TAVR comparable to SAVR in real-world intermediate-risk patients
Although previous randomized clinical trials (RCTs) have shown TAVR to be safe and effective in intermediate- and high-risk patients with aortic stenosis, the real-world GARY** trial showed a higher 1-year mortality rate among intermediate-risk patients who received TAVR than SAVR. This raised questions regarding how generalizable are RCT results of TAVR to the real world and to different patient subgroups with different risk profiles, according to Dr Matthew Brennan of Duke University Medical Center in Durham, North Carolina, US.
The current real-world observational ADVICE study included 9,464 propensity-matched patients (median age 82 years, 48 percent female) at intermediate or high risk for surgery (STS PROM*** ≥3 percent) in the TVT# Registry and STS## Database who underwent TAVR or SAVR in the US. [ACC.17, abstract 408-08]
Compared with SAVR, TAVR patients were more commonly being discharged home (70 percent vs 41 percent; p<0.01), which according to Brennan, “reflects a less demanding early recovery [among TAVR patients].”
In-hospital mortality rate was lower (3 percent vs 5 percent; p<0.001) and postoperative length of stay in hospital was shorter (4 vs 8 days; p<0.001) among patients who received TAVR compared with SAVR. On the other hand, new pacemaker implantation (12.8 percent vs 6.3 percent; p<0.001) and in-hospital major vascular complication (4.2 percent vs 0.4 percent; p<0.001) were higher with TAVR, while in-hospital stroke incidence was similar between the TAVR and SAVR groups (2.5 percent vs 2.7 percent; p=0.4), which Brennan said were consistent with results from previous clinical trials.
At 1 year postprocedure, rates of death (hazard ratio [HR], 0.93; p=0.18) and stroke (HR, 1.18; p=0.13) were similar between the two groups, with the data from subgroup analysis (including age, gender, previous cardiac surgery, prior stroke, and chronic lung disease) being consistent with the overall comparative findings for each clinical outcome.
Subanalyses indicate that patients with prior cardiac surgery or chronic lung disease might benefit more from TAVR than SAVR, observed Brennan.
Both the TAVR and SAVR groups also had similar ‘days alive and out of hospital (DAOH)’, with the majority of patients in both groups spending <1 month in an acute care hospital within the first year after treatment. In addition, similar DAOH between the two groups was observed even when patients were stratified by STS PROM score (≥3 and <5, ≥3 and <8, ≥8).