TAVI & Stroke: More Details Surface About PARTNER A

May 12th, 2011

TAVI & Stroke: More Details Surface About PARTNER A

Larry Husten, PHD

In the past year transcatheter aortic valve implantation (TAVI) has emerged as a possible new treatment for patients with aortic valve disease who are not surgical candidates (the PARTNER B study) and for some patients as a viable alternative to surgery (the PARTNER A study). TAVI was found to be noninferior to surgery in the PARTNER A trial, however, a major question lingers over the higher rate of stroke in the TAVI arm. In a presentation (PowerPoint slide set) earlier this week at the annual meeting of the American Association for Thoracic Surgery, Craig Miller presented results of the PARTNER A stroke substudy.

Overall, said Miller, the 30-day rate of stroke and TIA was low in both groups, considering the very high baseline risk of the patients:

Surgery=2.6% versus TAVI=5.6% (p=0.05)

PARTNER patients in whom the transfemoral (TF) approach was possible had an even lower risk of stroke and TIA:

TF group: Surgery=1.4% versus TAVI=4.6% (p=0.04)

Major stroke at 30 days:

Surgery=2.3% versus TAVI=3.8% (p=0.25)
TF group: Surgery=1.4% versus TAVI=2.5% (p=0.37)

Miller reported that in the early phase the risk of stroke was elevated in the TAVI group, particularly in patients with a smaller AVA index. In the subsequent period, patients with a “generalized heavy arteriosclerotic burden” who were not candidates for the TF approach had a higher risk of stroke or TIA.

“The higher observed incidence of neurological events in the ‘non-TF candidate’ stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se,” he concluded.

Stroke and TIA had a different effect on subsequent mortality depending on treatment group. In the surgery group, a neurological event was associated with an early high peak in mortality which quickly returned to baseline. In the TAVI group, the increase in mortality risk remained elevated during the 2-year follow-up period, especially in patients in the transapical group.

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May 12th, 2011