A Randomized Trial of Immediate versus Delayed Elective Angioplasty after Intravenous Tissue Plasminogen Activator in Acute Myocardial Infarction

Abstract

We compared the efficacy of immediate coronary angioplasty after acute myocardial infarction with that of elective angioplasty at 7 to 10 days in patients treated initially with intravenous tissue plasminogen activator. The plasminogen activator (150 mg) was administered 2.95 +/- 1.1 hours after the onset of symptoms, to 386 patients with acute myocardial infarction. Ninety minutes later, patency of the coronary artery serving the area of the infarct was demonstrated by coronary angiography in 288 patients (75 percent). Bleeding problems were frequently encountered, as evidenced by an average drop in hematocrit of 11.7 +/- 6.5 points from base line to nadir and by a need for transfusion not related to bypass surgery in 70 patients (18 percent). After successful thrombolysis, 197 patients with a patent but severely stenotic vessel suitable for angioplasty were randomly assigned to immediate angioplasty (n = 99) or, if indicated 7 to 10 days after infarction, to deferred (elective) angioplasty (n = 98). The incidence of reocclusion was similar in the two groups: 11 percent in the group assigned to immediate angioplasty and 13 percent in the group assigned to elective angioplasty. Neither group had a significant improvement in global left ventricular function, and regional wall motion in the infarct zone improved to a similar extent in the two groups. In the elective-angioplasty group, the rate of crossover to emergency angioplasty for recurrent ischemia was 16 percent (whereas 5 percent of the immediate-angioplasty group required emergency repeated angioplasty; P = 0.01). In 14 percent of the patients in the elective group, the stenosis was substantially reduced by the time of the seven-day follow-up angiography, obviating the need for angioplasty. We conclude that in patients with initially successful thrombolysis and suitable coronary-artery anatomy, immediate angioplasty offers no clear advantage over delayed elective angioplasty.

Rapid and sustained coronary artery recanalization with combined bolus injection of recombinant tissue-type plasminogen activator and monoclonal antiplatelet GPIIb/IIIa antibody in a canine preparation.

“…Thrombolytic therapy with rt-PA holds promise for improving the morbidity and mortality of coronary 10 To address these shortcomings, we have embarked on a series of studies in a dog preparation with anatomic features similar to those occurring in patients with acute myocardial infarction, i.e., coronary artery thrombosis in the presence of high-grade stenosis. One of our approaches consists of thrombolysis with rt-PA and heparin in combination with a murine monoclonal antibody against the platelet GPI1b/ILIa receptor (7E3).…”

Pharmacodynamics of thrombolysis with recombinant tissue-type plasminogen activator. Correlation with characteristics of and clinical outcomes in patients with acute myocardial infarction. The TAMI Study Group.

“…16 Briefly, patients presenting with symptoms of ischemic chest pain of 30 minutes to 6 hours duration with electrocardiographic ST-segment elevation of at least 0.1 mV in at least two adjacent leads were eligible for therapy with rt-PA as herein described. Patients were excluded for the usual contraindications to thrombolytic therapy, especially preexisting risk of hemorrhage, age over 75 years, or previous coronary bypass surgery.…”

Very Early versus Early Invasive Strategy after Successful Thrombolysis in Patients with ST Segment Elevation Myocardial Infarction

“…In our study we divided the optimum window of routine early intervention post thrombolysis into two groups, a very early group who performed the post thrombolysis intervention [3][4][5][6][7][8][9][10][11][12] hours and an early group who performed the intervention 12-24 hours. Since no other studies were designed to lay bare the assumption that very early revascularization might be superior compared to the early one, within the first 24 hours.…”

“…The study population consisted of patients aged 18-70 years who presented to another hospital without PCI facility within 6 hours of acute chest pain and STEMI, those patients received fibrinolytic therapy (streptokinase 1.500 million IU in most of the cases) as an early management then referred to our tertiary center, patients who had subsequent criteria indicative of successful reperfusion were enrolled in the study. The early criteria for successful reperfusion included: Resolving of more than 50% of ST segment elevation at 60-90 minutes, [10], Relief of chest pain within 60-90 minutes from initiation of thrombolysis [11]. Patients with one or more of the following criteria were excluded from the study: Failed reperfusion post thrombolysis, any indication requiring rescue PCI (cardiogenic shock, acute pulmonary edema, persistent chest pain, malignant arrhythmias), Mechanical complications (acute severe mitral regurgitation (MR), ventricular septal rupture (VSR), cardiac rupture), moderate and severe renal impairment (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2 using MDRD equation), post coronary artery bypass grafting (CABG) and post PCI patients, patients with previous STEMI or LV dysfunction, post thrombolysis major bleeding complications (intracranial bleeding, gastrointestinal bleeding), patients who received thrombolytic therapy after more than 6 hours of chest pain or presented more than 12 hours after successful thrombolysis (Lack of randomization), contraindications for antiplatelets such as bleeding disorder or known any bleeding tendency either inherited or acquired and thrombocytopenia (Platelet count<100.000/cm 3 ).…”