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SPRINT FROM @NEJM
BP TARGET < 120 VS < 140 MM HG
Daniel Schwartz, MD Nov 13, 2015
BP TARGETS
THEY KEEP CHANGING
WHAT’S YOUR
TARGET?
BACKGROUND
WHY TREAT HYPERTENSION
▸ Treatment to reduce elevated blood pressure can lead to reduction
in
▸ coronary artery...
BACKGROUND
OBSERVATIONAL
▸ Observational studies
▸ linear relationship between blood pressure and
cardiovascular risk down...
BACKGROUND
CURRENT CHEP GUIDELINES: BP TARGETS
▸ <130/80 mm Hg: Diabetes
▸ <150 mm Hg systolic: >80 years
▸ <140/90: All e...
BACKGROUND
IN DIABETES
▸ Action to Control Cardiovascular Risk in Diabetes
(ACCORD) trial
▸ Systolic BP < 120 mm Hg vs <14...
TRIAL
METHODOLOGY
TRIAL
TRIAL DESIGN
▸ randomized, controlled, open-label trial
▸ multicenter
▸ randomization stratified by site
▸ blinded ou...
TRIAL
FUNDING
▸ NIH
▸ no industry funds
TRIAL
INCLUSION
▸ age >= 50 years
▸ Systolic blood pressure
▸ 130 – 180 mm Hg on 0 or 1 medication
▸ 130 – 170 mm Hg on up...
TRIAL
EXCLUSION
▸ Diabetes
▸ Hx of stroke
▸ An indication for a specific BP lowering medication
▸ Secondary hypertension
▸ ...
TRIAL
INTERVENTION
▸ BP target <140 vs 120
▸ Treatment algorithm
▸ lifestyle
▸ drugs
TRIAL
PRIMARY OUTCOME
▸ Composite
▸ myocardial infarction
▸ acute coronary syndrome
▸ stroke
▸ acute decompensated heart f...
RESULTS
RESULTS
STOPPED EARLY
▸ 9361 patients enrolled
▸ Aug 20, 2015 - terminated early due to improved outcome
with intensive ta...
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 H...
RESULTS
RESULTS
▸ Intensive-treatment
▸ 25% RRR of major
cardiovascular events (95% CI,
11 to 36)
▸ 27% RRR of death (95% ...
RESULTS
NNT
TO PREVENT
A PRIMARY OUTCOME EVENT: 61
DEATH FROM ANY CAUSE: 90


DEATH FROM CARDIOVASCULAR
CAUSES: 172



OVE...
RESULTS
SERIOUS ADVERSE EVENTS
▸ Intensive arm: 4.7%

vs
▸ Standard arm: 2.5% serious adverse events

(HR, 1.88; P<0.001)
METHODS
METHODOLOGIC ISSUES?
▸ Stopping early
▸ can overestimate benefit in small trials
▸ unlikely with > 500 primary outc...
METHODS
GENERALIZABILITY
▸ Cannot apply to those with
▸ Diabetes
▸ History of Stroke
▸ Institutionalized Elderly
▸ Advance...
METHODS
RISK VS BENEFIT
▸ Do benefits outweigh risks?
CURRENT GUIDELINES …
REQUIRE REVISION.
Vlado Perkovic, for the NEJM
TAKE AWAY
REAL WORLD
▸ BP goal of 140/90 mm Hg
▸ US: 33-50% not at target
▸ Many developing countries: >90% not at target
16.8 MILLION US ADULTS
MEET INCLUSION CRITERIA
J Am Coll Cardiol. 2015;():. doi:10.1016/j.jacc.2015.10.037
TAKE AWAY
NEPHROLOGY PRACTICE
▸ 28% had GFR 20-60 ml/min
▸ Excluded
▸ GFR < 20
▸ Proteinuria > 1gm
▸ Excluded highest risk...
TAKE AWAY
SIGNIFICANT EFFORT
▸ in SPRINT
▸ initial combination therapy
▸ monthly visits until BP at target
CLINICAL TRIALS
ARE DIFFERENT
FROM REAL LIFE
TAKE AWAY
REAL WORLD
▸ Adoption of lower BP targets would mean
▸ more cautious titration of medications
▸ more combination...
TAKE AWAY
MORE HELP
▸ People
▸ Nurse practitioners
▸ Physician assistants,
▸ Pharmacists
▸ Others?
▸ Treatment algorithms
...
TWITTER:
POLL
REFERENCES
@nephrologynow
WHAT’S YOUR
TARGET?
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015
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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.

