CoreValve at 3 Years: Still Better Stroke-Free Survival With TAVR

Marlene Busko

April 15, 2016

CHICAGO, IL — Patients with severe aortic stenosis who were high-risk candidates for surgery and a received transcatheter aortic-valve replacement (TAVR) with the self-expanding CoreValve (Medtronic) device had improved clinical outcomes at 3 years compared with patients who received open surgical aortic-valve replacement (SAVR), new research shows[1].

Reporting these 3-year findings from CoreValve High-Risk Study at a clinical-research session at the the American College of Cardiology (ACC) 2016 Scientific Sessions, Dr G Michael Deeb (University of Michigan Medical Center, Ann Arbor) said that these results showed that the favorable 2-year findings were sustained.

Specifically, the combined end point of all-cause mortality and stroke was significantly lower in patients who had TAVR vs SAVR. However, unlike the 2-year findings, although all-cause mortality with TAVR remained lower than with SAVR, this difference was no longer statistically significant,

Nevertheless, patients in the TAVR group still had a lower incidence of major adverse cardiovascular and cerebrovascular events (MACCE), lower mean aortic-valve gradients, larger effective orifices, and fewer signs of valve hemodynamic deterioration—all significant—although they were more likely to have moderate or severe aortic regurgitation and to receive a pacemaker.

"We believe that these findings support the use of self-expanding TAVR as the treatment of choice in patients at increased risk for surgery," Deeb and colleagues conclude, in their article that was simultaneously published in the Journal of the American College of Cardiology.

The 3-year findings show "good outcomes, good durability, no echo gradient, good valve areas, low event rates, and low thrombosis in the percutaneous valve," session panelist Dr Jeroen J Bax (Leiden University, the Netherlands) agreed, speaking to heartwire from Medscape.

However, this was a study in old, frail patients, and "based on the little benefit we saw from the percutaneous valve, I don't think that this is now a reason to say immediately that they all need to go for a percutaneous valve," he cautioned. "I think you need to determine that patient by patient in the heart team."

High-Risk, Elderly Patients

As previously reported, 750 high-risk patients with severe aortic stenosis were randomized and received TAVR (391) or SAVR (359) at 45 US centers. The patients had a mean age of 83, and 53% were men. Most patients (86%) were NYHA class 3 or 4.

At 3 years, 407 patients (228 patients in the TAVR group and 179 patients in the SAVR group) were still alive and had outcome data.

Multiple survival outcomes and the incidence of MACCE were significantly better in the TAVR group.

3-Year Clinical Outcomes

Outcome TAVR group (%) SAVR group (%) P
All-cause mortality or any stroke 37.3 46.7 0.006
All-cause mortality 32.9 39.1 0.068
All stroke* 12.6 19.0 0.034
All-cause mortality or major stroke 35.0 41.6 0.046
MACCE 40.2 47.9 0.025
*Major stroke, minor stroke, and transient ischemic attack
MACCE=major adverse cardiovascular and cerebrovascular events

There was no evidence of clinical valve thrombosis or structural valve deterioration in either group.

"It's interesting that the stroke rates of both procedures were relatively low, and at the moment there's a lot of emphasis on stroke rates in relation to potential percutaneous valve thrombosis; that did not come out in the findings," Bax noted.

"Longer 10-year studies are needed to understand the longer-term durability in patients at lower risk with longer life expectancies," according to Deeb and colleagues.

The study was funded by Medtronic. Deeb serves on an advisory board and as a proctor for Medtronic, as a consultant and research investigator for Edwards Lifesciences, as a consultant and proctor for Terumo, and as a research investigator for Gore Medical, for which he receives no personal remunerations. Disclosures for the coauthors are listed in the article. Bax has no relevant financial relationships.

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