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Prehospital Anticoagulants Versus UFH in STEMI

Question Type:
Intervention
Full Question:
Among adult patients with suspected STEMI outside of a hospital transferred for primary PCI  (P), does does any anticoagulant prehospital (eg, bivalirudin, dalteparin, enoxaparin, fondaparinux)  (I), compared with compared with UFH prehospital  (C), change death, ICH, revascularization, major bleeding, stroke, reinfarction (O)?
Consensus on Science:
Bivalirudin Versus UFH RCTsFor the critical outcome of 30-day mortality, we have identified very-low-quality evidence (downgraded for risk of bias, indirectness, and imprecision) from 1 RCT(Steg 2013, 2207-2217) enrolling 2218 patients transferred for PPCI for STEMI showing no benefit of prehospital bivalirudin compared with prehospital UFH (OR, 0.96; 95% CI, 0.59–1.56). For the important outcome of stroke, we have identified very-low-quality evidence (downgraded for risk of bias, indirectness, and imprecision) from 1 RCT(Steg 2013, 2207-2217) enrolling 2218 patients transferred for PPCI for STEMI showing no benefit of prehospital bivalirudin compared with prehospital UFH (OR, 0.55; 95% CI, 0.2–1.5).For the important outcome of reinfarction, we have identified very-low-quality evidence (downgraded for risk of bias, indirectness, and imprecision) from 1 RCT(Steg 2013, 2207-2217) enrolling 2218 patients transferred for PPCI for STEMI showing no benefit of prehospital bivalirudin compared with prehospital UFH (OR, 1.95; 95% CI, 0.90–4.22).For the important outcome of major bleeding, we have identified very-low-quality evidence (downgraded for risk of bias, indirectness, and imprecision) from 1 RCT(Steg 2013, 2207-2217) enrolling 2218 patients transferred for PPCI for STEMI showing a benefit of prehospital bivalirudin compared with prehospital UFH (OR, 0.5; 95% CI, 0.26–0.96).

Bivalirudin Non-RCTsFor the critical outcome of 30-day mortality, we have identified very-low-quality evidence (downgraded for inconsistency, indirectness, and imprecision) from 2 non-RCTs(Sejersten 2009, 1635-1640; Hirschl 2012, 12-17) enrolling 543 patients transferred for PPCI for STEMI showing no benefit of prehospital bivalirudin compared with prehospital UFH (OR, 0.78; 95% CI, 0.39–1.56).For the important outcomes of stroke and reinfarction, we have identified very-low-quality evidence (downgraded for indirectness and imprecision) from 1 non-RCT(Hirschl 2012, 12-17) enrolling 369 patients transferred for PPCI for STEMI showing no benefit of prehospital bivalirudin over prehospital UFH for stroke (OR, 0.86; 95% CI, 0.12–6.19) or reinfarction (OR, 0.86; 95% CI, 0.17–4.33).For the important outcome of major bleeding, we have identified very-low-quality evidence (downgraded for indirectness and imprecision) from 2 non-RCTs(Sejersten 2009, 1635-1640; Hirschl 2012, 12-17) enrolling 543 patients transferred for PPCI for STEMI showing a benefit of prehospital bivalirudin compared with UFH (OR, 0.39; 95% CI, 0.2–0.76). Enoxaparin Versus UFHFor the critical outcome of 30-day mortality, we have identified low-quality evidence (downgraded for risk of bias and imprecision) from 1 RCT(Montalescot 2011, 693-703) enrolling 910 patients transferred for PPCI for STEMI showing no benefit of prehospital enoxaparin compared with prehospital UFH (OR, 0.58; 95% CI, 0.32–1.08).For the important outcome of stroke, we have identified low-quality evidence (downgraded for risk of bias and imprecision) from 1 RCT(Montalescot 2011, 693-703) enrolling 910 patients transferred for PPCI for STEMI showing no benefit of prehospital enoxaparin compared with prehospital UFH (OR, 3.08; 95% CI, 0.32–29.73).For the important outcome of reinfarction, we have identified low-quality evidence (downgraded for risk of bias and imprecision) from 1 RCT(Montalescot 2011, 693-703) enrolling 910 patients transferred for PPCI for STEMI showing no benefit of prehospital enoxaparin compared with prehospital UFH (OR, 0.5; 95% CI, 0.90–4.22).For the important outcome of major bleeding, we have identified low-quality evidence (downgraded for risk of bias and imprecision) from 1 RCT(Montalescot 2011, 693-703) enrolling 910 patients transferred for PPCI for STEMI showing no benefit of prehospital enoxaparin compared with prehospital UFH (OR, 0.61; 95% CI, 0.31–1.20).

Treatment Recommendation:
We have insufficient confidence in the treatment effect for prehospital administration of bivalirudin compared with prehospital administration of UFH in prehospital-identified STEMI patients to recommend a change in existing practice (weak recommendation, very-low-quality evidence). We suggest that prehospital enoxaparin may be used as an alternative to prehospital UFH as an adjunct for primary PCI for STEMI (weak recommendation, low-quality evidence).Values, Preferences, and Task Force InsightsIn making this recommendation regarding bivalirudin, we place a higher value on not recommending new resource allocation for an intervention where the relative benefit is unclear. In making this recommendation regarding enoxaparin, we place a higher value on recommending agents that may provide benefit with regard to the ease of administration and lack of need for monitoring. In making these recommendations, it is important to also consider the related review on anticoagulants given to STEMI patients in the prehospital versus in-hospital setting. Only UFH has been evaluated directly in this setting without clear evidence of benefit. We are not recommending that systems implement anticoagulant administration in the prehospital setting. However, in recognizing that some systems are doing this routinely, we conducted this review to look at the relative benefit of one agent over another. Although stent thrombosis was not considered as an a priori outcome, bivalirudin was strongly associated with the risk of acute stent thrombosis (RR, 6.11; 95% CI, 1.37–27.24).(Steg 2013, 2207-2217) Such association is also consistently reported in other published in-hospital studies and meta-analyses of this agent in patients undergoing PCI.(Bangalore 2014, g6419; Cavender 2014, 599-606) While the benefit of bivalirudin over UFH alone in reducing bleeding complications has been shown, this benefit has been challenged by the additional consistent risk of stent thrombosis. This stent thrombosis risk was considered by the task force in making its treatment recommendations.
CoSTR Attachments:
AMSTAR_pico 568 non RCTs.pdf    
bias assessment prehosp other AC vs ufh FB_n.xlsx    
prehosp other AC vs UFH nonRCTs bias assessment_n.docx    
should-pre-hospital-bivalirudin-vs-pre-hospital-ufh-be-used-for-adjunctive-therapy-for-ppci_n.docx    
should-prehospital-enoxaparin-vs-prehospital-ufh-be-used-for-adjunctive-therapy-for-ppci_n.docx    

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