Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial
Abstract
:1. Introduction
2. Methods
2.1. Patients
2.2. Percutaneous Coronary Intervention and Follow-Up
2.3. Clinical Outcome
2.4. Statistical Analyses
3. Results
3.1. Clinical Characteristics
3.2. Lesion Characteristics and In-Hospital Outcome
3.3. Clinical Outcomes at the 1-Year Follow-Up
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Total (n = 375) | Cilotax™ (n = 82) | DXR™ (n = 293) | p-Value | |
---|---|---|---|---|
Demographic data | ||||
Sex, male (%) | 245 (65.3) | 53 (64.5) | 192 (65.5) | 0.985 |
Age, year | 66.6 ± 10.4 | 69.8 ± 10.0 | 65.7 ± 10.3 | 0.002 |
Body mass index, kg/m2 | 25.9 ± 16.8 | 24.7 ± 3.4 | 26.3 ± 18.9 | 0.165 |
Current smokers, n (%) | 93 (24.8) | 19 (23.2) | 74 (25.3) | 0.113 |
Hypertension, n (%) | 227 (60.5) | 49 (59.8) | 178 (60.8) | 0.972 |
Diabetes, n (%) | 127 (33.9) | 28 (34.1) | 99 (33.8) | 1.000 |
Dyslipidemia, n (%) | 154 (41.1) | 33 (40.2) | 121 (41.3) | 0.965 |
History of CAD | ||||
Myocardial infarction, n (%) | 15 (4.0) | 2 (2.4) | 13 (4.4) | 0.619 |
PCI, n (%) | 54 (14.4) | 17 (20.7) | 37 (12.6) | 0.095 |
CABG, n (%) | 6 (1.6) | 2 (2.4) | 4 (1.4) | 0.852 |
Family history of CAD, n (%) | 10 (2.6) | 4 (4.9) | 6 (2.0) | 0.308 |
Congestive heart failure, n (%) | 13 (3.5) | 4 (4.9) | 9 (3.1) | 0.653 |
Peripheral vascular disease, n (%) | 7 (1.9) | 0 (0) | 7 (2.4) | 0.341 |
Stroke, n (%) | 34 (9.1) | 11 (13.4) | 23 (7.8) | 0.182 |
Chronic kidney disease, n (%) | 11 (2.9) | 2 (2.4) | 9 (3.1) | 1.000 |
Chronic lung disease, n (%) | 7 (1.9) | 2 (2.4) | 5 (1.7) | 1.000 |
Clinical presentation | 0.001 | |||
Stable angina, n (%) | 124 (33.1) | 14 (17.1) | 110 (37.5) | |
Unstable angina, n (%) | 160 (42.7) | 39 (47.6) | 121 (41.3) | |
Myocardial infarction, n (%) | 91 (24.3) | 29 (35.4) | 62 (21.2) | |
Discharge Medication | ||||
DAPT, n (%) | 359 (95.7) | 78 (95.1) | 281 (95.9) | 0.759 |
ACEi or ARB, n (%) | 214 (57.1) | 49 (59.8) | 165 (56.3) | 0.615 |
Beta blocker, n (%) | 216 (57.6) | 51 (62.2) | 165 (56.3) | 0.377 |
Statin, n (%) | 316 (84.3) | 68 (82.9) | 248 (84.6) | 0.732 |
DAPT ≥ 12 months, n (%) | 330 (88.0) | 72 (87.8) | 258 (88.1) | 1.000 |
Total (n = 375) | Cilotax™ (n = 82) | DXR™ (n = 293) | p-Value | |
---|---|---|---|---|
Number of treated lesions | 1.6 ± 5.1 | 2.1 ± 0.8 | 1.6 ± 0.7 | <0.001 |
Normal LVEF (≥50%) | 355 (94.7%) | 76 (92.7%) | 279 (95.2%) | 0.404 |
Type of vessel treated | 0.097 | |||
Left main, n (%) | 9 (2.4) | 5 (6.1) | 4 (1.4) | |
Left arterial descending, n (%) | 176 (46.9) | 34 (41.5) | 142 (48.5) | |
Left circumflex, n (%) | 76 (20.3) | 16 (19.5) | 60 (20.5) | |
Right coronary artery, n (%) | 111 (29.6) | 27 (32.9) | 84 (28.7) | |
Ramus, n (%) | 3 (0.8) | 0 (0) | 3 (1.0) | |
Lesion type | 0.298 | |||
A, n (%) | 45 (12.0) | 5 (6.1) | 40 (13.7) | |
B1, n (%) | 108 (28.8) | 22 (26.8) | 86 (28.9) | |
B2, n (%) | 136 (36.3) | 34 (41.5) | 102 (34.8) | |
C, n (%) | 86 (22.9) | 21 (25.6) | 65 (22.2) | |
Calcified lesion, n (%) | 40 (10.6) | 6 (7.3) | 34 (11.6) | 0.317 |
Bifurcation lesion, n (%) | 27 (7.2) | 4 (4.9) | 23 (7.8) | 0.921 |
Stent diameter, mm | 2.9 ± 0.7 | 2.9 ± 0.5 | 2.9 ± 0.7 | 0.354 |
Total stent length, mm | 22.5 ± 11.4 | 22.7 ± 13.8 | 22.4 ± 10.6 | 0.916 |
IVUS-guided PCI, n (%) | 69 (18.4) | 13 (15.9) | 56 (19.2) | 0.591 |
IABP, n (%) | 21 (5.6) | 3 (3.7) | 18 (6.1) | 0.587 |
Total (n = 375) | Cilotax (n = 82) | DXR (n = 293) | Log–Rank p | |
---|---|---|---|---|
Primary endpoint | ||||
Target lesion failure, n (%)(TLR + MI + Cardiac Death) | 14 (3.7) | 7 (8.5) | 7 (2.4) | 0.023 |
Secondary endpoints | ||||
Cardiac death, n (%) | 5 (1.3) | 4 (4.9) | 1 (0.3) | 0.002 |
MI, n (%) | 8 (2.1) | 5 (6.1) | 3 (1.0) | 0.005 |
TLR, n (%) | 9 (2.4) | 4 (4.9) | 5 (1.7) | 0.088 |
Stent thrombosis, n (%) | 4 (1.1) | 3 (3.7) | 1 (0.3) | 0.009 |
Stroke, n (%) | 6 (1.6) | 3 (3.7) | 3 (1.0) | 0.086 |
Univariate | Multivariate | |||||
---|---|---|---|---|---|---|
HR | 95% CI | p-Value | HR | 95% CI | p-Value | |
Age | 1.04 | 0.98–1.10 | 0.167 | 1.05 | 0.99–1.11 | 0.090 |
Sex | 1.97 | 0.55–7.06 | 0.298 | |||
Hypertension | 0.17 | 0.05–0.62 | 0.007 | 0.17 | 0.05–0.64 | 0.009 |
Diabetes mellitus | 0.44 | 0.10–1.99 | 0.288 | |||
Dyslipidemia | 0.79 | 0.27–2.36 | 0.675 | |||
Chronic kidney disease | 1.03 | 0.23–4.61 | 0.967 | |||
Current smoker | 0.50 | 0.11–2.25 | 0.369 | |||
Previous PCI | 1.63 | 0.46–5.85 | 0.453 | |||
Previous CABG | 4.76 | 0.62–36.67 | 0.133 | 2.70 | 0.32–22.57 | 0.359 |
Previous MI | 4.31 | 0.96–19.25 | 0.056 | 3.57 | 0.75–17.01 | 0.110 |
Acute coronary syndrome | 2.97 | 0.66–13.26 | 0.154 | 1.77 | 0.37–8.48 | 0.473 |
Bifurcation lesion | 2.57 | 0.80–8.18 | 0.111 | 2.92 | 0.86–9.91 | 0.086 |
DXR stent | 0.27 | 0.10–0.78 | 0.016 | 0.30 | 0.09–0.92 | 0.036 |
IVUS-guidance PCI | 0.42 | 0.04–4.46 | 0.289 | |||
Total number of stents | 1.04 | 0.28–3.88 | 0.953 | |||
Total lesion length | 1.00 | 0.96–1.05 | 0.945 |
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Cha, J.-J.; Kim, G.C.; Hur, S.H.; Bae, J.H.; Choi, J.W.; Jin, D.-K.; Woo, S.I.; Lee, S.U.; Park, J.S.; Cho, Y.-H.; et al. Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial. J. Clin. Med. 2021, 10, 69. https://doi.org/10.3390/jcm10010069
Cha J-J, Kim GC, Hur SH, Bae JH, Choi JW, Jin D-K, Woo SI, Lee SU, Park JS, Cho Y-H, et al. Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial. Journal of Clinical Medicine. 2021; 10(1):69. https://doi.org/10.3390/jcm10010069
Chicago/Turabian StyleCha, Jung-Joon, Gi Chang Kim, Seung Ho Hur, Jang Ho Bae, Jae Woong Choi, Dong-Kyu Jin, Seong Il Woo, Seung Uk Lee, Jong Seon Park, Yun-Hyeong Cho, and et al. 2021. "Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial" Journal of Clinical Medicine 10, no. 1: 69. https://doi.org/10.3390/jcm10010069
APA StyleCha, J.-J., Kim, G. C., Hur, S. H., Bae, J. H., Choi, J. W., Jin, D.-K., Woo, S. I., Lee, S. U., Park, J. S., Cho, Y.-H., Choi, C. U., Lim, D.-S., & Ahn, T. H. (2021). Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea—The Effect Trial. Journal of Clinical Medicine, 10(1), 69. https://doi.org/10.3390/jcm10010069