February 06, 2015
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TAVR improved 1-year outcomes in patients with aortic stenosis, prior CABG

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Patients with aortic stenosis at increased surgical risk who previously underwent CABG had lower rates of all-cause and mortality at 1 year after treatment with transcatheter aortic valve replacement compared with surgical aortic valve replacement, researchers reported at the Annual Meeting of The Society of Thoracic Surgeons.

The post-hoc subanalysis of the High Risk Study of the CoreValve US Pivotal Trial included 226 patients at 45 U.S. sites who were randomly assigned to TAVR with the self-expanding CoreValve system (Medtronic; n = 115) or surgical AVR (n = 111). The combined primary endpoint was all-cause mortality at major stroke.

The survival rate at 1 year was 90.4% for patients assigned TAVR vs. 81.9% for patients assigned surgical AVR (P = .06).

The primary endpoint was reported in 11.4% of the TAVR group vs. 21.8% of the surgical AVR group (P = .04).

Researchers observed no significant differences in CV mortality (TAVR, 7% vs. surgical AVR, 13.8%; P = .1), valve-related mortality (6.2% vs. 1.9%; P < .0128), overall stroke (10.6% vs. 14.3%; P < .39) or major stroke (8.8% vs. 6.6%; P < .54). At 1 year, 95.8% of the TAVR group and 93.8% of the surgical AVR group had NYHA class I/II HF.

At 1 year, patients assigned surgical AVR had significantly higher rates of acute kidney injury (16.3% vs. 5.3%; P < .007), life-threatening or debilitating bleeding (28.2% vs. 13.2%; P < .0043) and major arrhythmic events (63.1% vs. 50.5%; P < .04). The researchers also observed a trend toward increased frequency of major adverse cardiac and cerebrovascular events among patients assigned surgical AVR (28.1% vs. 17.5%; P = .05).

The rate of new pacemaker implantation was significantly higher among patients assigned TAVR (22.1% vs. 10.8%; P < .01).

“Prior to now, the treatment of this patient population has been confounded by the lack of data showing clinical benefit of TAVR vs. surgical AVR for prior-CABG aortic stenosis patients, who may have increased risks of mortality and morbidity with reoperation,” study researcher John Conte, MD, professor of surgery at The Johns Hopkins Hospital, said in a press release. “The CoreValve system demonstrated important clinical advantages, including faster recovery compared to surgical AVR, offering heart teams an alternative to open-heart surgery for this patient population.”

Reference:

Conte JV, et al. Transcatheter aortic valve replacement with a self-expanding valve and surgical aortic valve replacement for aortic stenosis in patients with prior coronary artery bypass grafting. Presented at: Annual Meeting of the Society of Thoracic Surgeons; Jan. 24-28, 2015; San Diego.

Disclosure: Conte reports consulting and serving on advisory boards for Medtronic.