Hypertension in the Post SPRINT era

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Presentation transcript:

Hypertension in the Post SPRINT era Mahboob Rahman MD, MS Division of Nephrology and Hypertension University Hospitals Cleveland Medical Center Case Western Reserve University Louis Stokes Cleveland VA Medical Center Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Outline Rationale for intensive blood pressure lowering Main results of SPRINT and ACCORD Implications for practice Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

What “goal” blood pressure should you target in hypertensive patients? 2014 Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Why should we consider a lower BP goal? Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Ischemic Heart Disease Mortality Rate in Each Decade of Age SBP DBP Age at risk: 256 256 80-89 y 128 128 70-79 y 64 64 60-69 y 32 32 IHD mortality (absolute risk and 95% CI) 50-59 y 16 16 40-49 y 8 8 4 4 2 2 1 1 120 140 160 180 70 80 90 100 110 Usual SBP (mm Hg) Usual DBP (mm Hg) Lancet. 2002;360:1903-1913. Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

POTENTIAL COSTS / RISKS OF LOWER BP TARGETS Increased cost of medications Increased risk of medication side effects Increased clinic visits Increased monitoring required Potential increased risk of lower BP goals Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

SPRINT Research Question Examine effect of more intensive high blood pressure treatment than is currently recommended Randomized Controlled Trial Intensive Treatment Goal SBP < 120 mm Hg Standard Treatment Goal SBP < 140 mm Hg Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Major Exclusion Criteria Stroke Diabetes mellitus Polycystic kidney disease Congestive heart failure (symptoms or EF < 35%) Proteinuria >1g/d CKD with eGFR < 20 mL/min/1.73m2 Adherence concerns Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Location of 102 SPRINT Clinical Centers Clinical Center Networks -Ohio -Southeast -Utah -UAB -VA Central Laboratory MRI Reading Center Project Office, NIH Coordinating Center Wake Forest School of Medicine ECG Reading Center Drug Distribution Center Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Demographic and Baseline Characteristics Total N=9361 Intensive N=4678 Standard N=4683 Mean (SD) age, years 67.9 (9.4) 67.9 (9.5) % ≥75 years 28.2% Female, % 35.6% 36.0% 35.2% White, % 57.7% African-American, % 29.9% 29.5% 30.4% Hispanic, % 10.5% 10.8% 10.3% Prior CVD, % 20.1% 20.0% Taking antihypertensive meds, % 90.6% 90.8% 90.4% Mean (SD) number of antihypertensive meds 1.8 (1.0) Mean (SD) Baseline BP, mm Hg Systolic 139.7 (15.6) 139.7 (15.8) 139.7 (15.4) Diastolic 78.1 (11.9) 78.2 (11.9) 78.0 (12.0) Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Systolic BP During Follow-up Average SBP (During Follow-up) Standard: 134.6 mm Hg Intensive: 121.5 mm Hg Standard Intensive Average number of antihypertensive medications Number of participants Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Decision to Stop BP Intervention On August 20th, 2015, after 3.2 years of follow up, NHLBI Director accepted DSMB recommendation to inform SPRINT investigators and participants of CVD results Concurrently, decision made to stop BP intervention Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

SPRINT Primary Outcome Results Hazard Ratio = 0.75 (95% CI: 0.64 to 0.89) Standard (319 events) 25% Lower risk of CV events Intensive (243 events) Number of Participants Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

All-cause Mortality Standard Intensive 27% Lower risk of mortality Hazard Ratio = 0.73 (95% CI: 0.60 to 0.90) 27% Lower risk of mortality Standard (210 deaths) Intensive (155 deaths) Number of Participants Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253. Intensive

Primary Outcome in Pre-specified Subgroups *Treatment by subgroup interaction Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Serious Adverse Events* (SAE) All SAE reports % of Participants Intensive Standard HR (P Value) 38.3 37.1 1.04 (0.25) Hypotension 2.4 1.4 1.67 (0.001) Syncope 2.3 1.7 1.33 (0.05) Injurious fall 2.2 0.95 (0.71) Bradycardia 1.9 1.6 1.19 (0.28) Electrolyte abnormality 3.1 1.35 (0.02) Acute kidney injury 4.1 2.5 1.66 (<0.001) Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Number (%) of Participants Intensive Standard HR (P Value) Number (%) of Participants Intensive Standard HR (P Value) Signs and Symptoms Orthostatic hypotension2 16.6 18.3 0.88 (0.013) Orthostatic hypotension with dizziness 1.3 1.5 0.85 (0.35) Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

What about BP goals in diabetic patients? Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

