冠状动脉疾病合并糖尿病患者经StentBoost技术指导的经皮冠状动脉介入治疗后5年的随访分析

doi:10.24920/003496

摘要/Abstract

摘要：

目的评估冠状动脉疾病合并糖尿病患者在经StentBoost技术指导的经皮冠状动脉介入治疗（PCI）后的即刻效果及5年的临床随访结果。

方法从2009年3月至2010年7月连续入选184例我院接受PCI术的患者,根据是否合并糖尿病将患者分为糖尿病组（n=73,39.67%）和非糖尿病组（n=111,60.33%）。术中植入支架后,通过StentBoost技术发现所有植入支架均存在支架膨胀不全或贴壁不良,经StentBoost技术指引的高压球囊后扩张后,评估两组术后即刻手术效果,并进行5年随访比较两组的临床结局。采用卡方检验或t检验进行组间比较,采用多元回归分析评估影响StentBoost指导的PCI手术远期预后的预测因子。

结果两组在StentBoost指引的扩张后,最小管腔直径（MinLD）,最大管腔直径（MaxLD）和平均直径较扩张前显著增加（P<0.001）,相应地（MaxLD-MinLD）/MaxLD比例和残余狭窄较扩张前显著降低（P<0.001）。5年随访结果显示:糖尿病组和非糖尿病组死亡率（4.92%比2.86%,P=0.67）,主要不良心脏事件（MACE）率（11.48%比11.43%,P=1.0）均相近,但糖尿病组心绞痛复发率较非糖尿病组高（47.54%比29.52%,P=0.02）。多因素回归分析提示:年龄和左室射血分数为影响预后的独立预测指标。

结论 StentBoost技术可显著改善即刻的PCI效果。冠状动脉疾病合并糖尿病患者在接受StentBoost技术指导PCI术治疗的远期预后与非糖尿病患者相似。年龄和左室射血分数是预后不良的独立预测指标。

关键词: 经皮冠状动脉介入治疗, 糖尿病, 支架, 预后

Abstract:

Objective To evaluate the instant effects and five-year clinical outcomes of coronary artery disease patients complicated with diabetes mellitus after StentBoost-optimized percutaneous coronary intervention (PCI).

Methods From March 2009 to July 2010, 184 patients undergoing PCI at our hospital were found stent underexpansion or malapposition by StentBoost after stents implantation and were divided into the diabetic (n=73, 39.67%) and the non-diabetic group (n=111, 60.33%). All patients received StentBoost-guided post-dilatation after stent implantation. The instant procedural results were measured and clinical outcome after five-year follow-up was analyzed in each group. Between-group comparisons were performed using Chi-square test or Student’s t test. Multivariate logistic regression analysis was carried out to reveal the independent predictors for long-term clinical outcomes of StentBoost-optimized PCI .

Results After StentBoost-guided post-dilatation, the minimum diameter (MinLD), maximum diameter (MaxLD) and average diameter in both groups increased significantly than before (P<0.001), the (MaxLD-MinLD)/MaxLD ratio and the in-stent residual stenosis decreased accordingly (P<0.001). The five-year follow-up showed similar mortality rate (4.92% vs. 2.86%, P=0.67) and major adverse cardiac event rate (11.48% vs. 11.43%, P = 1.0) between the diabetic and the non-diabetic group, whereas the recurrence of angina pectoris was higher in the diabetic group compared to the non-diabetic group (47.54% vs. 29.52%; P=0.02). A multivariate logistic regression analysis revealed that age and left ventricular ejection fraction rather than diabetes mellitus were independent predictors for long-term clinical outcomes.

Conclusions StentBoost could effectively improve instant PCI results; the long-term clinical outcomes of StentBoost-optimized PCI were similar between diabetic and non-diabetic patients. Age and left ventricular ejection fraction were the independent predictors for long-term clinical outcomes.

Key words: percutaneous coronary intervention, diabetes mellitus, stent, prognosis

Chen Qiang, Zhang Liwei, Huang Dangsheng, Zhang Chunhong, Wang Qiushuang, Shen Dong, Xiong Minjun, Yang Feifei. Five-year Clinical Outcomes of CAD Patients Complicated with Diabetes after StentBoost-optimized Percutaneous Coronary Intervention[J].Chinese Medical Sciences Journal, 2019, 34(3): 177-183.

