Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial
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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.
KeywordsST-elevation myocardial infarction Thrombus aspiration Mortality Registry-based clinical trial
Acute coronary syndrome
International classification of diseases
Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction
Percutaneous coronary intervention
Swedish coronary angiography and angioplasty registry
ST-elevation myocardial infarction
Swedish web system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies
Thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study
Thrombus aspiration during ST-segment elevation myocardial infarction in Scandinavia
Thrombolysis in myocardial infarction
Trial of routine aspiration thrombectomy with PCI versus PCI alone in patients with ST-segment elevation myocardial infarction undergoing primary PCI
Compliance with Ethical Standards
Conflict of Interest
Kristian Wachtell and Bo Lagerqvist declare that they have no conflict of interest.
Göran K. Olivecrona reports personal fees from AstraZeneca, Bbraun, Edwards Lifesciences, and Vascular Solutions.
Stefan K. James reports grants from Terumo, Medtronic, and Vascular Solutions.
Ole Fröbert reports personal fees from Biosensors and Biotronik.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 2.••Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, et al. Cardiac death and reinfarction after 1 year in the thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS): a 1-year follow-up study. Lancet. 2008;371:1915–20. This study provides a thorough description of the beneficial results of thrombectomy in TAPAS study.PubMedCrossRefGoogle Scholar
- 3.••Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013;369:1587–97. This study provides a thorough description of baseline and 30-day mortality results in TASTE.PubMedCrossRefGoogle Scholar
- 5.•Frobert O, Lagerqvist B, Gudnason T, Thuesen L, Svensson R, Olivecrona GK, et al. Thrombus aspiration in ST-elevation myocardial infarction in scandinavia (TASTE trial). a multicenter, prospective, randomized, controlled clinical registry trial based on the swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J. 2010;160:1042–8. This report provides a detailed description of the data collection in TASTE.PubMedCrossRefGoogle Scholar
- 10.Sarno G, Lagerqvist B, Frobert O, Nilsson J, Olivecrona G, Omerovic E, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2012;33:606–13.PubMedCrossRefGoogle Scholar
- 11.•Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, et al. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012;307:1817–26. This study provides data showing effect of abciximab but not thrombectomy in the INFUSE study.PubMedCrossRefGoogle Scholar
- 13.Fernandez-Rodriguez D, Regueiro A, Brugaletta S, Martin-Yuste V, Masotti M, Cequier A, et al. Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial. Circ Cardiovasc Interv. 2014;7:294–300.PubMedCrossRefGoogle Scholar