optimal ldl-c target in high-risk patients after pci

Conditions: Chronic Coronary Syndrome; Acute Coronary Syndromes; Percutaneous Coronary Intervention; High Risk Patient

Summary: extensive evidence from epidemiological, genetic, and randomized controlled trials (rcts) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (ldl-c) and atherosclerotic cardiovascular disease (ascvd), establishing ldl-c as both a pathogenic risk factor and a critical therapeutic target. lipid-lowering therapies targeting ldl-c have significantly decreased the overall risk in ascvd patients. consequently, current guidelines recommend, based on risk stratification, lowering ldl-c levels in high-risk ascvd patients to \<1.4 mmol/l with a ≥50% reduction from baseline. findings from prove it-timi 22, improve-it, odyssey outcomes, and fourier-ole trials suggest that achieving extremely low ldl-c levels may further reduce the risk of cardiovascular events in ascvd patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion. against these backgrounds, we have designed this trial to investigate whether targeting ldl-c levels \<0.8 mmol/l in high-risk ascvd patients results in a significant reduction in adverse events compared to targeting ldl-c levels of 0.8-1.4 mmol/l.


Eligibility criteria:
inclusion criteria: 1. patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome 2. patients with ascvd at extremely high risk 3. patients who are able to complete the follow-up and compliant with the allocated treatment * ascvd at extremely high risk is defined as fulfilling at least two of the following criteria: 1. pci for acute myocardial infarction (ami, including stemi or nstemi) 2. previous ami, previous stroke, or previous intervention or surgery for peripheral vascular disease 3. experienced cardiovascular event(s) with ldl-c≤1.8mmol/l 4. ldl-c≥4.9mmol/l 5. diabetes 6. ckd (egfr \< 60 ml/min/1.73m2) 7. current smoking 8. recurrent cardio/cerebrovascular events 9. history of premature ascvd (\< 55 male, \< 65 female) 10. complex pci (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion)) exclusion criteria: 1. age less than 18 years; 2. unable to give informed consent or currently participating in other trials; 3. patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment; 4. concurrent medical condition with a life expectancy of less than 3 years; 5. hemodynamic unstable; 6. active liver disease or hepatic dysfunction (persistent unexplained alt/ast elevations (≥ 3 × uln)), patients with a transient increase alt/ast due to the acute mi may be enrolled; 7. unable to reach the ldl-c target by known intolerance or contradiction of lipid control medications; 8. ldl-c ≤ 1.4 mmol/l at baseline without any lipid control medication lowering ldl-c; 9. known active infection or critical hematologic/endocrine dysfunction.

Keywords: acute coronary syndrome chronic coronary syndrome percutaneous coronary intervention ldl-c lipid