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Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial

  • New Therapies for Cardiovascular Disease (KW Mahaffey, Section Editor)
  • Published:
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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.

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Abbreviations

ACS:

Acute coronary syndrome

ICD:

International classification of diseases

INFUSE-AMI:

Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction

PCI:

Percutaneous coronary intervention

SCAAR:

Swedish coronary angiography and angioplasty registry

STEMI:

ST-elevation myocardial infarction

SWEDEHEART:

Swedish web system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies

TAPAS:

Thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study

TASTE:

Thrombus aspiration during ST-segment elevation myocardial infarction in Scandinavia

TIMI:

Thrombolysis in myocardial infarction

TOTAL:

Trial of routine aspiration thrombectomy with PCI versus PCI alone in patients with ST-segment elevation myocardial infarction undergoing primary PCI

References

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Authors and Affiliations

  1. Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden

    Kristian Wachtell & Ole Fröbert

  2. Section Cardiology Intervention, Department of Cardiology, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway

    Kristian Wachtell

  3. Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

    Bo Lagerqvist & Stefan K. James

  4. Department of Coronary Heart Disease, Skåne University Hospital, Clinical Sciences Section, Lund University, Lund, Sweden

    Göran K. Olivecrona

Authors
  1. Kristian Wachtell
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  2. Bo Lagerqvist
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  3. Göran K. Olivecrona
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  4. Stefan K. James
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  5. Ole Fröbert
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Correspondence to Kristian Wachtell.

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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.

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This article is part of the Topical Collection on New Therapies for Cardiovascular Disease

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Wachtell, K., Lagerqvist, B., Olivecrona, G.K. et al. Novel Trial Designs: Lessons Learned from Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction in Scandinavia (TASTE) Trial. Curr Cardiol Rep 18, 11 (2016). https://doi.org/10.1007/s11886-015-0677-6

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  • DOI: https://doi.org/10.1007/s11886-015-0677-6

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