Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators

• Published in: The Lancet (British edition) 1999-08, Vol.354 (9180), p.708-715
• Main Authors: Wallentin, L, Swahn, E, Kontny, F, Husted, S, Lagerqvist, B, Stahle, E, Nielsen, JD, Dellborg, M, Geiran, O, Grande, P, Hulting, J, Kyst-Madsen, J, Nordrehaug, JE, Naslund, U, Pilegaard, H, Rollag, A, Nielsen, TT, Saetre, H, Siegbahn, A, Ohlin, H, Arbeus, M, Bylund, H, Ekstrom, L, Eriksson, P, Holmgren, A, Kellerth, T, Lindblom, D, Lindvall, B, Nordrehaug, J, Radegran, K, Sjogren, I, Stenport, G, Stahl, E, Svane, B, Svedjeholm, R, Toftegaard-Nielsen, T, Hassan, SY, Persson, S, Jacobsson, KA, Thygesen, K, von der Lippe, G, Julian, D, Bertrand, M, Wedel, H, Andren, B, Diderholm, E, Frostfeldt, G, Jernberg, T, Abrahamsson, P, Lindahl, B, Venge, P, Janzon, M, Logander, E, Svensson, E, Lindstrom, G, Alsjo, G, Gulin, M, Setterberg, G, Wikstrom, L, M-Andersen, I, Seim, T
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Angina, Unstable - mortality; Angina, Unstable - therapy; Dalteparin - administration & dosage; Dalteparin - adverse effects; Female; Humans; Long-Term Care; Male; Medicin och hälsovetenskap; Middle Aged; Myocardial Revascularization; Prospective Studies; Scandinavian and Nordic Countries; Survival Rate
• ISSN: 0140-6736

In unstable coronary-artery disease early invasive procedures are common, despite lack of evidence for the superiority of this approach. We compared an early invasive with a non-invasive treatment strategy in unstable coronary-artery disease. In a prospective randomised multicentre study, we randomly assigned 2457 patients in 58 Scandinavian hospitals (median age 66 years, 70% men) an early invasive or non-invasive treatment strategy with placebo-controlled long-term low-molecular-mass heparin (dalteparin) for 3 months. Coronary angiography was done within the first 7 days in 96% and 10%, and revascularisation within the first 10 days in 71% and 9% of patients in the invasive and non-invasive groups, respectively. We followed up patients for 6 months. Analysis was by intention to treat. After 6 months there was a decrease in the composite endpoint of death or myocardial infarction of 9.4% in the invasive group, compared with 12.1% in the non-invasive group (risk ratio 0.78 [95% CI 0.62-0.98], p=0.031). There was a significant decrease in myocardial infarction alone (7.8 vs 10.1%, 0.77 [0.60-0.99]; p=0.045) and non-significantly lower mortality (1.9 vs 2.9%, 0.65 [0.39-1.09]; p=0.10). Symptoms of angina and re-admission were halved by the invasive strategy. Results were independent of the randomised dalteparin treatment. The greatest advantages were seen in high-risk patients. The early invasive approach should be the preferred strategy in most patients with unstable coronary-artery disease who have signs of ischaemia on electrocardiography or raised biochemical markers of myocardial damage.