Domestic versus imported drug-eluting stents for the treatment of patients with acute coronary syndrome

doi:10.5847/wjem.j.issn.1920-8642.2014.03.003

Abstract

Abstract:

BACKGROUND: The application of coronary stents, especially drug-eluting stents (DESs), has made percutaneous coronary intervention (PCI) one of important therapeutic methods for CHD. DES has reduced the in-stent restenosis to 5%-9% and significantly improved the long-term prognosis of patients with CHD. The study aimed to investigate the long-term efficacy and safety of domestic drug-eluting stents (DESs) in patients with acute coronary syndrome (ACS).
METHODS: All patients with ACS who had undergone successful percutaneous coronary intervention (PCI) in the First Affiliated Hospital of Zhengzhou University from July 2009 to December 2010 were included in this study. Patients were excluded from the study if they were implanted with bare metal stents or different stents (domestic and imported DESs) simultaneously. The included patients were divided into two groups according to different stents implanted: domestic DESs and imported DESs.
RESULTS: In the 1 683 patients of this study, 1 558 (92.6%) patients were followed up successfully for an average of (29.1±5.9) months. 130 (8.3%) patients had major adverse cardiovascular events (MACEs), including cardiac death in 32 (2.1%) patients, recurrent myocardial infarction in 16 (1%), and revascularization in 94 (6%). The rates of cardiac death, recurrent myocardial infarction, revascularization, in-stent restenosis, stent thrombosis and other MACEs were not significantly different between the two groups (all P>0.05). Multivarite logistic regression revealed that diabetes mellitus (OR=1.75, 95%CI: 1.09-2.82, P=0.021), vascular numbers of PCI (OR=2.16, 95%CI: 1.22-3.83, P=0.09) and PCI with left main lesion (OR=9.47, 95%CI: 2.96-30.26, P=0.01) were independent prognostic factors of MACEs. The Kaplan-Meier method revealed that there was no significant difference in cumulative survival rates and survival rates free from clinical events between the two groups (all P>0.05).
CONCLUSIONS: The incidences of clinical events and cumulative survival rates are not statistically different between domestic DESs and imported DESs. Domestic DES is effective and safe in the treatment of patients with ACS.

Key words: Acute coronary syndrome, Percutaneous coronary intervention, Drug-eluting stent, Cardiovascular adverse events

Hai-mu Yao, Tong-wen Sun, You-dong Wan, Xiao-juan Zhang, Xin Fu, De-liang Shen, Jin-ying Zhang, Ling Li. Domestic versus imported drug-eluting stents for the treatment of patients with acute coronary syndrome[J]. World Journal of Emergency Medicine, 2014, 5(3): 175-181.

Figures/Tables 6

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Variables	Imported DES (n=506)	Domestic DES (n=1052)	Total (n=1558)	t/χ² value	P value
Age (years)	59.57±11.66	59.95±11.29	59.83±11.4	-0.608	0.543
Male gender	360 (71.1)	718 (68.3)	1 078 (69.2)	1.344	0.246
Hypertension	234 (46.2)	518 (49.2)	752 (48.3)	1.227	0.268
Diabetes mellitus	111 (21.9)	230 (21.9)	341 (21.9)	0.001	1.000
Smoker	166 (32.8)	374 (35.6)	540 (34.7)	1.137	0.286
Peripheral vessel disease	0 (0)	4 (0.4)	4 (0.3)	1.929	0.311
AMI
Urgent PCI	40 (7.9)	30 (2.9)	70 (4.5)	20.33	0.000
Delayed PCI	109 (21.5)	224 (21.3)	333 (21.4)	0.013	0.911
Shock	2 (0.4)	3 (0.3)	5 (0.3)	1.29	0.662
Prior myocardial infarction	31 (6.1)	111 (10.6)	142 (9.1)	8.076	0.040
COPD	4 (0.8)	11 (1.0)	15 (1.0)	0.233	0.785
Heart failure	49 (9.7)	121 (11.5)	170 (10.9)	1.162	0.281
Renal failure	3 (0.6)	2 (0.2)	5 (0.3)	1.733	0.337
Stroke	27 (5.3)	42 (4.0)	69 (4.4)	1.457	0.227
Prior PCI	27 (5.3)	73 (6.9)	100 (6.4)	1.462	0.227
Prior CABG	2 (0.4)	9 (0.9)	11 (0.7)	1.032	0.519
TC (mmol/L)	4.29±1.02	4.25±1.03	4.26±1.03	0.709	0.478
TG (mmol/L)	1.94±1.33	1.94±1.34	1.94±1.33	-0.067	0.947
LDL (mmol/L)	2.74±0.95	2.72±1.12	2.73±1.07	0.377	0.706
HDL (mmol/L)	1.10±0.35	1.07±0.32	1.08±0.33	1.839	0.066
Glycemia (mmol/L)	6.31±2.87		6.25±3.59	0.466	0.606
Creatinine (μmol/L)	74.82±44.27		73.40±32.78	1.918	0.109
LVEF (%)	60.73±8.7	60.64±7.9	60.67±8.2	0.144	0.885
Medication at discharge
Aspirin	488 (96.4)	1 025 (97.5)	1 513 (97.2)	1.46	0.227
Clopidogrel	504 (98.8)	1 048 (99.7)	1 552 (99.7)	0.102	1.000
ACEI/ARB	247 (49)	638 (60)	885 (56.9)	18.82	0.000
Beta-blocker	303 (59.9)	736 (70)	1 039 (66.7)	15.84	0.000
Statins	447 (88.5)	936 (89)	1 383 (88.8)	0.072	0.788

