Review: Rescue percutaneous coronary intervention but not repeated fibrinolysis is effective for failed fibrinolysis in STEMIPDF
ACP J Club. 2008 Jul-Aug;149:11. doi:10.7326/ACPJC-2007-147-1-011
Clinical Impact Ratings
Wijeysundera HC, Vijayaraghavan R, Nallamothu BK, et al. Rescue angioplasty or repeat fibrinolysis after failed fibrinolytic therapy for ST-segment myocardial infarction: a meta-analysis of randomized trials. J Am Coll Cardiol. 2007;49:422-30. [PubMed ID: 17258087]
In patients with ST-segment elevation myocardial infarction (STEMI) in whom fibrinolytic therapy fails, what are the benefits and risks of rescue percutaneous coronary intervention (PCI) or repeated fibrinolytic therapy compared with conservative management?
Data sources: MEDLINE, EMBASE/Excerpta Medica, Cochrane Library (to February 2006), and reference lists.
Study selection and assessment: Randomized controlled trials (RCTs) that compared a strategy of either rescue PCI or repeated fibrinolytic therapy with conservative management (no further immediate reperfusion therapy) in patients with STEMI in whom initial fibrinolytic therapy had failed (by angiographic or clinical definitions). 6 RCTs (n = 908, mean age range 57 to 63 y, 76% men) of rescue PCI and 3 RCTs (n = 410, mean age range 56 to 63 y, 75% men) of repeated fibrinolysis (with tissue-type plasminogen activator) met the selection criteria. Quality of individual trials was assessed using the Jadad scale.
Outcomes: All-cause mortality, heart failure, reinfarction, stroke, and major and minor bleeding.
Rescue PCI reduced risk for reinfarction more than conservative management, but reductions in mortality and heart failure did not reach statistical significance (Table). Rescue PCI increased risks for stroke and minor bleeding (Table). Groups did not differ for major bleeding (1 RCT, n = 285). Repeated fibrinolysis and conservative management did not differ for mortality, reinfarction, major bleeding (Table), heart failure (1 RCT, n = 283), or stroke (1 RCT, n = 283). Risk for minor bleeding was higher in the repeated fibrinolysis group (Table).
In patients with ST-segment elevation myocardial infarction in whom fibrinolytic therapy fails, rescue percutaneous coronary intervention reduces risk for reinfarction more than conservative management, but repeated fibrinolytic therapy does not provide any benefit.
Source of funding: No external funding.
For correspondence: Dr. D.T. Ko, Institute for Clinical Evaluative Sciences, Toronto, ON, Canada. E-mail email@example.com.
Table. Rescue percutaneous coronary intervention (PCI) or repeated fibrinolytic therapy (FT) vs conservative management (control) for ST-segment elevation myocardial infarction with failed fibrinolysis*
|Outcomes||Number of trials (n)||Weighted event rates||RRR/RRI (95% CI)||NNT/NNH (CI)|
|Mortality||6 (908)||7.1%||10%||RRR: 31% (−5 to 54)||Not significant|
|Heart failure||4 (851)||13%||18%||RRR: 27% (0 to 46)||Not significant|
|Reinfarction||3 (700)||6.2%||11%||RRR: 42% (3 to 65)||NNT: 23 (15 to 312)|
|Composite endpoint†||3 (700)||30%||41%||RRR: 28% (12 to 41)||NNT: 9 (6 to 21)|
|Stroke||2 (592)||3.4%||0.7%||RRI: 398% (10 to 2148)||NNH: 38 (7 to 1475)|
|Minor bleeding||3 (620)||16%||3.6%||RRI: 358% (146 to 755)||NNH: 8 (4 to 20)|
|Mortality||3 (410)||11%||16%||RRR: 32% (−14 to 59)||Not significant|
|Reinfarction||2 (373)||12%||6.5%||RRI: 79% (−8 to 248)||Not significant|
|Major bleeding||2 (373)||4.1%||2.7%||RRI: 54% (−46 to 248)||Not significant|
|Minor bleeding||3 (410)||14%||7.8%||RRI: 84% (6 to 218)||NNH: 16 (6 to 213)|
*Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from relative risks and control event rates
in article using a fixed-effects model.
†Mortality, heart failure, or reinfarction.
It has been nearly impossible to conduct RCTs of rescue PCI in the United States because of the strong bias toward it. Guidelines considered rescue PCI to be a class 1 indication even before trials indicated its benefit (1). Although there are important differences among the trials included in the meta-analysis by Wijeysundera and colleagues, the data are sufficiently compelling to support routine performance of rescue PCI and its classification as a class 1 indication in STEMI guidelines. Rescue PCI increases bleeding complications, but a radial artery approach has been shown to reduce bleeding rates and may be particularly beneficial in this setting (2).
Many unanswered questions remain. In the 6 RCTs included in this meta-analysis, the time from administration of fibrinolytic therapy until it was deemed a failure varied from 60 minutes to several hours. If the interval was shorter, PCI might be even more beneficial. If it was too short, it might begin to resemble facilitated PCI, which seems to increase rather than decrease morbidity and mortality (3).
Administering a glycoprotein IIb/IIIa inhibitor shortly after a full dose of a fibrinolytic agent may be beneficial, but it clearly increases bleeding (4). The data are confounded because patients least likely to have major bleeding complications would preferentially be given such therapy, exaggerating any true benefit. True equipoise exists about whether to administer a IIb/IIIa inhibitor during rescue PCI; an RCT addressing this question is needed.
Should all patients treated with a fibrinolytic be transferred immediately to a center capable of performing PCI? Although Wijeysundera and colleagues did not address this issue directly, the data support such an approach. We are fully aware of the political and economic implications of this recommendation and that it will be greeted with antipathy in many quarters.
Peter Berger, MD
Kimberly Skelding, MD
Danville, Pennsylvania, USA
1. Smith SC Jr., Dove JT, Jacobs AK, et al. ACC/AHA guidelines of percutaneous coronary interventions (revision of the 1993 PTCA guidelines)—executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty). J Am Coll Cardiol. 2001;37:2215-39. [PubMed ID: 11419905]
2. Lo TS, Hall IR, Jaumdally R, et al. Transradial rescue angioplasty for failed thrombolysis in acute myocardial infarction: reperfusion with reduced vascular risk [Letter]. Heart. 2006;92:1153-4. [PubMed ID: 16844873]
3. Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet. 2006;367:579-88. [PubMed ID: 16488801]
4. Cantor WJ, Kaplan AL, Velianou JL, et al. Effectiveness and safety of abciximab after failed thrombolytic therapy. Am J Cardiol. 2001;87:439-42. [PubMed ID: 11179529]