Transcript Dia 1
PARTNER trial Objective: To compare the efficacy and safety of TAVI with standard therapy in high risk patients deemed not suitable for surgery. Study: Multicenter, randomized trial. Population: Patients with severe aortic stenosis (AVA < 0.8 cm2), deemed inoperable. No concomitant CAD, no LVEF < 20%, no renal failure, no severe MR or AR. No bicuspid valve, no recent stroke. Endpoint: All cause mortality, Death or repeat hospitalization. PARTNER trial TAVI Edwards SAPIEN valve N=179 Patients enrolled N=358 Standard therapy Including balloon valvuloplasty N=179 PARTNER trial Event rate at 1 year f-up (%) P<0.001 P<0.001 P<0.001 TAVI P=0.04 Standard therapy 71,6 80 60 40 P<0.001 50,7 58,0 42,5 30,7 25,2 20 32,4 7,3 10,6 4,5 0 Death Death/repeat hosp. NYHA III/IV vasc compl Stroke/TIA PARTNER trial Conclusion: In patients with severe aortic stenosis who were not suitable for surgery TAVI reduced the rate of death, death or repeat hospitalization and cardiac symptoms, despite a higher incidence of stroke and vascular events. Leon et al. N Engl J Med 2010;363:1597-1607