STREAM: Pre-hospital Fibrinolysis Strategy as Safe as Primary PCI at 1 Year in STEMI

DALLAS, TX—A pharmaco-invasive strategy of prehospital fibrinolysis with timely coronary angiography results in similar 1-year mortality after ST-segment elevation myocardial infarction (STEMI) compared with standard primary percutaneous coronary intervention (PCI), according to results presented November 18, 2013, at the American Heart Association Scientific Sessions.

The STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial 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.

Thirty-day results showed no difference in the primary composite endpoint (all-cause death, shock, congestive heart failure, or reinfarction) between patients in the fibrinolysis and primary PCI groups (P = 0.21). Fibrinolysis was associated with a small increase in intracranial hemorrhage.

Peter R. Sinnaeve, MD, PhD, of University Hospitals Leuven (Leuven, Belgium), presented 1-year mortality data, which showed similar outcomes with both strategies (table 1).

Table 1. Mortality

 

Pharmaco-invasive
(n = 944)

Primary PCI
(n = 948)

RR (95%CI)

P Value

1-year All-cause Death

6.7%

5.9%

1.13 (0.77-1.67)

0.515

1-year Cardiac Death

4.0%

4.1%

0.98 (0.62-1.54)

0.927

Death Between 30 Days and 1 Year

2.1%

1.5%

--

--


Cause of death between 30 days and 1 year was cardiac in half of primary PCI patients and one-third of the pharmaco-invasive group.

Results were maintained in all prespecified subgroups, with the exception of a benefit seen in patients treated after the tenecteplase dose was halved (P = 0.05).

Protocol Amendment Leads to Unintended Findings

Discussant Harold L. Dauerman, MD, of the University of Vermont (Burlington, VT), commented that as an unintended result of the study, the intracranial bleed rate was reduced by 80% after the protocol amendment was made “when the characteristics of patients were not changing dramatically due to the restrictions of the protocol.

“There is not level 1 evidence for a randomized clinical trial suggesting that we should convert all elderly patients to half-dose fibrinolysis, but to my knowledge there is no randomized clinical trial of fibrinolysis dosing in the elderly,” he continued. “In the absence of such a trial, this may warrant for clinicians a half-dose fibrinolytic strategy for elderly patients going forward.”

Still, a “burden” remains on pharmaco-invasive strategies to show superiority vs. transfer for primary PCI in order to change current practice standards, Dr. Dauerman observed.

The findings “generally support the ACC-AHA/ESC guideline recommendations,” he concluded. “The 120-minute window for transfer PCI remains in place. But there are many systems for which primary PCI is not possible, and in those systems pharmaco-invasive therapy for STEMI as done in a carefully dose-adjusted algorithm may be an option to improve reperfusion rates.”

 


Source:

Sinnaeve PR. One year mortality in STEMI patients randomized to primary PCI or a pharmaco-invasive strategy. The STREAM 1 year follow-up. Presented at: American Heart Association Scientific Sessions; November 18, 2013; Dallas, TX.

 

 

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Disclosures
  • STREAM was funded by Boehringer Ingelheim.
  • Dr. Sinnaeve reports serving on the speakers bureau for Bayer, Boehringer Ingelheim, BMS, and Pfizer and receiving honoraria form Johnson and Johnson.
  • Dr. Dauerman reports no relevant conflicts of interest.

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