Background
Methods
Study design, patient population, and treatment
Resource utilization and estimation of medical care cost
Effectiveness estimation
Cost-effectiveness analyses and threshold
Sensitivity analysis
Statistical analyses
Compliance with ethical standards
Results
Patient population
PCI (n = 205) | MT (n = 203) | CABG (203) |
P
a
| |
---|---|---|---|---|
Socio demographic characteristics | ||||
Age, year ± SD | 60 ± 9 | 60 ± 9 | 60 ± 9 | 0.959b |
Female, % | 33 | 31 | 28 | 0.412a |
Clinical characteristics, % | ||||
Hypertension | 61 | 55 | 63 | 0.215a |
Diabetes mellitus | 23 | 36 | 29 | 0.062a |
Previous MI | 52 | 39 | 41 | 0.024a |
Current or past smoker | 27 | 33 | 32 | 0.013a |
CCS angina classes | < 0.001a | |||
I and II | 72.2 | 59.1 | 50.2 | |
III and IV | 20.5 | 22.6 | 37.4 | |
Not applicable or no angina | 7.3 | 18.2 | 12.3 | |
Angiographic characteristics, % | ||||
LVEF ± SD | 67 ± 8 | 68 ± 7 | 67 ± 9 | 0.984a |
3-vessels disease | 58 | 59 | 58 | 0.980a |
Initial events, resource usage and cost
PCI (n = 205) | MT (n = 203) | CABG (203) |
P
| |
---|---|---|---|---|
Procedural resource use, % (n) | ||||
No of PCI procedures | < 0.001a | |||
0 | 6.8 (14) | 97.5 (198) | 99.5 (202) | |
1 | 96.6 (173) | 2.8 (5) | 0.6 (1) | |
2 | 8.3 (17) | 0.0 (0) | 0.0 (0) | |
3 | 0.5 (1) | 0.0 (0) | 0.0 (0) | |
Bare metal stent | < 0.001a | |||
0 | 22.9 (47) | 97.5 (198) | 100 (203) | |
1 | 35.1 (72) | 2.0 (4) | 0 (0) | |
2 | 32.2 (66) | 0.5 (1) | 0 (0) | |
3 | 8.3 (17) | 0 (0) | 0 (0) | |
≥ 4 | 1.5 (3) | 0 (0) | 0 (0) | |
Balloon angioplasty | < 0.001a | |||
0 | 6.8 (14) | 97.5 (198) | 99.5 (202) | |
1 | 26.8 (55) | 1.5 (3) | 0.5 (1) | |
2 | 37.1 (76) | 1.0 (2) | 0 (0) | |
3 | 21.0 (43) | 0 (0) | 0 (0) | |
≥ 4 | 8.3 (17) | 0 (0) | 0 (0) | |
CABG procedure | < 0.001a | |||
0 | 92.2 (189) | 94.1 (191) | 8.9 (18) | |
1 | 7.8 (16) | 5.9 (12) | 91.1 (185) | |
Diagnostic catheterization | < 0.001a | |||
1 | 80.5 (165) | 96.6 (196) | 95.6 (194) | |
2 | 18.5 (38) | 3.4 (7) | 4.4 (9) | |
3 | 1.0 (2) | 0.0 (0) | 0 (0) | |
Clinical outcomes, % (n) | ||||
Death | 4.9 (10) | 1.0 (2) | 3.9 (8) | 0.07a |
AMI | 14.9 (30) | 5.9 (12) | 7.4 (15) | 0.005a |
Stroke | 2.0 (4) | 1.0 (2) | 4.4 (9) | 0.068a |
Unstable angina | 2.9 (6) | 0.5 (1) | 1.0 (2) | 0.263a |
Cost, $ mean ± SD | ||||
Medication | 47 ± 32 [38] | 80 ± 104 [64] | 40 ± 29 [30] | < 0.001b |
Outpatient service | 303 ± 85 [274] | 284 ± 112 [261] | 248 ± 53 [233] | < 0.001b |
PCI procedure | 1490 ± 741 [1385] | 35 ± 225 [0] | 3 ± 46 [0] | < 0.001b |
CABG procedure | 152 ± 523 [0] | 115 ± 460 [0] | 1775 ± 555 [1947] | < 0.001b |
Total cost | 1952 ± 841 [1807] | 446 ± 525 [277] | 2037 ± 559 [2180] | < 0.001b |
Follow-up events, resource usage, and costs
Year 1 | Year 2 | Year 3 | |||||||
