SOLACI | Latin American Society of Interventional Cardiology

TAVR has been reported beneficial in the treatment of high and intermediate risk patients but, initially, randomized clinical trials have shown vascular complication and pacemaker implantation rates higher than SAVR in low-risk patients. This will most certainly improve as operator experience and device development advance.

TAVI, más información que avala su utilidad

This is a randomized 1:1 study including 458 patients receiving TAVR and 455 receiving surgical aortic valve replacement (SAVR).

Primary end point was all cause mortality at one year.

There were no differences between the groups. Mean age was 81, 53% were men, BMI was 27%, STS mortality 26%, 13% were fragile, 30% had coronary artery disease. Ejection fraction was 57%; aortic valve area 0.70 cm2.

Mean time from randomization to procedure was 40 days for TAVR and 37 for SAVR.

There were no differences in primary end point at one year (4.6% for TAVR vs. 6.6% for SAVR (adjusted absolute risk difference, −2.0% [1-sided 97.5% CI,-∞ to 1.2%]), showing TAVR is non-inferior to SAVR (P<.001 for non-inferiority).

The presence of major bleeding both at 30 days and one year was lower with TAVR, but vascular complications rate was higher in both periods.

The need for definite pacemaker at 30 days and one year was higher with TAVR (11% vs 6.7% p=0.1 and 14.2% vs. 7.3% p<0.001), with no difference in stroke rate for both periods.

There were no differences in gradient, area, or the presence of severe leak.

Both groups saw improved functional class and quality of life.

Conclusion

≥70 year old patients with severe symptomatic aortic stenosis and moderately increased surgical risk, TAVR was non inferior to SAVR as regards all-cause mortality at one year.