Early Percutaneous Coronary Intervention (PCI) After Fibrinolysis Versus Standard Therapy in ST Segment Elevation Myocardial Infarction (STEMI) Patients

NCT01014182 | Unknown

• 1 other identifier: OTTER220179
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Several recent trials (1,2) suggest that all STEMI patients receiving fibrinolysis in non-PCI centres should be routinely transferred for elective early PCI within 24 hours from hospitalization, with no additive risk of major bleeding complications or other severe adverse events compared standard therapy. These results in favour of a routine invasive strategy in STEMI patients suggest a potential change to the current approach of awaiting the response to treatment in patients receiving fibrinolysis, and draw the attention to the potential need for an appropriate network organization with adequate first hospitalization treatment (spoke) and prompt transfer to centres with 24/7 PCI capabilities (hub). The recent ESC (3) and ACC (4) guidelines on STEMI are consistent with the early ESC PCI Guidelines, recommending that angioplasty after fibrinolysis should be performed within a time-window ranging between 3 and 24 hours after successful lytic administration (level evidence IIA). The reason for the weighting of the recommendation is due to the heterogeneity of trial results with different planned-revascularization strategies, variable primary end-points definitions, and small individual trial sample sizes. Therefore, a consistent analysis of single patient dataset from all published randomized trials would be of value to better define the magnitude and duration of clinical benefit of the routine invasive strategy after lytic treatment as well as the potential optimal timing of such a strategy. The main aim of the OTTER meta-analysis is to define the benefits of immediate PCI after fibrinolysis for STEMI patients. Moreover, the OTTER meta-analysis will investigate the optimal timing of post-fibrinolysis elective revascularization.

Conditions

Myocardial Infarction

Keywords

Early PCI; Myocardial Infarction; Thrombolysis; Optimal revascularization therapy in STEMI patients

Outcome Measures

Primary Outcomes (1)

• Combined death/reinfarction

  30 days

Secondary Outcomes (5)

• Death, reinfarction, recurrent ischemia and urgent revascularization

  30 days

• Combined death/reinfarction/recurrent ischemia/urgent revascularization and new presentation CHF and shock

  30 days.

• Major bleeding and hemorrhagic stroke

  30 days

• Combined death/reinfarction and combined revascularization/recurrent ischemia

  6-12 months

• Influence of Optimal Timing of Post-Thrombolysis early revascularization on primary and secondary clinical end-points

  0-24 hours from thrombolysis

Study Arms (2)

Early PCI

Routine invasive strategy with early PCI performed in STEMI patients within 24 hours from successful fibrinolysis

Standard Therapy

Standard therapy in STEMI patients with fibrinolysis and/or conventional ischaemic-guided therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

STEMI patients.

You may qualify if:

• STEMI patients enrolled within 12 hours from onset of symptoms
• Controlled randomized trials comparing a routine invasive strategy with standard therapy in STEMI patients
• Modern fibrin-specific therapy in both groups
• Stenting PCI \> 80% of invasive procedures
• English language

You may not qualify if:

• Cardiogenic shock at presentation
• Need for concomitant
• Major surgery
• Severe chronic renal or hepatic impairment
• Myocardial infarction within the previous 2 weeks
• Contraindications to thrombolytic therapy, abciximab, aspirin, or clopidogrel
• Non randomized trials
• Single patient data not available
• Non fibrin-specific lytic therapy
• Stenting PCI \< 80% of invasive procedures
• Not English language

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, SW6 3NP, United Kingdom

RECRUITING

Related Publications (2)

• Abdel-Qadir H, Yan AT, Tan M, Borgia F, Piscione F, Di Mario C, Halvorsen S, Cantor WJ, Westerhout CM, Scheller B, Le May MR, Fernandez-Aviles F, Sanchez PL, Lee DS, Goodman SG. Consistency of benefit from an early invasive strategy after fibrinolysis: a patient-level meta-analysis. Heart. 2015 Oct;101(19):1554-61. doi: 10.1136/heartjnl-2015-307815. Epub 2015 Jul 14.

  PMID: 26175478 DERIVED

• Madan M, Halvorsen S, Di Mario C, Tan M, Westerhout CM, Cantor WJ, Le May MR, Borgia F, Piscione F, Scheller B, Armstrong PW, Fernandez-Aviles F, Sanchez PL, Graham JJ, Yan AT, Goodman SG. Relationship between time to invasive assessment and clinical outcomes of patients undergoing an early invasive strategy after fibrinolysis for ST-segment elevation myocardial infarction: a patient-level analysis of the randomized early routine invasive clinical trials. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):166-174. doi: 10.1016/j.jcin.2014.09.005. Epub 2014 Oct 31.

  PMID: 25616922 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carlo Di Mario, MD

CONTACT

0044 20 7351; c.dimario@rbht.nhs.uk

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 16, 2009

Record last verified: 2009-11

Locations

GB (1)