ABSTRACT
OBJECTIVES: This study sought to assess whether intracoronary adenosine or nitroprusside following thrombus aspiration (TA) is superior to TA alone for the prevention of microvascular obstruction (MVO) in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: MVO, due to its multifactorial pathogenesis, still occurs after TA in a sizeable portion of patients. METHODS: We performed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial. A total of 240 STEMI patients with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0/1 were randomly allocated 1:1:1 to receive adenosine (n = 80), nitroprusside (n = 80), or saline (n = 80) given distal to the occluded site after TA. The primary endpoint was the incidence of ST-segment resolution (STR) >70% on surface electrocardiogram at 90 min after PCI. Secondary endpoints were angiographic MVO incidence (TIMI flow grade ≤2 or 3 with a myocardial blush grade <2) and major adverse cardiac event (MACE) rate at 30 days as a composite of cardiac death, myocardial infarction, target lesion revascularization, and heart failure requiring hospitalization. RESULTS: STR >70% occurred in in 71% of adenosine-treated patients, in 54% of nitroprusside-treated patients, and in 51% of saline-treated patients (p = 0.009 and p = 0.75, respectively, vs. saline). Angiographic MVO occurred in 18% of adenosine-treated patients, in 24% of nitroprusside-treated patients, and in 30% of saline-treated patients (p = 0.06 and p = 0.37, respectively, vs. saline). MACE occurred in 10%, 14%, and 20% of patients, respectively (p = 0.08 and p = 0.29 vs. saline). CONCLUSIONS: In STEMI patients treated by PCI and TA, the additional intracoronary administration of adenosine, but not that of nitroprusside, results in a significant improvement of MVO, as assessed by STR.
Subject(s)
Adenosine/administration & dosage , Coronary Circulation/drug effects , Microcirculation/drug effects , Myocardial Infarction/therapy , Nitroprusside/administration & dosage , Percutaneous Coronary Intervention/adverse effects , Thrombectomy , Vasodilation/drug effects , Vasodilator Agents/administration & dosage , Aged , Coronary Angiography , Drug Administration Schedule , Electrocardiography , Female , Heart Failure/etiology , Heart Failure/therapy , Hospitalization , Humans , Italy , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/drug therapy , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Percutaneous Coronary Intervention/mortality , Recurrence , Suction , Thrombectomy/adverse effects , Thrombectomy/methods , Time Factors , Treatment OutcomeABSTRACT
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 < 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.
