Win Htut K, Caldera Angel E, Maresh Kelly, Lopez John, Rihal Charanjit S, Parikh Manish A, Granada Juan F, Marulkar Sachin, Nassif Deborah, Cohen David J, Kleiman Neal S
Baylor College of Medicine, Houston, Tex. USA.
JAMA. 2007 May 9;297(18):2001-9. doi: 10.1001/jama.297.18.2001.
Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear.
To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features.
DESIGN, SETTING, AND PATIENTS: From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents.
The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated.
Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05).
Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.
排除心脏事件高危患者的临床试验已促成药物洗脱支架获得商业标签批准；然而，这类高危患者在临床实践中通常会接受支架植入。目前尚不清楚他们发生心脏事件的几率比非高危患者高多少。
评估具有高危血管造影和临床特征的患者在首次住院期间以及药物洗脱支架植入后1年内发生主要不良心脏事件的几率。
设计、地点和患者：2004年7月至2005年9月，在美国42家不同医院接受支架植入尝试的连续患者被纳入一项前瞻性多中心注册研究。我们分析了3323例因急性ST段抬高型心肌梗死以外的原因接受至少1枚药物洗脱支架的患者的结局。根据美国食品药品监督管理局目前批准的西罗莫司和紫杉醇洗脱支架适应症，基于9种标签外特征中至少存在1种，将研究人群分为2组。
评估首次住院期间死亡、心肌梗死或靶血管血运重建以及1年时死亡、心肌梗死或靶病变血运重建的综合临床结局。
3323例患者中，1817例（54.7%）至少有1种标签外特征。在首次住院期间，标签外组198例（10.9%）患者发生了综合临床结局，标签内组76例（5.0%）患者发生了该结局（校正优势比，2.32；95%置信区间[CI]，1.75 - 3.07；P <.001）。1年时，与标签内组相比，标签外组更常发生综合临床结局；分别为309例（17.5%）和131例（8.9%）（校正风险比[HR]，2.16；95% CI，1.74 - 2.67；P <.001）。在首次住院期间，标签外组患者支架血栓形成也更频繁（8例[0.4%] vs 0例），1年时也是如此：29例（1.6%） vs 13例（0.9%），校正HR，2.29（95% CI，1.02 - 5.16；P = 0.05）。
与标签内使用相比，药物洗脱支架的标签外使用在首次住院期间和1年时不良结局发生率更高。支架血栓形成主要发生在接受标签外药物洗脱支架植入的患者中。临床医生在将随机临床试验中观察到的药物洗脱支架相对于裸金属支架的益处外推至未评估的高风险临床情况时应谨慎。