ACCORD BP-Lowering: Reduction of SBP to <120 mmHg significantly Reduces the Rate of STROKE Intensive Therapy (n = 2363) Standard Therapy (n = 2371) Outcome Number of Events %/Year Hazard Ratio (95% CI) P Value Primary outcome* 208 1.87 237 2.09 0.88 (0.73-1.06) 0.20 Prespecified secondary outcomes Nonfatal MI 126 1.13 146 1.28 0.87 (0.68-1.10) 0.25 Any stroke 36 0.32 62 0.53 0.59 (0.39-0.89) 0.01 Nonfatal stroke 34 0.30 55 0.47 0.63 (0.41-0.96) 0.03 Death from any cause 150 144 1.19 1.07 (0.85-1.35) 0.55 Death from CV cause 60 0.52 58 0.49 1.06 (0.74-1.52) 0.74 Primary outcome plus revascularization or nonfatal heart disease 521 5.10 551 5.31 0.95 (0.84-1.07) 0.40 Major coronary disease event† 253 2.31 270 2.41 0.94 (0.79-1.12) 0.50 Fatal or nonfatal heart failure 83 0.73 90 0.78 0.94 (0.70-1.26) 0.67 *Primary outcome: composite of nonfatal MI, nonfatal stroke, or death from CV causes †Major coronary disease events included fatal coronary events, nonfatal MI, and unstable angina ACCORD: Action to Control Cardiovascular Risk in Diabetes Study The ACCORD Study Group. N Engl J. Med. 2010;doi: 10.1056/NEJMoa1001286. Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Antihypertensive meds Primary outcome ACCORD SPRINT Patient Population All diabetic CKD excluded All non-diabetic Older, CKD Interventions 3 (factorial design) 1 Sample size 4733 9200 Event rate 2-2.2% per year (lower than expected) 1.6-2% (as expected) Antihypertensive meds More HCTZ More chlorthalidone Primary outcome CVD Death, Non-fatal MI, Nonfatal stroke MI, ACS, Stroke HF CVD death Main results HR 0.88 (0.73 to 1.06), p=0.2 HR 0.75 (0.64 to 0.89) p<0.05) Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Perkovic B and Rodgers A. N Engl J Med. 2015;373:2175-2178. Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

SPRINT OUTCOMES IN PREDIABETICS VS. NORMOGLYCEMICS Incidence rates and hazard ratios for study outcomes by treatment arm among those with normoglycemia and prediabetes at baseline Outcome Normoglycemia FSG < 100 mg/dL Prediabetes FSG ≥ 100 mg/dL P for Interaction Intensive (n=2,721) Standard (n=2,704) Hazard Ratio (95% CI) (n=1,941) (n=1,957) Primary outcome 142 (1.7) 174 (2.1) 0.83 (0.66-1.03) 101 (1.6) 144 (2.3) 0.69 (0.53-0.89) 0.30 MI 57 (0.7) 72 (0.8) 0.80 (0.57-1.14) 40 (0.6) 44 (0.7) 0.95 (0.61-1.45) 0.56 ACS 23 (0.3) 17 (0.2) 1.32 (0.7-2.47) 17 (0.3) 23 (0.4) 0.76 (0.4-1.44) 0.23 Stroke 36 (0.4) 32 (0.4) 1.19 (0.73-1.91) 26 (0.4) 38 (0.6) 0.72 (0.44-1.20) 0.16 Heart failure 37 (0.4) 52 (0.6) 0.72 (0.47-1.10) 25 (0.4) 48 (0.8) 0.47 (0.29-0.76) 0.19 CVD Death 21 (0.2) 0.62 (0.36-1.06) 16 (0.3) 27 (0.4) 0.56 (0.3-1.04) 0.81 All-cause Death 89 (1.0) 125 (1.4) 0.71 (0.54-0.94) 65 (1) 84 (1.3) 0.77 (0.55-1.06) 0.74 All SEAs 1052 (38.7) 1000 (37.0) 1.06 (0.97-1.15) 737 (38) 733 (37.5) 1.03 (0.93-1.14) 0.67 Hypotension 61 (2.2) 44 (1.6) 1.33 (0.90-1.97) 49 (2.5) 22 (1.1) 2.38 (1.43-3.95) 0.08 Syncope 66 (2.4) 46 (1.7) 1.42 (0.97-2.07) 40 (2.1) 34 (1.7) 1.20 (0.75-1.91) 0.58 Bradycardia 51 (1.9) 41 (1.5) 1.20 (0.79-1.81) 36 (1.9) 32 (1.6) 1.10 (0.67-1.78) 0.79 Electrolyte abnrm 88 (3.2) 60 (2.2) 1.45 (1.04-2.02) 56 (2.9) 47 (2.4) 1.17(0.79-1.74) 0.41 Numbers are counts and annual rates. CVD=cardiovascular disease, CI= Confidence interval, FSG= Fasting serum glucose, ACE =acute coronary syndrome, abnrm=abnormality, MI=myocardial infarction Bress A, Beddhu S, King J, et al. Intensive blood pressure control reduces cardiovascular events in patients with prediabetes. Presented at: American Diabetes Association 77th Scientific Sessions; June 9-13, 2017. Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

American Heart Association guidelines to be released this year Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

So what does all this mean? Ensure standard practices for measuring BP in the office The field is moving toward more intensive blood pressure lowering New guidelines will likely recommend lower goals Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Clinicians need to discuss risks benefits with individual participants Appreciate that tighter blood pressure control will require more medications, office visits and cost Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Policy makers and health care systems will have to consider costs of lowering blood pressure in balance with long term lowering of cardiovascular risk Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.

Thank you Confidential Quality Assurance Peer Review Report Privileged Pursuant to O.R.C. Sections 2305.24, 2305.25, 2305.251, 2305.252, and 2305.253.