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FRISC II 15 Year Follow-up

Professor Wallentin et al report on the 15 year follow-up of the FRISC II study. Sustained benefit in reduction of non-fatal cardiovascular events and a modest mortality benefit were observed. The editorial is available here.

Abstract

Background

The FRISC-II trial was the first randomised trial to show a reduction in death or myocardial infarction
with an early invasive versus a non-invasive treatment strategy in patients with non-ST-elevation acute coronary
syndrome. Here we provide a remaining lifetime perspective on the effects on all cardiovascular events during
15 years’ follow-up.

Methods

The FRISC-II prospective, randomised, multicentre trial was done at 58 Scandinavian centres in Sweden,
Denmark, and Norway. Between June 17, 1996, and Aug 28, 1998, we randomly assigned (1:1) 2457 patients with
non-ST-elevation acute coronary syndrome to an early invasive treatment strategy, aiming for revascularisation within
7 days, or a non-invasive strategy, with invasive procedures at recurrent symptoms or severe exercise-induced
ischaemia. Plasma for biomarker analyses was obtained at randomisation. For long-term outcomes, we linked data
with national health-care registers. The primary endpoint was a composite of death or myocardial infarction.
Outcomes were compared as the average postponement of the next event, including recurrent events, calculated as
the area between mean cumulative count-of-events curves. Analyses were done by intention to treat.

Findings

At a minimum of 15 years’ follow-up on Dec 31, 2014, data for survival status and death were available for
2421 (99%) of the initially recruited 2457 patients, and for other events after 2 years for 2182 (89%) patients. During
follow-up, the invasive strategy postponed death or next myocardial infarction by a mean of 549 days (95% CI 204–888;
p=0·0020) compared with the non-invasive strategy. This eff ect was larger in non-smokers (mean gain 809 days,
95% CI 402–1175; pinteraction=0·0182), patients with elevated troponin T (778 days, 357–1165; pinteraction=0·0241), and
patients with high concentrations of growth diff erentiation factor-15 (1356 days, 507–1650; pinteraction=0·0210). The
diff erence was mainly driven by postponement of new myocardial infarction, whereas the early diff erence in mortality
alone was not sustained over time. The invasive strategy led to a mean of 1128 days (95% CI 830–1366) postponement
of death or next readmission to hospital for ischaemic heart disease, which was consistent in all subgroups (p<0·0001).

Interpretation

During 15 years of follow-up, an early invasive treatment strategy postponed the occurrence of death or
next myocardial infarction by an average of 18 months, and the next readmission to hospital for ischaemic heart
disease by 37 months, compared with a non-invasive strategy in patients with non-ST-elevation acute coronary
syndrome. This remaining lifetime perspective supports that an early invasive treatment strategy should be the
preferred option in most patients with non-ST-elevation acute coronary syndrome.

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