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TFQO: Hiroshi Nonogi #254EVREVs: Hiroshi Nonogi #254 Tony Scott #138Taskforce: ACS

Fibrinolytic and immediate PCI for STEMI 882

Dallas 2015COI Disclosure

(SPECIFIC to this systematic review)

EVREV 1 Hiroshi Nonogi #254Commercial/industry : NonePotential intellectual conflicts: None

EVREV 2 Tony Scott #138Commercial/industry: NonePotential intellectual conflicts: None

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2010 Treatment Recommendation

The routine use of fibrinolysis-facilitated PPCI, compared with PPCI, is not recommended in patients with suspected STEMI.

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C2015 PICO

Population: patients who are having ST-elevation myocardial infarction in the emergency department Intervention: fibrinolytic administration combined with immediate PCI Comparison: immediate PCI alone Outcomes: death, reinfarction, urgent target vessel revascularization, major bleeding, intracranial hemorrhage

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Inclusion/Exclusion/Articles FoundList Inclusions/Exclusions

Inclusion criteria: study comparing primary (immediate) PCI with thrombolysis-based facilitated PCI, and RCTExclusion criteria: Rescue PCI only for failed thrombolysis, primary PCI with antithrombotic regimen including IIb/IIIa inhibitors or antithrombin drugs for facilitated PCI, and half dose lytic

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After Banff, re-review using ILCOR librarian search strategy

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RCT

5 articles

PRISMA Flow Diagram 2014June4

Records identified through PubMed searching (n =1428)

Embase (n=729)

Additional records identified through Cochrane Library

(n =569)

Records after duplicates removed (n =1952 )

Records screened (n =14 )

Records excluded (n = 1938 )

Full-text articles assessed for eligibility

(n =14)

Abstract-only (n=3)

Studies included in qualitative synthesis

(n =11)

Studies included in quantitative synthesis

(meta-analysis) (n = 5 )

Full-text articles excluded, with reasons(n =6)

Primary PCI arm is not randomized (n=2) ,

reduced dose of tPA (n=3) and Fibrinolytic agent was

SK (n=1).

2726

Dallas 2015 Risk of Bias in studies table

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Outcome: Death

Outcome: Nonfatal MI

ROB: serious due to unclear for selection bias 、 Inconsistency::serious due to high i2Imprecision: serious due to no significant difference→ Very low quality of evidence

Imprecision: serious due to no significant difference →Moderate quality of evidence

Dallas 2015Outcome: Major Bleeding

Outcome: Intracranial hemorrhage High quality of evidence

Imprecision : serious due to few events (n=14)→Moderate quality of evidence

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Outcome: Revascularization

ROB: serious due to unclear for selection bias, Inconsistency : serious due to heterogeniety p=0.01, i2=71% and Imprecision: serious due to no significant difference → very low quality of evidence

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NS

NS

NS

harm

harm

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1. Unclear for selection bias2. Performance bias is high in 3 studies, however for death, riskof bias is not serious.3. Heterogeneity; P=0.85, i2=0%<40%4. All 5 studies used tPA.5. More than 2000 cases (3533) with 189 events, OR: 0.96-1.74 NS6. no high risk in 2 studies7. heterogeneity: P=0.49, i2=0%8. more than 2000 case with few events (14 cases)9. concealment unclear10. heterogeneity; P=0.01, i2=71%11. OR 0.91-1.4712. heterogeneity; P=0.18, i2=36%13. OR: 0.73-1.81, NS

Dallas 2015Proposed Consensus

on Science statementsFor the critical outcome of mortality, we have identified moderate quality of evidence (downgraded for imprecision) from 5 RCTs (Van de Werf, F., 2006, 569; Ellis, S. G,2008,2205; Itoh, T., 2010, 1625; Kurihara, H., 2004,e14; Thiele, H.,2006,1132) enrolling 3533 patients showing no benefit (OR 1.29 95% CI 0.96 to 1.74) when fibrinolytic administration is combined with immediate PCI vs immediate PCI alone.

For the critical outcome of nonfatal MI, we have identified very low quality of evidence (downgraded for bias, inconsistency, and imprecision) from 5 RCTs (Van de Werf, F., 2006, 569; Ellis, S. G,2008,2205; Itoh, T., 2010, 1625; Kurihara, H., 2004,e14; Thiele, H.,2006,1132) enrolling 3498 patients showing no benefit (OR 1.15 95% CI 0.73 to 1.81).

For the critical outcome of target vessel revascularization, we have identified very low quality of evidence (downgraded for bias, inconsistency and imprecision) from 4 RCTs (Van de Werf, F., 2006, 569; Ellis, S. G,2008,2205; Itoh, T., 2010, 1625; Kurihara, H., 2004, e14) enrolling 3360 patients showing no benefit (OR 1.16 95% CI 0.91 to 1.47).

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Proposed Consensus on Science statements

For the critical outcome of intracranial hemorrhage, we have identified moderate quality evidence (downgraded for imprecision) from 3 RCTs (Van de Werf, F., 2006, 569; Ellis, S. G,2008,2205; Itoh, T., 2010, 1625) enrolling 3342 patients showing harm (OR 7.75 95% CI 1.39 to 43.15) when fibrinolytic administration is combined with immediate PCI vs immediate PCI alone.

For the important outcome of major bleeding, we have identified high quality of evidence from 5 RCTs (Van de Werf, F., 2006, 569; Ellis, S. G,2008,2205; Itoh, T., 2010, 1625; Kurihara, H., 2004,e14; Thiele, H.,2006,1132) enrolling 3543 patients showing harm (OR 1.52 95% CI 1.05 to 2.20).

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Draft Treatment Recommendations

We recommend against the routine use of fibrinolytic administration combined with immediate PCI, compared with immediate PCI alone in patients with ST elevation myocardial infarction.

(strong recommendation, low quality of evidence).

In making this recommendation, we place a higher value on avoiding harm when the evidence available suggests no benefit and potential harm in fibrinolytic administration combined with immediate PCI.

Dallas 2015Knowledge Gaps

*DO NOT USE FOR PLENARY* - BREAKOUT ONLY

Other specific systematic review that would be helpful

Relationship with delayed PCI after fibrinolysis

Specific research requiredFacilitated and delayed PCI with new anti-coagulants