||Clinical trial updates: Percutaneous coronary intervention
- The Fragmin and Fast Revascularisation during InStability in Coronary artery disease (FRISC II) was the first trial to show a significant event rate reduction favoring the invasive over the noninvasive strategy at 6 months in patients with unstable angina (UA) or non-ST-elevation acute MI (NSTEMI).1
- This trial randomized 2457 patients in 58 Scandinavian hospitals to an early-invasive (n = 1222) or noninvasive (n = 1235) treatment strategy with placebo-controlled long-term LMWH (dalteparin) for 3 months.
- At 6 months, the rate of death, MI, or both, was 9.4% in the invasive group (113/1207) and 12.1% in the noninvasive group (148/1226) (risk ratio [RR] 0.78; 95% CI, 0.62 to 0.98; P = 0.031).
- As shown on the slide, benefit was maintained at 2 years.2 There was a 32% reduction in risk of death in the invasive-strategy group (RR 0.68; 95% CI, 0.47 to 0.98; P = 0.038).
- There was also a significant 28% reduction in risk of MI at 2 years (RR 0.72; 95% CI, 0.57 to 0.91; P = 0.005; data not shown).
- These findings are supported by a second study that is discussed in the next slide.
1 Fragmin and Fast Revascularisation during Instability in Coronary Artery Disease (FRISC II) Investigators. Invasive compared with non-invasive treatment in unstable coronary-artery disease. FRISC II prospective randomised multicentre study. Lancet. 1999;354:708-715.
2 Lagerqvist B, Husted S, Kontny F, Näslund U, Ståhle E, Swahn E, Wallentin L. A long-term perspective on the protective effects of an early invasive strategy in unstable coronary artery disease. Two-year follow-up on the FRISC-II invasive study. J Am Coll Cardiol. 2002;40:1902-1914.