Introduction: Evolocumab (EvoMab) significantly reduced the relative risk of cardiovascular (CV) death, MI or stroke by 20% (absolute risk reduction 2% at 3 years) in patients with atherosclerotic CV disease. However, such patients vary in their risk for CV events.
Hypothesis: Risk stratification with the TIMI Risk Score for Secondary Prevention (TRS 2°P) will identify patients who have the greatest potential for benefit from EvoMab.
Methods: We applied the TRS 2°P prospectively to 27,564 pts with atherosclerotic CV disease and an LDL-C ≥70mg/dL randomized to EvoMab or placebo (Pbo) in FOURIER. The baseline risk as well as the relative and absolute risk reductions in CV death, MI or stroke with EvoMab were calculated by TRS 2°P strata.
Results: The 10-point integer-based scheme showed a strong graded relationship with the rate of CV death, MI or stroke and the individual components (p-trend<0.0001 for all). Intermediate-risk patients (TRS 2°P Score=2-4; 79% of population) had a 1.9% absolute risk reduction (ARR) in CV death, MI or stroke at 3 yrs with EvoMab compared to Pbo alone and high-risk patients (Score≥5; 16%) had a 3.6% ARR, translating to a number-needed-to-treat for 3 years of 53 and 28, respectively (Fig).
Conclusion: The TRS 2°P identifies high-risk patients with atherosclerotic CV disease who demonstrate a pattern of greater absolute risk reduction in major CV events with EvoMab.