ESPIRIT: Intensive blood pressure control lowers MACE vs Standard Treatment

By Lucas Marinacci on

Key Points

  • This randomized trial of 11255 patients in China with established CVD or at least 2 CVD risk factors but without a significantly reduced ejection fraction or advanced kidney disease (mean age ~65 years, 100% Asian, baseline SBP 147, 39% with diabetes, 27 % with stroke) found that a blood pressure target of <120 led to a 12% reduction in major vascular events, 39% reduction in cardiovascular mortality, and 21% reduction in all-cause mortality compared to a blood pressure target of <140.
  • This was the first major randomized trial to show benefit of aggressive blood pressure in those with prior stroke, diabetes, or Asian ancestry.  

While strong evidence exists that lowering blood pressure reduces the risk of major adverse cardiovascular events, especially among those with high baseline risk, how aggressive our target should be remains unclear, especially for Asian patients and patients with diabetes or prior stroke.

On November 12, 2023 the results of  “ESPIRT: Effects Of Intensive Blood Pressure Lowering Treatment In Reducing Risk Of Cardiovascular Events” were presented at AHA Scientific Sessions 2023.

This open-label randomized controlled trial compared a systolic blood pressure (SBP) target of <120mmHg to a target of <140mmHg.  Patients must have been >=50 years with an SBP 130-180 and at increased risk of cardiovascular disease (CVD), defined as established CVD or at least 2 major risk factors.  Patients with secondary causes of hypertension, SBP <110 mmHg after 1 minutes of standing, left ventricular ejection fraction (EF) < 35% or estimated glomerular filtration rate <45/ml/min/1.73m were excluded.  The primary outcome was a composite of myocardial infarction (MI), revascularization, heart failure hospitalization (HFH), stroke, or CV death.  

Of the 16329 screened, 11255 were randomized in total, 5624 to the intensive treatment arm and 5621 to the standard treatment arm and followed for a median of 3.4 years.  There was minimal treatment discontinuation and loss to follow up.  Both groups were 100% Asian and 41% female and were well balanced in clinical characteristics, with a mean age of 65, mean SBP of 147, and 39% with prior diabetes, and 27% with prior stroke.   Notably, the SPRINT trial had <2% Asian participants and no patients with stroke or diabetes.  

At 1 year, the mean SBP in the intensive group was 120.3 mmHg and 135.6mmHg in the standard group.  The risk of the primary outcome composite was significantly lower in the intensive arm (HR 0.88, 95% CI 0.78,0.99; NNT =74), as was the risk of cardiovascular death (HR 0.61, 95% CI 0.44,0.84) all-cause death (HR 0.79, 95% CI 0.64,0.97; NNT = 132).  The intensive arm showed a consistent treatment effect of benefit or trend towards benefit in pre-specified subgroups, including those with a history of stroke or diabetes.  The intensive arm was associated with significantly greater risk of syncope (0.4% vs 0.1%, HR 3.00, P <0.05) or emergency visit for hypotension (0.3% vs 0.1%, HR 3.40, P <0.05),  

Dr. Jing Li of the National Center for Cardiovascular Disease in China concluded: “Our study generates new evidence about the benefit and safety of treatment targeting SBP below 120 among a diverse Asian population, which is generally consistent with those from other ethnicities. When 1000 such patients are treated targeting SBP below 120 mm Hg rather than below 140 mm Hg for 3 years, 14 major vascular events and 8 deaths will be further prevented. Meanwhile, 3 patients will experience serious adverse event of syncope.”