Rescue Angioplasty Versus Conservative Therapy or Repeat Thrombolysis - REACT: 6-Month and Longer-Term Follow-Up Results

Jun 29, 2009
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Trial Sponsor:
British Heart Foundation
Date Presented:
01/01/2004
Date Published:
01/01/2009
Date Updated:
06/29/2009
Original Posted Date:
06/29/2009
References

Description:

The goal of the trial was to evaluate the use of repeat thrombolysis versus rescue angioplasty versus conservative management without additional treatment in patients with acute myocardial infarction (MI) with failed reperfusion.

Hypothesis:

Rescue angioplasty would be more effective in reducing major adverse events.

Study Design

Study Design:

Patients Enrolled: 427
Mean Follow Up: 6 months
Mean Patient Age: 61.1 years
Female: 21

Patient Populations:

  • Acute MI treated with aspirin and thrombolytic therapy within 6 hours of chest pain onset, <50% resolution of ST changes on ECG at 90 minutes, age 21-85 years, and ability to perform an intervention within 12 hours of symptom onset

Exclusions:

  • Age >85 years, cardiogenic shock, evidence of bleeding, hypertension, and low body weight (<67 kg)

Primary Endpoints:

  • Composite of death, reinfarction, CVA, or severe heart failure at 6 months

Secondary Endpoints:

  • Event-free survival at 1 year
  • Repeat revascularization at 1 year

Drug/Procedures Used:

Patients previously treated with thrombolytic therapy were randomized to: 1) repeat thrombolysis, 2) angiography with or without revascularization, or 3) conservative management with unfractionated heparin for 24 hours.

Principal Findings:

Streptokinase was used as the initial thrombolytic regimen in 60% of patients; 42.5% of patients presented with an anterior infarction. Baseline characteristics were well matched between the treatment groups.

The primary composite endpoint of death, MI, cerebrovascular accident (CVA), or severe heart failure at 6 months occurred in 31.0% of patients in the repeat lysis group, 29.8% of patients in the conservative group, and 15.3% of patients in the angiography group, a significantly lower rate in the angiography group compared with either the repeat lysis group (adjusted hazard ratio [HR] 0.43, p = 0.001) or the conservative group (HR 0.47, p = 0.004).

Freedom from revascularization was also higher in the angiography group (86.2%) compared with the repeat lysis group (74.4%) or the conservative group (77.6%, p = 0.05). Minor bleeding occurred more frequently in the angiography group (n = 33) compared with the repeat lysis group (n = 10) or the conservative group (n = 8) (p < 0.001), but there was no difference in major bleeding (n = 4, n = 7, n = 5, respectively).

Event-free survival at 1 year was 81.5% in the rescue angiography group, 64.1% in the repeat thrombolysis group, and 67.5% in the conservative group (overall p = 0.004). This difference persisted up to a median of 4.4 years of follow-up. Repeat revascularization at 1 year was required in 25 patients in the rescue angiography group (p < 0.05 compared with either the repeat thrombolysis group or conservative group), 41 patients in the repeat thrombolysis group, and 40 patients in the conservative group.

Interpretation:

Among patients with acute MI with failed reperfusion, treatment with rescue angiography was associated with a reduction in the primary composite endpoint at 6 months compared with both repeat thrombolysis or conservative management. Event-free survival at 1 year and longer was greatest in the rescue angiography group. The need for long-term (1-year) repeat revascularization was lowest in the rescue angiography group.

Randomized trials evaluating therapy in patients with failed reperfusion are limited. In the RESCUE trial, the endpoints of death or heart failure trended lower in the rescue angioplasty group compared with conservative management, but the sample size was small and the trial was conducted prior to widespread use of current therapies, including stenting.

The more recent MERLIN trial showed no difference in treatment strategy of rescue angiography compared with a conservative strategy. The differences in outcomes between the trials may be due to differences in concomitant therapy (more streptokinase use and less stent use in MERLIN) and/or differences in inclusion criteria, including the longer duration of time from symptom onset to treatment in MERLIN (10 hours) compared with REACT (6 hours).

References:

Carver A, Rafelt S, Gershlick AH, et al. Longer-term follow-up of patients recruited to the REACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) trial. J Am Coll Cardiol 2009;54:118-26.

Gershlick AH, et al. Rescue angioplasty after failed thrombolytic therapy for acute myocardial infarction. N Engl J Med 2005;353:2758-68.

Presented by Anthony H. Gershlick at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.

Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Follow-Up Studies, Heparin, Disease-Free Survival, Neurofibromin 2, Fibrinolytic Agents, Electrocardiography, Angioplasty, Stents, Streptokinase, Chest Pain, Heart Failure


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