European Heart Journal Advance Access originally published online on January 5, 2008
European Heart Journal 2008 29(4):499-508; doi:10.1093/eurheartj/ehm583
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The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure
1 International Centre for Circulatory Health, Imperial College London, 59 North Wharf Road, London W2 1PG, UK
2 Sahlgrenska University Hospital/Östra, Göteborg, Sweden
3 Nordic School of Public Health, Göteborg, Sweden
4 City Hospital, Birmingham, UK
5 St Bartholomew’s and the London, Queen Mary’s School of Medicine, London, UK
6 Oxford University, Oxford, UK
7 Ullevål Sykehus, Oslo, Norway
8 University of Michigan, Ann Arbor, MI, USA
9 University Hospital, Reykjavik, Iceland
10 University of Glasgow, Glasgow, UK
11 H S Frederiksberg Hospital, Frederiksberg, Denmark
12 University Central Hospital, Helsinki, Finland
13 Beaumont Hospital and Royal College of Surgeons, Dublin, Ireland
14 Karolinska Hospital, Stockholm, Sweden
Received 8 June 2007; revised 31 October 2007; accepted 22 November 2007; online publish-ahead-of-print 5 January 2008.
* Corresponding author. Tel: +44 207 594 1100, Fax: +44 207 594 1145. Email: p.sever{at}imperial.ac.uk
See page 425 for the editorial comment on this article (doi:10.1093/eurheartj/ehm628)
Aims: To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial—2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA).
Methods and results: The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of 
6.5 mmol/L.
A total of 19 342 hypertensive patients were enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all ASCOT-LLA patients until the end of ASCOT-BPLA.
The primary outcome of ASCOT-LLA was combined fatal coronary heart disease (CHD) or non-fatal myocardial infarction.
Secondary outcomes included all coronary events, all cardiovascular events and procedures, fatal and non-fatal stroke, cardiovascular mortality, all cause mortality, development of chronic stable angina, heart failure, and peripheral arterial disease.
By the end of ASCOT-LLA, there was a 36% relative risk reduction in primary events (n = 254) in favour of atorvastatin [hazard ratio (HR) 0.64, 95% CI: 0.50–0.83, P = 0.0005]. At the end of ASCOT-BPLA, 2.2 years later, despite extensive crossovers from and to statin usage, the relative risk reduction in primary events (n = 412) among those originally assigned atorvastatin remained at 36% (HR 0.64, 95% CI: 0.53–0.78, P = 0.0001). For almost all other endpoints, risk reductions also remained essentially unchanged and in the case of all cause mortality, the risk reduction of 15% now achieved borderline statistical significance (P = 0.02).
Conclusion: Carry-over benefits from those originally assigned atorvastatin but no longer taking the drug may account for unchanged relative risk reductions in most cardiovascular endpoints observed 2 years after ASCOT-LLA closed.
Key Words: Coronary and stroke events • Atorvastatin • ASCOT-LLA • Extension
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