Shelley Wood

May 21, 2013

PARIS, France — The full one-year results from the ADVANCE registry using the CoreValve transcatheter aortic valve (Medtronic) hold few surprises: a relatively stable stroke rate, moderate paravalvular regurgitation in 12% of patients, and a need for a new pacemaker that climbed from 26% at 30 days to 29% at one year.

Dr Axel Linke (University of Leipzig Heart Center, Germany) was to present new one-year results here at EuroPCR 2013 today but was held up at his own hospital. Linke provided a first glimpse of these results back at TCT 2012 . In his stead, ADVANCE coinvestigator Dr Stephen Brecker (St George's Hospital, London, UK) presented the full clinical outcomes here today, saying they "continue to demonstrate low one-year mortality, low stroke rates, and low rates of aortic regurgitation and paravalvular leak."

As previously reported, one-year cardiovascular survival in the high-surgical-risk patients (mean logistic EuroSCORE of 19.2) was 88.3%, and all-cause survival was 82.1%. As expected, survival varied considerably according to baseline EuroSCORE, with those with scores over 20 with the lowest survival rates at one year (76.4%) and those at the lowest risk (EuroSCORE 0–10) with survival rates at 88.9%.

The study's primary end point (all-cause mortality, MI, emergent surgery or percutaneous reintervention, or stroke) was 21.2%. Freedom from stroke at one year was 95.5%.

Paravalvular-Leak Data

Paravalvular leak has emerged as a key safety end point in transcatheter aortic-valve replacement (TAVR) studies. In ADVANCE, echo data from the 609 patients in whom follow-up echo was performed showed that no patients had severe aortic regurgitation (AR), while 13% had moderate AR. As previous studies have shown, AR after TAVR is associated with worse outcomes, and in ADVANCE, freedom from all-cause death was lowest among patients with moderate to severe AR, at 78.5%. In patients with no or mild aortic regurgitation, however, survival rates were no different, potentially allaying concerns from other series, including the two-year PARTNER A results, suggesting that even mild paravalvular leak can reduce survival.

Cost-Efficacy Analysis Using ADVANCE One-Year Data

In a separate presentation, Brecker showed an updated cost-effectiveness model for TAVR, using patient-level data from ADVANCE. For the purposes of comparison, costs and benefits of medical management were pulled from the PARTNER B study.

According to Brecker et al's analysis, the lifetime costs of TAVR were approximately £32 000, as compared with £2343 for medical management. But the life-years gained were 4.22 for TAVI vs 1.56 for medical management. Quality-adjusted life-years (QALYs) also favored TAVR, at a cost per QALY of £11 265. That cost rose to £13 778 when researchers looked only at the highest-risk patients (EuroSCORE >20), but "both of these figures are well within the benchmark used by national regulatory bodies in the UK and elsewhere," Brecker noted.

Both Brecker and Linke are consultants for Medtronic and St Jude Medical; Medtronic was the sponsor for the CoreValve ADVANCE registry.

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