SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
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We discussed the recently published SPRINT trial, which compared a BP systolic target of <140><120 mm Hg in patients with hypertension.
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SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
- 1. SPRINT FROM @NEJM BP TARGET < 120 VS < 140 MM HG Daniel Schwartz, MD Nov 13, 2015
- 2. BP TARGETS THEY KEEP CHANGING
- 4. BACKGROUND WHY TREAT HYPERTENSION ▸ Treatment to reduce elevated blood pressure can lead to reduction in ▸ coronary artery disease (CAD) ▸ congestive heart failure ▸ stroke ▸ chronic kidney disease irrespective of age, sex, race or ethnic background and HTN severity
- 5. BACKGROUND OBSERVATIONAL ▸ Observational studies ▸ linear relationship between blood pressure and cardiovascular risk down to 115/75 mm Hg ▸ J-curve - is it confounded?
- 6. BACKGROUND CURRENT CHEP GUIDELINES: BP TARGETS ▸ <130/80 mm Hg: Diabetes ▸ <150 mm Hg systolic: >80 years ▸ <140/90: All else
- 7. BACKGROUND IN DIABETES ▸ Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial ▸ Systolic BP < 120 mm Hg vs <140 mm Hg ▸ no difference in cardiovascular events in DM2
- 8. TRIAL
- 9. METHODOLOGY
- 10. TRIAL TRIAL DESIGN ▸ randomized, controlled, open-label trial ▸ multicenter ▸ randomization stratified by site ▸ blinded outcome adjudicators (patients/researchers not blinded) ▸ primary analysis compared time to 1st occurrence of primary outcome event with intention-to-treat ▸ independent data and safety monitoring board monitored unblinded trial results and safety events
- 11. TRIAL FUNDING ▸ NIH ▸ no industry funds
- 12. TRIAL INCLUSION ▸ age >= 50 years ▸ Systolic blood pressure ▸ 130 – 180 mm Hg on 0 or 1 medication ▸ 130 – 170 mm Hg on up to 2 medications ▸ 130 – 160 mm Hg on up to 3 medications ▸ 130 – 150 mm Hg on up to 4 medications ▸ increased risk of cardiovascular events ▸ clinical or subclinical cardiovascular disease other than stroke ▸ CKD excluding polycystic kidney disease (eGFR 20-60) ▸ 10-year risk of cardiovascular disease >= 15% (Framingham) ▸ age >= 75 years
- 13. TRIAL EXCLUSION ▸ Diabetes ▸ Hx of stroke ▸ An indication for a specific BP lowering medication ▸ Secondary hypertension ▸ Orthostatic BP < 110 ▸ PKD, GN needing immunosuppression ▸ >1gm/day proteinuria ▸ EF < 35% ▸ Recent heart failure < 6 months, cardiac event < 3 months
- 14. TRIAL INTERVENTION ▸ BP target <140 vs 120 ▸ Treatment algorithm ▸ lifestyle ▸ drugs
- 15. TRIAL PRIMARY OUTCOME ▸ Composite ▸ myocardial infarction ▸ acute coronary syndrome ▸ stroke ▸ acute decompensated heart failure ▸ death from cardiovascular causes
- 16. RESULTS
- 17. RESULTS STOPPED EARLY ▸ 9361 patients enrolled ▸ Aug 20, 2015 - terminated early due to improved outcome with intensive target
- 20. RESULTS BLOOD PRESSURES ▸ Baseline ▸ 139.7/78.2 mm Hg (intensive) ▸ 139.7/78.0 mm Hg (standard) ▸ 1 year ▸ 121.4/68.7 mm Hg (intensive) with 2.8 meds ▸ 136.2/76.3 mm Hg (standard) with 1.8 meds
- 21. RESULTS RESULTS ▸ Intensive-treatment ▸ 25% RRR of major cardiovascular events (95% CI, 11 to 36) ▸ 27% RRR of death (95% CI, 10 to 40)
- 23. RESULTS NNT TO PREVENT A PRIMARY OUTCOME EVENT: 61 DEATH FROM ANY CAUSE: 90 DEATH FROM CARDIOVASCULAR CAUSES: 172 OVER MEDIAN 3.26 YEARS
- 24. RESULTS SERIOUS ADVERSE EVENTS ▸ Intensive arm: 4.7% vs ▸ Standard arm: 2.5% serious adverse events (HR, 1.88; P<0.001)
- 26. METHODS METHODOLOGIC ISSUES? ▸ Stopping early ▸ can overestimate benefit in small trials ▸ unlikely with > 500 primary outcome events ▸ Lack of blinding (BP can be measured) ▸ mitigated by structured assessment of outcomes and adverse events
- 27. METHODS GENERALIZABILITY ▸ Cannot apply to those with ▸ Diabetes ▸ History of Stroke ▸ Institutionalized Elderly ▸ Advanced/highly proteinuric CKD
- 28. METHODS RISK VS BENEFIT ▸ Do benefits outweigh risks?
- 29. CURRENT GUIDELINES … REQUIRE REVISION. Vlado Perkovic, for the NEJM
- 30. TAKE AWAY REAL WORLD ▸ BP goal of 140/90 mm Hg ▸ US: 33-50% not at target ▸ Many developing countries: >90% not at target
- 31. 16.8 MILLION US ADULTS MEET INCLUSION CRITERIA J Am Coll Cardiol. 2015;():. doi:10.1016/j.jacc.2015.10.037
- 32. TAKE AWAY NEPHROLOGY PRACTICE ▸ 28% had GFR 20-60 ml/min ▸ Excluded ▸ GFR < 20 ▸ Proteinuria > 1gm ▸ Excluded highest risk for progression to ESRD
- 33. TAKE AWAY SIGNIFICANT EFFORT ▸ in SPRINT ▸ initial combination therapy ▸ monthly visits until BP at target
- 36. CLINICAL TRIALS ARE DIFFERENT FROM REAL LIFE
- 37. TAKE AWAY REAL WORLD ▸ Adoption of lower BP targets would mean ▸ more cautious titration of medications ▸ more combination treatment ▸ more care watching for adverse effects ▸ more frequent visits ▸ addressing lifestyle issues (physical activity, salt intake, obesity, sleep apnea, and alcohol use) ▸ population-level initiatives (eg sodium in food)
- 38. TAKE AWAY MORE HELP ▸ People ▸ Nurse practitioners ▸ Physician assistants, ▸ Pharmacists ▸ Others? ▸ Treatment algorithms ▸ Algorithmic monitoring/EHRs?