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

1. STACCATO: TAVI vs conventional aortic-
valve replacement surgery

2. STACCATO: TAVI vs conventional aortic-valve
replacement surgery
L 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. STACCATO: Results
• Study stopped due to an increase in adverse events in the TAVI arm after the
inclusion of 70 patients
Primary 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. STACCATO: Commentary*
"There is no doubt there are patients who can't be operated on, and they should be
treated with TAVI . . . It's the operable patients, the low-risk patients; they should not
have the TAVI procedures, but that's what is happening. We had one patient, for
instance, who did not want the conventional operation, so he had the TAVI
procedure in Canada. That's how it is. Indications are slipping."
- Dr Leif Thuesen
"I think there is some misinformation here, based on invalid trial design, that is likely
to hurt the field."
- Dr Michael Mack
*All comments from STACCATO: Transapical TAVI in surgery-eligible patients stopped due to adverse
events (http://www.theheart.org/article/1307437.do)

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