Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial
Open accessAbstract
Background Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT).Methods In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22.Findings Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (p non-inferiority=0·0004; hazard ratio [HR] 0·81 [95% CI 0·62-1·06], p superiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; p non-inferiority=0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%) in the control group (HR 0·82 [95% CI 0·59-1·13]; p=0·23).Interpretation Guided de-escalation of antiplatelet treatment was non-inferior to standard treatment with prasugrel at 1 year after PCI in terms of net clinical benefit. Our trial shows that early de-escalation of antiplatelet treatment can be considered as an alternative approach in patients with acute coronary syndrome managed with PCI.Funding Klinikum der Universität München, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo.
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RCTs on shorter DAPT duration followed by ASA or a P2Y12 inhibitor monotherapy are relatively small, often with non-inferiority design for efficacy, relatively low power, and wide noninferiority margins.
“since RCTs on shorter DAPT duration followed by ASA or a P2Y 12 inhibitor monotherapy are relatively small, often with non-inferiority design for efficacy, relatively low power, and wide noninferiority margins.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [320]
No evidence supports shortening or de-escalating DAPT post-ACS specifically in patients with diabetes.
“No evidence supports shortening or de-escalating DAPT post-ACS specifically in patients with diabetes”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [320]
These RCTs had primary endpoints combining minor bleeding with traditional efficacy outcomes, efficacy outcomes including not only MACE, and diabetes sub-groups that contain few patients and events, especially on the major hard endpoints.
“In addition, these RCTs had primary endpoints combining minor bleeding with traditional efficacy outcomes, efficacy outcomes including not only MACE, and diabetes sub-groups that contain few patients and events, especially on the major hard endpoints”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [320]
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- Authors
- Sibbing, D., Aradi, D., Jacobshagen, C., Gross, L., Trenk, D., Geisler, T., Orban, M., Hadamitzky, M., Merkely, B., Kiss, R. G., Komócsi, A., Dézsi, C. A., Holdt, L., Felix, S. B., Parma, R., Klopotowski, M., Schwinger, R. H. G., Rieber, J., Huber, K., Neumann, F.-J., Koltowski, L., Mehilli, J., Huczek, Z., Massberg, S., Parma, R., Parma, Z., Lesiak, M., Komosa, A., Huczek, Z., Koltowski, L., Kowara, M., Rymuza, B., Klopotowski, M., Malek, L., Aradi, D., Veress, G., Dézsi, A. D., Merkely, B., Lux, Á., Kiss, R. G., Papp, J., Kovács, A., Dézsi, C. A., Amer, S., Ruzsa, Z., Róna, S., Komócsi, A., Ili, R., Ungi, I., Nagy, F., Zweiker, R., Tóth-Gayor, G., Huber, K., Haller, P., von Scheidt, W., Blüthgen, A., Neumann, F.-J., Trenk, D., Leggewie, S., Kreider-Stempfle, H. U., Remp, T., Kara, K., Mügge, A., Wutzler, A., Fichtlscherer, S., Zeiher, A. M., Seeger, F., Hinterseer, M., König, A., Lederle, S., Jacobshagen, C., Czepluch, F., Maier, L., Schillinger, W., Sossalla, S., Hummel, A., Felix, S., Karakas, M., Sydow, K., Rudolph, T., Halbach, M., Gori, T., Münzel, T., May, A., Gerstenberg, C.-M., Pilecky, D., Rieber, J., Deichstetter, M., Sibbing, D., Mehilli, J., Gross, L., Kääb, S., Löw, A., Orban, M., Orban, M., Sattler, S., Deuschl, S., Teupser, D., Holdt, L., Mudra, H., Räder, T., Schütz, T., Vahldiek, F., Divchev, D., Ince, H., Nienaber, C. A., Radunski, H., Boekstegers, P., Horstkotte, J., Mueller, R., Geisler, T., Müller, K., Schwinger, R., & Rasp, O.
- Affiliations
- Deutsches Herzzentrum München (DE)
- German Centre for Cardiovascular Research (DE)
- Medical University of Silesia (PL)
- Semmelweis University (HU)
- Klinikum Weiden (DE)
- Universitätsmedizin Greifswald (DE)
- Ludwig-Maximilians-Universität München (DE)
- ORCID
- Hadamitzky, Martin
- Massberg, Steffen
- Lesiak, Maciej
- Komosa, Anna
- Lux, Árpád
- Kovács, Andrea
- Ruzsa, Zoltán
- Ungi, Imre
- Nagy, Ferenc
- Zweiker, Robert
- Tóth-Gayor, Gábor
- Haller, Paul
- Mügge, Andreas
- Wutzler, Alexander
- Zeiher, Andreas M.
- Hinterseer, Martin
- König, Andreas
- Maier, Lars
- Sossalla, Samuel
- Karakas, Mahir
- Rudolph, Tanja
- Halbach, Marcel
- Gori, Tommaso
- Münzel, Thomas
- Kääb, Stefan
- Sattler, Stefan
- Mudra, Harald
- Divchev, Dimitar
- Nienaber, Christoph A
- Boekstegers, Peter
- Müller, Karin
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 390
- Issue
- 10104
- Pages
- 1747-1757
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2748517697
- Cited by
- 615
- References
- 38
- Citations by year
- 2026: 49 · 2025: 43 · 2024: 40 · 2023: 64 · 2022: 87 · 2021: 89 · 2020: 62 · 2019: 77 · 2018: 81 · 2017: 18
- FWCI
- 50.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (acceptedVersion)
- PubMed (publishedVersion)
- SZTE Publicatio Repozitórium (University of Szeged) (acceptedVersion, other-oa)
- Repository of the Academy's Library (Library of the Hungarian Academy of Sciences) (acceptedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- Eli Lilly and Company
- Technische Universität Dresden
- Daiichi Sankyo Company
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- antiplatelet therapy de-escalation, acute coronary syndrome, percutaneous coronary intervention, prasugrel, clopidogrel, platelet function testing, dual antiplatelet therapy, bleeding risk, non-inferiority, cardiovascular mortality, myocardial infarction, stroke, bleeding complications
- MeSH terms
- Prasugrel Hydrochloride, Clopidogrel, Drug Administration Schedule, Europe, Female, Hemorrhage, Humans, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Platelet Function Tests, Ticlopidine, Drug Monitoring, Stroke, Acute Coronary Syndrome, Percutaneous Coronary Intervention
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