Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction

NCT00164190 | Completed DMC

• 2 other identifiers: MCT-69798FRN:69798
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in these centres. However, thrombolytic therapy achieves normal coronary flow and myocardial perfusion in less than 50% of patients, and is associated with reocclusion, reinfarction, and recurrent ischemia. Primary angioplasty results in more complete reperfusion and lower rates of reocclusion, reinfarction and recurrent ischemia, but is not available in most centres. Although patients can be transferred for primary angioplasty, long transport times are associated with worse outcomes. An alternative strategy, described as facilitated angioplasty, involves administration of thrombolytic therapy at the community hospital followed by immediate transport for angioplasty. This approach achieves the benefits of primary angioplasty without delaying treatment. A well-conducted, prospective, randomized trial is needed to compare this strategy of facilitated angioplasty with standard thrombolytic therapy. Objectives: To evaluate the safety, feasibility, and efficacy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous coronary intervention (PCI). Hypothesis: A strategy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous intervention is associated with a significantly lower incidence of the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days compared with the conventional strategy of thrombolysis with transfer reserved for failed reperfusion and/or development of shock. Research Plan: Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be randomized to one of two strategies: facilitated PCI or standard treatment (thrombolysis with provisional rescue PCI). In the facilitated PCI group, patients will be transferred immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if appropriate. In the standard treatment group, patients will only undergo urgent angiography for evidence of failed reperfusion and/or development of cardiogenic shock. The primary endpoint will be the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Thrombolysis; Angioplasty; ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

• 30-day composite of death (all cause)

  30 day

• Reinfarction

  30 day

• Recurrent ischemia

  30 day

• New or worsening congestive heart failure, including readmission for heart failure

  30 day

• Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion

  30 day

Secondary Outcomes (6)

• The incidence of major/severe bleeding, as defined by the thrombolysis in myocardial ischemia (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding classifications in the first 30 days

  30 day

• The proportion of patients with complete (> 70%) and partial (30-70%) ST-segment resolution from the qualifying electrocardiogram (ECG) to 6 hours after randomization

  30 day

• Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram

  30 day

• The composite of death or reinfarction at 6 months

  30 day

• The composite of death or reinfarction at 1 year

  30 day

Interventions

Routine Early Percutaneous Coronary Intervention after Thrombolysis PROCEDURE

early or delayed PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients \>= 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction to a centre that does not perform primary PCI, with either:
• \>= 2 mm ST-segment elevation in 2 or more contiguous anterior leads
• \>= 1 mm ST-segment elevation in 2 or more contiguous inferior leads with at least one of the following high-risk features:
• Systolic blood pressure \< 100 mm Hg
• Heart rate \> 100/minute
• Killip Class II-III
• \>= 2 mm ST-segment depression in anterior leads
• \>= 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement

You may not qualify if:

• Left bundle branch block
• Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure \> 90) prior to randomization
• Active bleeding or known hemorrhagic diathesis
• Availability of primary PCI with door-to-balloon time ≤ 60 minutes
• Time from thrombolysis to initiation of consent process \> 30 minutes
• Use of thrombolytic agent other than tenecteplase (TNK) for index event
• Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
• Systolic blood pressure \> 200 mm Hg or diastolic \> 110 mm Hg after arrival to the hospital and before enrollment
• Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of \> 2
• Recent non-compressible vascular puncture
• History of central nervous system structural damage (e.g. aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischemic attack within the last year
• History of heparin-induced thrombocytopenia
• Documented allergy to aspirin
• Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrollment or prior participation in this study
• Inability to cooperate with the protocol or undergo cardiac catheterization

Sponsors & Collaborators

• Canadian Heart Research Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Hoffmann-La Roche: collaborator
• Guidant Corporation: collaborator

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2R2, Canada

Location

Related Publications (8)

• Arbel Y, Ko DT, Yan AT, Cantor WJ, Bagai A, Koh M, Eberg M, Tan M, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Morrison LJ, Langer A, Dzavik V, Mehta SR, Goodman SG; TRANSFER-AMI Trial Investigators. Long-term Follow-up of the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Can J Cardiol. 2018 Jun;34(6):736-743. doi: 10.1016/j.cjca.2018.02.005. Epub 2018 Feb 10.

