急性心肌梗死患者PCI延时与无延时应用比伐芦定的对照研究

李雪冬; 胡业梅; 王真; 吴纲; 李君; 武永元; 商卓

doi:10.16766/j.cnki.issn.1674-4152.002587

急性心肌梗死患者PCI延时与无延时应用比伐芦定的对照研究

doi: 10.16766/j.cnki.issn.1674-4152.002587

蚌埠市第二人民医院心血管内科，安徽蚌埠 233000

基金项目:

安徽省卫生健康委科研项目 AHWJ2021b095

蚌埠市科技创新指导类项目 20190338

详细信息

通讯作者:
商卓, E-mail: zhuoshangdl@163.com

中图分类号: R542.22R973.2
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出版历程
- 收稿日期: 2022-02-22
- 网络出版日期: 2022-09-26

Randomised controlled trial of delayed versus undelayed bivalirudin in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

Department of Cardiovascular Medicine, the Second People's Hospital of Bengbu, Bengbu, Anhui 233000, China

摘要

摘要: 目的评价急性心肌梗死(AMI)患者接受经皮冠状动脉介入治疗(PCI)时无延时比伐芦定联合仅冠脉内替罗非班方案的疗效和安全性。方法选取2020年4月—2021年3月蚌埠市第二人民医院心内科收治的150例AMI患者，采用随机数字表法随机分为2组: 试验组(无延时组，75例)和对照组(延时组，75例)。观察2组患者术后TIMI血流分级(TFG)及校正的TIMI血流帧数计数(cTFC)，术后90 min心电图ST段回落(STR)情况，术后第7天心功能指标，术后30 d内所有出血事件及术后30 d主要不良心血管事件(MACE)。结果 2组TFG、cTFC、术后90 min心电图STR(Z=0.524，P=0.770)、MACE(1.3% vs. 0，P=0.999)、左心室射血分数[(49.5±6.6) vs. (50.6±5.7)，t=-1.092，P=0.276]、左心室舒张末期内径[(50.0±8.9) mm vs. (51.2±7.6) mm，t=-0.888，P=0.376]及室壁运动异常(86.7% vs. 90.1%，χ²=0.597，P=0.440)比较，差异均无统计学意义。试验组30 d内出血事件显著少于对照组，差异有统计学意义(5.3% vs. 18.7%，χ²=6.221，P=0.035)。结论对于急性心肌梗死接受直接PCI的患者，无延时比伐芦定联合仅冠脉内替罗非班方案，疗效确定且具有更佳的安全性，是临床实践中可供选择的治疗方案。
- 比伐芦定 /
- 替罗非班 /
- 经皮冠状动脉介入治疗 /
- 急性心肌梗死
Abstract: Objective To evaluate the efficacy and safety of undelayed bivalirudin combined with intracoronary tirofiban only during primary percutaneous coronary intervention (PCI) in patients with acute elevation myocardial infarction (AMI). Methods A total of 150 patients with AMI admitted to the Department of Cardiology, Bengbu Second People's Hospital from April 2020 to March 2021 were selected and randomly divided into two groups: the experimental group (n=75) and the control group (n=75). Postoperative TIMI flow grade (TFG), corrected TIMI frame count(cTFC), 90 min postoperative ST segment resolution (STR), postoperative cardiac function parameters, any bleeding events and major adverse cardiovascular events (MACEs) after 30 days were recorded and analysed after completion of primary PCI. Results No significant differences between the two groups were found in terms of the TFG, cTFC, STR (Z=0.524, P=0.770), MACE (1.3% vs. 0, P=0.999), left ventricular ejection fraction [(49.5±6.6)% vs. (50.6±5.7) %, t=-1.092, P=0.276], left ventricular end-diastolic dimension [(50.0±8.9) mm vs. (51.2±7.6) mm, t=-0.888, P=0.376] and regional wall motion abnormality (86.7% vs. 90.1%, χ²=0.597, P=0.440). The bleeding events in the experimental group were significantly less than those in the control group, and the difference was statistically significant (5.3% vs. 18.7%, χ²=6.221, P=0.035). Conclusion The undelayed bivalirudin combined with intracoronary tirofiban only strategy, which is associated with good safety demonstrated by reduced bleeding events, is an alternative regimen for patients with AMI undergoing primary PCI.
- Bivalirudin /
- Tirofiban /
- Percutaneous coronary intervention /
- Acute myocardial infarction

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表 1 2组急性心肌梗死患者基线情况比较

Table 1. Comparison of baseline conditions of patients with acute myocardial infarction between the two groups

