EuroPCR 2017: No risk factor identified for early stroke events in SURTAVI trial



CoreValve Evolut R

A review of the neurological complications that occurred after surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) in the SURTAVI (Surgical replacement and transcatheter aortic valve implantation) trial indicates that there were no significant differences in baseline characteristics between patients who experienced an early stroke and those who did not have a stroke. Furthermore, as seen as in the original SURTAVI findings, TAVI with a self-expanding device (CoreValve/CoreValve Evolut R, Medtronic) was associated with a significantly lower 30-day rate of stroke than was surgery.

The SURTAVI trial, which was simultaneously presented at the 2017 scientific session of the American College of Cardiology (17–19 March, Washington, DC, USA) and published in The New England Journal of Medicine, found that there were no significant differences in the rate of all-cause mortality or disabling stroke at two years between patients at intermediate risk who underwent TAVI and those who had underwent surgery. It also showed that at 30 days, TAVI was associated with fewer strokes, less acute kidney injury, and less new or worsening atrial fibrillation than was surgery. However, at 30 days, major vascular complications and the need for a permanent pacemaker was higher with TAVI.

Speaking at EuroPCR (16–19 May, Paris, France), A Pieter Kappetein (Erasmus Medical Centre, Rotterdam, The Netherlands) said that the need to better understand the relative risk of neurological complications and “their clinical consequences” following TAVI was “critical” given the current trend towards using TAVI in lower risk populations. The aim of the present review was to further explore the 30-day rates of stroke and encephalopathy events in the SURTAVI trial.

At 30 days, the incidence of all strokes was significantly higher with surgery: 5.4% vs. 3.3% for TAVI (p=0.031). When stroke events were divided into disabling and non-disabling events, they were numerically higher with surgery in both evaluations (although not to a significant extent)—2.4% vs. 1.2% for TAVI (p=0.057) and 3% vs. 2.1% (p=0.230), respectively. Kappetein observed that, for both groups, “most strokes occurred around the procedure; within the first couple of days afterwards” but added that patients in the surgery group tended to have “more severe symptoms”. There were no differences in stroke rates between groups at the one-year follow-up point.

Reviewing the baseline characteristics of those who experienced an early stroke, Kappetein and colleagues found that there were no significant differences between those who underwent TAVI and those who underwent surgery. Also, within the group of patients who underwent TAVI, there were no significant differences in baseline characteristics between those experienced early stroke and those who did not have any stroke. However, within the surgery group, significantly more patients without stroke had a history of hypertension than those with stroke (91% vs. 79.1%; p=0.01). Given that this finding seems counterintuitive, Kappetein observed that it may be a “coincidence”.

Additionally, there were no significant differences in procedural characteristics between the stroke TAVI patients and the non-stroke TAVI patients; although, Kappetein commented that procedure time was “a little bit longer” with the stroke patients: 68±42 minutes vs. 52±32 minutes for non-stroke patients (p=0.07). He and his colleagues also did not find any differences in procedural characteristics between stroke and non-stroke patients in the surgical group, noting “It is difficult to identify a risk factor for stroke. Any patient in the study had a chance of getting a stroke”.

As to be expected, in both TAVI and surgery groups, stroke patients stayed in hospital for longer and were more frequently discharged to a non-home location (such as another hospital or a rehabilitation centre). “Stoke has a major impact on patients’ well-being,” Kappetein noted.

There were no significant differences in one-year mortality between TAVI and surgery groups among those experienced an early stroke or among those who experienced early encephalopathy. However, Kappetein said: “With or without stroke, TAVI patients recovered quality of life sooner than surgical patients.” He added that for both surgical and TAVI patients, “we have to find ways of avoiding stroke because it has such an impact on patients”.

However, according to Kappetein, identifying methods—such as cerebral protection devices—to prevent stroke may be difficult. He explained that as overall stroke rates go down, the number of patients needed to evaluate such a method would increase.