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Dawn M. Bravata, MD; Nancy Kim, MD; John Concato, MD, MPH; Harlan M. Krumholz, MD, MSc; Lawrence M. Brass, MD

Arch Intern Med. 2002;162:1994-2001.

Background  Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation.

Objectives  To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events.

Methods  Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort).

Results  Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P = .01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P = .001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P = .002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P = .001).

Conclusions  Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of in-hospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.

From the Departments of Internal Medicine (Drs Bravata, Kim, and Concato), Cardiology (Dr Krumholz), and Neurology (Dr Brass), Yale University School of Medicine, New Haven, Conn, and the Veterans Affairs Connecticut Healthcare System (Drs Bravata, Concato and Brass), West Haven.

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