Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Source
2.2. Baseline Patient Cohort
2.3. Follow-Up Patient Cohort
2.4. Statistical Analysis
2.4.1. Baseline Cohort Analysis
2.4.2. Follow-up Cohort Analysis
3. Results
3.1. Baseline Characteristics
3.2. Trial Eligibility
3.3. Follow-up Cohort
4. Discussion
Study Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Variables | Comparison between the ISCHEMIA Trial and JCD–KiCS | Comparison within the JCD–KiCS | |||
---|---|---|---|---|---|
Actual ISCHEMIA Participants | ISCHEMIA-Eligible Patients in the JCD–KiCS | Non-Eligible Patients | Eligible Patients | p Value | |
n | 5179 | 1655 | 486 | 1655 | |
Background | |||||
Age (years) | 64 (58, 70) | 69 (63, 75) | 70 (64, 76) | 69 (63, 75) | 0.015 |
Male (%) | 4011 (77.4) | 1364 (83.2) | 392 (81.3) | 1364 (83.2) | 0.37 |
BMI (kg/m2) | 27.7 (25.0, 31.2) | 24 (22, 27) | 24 (22, 26) | 24 (22, 27) | <0.001 |
Smoking (%) | 639 (12.4) | 418 (25.6) | 136 (28.2) | 418 (25.6) | 0.27 |
EF (%) | 60 (55, 65) | 63 (55, 69) | 58 (44, 67) | 63 (55, 69) | <0.001 |
eGFR (mL/min/1.73m2) | 82 (69, 97) | 64 (54, 75) | 47 (15, 64) | 64 (54, 75) | <0.001 |
CCS (%) | <0.001 | ||||
0 | 1039 (20.1) | 609 (38.5) | 178 (40.4) | 609 (38.5) | |
1 | 1384 (26.7) | 247 (15.6) | 64 (14.5) | 247 (15.6) | |
2 | 2524 (48.8) | 591 (37.3) | 131 (29.7) | 591 (37.3) | |
3 | 230 (4.4) | 136 (8.6) | 48 (10.9) | 136 (8.6) | |
4 | 0 (0.0) | 0 (0.0) | 20 (4.5) | 0 (0.0) | |
Hypertension (%) | 3789 (73.4) | 1303 (79.5) | 405 (84.0) | 1303 (79.5) | 0.034 |
Diabetes mellitus (%) | 2122 (41.0) | 754 (46.1) | 282 (58.8) | 754 (46.1) | <0.001 |
PAD (%) | 205 (4.0) | 130 (7.9) | 74 (15.4) | 130 (7.9) | <0.001 |
Past medical history | |||||
History of HF (%) | 206 (4.0) | 86 (5.3) | 134 (27.9) | 86 (5.3) | <0.001 |
History of stroke (%) | 150 (2.9) | 147 (9.0) | 69 (14.3) | 147 (9.0) | 0.001 |
History of MI (%) | 990 (19.2) | 507 (31.0) | 176 (36.5) | 507 (31.0) | 0.025 |
History of PCI (%) | 1050 (20.3) | 804 (49.0) | 261 (54.1) | 804 (49.0) | 0.053 |
History of CABG (%) | 200 (3.9) | 98 (6.0) | 73 (15.1) | 98 (6.0) | <0.001 |
Angiographic characteristics | |||||
Proximal LAD (%) | 1749 (46.8) | 569 (34.7) | 221 (45.8) | 569 (34.7) | <0.001 |
LCX lesion (%) | 2354 (67.4) | 867 (52.9) | 323 (66.7) | 867 (52.9) | <0.001 |
RCA lesion (%) | 2311 (68.8) | 876 (53.9) | 305 (63.9) | 876 (53.9) | <0.001 |
Multivessel disease (%) | 2679 (79.0) | 1029 (62.2) | 408 (84.0) | 1029 (62.2) | <0.001 |
Medication at discharge | |||||
Aspirin (%) | 4871 (94.1) | 1613 (98.7) | 471 (97.7) | 1613 (98.7) | 0.17 |
RAASi (%) | 3413 (66.0) | 960 (58.8) | 319 (66.2) | 960 (58.8) | 0.004 |
Beta blockers (%) | 4161 (80.4) | 1129 (69.1) | 361 (74.9) | 1129 (69.1) | 0.017 |
Statins (%) | 4904 (94.8) | 1419 (86.8) | 389 (80.7) | 1419 (86.8) | 0.001 |
Outcome | Time | Patients in Invasive Strategy in the ISCHEMIA Trial (%) | ISCHEMIA-Eligible Patients in JCD–KiCS (95% CI) (%) |
---|---|---|---|
Primary outcome | 0 to 6 month | 4.8 | 1.7 (0.7–2.7) |
6 month to 1 year | 1.4 | 1.4 (0.5–2.4) | |
1 year to 2 year | 1.7 | 1.6 (0.6–2.6) | |
All-cause death | 0 to 6 month | 0.8 | 0.8 (0.1–1.5) |
6 month to 1 year | 0.9 | 0.5 (0.0–1.0) | |
1 year to 2 year | 1.1 | 1.3 (0.4–2.1) |
Endpoint | Eligible Patients (n = 641) | Non-Eligible Patients (n = 170) | aHR (95% CI) | p Value |
---|---|---|---|---|
Events Rate (%) | Events Rate (%) | |||
Primary outcome | 4.7 (3–6.3) | 13.5 (8.2–18.5) | 2.89 (1.68–4.98) | <0.001 |
All-cause death | 2.5 (1.3–3.7) | 11.2 (6.3–15.8) | 4.5 (2.31–8.77) | <0.001 |
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Niimi, N.; Sawano, M.; Ikemura, N.; Nagai, T.; Nakano, S.; Shoji, S.; Shiraishi, Y.; Ueda, I.; Numasawa, Y.; Suzuki, M.; et al. Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention. J. Clin. Med. 2020, 9, 2889. https://doi.org/10.3390/jcm9092889
Niimi N, Sawano M, Ikemura N, Nagai T, Nakano S, Shoji S, Shiraishi Y, Ueda I, Numasawa Y, Suzuki M, et al. Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention. Journal of Clinical Medicine. 2020; 9(9):2889. https://doi.org/10.3390/jcm9092889
Chicago/Turabian StyleNiimi, Nozomi, Mitsuaki Sawano, Nobuhiro Ikemura, Toshiyuki Nagai, Shintaro Nakano, Satoshi Shoji, Yasuyuki Shiraishi, Ikuko Ueda, Yohei Numasawa, Masahiro Suzuki, and et al. 2020. "Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention" Journal of Clinical Medicine 9, no. 9: 2889. https://doi.org/10.3390/jcm9092889