Photo: Hush Naidoo / Unsplash (illustrative)
A method that uses heart-artery images to help doctors decide whether a narrowed artery needs treatment met the main comparison goal in a German trial presented Monday, November 2, at TCT 2026. The finding comes with important limits: it did not show that the image-based approach was better, and a separate follow-up analysis did not pass the same kind of test.
The LIPSIA-STRATEGY trial randomly assigned 1,053 patients at eight German centers to one of two ways of guiding treatment, according to the American College of Cardiology’s report. Patients had heart-artery disease and at least one narrowing whose effect on blood flow needed assessment. Their median age was 69.
The usual pressure-wire method, called FFR, takes measurements with a wire inside the artery. The image-based method, called vFFR, calculates an estimate from artery images and a pressure measurement. It avoids the separate pressure wire for this assessment, but still uses an invasive artery-imaging procedure. The trial compared treatment decisions guided by these methods, rather than the images alone.
After one year, the combined rate of heart-related death, a nonfatal heart attack or an unplanned procedure to restore blood flow was 3.0% in the vFFR group and 4.1% in the wire-based FFR group. That was 15 versus 20 patients, with one-year outcome data available for 493 patients in each group.
The image-guided strategy met the trial’s prespecified absolute noninferiority rule. In plain language, the statistical test ruled out an increase in the combined event rate as large as the trial’s chosen limit of 3.5 percentage points. This is not proof that the methods are equivalent or that vFFR produces better outcomes.
Fewer events occurred than researchers had expected. That made the chosen limit less demanding when viewed as a relative increase in risk. In an additional analysis performed afterward, using a relative-risk limit of 1.44, noninferiority was not met in the main modified intention-to-treat group. That group kept patients in their assigned treatment groups and included those eligible for the analysis with known one-year outcomes.
The same relative-risk test was met in the per-protocol analysis, which focused on patients who followed the study protocol. Because these extra analyses gave different answers, the main result should be read with caution, not as a finding that the image-based method can simply replace the wire-based test.
The results were also published in JACC. The researchers said the similar one-year event rates do not answer whether the additional artery treatments performed in the vFFR group were beneficial.
JBizNews Desk
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