Value of First Day Angiography/Angioplasty In Evolving Non-ST Segment Myocardial Infarction: An Open Multicenter Randomized Trial - VINO

Description:

VINO was a multicenter, randomized, controlled trial of a very early invasive management strategy (with angiography within 24 hours of presentation) versus a conservative, ischemia-guided management strategy for patients with non-ST-elevation myocardial infarction (NSTEMI).

Hypothesis:

The hypothesis was to establish the efficacy of first-day coronary angiography with immediate percutaneous coronary intervention (PCI) or appropriately timed surgical revascularization in comparison with a “classical” early conservative strategy (coronary angiography performed only after recurrent or stress-induced myocardial ischemia) in patients with NSTEMI.

Study Design

Study Design:

Patients Screened: 380
Patients Enrolled: 131
Mean Follow Up: 6 months
Mean Patient Age: Mean 66 years
Female: 25

Patient Populations:

All of the following had to be present: 1) Rest, ischemic chest pain lasting >20 minutes, within the last 24 hours before randomization; 2) ECG evidence of acute myocardial ischemia without ST-segment elevations; 3) creatine kinase-MB higher than 1.5 times the upper limit of normal and/or positive troponin I assay

Exclusions:

Unstable postinfarction angina resistant to maximal pharmacotherapy, cardiogenic shock, acute left or right bundle branch block or ST-segment elevations, Q-wave MI or intravenous thrombolysis within one month, coronary angioplasty or bypass surgery within six months, or comorbid illnesses

Primary Endpoints:

Death or nonfatal MI within six months

Secondary Endpoints:

Revascularization at six months, length of hospitalization, and subsequent hospitalizations

Drug/Procedures Used:

Angiography with PCI as appropriate within 24 hours of the last episode of chest pain versus conservative management with angiography only in cases of recurrent ischemia or provocable ischemia on stress testing (symptom-limited exercise test on day 30)

Concomitant Medications:

Aspirin and heparin

Principal Findings:

A total of 131 patients were randomized in the trial that was conducted at one university hospital and 10 community hospitals in the Czech Republic. There were no significant differences between the study arms, although patients in the conservative arm did require a greater use of nitrates through the first 30 days.

The average time to angiography was 6.2 hours in the early invasive group (vs. 61 days in the conservative group, p<0.0001) with an average time to angioplasty of 8.6 hours in the early invasive group, despite the fact that all interventions were performed at the university hospital. There was almost a twofold greater incidence of revascularization in patients randomized to the early invasive strategy. The incidence of ischemia on exercise testing was significantly lower in the early invasive group (17.2% vs. 37.3%, p<0.001).

The rates of death, nonfatal myocardial infarction (MI), and the combined endpoint were lower in the early invasive arm (combined death/MI of 6.3% vs. 22.4%, p<0.001), although the total number of events was low. There were fewer subsequent hospitalizations among patients in the early invasive group.

Interpretation:

In this small, randomized trial of a very early invasive versus conservative management strategy for NSTEMI, early invasive management was associated with a reduction in clinical events at six months. These findings are consistent with the findings of the larger TACTICS-TIMI 18, FRISC II, and RITA-3 trials.

Nonetheless, two unique features of this trial are noteworthy: the clinical setting of this trial (based in the Czech Republic’s health care system, primarily in community hospitals) and the average 6.2 hours to angiography in the invasive arm. These features broaden the applicability of an early invasive strategy for management of NSTEMI and demonstrate that even earlier catheterization may be beneficial for these patients.

References:

Spacek R, Widimsky P, Straka Z, et al. Value of first day angiography/angioplasty in evolving non-ST segment elevation myocardial infarction: an open multicenter randomized trial. The VINO Study. Eur Heart J 2002;23:230-8.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Myocardial Infarction, Myocardial Ischemia, Coronary Angiography, Troponin I, Nitrates, Creatine Kinase, MB Form, Catheterization, Electrocardiography, Angioplasty, Exercise Test, Percutaneous Coronary Intervention


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