CoreValve US Pivotal High Risk Trial: at 5 years, similar results

Courtesy of Dr. Carlos Fava.

We are well aware of transcatheter aortic valve replacement’s (TAVR) effect in high-risk or inoperable patients at 5 years, even more after the PARTNER 1 trial. Yet, the outcomes of another relevant randomized study remained pending: el CoreValve US Pivotal High-Risk Trial.

The CoreValve US Pivotal High-Risk Trial looked at the 5-year evolution of 391 patients undergoing TAVR and 359 undergoing  surgical valve replacement (SAVR).

Mean age was 83.2 years and STS was 7.3%, with no differences between the groups.

At 5 year follow up, all-cause mortality was 55.3% for TAVR and 55.4% for SAVR (p 0 0.50). Cardiac mortality was 39.7% vs. 39.5% (p= 0.80) respectively, and even though these rates were similar, the TAVR group presented better survival: 1,241.4 ± 627.1 vs. 1,109.8 ± 683.3 (p= 0.006). There were no differences in stroke, major stroke rates (17.5% vs. 21.0% and 12.3% vs. 13.2%) or functional class. The need for pacemaker implantation was higher with TAVR (33.0% vs. 19.8% p < 0.001), but this was not associated to higher mortality.

Read also: Clinical Utility of CT-Derived FFR for Decision-Making.

The Eco-Doppler at 5 years showed TAVR was superior seeing as this group of patients presented larger aortic area and lower gradient, with no differences in valve thrombosis. Freedom from structural valve deterioration and reintervention were similar (99.2% vs. 98.3% and 97% vs. 98.9%). 

There were no differences in mortality between both strategies in subgroups, such as >85 years, sex, BMI, STS, ejection fraction, hypertension, prior CABG, peripheral vascular disease or diabetes.

Conclusion

This study showed similar survival and stroke rate at mid-term in high-risk patients undergoing TAVR or SAVR. Structural valve deterioration and reintervention were uncommon.

Gentileza del Dr. Carlos Fava.

Original title: Self-Expanding Transcatheter Aortic Valve Replacement or Surgical Valve Replacement in High-Risk Patients 5-Year Outcomes.

Reference: Thomas G. Gleason, et al. J Am Coll Cardiol 2018. Article in Press.

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