Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS) a randomised, open-label, multicentre trial /
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 clopid...
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| Format: | Article |
| Published: |
2017
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| Series: | LANCET
390 No. 10104 |
| Subjects: | |
| doi: | 10.1016/S0140-6736(17)32155-4 |
| mtmt: | 3262256 |
| Online Access: | http://publicatio.bibl.u-szeged.hu/24065 |
| LEADER | 04707nab a2200445 i 4500 | ||
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| 024 | 7 | |a 10.1016/S0140-6736(17)32155-4 |2 doi | |
| 024 | 7 | |a 3262256 |2 mtmt | |
| 040 | |a SZTE Publicatio Repozitórium |b hun | ||
| 041 | |a Angol | ||
| 100 | 1 | |a Sibbing Dirk | |
| 245 | 1 | 0 | |a Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS) |h [elektronikus dokumentum] : |b a randomised, open-label, multicentre trial / |c Sibbing Dirk |
| 260 | |c 2017 | ||
| 300 | |a 1747-1757 | ||
| 490 | 0 | |a LANCET |v 390 No. 10104 | |
| 520 | 3 | |a 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 (pnon-inferiority=0.0004; hazard ratio [HR] 0.81 [95% CI 0.62-1.06], psuperiority=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%]; pnon-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 Universitat Munchen, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo. | |
| 650 | 4 | |a Klinikai orvostan | |
| 700 | 0 | 1 | |a Aradi Dániel |e aut |
| 700 | 0 | 1 | |a Jacobshagen Claudius |e aut |
| 700 | 0 | 1 | |a Gross Lisa |e aut |
| 700 | 0 | 1 | |a Trenk Dietmar |e aut |
| 700 | 0 | 1 | |a Geisler Tobias |e aut |
| 700 | 0 | 1 | |a Orban Martin |e aut |
| 700 | 0 | 1 | |a Hadamitzky Martin |e aut |
| 700 | 0 | 1 | |a Merkely Béla Péter |e aut |
| 700 | 0 | 1 | |a Kiss Róbert Gábor |e aut |
| 700 | 0 | 1 | |a Komócsi András |e aut |
| 700 | 0 | 1 | |a Dézsi Csaba András |e aut |
| 700 | 0 | 1 | |a et. al. |e aut |
| 700 | 0 | 2 | |a TROPICAL-ACS Investigators |e aut |
| 700 | 0 | 2 | |a Lux Árpád |e aut |
| 700 | 0 | 2 | |a Ruzsa Zoltán |e aut |
| 700 | 0 | 2 | |a Komócsi András |e aut |
| 700 | 0 | 2 | |a Ungi Imre |e aut |
| 700 | 0 | 2 | |a Nagy Ferenc Tamás |e aut |
| 700 | 0 | 2 | |a et al. |e aut |
| 856 | 4 | 0 | |u http://publicatio.bibl.u-szeged.hu/24065/1/Sibbing.pdf |z Dokumentum-elérés |