Limitations of the SCORE-guided European guidelines on cardiovascular disease prevention

Recently, primary prevention with statins was liberalized in the USA and UK but restricted in many comparable European countries. Supported by risk-benefit and cost-effectiveness analyses, the 2013 ACC/AHA (American College of Cardiology/American Heart Association)1 and 2014 UK-NICE (National Institute for Health and Care Excellence)2 risk assessment and prevention guidelines lowered the risk threshold above which primary prevention with statins should be considered. In contrast, the 2016 update of the European guidelines on cardiovascular disease prevention in clinical practice,3 issued jointly by the European Society of Cardiology (ESC) and nine other societies, continued a conservative position on statin use in primary prevention by preserving the high-risk decision threshold introduced in 2003: 5% 10-year risk for fatal atherosclerotic cardiovascular disease (ASCVD) estimated by SCORE (Systematic Coronary Risk Evaluation).4 The 5% high-risk threshold introduced by the SCORE-based 2003 ESC prevention guidelines4 was chosen because 5% 10-year risk for fatal ASCVD was considered to equate with 20% 10-year risk for fatal and non-fatal coronary heart disease (CHD) arbitrarily defined as high-risk under previous ESC guidelines. No rationale was provided for choosing ≥20% 10-year CHD risk as high risk when introduced in 1994,5 neither for preserving it as ≥5% 10-year risk for fatal ASCVD.4 Hence, except for UK and possibly a few other European countries, the most important threshold for initiating primary prevention with statins has not been revised in Europe for more than 20 years, during which time long-awaited generic and inexpensive statins became available, and their efficacy and safety convincingly documented. Considering that the prevalence and treatment costs of ASCVD remain high, such a development would normally favour a more widespread use of statins in primary prevention. However, because SCORE depends solely on the ultimate cause of death, in countries with declining ASCVD mortality it is becoming harder …