Disclosures: The study was funded by Janssen Pharmaceuticals, the sponsor of the REVEAL Registry. Benza reports he received grants from the American Heart Association, Bayer, the National Heart, Lung, and Blood Institute, and United Therapeutics; and received research support and served as a paid consultant for Janssen Please see the study for all other authors’ relevant financial disclosures.
February 23, 2021
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REVEAL Lite 2 risk calculator a simplified model to assess mortality risk in PAH

Disclosures: The study was funded by Janssen Pharmaceuticals, the sponsor of the REVEAL Registry. Benza reports he received grants from the American Heart Association, Bayer, the National Heart, Lung, and Blood Institute, and United Therapeutics; and received research support and served as a paid consultant for Janssen Please see the study for all other authors’ relevant financial disclosures.
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Use of an abridged version of the REVEAL 2.0 risk calculator, REVEAL Lite 2, provided a simplified method of mortality risk assessment for patients with pulmonary arterial hypertension, researchers reported in Chest.

“REVEAL Lite 2 was developed to provide clinicians with a simplified risk calculation method that can be routinely implemented in clinical practice, where data for patients may lack and be time-constrained,” Raymond L. Benza, MD, cardiologist in the department of medicine at The Ohio State University Wexner Medical Center, told Healio. “It provides discrimination between patients at low, intermediate and high risk, using six noninvasive variables with potential applicability to remote telehealth in today’s current environment due to the COVID-19 pandemic.”

Raymond L. Benza, MD, quote.

REVEAL Lite 2 uses six, rather than 13, noninvasive and modifiable variables: functional class; vital signs, including systolic blood pressure and heart rate; 6-minute walk distance; brain natriuretic peptide/N-terminal pro-B-type natriuretic peptide; and renal insufficiency.

The current analysis included 2,529 of the 3,515 adults enrolled in the REVEAL Registry. The mean age was 53.6 years and 80% were women. All patients had hemodynamic criteria for PAH and at least 12 months of available follow-up data. Half of the patients had idiopathic PAH and 25% had connective tissue-associated PAH. About eighty-seven percent of patients were classified as New York Heart Association functional class II/III.

“REVEAL Lite 2 approximates REVEAL 2.0 at discriminating low, intermediate and high risk for 1 year-mortality in patients in the REVEAL Registry,” the researchers wrote in Chest.

The c-index calculation for 1-year survival using categorical values was 0.73 (95% CI, 0.71-0.75) with REVEAL Lite 2 and 0.7 (95% CI, 0.68-0.72) with REVEAL 2.0 and using numerical values was 0.76 (95% CI, 0.74-0.78) and 0.73 (95% CI, 0.71-0.75), respectively, according to the results.

When the researchers applied REVEAL Lite 2 at the time of patient enrollment among the 3,046 patients, the c-index was 0.71 (95% CI, 0.69-0.73), which indicated good discrimination, according to the researchers.

REVEAL Lite 2 also indicated good discrimination in subgroups of patients with idiopathic PAH and connective tissue-associated PAH.

Brain natriuretic peptide/N-terminal pro-B-type natriuretic peptide was the most highly predictive REVEAL Lite 2 parameter, followed by 6-minute walk distance and NYHA or WHO functional class. REVEAL Lite 2 still discriminated among risk groups even when multiple, less predictive variables such as heart rate, systolic blood pressure and estimated glomerular filtration rate were missing, according to the researchers.

The researchers noted several limitations of the current analysis, including the need for REVEAL Lite 2 to be validated in a nonderivative cohort and in other populations and that patients in the REVEAL Registry were treated at specialized PAH centers within the U.S. and the results may not be applicable to patients in other treatment settings.

“Our analysis demonstrated that REVEAL Lite 2 offers a simplified method of risk assessment that may be implemented routinely in daily clinical practice and can be used in conjunction with REVEAL 2.0,” Benza told Healio.

For example, the researchers recommended in the study use of the full REVEAL 2.0 for evaluations at baseline, 4 months, 6 months and 12 months in treatment-naive patients with PAH, and the REVEAL Lite 2 could be used between those time points.

According to Benza, risk calculators that assess fewer and noninvasive variables without compromising discrimination and accuracy may expedite and enhance decision-making in routine clinical settings.

Looking ahead, “[a]dditional research is needed around how REVEAL Lite 2 is used within a real-world clinical setting. There are also ongoing efforts to further improve the usability of REVEAL Lite 2 within the clinical setting, including potential incorporation of the tool into electronic medical records,” Benza said. “Furthermore, findings from this analysis should encourage discussion as to how risk categories are assigned and whether any additional categories are needed to represent patients with risk scores that do not fall into existing categories.”

For more information:

Raymond L. Benza, MD, can be reached at raymond.benza@osumc.edu.