National Institute for Clinical Excellence guidance: too NICE to glycoprotein IIb/IIIa inhibitors?

The arrival of the National Institute for Clinical Excellence (NICE) in 1999 was greeted with suspicion by many clinicians who regarded it as the beginning of an era of overt health care rationing. From a cardiological perspective, this has not proved to be the case. The guidelines issued on implantable defibrillators, intracoronary stents, and glyco-protein (GP) IIb/IIIa inhibitors have been liberal and in the last instance surprising to many cardiologists. 1 Given our original misgivings, it might seem churlish to complain about NICE's liberality, but an endorsement from NICE gives a treatment the appearance of an oYcial seal of approval. This has important medico-legal implications and may also inhibit further research into the use and targeting of these compounds—no drug company is going to look such an attractive gift horse in the mouth and fund selective studies. Has NICE gone too far with GP IIb/IIIa inhibitors? GP IIb/IIIa inhibitors are powerful antiplatelet agents that represent one of the most important and exciting advances in the treatment of coronary thrombosis. The growth in their use over the last few years has been explosive and the market in GP IIb/IIIa inhibitors is now worth around $500 million a year in the USA alone. These agents have well established beneficial eVects in limiting adverse events around the time of percutaneous coronary intervention in patients with stable angina and acute coronary syndromes. 2–5 More recently these agents have moved out of the catheter laboratory setting and into the " medical " management of acute coronary syndromes in the coronary care unit. This wider usage is based upon the results of a number of trials that have been conducted without mandatory early angiography and revascularisation, comparing the addition of either a GP IIb/IIIa inhibitor or placebo to aspirin and heparin. 6–10 There are variations between these trials in the drug used, dose, duration of treatment, and interventional policy (table 1). Inevitably these trials contain a mixture of patients that underwent percutaneous coronary intervention (and would be expected to benefit) and those that did not (who might benefit). These studies do not provide any evidence that GP IIb/IIIa inhibitors reduce mortality in acute coronary syndromes, but the combined end point of death/ myocardial infarction is reduced in most trials. A recent meta-analysis of the trials showed a modest but significant decrease in 30 day death/myocardial infarction (11.5% v 10.7%, p = 0.04). 11 After examining this …