The ADVANCE study findings were presented this week at Transcatheter Cardiovascular Therapeutics (TCT) Meeting 2012 (Miami, USA, 22–27 October). Initial one year results of the study revealed that patients experienced high survival rates, with one year survival at 82.1% and one year cardiovascular survival at 88.2% Health-related quality of life (HRQoL) measured for patients in the study had improved significantly at one and six months, compared with their status prior to receiving the Medtronic CoreValve System. The study represents the largest, most rigorously collected evaluation of HRQoL findings published on transcatheter aortic valve implantation (TAVI). The CoreValve System is currently limited to investigational use in the United States.
The ADVANCE study is one of the largest multicentre TAVI trials to date, with 996 patients consecutively treated at 44 experienced TAVI centres in 12 countries. Clinical endpoints were calculated according to Valve Academic Research Consortium (VARC) standardised definitions.
All data were independently monitored, all adverse events related to the primary endpoints were adjudicated by an independent Clinical Events Committee (CEC) consisting of experienced cardiac surgeons and interventional cardiologists, and all cerebrovascular events (including stroke and other events) were adjudicated by an independent neurologist using neuroimaging and systematic NIH Stroke Scale assessments.
In the study, on the SF-12 scale at six months, the patients’ health scores significantly improved by 6.92 points from baseline for the physical component summary score (p<0.001), and significantly improved by 3.80 points from baseline for the mental component summary score (p<0.001) (based on the SF-12 scale from 0 to 100 with a higher score reflecting a better HRQoL). On the EQ-5D scale from 0 (death) to one (perfect health), patients’ health scores significantly increased by 0.10 points at both one and six months from baseline, (p-value < 0.001). All differences reported were statistically significant.
The highest risk patients experienced, according to the authors, significant improvements in HRQoL after TAVI: When evaluating the improvements by patient risk, patients with higher risk profiles (EuroSCORE >20) had significantly worse baseline HRQoL than patients with lower risk profiles but demonstrated significant improvements at to six months (EQ-5D p<0.001).
Additionally, patients who were implanted with the CoreValve System via direct aortic and subclavian access routes demonstrated similar HRQoL improvements, as measured by EQ-5D, as patients undergoing transfemoral implantation (the CoreValve System can be implanted via three different delivery routes).
Quality of life was measured at baseline, one month and six months using two general validated questionnaires (the EQ-5D and the SF-12 physical and mental), and health status was self-reported by patients. The study will continue to measure HRQoL benefits over time; one year results will be reported in 2013.
“Transcatheter aortic valve implantation already has been shown to improve survival compared with standard therapy, but quality of life can be at least as important as survival in elderly patients, especially since TAVI patients can be frail with multiple comorbidities,” said Johan Bosmans, University Hospital of Antwerp, Belgium. “We are extremely proud of this data which confirms that the benefits of transcatheter aortic therapy extend beyond survival even in this challenging patient population.”