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非心脏动脉手术中5000 IU肝素与活化凝血时间引导下肝素化的临床结局:一项倾向评分匹配分析

Clinical Outcomes of 5000 IU Heparin Versus Activated Clotting Time-Guided Heparinization During Noncardiac Arterial Procedures: A Propensity Score Matched Analysis.

作者信息

Hoebink Max, Roosendaal Liliane C, Beverloo Marie-José, Wiersema Arno M, van der Ploeg T, Steunenberg Thomas A H, Yeung Kak Khee, Jongkind Vincent

机构信息

Department of Vascular Surgery, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, The Netherlands.

Department of Vascular Surgery, Dijklander Ziekenhuis, Hoorn, The Netherlands.

出版信息

J Endovasc Ther. 2024 Sep 18:15266028241278137. doi: 10.1177/15266028241278137.

Abstract

PURPOSE

Previous studies have shown that activated clotting time (ACT)-guided heparinization leads to better anticoagulation levels during noncardiac arterial procedures (NCAP) than a standardized bolus of 5000 IU. Better anticoagulation should potentially result in lower incidence of thrombo-embolic complications (TEC). Comparative investigations on clinical outcomes of these heparinization strategies are scarce. This study investigated clinical outcomes of ACT-guided heparinization with a starting dose of 100 IU/kg in comparison with a single standardized bolus of 5000 IU heparin during NCAP.

MATERIALS AND METHODS

Analysis from a prospectively collected database of patients undergoing NCAP in 2 vascular centers was performed. Patients receiving ACT-guided heparinization were matched 1:1 with patients receiving 5000 IU heparin using propensity score matching (PSM). Primary outcomes were TEC, bleeding complications, and mortality within 30 days of procedure or during the same admission.

RESULTS

A total of 759 patients (5000 IU heparin: 213 patients, ACT-guided heparinization: 546 patients) were included. Propensity score matching resulted in 209 patients in each treatment group. After PSM, the groups were comparable, with the exception of a higher prevalence of peripheral arterial disease in the ACT-guided heparinization group (103 patients, 49% vs 82 patients, 39%, p=0.039). The target ACT (>200 seconds) was reached in 198 patients (95%) of the ACT-guided group versus 71 patients (34%) of the 5000 IU group (p<0.001), indicating successful execution of the ACT-guided protocol. Incidence of TEC (13 patients, 6.2% vs 10 patients, 4.8%, p=0.52), mortality (3 patients, 1.4% vs 0 patients, p=0.25), and bleeding complications (32 patients, 15% vs 25 patients, 12%, p=0.32) did not differ between patients receiving ACT-guided heparinization and 5000 IU heparin. Protamine was administered in 118 patients (57%) in the ACT group versus 11 patients (5.3%) in the 5000 IU group (p<0.001), but did not influence incidence of TEC (17 patients, 5.9% vs 6 patients, 4.7%, p=0.61) or bleeding complications (34 patients, 12% vs 22 patients, 17%, p=0.14).

CONCLUSION

No difference in TEC, bleeding complications, or mortality was found between ACT-guided heparinization and a single bolus of 5000 IU heparin during NCAP.

CLINICAL IMPACT

Previous studies have shown that activated clotting time (ACT)-guided heparinization leads to better anticoagulation levels during non-cardiac arterial procedures (NCAP) then a standardized bolus of 5000 IU. Comparative investigations on clinical outcomes are scarce. This study focussed on clinical outcomes of both protocols in NCAP in a propensity score matched cohort. Thrombo-embolic complications (TEC), bleeding complications and mortality within 30 days after NCAP or during the same admission were comparable between groups. Future studies should focus on optimizing ACT-guided protocols, specifically in patients with a high risk of TEC and bleeding complications.

摘要

目的

既往研究表明,在非心脏动脉手术(NCAP)期间,活化凝血时间(ACT)引导下的肝素化比5000 IU的标准推注剂量能带来更好的抗凝水平。更好的抗凝效果可能会降低血栓栓塞并发症(TEC)的发生率。关于这些肝素化策略临床结局的比较研究较少。本研究调查了在NCAP期间,起始剂量为100 IU/kg的ACT引导下肝素化与单次5000 IU肝素标准推注相比的临床结局。

材料与方法

对2个血管中心前瞻性收集的接受NCAP患者的数据库进行分析。采用倾向评分匹配(PSM)将接受ACT引导下肝素化的患者与接受5000 IU肝素的患者按1:1匹配。主要结局为TEC、出血并发症以及手术30天内或同一住院期间的死亡率。

结果

共纳入759例患者(5000 IU肝素组:213例患者,ACT引导下肝素化组:546例患者)。倾向评分匹配后,每个治疗组有209例患者。PSM后,两组具有可比性,但ACT引导下肝素化组外周动脉疾病的患病率较高(103例患者,49%对82例患者,39%,p = 0.039)。ACT引导组198例患者(95%)达到目标ACT(>200秒),而5000 IU组71例患者(34%)达到目标ACT(p<0.001),表明ACT引导方案执行成功。接受ACT引导下肝素化的患者与接受5000 IU肝素的患者之间,TEC发生率(13例患者,6.2%对10例患者,4.8%,p = 0.52)、死亡率(3例患者,1.4%对0例患者,p = 0.25)和出血并发症发生率(32例患者,15%对25例患者,12%,p = 0.32)无差异。ACT组118例患者(57%)使用了鱼精蛋白,而5000 IU组11例患者(5.3%)使用了鱼精蛋白(p<0.001),但这并未影响TEC发生率(17例患者,5.9%对6例患者,4.7%,p = 0.61)或出血并发症发生率(34例患者,12%对22例患者,17%,p = 0.14)。

结论

在NCAP期间,ACT引导下肝素化与单次5000 IU肝素推注在TEC、出血并发症或死亡率方面无差异。

临床影响

既往研究表明,在非心脏动脉手术(NCAP)期间,活化凝血时间(ACT)引导下的肝素化比5000 IU的标准推注剂量能带来更好的抗凝水平。关于临床结局的比较研究较少。本研究聚焦于倾向评分匹配队列中NCAP两种方案的临床结局。两组在NCAP后30天内或同一住院期间的血栓栓塞并发症(TEC)、出血并发症和死亡率相当。未来研究应聚焦于优化ACT引导方案,特别是在TEC和出血并发症高风险患者中。

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