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Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention
Remo H M Furtado1,2,3, Antônio Aurélio Fagundes3, Kazuma Oyama3,4
1Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo, Brazil (R.H.M.F.).
Insights
Evolocumab significantly reduces major adverse cardiovascular events in patients with prior percutaneous coronary intervention (PCI). This PCSK9 inhibitor therapy offers consistent risk reduction across various revascularization procedures.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Patients with a history of percutaneous coronary intervention (PCI) face elevated risks of recurrent coronary events.
- Intensive low-density lipoprotein cholesterol (LDL-C) lowering may reduce this residual risk beyond statin therapy.
Purpose of the Study:
- To evaluate the efficacy of evolocumab, a PCSK9 inhibitor, in reducing cardiovascular events in patients with prior PCI.
- To compare the risk reduction of major adverse cardiovascular events (MACE) and major coronary events with evolocumab versus placebo in patients with and without prior PCI.
Main Methods:
- The FOURIER trial randomized 27,564 patients with stable atherosclerotic disease on statin therapy.
- Participants received either evolocumab or placebo, with a median follow-up of 2.2 years.
- Outcomes included MACE and major coronary events; subgroup analysis focused on patients with prior PCI.
Main Results:
- Patients with prior PCI had higher MACE and major coronary event rates compared to those without prior PCI.
- Evolocumab demonstrated similar relative risk reductions for MACE and major coronary events in both patient groups.
- Absolute risk reductions were notable in the prior PCI group, particularly for MACE and major coronary events.
Conclusions:
- Evolocumab effectively reduces MACE in patients with prior PCI, including the risk of coronary revascularization.
- The benefits of evolocumab extend to various revascularization procedures, such as coronary artery bypass grafting and PCI for stent or graft failure.
Background:
Patients with prior percutaneous coronary intervention (PCI) are at high residual risk for multiple types of coronary events within and beyond the stented lesion. This risk might be mitigated by more intensive LDL-C (low-density lipoprotein cholesterol)-lowering beyond just with statin therapy.
Methods:
FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) randomized 27 564 patients with stable atherosclerotic disease on statin to the PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitor evolocumab or placebo with a median follow-up of 2.2 years. The end points of interest were major adverse cardiovascular events (MACE; a composite of cardiovascular death, myocardial infarction, stroke, unstable angina or coronary revascularization), and major coronary events (a composite of coronary heart death, myocardial infarction, or coronary revascularization). We compared the risk of MACE and the magnitude of relative and absolute risk reductions with evolocumab in patients with and without prior PCI.
Results:
Seventeen thousand seventy-three patients had prior PCI. In the placebo arm, those with prior PCI had higher rates of MACE (13.2% versus 8.3%; hazard ratio [HR]adj 1.61 [95% CI, 1.42-1.84]; P<0.0001) and major coronary events (11.5% versus 6.0%; HRadj, 1.72 [95% CI, 1.49-1.99]; P<0.0001). Relative risk reductions with evolocumab were similar in patients with and without prior PCI (MACE: HR, 0.84 [0.77-0.91] versus HR, 0.88 [0.77-1.01]; Pinteraction 0.51; major coronary events: HR, 0.82 [0.75-0.90] versus HR, 0.88 [0.75-1.04]; Pinteraction 0.42). Absolute risk reductions for MACE were 2.0% versus 0.9% (Pinteraction 0.14) and for major coronary events 2.0% versus 0.7% (Pinteraction 0.045). In those with prior PCI, the effect of evolocumab on coronary revascularization (HR, 0.76 [0.69-0.85]) was directionally consistent across types of revascularization procedures: coronary artery bypass grafting (HR, 0.71 [0.54-0.94]); any PCI (HR, 0.77 [0.69-0.86]); PCI for de novo lesions (HR, 0.76 [0.66-0.88]); and PCI for stent failure or graft lesions (HR, 0.76 [0.63-0.91]).
Conclusions:
Evolocumab reduces the risk of MACE in patients with prior PCI including the risk of coronary revascularization, with directionally consistent effects across several types of revascularization procedures, including coronary artery bypass grafting and PCI for stent or graft failure.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT01764633.
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