New Rationale Statement for tPA Inclusion and Exclusion Criteria

Each year, approximately 800,000 individuals in the United States experience a stroke, and more than 690,000 of those strokes are caused by decreased perfusion to an area of the brain because of a blood clot. This critical and life-threatening emergency requires urgent medical attention to prevent further damage to the brain.^1,2

The American Heart Association (AHA) and American Stroke Association (ASA) have partnered with hospitals nationwide to participate in the “Get with the Guidelines” initiative, which stresses the importance of maintaining the window of eligibility to administer tissue plasminogen activator (tPA).

During a stroke, every minute without treatment equates to the loss of close to 2 million neurons. tPA lyses the blood clot, returning blood flow to the brain to prevent further injury and neurological deficit.^3,4

The Joint Commission and AHA/ASA promote a 60-minute window for tPA administration from the time a stroke patient arrives at the emergency department. However, data collected by the “Get with the Guidelines” database demonstrated that only 5% to 8% of stroke patients had fallen within this tPA-eligible time period. In addition, only 77% of tPA-eligible patients were actually given tPA within the allotted time frame.

Many clinicians attribute this to the stringent inclusion and exclusion criteria associated with tPA use.^4,5

Stroke experts consider some of the exclusion criteria and/or contraindications to be relative, while others may be considered absolute. Research has even shown broad variation in what stroke experts would or would not treat.

The new AHA/ASA statement on the rationale for tPA inclusion and exclusion criteria is meant to serve as a guideline for practitioners to maximize the benefit of thrombolysis in stroke patients. The statement places a strong emphasis on ensuring that the therapeutic benefit of tPA outweighs its risks. In fact, each adverse event outlined in the statement has been evaluated for substantial evidence behind the possibility of its occurrence.⁵

The new recommendations allow for the use of tPA in elderly patients aged 80 years or older, although there is a greater risk for adverse events in this population. Patients with diabetes, hyperglycemia, and hypoglycemia are also now eligible for tPA. Lastly, patients with prior but not recent intracranial hemorrhage may also be considered based on clinician discretion and risk-benefit ratio.

These updates warrant several future studies assessing the safety and efficacy in expanding the use of tPA in different patient populations. The most intriguing recommendation is the use of multimodal cerebral imaging to identify candidates for tPA with the development of a “tissue clock,” which would assess tissue viability as opposed to a subjective time frame.

With newer technology and more data, the goal is to ensure that all stroke patients who are eligible for tPA actually receive it.⁵

References

• Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics—2016 Update A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-e360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16.
• American Heart Association, American Stroke Association. Advanced stroke treatment: attacking brain clots to save lives. http://www.strokeassociation.org/idc/groups/stroke-public/@wcm/@hcm/@sta/documents/downloadable/ucm_475781.pdf. Accessed February 20. 2016.
• Nguyen VV, Wong BM, Shen DD, Woo DT, Vu AV, Lie JD. Early management of acute ischemic stroke: focus on IV tPA and timely reperfusion. US Pharm. 2016:41(1)HS9-HS12.
• American Heart Association. Stroke fact sheet. http://www.heart.org/idc/groups/heart-public/@wcm/@gwtg/documents/downloadable/ucm_310976.pdf. Accessed February 20, 2016.
• Demaerschak BM, Kleindorfer DO, Adeyoe OM, et al. Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke—a statement for healthcare professionals from the AHA/ASA. Stroke. 2016;47:00-00. doi: 10.1161/STR.0000000000000086. Epub 2015 Dec 22.