SAN FRANCISCO—Despite early termination of the STACCATO trial and criticism from his colleagues, Leif Thuesen, MD, of the department of cardiology at Aarhus University Hospital in Skejby, Denmark, defend the trial, which compared a new aortic vavular treatment with surgery during a Nov. 10 press conference at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
“It was not stopped because of the mortality,” Thuesen said, citing problems with leakage and left main occlusion.
STACCATO compared the transapical transcatheter aortic valve implantation (TAVI) treatment with conventional surgical intervention (SAVR) in patients with severe aortic valve stenosis on a 1:1 basis. Two hundred patients were enrolled from two Danish hospitals with experience treating apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study was initiated at Aarhus University Hospital, Skejby, Denmark; Odense University Hospital also participated in the trial.
Inclusion criteria were significant aortic valve stenosis (valve area of less than 1cm2); age greater or equal to 70 or 75 years old; operable by either transapical TAVI or conventional surgery; and expected survival of more than one year following successful treatment. Patients with coronary artery disease requiring PCI or CABG; earlier cardiac surgery; MI within 24 hours; need for emergency surgery; unstable cardiac condition; stroke within one month; reduced pulmonary condition; and kidney failure requiring dialysis were excluded.
Primary end point was 30-day all-cause mortality, major stroke and/or renal failure. Secondary endpoints included operation from bleeding, permanent Pacemaker treatment, duration of hospital stay, echocardiographic parameters and NYHA class SF-36 composite physical and mental functional status.
The trial initially was designed to enroll 200 patients, randomized into two groups: one that received conventional aortic valve surgery and a second that received transapical TAVI. Instead, of 525 patients assessed for eligibility, the trial enrolled 70 patients: 34 in the transapical TAVI group and 36 in the SAVR group.
Most of the patients were excluded due to ischemic-related issues, said Thuesen, addeing that 144 were too "high risk."
In the transpical TAVI group there was one death; one left coronary artery blockage with death resulting; two major strokes (one with death at 34 days) and one renal failure that required dialysis. In the SAVR group there was one perioperative major stroke.
Moderate to severe paravalvular leakage after treatment occurred in 13 percent of the transapical TAVI group compared with none of the SAVR group. Minimal leakage occurred in 43 percent of the transapical TAVI group while only 6 percent of the SAVR group.
Thuesen pointed out that multislice CT (MDCT) was not used in perioperative assessment but after the trial was terminated, the procedure had been optimized using MSCT. He said that they designed the study three years ago hypothesizing that a-TAVI would prove superior, and described the procedure as “excellent” and “safe.”
Some panelists disagreed about the trial.
“This was poorly designed, poorly executed and set up to fail,” said Michael J. Mack, MD, president of the Society for Thoracic Surgeons (STS). Samir R. Kapadia, MD, of the Cleveland Clinic, described the trial as having a “huge selection bias” while Joseph Bavaria, MD, of the division of cardiovascular surgery at the Hospital of the University of Pennsylvania, in an alternative interpretation, called it more of a “wake-up call.”