CoreValve Extreme Risk Pivotal Trial: Improved Benefits Confirmed After 3 Years

New data from the CoreValve US Pivotal Extreme Risk trial presented at TCT 2015 confirms that transcatheter aortic valve replacement (TAVR) confers favorable long-term clinical outcomes and durable valve performance in this challenging patient population.

James B. Hermiller Jr., MD, of the St. Vincent Hospital/The Heart Center of Indiana in Indianapolis, presented 3-year results of the trial, which included 489 patients (mean age, 83.1 years, NYHA class III or IV, 91.9%) who were enrolled at 40 sites and deemed to be at extreme surgical risk as defined by a 50% or greater 30-day risk of operative mortality or serious, irreversible comorbidity.

At 3 years, life-threatening or disabling bleeding occurred in 22.4% of patients, and major bleeding occurred in 30.2%. Four percent of patients suffered an MI, 32.3% required a permanent pacemaker and 8.4% had major vascular complications, findings that were unchanged from the 1-year to the 2-year follow-up.

“Although surgical candidates at high risk are now often treated with TAVR, the extreme-risk population continues to constitute a significant proportion of all patients undergoing TAVR,” Hermiller said. “The long-term outcomes, therefore, in these patients can provide important insights for decision makers.”

Challenging population 

At 3 years, there were 240 trial patients available for analysis — between 2 and 3 years, 58 patients died while 8 patients exited the study. However, follow-up at 3 years remained high at 91.3%.

“The performance goal for all-cause mortality or major stroke at 1 year was 43% and at 3 years — 52%,” Hermiller said. “The results show that the percent [of mortality] due to non-cardiovascular disease increases over time, which is not surprising, given the patient population we are dealing with.”

Additionally, Hermiller noted that at 1 year, 95% of patients were NYHA functional class I or II, while 3-year results showed 14% of patients had progressed to NYHA class III or IV, which was “not surprising given the age and comorbidities” of the cohort.

“At 3 years, the CoreValve US Pivotal Extreme Risk study showed durable improvement in hemodynamic valve performance — both in terms of [effective orifice area] and gradients — low rates of moderate-to-severe aortic insufficiency, durable improvements in the NYHA functional class, and an increased proportion of non-cardiac deaths over time,” Hermiller concluded.

Disclosures: 

• Hermiller reports serving on the steering committee for the CoreValve US Pivotal Extreme Risk trial and as a faculty educator for Medtronic.