Two Trials to Assess TAVR in Moderate-Risk Patients

San Francisco, CA—Presentations on two randomized trials at TCT 2013 — PARTNER IIA and SurTAVI — addressed study status and issues surrounding transcatheter aortic valve replacement (TAVR) in moderate-risk patients, a lower-risk group than previously evaluated.

PARTNER IIA early status update 

TCT course director Martin B. Leon, MD, of Columbia University Medical Center, New York, announced completion of trial enrollment in the PARTNER IIA study. For this study, Leon and colleagues plan to assess all-cause mortality and disabling stroke after treatment with the Sapien XT 18-Fr valve (Edwards Lifesciences) in moderate-risk (lower risk than PARTNER I) patients. Disabling stroke is defined in this study as a modified Rankin score of ≥2 at 90-day follow-up and will include neurology assessments. 

Leon said that while much is known about high-risk patients and it has been previously suggested that low-risk patients should not be operated on, not much is known about moderate-risk patients.

“We have been able to enroll what we know of as the largest randomized trial in aortic valve disease. We take great pride in presenting at least the early status update on behalf of all PARTNER IIA investigators,” said Leon. 

Inclusion criteria consists of patients with severe, symptomatic, calcific aortic stenosis with a STS score from 4% to 8%. Patients were recruited across 60 sites in the United States and Canada. As of Oct. 10, 2013, there were 2,011 patients from 57 US sites and two Canadian sites enrolled.

“This is a ‘real world’ comparison,” Leon said. “It’s a larger study, including more sites, and is politically more challenging. About 75% of patients were treated with transfemoral access and the mean Society of Thoracic Surgeons score for this study is about 6. Stay tuned because not too far in the future we will have some interesting results to report.” 

SurTAVI trial update

During another presentation, Patrick W. Serruys, MD, PhD, of Erasmus Medical Center in the Netherlands, discussed the completion of enrollment for the SurTAVI trial that will assess the use of CoreValve (Medtronic CardioVascular) vs. surgical aortic valve replacement (SAVR) in about 2,500 patients with severe, symptomatic aortic stenosis at moderate risk for complications. Inclusion criteria consisted of patients aged 75 years or older, or those with an STS mortality risk score from ≥2% to ≤10%.

The primary outcome measure is all-cause mortality or disabling stroke at 2 years. Secondary outcome measures include MACE at 5 years. Current enrollment is 326 patients. An additional 13 patients are pending randomization. The current overall STS score is 5.8.  

“I have been extremely impressed by the electronic case-by-case assessment that the company has organized. I was skeptical, but it’s true that in Europe we are struggling with the STS criteria without possible interaction with comorbidity — it is quite difficult,” Serruys said. “We are struggling with SurTAVI, but I think we have good news. I have to remind you that it is a trial that includes STS [scores] above [2]% and below 10%. We are aiming at 2,500 patients from 75 different centers across Europe, Canada and the United States and it [features] a long-term follow-up.”

Patients randomized to TAVR will receive CoreValve with or without PCI. In the surgery arm, surgical valve replacement will be performed with or without CABG.


Leon has received grant/research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences and Medtronic CardioVascular; consultant fees/honoraria from AngioScore, Meril Life Sciences and Micell; and shareholder/equity from Apica, Angiometrix, BackBeat Medical, Caliber, Claret, Coherex, Elixir Medical Corporation, Guided Delivery Systems, Medinol, Mitralign and Valve Medical.

Serruys reports no relevant financial disclosures.