LIPS 2002.

Methods	Design: multi‐center randomized controlled trial Setting: 57 centers in 10 countries Patient recruitment: April 1996 to October 1998 Blinding: patients, caregivers, and outcome adjudicators Intention‐to‐treat: yes Follow‐up period: median of 3.9 years Lost to follow‐up: 0 up to 12 months of follow‐up
Participants	Number randomized: statin 417, control 407 (these individuals just represent the subgroup of patients with unstable angina; the LIPS trial originally included another 853 individuals with stable angina) Mean age (SD) in years: statin 61 (10), control 60 (10) Men, n (%): statin 344 (83%), control 336 (83%) Diabetes, n (%): statin 65 (16%), control 34 (8%) Hypertension, n (%): statin not available, control not available Current smoker, n (%): statin not available, control not available Prior myocardial infarction, n (%): statin 184 (44%), control 172 (42%) Index event, n (%): Myocardial infarction: statin 0, control 0 Unstable angina: statin 417 (100%), control 407 (100%) Fibrinolysis therapy: statin 0, control 0 Percutaneous coronary intervention (PCI): statin 417 (100%), control 407 (100%) Inclusion criteria: patients with unstable angina, who had successfully undergone their first PCI of 1 or more lesions in the native coronary arteries. Successful PCI was defined as a reduction of the stenosis diameter to less than 50% in the target lesion without evidence of myocardial necrosis, need for repeat PCI or CABG, or death before hospital discharge. Any type of PCI was allowed and included balloon angioplasty with or without stent placement, rotational or directional atherectomy, laser ablation, transluminal extraction catheter, or cutting balloon. Patients further needed to have a total cholesterol level between 135 and 270 mg/dL (3.5 to 7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L) before the index procedure. The upper total cholesterol limit for eligibility was 212 mg/dL (5.5 mmol/L) for patients whose baseline lipids were measured from blood drawn 24 hours to 4 weeks following MI and 232 mg/dL (6.0 mmol/L) for patients with type 1 or 2 diabetes mellitus Exclusion criteria: sustained systolic blood pressure of more than 180 mmHg and diastolic blood pressure of more than 100 mmHg despite medical therapy, left ventricular ejection fraction of less than 30%, a history of previous PCI or CABG, severe valvular disease, idiopathic cardiomyopathy or congenital heart disease, severe renal dysfunction (defined as serum creatinine level > 1.8 mg/dL, obesity (defined as a body mass index > 35 kg/m2), and the presence of malignant or other disease with a life expectancy of less than 4 years
Interventions	Fluvastatin 80 mg initiated at a median of 2 days after the index PCI
Outcomes	Primary: development of a major adverse cardiac event (MACE), defined as cardiac death (any death unless an unequivocal noncardiac cause could be established); non‐fatal MI (appearance of pathological Q waves that were absent at baseline or a total creatine kinase level > 2 times the upper limit of normal (ULN) with presence of CK isoenzyme MB higher than the ULN); or a re‐intervention procedure (CABG, repeat PCI, or PCI for a new lesion). Angiographic assessments without interventions were not included Secondary: MACE, excluding re‐intervention procedures (surgical or PCI) occurring in the first 6 months of follow‐up for lesions treated at the index procedure, cardiac mortality, non‐cardiac mortality, all‐cause mortality, combined cardiac mortality and MI, and combined all‐cause mortality and MI
Source	Funded by Novartis Pharma AG who also provided the fluvastatin and matching placebo
Daily intervention	Dietary and lifestyle counseling
Control	Placebo
Notes	Outcome data for the subgroup of patients with unstable angina at 1, 4, and 12 months of follow‐up were provided by original investigators
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Block randomization ‐ sequence generation unclear
Allocation concealment (selection bias)	Low risk	Adequate. Coded medication containers
Blinding (performance bias and detection bias) All outcomes	Low risk	Blinded patients, caregivers, and outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete patient follow‐up within first 12 months
Selective reporting (reporting bias)	Low risk	Author contact established; data on relevant outcomes provided
Other bias	Low risk	Adherence to intention‐to‐treat principle; not stopped early for benefit