TUXEDO-2 Results
These results are of Primary Objective of The TUXEDO study
Primary Outcomes
TLF Rate at 1 Year
Ischemia Driven-target Lesion Revascularization
Target-vessel Myocardial Infarction
Summary of Primary Outcomes
| BP-SES (N=901) | DP-EES (N=899) | Hazard Ratio | 95% CI | P-value | |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Target lesion failure | 70 (7.92%) | 78 (8.75%) | 0.89 | 0.64-1.23 | 0.49 |
| - Ischemia-driven target lesion revascularization | 6 (0.82%) | 9 (1.07%) | 0.67 | 0.24-1.88 | 0.44 |
| - Cardiac death | 32 (3.56%) | 30 (3.36%) | 1.07 | 0.65-1.76 | 0.80 |
| - Target vessel myocardial infarction | 58 (6.61%) | 67 (7.54 %) | 0.86 | 0.60-1.22 | 0.40 |
Secondary Outcomes
All-cause Death
Non-fatal Myocardial Infarction
Major Adverse Cardiovascular Events
Summary of Secondary Outcomes
| BP-SES (N=901) | DP-EES (N=899) | Hazard Ratio | 95% CI | P-value | |
|---|---|---|---|---|---|
| Secondary outcome | |||||
| Ischemia-driven target-vessel revascularization | 7 (0.93%) | 11 (1.32%) | 0.64 | 0.25-1.64 | 0.35 |
| Target vessel failure | 70 (7.92%) | 78 (8.75%) | 0.89 | 0.64-1.23 | 0.49 |
| All-cause death | 36 (4.00%) | 38 (4.67%) | 0.95 | 0.60-1.50 | 0.82 |
| Nonfatal myocardial infarction | 41 (4.72%) | 57 (6.45%) | 0.72 | 0.48-1.07 | 0.10 |
| MACE | 77 (8.69%) | 90 (10.35%) | 0.85 | 0.63-1.15 | 0.29 |
| Peri Procedural MI | 29 (3.22%) | 41 (4.56%) | 0.70 | 0.44- 1.13 | 0.14 |
| Spontaneous MI | 32 (3.73%) | 33 (3.79%) | 0.97 | 0.60-1.58 | 0.91 |
| Stent thrombosis | 9 (1.00%) | 6 (0.67%) | 1.50 | 0.53-4.20 | 0.44 |
| - Acute stent thrombosis | 2 (0.22%) | 2 (0.22%) | 1.00 | 0.14-7.08 | 0.99 |
| - Subacute stent thrombosis | 6 (0.67%) | 3 (0.34%) | 1.99 | 0.50-7.98 | 0.32 |
| - Late stent thrombosis | 1 (0.11%) | 1 (0.11%) | 1.00 | 0.06-15.91 | 0.99 |
| - Definite stent thrombosis | 1 (0.11%) | 2 (0.23%) | 0.50 | 0.05-5.50 | 0.56 |
| - Probable stent thrombosis | 8 (0.89%) | 4 (0.45%) | 2.00 | 0.60-6.63 | 0.25 |
| Stroke | 8 (0.91%) | 2 (0.23%) | 3.98 | 0.84-18.72 | 0.06 |
Conclusion
- The Supraflex Cruz (BP-SES) with ultra-thin strut was noninferior to the Xience (DP-EES) for target lesion failure in a complex patient population with diabetes and MVD on optimal medical treatment.
- The BP-SES provide comparable safety and efficacy to established DP-EES in this high-risk diabetic population with multivessel coronary disease
Additional Information
Baseline Characteristics (ITT population)
| Parameter | BP-SES (N=901 patients) | DP-EES (N=899 patients) | Overall (N=1800 patients) | P-value |
|---|---|---|---|---|
| Age (years) | 60.49 ± 10.06 | 60.08 ± 10.29 | 60.28 ±10.18 | 0.39 |
| BMI (Kg/m2) | 24.73 ± 3.86 | 24.76 ± 3.90 | 24.75 ± 3.88 | 0.88 |
| Men | 635 (70.48%) | 661 (73.53%) | 1296 (72.00%) | 0.15 |
| Duration of diabetes (Years) | 5.84 ± 5.59 | 5.98 ± 5.97 | 5.91 ±5.78 | 0.61 |
| Type 1 diabetes | 2 (0.22%) | 6 (0.67%) | 8 (0.44%) | 0.16 |
| Type 2 diabetes | 899 (99.78%) | 893 (99.33%) | 1792 (99.56%) | |
| - Insulin requiring | 231 (25.64%) | 205 (22.80%) | 436 (24.22%) | 0.15 |
| Family history of coronary artery disease | 74 (8.21%) | 89 (9.90%) | 163 (9.06%) | 0.21 |
| Prior smoking | 131 (14.54%) | 155 (17.24%) | 286 (15.89%) | 0.12 |
| Hypertension | 551 (61.15%) | 533 (59.29%) | 1084 (60.22%) | 0.42 |
| Dyslipidemia | 753 (83.57%) | 744 (82.76%) | 1497 (83.17%) | 0.64 |
| Prior myocardial infarction | 199 (22.09%) | 188 (20.91%) | 387 (21.50%) | 0.54 |
| Prior percutaneous coronary intervention | 32 (3.55%) | 42 (4.67%) | 74 (4.11%) | 0.23 |
| LVEF | 48.3 ± 10.0 | 48.4 ±9.6 | 48.3 ± 9.8 | 0.74 |
| Ejection fraction ≤40% | 254 (28.19%) | 234 (26.03%) | 488 (27.11%) | 0.32 |
| Coronary artery disease presentation | ||||
| - Myocardial infarction | 545 (60.49%) | 514 (57.17%) | 1059 (58.83%) | 0.15 |
| - Unstable angina | 169 (18.76%) | 192 (21.36%) | 361 (20.06%) | 0.17 |
| - CCS | 187 (20.75%) | 193 (21.47%) | 380 (21.11%) | 0.71 |
| NYHA Class | ||||
| - Class I | 163 (18.09%) | 159 (17.69%) | 322 (17.89%) | 0.82 |
| - Class II | 738 (81.91%) | 740 (82.31%) | 1478 (82.11%) | |
| Syntax score | 0.72 | |||
| - High (≥33) | 19 (2.11%) | 15 (1.67%) | 34 (1.89%) | |
| - Intermediate (23-32) | 151 (16.76%) | 144 (16.02%) | 295 (16.39%) | |
| - Low (≤22) | 718 (79.69%) | 725 (80.65%) | 1443 (80.17%) | |
| - Syntax Score | 17.5 ±6.7 | 17.4 ± 6.4 | 17.5 ± 6.5 | 0.61 |
| Serum Creatinine (mg/dl) | 1.04 ± 0.48 | 1.06 ± 0.68 | 1.05 ± 0.59 | 0.45 |
| eGFR ≤60 | 194 (21.53%) | 186 (20.69%) | 380 (21.11%) | 0.56 |
| HBA1c | 7.95 ± 1.80 | 8.11 ± 1.86 | 8.03 ± 1.83 | 0.06 |
Abbreviation: BP-SES: Biodegradable Polymer–Sirolimus-Eluting Stent, DP-EES: Durable Polymer–Everolimus-Eluting Stent, NI: Non-Inferiority, CI: Confidence Interval, MVD: Multivessel Disease, NYHA: New York Heart Association (Functional Classification), ITT: Intention-To-Treat
All data are presented as frequency (%) or mean ± standard deviation