项目	试验组(n=75)	对照组(n=75)	统计量	P值
年龄(x ±s，岁)	65.1±7.5	69.6±8.7	-1.392^a	0.090
男性[例(%)]	36(48.8)	37(49.3)	0.027^b	0.870
体重指数(x ±s)	25.3±5.0	26.5±5.5	-1.398^a	0.164
糖尿病[例(%)]	29(38.7)	24(32.0)	0.729^b	0.393
吸烟[例(%)]	28(37.3)	30(40.0)	0.112^b	0.737
高血压[例(%)]	48(64.0)	55(77.3)	1.518^b	0.218
早发冠心病家族史[例(%)]	12(16.0)	10(13.3)	0.213^b	0.644
糖化血红蛋白(x ±s，%)	6.1±2.1	5.8±1.9	1.662^a	0.246
血肌酐(x ±s，μmol/L)	88.3±32.5	82.1±27.6	0.562^a	0.383
血红蛋白(x ±s，g/L)	128.2±19.5	120.6±20.8	1.342^a	0.165
血小板计数(x ±s，10⁹/L)	198.3±90.5	205.6±82.3	1.329^a	0.175
收缩压(x ±s，mm Hg)	135.5±30.8	132.6±25.7	0.965^a	0.326
舒张压(x ±s，mm Hg)	80.6±20.3	77.3±19.8	1.811^a	0.091
低密度脂蛋白胆固醇(x ±s，mmol/L)	2.8±0.9	2.9±0.9	-0.680^a	0.497
总胆固醇(x ±s，mmol/L)	4.2±0.9	4.1±0.9	0.680^a	0.497
KillipⅡ级及以上[例(%)]	13(17.3)	11(14.6)	0.198^b	0.656
药物应用[例(%)]
β受体阻滞剂	60(80.0)	58(77.3)	0.159^b	0.690
ACEI、ARB、ARNI	68(90.6)	65(86.7)	0.597^b	0.440
心肌梗死部位[例(%)]			0.109^b	0.741
前壁	33(44.0)	31(41.3)
非前壁	42(56.0)	44(58.7)
梗死相关动脉[例(%)]			0.838^b	0.658
LAD	33(44.0)	31(41.3)
LCX	22(29.3)	19(25.3)
RCA	20(26.7)	25(33.3)
基线TIMI血流0/1级[例(%)]	55(73.3)	51(68.0)	0.515^b	0.473
发病-球囊扩张时间[M(P₂₅, P₇₅)，h]	6.5(2.0，9.8)	5.5(2.0，8.8)	1.858^c	0.065
TNI[M(P₂₅, P₇₅)，ng/mL]	4.8(2.0，7.3)	4.5(2.0，7.1)	0.717^c	0.475
血栓抽吸[例(%)]	8(10.7)	8(10.7)
注：^a为t值，^b为χ²值, ^c为Z值。1 mm Hg=0.133 kPa。ACEI为血管紧张素转换酶抑制剂；ARB为血管紧张素受体拮抗剂；ARNI为血管紧张素受体脑啡肽酶抑制剂；LAD为左前降支；LCX为左回旋支；RCA为右冠状动脉；TIMI为心肌梗死溶栓试验；TnI为肌钙蛋白I。

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表 2 2组急性心肌梗死患者术后再灌注水平比较

Table 2. Comparison of reperfusion level between two groups of patients with acute myocardial infarction after operation

组别	例数	术后TIMI血流分级(TFG)[例(%)]			cTFC(x ±s，帧)	STR[例(%)]
组别	例数	0或1	2	3	cTFC(x ±s，帧)	CR	PR	NR
试验组	75	0	2(2.7)	73(97.3)	16.2±4.5	46(61.3)	20(26.7)	9(12.0)
对照组	75	0	3(4.0)	72(96.0)	16.3±5.0	43(57.3)	24(32.0)	8(10.7)
统计量		0.453^a			-0.129^b	0.524^c
P值		0.650			0.898	0.770
注：^a为χ²值，^b为t值, ^c为Z值。TIMI为心肌梗死溶栓试验；TFG为TIMI血流分级；cTFC为校正的TIMI帧数；STR为ST段回落；CR为完全ST段回落；PR为部分ST段回落；NR为无ST段回落。

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表 3 2组术后心脏功能指标比较

Table 3. Comparison of postoperative cardiac function indexes between the two groups

组别	例数	LVEF(x ±s, %)	LVEDD(x ±s，mm)	室壁运动异常[例(%)]
试验组	75	49.5±6.6	50.0±8.9	65(86.7)
对照组	75	50.6±5.7	51.2±7.6	68(90.1)
统计量		-1.092^a	-0.888^a	0.597^b
P值		0.276	0.376	0.440
注：^a为t值，^b为χ²值。LVEF为左心室射血分数；LVEDD为左心室舒张末期内径。

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表 4 2组术后30 d出血事件及术后30 d的MACE比较[例(%)]

Table 4. Comparison of bleeding events and MACE at 30 d after operation between the two groups [cases (%)]

组别	例数	MACE				BARC出血分级
组别	例数	全因死亡	支架内血栓	紧急血运重建	心肌梗死	0	1	2	3	4	5
试验组	75	1(1.3)	0	0	0	71(94.7)	3(4.0)	1(1.3)	0	0	0
对照组	75	0	0	0	0	61(81.3)	11(14.7)	3(4.0)	0	0	0
统计量						6.221^b
P值		0.999^a				0.035
注：^a为采用Fisher精确检验，^b为χ²值。MACE为主要不良心血管事件；BARC为出血学术研究联合会。

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