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非 ST 段抬高型急性冠脉综合征患者的肥胖问题:来自 SYNERGY 试验的结果。

Obesity in patients with non-ST-segment elevation acute coronary syndromes: results from the SYNERGY trial.

机构信息

Duke Clinical Research Institute, Durham, NC 27715, USA.

出版信息

Int J Cardiol. 2010 Mar 4;139(2):123-33. doi: 10.1016/j.ijcard.2008.10.008. Epub 2008 Nov 14.

DOI:10.1016/j.ijcard.2008.10.008
PMID:19012977
Abstract

BACKGROUND

Obese patients are at increased risk of acute coronary syndromes (ACS). We evaluated the prevalence of obesity in a large ACS population, as well as the relationship between body mass index (BMI) and the use of cardiac medications and procedures, clinical outcomes, and treatment effects between enoxaparin and unfractionated heparin (UFH).

METHODS

Using the database of the SYNERGY trial, we identified 9978 patients in 12 countries who were randomly assigned to receive enoxaparin or UFH. Patient weight at baseline and 30-day follow-up was recorded. BMI information was available on 9837 patients. BMI was analyzed in clinically meaningful categories (<20, 20-25, 30-35, > or =35 kg/m(2)) and as a continuous variable.

RESULTS

Thirty-two percent of patients were obese (BMI> or =30), with a greater proportion of patients with obesity from North America (36%) compared with other regions. Enoxaparin was dosed as 1 mg/kg regardless of body weight without maximum. The first dose of enoxaparin was underdosed in 15% of patients assigned enoxaparin, and obese patients were more likely to be underdosed than non-obese patients. Obese patients were younger, less often white, had more diabetes, hypertension, hyperlipidemia, family history of coronary artery disease, and congestive heart failure but fewer strokes, less peripheral vascular disease, and less often smoked. After adjustment, increased BMI was not an independent predictor of bleeding outcomes or 30-day death/myocardial infarction (MI), but increased BMI was predictive of lower 1-year mortality in the subgroup of patients with BMI at baseline below approximately 30 kg/m(2). No statistical interaction term was observed between obesity and randomized therapy for the outcomes of death/MI at 30 days and 6 months; death at 30 days, 6 months, and 1 year; and GUSTO or TIMI bleeding.

CONCLUSIONS

Nearly one third of patients in SYNERGY were obese. Despite multiple comorbidities, obese patients had better unadjusted short- and long-term outcomes. After adjustment, higher BMI was not an independent predictor of in-hospital bleeding events or 30-day death/MI, but increased BMI was an independent predictor of 1-year mortality in patients with lower BMI but not in heavier patients. No interaction between the randomized treatment and obesity for efficacy and safety outcomes was observed across the range of BMI in this dataset. Standard dosing of enoxaparin should be used in patients without extreme obesity due to limited outcome data in these patients.

摘要

背景

肥胖患者发生急性冠状动脉综合征(ACS)的风险增加。我们评估了大量 ACS 患者中肥胖的患病率,以及体重指数(BMI)与心脏药物和程序的使用、临床结局以及依诺肝素与未分级肝素(UFH)之间的治疗效果之间的关系。

方法

我们使用 SYNERGY 试验的数据库,确定了来自 12 个国家的 9978 名随机分配接受依诺肝素或 UFH 的患者。记录患者基线和 30 天随访时的体重。9837 名患者有 BMI 信息。BMI 按临床有意义的类别(<20、20-25、30-35、≥35kg/m²)和连续变量进行分析。

结果

32%的患者肥胖(BMI≥30),来自北美的患者肥胖比例较高(36%)。依诺肝素的剂量为 1mg/kg,与体重无关,无最大剂量。接受依诺肝素治疗的患者中,有 15%的患者首次剂量不足,肥胖患者比非肥胖患者更有可能剂量不足。肥胖患者更年轻,非白人患者较少,糖尿病、高血压、高脂血症、冠心病家族史和充血性心力衰竭更多,但中风较少,外周血管疾病较少,吸烟较少。调整后,BMI 增加不是出血结局或 30 天死亡/心肌梗死(MI)的独立预测因素,但在基线 BMI 约低于 30kg/m²的患者亚组中,BMI 增加预测 1 年死亡率降低。未观察到肥胖与随机治疗对 30 天和 6 个月时死亡/MI、30 天、6 个月和 1 年时死亡以及 GUSTO 或 TIMI 出血的结局之间存在统计学交互作用。

结论

SYNERGY 中的近三分之一患者肥胖。尽管存在多种合并症,肥胖患者的短期和长期预后仍较好。调整后,较高的 BMI 不是住院期间出血事件或 30 天死亡/MI 的独立预测因素,但在 BMI 较低的患者中,BMI 增加是 1 年死亡率的独立预测因素,而在较重的患者中则不是。在该数据集的 BMI 范围内,未观察到随机治疗与肥胖对疗效和安全性结局的相互作用。由于这些患者的结局数据有限,因此不应在肥胖患者中使用依诺肝素的标准剂量。

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