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RARE SALAMIJoe Segen2016-11-29T16:03:36+00:00
CARDIOLOGY, CLINICAL TRIALS
A planned clinical trial in Australia in which patients with an acute myocardial infarction were to be immediately transported to a regional heart attack centre where percutaneous coronary artery intervention–PCI would be performed, rather than to the closest hospital.
RARE SALAMI never enrolled patients, because of concerns voiced by obtuse media types that patients were not fully informed about therapeutic options.
The Trial’s authors concluded: “In a democratic society, the Press has the right to investigate any issue it chooses, and individuals have the right to lodge complaints with any authority they see fit. However, these rights should come with a responsibility for accuracy and freedom from bias. Society now has a justified expectation of medical practice based on evidence, and processes are in place to ensure the ethical conduct of the necessary research to produce this evidence. These processes may be in need of protection from sensationalism based on suppositions rather than evidence and expertise. The establishment of ethics committees with guaranteed protection from interference, similar to the protection for courts, should be considered” www.mja.com.au/public/issues/177_08_211002/rasmussen_211002.htm
Rasmussen et al explain in their words “Patients presenting to the Ambulance Service with suspected AMI within the geographic limits of the Northern Sydney Area Health Service, but outside the normal catchment area of Royal North Shore Hospital (RNSH), were to be allocated at random to treatment at their local district hospital or at RNSH. Our trial was to compare two strategies: one based on PCI, backed by facilities at a large centre, and the other based on treatment with fibrinolytics at local hospitals with fewer facilities. Our comparison between the two strategies was to be based on the number of deaths and the number of recurrent non-fatal myocardial infarctions and non-fatal strokes in the two groups of patients during the admission for AMI and six months later. Our trial was designed to determine if there were benefits of a PCI-based strategy at a large centre despite the additional transport time. The potential benefits of such a strategy might be considerable. Careful analysis of registry data on AMI indicated that the hospital mortality rate for patients treated at small centres without facilities for PCI is almost twice as high as that at large centres with facilities for PCI.8,12 Had our randomised, controlled trial replicated these results, it would have indicated that many lives could be saved with centralised care of all patients with AMI in large cities in a few, highly specialised Regional Heart Attack Centres. Because of the urbanised distribution of our population, many patients in Australia would stand to benefit. However, such centralised treatment would require a major change from current practice and have important consequences for resource allocation. In 1997, the RNSH institutional ethics committee requested that we perform a pilot study to document that we could reproduce the published results of PCI on a 24/7 basis before a randomised study could be considered. The pilot study (Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction — SALAMI) was completed in 1998. It was confined to patients eligible for fibrinolysis within the RNSH catchment area. No inhospital deaths occurred in 102 patients. PCI became our standard treatment at RNSH for all patients with AMI. Subsequent outcomes for patients in a wide age range with virtually no exclusions have remained excellent, and much better than expected for the alternative strategy based on fibrinolysis/medical therapy. Despite these good outcomes, the SMH reported that there were concerns about the trial related to risks to participants and lack of fully informed consent. MJA 2001; 175: 625-628
Abbreviation for Royal North Shore & Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction