The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study

https://doi.org/10.1016/j.ahj.2010.04.007Get rights and content

Background

Primary percutaneous coronary intervention (PCI) has emerged as the preferred therapy for acute ST-elevation myocardial infarction (STEMI) provided it is performed in a timely fashion at an expert 24/7 facility. Fibrinolysis is a well-accepted alternative, especially in patients presenting early after symptom onset. The STREAM study will provide novel information on whether prompt fibrinolysis at first medical contact, followed by timely catheterization or rescue coronary intervention in STEMI patients presenting within 3 hours of symptom onset, represents an appropriate alternative strategy to primary PCI.

Methods

Acute STEMI patients presenting early after symptom onset are eligible if PCI is not feasible within 60 minutes of first medical contact. This is an open-label, prospective, randomized, parallel, comparative, international multicenter trial. Patients are randomized to fibrinolysis combined with enoxaparin, clopidogrel, and aspirin, and cardiac catheterization within 6 to 24 hours or rescue coronary intervention if reperfusion fails within 90 minutes of fibrinolysis versus PCI performed according to local guidelines. Composite efficacy end points at 30 days include death, shock, heart failure, and reinfarction. Safety end points include ischemic stroke, intracranial hemorrhage, and major nonintracranial bleeding. Follow-up is extended to 1 year and includes all-cause mortality.

Discussion

Continuing delays in achieving timely PCI remain a difficult issue. Many patients fail to achieve the desired reperfusion times of 90 to 120 minutes after first medical contact. The STREAM results will provide useful additional data on which to base informed therapeutic decisions.

Section snippets

Trial methods

The trial was designed to enroll patients presenting within 3 hours of symptom onset who demonstrate acute STEMI and in whom primary PCI is not feasible within 60 minutes of a qualifying diagnostic electrocardiogram (ECG) (first medical contact).

The trial is an open-label, prospective, randomized, parallel, comparative, international multicenter trial. The inclusion and exclusion criteria are depicted in Table I. Patients are randomized to a strategy of fibrinolysis with tenecteplase coupled

Discussion

Since the Strategic Reperfusion Early After Myocardial Infarction (STREAM) protocol was designed in 2007 and commenced in 2008, the care of patients with STEMI has continued to evolve. Despite multiple attempts at facilitation with full-dose fibrinolysis or combination therapy, this approach to reperfusion has not proven to be successful.20, 21 What has proven to be useful however is strategic cointervention with timely rescue of patients receiving fibrinolysis and coronary revascularization in

Disclosures

Funding for this trial was provided by Boehringer Ingelheim. The sponsor and executive committee were responsible for the design and conduct of the trial. The academic authors vouch for the integrity and completeness of the data and analyses.

Acknowledgements

We would like to acknowledge the collaboration of Anne Regelin (Trial Clinical Monitor, Boehringer-Ingelheim), Katleen Vandenberghe (Leuven Coordinating Center), Tracy Temple (Canadian VIGOUR Center), and Yuling Fu and Hany Siha (ECG Core Laboratory, Canadian VIGOUR Center) as well as the editorial assistance of Jo-An Padberg.

References (27)

  • DanchinN. et al.

    Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment elevation acute myocardial infarction: data from the French Registry on Acute ST-elevation Myocardial Infarction (FAST-MI)

    Circulation

    (2008)
  • GershlickA.H. et al.

    Rescue angioplasty after failed thrombolytic therapy for acute myocardial infarction

    N Engl J Med

    (2005)
  • PintoD.S. et al.

    Hospital delays in reperfusion for ST-elevation myocardial infarction: implications when selecting a reperfusion strategy

    Circulation

    (2006)
  • Cited by (73)

    • Primary PCI versus pharmacoinvasive strategy for ST elevation myocardial infarction

      2018, IJC Heart and Vasculature
      Citation Excerpt :

      However, primary PCI is performed in <25% of acute care hospitals in the United States [1]. Many patients with STEMI present to hospitals that do not have on site PCI capabilities and therefore cannot undergo PCI within the timelines recommended in the guidelines; instead, they receive fibrinolytics as the initial reperfusion therapy [2]. Despite the effectiveness and worldwide availability of intravenous thrombolysis, the usefulness of this therapy is greatly threatened by a high proportion of failed reperfusion and a substantial rate of re-occlusion [3].

    • Implementation of a Nationwide Strategy for the Prevention, Treatment, and Rehabilitation of Cardiovascular Disease “A Todo Corazón”

      2018, Archives of Medical Research
      Citation Excerpt :

      Although the global trend is to increase primary angioplasty and data has consistently shown greater benefits in multiple randomized clinical trials, there is point of equivalence between both treatments in the first 2 h of after clinical presentation, so that in places with limited access to a cath lab, fibrinolytic therapy provides benefits to patients without absolute contraindications that increase the risks of bleeding. To continue with a pharmacoinvasive strategy between the 2–24 h (26) (Figure 4). Adjunct therapy is essential to the success of the strategies of reperfusion, which includes the use of antiplatelet agents (aspirin, clopidogrel, heparin and some new antiplatelet) (27,28), associated with the suitable use of beta blockers (29), statins (30) and calcium antagonists (in the absence of contraindications).

    View all citing articles on Scopus

    Clinical Trial Identifier: NCT00623623 on clinicaltrials.gov.

    h

    See online Appendix for a complete listing of STREAM Steering Committee.

    View full text