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STACCATO trial - Summary & Results

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http://www.theheart.org/web_slides/1327459.do

A randomized research comparing TAVI vs conventional aortic-valce replacement survery using patients with valvular aortic stenosis who could be treated with surgery or transapical TAVI

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STACCATO trial - Summary & Results

  1. 1. STACCATO: TAVI vs conventional aortic-valve replacement surgery
  2. 2. STACCATO: TAVI vs conventional aortic-valvereplacement surgeryL Thuesen (Aarhus University Hospital, Denmark)TCT 2011• Population and treatment: Patients ≥ 75 years with valvular aortic stenosis who could be treated with surgery or transapical TAVI 1:1 randomization planned for 200 unselected patients• Primary end point: Composite of death, stroke and/or renal failure at 30 days• Researchers anticipated a surgical-event rate—defined as a composite of 30- day all-cause mortality, major stroke, and/or renal failure—of 13.5% and an estimated event rate in the TAVI arm of 2.5%
  3. 3. STACCATO: Results• Study stopped due to an increase in adverse events in the TAVI arm after the inclusion of 70 patientsPrimary end point events TAVI arm Surgical arm One non-treatment-related death One perioperative major stroke One left coronary artery blockage Two major strokes One patient who had renal failure requiring dialysis• Other adverse events in the TAVI arm Ischemic attack followed later with a major stroke Two perioperative cases of severe paravalvular leakage One perioperative aortic rupture One left main occlusion during balloon valvuloplasty One case of major bleeding
  4. 4. STACCATO: Commentary*"There is no doubt there are patients who cant be operated on, and they should betreated with TAVI . . . Its the operable patients, the low-risk patients; they should nothave the TAVI procedures, but thats what is happening. We had one patient, forinstance, who did not want the conventional operation, so he had the TAVIprocedure in Canada. Thats how it is. Indications are slipping." - Dr Leif Thuesen"I think there is some misinformation here, based on invalid trial design, that is likelyto hurt the field." - Dr Michael Mack*All comments from STACCATO: Transapical TAVI in surgery-eligible patients stopped due to adverseevents (http://www.theheart.org/article/1307437.do)
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