Efficacy of Different Perioperative Statin Regimens on the Protection Against Post Coronary Artery Bypass Grafting Major Adverse Cardio-cerebral Events
Condition: Coronary Artery Bypass Grafting
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at comparing different perioperative statin regimens for the prevention of
      post CABG adverse events.

      This was a randomized, prospective clinical trial. Ninety four patients scheduled for
      elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups;
      80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for 5-9 days
      preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29). The
      corresponding preoperative doses were restarted postoperatively (post-op) when patients were
      able to take the medication orally and were continued for one month. Cardiac troponin I
      (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and
      post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the
      three groups. The incidence of post-operative major adverse cardiac and cerebrovascular
      events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction,
      atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and
      target-vessel revascularization. The incidence of renal or hepatic impairment and
      post-operative infections were also assessed. A Quality of life (QoL) questionnaire
      (EQ-5D-3L) was administered preoperatively and 1 month after CABG.
    

Detailed description: 
      This study was conducted at the National Heart Institute (NHI), Cairo, Egypt, during the
      period between June 2013 and February 2015. It was approved by the ethics committee at the
      Faculty of Pharmacy, Cairo University, and the scientific committee at the NHI. An informed
      consent was obtained from all study participants after they have been approached with the
      nature, purpose and possible risks of the study.

      Preoperative baseline demographic characteristics, preoperative medications, comorbid
      conditions and risk factors were identified and summarized.

      Design: This is a randomized, prospective, interventional, open label study. Upon admission
      to the NHI, eligible patients were randomly assigned to one of 3 treatment groups; group I
      (80 mg atorvastatin/day for 2 days preoperatively), group II (40 mg atorvastatin/day for 5-9
      days preoperatively) or group III (80 mg atorvastatin/day for 5-9 days preoperatively).
      Atorvastatin doses were reinitiated postoperatively as soon as patients could take the
      medication orally and was continued for one month after operation.

      The following intra-operative data were recorded for each patient; cardiopulmonary bypass
      time, aortic clamp time, type of anesthesia, number of grafts and need for blood transfusion.

      Blood samples were drawn preoperatively (baseline) then at 8 hours, 24 hours, 48 hours
      postoperatively and before hospital discharge. Blood samples were spun and sera were
      separated, stored according to the storage conditions specified by the manufacturer, and used
      to measure the TnI, CK-MB and CRP at the time of analysis. Cardiac TnI was assayed by the
      Dimension® TNI method, a homogenous sandwich chemiluminescent assay based on LOCI®
      technology, using SIEMENS Dimension® EXL™, LOCI® Module system. Siemens Healthcare
      Diagnostics Inc. Newark, USA. CK-MB isoenzyme was measured by the Mass MMB method, a one-step
      enzyme immunoassay based on the sandwich principle, using SIEMENS Dimension® Heterogeneous
      Immunoassay Module system. Siemens Healthcare Diagnostics Inc. Newark, USA. CRP was measured
      by the C-Reactive Protein Extended Range (RCRP) method, a method based on a particle enhanced
      turbidimetric immunoassay (PETIA) technique, using SIEMENS Dimension® system. Siemens
      Healthcare Diagnostics Inc. Newark, USA.

      A-12 lead electrocardiogram (ECG) was performed pre-operatively, in the intensive care unit
      (ICU) and upon patient transfer to the ward. The appearance of new Q-waves indicating
      myocardial infarction (MI) or incidence of any arrhythmias was reported. Echocardiography was
      performed pre-operatively and post-operatively after ICU discharge to detect any new wall
      movement abnormalities as well.

      Measured end points were as follows: 1) Incidence of post-operative major adverse cardiac and
      cerebrovascular events (MACCE) including; 30-days all-cause mortality, MI, AF, ventricular
      tachycardia or ventricular fibrillation, debilitating stroke or transient ischemic attack
      (TIA) or target-vessel revascularization; 2) renal impairment; 3) hepatic impairment; 4)
      postoperative infections; 5) persistent blood glucose abnormalities; 6) length of ICU and
      hospital stays, and a health-related quality-of-life (HRQoL). HRQoL was assessed using the
      Euro Quality of Life 5-Dimensional Classification (EQ-5D-3L) 19 at baseline (preoperatively)
      as patients were admitted to the NHI and then one month postoperatively during the follow-up
      visit or by contacting the patient via a phone call.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention