TY - JOUR
T1 - 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
T2 - The REOPEN-AMI study protocol
AU - Niccoli, Giampaolo
AU - D'amario, Domenico
AU - Spaziani, Cristina
AU - Cosentino, Nicola
AU - Marino, Marcello
AU - Rigattieri, Stefano
AU - Schiavo, Paolo Lo
AU - De Vita, Maria Rosaria
AU - Tarantino, Fabio
AU - Bartorelli, Antonio
AU - Fabbiocchi, Franco
AU - Prati, Francesco
AU - Imola, Fabrizio
AU - Valgimigli, Marco
AU - Ferrari, Roberto
AU - Crea, Filippo
PY - 2009/7
Y1 - 2009/7
N2 - 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. METHODS AND 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 ≤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.
AB - 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. METHODS AND 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 ≤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.
KW - Acute myocardial infarction
KW - Intracoronary adenosine
KW - Intracoronary nitroprusside
KW - Randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=67650469566&partnerID=8YFLogxK
U2 - 10.2459/JCM.0b013e32832b3571
DO - 10.2459/JCM.0b013e32832b3571
M3 - Article
SN - 1558-2027
VL - 10
SP - 585
EP - 592
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
IS - 7
ER -