YEARS Algorithm for Diagnosis of Suspected Pulmonary Embolism in Patients With Cancer: A Randomized Clinical Trial.
Summary
In a multicenter randomized noninferiority trial of 698 cancer patients with suspected PE, the YEARS algorithm was as safe as CTPA-only management and enabled avoidance of CTPA in 22% of patients. The 90-day thromboembolic event rate after PE exclusion was lower in the YEARS group in per-protocol analysis, meeting noninferiority criteria.
Key Findings
- Noninferiority met: 90-day symptomatic VTE/PE-related death after PE exclusion was 1.8% (YEARS) vs 5.5% (CTPA-only) in per-protocol analysis.
- CTPA was avoided in 22% of patients managed with the YEARS algorithm.
- No difference in the proportion of negative CTPA between groups (P=.93).
- Central blinded adjudication and intention-to-diagnosis analysis confirmed robustness.
Clinical Implications
For cancer patients with suspected PE, applying the YEARS algorithm can safely reduce CTPA utilization and streamline diagnostic workflows. Implementation may lower contrast-related risks and resource use without increasing missed VTE events.
Why It Matters
This trial provides high-level evidence to safely reduce imaging and contrast exposure in a high-risk oncology population while maintaining diagnostic safety.
Limitations
- Open-label design may introduce management biases
- Heterogeneity of cancer types and treatments may affect generalizability; no reduction in negative CTPA proportion
Future Directions
Assess implementation in diverse oncology settings, evaluate patient-centered outcomes and cost-effectiveness, and explore integration with cancer-specific pretest probability tools.
Study Information
- Study Type
- RCT
- Research Domain
- Diagnosis
- Evidence Level
- I - Randomized clinical trial with blinded adjudication provides highest level of evidence for diagnostic strategy.
- Study Design
- OTHER