FRANCE2: Registry Shows Positive Outcomes for TAVR in High-Risk Diabetic Patients

BARCELONA, Spain—Patients with diabetes undergoing transcatheter aortic valve replacement (TAVR) for high-risk aortic stenosis have favorable outcomes compared with their nondiabetic counterparts, according to results presented on September 2, 2014, at the European Society of Cardiology Congress. Moreover, diabetics do not seem to be negatively affected by nonfemoral procedures.

These results are consistent with an analysis of the PARTNER A cohort presented last year at the same meeting.

“[Diabetes] should not be counted as a ‘negative variable’ in preprocedural TAVR scores,” said presenter Eric Van Belle, MD, PhD, of Centre Hospitalier Regional (Lille Cedex, France).

Methods
Dr. Van Belle and colleagues looked at data from 3,195 consecutive TAVR patients from 34 centers enrolled in the FRANCE2 Registry between January 2010 and October 2011. Compared with nondiabetic patients (n = 2,298), those with diabetes (n = 797) were younger and more likely to be men and tended to have lower LVEF, more comorbidities, and a higher median STS score. Diabetic patients remained higher risk than nondiabetics even after adjustment for age, gender, and BMI.


Postprocedural aortic regurgitation ≥ 2 was seen less (11.8% vs 17.1%; P = .001) and device success was higher (86.9% vs 82.7%; P = .005) in diabetic vs nondiabetic patients. These results were confirmed after multivariate analysis and were independent of device technology and delivery route. 

On multivariate analysis, death or stroke at 1 year (primary endpoint) was lower in the diabetic than nondiabetic group, as driven by a decrease in stroke (table 1).

Table 1. One-Year Outcomes

 

Adjusted HR (95% CI)

P Value

Death or Stroke

0.62 (0.43-0.91)

.01

Stroke

0.27 (0.08-0.86)

.01

Death

0.84 (0.68-1.13)

.10

 

While there was no difference in the rate of death or stroke between diabetics and nondiabetics treated transfemorally (19.9% vs 20.6%; P = .67), diabetics who were treated nontransfemorally fared better than those without diabetes (19% vs. 30.3%; P = .001; P = .02 for interaction). Moreover, diabetic patients treated nontransfemorally fared better in terms of both stroke (P = .04 for interaction) and death (P = .04 for interaction).

Nonfemoral TAVR ‘Treatment of Choice’ For Diabetics

“Despite a higher risk profile, diabetic patients with aortic stenosis undergoing TAVR have a favorable outcome compared to nondiabetic patients,” Dr. Van Belle said. Moreover, diabetics did not seem to “experience the extra risk usually associated” with a nonfemoral approach, he added.

Transfemoral TAVR “must remain the standard approach for nondiabetic patients [but] a nonfemoral approach is a very reasonable alternative in the diabetic population,” Dr. Van Belle commented. “Considering the high risk associated with the presence of [diabetes] in patients with aortic stenosis undergoing conventional surgical valve replacement, our data suggest that TAVR, including through a nonfemoral route, could become the treatment of choice for high-risk diabetic patients with aortic stenosis.”

 


Source:
Van Belle E. Is TAVR the treatment of choice for high-risk diabetic patients with aortic stenosis? Insights from the FRANCE2 registry. Presented at: European Society of Cardiology Congress; September 2, 2014; Barcelona, Spain.

 

Disclosures:

 

  • Dr. Van Belle reports no relevant conflicts of interest.

 

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