In patients with acute ischemic stroke who have not received thrombolysis or thrombectomy, early antihypertensive treatment compared with delayed antihypertensive treatment did not reduce the likelihood of death and major disability at 3 months in the CATIS-2 trial.
The trial was presented by Liping Liu, MD, Beijing Tiantan Hospital, China, on February 10 at the International Stroke Conference (ISC) 2023 in Dallas, Texas.
“Antihypertensive treatment can be delayed for at least 7 days following ischemic stroke onset, unless there are severe acute comorbidities that demand emergency blood pressure reduction to prevent serious complications,” Liu concluded.
But he acknowledged that the optimal blood pressure management strategy in these patients remains uncertain and should be the focus of future research.
Discussing the trial at an ISC 2023 Highlights session, Lauren Sansing, MD, Yale University School of Medicine, New Haven, Connecticut, and ISC program vice chair, said: “These results seem to support waiting for a week or so before treating blood pressure in these patients.”
But Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, New Jersey, and ISC program chair, countered: “To me, it’s kind of a neutral result, so what I take home from this is that you don’t necessarily have to wait.”
Jovin continued, “We used to think that it was mandatory not to treat blood pressure early because of the risk of deceasing the perfusion pressure, but this trial suggests the effects are neutral and there is probably as much benefit from lowering blood pressure for other reasons that offsets the potential harm.
“I think these are good data to rely on when we make these kinds of treatment decisions. Personally, I am a bit more aggressive with early blood pressure management and it’s good to see that you don’t get punished for that,” he added.
Optimal Strategy Controversial
In his presentation, Liu explained that increased blood pressure is common in acute stroke and is strongly associated with poor functional outcome and recurrence of ischemic stroke, but the optimal blood pressure management strategy in acute ischemic stroke remains controversial.
In the first CATIS trial (China Antihypertensive Trial in Acute Ischemic Stroke), which compared antihypertensive treatment within 48 hours of stroke onset with no antihypertensive treatment in ischemic stroke patients not receiving thrombolysis, the main results suggested that blood pressure reduction with antihypertensive medications did not reduce the likelihood of death and major disability at 14 days or hospital discharge. But a subgroup analysis found that initiating antihypertensive treatment between 24 and 48 hours of stroke onset showed a beneficial effect on reducing death or major disability.
Current AHA/ASA guidelines suggest that in patients with blood pressure > 220/120 mm Hg who have not received thrombolysis or thrombectomy and have no comorbid conditions requiring urgent antihypertensive treatment, the benefit of initiating or re-initiating antihypertensive treatment within the first 48 to 72 hours is uncertain, although the guidelines say it might be reasonable to lower blood pressure by around 15% during the first 24 hours after stroke onset, Liu noted.
The CATIS-2 trial was a multicenter, randomized, open-label, blinded-endpoints trial conducted at 106 centers in China that enrolled 4810 patients within 24 to 48 hours of onset of acute ischemic stroke who had elevated blood pressure. Patients had not received thrombolytic therapy or mechanical thrombectomy.
Patients were randomly assigned to early antihypertensive therapy (initiated after randomization and aiming for a 10% to 20% reduction in systolic blood pressure) or delayed antihypertensive therapy (restarted antihypertensive therapy on day 8 of randomization, aiming for a blood pressure of < 140/90 mm Hg).
The median age of the patients was 64 years, 65% were male, 80% had a history of hypertension, and the median National Institutes of Health Stroke Scale score was 3. Baseline blood pressure averaged 163/92 mm Hg in both groups. The median time from stroke onset to antihypertensive treatment was 1.5 days in the early group and 8.5 days in the delayed group.
Blood pressure results showed that at 24 hours after randomization, mean systolic pressure was reduced by 16.4 mm Hg (9.7%) in the early-treatment group and by 8.6 mm Hg (4.9%) in the delayed-treatment group (difference, –7.8 mm Hg; P < .0001).
At day 7, mean systolic pressure was 139.1 mm Hg in the early-treatment group compared to 150.9 mm Hg in the delayed-treatment group, with a net difference in systolic BP of –11.9 mm Hg (P < .0001).
The primary outcome was the composite of death and major disability (mRS ≥ 3) at 3 months. This did not differ between the groups, occurring in 12.1% in the early antihypertensive treatment group vs 10.5% in the delayed antihypertensive treatment group (risk ratio, 1.15; P = .08).
There was also no difference in the major secondary outcome of shift in scores of mRS at 3 months, with a common odds ratio of 1.05 (95% CI, 0.95 – 1.17).
There was no interaction with the composite outcome of death or major disability at 90 days in the prespecified subgroups.
Liu pointed out several limitations of the study. These included an observed primary outcome rate substantially lower than expected; the blood pressure reduction seen within the first 7 days in the early-treatment group was moderate; and the results of the study cannot be applied to patients treated with thrombolysis or thrombectomy.
Liu has disclosed no relevant financial relationships.
International Stroke Conference 2023: Presentation LB19. Presented February 10, 2023.
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