Dunkelgrun Martin, Boersma Eric, Schouten Olaf, Koopman-van Gemert Ankie W M M, van Poorten Frans, Bax Jeroen J, Thomson Ian R, Poldermans Don
Departments of Vascular Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
Ann Surg. 2009 Jun;249(6):921-6. doi: 10.1097/SLA.0b013e3181a77d00.
This study evaluated the effectiveness and safety of beta-blockers and statins for the prevention of perioperative cardiovascular events in intermediate-risk patients undergoing noncardiovascular surgery.
Beta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery by restoring the myocardial oxygen supply/demand balance and/or stabilizing coronary plaques. However, their effects in intermediate-risk patients remained ill-defined.
In this randomized open-label 2 x 2 factorial design trial 1066 intermediate cardiac risk patients were assigned to bisoprolol, fluvastatin, combination treatment, or control therapy before surgery (median: 34 days). Intermediate risk was defined by an estimated risk of perioperative cardiac death and myocardial infarction (MI) of 1% to 6%, using clinical data and type of surgery. Starting dose of bisoprolol was 2.5 mg daily, titrated to a perioperative heart rate of 50 to 70 beats per minute. Fluvastatin was prescribed in a fixed dose of 80 mg. The primary end point was the composite of 30-day cardiac death and MI. This study is registered in the ISRCTN registry and has the ID number ISRCTN47637497.
Patients randomized to bisoprolol (N = 533) had a lower incidence of perioperative cardiac death and nonfatal MI than those randomized to bisoprolol-control (2.1% vs. 6.0% events; hazard ratios: 0.34; 95% confidence intervals: 0.17-0.67; P = 0.002). Patients randomized to fluvastatin experienced a lower incidence of the end point than those randomized to fluvastatin-control therapy (3.2% vs. 4.9% events; hazard ratios: 0.65; 95% confidence intervals: 0.35-1.10), but statistical significance was not reached (P = 0.17).
Bisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.
本研究评估了β受体阻滞剂和他汀类药物在接受非心脏手术的中度风险患者中预防围手术期心血管事件的有效性和安全性。
β受体阻滞剂和他汀类药物通过恢复心肌氧供需平衡和/或稳定冠状动脉斑块，可降低接受血管手术的高危患者围手术期心脏事件的发生率。然而，它们在中度风险患者中的作用仍不明确。
在这项随机开放标签的2×2析因设计试验中，1066例中度心脏风险患者在手术前（中位数：34天）被分配接受比索洛尔、氟伐他汀、联合治疗或对照治疗。根据临床数据和手术类型，将中度风险定义为围手术期心脏死亡和心肌梗死（MI）的估计风险为1%至6%。比索洛尔的起始剂量为每日2.5毫克，滴定至围手术期心率为每分钟50至70次。氟伐他汀的固定剂量为80毫克。主要终点是30天心脏死亡和MI的复合终点。本研究已在国际标准随机对照试验编号注册中心注册，编号为ISRCTN47637497。
随机接受比索洛尔治疗的患者（N = 533）围手术期心脏死亡和非致命性MI的发生率低于随机接受比索洛尔对照治疗的患者（事件发生率：2.1%对6.0%；风险比：0.34；95%置信区间：0.17 - 0.67；P = 0.002）。随机接受氟伐他汀治疗的患者终点事件发生率低于随机接受氟伐他汀对照治疗的患者（事件发生率：3.2%对4.9%；风险比：0.65；95%置信区间：0.35 - 1.10），但未达到统计学显著性（P = 0.17）。
比索洛尔与30天心脏死亡和非致命性MI的显著降低相关，而氟伐他汀显示出改善预后的趋势。
