Key result
Intravascular ultrasound-guided drug-coated balloons resulted in significantly less lumen loss at 6 months compared to drug-eluting stents (0.31 mm vs 0.48 mm; P<0.05).
Why the study?
The efficacy and safety of intravascular ultrasound-guided drug-coated balloon in PCI for situ coronary artery lesions in ACS patients and its effect on thrombus precursor protein were unclear.
RCT (n=78)
Random digits table method
No
Objective To evaluate the efficacy and safety of intravascular ultrasound guidance drug-coated balloon (DCB) in percutaneous coronary intervention (PCI) of situ coronary artery lesions in patients with acute coronary syndrome (ACS), and its effect on thrombus precursor protein (TpP). Methods Seventy-eight patients with ACS in Central Hospital of Changchun City from January 2015 to January 2019 were selected, including 46 cases with unstable angina pectoris and 32 cases with acute non-ST-segment elevation myocardial infarction. The patients were divided into DCB group (38 cases) and drug-eluting stent (DES) group (40 cases) by random digits table method. Intravascular ultrasound was used to guide PCI in both groups, and DCB and DES were used respectively. Coronary angiography was performed immediately and 6 months after PCI in both groups. Minimum lumen diameter (MLD) was measured by QCA system, and the lumen loss (LLL) was calculated at 6 months after PCI. Plasma TpP before PCI, 1 and 6 months after PCI was measured by enzyme-linked immunosorbent assay (ELISA). Major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction and target lesion revascularization (TLR) were followed up 1, 3, 6 and 12 months after PCI. Results Immediately after PCI, there was no statistical difference in MLD between DCB group and DES group: (1.87 ± 0.23) mm vs. (2.16 ± 0.15) mm, P>0.05; 6 months after PCI, the LLL in DCB group was significantly smaller than that in DES group: (0.31 ± 0.28) mm vs. (0.48 ± 0.19) mm, and there was statistical difference (P 0.05). Before PCI and 6 months after PCI, there was no statistical difference in TpP between 2 groups (P>0.05); 1 month after PCI, the TpP in DCB group was significantly lower than that in DES group: (15.31 ± 6.13) mg/L vs. (19.46 ± 8.24) mg/L, and there was statistical difference (P<0.05). Conclusions DCB is an accurate and effective treatment for ACS patients with situ coronary artery disease under the intravascular ultrasound guidance, and it can reduce the risk of thrombosis.
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Lu et al. (2019) conducted an RCT in Acute coronary syndrome with situ coronary artery lesions (n=78). Intravascular ultrasound-guided drug-coated balloon (DCB) vs. Drug-eluting stent (DES) was evaluated on Lumen loss (LLL) at 6 months after PCI (p=<0.05). Intravascular ultrasound-guided drug-coated balloons resulted in significantly less lumen loss at 6 months compared to drug-eluting stents (0.31 mm vs 0.48 mm; P<0.05).
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