Belgian Registry Reports Similar 3-Year Survival for Sapien, CoreValve in Transfemoral TAVR


In patients with aortic stenosis who are not candidates for surgery, midterm survival is equivalent regardless of whether they receive transfemoral TAVR with balloon-expandable or self-expanding devices, according to a Belgian registry study published online May 11, 2015, ahead of print in Catheterization and Cardiovascular Interventions.

The Take Home:  Belgian Registry Reports Similar 3-Year Survival for Sapien, CoreValve in Transfemoral TAVR

Valérie M. Collas, MSc, of University Hospital Antwerp (Edegem, Belgium), and colleagues looked at 861 consecutive inoperable patients (average age 83 years; 47% men) who underwent TAVR at 23 Belgian sites between December 2007 and March 2012. Eleven sites exclusively used the balloon-expandable Sapien valve (Edwards Lifesciences; n = 460), while 12 exclusively used the self-expanding CoreValve device (Medtronic; n = 461).

Median logistic EuroSCORE was 22.8 and was higher in patients treated with Sapien compared with CoreValve. Additionally, Sapien-treated patients tended to have a greater comorbidity burden than those who received CoreValve. Transfemoral access was used in 74% of patients—representing 89% of CoreValve and 61% of Sapien procedures. While procedural success was 98% in both treatment groups, new permanent pacemakers were required in more than 4 times as many CoreValve patients as Sapien patients (29% vs 7%; P < .001).

Kaplan-Meier estimated survival at 3 years was 55% overall, with an advantage for those who received CoreValve compared with Sapien (60% vs 51%; P = .021). However, when looking only at transfemorally treated patients, survival was similar between the devices regardless of baseline EuroSCORE (table 1).

Table 1. Three-Year Survival for Transfemoral TAVR Patients by Baseline EuroSCORE


On multivariable analysis, independent predictors of reduced 30-day mortality were low mean gradient (HR 0.98; 95% CI 0.96-0.99) and the presence of CAD (HR 0.51; 95% CI 0.29-0.88). Mortality at 30 days was higher for valve-in-valve procedures (HR 5.27; 95% CI 1.20-23.14), patients who developed new MI (HR 5.40; 95% CI 1.88-15.53), and those experiencing new clinically relevant stroke or TIA (HR 3.81; 95% CI 1.71–8.50). Predictors of midterm mortality included gender, logistic EuroSCORE, carotid disease, chronic obstructive pulmonary disease, previous stroke or TIA, new MI, and new clinically relevant stroke or TIA.

Approximating a Randomized Trial?

The Belgian TAVI registry stands out in that it includes data on both Sapien and CoreValve, Ms. Collas and colleagues write. In addition, because each site relied on only 1 device, they suggest that comparisons can be made in lieu of randomized trials evaluating both valves simultaneously.

The results “confirm excellent early and midterm clinical outcomes” after TAVR in a real-world population, they observe.

“Completion of medium and long-term follow-up in registries remains a challenging issue, especially when follow-up is based on voluntary cooperation of the different centers, as was the case in this registry,” the authors comment. “However, this is also a limitation in other published registries.”

An additional limitation, they say, is that details on paravalvular regurgitation after TAVR were “not uniformly quantified by [a] central core lab and therefore not included in the report.”

EuroSCORE Still Relevant

While valve choice is “generally guided by operator preference and specific anatomical and technical considerations,” there are no direct comparisons available between CoreValve and Sapien, they say, “except for procedural characteristics and early outcomes.”

Given that Sapien-treated patients “had significantly more associated comorbidities and more severe aortic valve disease…, probably some of the larger Belgian CoreValve sites were somewhat more restrictive in performing TAVI in patients with very high logistic EuroSCORE (related to limited reimbursement for TAVI in Belgium and limited hospital resources) [and] by this contributing to somewhat lower EuroSCORE values of the total CoreValve cohort,” the authors write.

“Therefore, stratification of patients according to access route and EuroSCORE remains of interest to compare clinical outcomes with different devices,” the authors continue. “Despite its limitations, the EuroSCORE remains a valuable tool to distinguish patient cohorts at low, intermediate, or high overall risk.”

 


Source:
Collas VM, Dubois C, Legrand V, et al. Midterm clinical outcome following Edwards Sapien or Medtronic CoreValve transcatheter aortic valve implantation (TAVI): results of the Belgian TAVI registry. Catheter Cardiovasc Interv. 2015;Epub ahead of print.

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Disclosures
  • Ms. Collas reports no relevant conflicts of interest.

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