT 都必须使用完整的现有证据和良好的临床判断进行仔细解释和应用。
