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The CARDia trial protocol
  1. D Smith
  1. Correspondence to:
    Dr David Smith, Department of Cardiology, Royal Devon and Exeter Hospital, Exeter, Devon, UK;

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The question of which revascularisation strategy is best in diabetics is a very important one, and it demands a robust answer

An earlier edition of the web based version of Heart (May 2003) saw the electronic publication of the protocol of the CARDia (coronary artery revascularisation in diabetes) trial. The CARDia trial is a multi-centre, “prospective, randomised comparison of optimal coronary angioplasty—with use of stenting and abciximab recommended—versus up to date coronary artery bypass grafting in patients with diabetes mellitus suitable for either intervention”. It will recruit 600 patients through 20 centres over a two year period. Patients suitable for either procedure will be randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The PCI group will be further randomised to receive bare stents or rapamycin eluting stents.

The publication of a trial protocol is a new departure for Heart but follows precedents in other journals when important trials are planned or underway. It might at first sight seem odd to publish protocols of trials in peer review journals before the trial has completed and the results are available. After all a trial protocol without the results is little more than a well thought out idea and as such has little more value than reading the product of a bar-side brainstorming session among colleagues. Where will it end—will we see publication of lists of ideas that bubbled up at cardiologists’ bath time? Clearly the gravity, relevance, and importance of a trial will determine whether the protocol should be published on its own. Does the CARDia trial meet such criteria and warrant web space? I believe it does.

At rates of 15–20%, patients with diabetes form a very significant proportion of those undergoing revascularisation procedures and they are at considerably higher risk than …

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