Construction of long term restenosis prediction model for patients with severe subpatellar artery lesions in type 2 diabetes treated with paclitaxel coated balloon

doi:10.11958/20240057

Abstract

Abstract:

Objective To analyze influencing factors of paclitaxel coated ballon (PCB) on long-term restenosis in patients with severe subpatellar artery lesions in type 2 diabetes mellitus (T2DM), and to construct a prediction model. Methods A total of 268 T2DM patients with severe infra-popliteal artery disease and received PCB treatment were selected. Patients were followed up for 1 year after treatment. Patients with target vessel restenosis were included in the observation group, and the other patients were included in the control group. Clinical data of two groups were analyzed.Multivariable Logistic regression analysis was used to analyze influencing factors of long-term restenosis in T2DM patients with severe infra-knee arterial disease, and a nomogram prediction model was constructed. Results A total of 260 patients (97.00%) completed the follow-up, and the incidence of restenosis was 13.85% (36/260). Both univariate and multivariate Logistic regression analysis showed that age, coexisting coronary heart disease, Trans-Atlantic Inter-Society Consensus (TASC) Ⅱ classification, Fontaine staging, glycosylated hemoglobin (HbA1c) and low density lipoprotein cholesterol (LDL-C) were independent influencing factors for the occurrence of long-term restenosis in T2DM patients with severe infra-popliteal artery disease (P < 0.05). The risk factor with the highest score in the constructed nomogram prediction model was HbA1c, followed by age, LDL-C, TASCⅡ classification, Fontaine stage and coronary heart disease. According to the column chart, the total score was 210 points, and the probability of long-term restenosis was 90%. The discrimination of the nomogram model was 0.866, with a Brier score of 0.081 and a calibration slope of 0.733. When the risk threshold was 0.15 to 1.0, the net benefit rate of long-term restenosis in T2DM patients with severe infra-popliteal artery disease was greater than that of individual evaluation. The smaller the risk threshold, the greater the net benefit rate. The benefit was the best when the threshold reached 0.23. Conclusion The influencing factors for long-term restenosis in T2DM patients with severe subknee artery disease treated by PCB include age, combined coronary heart disease, TASCⅡ grade, Fontaine stage, HbA1c and LDL-C. The prediction model based on the above influencing factors has important value in predicting long-term restenosis in patients.

Key words: diabetes mellitus, type 2, paclitaxel coated balloon, severe lesion of subpatellar artery, long-term restenosis, prediction model

CLC Number:

R587.2，R654.4

Figures/Tables 7

References 21

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组别	n	性别（男/女）		年龄/岁		BMI/（kg/m²）		合并高血压		合并冠心病		吸烟史		饮酒史		糖尿病病程/年		主要临床表现（A/B/C）^▲
对照组	224	126/98		65.37±4.50		25.04±2.08		133（59.38）		40（17.86）		95（42.41）		103（45.98）		8.16±2.28		195/17/12
观察组	36	24/12		68.69±4.21		25.31±2.15		23（63.89）		12（33.33）		19（52.78）		22（61.11）		8.30±2.41		31/3/2
χ²或t		1.379		4.144^＊＊		0.720		0.263		4.643^＊		1.354		2.844		0.339		0.028
组别	ABI （<0.5/≥0.5）		TASCⅡ分级（A/B/C/D）		Fontaine分期（Ⅱ/Ⅲ/Ⅳ）		HbA1c/%		FPG/ （mmol/L）		2 hPG/ （mmol/L）		TC/ （mmol/L）		TG/ （mmol/L）		LDL-C/（mmol/L）		HDL-C/（mmol/L）
对照组	125/99		57/70/51/46		90/73/61		8.20±0.97		9.24±1.22		11.73±2.85		4.16±0.61		1.48±0.37		2.49±0.49		1.13±0.20
观察组	20/16		2/10/16/8		7/15/14		8.93±1.02		9.52±1.31		12.12±2.67		4.32±0.57		1.55±0.34		2.78±0.45		1.08±0.22
χ²、t或Z	0.001		2.376^＊		2.128^＊		4.162^＊＊		1.265		0.769		1.474		1.065		3.332^＊＊		1.373

