Department of Internal Medicine, Division of Cardiovascular Medicine, The University of Michigan, Ann Arbor, Michigan, USA.
Clin Cardiol. 2010 Feb;33(2):111-6. doi: 10.1002/clc.20717.
We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC).
To determine whether the decrease in use of DES has affected both on and off-label indications.
The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated.
The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%-56%).
The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies.
我们试图研究在 2006 年欧洲心脏病学会（ESC）会议上报告了药物洗脱支架（DES）治疗患者的极晚期支架血栓形成风险增加后，未经批准适应证的裸金属支架（BMS）和药物洗脱支架（DES）使用率的时间变化。
确定 DES 使用量的减少是否影响了适应证和超适应证。
研究队列包括在大型区域注册中心——蓝十字蓝盾密歇根心血管联盟（BMC2）接受冠状动脉介入治疗的患者。将 2006 年第三季度（ESC 前）接受 DES 治疗的患者的患者人口统计学和临床特征与 2008 年第四季度（指南变化后）的患者进行比较。评估 DES 用于超适应证，如 ST 段抬高型心肌梗死（STEMI）、支架内再狭窄（ISR）和大隐静脉桥（SVG）介入治疗的情况。
ESC 前，DES 的总体使用率从 83%急剧下降到 2008 年第一季度的 58%。这与 BMS 使用量的增加相对应，而血管成形术保持不变。STEMI 亚组的变化最为显著，从 78%降至 36%。SVG 的超适应证使用也呈现出类似的趋势，从 74%降至 43%。ISR 的 DES 使用率受影响较小，尽管也下降了 25%（从 79%降至 56%）。
自 2006 年 6 月至 2008 年 12 月，DES 的使用率大幅下降，特别是对于未经批准的适应证。我们的研究提供了对 DES 使用变化的真实世界评估，以应对负面观察性研究的发表。