---|---|---|---|---|---|---|---|---|---|
PCI (n = 195) | MT (n = 201) | CABG (n = 195) | PCI (n = 191) | MT (n = 197) | CABG (n = 191) | PCI (n = 189) | MT (n = 189) | CABG (n = 185) | |
Clinical outcomes, n (%) | |||||||||
Death | 4 (2.1) | 4 (2.0) | 4 (2.1) | 2 (1.0) | 8 (4.1) | 6 (3.1) | 0 (0) | 11 (5.8) | 1 (0.5) |
AMI | 3 (1.5) | 6 (3.0) | 2 (1.0) | 4 (2.1) | 9 (4.6) | 4 (2.1) | 0 (0) | 11 (5.8) | 0 (0) |
Stroke | 1 (0.5) | 3 (1.5) | 3 (1.5) | 0 (0) | 3 (1.5) | 3 (1.0) | 1 (0.5) | 2 (1.1) | 3 (1.6) |
Angina | 5 (2.6) | 1 (0.5) | 0 (0) | 3 (1.6) | 0 (0) | 0 (0) | 1 (0.5) | 1 (0.5) | 3 (1.0) |
Resource use, n events/100 patients | |||||||||
Repeat revascularization (any) | 12.3 | 5.0 | 4.6 | 5.8 | 7.1 | 3.7 | 1.6 | 5.3 | 1.1 |
PCI procedure | 12.3 | 2.5 | 0.5 | 5.2 | 3.6 | 0.5 | 1.1 | 1.6 | 0.5 |
CABG procedure | 0.0 | 2.5 | 4.1 | 0.5 | 3.6 | 3.1 | 0.5 | 3.7 | 0.5 |
Bare metal stent | 11.3 | 3.0 | 1.0 | 4.2 | 4.6 | 0.5 | 1.1 | 1.6 | 0.5 |
Balloon angioplasty | 21.5 | 3.0 | 1.5 | 9.9 | 5.6 | 0.5 | 1.1 | 1.6 | 0.5 |
Diagnostic catheterization | 15.4 | 5.5 | 15.9 | 11.0 | 6.1 | 4.2 | 3.7 | 10.1 | 1.1 |
Cost per patient, $ | |||||||||
Medication | 47 ± 32 [39] | 80 ± 104 [64] | 39 ± 29 [30] | 93 ± 63 [78] | 162 ± 210 [127] | 78 ± 58 [60] | 93 ± 63 [78] | 163 ± 212 [127] | 72 ± 53 [56] |
Outpatient service | 116 ± 82 [91] | 111 ± 116 [85] | 90 ± 82 [61] | 160 ± 99 [124] | 200 ± 229 [157] | 115 ± 72 [98] | 146 ± 81 [123] | 209 ± 223 [166] | 110 ± 71 [97] |
PCI procedure | 150 ± 433 [0] | 34 ± 221 [0] | 10 ± 141 [0] | 63 ± 360 [0] | 48 ± 290 [0] | 6 ± 90 [0] | 13 ± 127 [0] | 20 ± 155 [0] | 7 ± 91 [0] |
CABG procedure | 0 | 48 ± 304 [0] | 80 ± 387 [0] | 10 ± 141 [0] | 69 ± 361 [0] | 61 ± 340 [0] | 10 ± 141 [0] | 72 ± 369 [0] | 10 ± 143 [0] |
Revascularization procedure (any) | 150 ± 433 [0] | 83 ± 371 [0] | 90 ± 410 [0] | 73 ± 385 [0] | 118 ± 456 [0] | 48 ± 294 [0] | 23 ± 190 [0] | 92 ± 397 [0] | 17 ± 234 [0] |
Total | 221 ± 474 [54] | 120 ± 408 [18] | 146 ± 417 [16] | 233 ± 432 [124] | 316 ± 576 [160] | 183 ± 365 [100] | 171 ± 222 [123] | 306 ± 489 [170] | 131 ± 281 [97] |
Year 4 | Year 5 | 5-years cumulative | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
PCI (n = 188) | MT (n = 178) | CABG (n = 183) | PCI (n = 182) | MT (n = 170) | CABG (n = 178) | PCI (n = 195) | MT (n = 201) | CABG (n = 195) | P valuec | |
Clinical outcomes, n (%) | ||||||||||
Death | 7 (3.7) | 8 (4.5) | 6 (3.3) | 5 (2.7) | 2 (1.2) | 7 (3.9) | 18 (9.2) | 33 (16.4) | 24 (12.3) | 0.098a |
AMI | 5 (2.6) | 2 (1.1) | 1 (0.5) | 2 (1.1) | 2 (1.2) | 7 (3.9) | 14 (7.2) | 30 (14.9) | 14 (7.2) | 0.022a |
Stroke | 0 (0) | 3 (1.7) | 2 (1.1) | 2 (1.1) | 2 (1.2) | 0 (0) | 4 (2.1) | 13 (6.5) | 11 (5.6) | 0.178a |
Angina | 2 (1.1) | 1 (0.6) | 1 (0.5) | 4 (2.2) | 4 (2.4) | 6 (3.4) | 15 (7.7) | 7 (3.5) | 10 (5.1) | 0.395a |
Resource use, n events/100 patients | ||||||||||
Repeat revascularization (any) | 3.2 | 1.7 | 0.0 | 5.5 | 7.6 | 1.1 | 27.7 | 24.9 | 10.3 | 0.001a |
PCI procedure | 2.1 | 1.1 | 0.0 | 4.4 | 2.9 | 1.1 | 24.6 | 10.9 | 2.6 | < 0.001a |
CABG procedure | 1.1 | 0.6 | 0.0 | 1.1 | 4.7 | 0.0 | 3.1 | 13.9 | 7.7 | < 0.001a |
Bare metal stent | 0.5 | 1.1 | 0.0 | 3.3 | 4.1 | 1.1 | 20.0 | 13.4 | 3.1 | 0.014a |
Balloon angioplasty | 2.7 | 1.1 | 0.0 | 4.4 | 5.3 | 1.1 | 39.0 | 15.4 | 3.6 | < 0.001a |
Diagnostic catheterization | 4.8 | 3.4 | 0.5 | 12.6 | 14.7 | 7.3 | 46.2 | 36.3 | 28.2 | 0.042a |
Cost per patient, $ | ||||||||||
Medication | 93 ± 63 [78] | 165 ± 218 [127] | 77 ± 57 [72] | 92 ± 63 [78] | 166 ± 222 [127] | 77 ± 57 [60] | 403 ± 284 [329] | 680 ± 939 [558] | 334 ± 255 [262] | < 0.001b |
Outpatient service | 148 ± 83 [123] | 199 ± 228 [158] | 108 ± 63 [96] | 162 ± 97 [127] | 220 ± 246 [168] | 120 ± 76 [100] | 707 ± 373 [635] | 867 ± 995 [733] | 523 ± 306 [470] | < 0.001b |
PCI procedure | 18 ± 126 [0] | 14 ± 131 [0] | 0 | 48 ± 297 [0] | 42 ± 257 [0] | 14 ± 131 [0] | 287 ± 717 [0] | 149 ± 473 [0] | 36 ± 226 [0] | < 0.001b |
CABG procedure | 20 ± 200 [0] | 11 ± 146 [0] | 0 | 21 ± 203 [0] | 91 ± 413 [0] | 0 | 60 ± 337 [0] | 271 ± 676 [0] | 151 ± 522 [0] | < 0.001b |
Revascularization procedure (any) | 38 ± 234 [0] | 25 ± 195 [0] | 0 | 69 ± 357 [0] | 134 ± 508 [0] | 14 ± 131 [0] | 347 ± 802 [0] | 420 ± 849 [0] | 167 ± 553 [0] | 0.003b |
Total | 189 ± 283 [123] | 229 ± 32 [161] | 111 ± 65 [97] | 235 ± 413 [133] | 359 ± 606 [176] | 142 ± 171 [103] | 1402 ± 1780 [673] | 1707 ± 2090[0] | 877 ± 1184 [501] | < 0.001b |
Utility weights, QALYs, LYs
Period (month) | PCI (n = 194) Mean ± SD | Imputation, n (%) | MT (n = 197) Mean ± SD | Imputation, n (%) | CABG (n = 188) Mean ± SD | Imputation n, (%) |
---|---|---|---|---|---|---|
Baseline | 0.77 ± 0.84 [0.76] | 0 (0) | 0.76 ± 0.72 [0.76] | 0 (0) | 0.75 ± 0.07 [0.72] | 0 (0) |
6 | 0.79 ± 0.16 [0.79] | 5 (2.6) | 0.78 ± 0.11 [0.78] | 3 (1.5) | 0.78 ± 0.13 [0.77] | 4 (2.2) |
12 | 0.78 ± 0.19 [0.81] | 4 (2.2) | 0.77 ± 0.15 [0.78] | 5 (2.6) | 0.78 ± 0.16 [0.77] | 6 (3.3) |
24 | 0.76 ± 0.21 [0.80] | 4 (2.2) | 0.73 ± 0.22 [0.76] | 9 (4.9) | 0.76 ± 0.18 [0.78] | 12 (6.7) |
36 | 0.77 ± 0.21 [0.81] | 5 (2.7) | 0.69 ± 0.27 [0.76] | 11 (6.3) | 0.76 ± 0.21 [0.80] | 14 (8.6) |
48 | 0.75 ± 0.24 [0.81] | 12 (6.7) | 0.66 ± 0.30 [0.76] | 10 (6.1) | 0.74 ± 0.24 [0.79] | 13 (7.9) |
60 | 0.72 ± 0.29 [0.81] | 8 (4.7) | 0.65 ± 0.31 [0.75] | 8 (4.9) | 0.72 ± 0.28 [0.78] | 11 (6.6) |
