Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for ST-Segment Myocardial Infarction: A
Meta-Analysis of Randomized Trials
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for ST-Segment Myocardial
Infarction: A Meta-Analysis of Randomized Trials
Harindra C. Wijeysundera, MD; Ram Vijayaraghavan, MD;
Brahmajee K. Nallamothu, MD, MPH; JoAnne M. Foody, MD; Harlan
M. Krumholz, MD, SM; Christopher O. Phillips, MD, MPH; Amir
Kashani, MD, MS; John J. You, MD; Jack V. Tu, MD, PhD; Dennis T.
Ko, MD, MSc
Published in the Journal of the American
College of Cardiology
January 30, 2007
Clinical Trial Results . org
Rescue Angioplasty or Repeat Fibrinolysis After
Failed Fibrinolytic Therapy for STEMI: Background
• The investigators sought to best
estimate the benefits and risks
associated with rescue PCI and repeat
fibrinolytic therapy as compared with
conservative management in patients
with failed fibrinolytic therapy for STsegment myocardial infarction (STEMI).
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for STEMI: Background (cont.)
• Fibrinolytic therapy is the most common
treatment for STEMI; however, the best
strategy to treat patients who fail to
acheive reperfusion after fibrinolytic
therapy remains uncertain.
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After
Failed Fibrinolytic Therapy for STEMI: Study Design
1177 patients from 8 clinical trials with follow-up duration ranging from hospital
discharge to 6 months
Meta-Analysis of randomized trials using fixed-effects model.
There were 6 trials that randomized 908 patients to rescue PCI or conservative therapy and 3 trials that
randomized 410 patients to repeat fibrinolysis or conservative therapy (REACT trial used for both analyses).
Rescue
PCI
Conservative
Treatment
Repeat
Fibrinolysis
Conservative
Treatment
n=454
n=454
n=206
n=204
Follow-up ranged from hospital
discharge to 6 months


Follow-up ranged from
hospital discharge to 6
months
Clinical efficacy outcomes: All-cause mortality, heart failure, and
reinfarction
Safety outcomes: Stroke, major bleeding, and minor bleeding
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue PCI vs Conservative Treatment:
Outcomes
Rescue PCI vs Conservative Treatment
p = 0.05
20
p < 0.001
17.8
Patients (%)
16.6
15
p = 0.09 12.7
p = 0.04
10.7
10.4
10
7.3
p = 0.04
6.1
5
3.6
3.4
• The overall absolute
reduction in the
composite endpoint
of all-cause mortality,
heart failure, or
reinfarction was
substantial in the
rescue-PCI group,
requiring only 9
patients to be treated
to yield 1 patient with
benefit.
0.7
0
Mortality
CHF
Rescue PCI
Clinical Trial Results . org
ReMI
Stroke
Minor
Bleed
Conservative treatment
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Repeat Fibrinolysis vs Conservative
Treatment: Outcomes
Repeat Fibrinolysis vs Conservative Treatment
20
p = 0.14
Patients (%)
15.7
p = 0.09
15
10.7
11.8
10
p = 0.42
6.5
• On the contrary, repeat
fibrinolysis was not
p = 0.03
associated with
significant
14.6
improvements in allcause mortality or
reinfarction, and it also
showed an increased
7.8
risk for minor bleeding.
4.3
5
2.7
0
Mortality
ReMI
Repeat fibrinolysis
Clinical Trial Results . org
Major Bleed Minor Bleed
Conservative treatment
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for STEMI: Limitations
• Despite the absence of statistically significant
heterogeneity, there are substantial differences in
the entrance criteria of the included trials.
• It is difficult to evaluate reperfusion without
performing angiography, and this is a major
barrier to the adoption of a standardized rescue
policy for management of failed fibrinolytic
therapy.
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for STEMI: Limitations (cont.)
• The meta-analysis’ pooled estimates are based on
<500 patients randomized per arm reflecting the
difficulty in recruiting patients for trials in this area.
• Given the small numbers in these analyses, the
ability to detect a reduction in mortality may have
been underpowered (particularly in the repeat lytic
arm), and likewise spuriously false positive results
may emerge.
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for STEMI: Summary
• This meta-analysis, which systematically reviewed
the existing literature of randomized trials on
treatment strategies for STEMI patients who fail
fibrinolytic therapy, found that rescue PCI was
associated with significant risk reductions for heart
failure and reinfarction.
• In addition, the overall absolute reduction in the
composite end point of all-cause mortality, heart
failure, or reinfarction was statistically significant for
rescue PCI.
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.
Rescue Angioplasty or Repeat Fibrinolysis After Failed
Fibrinolytic Therapy for STEMI: Summary (cont.)
• Rescue PCI was associated with an
increased risk of stroke and minor bleeding
and thus, the potential benefits of rescue PCI
must be interpreted in the context of its risks.
• Few conclusions can be reached regarding
repeat fibrinolysis given the small sample
sizes, although more bleeding was observed
with this approach.
Clinical Trial Results . org
Wijeysundera HC, et al. JACC. 30 Jan 2007:49(4): 422-30.