ALL-RISE

Population

• Adults undergoing coronary angiography with at least one intermediate coronary stenosis selected for physiologic assessment.
• Study lesions generally had 50-90% diameter stenosis and were considered suitable for either FFRangio or pressure-wire assessment.

Intervention

Physiologic assessment with FFRangio derived from angiographic images, with PCI decisions guided by the result.

Comparator

Conventional pressure-wire-based physiologic assessment using FFR or nonhyperemic pressure ratio tools.

Key results

• Primary endpoint: 6.9% with FFRangio vs 7.1% with pressure-wire guidance; HR 0.98; 95% CI 0.70-1.39.
• The absolute difference was -0.2 percentage points; the upper boundary of the one-sided 97.5% CI was 2.1 percentage points, meeting the 3.5-percentage-point noninferiority margin.
• There were no apparent differences in bleeding, acute kidney injury, or procedure-related adverse events.
• Reports noted shorter physiology assessment time and overall procedure duration with FFRangio.

Harms

• No apparent excess in bleeding, acute kidney injury, or procedure-related adverse events was reported with FFRangio.
• As with any PCI decision strategy, downstream procedural risks depend on whether the physiology result leads to revascularization.

Practice impact

• Provides randomized clinical-outcome evidence that angiography-derived FFR can substitute for invasive pressure-wire physiology in selected intermediate lesions.
• May reduce barriers to physiologic lesion assessment by avoiding wire instrumentation and pharmacologic hyperemia when FFRangio is used.

Applicability

• Patients in the cath lab with intermediate coronary stenoses being evaluated for PCI and anatomy suitable for angiography-derived analysis.
• Most relevant to settings with validated FFRangio software, adequate angiographic image quality, and operators comfortable acting on physiologic thresholds.

Limitations

• Open-label device strategy trial.
• Noninferiority design supports similar outcomes within the prespecified margin, not superiority for hard clinical endpoints.
• Follow-up was limited to 1 year in the primary report.
• Findings apply to intermediate lesions selected for physiologic assessment, not obvious culprit lesions in acute coronary syndromes or left main/high-risk anatomy outside the trial context.

Common misinterpretations

• Do not interpret ALL-RISE as showing that angiography alone is enough; the intervention was computational angiography-derived physiology.
• Do not use the trial to justify PCI for stable CAD independent of symptoms, anatomy, and ischemia; it tested how to guide lesion assessment, not whether PCI improves prognosis broadly.