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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

PRECISE‐IVUS 2015.

Methods Design: prospective, randomised, controlled, assessor‐blind, parallel assignment, open‐label, multi‐centre study
Number of study centres: 17 centres in Japan
Setting: inpatient and outpatient follow‐up
Patient recruitment: January 2010 to September 2014
Duration of study: 12 months
Clinical setting: hypercholesterolemia and coronary artery disease
Participants Enrolment (N): 246
Randomised (N): intervention: 122; control: 124
Withdrawn (N): intervention: 1; control: 2
Lost to follow‐up (N): not reported
Completed the study (N): intervention: 100; control: 102
Analysed (N): intervention: 121; control: 122
Age (years) (mean ± SD): intervention: 66 ± 10; control: 67 ± 10
Sex (male, N, %): intervention: 78 (78 %); control: 80 (78%)
Smoking history (N, %): intervention: 20 (20%); control: 32(32 %)
BMI (kg/m², mean ± SD):): intervention: 24.8 ± 3.4; control: 24.9 ± 3.1
Diabetes (N, %): intervention: 29 ( 29%); control: 31 (30 %)
Hypertension (N, %): intervention: 75 (75%); control: 67 (66%)
Existing CHD: intervention: 100 ( 100%); control: 102 ( 100%)
History of MI (N, %): intervention: 15 (15%); control: 13 (13%)
Statin pretreatment (N, %): intervention: 46 (46%) ; control: 49 (48%)
Inclusion criteria:

  1. aged 30–85 years at the time of their consent;

  2. patients who have been diagnosed as ACS or stable coronary heart disease;

  3. patients who undergo CABG or PCI under IVUS guidance;

  4. patients with LDL‐C ≥100 mg/dL at the time of their consent.


Exclusion criteria:

  1. familial hypercholesterolaemia;

  2. being treated with ezetimibe;

  3. being treated with fibrates;

  4. renal insufficiency (serum creatinine >= 2.0 mg/dL);

  5. altered hepatic function (serum AST or ALT >= 3‐fold of standard value in each institute);

  6. undergoing haemodialysis or peritoneal dialysis;

  7. allergic to Lipitor and/or Zetia;

  8. severe underlying disease;

  9. lack of decision‐making capacity;

  10. recognised as inadequate by attending doctor.
Interventions Intervention: ezetimibe 10 mg/day + atorvastatin( the dosage of atorvastatin will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL‐C below 70 mg/dL)
Comparison: atorvastatin
Details of any 'run‐in' period: not reported
Concomitant medications: not reported
Excluded medications: not reported
Outcomes Primary: absolute change from baseline to follow‐up in per cent atheroma volume (PAV) in the target lesion
Secondary:

  1. percentage change from baseline (before randomisation) to follow‐up (9‐12 months after randomisation) in the atheroma volume;

  2. change and percentage change from baseline to follow‐up in the minimum lumen diameter (MLD) and per cent diameter stenosis (%DS;

  3. percentage changes from baseline to follow‐up in serum lipids;

  4. correlation between regression of coronary plaque and serum lipids profiles;

  5. changes in high‐sensitivity CRP (hs‐CRP) from baseline to follow‐up;

  6. correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs‐CRP);

  7. change and percentage change from baseline to follow‐up in the plaque volume of the PCI target lesion;

  8. change and percentage change from baseline to follow‐up in the MLD and %DS of the PCI target lesion;

  9. major adverse cardiac events (cardiac death, non‐fatal myocardial infarction, non‐fatal stroke, coronary revascularization);

  10. all‐cause death;

  11. safety (adverse events, subjective symptoms/objective findings, physical tests), blood tests (haematology, clinical chemistry, glucose metabolism test), urinalysis).
Notes Funding: Quote: "This work was supported in part by a Grant‐in‐Aid for Young Scientists B (22790713, 24790769) and a Grant‐in‐aid for Scientific Research C (26461075) from the Ministry of Education, Science, and Culture, Japan (to Dr. Tsujita)."
NCT01043380
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned by using a web‐based randomization software"
Allocation concealment (selection bias) Low risk Quote: "randomly assigned by using a web‐based randomization software"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study, no blinding of participants and personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "randomized, controlled, assessor‐blind, multicenter study"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Safety outcomes analyses were performed by using 'safety analysis set',
Number of participants that discontinued were reported and reasons were stated
Selective reporting (reporting bias) Low risk The study protocol was published and all of the study's prespecified outcomes have been reported.
Other bias Low risk Quote: "This work was supported in part by a Grant‐in‐Aid for Young Scientists B (22790713, 24790769) and a Grant‐in‐aid for Scientific Research C (26461075) from the Ministry of Education, Science, and Culture, Japan (to Dr. Tsujita)."
Quote: "Dr. Ogawa has received remuneration for lectures from Bayer, Boehringer Ingelheim, Daiichi‐Sankyo, MSD, Pfizer, and Takeda; has received trust research/joint research funds from Bayer, Daiichi‐Sankyo, and Novartis; and has received scholarship funds from AstraZeneca, Astellas, Bristol‐Myers Squibb, Chugai, Daiichi‐Sankyo, Dainippon Sumitomo Pharma, Kowa, MSD, Otsuka, Pfizer, Sanofi, Shionogi, and Takeda. Dr. Ishihara has received remuneration for lectures from MSD. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose."