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STREAM: Fibrinolysis Strategy Effective for STEMI Patients Far From PCI Hospital

By Yael L. Maxwell

SAN FRANCISCO, CA—Prehospital fibrinolysis with timely coronary angiography results in equally effective reperfusion compared with primary percutaneous coronary intervention (PCI) in patients presenting early after ST-segment elevation myocardial infarction (STEMI) who are unable to undergo prompt primary PCI after first medical contact, according to results presented on March 10, 2013, at the American College of Cardiology Scientific Session/i2 Summit. The study, published simultaneously in the New England Journal of Medicine, however, found that fibrinolysis is associated with a slightly increased risk of intracranial bleeding.

For the STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial, Frans Van de Werf, MD, PhD, of Katholieke Universiteit Leuven (Leuven, Belgium), and colleagues looked at 1,892 STEMI patients who presented within 3 hours of symptom onset and who were unable to undergo primary PCI within 1 hour of medical contact. Patients from 99 institutions in 15 countries were randomized to either primary PCI (n = 948) or fibrinolytic therapy with bolus tenecteplase (half dose in patients older than 75 years amended midway through the study), clopidogrel, and enoxaprin (n = 944) before transport to a PCI-capable hospital from March 19, 2008 to September 7, 2012. 

At 30 days, there was no difference in the primary composite endpoint (all-cause death, shock, congestive heart failure, or reinfarction) between patients in the fibrinolysis (12.4%) and primary PCI (14.3%) groups (RR 0.86; 95% CI 0.68-1.09; P = 0.21). 

Cardiogenic shock and congestive heart failure were slightly more common in the primary PCI arm, but other clinical endpoints were similar regardless of treatment (table 1). The results were maintained in an analysis of multiple prespecified subgroups.

Table 1. Clinical Endpoints at 30 Days

 

 

Fibrinolysis
(n = 944)

Primary PCI
(n = 948)

P Value

All-cause Death

4.6%

4.4%

0.88

Cardiac Death

3.3%

3.4%

0.92

Congestive Heart Failure

6.1%

7.6%

0.18

Cardiogenic Shock

4.4%

5.9%

0.13

Reinfarction

2.5%

2.2%

0.74

Rehospitalization for Cardiac Reason

4.8%

4.3%

0.64


Emergency angiography was performed in 36.3% of patients in the fibrinolysis group, while the remainder of patients underwent angiography at a median 17 hours after randomization.

Rates of stroke were low in each study group, but intracranial hemorrhage was more common in the fibrinolysis group compared with those treated with primary PCI (1.0% vs. 0.2%; P = 0.05; after protocol amendment 0.5% vs. 0.3% P = 0.45). Rates of nonintracranial bleeding were 6.5% in the fibrinolysis group and 4.8% in the primary PCI group (P = 0.11).

Will Change Practice, But Not Guidelines 

“Fibrinolysis with bolus tenecteplase and contemporary antithrombotic therapy given before transport to a PCI-capable hospital coupled with timely angiography circumvents the need for urgent procedures in about two-thirds of fibrinolytic-treated STEMI patients, is associated with a small increase of intracranial bleeding, but is as effective as primary PCI in these patients,” Dr. Van de Werf said. 

“It’s the first trial to prove that a strategy of early fibrinolysis followed by a. . .timely angiographic strategy is as effective as PCI in patients who live far away from a PCI hospital,” said panelist Freek W. A. Verheugt, MD, of Onze Lieve Vrouwe Gasthuis (Amsterdam, The Netherlands). Although he does not think this study will change guidelines, Dr. Verheugt said “it will change practice in certain parts of the world.” 

Study Details 

Baseline characteristics were similar between the study groups; however, those treated with primary PCI were more likely to have a history of congestive heart failure (P = 0.004). PCI was more likely to be performed in the primary PCI group (P < 0.001), while CABG was more common in those treated with fibrinolytic therapy (P = 0.002). Of those undergoing PCI, 96% in each group received at least 1 stent. 

 

 

 

Source:Armstrong PW, Gershlick AH, Goldstein P, et al. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013;Epub ahead of print.

 

 

 

 

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Disclosures
  • The STREAM trial was sponsored by Boehringer Ingelheim.
  • Dr. Van de Werf reports receiving consulting and lecture fees and grant support from Boehringer Ingelheim.

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