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Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial
Univ Orebro, Fac Hlth, Dept Cardiol, SE-70182 Orebro, Sweden.;Oslo Univ Hosp, Div Cardiovasc & Pulm Dis, Sect Cardiol Intervent, Dept Cardiol, Oslo, Norway..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
Lund Univ, Clin Sci Sect, Skane Univ Hosp, Dept Coronary Heart Dis, Lund, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
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2016 (English)In: Current Cardiology Reports, ISSN 1523-3782, E-ISSN 1534-3170, Vol. 18, no 1, 11Article, review/survey (Refereed) Published
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Abstract [en]

In ST-elevation myocardial infarction (STEMI), thrombus material is often present in partial or total coronary occlusion of the coronary vessel. However, prior to the thrombus aspiration during ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) trial, it remained unclear whether routine thrombus aspiration during percutaneous coronary intervention (PCI) treatment of STEMI would result in patients overall survival benefit. The TASTE trial was a multicenter, prospective, open-label, randomized, controlled clinical trial. In order to randomize patients to treatment and collect data, the infrastructure of a clinical population-based registry was used. Online data collection used the national comprehensive Swedish Coronary Angiography and Angioplasty Registry, a part of the SWEDEHEART registry. Monitoring and adjudication was done as part of the regular registry validation. There was no separate, dedicated monitoring or adjudication of endpoints. Included were 7244 patients with STEMI with chest pain and time of symptoms to hospital admission <24 h, in addition to new electrocardiographic ST-segment elevation or left bundle-branch block. Exclusion criteria were the need for emergency coronary artery bypass grafting. All-cause mortality at 30 days occurred in 2.8 % of the patients in the thrombus-aspiration group, as compared with 3.0 % in the PCI-only group (hazard ratio [HR] 0.94, 95 % confidence interval [CI] 0.72-1.22; p = 0.63). Allcause mortality at 1 year occurred in 5.3 % of the patients in the thrombus-aspiration group, as compared with 5.6 % in the PCI-only group (HR 0.94, 95 % CI 0.78-1.15; p = 0.57). No patients were lost to follow-up at 1 year. The incremental cost for trial execution was approximately US$ 300,000 or $50 per patient. Routine thrombus aspiration during PCI in patients with STEMI did not reduce the rate of all-cause mortality at 1 year. It is possible to design and conductmega-trial at only small cost compared to a similar-sized conventional randomized clinical trial.

Place, publisher, year, edition, pages
2016. Vol. 18, no 1, 11
Keyword [en]
ST-elevation myocardial infarction, Thrombus aspiration, Mortality, Registry-based clinical trial
National Category
Cardiac and Cardiovascular Systems
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URN: urn:nbn:se:uu:diva-280994DOI: 10.1007/s11886-015-0677-6ISI: 000368145400011PubMedID: 26758999OAI: oai:DiVA.org:uu-280994DiVA: diva2:916141
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AstraZeneca
Available from: 2016-04-01 Created: 2016-03-16 Last updated: 2017-11-30Bibliographically approved

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Lagerqvist, BoJames, Stefan K.

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