ART TRIAL SATYA SHANBHAG WAIKATO CARDIOTHORACIC UNIT INTRODUCTION
ART TRIAL SATYA SHANBHAG WAIKATO CARDIOTHORACIC UNIT
INTRODUCTION • USE OF BITA/BIMA GRAFT FOR CABG HAS TILL NOW SHOWN GOOD LONG TERM BENEFIT • POOLED DATA SHOW THAT BITA GRAFTS DECREASE MORTALITY BY 20% AT 10 YEARS COMPARED TO SINGLE LIMA GRAFTS • BIMA GRAFTS NOT WIDELY ADOPTED: DIFFICULT, CAUSE INCREASED STERNAL EVENTS AND BENEFIT NOT FULLY KNOWN THROUGH RANDOMISED STUDIES
METHODS • PATIENTS RANDOMLY ASSIGNED TO UNDERGOLIMA ORBIMA GRAFT (JUNE 2004 D – EC 2007) • STUDY IN 28 CARDIAC CENTERS IN 7 COUNTRIES • F/U PERIOD UP TO 10 YEARS (5 YRS INTERIM ANALYSIS) • PRIMARY OUTCOME: DEATH FROM ANY CAUSE IN 10 YRS • SECONDARY OUTCOME: COMPOSITE OF DEATH FROM ANY CAUSE, MI AND STROKE
METHODS • STATISTICS: KAPLAN MEIER WITH LOG RANK CORRECTION, COX PROPORTIONAL HAZARD MODEL FOR HR • PRE-SPECIFIED SUB GROUP ANALYSIS FOR: AGE (<70 AND >70), DM (YES/NO), RADIAL ARTERY GRAFT( YES/NO), EF (<50% AND >50%) AND NUMBER OF GRAFTS (<3 AND >3).
AUTHOR CONCLUSIONS • THE STUDY IS AN INTERIM ANALYSIS (AT 5 YRS) OF THE ART TRIAL • AT 5 YRS NO DIFFERENCE IN PRIMARY AND COMPOSITE OUTCOMES BETWEEN THE TWO GROUP • HIGHER STERNAL COMPLICATION IN THEBIMA GROUP
STUDY STRENGTHS • WELL CONDUCTED MULTI INSTITUTIONAL RANDOMISED STUDY • THE STUDY MET THE REQUIRED NUMBER OF PATIENTS • SOME AMOUNT OF BLINDING PERFORMED FOR SELECTION • PUBLISHED IN A REPUTED JOURNAL
STUDY WEAKNESS • INTERIM ANALYSIS ONLY- NO DEFINITIVE CONCLUSION CAN BE DRAWN • THE GRAFT CONFIGURATION NOT STANDARDISED • 25% OF PATIENTS >70 YR OLD UNDERWENT COMPLEX BIMA GRAFTS • THE TRIAL MAY NOT FIND SIGNIFICANCE BECAUSE 16. 4% OF BIMA PATIENTS DID NOT GET THE GRAFT.
STUDY WEAKNESS • STERNAL COMPLICATION HIGH DUE TO 49%BIMA HAVING PEDICLED GRAFTS • DOUBTFUL LATERAL WALL REVASCULARISATION DUE TO 49%PEDICLEDBIMA • MORE THAN 20% OFLIMA PATIENTS RECEIVED SUPPLEMENTAL RADIAL ARTERY GRAFTSHOWN TO BE BETTER THAN SINGLE GRAFT (POSSIBLE EQUIVALENT TOBIMA)
WHAT ARE THE EVIDENCE/GUIDELINES?
WHAT ARE THE EVIDENCE/GUIDELINES?
LIMA VS BIMA
RIMA VS RADIAL
CABG: LONG TERM GRAFT PATENCY
CONCLUSIONS • BIMA AND TOTAL ARTERIAL GRAFT HAS ITS OWN USE AND ADVANTAGES • THESE SHOULD BE OFFERED FOR THE IDEAL CANDIDATE PATIENTS • RADIAL ARTERY GRAFT OFFERS AN ALTERNATIVE TORIMA AND IS AS EFFECTIVE • FURTHER RANDOMISED STUDIES REQUIRED WITH LONG TERM F/U
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