Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)

Prior treatment

• Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil
• Systolic blood pressure \<90 mmHg on the day of surgery
• Acute coronary syndrome within 2 months before surgery;
• Stroke or transient cerebral ischaemia within 1 month before surgery
• Low-risk surgical procedure based on individual physician's judgment
• Previously enrolled in the PREVENT-MINS study

Other illness

• Transplanted heart (or on waiting list)
• Resting heart rate \<65 beats per minute on the day of surgery
• Acute decompensated heart failure, cardiogenic shock, acute myocarditis
• Known allergy or hypersensitivity to ivabradine

Lab values

• Conduction abnormalities:
  • Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent
• Known severe liver or kidney disease (MDRD creatinine clearance \<15 mL/min)

Other

• Inability to tolerate oral intake
• Recent use of ivabradine (\<1 month)
• Investigator considers the patient unreliable regarding requirement for study compliance
• Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding

• Undergoing noncardiac surgery
• ≥45 years of age
• Expected to require at least an overnight hospital admission after surgery
• Provide written informed consent to participate in the PREVENT-MINS Trial, AND
• Fulfill ≥1 of the following 5 criteria (A-E):
• History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR
• Any 3 of 9 risk criteria:
• Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine \>175 µmol/L (\>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery