Very Encouraging Results for TAVR in Low-Risk Patients

Courtesy of Dr. Carlos Fava.

About 12% of patients >75 years old have aortic stenosis. In 3%-4% of them, such disease is severe.

Transcatheter aortic valve replacement (TAVR) has already proven to be beneficial for extreme-, high-, and intermediate-risk patients. Regarding low-risk patients, we currently have different analyses; two of them are randomized and their results are very encouraging.

This meta-analysis included 4 trials, 3 of which were randomized: NOTION Trial, SURTAVI Trial (<3 STS), PARTNER 3, and EVOLUTE Low Risk Trail. Consequently, 2887 patients were analyzed. Among them, 1497 underwent TAVR and 1390 underwent surgery. Three of them used self-expanding valves.

The mean age was 75.3 years, over half the patients were male, and the mean Society of Thoracic Surgeons (STS) score was 2.3%.

After a 1-year follow-up, TAVR was associated with lower all-cause mortality (2.1% vs. 3.5%; risk ratio [RR]: 0.61; 95% confidence interval [CI]: 0.39 to 0.96; p = 0.03; I2 = 0%) and lower cardiovascular  mortality (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%), new or worsening atrial fibrillation (10.0% vs. 39.4%; RR: 0.27; 95% CI: 0.20 to 0.32; p < 0.001; I2 = 63%), major or life-threatening bleeding (3.9% vs. 11.2%; RR: 0.37; 95% CI: 0.24 to 0.55; p < 0.001; I2 = 42%), and renal impairment stage 2/3 (0.7% vs. 2.9%; RR: 0.26; 95% CI: 0.13 to 0.52; p < 0.001; I2 = 0%).

Read also: TAVR and Pacemakers, New Strategies.

There were no differences as regards stroke, acute myocardial infarction (MI), or heart failure/valve-related readmission; endocarditis, bleeding, reintervention, or New York Heart Association functional class ≥II. TAVR, however, was associated with higher rates of permanent pacemaker implantation (17.4% vs. 5.5%; RR: 3.85; 95% CI: 1.73 to 8.58; p = 0.001; I2 = 85%), and moderate/severe leak (3.6% vs. 1.7%; RR: 2.16; 95% CI: 1.03 to 4.54; p = 0.04; I2 = 18%).

Conclusion

In this meta-analysis of four trials (three of which were randomized) comparing TAVR and aortic valve surgery, the former was associated with significantly lower risk of all-cause mortality and cardiac mortality at one year. These findings suggest that TAVR may be the preferred option over surgery in patients with severe aortic stenosis who are candidates for aortic valve replacement with a bioprosthesis.

Courtesy of Dr. Carlos Fava.

Original Title: Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

Reference: Dhaval Kolte, et al. J Am Coll Cardiol 2019;74:1532–40.

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