Outcomes
CKD, chronic kidney disease, stroke, coronary artery diseases, end‐stage renal disease, heart failure, deaths, ventricular hypertrophy, fibrillation, albuminuria
MYOCARDIAL INFARCTION, STROKE, UNSTABLE ANGINA, CORONARY ARTERY DISEASES, KIDNEY, EVENTS, HEART FAILURE, FIBRILLATION, VENTRICULAR HYPERTROPHY
Occurrence of study outcomes will be collected every 3 months beginning at the 3‐month visit and throughout the follow‐up. The physician who collects outcome data is masked to treatment assignment. Photocopies of inpatient record, discharge summary, electrocardiogram, and imaging reports, etc. will be obtained for outcome adjudication by members of an outcome assessment committee who are unaware of treatment assignment. At least two committee members will review the medical records independently. Clinical events occurring during follow‐up will be ascertained equally in both treatment groups.BPROAD study outcomes are listed in Table Age at baseline (<65 vs ≥65 years; <80 vs ≥80 years).Men vs women.Systolic BP levels at baseline (tertiles).Previous CVD.Previous chronic kidney disease (CKD, estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 mGlycated hemoglobin (HbA1c) at baseline (tertiles).Diabetes duration at baseline (< vs ≥ the median).High BP duration at baseline (< vs ≥ the median).Study outcomes.Primary outcome
Secondary outcomesA composite of the primary outcome and all‐cause mortalityMacrovascular outcome including the composite primary outcome, hospitalized unstable angina, and all cardiovascular revascularization proceduresMajor coronary artery diseases including nonfatal MI, hospitalized unstable angina, revascularization of coronary arteries, and deaths due to coronary artery diseasesTotal MI including fatal and nonfatal MITotal stroke including fatal and nonfatal strokeIschemic strokeHemorrhagic strokeHospitalized or treated heart failure or heart failure deathCardiovascular deathTotal mortalityCognitive functionHealth related quality of life
Kidney outcomesProgression of CKD defined as the composite of a 50% decrease in eGFR, development of end‐stage renal disease requiring chronic dialysis or kidney transplantation, or eGFR <15 mL/min/1.73 mDevelopment of CKD defined as a >30% decrease in eGFR and eGFR <60 mL/min/1.73 mIncident albuminuria defined as a doubling of urinary ACR from a value of <10 mg/g to a value of >10 mg/g in all patients with or without CKD.
Other outcomesAll cardiovascular revascularization proceduresHospitalized unstable anginaRetinopathyTransient ischemic attackLeft ventricular hypertrophy diagnosed by ECGAtrial fibrillation or flutterAll cancersCost‐effectiveness measuresAbbreviations: ACR, albumin‐to‐creatinine ratio; BP, blood pressure; CKD, chronic kidney disease; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; MI, myocardial infarction.Secondary outcomes, cognitive outcomes, kidney outcomes, and other outcomes are specified in Table 