Time since randomization, years | Cumulative costs, $ | Difference costs, $ | Cumulative QALYs | Difference QALYs | Cumulative LYs | Difference LYs | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CABG PCI MT | CABG vs. MT | PCI vs. MT | PCI vs. CABG | CABG | PCI | MT | CABG vs. MT | PCI vs. MT | PCI vs. CABG | CABG | PCI | MT | CABG vs. MT | PCI vs. MT | PCI vs. CABG | |
1 | 2213 2208 645 | 1568 | 1563 | − 5 | 0.77 | 0.78 | 0.77 | 0.00 | 0.01 | 0.01 | 0.97 | 0.96 | 0.99 | − 0.02 | − 0.03 | − 0.01 |
2 | 2388 2428 958 | 1430 | 1470 | 40 | 1.54 | 1.54 | 1.51 | 0.03 | 0.03 | 0.00 | 1.90 | 1.88 | 1.94 | − 0.04 | − 0.06 | − 0.02 |
3 | 2508 2585 1243 | 1265 | 1342 | 77 | 2.29 | 2.31 | 2.31 | − 0.02 | 0.00 | 0.02 | 2.81 | 2.80 | 2.85 | − 0.04 | − 0.05 | − 0.01 |
4 | 2609 2759 1443 | 1166 | 1317 | 150 | 3.04 | 3.07 | 2.88 | 0.16 | 0.19 | 0.03 | 3.70 | 3.72 | 3.71 | − 0.01 | 0.01 | 0.02 |
5 | 2753 3002 1740 | 1013 | 1262 | 249 | 3.77 | 3.80 | 3.54 | 0.23 | 0.26 | 0.03 | 4.56 | 4.59 | 4.55 | 0.01 | 0.04 | 0.03 |
Cost-effectiveness analyses: overall population
Cost, $ | QALYs | ICER ($/QALYs) | % Dominant | % Dominated | ≤ 3 GDP/capita | ≤ $100,000 | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PCI | MT | Δ (PCI–MT) | Δ (95% CI) | PCI | MT | Δ (PCI–MT) | Δ (95% CI) | ||||||
Overall (n = 391) | 3002 | 1740 | 1262 | (994; 1513) | 3.80 | 3.54 | 0.26 | (0.07; 0.45) | 4854 | 0 | 0 | 99 | 99 |
Overall and additional cost (n = 391) | 3131 | 1764 | 1366 | (1095; 1630) | 3.80 | 3.54 | 0.26 | (0.07; 0.45) | 5255 | 0 | 1 | 98 | 99 |
Higher cost (n = 391) | 78,063 | 45,253 | 32,811 | (25,837; 39,331) | 3.80 | 3.54 | 0.26 | (0.07; 0.45) | 126,197 | 0 | 6 | 0 | 25 |
Cost, $ | QALYs | ICER ($/QALYs) | % Dominant | % Dominated | ≤ 3 GDP/capita | ≤ $100,000 | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CABG | MT | Δ (CABG–MT) | Δ (95% CI) | CABG | MT | Δ (CABG–MT) | Δ (95% CI) | ||||||
Overall (n = 385) | 2753 | 1740 | 1013 | (761; 1235) | 3.77 | 3.54 | 0.23 | (0.03; 0.42) | 4403 | 0 | 1 | 97 | 98 |
Overall and additional cost (n = 385) | 2772 | 1764 | 1008 | (757; 1234) | 3.77 | 3.54 | 0.23 | (0.03; 0.42) | 4384 | 0 | 1 | 97 | 98 |
Higher cost (n = 385) | 71,583 | 4525 | 26,331 | (19,782; 32,111) | 3.77 | 3.54 | 0.23 | (0.03; 0.42) | 114,482 | 0 | 8 | 0 | 36 |
Cost, $ | QALYs | ICER ($/QALYs) | % Dominant | % Dominated | ≤ 3 GDP/capita | ≤ $100,00 | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PCI | CABG | Δ (PCI–CABG) | Δ (95% CI) | PCI | CABG | Δ (PCI–CABG) | Δ (95% CI) | ||||||
Overall (n = 382) | 3002 | 2753 | 249 | (64; 445) | 3.80 | 3.77 | 0.03 | (− 0.14; 0.21) | 8308 | 0 | 35 | 61 | 64 |
Overall and additional cost (n = 382) | 3130 | 2772 | 358 | (160; 565) | 3.80 | 3.77 | 0.03 | (− 0.14; 0.21) | 11,938 | 0 | 35 | 60 | 64 |
Higher cost (n = 382) | 78,064 | 71,583 | 6480 | (1672; 11,566) | 3.80 | 3.77 | 0.03 | (− 0.14; 0.21) | 216,014 | 0 | 43 | 4 | 38 |