title: Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial.
abstract: 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). All-cause 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 conduct mega-trial at only small cost compared to a similar-sized conventional randomized clinical trial.
authors.affiliation: Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden. kristian@wachtell.net.|Section Cardiology Intervention, Department of Cardiology, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway. kristian@wachtell.net.
authors.forename: Kristian
authors.initials: K
authors.lastname: Wachtell
authors.affiliation: Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Bo
authors.initials: B
authors.lastname: Lagerqvist
authors.affiliation: Department of Coronary Heart Disease, Skåne University Hospital, Clinical Sciences Section, Lund University, Lund, Sweden.
authors.forename: Göran K
authors.initials: GK
authors.lastname: Olivecrona
authors.affiliation: Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Stefan K
authors.initials: SK
authors.lastname: James
authors.affiliation: Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden.
authors.forename: Ole
authors.initials: O
authors.lastname: Fröbert
mesh_terms: D003131:Combined Modality Therapy; D003328:Coronary Thrombosis / Q000401:mortality / Q000628:therapy*; D003362:Cost-Benefit Analysis; D004562:Electrocardiography; D006801:Humans; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D012107:Research Design; D012537:Scandinavian and Nordic Countries; D017131:Thrombectomy; D016896:Treatment Outcome
keywords: Mortality; Registry-based clinical trial; ST-elevation myocardial infarction; Thrombus aspiration