  PMID: 29801739 DERIVED

• Russo JJ, Goodman SG, Cantor WJ, Tan MK, Borgundvaag B, Fitchett D, Dzavik V, Yan RT, Graham JJ, Mehta SR, Yan AT; TRANSFER-AMI Investigators. Efficacy and safety of a routine early invasive strategy in relation to time from symptom onset to fibrinolysis (a subgroup analysis of TRANSFER-AMI). Am J Cardiol. 2015 Apr 15;115(8):1005-12. doi: 10.1016/j.amjcard.2015.01.533. Epub 2015 Jan 31.

  PMID: 25711435 DERIVED

• Russo JJ, Goodman SG, Cantor WJ, Fitchett D, Heffernan M, Borgundvaag B, Ducas J, Cohen EA, Dzavik V, Mehta SR, Buller CE, Yan AT; TRANSFER-AMI investigators. Efficacy and safety of a routine early invasive strategy after fibrinolysis stratified by glycoprotein IIb/IIIa inhibitor use during percutaneous coronary intervention: a pre-specified subgroup analysis of the TRANSFER-AMI randomised controlled trial. Heart. 2014 Jun;100(11):873-80. doi: 10.1136/heartjnl-2013-305231. Epub 2014 Jan 21.

  PMID: 24449716 DERIVED

• Bagai A, Cantor WJ, Tan M, Tong W, Lamy A, Fitchett D, Cohen EA, Mehta SR, Borgundvaag B, Ducas J, Heffernan M, Dzavik V, Morrison L, Schwartz B, Lazzam C, Langer A, Goodman SG. Clinical outcomes and cost implications of routine early PCI after fibrinolysis: one-year follow-up of the Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) study. Am Heart J. 2013 Apr;165(4):630-637.e2. doi: 10.1016/j.ahj.2012.12.016. Epub 2013 Feb 19.

  PMID: 23537982 DERIVED

• Bhan V, Cantor WJ, Yan RT, Mehta SR, Morrison LJ, Heffernan M, Fitchett D, Dzavik V, Ducas J, Borgundvaag B, Cohen EA, Goodman SG, Yan AT. Efficacy of early invasive management post-fibrinolysis in men versus women with ST-elevation myocardial infarction: a subgroup analysis from Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Am Heart J. 2012 Sep;164(3):343-50. doi: 10.1016/j.ahj.2012.05.022. Epub 2012 Aug 17.

  PMID: 22980300 DERIVED

• Lavi S, Cantor WJ, Casanova A, Tan MK, Yan AT, Dzavik V, Fitchett D, Cohen EA, Borgundvaag B, Heffernan M, Ducas J, Goodman SG. Efficacy and safety of enoxaparin compared with unfractionated heparin in the pharmacoinvasive management of acute ST-segment elevation myocardial infarction: Insights from the TRANSFER-AMI trial. Am Heart J. 2012 Feb;163(2):176-81.e2. doi: 10.1016/j.ahj.2011.10.015.

  PMID: 22305834 DERIVED

• Yan AT, Yan RT, Cantor WJ, Borgundvaag B, Cohen EA, Fitchett DH, Dzavik V, Ducas J, Tan M, Casanova A, Goodman SG; TRANSFER-AMI Investigators. Relationship between risk stratification at admission and treatment effects of early invasive management following fibrinolysis: insights from the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Eur Heart J. 2011 Aug;32(16):1994-2002. doi: 10.1093/eurheartj/ehr008. Epub 2011 Feb 8.

  PMID: 21307037 DERIVED

• Cantor WJ, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Cohen EA, Morrison LJ, Langer A, Dzavik V, Mehta SR, Lazzam C, Schwartz B, Casanova A, Goodman SG; TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009 Jun 25;360(26):2705-18. doi: 10.1056/NEJMoa0808276.

  PMID: 19553646 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Warren J. Cantor, MD

  Caribbean Health Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2009
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

CA (1)