组别	n	性别（男/女）		年龄/岁		BMI/（kg/m²）		合并高血压		合并冠心病		吸烟史		饮酒史		糖尿病病程/年		主要临床表现（A/B/C）^▲
对照组	224	126/98		65.37±4.50		25.04±2.08		133（59.38）		40（17.86）		95（42.41）		103（45.98）		8.16±2.28		195/17/12
观察组	36	24/12		68.69±4.21		25.31±2.15		23（63.89）		12（33.33）		19（52.78）		22（61.11）		8.30±2.41		31/3/2
χ²或t		1.379		4.144^＊＊		0.720		0.263		4.643^＊		1.354		2.844		0.339		0.028
组别	ABI （<0.5/≥0.5）		TASCⅡ分级（A/B/C/D）		Fontaine分期（Ⅱ/Ⅲ/Ⅳ）		HbA1c/%		FPG/ （mmol/L）		2 hPG/ （mmol/L）		TC/ （mmol/L）		TG/ （mmol/L）		LDL-C/（mmol/L）		HDL-C/（mmol/L）
对照组	125/99		57/70/51/46		90/73/61		8.20±0.97		9.24±1.22		11.73±2.85		4.16±0.61		1.48±0.37		2.49±0.49		1.13±0.20
观察组	20/16		2/10/16/8		7/15/14		8.93±1.02		9.52±1.31		12.12±2.67		4.32±0.57		1.55±0.34		2.78±0.45		1.08±0.22
χ²、t或Z	0.001		2.376^＊		2.128^＊		4.162^＊＊		1.265		0.769		1.474		1.065		3.332^＊＊		1.373

因素	β	SE	Wald χ²	P	OR（95%CI）
年龄	0.192	0.053	13.207	<0.001	1.212（1.093~1.345）
合并冠心病	1.569	0.563	7.755	0.005	4.802（1.592~14.490）
TASCⅡ分级			12.732	0.005
B级vs. A级	1.758	0.892	3.887	0.049	5.803（1.010~33.332）
C级vs. A级	3.094	0.921	11.273	0.001	22.055（3.625~134.207）
D级vs. A级	2.500	0.949	6.935	0.008	12.184（1.895~78.328）
Fontaine分期			6.789	0.009
Ⅲ期vs. Ⅱ期	1.556	0.464	11.239	0.001	4.742（1.909~11.780）
Ⅳ期vs. Ⅱ期	1.387	0.613	5.118	0.024	4.003（1.204~13.312）
HbA1c	1.099	0.268	16.817	<0.001	3.002（1.775~5.076）
LDL-C	1.756	0.523	11.293	0.001	5.791（2.079~16.130）

因素	β	SE	Wald χ²	P	OR（95%CI）
年龄	0.192	0.053	13.207	<0.001	1.212（1.093~1.345）
合并冠心病	1.569	0.563	7.755	0.005	4.802（1.592~14.490）
TASCⅡ分级			12.732	0.005
B级vs. A级	1.758	0.892	3.887	0.049	5.803（1.010~33.332）
C级vs. A级	3.094	0.921	11.273	0.001	22.055（3.625~134.207）
D级vs. A级	2.500	0.949	6.935	0.008	12.184（1.895~78.328）
Fontaine分期			6.789	0.009
Ⅲ期vs. Ⅱ期	1.556	0.464	11.239	0.001	4.742（1.909~11.780）
Ⅳ期vs. Ⅱ期	1.387	0.613	5.118	0.024	4.003（1.204~13.312）
HbA1c	1.099	0.268	16.817	<0.001	3.002（1.775~5.076）
LDL-C	1.756	0.523	11.293	0.001	5.791（2.079~16.130）