Quality-of-life outcomes superior at 1 month for TAVR vs. surgery, but not at 2 years

WASHINGTON — Patients with severe aortic stenosis at intermediate surgical risk showed improved quality-of-life benefits at 1 month when treated with transcatheter aortic valve replacement compared with surgical AVR, but 2-year follow-up results showed similar quality-of-life outcomes, according to data presented at TCT 2016.

“Prior studies have shown that TAVR results in substantial and durable quality-of-life benefits in extreme risk or inoperable patients and early quality-of-life benefit compared with [surgical] AVR patients at high surgical risk,” David J. Cohen, MD, MSc, from Saint-Luke’s Mid America Heart Institute, Kansas City, Missouri, said in a presentation. “However, the early [quality-of-life] benefit of TAVR was confined to patients who were suitable for transfemoral access and was not seen in patients treated via the transapical approach.”

To compare health-related quality-of-life outcomes among patients with severe aortic stenosis and intermediate surgical risk treated with TAVR or surgical AVR and to determine whether those benefits vary over time, researchers analyzed patients with severe, symptomatic aortic stenosis (aortic valve area < 0.8 cm² and mean gradient > 40 mm Hg) and predicted risk for operative mortality ≥ 4%. The patients were enrolled in the PARTNER II trial and assigned TAVR with a balloon-expandable valve (Sapien family of products, Edwards Lifesciences) or surgical AVR.

David J. Cohen

Cohen, a Cardiology Today’s Intervention Editorial Board Member, and colleagues assessed 1,833 patients (mean age, 81 years; 55% men) with baseline quality-of-life data via the Kansas City Cardiomyopathy Questionnaire score, the Short Form 36 score and the EQ5D (EuroQol) score. The KCCQ was the primary endpoint and the other scores were secondary endpoints.

Scores between groups were compared using analysis of covariance, which was adjusted for baseline health status and access site.

The researchers performed separate analysis for the transfemoral and transthoracic groups in case there was a significant interaction between treatment effect and access site.

At 1 month, those assigned TAVR had a KCCQ score 11.4 points higher than those assigned surgery (P < .001), but there was no significant difference between the groups at 1 year and 2 years, Cohen said, noting the there was a significant interaction between treatment effect and access site for the primary and secondary endpoints (P < .001).

The 1-month difference vs. surgical AVR was significant in those who underwent transfemoral TAVR (14.1; P < .001) but not in those who underwent transthoracic TAVR (3.5), he said. A similar pattern was seen in the secondary endpoints.

At 1 month, KCCQ summary score was moderately or substantially improved in 64% of those who underwent TAVR vs. 41.2% of those who had surgery (P < .001), but the groups were similar at 1 year and 2 years, Cohen said.

Overall clinical status, a metric of mortality plus quality-of-life improvement, was superior in transfemoral TAVR vs. surgery at 1 month (P < .001), 1 year (P = .04) and 2 years (P = .04), but there were no differences between the transthoracic TAVR group and the surgery group, according to Cohen.

“Taken together with previous data, these findings demonstrate that for intermediate-risk patients suitable for a transfemoral approach, TAVR provides both early and late benefits compared with surgical AVR from the patient’s perspective, and to me, that is the most important perspective here,” Cohen said in a press release. – by Dave Quaile

Reference:

Cohen DJ. Late-Breaking Clinical Trials 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington.

Disclosure: The PARTNER II trial was funded by Edwards Lifesciences. Cohen reports receiving research grants from Edwards Lifesciences.