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The REFLO-STEMI trial comparing intracoronary adenosine , sodium nitroprusside and standard therapy for the attenuation of infarct size and microvascular obstruction during primary percutaneous coronary intervention : study protocol for a randomised controlled trial . BACKGROUND Microvascular obstruction ( MVO ) secondary to ischaemic-reperfusion injury is an important but underappreciated determinant of short- and longer-term outcome following percutaneous coronary intervention ( PCI ) treatment of ST-elevation myocardial infarction ( STEMI ) . Several small studies have demonstrated a reduction in the degree of MVO utilising a variety of vasoactive agents , with adenosine and sodium nitroprusside ( SNP ) being most evaluated . However , the evidence base remains weak as the trials have had variable endpoints , differing drug doses and delivery . As such , the results regarding benefit are conflicting . METHODS The REperfusion Facilitated by LOcal adjunctive therapy in STEMI ( REFLO-STEMI ) trial is a multicentre , prospective , randomised , controlled , open label , study with blinded endpoint analysis : Patients presenting within 6 h of onset of STEMI and undergoing planned primary PCI ( P-PCI ) with TIMI 0/1 flow in the infarct-related artery ( IRA ) and no significant bystander coronary artery disease on angiography , are randomised into one of three groups : PCI with adjunctive pharmacotherapy ( intracoronary adenosine or SNP ) or control ( standard PCI ) . All receive Bivalirudin anticoagulation and thrombus aspiration . The primary outcome is infarct size ( IS ) ( determined as a percentage of total left ventricular mass ) measured by cardiac magnetic resonance imaging ( CMRI ) undertaken at 48 to 72 h post P-PCI . Secondary outcome measures include MVO ( hypoenhancement within infarct core ) on CMRI , angiographic markers of microvascular perfusion and MACE during 1-month follow-up . The study aims to recruit 240 patients ( powered at 80 % to detect a 5 % absolute reduction in IS ) . DISCUSSION The REFLO-STEMI study has been designed to address the weaknesses of previous trials , which have collectively failed to demonstrate whether adjunctive pharmacotherapy with adenosine and/or SNP can reduce measures of myocardial injury ( infarct size and MVO ) and improve clinical outcome , despite good basic evidence that they have the potential to attenuate this process . The REFLO-STEMI study will be the most scientifically robust trial to date evaluating whether adjunctive therapy ( intracoronary adenosine or SNP following thrombus aspiration ) reduces CMRI measured IS and MVO in patients undergoing P-PCI within 6 h of onset of STEMI . TRIAL REGISTRATION Trial registered 20th November 2012 : ClinicalTrials.gov Identifier NCT01747174 .
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Intervention_Pharmacological
intracoronary adenosine
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Intervention_Pharmacological
sodium nitroprusside
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Intervention_Control
standard therapy
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Intervention_Surgical
percutaneous coronary intervention ( PCI )
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Intervention_Pharmacological
vasoactive agents
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Intervention_Pharmacological
adenosine
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Intervention_Pharmacological
sodium nitroprusside ( SNP )
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Intervention_Surgical
angiography
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Intervention_Pharmacological
Bivalirudin anticoagulation
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Intervention_Pharmacological
thrombus aspiration
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Intervention_Pharmacological
adjunctive pharmacotherapy
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Intervention_Pharmacological
adjunctive therapy ( intracoronary adenosine or SNP following thrombus aspiration )
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Participant_Condition
6 h of onset of STEMI and undergoing planned primary PCI ( P-PCI ) with TIMI 0/1 flow in the infarct-related artery ( IRA )
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Participant_Condition
no significant bystander coronary artery disease on angiography , are randomised into one of three groups : PCI with adjunctive pharmacotherapy ( intracoronary adenosine or SNP ) or control ( standard PCI )
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Participant_Condition
Bivalirudin anticoagulation
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Participant_Condition
thrombus aspiration
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Participant_Sample-size
240 patients