Registry-based randomized clinical trials are here


The results from the TASTE trial reported last week at the annual congress of the European Society of Cardiology and in the New England Journal of Medicine – which showed no 30-day survival benefit for ST-segment elevation myocardial infarction patients treated with thrombus aspiration compared with conventional stenting – received more kudos for the study’s design than for its primary finding.

A big reason was that the study design was so unprecedented. Called a "registry-based randomized clinical trial" (RRCT), the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial enrolled STEMI patients as they entered the long-standing, pan–Sweden and Iceland Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry.

© Kenneth Allen/Wikimedia Commons

The results from the TASTE trial reported last week received more kudos for the study's design than for its primary finding.

On the SWEDEHEART registry backbone, which automatically provided comprehensive data collection and follow-up, the researchers who collaborated on TASTE built in a web-based randomization that allocated more than 7,200 patients to either treatment by thrombus aspiration followed by percutaneous coronary intervention (PCI) or to PCI only.

The main result was clear, but several experts who heard it hedged on the immediate impact of the TASTE results on use of thrombus aspiration.

This treatment "is still logical, feasible, and relatively easy, and will continue to be attractive to many," especially until the results of a more conventionally designed, similarly-sized trial, TOTAL, are available, commented Dr. Raffaele De Caterina, the designated discussant for the report at the meeting.

Despite their skepticism on what the TASTE findings mean for current practice, Dr. De Caterina and others had unbridled enthusiasm for the new RRCT. The design "allowed completeness of follow-up and a much lower cost," and with no commercial involvement, he said.

"This is an exciting and innovative approach. Automatic collection of outcomes makes it incredibly cost effective, and a number of countries have large registry programs," said Dr. Keith A.A. Fox, a professor of cardiology at the University of Edinburgh.

A commentary that ran with the published report on TASTE called the RRCT concept "a disruptive technology" that "transforms existing standards, procedures, and cost structures." The commentary, cowritten by Dr. Michael S. Lauer, director of cardiovascular sciences at the National Heart, Lung, and Blood Institute, noted that the incremental cost to run TASTE was about $300,000, roughly the size of an average research grant from the National Institutes of Health to an academic laboratory.

The RRCT model inaugurated by TASTE produced enough interest to have the TASTE investigators give a second talk at the ESC meeting focused just on their study’s design and its implications. Dr. Stefan James, a TASTE researcher, highlighted several other clinical questions that he and his colleagues are addressing in ongoing RRCTS: the role of supplemental oxygen in acute MI patients, a comparison of bivalirudin (Angiomax) and heparin in acute MI patients on contemporary antiplatelet treatment, the value of drug-eluting technologies for treating peripheral artery disease, and the ability of bioabsorbable vascular scaffolds to prevent events.

The RRCT is "ideal for one clinically important hypothesis with reliable, hard endpoints," Dr. James said.

On Twitter @mitchelzoler

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