Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography

Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography

The Effect of Continuing or Discontinuing ACE-I/ARBs Therapy on the Incidence of Contrast-induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Coronary Angiography; a Randomized Controlled Trial

Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI. Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization. This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.

The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs). The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine. Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography. Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set. They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants. Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.

Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy, ACEI, ARBs

Patients enrolled to the study were randomized into continuing or discontinuing (ACEI/ARBs) group. Care providers and investigators collected their data before and after the coronary angiography. The independent variable - continuing or discontinuing (ACEI/ARBs) - was coded into A or B groups, then data was sent to the outcomes assessor.

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-72 hours post)

Randomized to continue on prescribed ACE1 or ARBs ( Enalapril 5, 10, 20 mg // Ramipril 2.5 , 5 mg // Valsartan 80 , 160 mg // Candesartan 8, 16 mg // Losartan 50 mg )

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-72 hours post-catheterization (after creatinine measurement) Other Name: Includes all ACEI inhibitors or ARBs

Contrast induced nephropathy (creatinine rise of ≥0.5 mg/dL or a relative increase ≥25%compared to the pre-randomization creatinine level) at 48-72hrs

Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs

Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs

Inclusion Criteria: At least one month of continuous therapy with an ACEI or an ARBs and Undergoing elective coronary angiography and Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2). Exclusion Criteria: Acute STEMI within 2 weeks NYHA class IV heart failure by history Administration of contrast load within the previous 6 days acute renal failure (ARF) preceding coronary angiography potassium level more than 5.0 meq/l GFR <15 ml/min/1.73 m2 previous percutaneous cardiac catheterization within one month Acute pulmonary edema hemodynamically instability uncontrolled hypertension combination ACEI and ARB therapy Cardiogenic shock Sepsis pregnancy Age below 18 year