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Introduction
Plaque debris, which impacts blood flow to the capillaries, can result in microvascular mechanical obstruction,
platelet activation, and the formation of microthrombi,
leading to myocardial injury in patients undergoing
a percutaneous coronary intervention (PCI) [1,2].
Anticoagulation with effective and safe measures is
important during PCI. Currently, unfractionated heparin
(UFH) is used widely as an anticoagulant during the PCI
procedure. However, because of its undesirable defects
in terms of structure and composition, UFH is associated
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ulcer within the last 3 months; acute pericarditis; significant retinopathy; platelet count less than 100 109/l;
serum creatinine greater than 177 mol/l; hemodialysis;
and a lack of willingness to participate in the study.
All of the study protocols were approved by the Ethics
Committee of the Second Hospital of Hebei Medical
University and the six other participating hospitals.
Informed consent was obtained from each patient before
enrollment.
Methods
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Table 1
Age (years)
Male
Hemoglobin (g/l)
BMI (kg/m2)
Risk factors
Hypertension
Hyperlipidemia
Diabetes mellitus
Smoking
Femoral artery approach
(%)
Group 1 (n = 323)
Group 2 (n = 410)
P-values
59.0 9.9
230 (71.2)
130.1 11.2
25.3 3.59
58.1 8.9
317 (77.3)
135.3 12.6
25.7 3.10
0.17
0.06
0.16
0.08
215
100
66
176
24
(66.7)
(30.1)
(20.5)
(54.5)
(7.4)
286
143
96
224
18
(69.8)
(34.9)
(23.4)
(54.6)
(4.4)
0.36
0.26
0.33
0.97
0.08
Results
Baseline data
Safety evaluation
Group 1 (n = 323)
Group 2 (n = 410)
P-values
1.46 0.71
13.13 3.27
1.25 0.52
12.86 2.12
0.08
0.63
14.85 5.56
2.94 0.42
19.35 6.87
12.8 5.93
2.97 0.42
18.74 5.10
0.07
0.33
0.18
0.54
180
74
61
8
(55.7)
(22.9)
(18.9)
(2.5)
196
88
120
6
(47.8)
(21.5)
(29.3)
(1.5)
0.09
98 (30.3)
111 (34.4)
114 (35.3)
140 (34.2)
156 (38.0)
114 (27.8)
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Table 3
group 2
cTnI
> 1 g/l
3 ULN
5 ULN
CK-MB
> 25 g/l
2 ULN
5 ULN
Table 4
group 2
Group 1 (n = 323)
Group 2 (n = 410)
2 values
P-values
97 (30.0)
43 (13.3)
23 (7.1)
127 (31.0)
52 (12.7)
30 (7.3)
0.076
0.064
0.01
0.783
0.801
0.919
37 (11.5)
10 (3.1)
0 (0.0)
33 (8.1)
12 (2.9)
1 (0.2)
2.427
0.018
0.00
0.119
0.894
1.00
Major bleeding
Minor bleeding
Total number of bleeding events
Bleeding site
Puncture-site hematoma
(< 5 cm)
Puncture-site hematoma
(>5 cm)
Gingival bleeding
Gastrointestinal bleeding
Hematuria
Thrombocytopenia
Cerebral bleeding
Group 1
(n = 323)
Group 2
(n = 410)
P-values
1 (0.3)
2 (0.6)
9 (2.8)
0 (0)
4 (1.0)
6 (1.5)
1.00
0.60
0.21
4 (1.2)
2 (0.5)
0.26
2 (0.6)
4 (1.0)
0.60
2
1
0
0
0
0
0
0
0
0
1.00
1.00
1.00
1.00
1.00
(0.6)
(0.3)
(0)
(0)
(0)
(0)
(0)
(0)
(0)
(0)
Table 5
Group 1 (n = 323)
Death
Nonfatal myocardial
infarction
TLR rate
TVR rate
MACE incidence
Incidence of stent
thrombosis
Group 2 (n = 410)
P-values
0 (0)
0 (0)
0 (0)
1 (0.2)
1.00
1.00
1
1
2
1
1
1
2
1
0.87
0.87
0.81
0.87
(0.3)
(0.3)
(0.6)
(0.3)
(0.2)
(0.2)
(0.5)
(0.2)
Discussion
This study shows that dalteparin as an anticoagulant
during elective PCI might be as effective and safe as
UFH. There was no significant difference between the
two groups with respect to the mean serum levels and
incidence of an increase in cTnI and CK-MB levels after
PCI (P = 0.80 and 0.89). Moreover, the rates of bleeding
and MACEs after PCI were also similar in both groups.
These results suggest that dalteparin is a safe and
effective anticoagulant for use in the context of
elective PCI.
In recent years, researchers have confirmed the safety
and effectiveness of using LMWH as an anticoagulant in
PCI. Rabah et al. [20] first found that the use of
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evidence of adjunctive anticoagulation in such a situation. Our results also further confirmed the feasibility of
using dalteparin instead of UFH for anticoagulation
during PCI.
Notwithstanding the weaker effect of LMWH against
thrombosis induced by foreign objects compared with
UFH [9,33], thrombosis within the sheath occurred in
only one patient of the dalteparin group, which is not
statistically different from that of the UFH group.
Therefore, the choice of dalteparin does not mean that
more thrombosis was induced by foreign objects.
Some studies indicate that LMWH can reduce the incidence of MACEs and stent thrombosis compared with
UFH. Kim et al. [34] have suggested that tirofiban in
combination with dalteparin in patients with acute coronary syndrome can significantly lower the incidence of
MACEs compared with UFH plus tirofiban. In our study,
no significant differences in the incidence of MACEs or
stent thrombosis were found between the two groups
(P = 0.81 and 0.87).
Limitations of the study
Conclusion
Dalteparin is applicable for anticoagulation during elective PCI and is not inferior to UFH in terms of postoperative myocardial injury markers or bleeding
complications. Thus, the use of dalteparin might be a
feasible alternative to UFH in elective PCI. This study
had a small sample size; therefore, the findings may be
used to generate hypotheses rather than to provide
definite conclusions.
Acknowledgements
The authors are indebted to the patients who agreed to
participate in this trial, the study contributors, and the
investigators who recruited patients. Prof. Wei Cui had
full access to all data in the study and takes responsibility
for the integrity of the data and the accuracy of the data
analysis.
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Conflicts of interest
19
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