Journal Club Presentation

. 533150189-6

A Randomized Trial of Intensive versus Standard

Blood-Pressure Control

Systolic Blood Pressure Intervention Trial (SPRINT)

Impact factor = 55.873 (2014)

Background and Rationale SBP

JNC8

Outline

Objective

Methods

Results

Conclusion

Critical Appraisal Worksheet

Objective

Blood Pressure target 140 mmHg Blood Pressure target 120 mmHg

Methods

Randomized, controlled, open-label trial ( 102 clinical sites Puerto Rico) Independent data and safety monitoring boards Steering committee Writing committee NHLBI

Methods

2 1. Intensive treatment (SBP

Study Eligibility 50 SBP 130-180 mmHg () cardiovascular disease 1

Clinical or subclinical cvs diseases ( stroke) CKD (eGFR 20-60 ml/min/1.73m2) Framingham risk score for 10 years CVD risk 15% 75

Study eligibility Stroke Polycystic kidney disease CHF ( EF1g/d CKD eGFR

Outcome Primary outcome

CVD composite: first occurrence of Myocardial infarction (MI) Acute coronary syndrome (ACS) Stroke Acute decompensated heart failure Cardiovascular disease death

Primary hypothesis CVD composite event intensive

standard

Additional outcomes All cause mortality Primary outcome + all cause mortality Renal

Secondary outcome: CKD

eGFR 50% ESRD CKD eGFR 30%

albuminuria

Pre-specified subgroup of interest

( < 75 ) ( ) (African-American ) CKD (< 60ml/min/1.73m2) CVD () Baseline SBP ( 132mmHg, 132-145mmHg 145mmHg)

Follow up

3 3

( 3 visit) orthostatic hypotension syncope

(periodic assessment)

Statistical Analysis

Intention to treat approach Cox proportional hazards regression with two

sided tests Fine gray model in sensitivity analysis

Results

Conclusion

Critical Appraisal for Therapy Articles

Are the results of the trial valid? What questions did they ask?

Patients = SBP 130-180 mmHg

Intervention = SBP

1a. R- Was the assignment of patients to treatments randomised?

1b. R- Were the groups similar at the start of the trial?

Methods: randomized, controlled open label trial

Table 1: baseline characteristics of study participants

2a. A Aside from the allocated treatment, were groups treated equally?

2b. A Were all patients who entered the trial accounted for? and were they analysed in the groups to which they were randomised?

Intention to treat approach

Lifestyle modification

3. M - Were measures objective or were the patients and clinicians kept blind to which treatment was being received?

objective composite CVD event all cause mortality renal outcome

blind clinician

outcome adjudicator

What were the results?

1. How large was the treatment effect?

2. How precise was the estimate of the treatment effect?

Will the results help me in caring for my patient? (External Validity/Applicability)

Is my patient so different to those in the study that the results cannot apply? There are no Asian populations studied but from subgroup analysis, race doesnt affect the outcome

Is the treatment feasible in my setting? Hard to apply since it requires more medications and more adherence from patients.

Will the potential benefits of treatment outweigh the potential harms of treatment for my patient?

NNT for primary outcome event is 61 NNT for death from any cause is 90 NNT for death from CVD event is 172 Serious adverse events occur more frequently in intensive than standard

Appendix

Journal Club PresentationSlide Number 2Background and RationaleSlide Number 4OutlineObjectiveMethodsMethodsStudy EligibilityStudy eligibilityOutcomeAdditional outcomesPre-specified subgroup of interestFollow upSlide Number 15Slide Number 16Slide Number 17Slide Number 18Slide Number 19Statistical AnalysisResultsSlide Number 22Slide Number 23Slide Number 24Slide Number 25Slide Number 26Slide Number 27Slide Number 28Slide Number 29ConclusionSlide Number 31Are the results of the trial valid?Slide Number 33Slide Number 34Slide Number 35Slide Number 36Slide Number 37Slide Number 38Slide Number 39Will the results help me in caring for my patient? (External Validity/Applicability)Slide Number 41AppendixSlide Number 43Slide Number 44Slide Number 45Slide Number 46Slide Number 47