31 Aug Early Invasive Cardiac Treatment Provided Longterm Benefit For Patients With Non-STEMI Acute Coronary Syndrome
MedicalResearch.com Interview with:
Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.
Still there are remaining controversies concerning the long-term effects, the appropriate selection of patients for this approach and the opportunities for a more personalised approach to early invasive procedures. We therefore performed a 15 years follow-up of the FRISC2 trial concerning the effects of an early invasive compared with a non-invasive strategy on all cardiovascular events, including not only first events but also repeated non-fatal events. We also evaluated the effects in subgroups that previously seemed to have a differential effect of the early invasive treatment strategy.
MedicalResearch.com: What are the main findings?
Response: For these purposes the present long-term study used a new methodology to estimate the difference in time to death or next non-fatal event between the randomized treatment strategies. This methodological approach allowed the inclusion not only of first non-fatal events but also repeated events, which is a necessity to provide a fair comparison of treatment effects over long time periods. Thereby this study showed, for the first time, that an early invasive compared with a non-invasive treatment strategy provided a lifelong postponement of the occurrence of death or the next MI by an average of 18 months and of death or the next rehospitalisation for ischemic heart disease by 37 months. The study also showed that the long-term effects on death or MI were significantly larger in non-smokers and in patients with elevated troponin or GDF-15 levels.
MedicalResearch.com: What should readers take away from your report?
Response: As this study provided information on gains in survival time without new non-fatal events and as almost half the patients were deceased during follow-up, the study can be considered to provide a remaining lifetime perspective on the effects of an early invasive compared with a non-invasive treatment strategy in patients with NSTE-ACS.
Even in such a remaining life-time perspective the results from the FRISC2 study support that an early invasive strategy should be the preferred regimen in the majority of patients with NSTE-ACS and especially in non-smokers and at elevated plasma levels of troponin and GDF-15.
The clarification of the remaining life-time consequences of an early invasive treatment strategy in NSTE-ACS are pioneering and have major interest to a broad spectrum of physicians as this one of the most common cardiac emergencies worldwide.
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Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study
Wallentin, Lars et al. The Lancet , Volume 0 , Issue 0 ,
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Last Updated on August 31, 2016 by Marie Benz MD FAAD