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Real World Outcomes after Intra-Arterial Thrombolysis

a PSC Small Fund Research Project

Investigator:   James F. Burke

Background: Stroke is a leading cause of death and disability in the United States and an increasingly important cause of death and disability in the developing world. The only approved medication for treating acute stroke, intra-venous tissue plasminogen activator (tPA) is effective, but only a small percentage of patients receive the treatment, largely because of the narrow time window of efficacy. Intra-arterial (IA) thrombolysis has the potential to deliver stroke treatment to more patients by extending the time window of efficacy.

While IA thrombolysis is promising there are limited data to support its efficacy, particularly for recently approved devices that have not undergone randomized clinical trials. Furthermore, recent revisions to the Medicare Diagnosis Related Group (DRG) based payment system have created financial incentives for hospitals to adopt IA practices. Given that little is known about patient selection for IA thrombolysis, this incentive could lead to IA utilization in patients unlikely to benefit. Consequently, it is unclear whether the benefits generated by IA clinical trials will translate into a broader clinical context.

Specific Aims:
1. Describe temporal trends in utilization and patient selection (age, race, ethnicity, gender) for intra-arterial-thrombolysis.
2. Compare 90-day and one-year mortality of intra-arterial thrombolysis in Medicare beneficiaries to mortality in clinical trials.
3. Describe all-cause rehospitalization and number of outpatient visits in Medicare beneficiaries treated with intra-arterial thrombolysis.

Methods: The study population will consist of all stroke patients admitted from the emergency department with a primary ICD-9-CM discharge diagnosis of stroke. IA procedures will be identified using Medicare data and we will establish 90-day and one-year mortality by linking to the Medicare Denominator file.

Funding Period: 02/01/2011 to 06/30/2012

Country of Focus: USA

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