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Letters

RARE SALAMI trial revisited

Helge H Rasmussen, Peter S Hansen and Gregory I C Nelson
MJA 2002 177 (8): 462

To the Editor: According to the article by Kennedy in the Journal,1 we failed to address the objections to the RARE SALAMI trial (the Royal North Shore and Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction) in our account of the fate of this trial.2

Allegedly, we contravened standard advice regarding emergency cardiac care ("to attend the nearest hospital emergency department as quickly as possible").1 However, the standard advice is to call an ambulance,3 not to go to hospital by private transport. Kennedy also claimed that the trial would interfere with " . . . established therapeutic networks and ongoing therapeutic relationships, including relationships with hospitals".1 The reason we ignored such objections was that the wellbeing of networks seemed unimportant in comparison with the welfare of patients with life-threatening illness.

The issue of the risk to patients of transport time and treatment delays with the new strategy was also raised,1 but Kennedy did not challenge the actual measured delays or other published evidence we referred to.2 These suggested that mortality was likely to be reduced with the RARE SALAMI strategy. Without reference to published data, he quoted the opinions of clinicians and a municipal council to support the opposite conclusion. The northern suburbs of Sydney are not so remote or exotic that opinion based on knowledge of the "local practicalities" he referred to1 would outweigh the evidence of published data.

We argued that complexities of treatments, patients' condition and the pressure of time precluded fully informed consent.2 Allegedly, established guidelines were breached.1 However, the ethics committee, well aware of these, waived conventional informed consent after careful deliberation. A new area ethics committee, constituted subsequently,2 concurred with this decision.

Now, in the light of new evidence, the RARE SALAMI trial, as originally proposed five years ago, can no longer be done. The recently presented DANAMI II study4 randomised 1129 patients to treatment with fibrinolysis at local hospitals or to transportation to angioplasty centres up to 153 km away. Transport was found to be safe, and angioplasty was associated with a 40% reduction in adverse outcomes. Field triage was not tested. However, we believe the results of the DANAMI II study now preclude randomisation of 50% of patients with suspected acute myocardial infarction presenting to the Ambulance Service (and eligible for the RARE SALAMI trial) to treatment at district hospitals. Ironically, in northern Sydney, status quo reigns and 100% of trial-eligible patients are taken to district hospitals and delays in achieving reperfusion persist!

Thiemann, in a recent editorial, concluded that accrued evidence now favours treatment of patients with acute myocardial infarction in a few high-volume centralised angioplasty centres,5 and that field triage and direct transport to such centres holds great promise. He also deplored the lack of research into system changes and the economic self-interest that, he believed, had stymied change in the United States. Opposition to the RARE SALAMI trial was altruistic.6 However, it nevertheless stopped much needed research and hence may have compromised patients' rights to optimal care.

  1. Kennedy MC. Clinical trials without consent: some experiments simply cannot be done. Med J Aust 2002; 177: 40-42. <eMJA full text> <PubMed>
  2. Rasmussen HH, Hansen PS, Koyama Y, et al. Trial of a trial by media. Med J Aust 2001; 175: 625-628. <eMJA full text> <PubMed>
  3. Heart Attack Every Minute Counts. Information from the Heart Foundation. Available at: http://www.heartfoundation.com.au/index.cfm?page=185 (accessed September 2002).
  4. The Danish Multicenter Randomised Trial of Thrombolytic Therapy Versus Coronary Angioplasty in Acute Myocardial Infarction. Presented as Late Breaking Clinical Trial at the 51st Annual Scientific Session of the American College of Cardiology. Abstract available at: http://www.meetingcast.com/acc02wc/index.php3?l=faculty#andersen (accessed September 2002). Slides of presentations available at: http://www.danami-2.dk/newslet/apr02/apr02main_results.htm (accessed September 2002).
  5. Thiemann DR. Primary angioplasty for elderly patients with myocardial infarction [editorial]. Theory, practice and possibilities. J Am Coll Cardiol 2002; 39: 1729-1732. <PubMed>
  6. Ryle G. A trial of the heart. The Sydney Morning Herald 2001; 29 March: 11.

(Received 6 Aug 2002, accepted 15 Aug 2002)

Department of Cardiology, Level 6, Main Building, Royal North Shore Hospital, St Leonards, NSW.

Helge H Rasmussen, FRACP, DMSc, Cardiologist; and Professor of Cardiology, University of Sydney; Peter S Hansen, FRACP PhD, Cardiologist; and Senior Lecturer, University of Sydney; Gregory I C Nelson, MB BS, FRACP, Director of Cardiology.

Correspondence: Professor Helge H Rasmussen, Department of Cardiology, Level 6, Main Building, Royal North Shore Hospital, St Leonards, NSW 2065. helgerATmed.usyd.edu.au

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©The Medical Journal of Australia 2002 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377