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Heart Institute (InCor), University of Sao Paulo, Sao Paulo, Brazil

Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS-II): a Randomized Controlled Clinical Trial of Therapeutic Strategies for Multivessel Coronary Artery Disease.

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Heart Institute (InCor), University of Sao Paulo, Sao Paulo, Brazil

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  1. Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS-II): a Randomized Controlled Clinical Trial of Therapeutic Strategies for Multivessel Coronary Artery Disease Whady Hueb, Neuza Lopes, Bernard J. Gersh, Paulo R. Soares, Expedito E. Ribeiro, Alexandre C. Pereira, Desiderio Favarato, Antonio Sérgio C. Rocha, Alexandre C. Hueb and Jose A.F. Ramires Heart Institute (InCor), University of Sao Paulo, Sao Paulo, Brazil

  2. Competing Interests • The authors declare no potential competing interest.

  3. BACKGROUND • Revascularization therapy in stable multivessel coronary artery disease (CAD) and preserved ventricular function remains controversial. • Compared to CABG treatment, PCI or MT is associated with higher rates of angina and subsequent revascularization, but no significant differences in mortality or rates of MI have been found.

  4. BACKGROUND • To our Knowledge, there is no study that has ever compared end points among these 3 therapeutic strategies for more than a 5-year follow-up period.

  5. OBJECTIVE • To compare 10-year follow-up survival of the medical treatment, angioplasty, or surgical strategies among patients with stable multivessel CAD and preserved ventricular function.

  6. SURGERY (on-pump CABG) METHODS MEDICAL TREATMENT (alone) Stable Angina Multivessel Coronary Artery Disease Preserved Left Ventricular Function ANGIOPLASTY (BMS) Surgeon / Interv. Cardiologist / Clinical Cardiologist Team approval RANDOMIZATION Recruitment: May 1995 - May 2000 (Heart Institute - InCor) Hueb W., et al. Circulation 2007;115:1082-1089

  7. METHODS • Primary end-point (composite): • overall mortality, • myocardial infarction, • refractory angina requiring new revascularization • Ten-Year Follow-Up

  8. StatisticalAnalysis • All analysis were done according to intention to treat principle. • Sample size: power 80% and a two-side level of significance of 0.05% - 191 patients in each group. • Statistical test: Chi-Square, log-rank test, ANOVA, Tukey multiple-comparisons test, Cox’s regression and McNemar test.

  9. coronary <30% lesion - 5192 single coronary disease - 3531 previous CABG/PCI - 2908 valvar disease 2701 other - 4361 refused to participate in this trial or refused the surgical procedure RESULTS excluded 18.692 patients: 1465 patients non-randomized: Database: 20.769 coronary angiographies Elegible: 2.076 patients (suitable to PCI-CABG) MASS II Randomized: 611 patients Angioplasty (n=205) Surgery (n=203) Medical Treatment (n=203) Hueb W, et al. J Am Coll CardioI 2004; 43:1743-51

  10. Baseline Characteristics ofMASSII CABG (n = 203) MT (n = 203) PCI (n=205) P Characteristic 67 60±4 52 27 60 26 76 72 61±8 41 32 63 29 85 0.412 0.959 0.024 0.013 0.215 0.062 0.006 Demographic Profile Male, (%) Age (years) mean±SD Medical History Previous MI, (%) Smoker, (%) Hypertension, (%) Diabetes mellitus, (%) CCS class 2 or 3, (%) 69 60±9 39 33 55 36 78

  11. MT PCI CABG (n=203) (n=205) (n=203) Total Cholesterol (mg/l) 222±39 220±41 214±42 0.063 LDLChol (mg/dl) 148±34 147±36 143±36 0.305 HDL Chol (mg/dl) 37±10 38±10 37±10 0.870 Triglicerides (mg/dl) 178±82 181±73 169±84 0.235 Glucose mg/dl) 139±68 128±60 122±44 0.062 ClinicalCharacteristics - Metabolic Aspects - P

  12. BaselineCharacteristics - Angiographic Profile - PCI (n = 205) CABG (n = 203) MT (n = 203) Double-Vessel Disease, (%) Triple-Vesel Disease, (%) Proximal LAD disease, (%) Mean ejection fraction (mean±DP) P 42 58 93 0.67±0.08 0.980 0.980 0.312 0.984 41 59 89 0.68±0.07 42 58 93 0.67±0.09

  13. Major Adverse Cardiac Events- 10-Year Follow-Up - PCI (n = 205) CABG (n = 203) MT (n = 203) Outcomes Primary Endpoints, (%) Overall Mortality, (%) Myocardial Infarction, (%) Aditional Intervention, (%) P 42.4 24.1 13.3 41.9 59.1 31 20.7 39.4 33 25.1 10.3 7.4 <0.001 0.089 0.010 0.001

  14. Overall Mortality-Free Survival PCI CABG MT 205 203 203 189 184 179 164 168 159 156 152 140 Treatment Group Initial 3 Year 6 Year 10 Year

  15. Ten-Year Follow-up Event-free Survival Treatment Group Initial 3 Year 6 Year 10 Year 203 205 203 175 147 140 155 130 121 CABG PCI MT 150 108 93

  16. End Point and Treatment Allocation - CABG vs MT -

  17. End Point and Treatment Allocation - CABG vs PCI -

  18. End Point and Treatment Allocation - PCI vs MT -

  19. Multivariate Analysis for Treatment Allocation Multivariate HR Variables 95% CI p Primary end points Treatment PCI/CABG MT/CABG 1.06-2.02 1.69-3.10 <0.001 0.021 <0.001 1.46 2.29 Overall Death Treatment PCI/CABG MT/CABG 0.97 1.29 0.65-1.44 0.89-1.87 0.241 0.878 0.175

  20. Multivariate Analysis for Treatment Allocation Multivariate HR Variables 95% CI p 1.39-6.01 1.30-5.60 0.012 0.004 0.008 Myocardial Infarction Treatment PCI/CABG MT/CABG 2.90 2.69 Additional Intervention Treatment PCI/CABG MT/CABG 3.71 7.58 1.82-7.52 3.88-14.81 <0.001 <0.001 <0.001

  21. CONCLUSION • All three therapeutic regimens yielded similar andrelatively low rates of overall mortality. • Compared with CABG,angioplasty was associated with elevated rate of myocardial infarction and need for revascularization. • Medical therapy showed significant incidenceof myocardial infarction and high rate of additional revascularization.

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