The VICTORIA study evaluated the efficacy of vericiguat in heart failure patients with reduced ejection fraction, and found that vericiguat reduced the risk of the primary outcome of heart failure hospitalization (HFH) or cardiovascular death (CVD) when compared to placebo. In a recent secondary analysis published in the Journal of Cardiac Failure, researchers applied two alternative methods, the weighted composite endpoint (WCE) and win ratio (WR), to provide supplementary insights into the treatment effect of vericiguat.
The WCE method examined all 3,412 primary clinical events and weighed the variable severity of HFH as mild, moderate, or severe. The weighting utilized was established through an online survey developed and administered by the CVC to a panel of VICTORIA trial leadership and national leaders prior to the availability of the main trial results. The WR method prioritized events through a descending hierarchy of severity: CVD followed by recurrent HFH. This approach evaluated treatment effectiveness by comparing 6,375,624 pairs of study participants, and categorized outcomes as wins or losses for the treatment.
The researchers found that the WCE and WR analyses confirmed the clinical benefits of vericiguat and enhanced the findings of the primary study results. While both approaches are designed to include recurrent HFH events, the WCE method in particular captured all recurrent events, provided insights into the severity of HFH, and offered an absolute measure of the treatment experience of participants. The researchers conclude that the WCE enhances traditional methods of analysis, offering valuable insights for evaluating new treatment options and presents a viable opportunity to advance the design of future cardiovascular clinical trials.
This research was conducted on behalf of the VICTORIA Study Group, and CVC co-authors include Cindy Westerhout, PhD, Sarah Rathwell, MSc, Justin Ezekowitz, MBBCh, MSc, and Paul Armstrong, MD.
