IV tPA in Patients With Prior Stroke Plus Diabetes

Study Questions:

What are the characteristics and outcomes among patients with acute ischemic stroke treated with intravenous (IV) tissue-type plasminogen activator (tPA), who had a history of stroke plus diabetes mellitus (HxS+DM)?

Methods:

The investigators used data from the Get With The Guidelines–Stroke Registry between February 2009 and September 2017 (n = 1,619 hospitals) to examine characteristics and outcomes among patients with acute ischemic stroke treated with IV tPA within the 3- to 4.5-hour window who had a history of stroke plus diabetes mellitus (HxS+DM) (n = 2,129) vs. those without either history (n = 16,690). Multivariable logistic regression modeling was performed to evaluate the association between HxS+DM and in-hospital outcomes including symptomatic intracerebral hemorrhage (sICH), in-hospital mortality, serious and life-threatening hemorrhage, modified Rankin Scale (mRS) score at discharge, ambulatory status, and discharge disposition.

Results:

Compared with patients without either history, those with both prior stroke and DM treated with IV tPA after an acute ischemic stroke had a higher prevalence of cardiovascular risk factors in addition to history of stroke, DM, and more severe stroke (National Institutes of Health Stroke Scale score: median, 8 [interquartile range, 5–15] vs. 7 [4–13]). The unadjusted rates of sICH and in-hospital mortality were 4.3% (HxS+DM) vs. 3.8% (without either history; p = 0.31) and 6.2% vs. 5.5% (p = 0.20), respectively. These differences were not statistically significant after risk adjustment (sICH: adjusted odds ratio, 0.79; 95% confidence interval [CI], 0.51–1.21; p = 0.28; in-hospital mortality: odds ratio, 0.77; 95% CI, 0.52–1.14; p = 0.19). Unadjusted rate of functional independence (mRS score, 0–2) at discharge was lower in those with HxS+DM (30.9% HxS+DM vs. 44.8% without either history; p ≤ 0.0001), and this difference persisted after adjusting for baseline clinical factors (adjusted odds ratio, 0.76; 95% CI, 0.59–0.99; p = 0.04).

Conclusions:

The authors concluded that among patients with acute ischemic stroke treated with IV tPA within the 3- to 4.5-hour window, HxS+DM was not associated with statistically significant increased sICH or mortality risk.

Perspective:

This registry study reports that a combined history of stroke and concomitant DM as compared with healthier controls was not associated with increased risk of sICH or death when treated with IV tPA in the 3- to 4.5-hour window. However, patients with HxS+DM were less likely to be able to ambulate and function independently at discharge. Patients with a combined history of stroke and concomitant DM were excluded from prior clinical trials because of concern for increased risk of sICH or death and potential decreased clinical benefit, but given the current data, it appears reasonable to consider thrombolytic treatment in the 3- to 4.5-hour window for patients with HxS+DM.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism

Keywords: Brain Ischemia, Cerebral Hemorrhage, Diabetes Mellitus, Fibrinolytic Agents, Hospital Mortality, Metabolic Syndrome, Primary Prevention, Risk Factors, Stroke, Tissue Plasminogen Activator, Thrombolytic Therapy, Vascular Diseases


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