Randomized evaluation of intracoronary nitroprusside vs. adenosine after thrombus aspiration during primary percutaneous coronary intervention for the prevention of no-reflow in acute myocardial infarction: the REOPEN-AMI study protocol.
BACKGROUND
Thrombus aspiration improves microvascular obstruction in patients with acute myocardial infarction treated by percutaneous coronary intervention. However, drugs such as nitroprusside and adenosine have not yet been tested as adjuncts to thrombus aspiration. Therefore, we designed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial assessing the effects of intracoronary nitroprusside or adenosine on microvascular obstruction in patients undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration.


RESULTS
Six hospitals in Italy participate in the REOPEN-AMI study. Two hundred and forty consecutive patients with acute myocardial infarction undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration are randomly allocated 1: 1: 1 to receive either intracoronary nitroprusside, adenosine or placebo. The primary end-point is the incidence of ST resolution greater than 70% on surface ECG at 90 min after the procedure. Secondary end-points are: incidence of angiographic no-reflow (thrombolysis in myocardial infarction flow < or =2 or 3 with a myocardial blush grade <2); changes of left ventricular volumes at follow-up (at bidimensional echocardiography); rate of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization and heart failure requiring hospitalization).


CONCLUSIONS
REOPEN-AMI will provide important data on the efficacy and safety of intracoronary nitroprusside and adenosine as an adjunctive treatment to percutaneous coronary intervention after thrombus aspiration for patients with acute myocardial infarction.
Niccoli
Giampaolo
G
Institute of Cardiology, Catholic University of the Sacred Heart, Italy. gniccoli73@hotmail.it
D'amario
Domenico
D
Spaziani
Cristina
C
Cosentino
Nicola
N
Marino
Marcello
M
Rigattieri
Stefano
S
Schiavo
Paolo Lo
PL
De Vita
Maria Rosaria
MR
Tarantino
Fabio
F
Bartorelli
Antonio
A
Fabbiocchi
Franco
F
Prati
Francesco
F
Imola
Fabrizio
F
Valgimigli
Marco
M
Ferrari
Roberto
R
Crea
Filippo
F
D000241:Adenosine / Q000008:administration & dosage*; D015906:Angioplasty, Balloon, Coronary; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D004452:Echocardiography; D004562:Electrocardiography; D006801:Humans; D007558:Italy; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D009599:Nitroprusside / Q000008:administration & dosage*; D054318:No-Reflow Phenomenon / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D013396:Suction; D017131:Thrombectomy / Q000379:methods*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
D014665:Vasodilator Agents; D009599:Nitroprusside; D000241:Adenosine