Published in: Health & Medicine
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SPRINT, Royal Columbian Hospital Medicine rounds, Nov 10, 2015

  1. 1. SPRINT FROM @NEJM BP TARGET < 120 VS < 140 MM HG Daniel Schwartz, MD Nov 13, 2015
  2. 2. BP TARGETS THEY KEEP CHANGING
  3. 3. WHAT’S YOUR TARGET?
  4. 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. 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. 6. BACKGROUND CURRENT CHEP GUIDELINES: BP TARGETS ▸ <130/80 mm Hg: Diabetes ▸ <150 mm Hg systolic: >80 years ▸ <140/90: All else
  7. 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. 8. TRIAL
  9. 9. METHODOLOGY
  10. 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. 11. TRIAL FUNDING ▸ NIH ▸ no industry funds
  12. 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. 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. 14. TRIAL INTERVENTION ▸ BP target <140 vs 120 ▸ Treatment algorithm ▸ lifestyle ▸ drugs
  15. 15. TRIAL PRIMARY OUTCOME ▸ Composite ▸ myocardial infarction ▸ acute coronary syndrome ▸ stroke ▸ acute decompensated heart failure ▸ death from cardiovascular causes
  16. 16. RESULTS
  17. 17. RESULTS STOPPED EARLY ▸ 9361 patients enrolled ▸ Aug 20, 2015 - terminated early due to improved outcome with intensive target
  18. 18. 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
  19. 19. RESULTS RESULTS ▸ Intensive-treatment ▸ 25% RRR of major cardiovascular events (95% CI, 11 to 36) ▸ 27% RRR of death (95% CI, 10 to 40)
  20. 20. RESULTS NNT TO PREVENT A PRIMARY OUTCOME EVENT: 61 DEATH FROM ANY CAUSE: 90 
 DEATH FROM CARDIOVASCULAR CAUSES: 172
 
 OVER MEDIAN 3.26 YEARS
  21. 21. RESULTS SERIOUS ADVERSE EVENTS ▸ Intensive arm: 4.7%
 vs ▸ Standard arm: 2.5% serious adverse events
 (HR, 1.88; P<0.001)
  22. 22. 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
  23. 23. METHODS GENERALIZABILITY ▸ Cannot apply to those with ▸ Diabetes ▸ History of Stroke ▸ Institutionalized Elderly ▸ Advanced/highly proteinuric CKD
  24. 24. METHODS RISK VS BENEFIT ▸ Do benefits outweigh risks?
  25. 25. CURRENT GUIDELINES … REQUIRE REVISION. Vlado Perkovic, for the NEJM
  26. 26. TAKE AWAY REAL WORLD ▸ BP goal of 140/90 mm Hg ▸ US: 33-50% not at target ▸ Many developing countries: >90% not at target
  27. 27. 16.8 MILLION US ADULTS MEET INCLUSION CRITERIA J Am Coll Cardiol. 2015;():. doi:10.1016/j.jacc.2015.10.037
  28. 28. TAKE AWAY NEPHROLOGY PRACTICE ▸ 28% had GFR 20-60 ml/min ▸ Excluded ▸ GFR < 20 ▸ Proteinuria > 1gm ▸ Excluded highest risk for progression to ESRD
  29. 29. TAKE AWAY SIGNIFICANT EFFORT ▸ in SPRINT ▸ initial combination therapy ▸ monthly visits until BP at target
  30. 30. CLINICAL TRIALS ARE DIFFERENT FROM REAL LIFE
  31. 31. 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)
  32. 32. TAKE AWAY MORE HELP ▸ People ▸ Nurse practitioners ▸ Physician assistants, ▸ Pharmacists ▸ Others? ▸ Treatment algorithms ▸ Algorithmic monitoring/EHRs?
  33. 33. TWITTER: POLL REFERENCES @nephrologynow
  34. 34. WHAT’S YOUR TARGET?

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