图/表 4

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Groups	n	Age^§(yrs)	Gender (% male)	Previous MI (%)	Previous PCI (%)	Hypertension (%)	Hyperlipidemia (%)	Smoking status (%)	LVEF^§
Non-DM	111	65.11±11.24	77.48	18.92	18.02	61.26	56.76	46.85	57.85±8.99
DM	73	63.89±10.48	72.60	17.81	15.07	68.49	50.68	36.99	54.80±11.42
χ²/t value		-0.83	0.566	0	0.273	1.001	0.377	1.748	-1.91
P value		0.462	0.486	1.000	0.689	0.349	0.452	0.224	0.065

Parameters	DM group (n = 73)	Non-DM group (n=111)	χ²/t value	P value
Baseline lesion parameters
Single vessel (%)	54.79	52.25	0.114	0.764
Double vessels (%)	28.77	27.93	0.015	0.902
Triple vessels (%)	12.33	16.22	0.532	0.528
Left main lesion (%)	4.11	3.60	0	1.000
Details of stent implantation
Number of stents^§	1.92±1.07	1.76±0.99	1.013	0.313
Stent diameter^§ (mm)	2.92±0.38	2.95±0.37	-0.490	0.507
Stent length^§ (mm)	26.52±6.62	25.64±6.45	0.799	0.227
Maximal pressure^§ (atm)	15.16±2.82	15.67±3.29	-1.000	0.077
Post-dilatation balloon diameter^§ (mm)	3.06±0.43	3.15±0.36	-0.990	0.068
Post-dilatation balloon maximal pressure^§ (atm)	18.09±3.4	17.89±3.31	-0.230	0.517
Instant PCI results
MinLD^§ (mm)	2.76±0.37	2.70±0.35	1.250	0.270
MaxLD^§ (mm)	3.32±0.40	3.23±0.35	0.909	0.110
Average diameter after SB^§ (mm)	3.04±0.38	2.97±0.34	1.134	0.190
(MaxLD-MinLD)/MaxLD ratio^§	0.17±0.04	0.16±0.04	0.862	0.100
Early gain^§ (mm)	0.28±0.18	0.31±0.19	1.351	0.229
Residual stenosis after SB^§ (%)	16.37±2.88	16.23±3.63	0.173	0.780

Post-dilatation measurements	DM group (n = 73)				Non-DM group (n = 111)
Post-dilatation measurements	Before	After	t value	P value	Before	After	t value	P value
MinLD (mm)	2.48±0.39	2.76±0.37	-3.356	0.001	2.39±0.39	2.70±0.35	-3.723	0.000
MaxLD (mm)	3.16±0.41	3.32±0.40	-2.299	0.025	3.06±0.37	3.23±0.35	-2.419	0.017
Average diameter (mm)	2.80±0.53	3.04±0.38	-2.788	0.008	2.74±0.36	2.97±0.34	-3.720	0.000
(MaxLD-MinLD)/MaxLD ratio	0.22±0.06	0.17±0.04	-2.842	0.002	0.22±0.06	0.16±0.04	-2.621	0.001
Residual stenosis (%)	21.89±5.80	16.37±2.88	4.443	0.000	22.53±6.46	16.23±3.63	4.526	0.000

Groups	n	Death	Cardiac death	Non-cardiac death	Non-fatal AMI	Recurrent angina	Revascularization	MACEs
Groups	n	Death	Cardiac death	Non-cardiac death	Non-fatal AMI	Recurrent angina	Revascularization	TLR	TVR	CABG	Total
DM group	61	4.92	0	4.92	1.64	47.54	9.84	3.28	4.92	1.64	11.48
Non-DM group	105	2.86	1.9	0.95	0.95	29.52	8.57	3.81	4.76	0	11.43
χ² value		0.065	-	1.170	0	5.427	0.075	0	0	-	0
P value		0.799	0.532	0.280	1.000	0.020	0.785	1.000	1.000	0.367	1.000

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