Prespecified subgroup analysis of VESALIUS-CV in 3,627 patients (29.6% of the total study population) with prior PCI but no prior myocardial infarction or stroke, randomised to evolocumab or placebo (median follow-up 4.6 years). Median age 66 years, 30.7% women, median time since PCI 4 years. At 48 weeks, median LDL-C was 41.5 versus 107.0 mg/dL with evolocumab versus placebo. Evolocumab reduced 3-point MACE by 30% (5-year KM 7.0% vs 9.5%; HR 0.70; 95% CI 0.56-0.89; p=0.004), 4-point MACE by 18%, MI risk by 50% (3.0% vs 6.1%; HR 0.50; p<0.001), and urgent coronary revascularisation by 39%. The effect was apparent within 6 months. Numerically lower cardiovascular mortality (HR 0.66) and all-cause mortality (HR 0.76). The findings support intensive LDL-C lowering with evolocumab in stable patients with prior PCI even without prior MI — a substantial practical expansion of the indication.
Background: The clinical benefit of intensive LDL-C-lowering with evolocumab in patients with prior percutaneous coronary intervention (PCI) but without a prior myocardial infarction (MI) is not established.Methods: VESALIUS-CV randomized patients with atherosclerosis or high-risk diabetes but without prior MI or stroke and with LDL-C ≥90 mg≥dL to evolocumab vs placebo. The median follow-up was 4.6 years. The dual primary endpoints were: coronary heart disease death, MI, or ischemic stroke (3-point MACE); and the same composite plus ischemia-driven arterial revascularization (4-point MACE). For this pre-specified subgroup analysis, patients were categorized by whether they had undergone PCI at any time prior to trial enrollment.Results: Among 12,257 randomized patients, 3,627 (29.6≥) had undergone prior PCI with a median time between PCI and enrollment of 4 years. Their median age was 66 years and 30.7≥ were women. The median LDL-C at 48 weeks was 41.5 (26.0-67.0) mg/dL vs. 107.0 (84.0-135.0) mg/dL in the evolocumab vs. placebo arms (p<0.0001). Evolocumab reduced the risk of 3-point MACE by 30% (5yr KM 7.0% vs 9.5%; HR 0.70; 95%CI 0.56-0.89; P=0.004) and 4-point MACE by 18% (17.9% vs 21.7%HR 0.82; 95%CI 0.71-0.96; P=0.012), and reduced the risk of MI by 50% (3.0%vs 6.1%; HR 0.50; 95%CI 0.36-0.70; P<0.001), with the effect apparent as soon as 6 months after randomization, and of urgent coronary revascularization by 39% (HR 0.61; 95%CI 0.46-0.80; P<0.001). There were nominally lower rates of CV death (2.6% vs 3.7%; HR 0.66; 95%CI 0.45-0.96; P=0.030) and all-cause death (8.2% vs 10.2%; HR 0.76; 95%CI 0.60-0.95; P=0.016) with evolocumab.Conclusions: Evolocumab reduced the risk of major CV events in stable patients with prior PCI but no MI. These findings support intensive LDL-C-lowering in patients who have undergone PCI even in the absence of prior MI.