Variables	Imported DES (n=506)	Domestic DES (n=1052)	Total (n=1558)	t/χ² value	P value
Radial artery access	494 (97.6)	1 034 (98.3)	1 528 (98.1)	0.789	0.374
Number of diseased vessels
1-vessel disease	240 (47.4)	373 (35.5)	613 (39.3)	20.53	0.000
2-vessel disease	160 (31.6)	389 (37)	549 (35.2)	4.296	0.038
Multi-vessel disease	100 (19.8)	282 (26.8)	382 (24.5)	9.158	0.002
Location of lesion
LM	9 (1.8)	41 (3.9)	50 (3.2)	4.937	0.026
LAD	410 (81)	884 (84)	1 294 (83.1)	2.189	0.139
LCX	211 (41.7)	511 (48.6)	722 (46.4)	6.578	0.481
RCA	215 (42.6)	543 (51.6)	758 (48.7)	11.166	0.001
Ostial lesion	50 (9.9)	124 (11.8)	174 (11.2)	1.264	0.261
Bifurcation lesion	69 (13.6)	177 (16.8)	246 (15.8)	2.613	0.106
Total chronic occlusion	94 (18.6)	209 (19.9)	303 (19.5)	0.373	0.541
Long lesion	33 (6.5)	119 (11.3)	152 (9.8)	8.9	0.003
Number of treated vessels^a	1 (1-2)	1 (1-2)	1 (1-2)		0.000
Location of target lesions
LM	8 (1.6)	28 (1.7)	36 (2.3)	1.767	0.184
LAD	354 (70)	748 (71.1)	1 102 (70.7)	0.215	0.643
LCX	152 (30)	384 (36.5)	536 (34.4)	6.323	0.012
RCA	153 (30.2)	444 (42.2)	597 (38.3)	20.706	0.000
Number of stents per patient^a	1 (1-2)	2 (1-3)	2 (1-3)		0.000
Total stent length per patient^a	33 (23-51)	42 (24-66)	38 (23-61)		0.000
Stent diameter (mm)^a	3 (2.75-3.5)	3 (2.76-3.44)	3 (2.75-3.5)		0.925

Variables	Imported DES (n=506)	Domestic DES (n=1 052)	Total (n=1 558)	t/χ² value	P value
Follow-up angiography	93 (18.4)	153 (14.5)	246 (15.8)	3.846	0.050
All cause death	18 (3.6)	33 (3.1)	51 (3.3)	0.191	0.670
Cardiac death	9 (1.8)	23 (2.2)	32 (2.1)	0.282	0.595
Recurrent myocardial infarction	8 (1.6)	8 (0.8)	16 (1.0)	2.263	0.132
Revascularization	33 (6.5)	61 (5.8)	94 (6.0)	0.315	0.574
MACE	44 (8.7)	86 (8.2)	130 (8.3)	0.121	0.728
In-stent restenosis	15 (3.0)	38 (3.6)	53 (3.4)	0.436	0.509
Stent thrombosis (definite/probable)	4 (0.8)	10 (1.0)	14 (0.9)	0.001	0.979

Variables	B	S.E.	Wals	OR	95%CI	P value
Diabetes mellitus	0.79	0.342	5.329	1.75	1.088-2.818	0.021
Number of treated vessels	0.954	0.420	5.156	2.159	1.215-3.834	0.090
Target lesion=LM	1.515	0.597	12.364	9.465	2.960-30.264	0.001

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