Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial

Sibbing, Dirk; Aradi, Dániel; Jacobshagen, Claudius; Groß, Lisa; Trenk, Dietmar; Geisler, Tobias; Orban, Martin; Hadamitzky, Martin; Merkely, Béla; Kiss, Róbert Gábor; Komócsi, András; Holdt, Lesca M.; Felix, Stephan B.; Parma, Radosław; Kłopotowski, Mariusz; Rieber, Johannes; Huber, Kurt; Neumann, Franz‐Josef; Kołtowski, Łukasz; Mehilli, Julinda; Huczek, Zenon; Maßberg, Steffen; Parma, Zofia; Lesiak, Maciej; Komosa, Anna; Kowara, Michał; Rymuza, Bartosz; Małek, Łukasz A.; Veress, Gábor; Dézsi, András Döme; Lux, Árpád; Papp, Judit; Kovács, Andrea; Dézsi, Csaba András; Amer, Sayour; Ruzsa, Zoltán; Róna, Szilárd; Ili, Renáta; Ungi, Imre; Nagy, Ferenc; Zweiker, Robert; Tóth-Gayor, Gábor; Haller, P; Scheidt, Wolfgang von; Blüthgen, A.; Leggewie, Stefan; Kreider-Stempfle, Hans Ulrich; Remp, T.; Kara, Kaffer; Mügge, Andreas; Wutzler, Alexander; Fichtlscherer, Stephan; Zeiher, Andreas M.; Seeger, Florian; Hinterseer, Martin; König, Andreas; Lederle, Susanne; Czepluch, Frauke S.; Maier, Lars S.; Schillinger, Wolfgang; Sossalla, Samuel; Hummel, Astrid; Karakas, Mahir; Sydow, Karsten; Rudolph, Tanja K.; Halbach, Marcel; Gori, Tommaso; Münzel, Thomas; May, Andreas E.; Gerstenberg, Carsten-Manuel; Pilecky, Dávid; Deichstetter, Markus; Kääb, Stefan; Löw, Anja; Orban, Matthias; Sattler, Stefan; Deuschl, Sabine; Teupser, D.; Mudra, Harald; Räder, T.; Schütz, Torsten; Vahldiek, Felix; Divchev, Dimitar; İnce, Hüseyin; Nienaber, Christoph; Radunski, Henning; Boekstegers, Peter; Horstkotte, Jan; Mueller, Ralf; Müller, K.; Schwinger, Robert H. G.; Rasp, Oliver

doi:10.1016/s0140-6736(17)32155-4

Cited by 485 publications

(422 citation statements)

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“…Further on, switching and especially a de-escalation of DAPT (switching from potent P2Y 12 -inhibitors to clopidogrel) was subject to a number of randomized clinical trials. 716,717 Triggers for DAPT de-escalation include clinical (bleeding events or presumed high bleeding risk) and socio-economic factors. 716 Based on recent results from the randomized TROPICAL-ACS (Testing responsiveness to platelet inhibition on chronic antiplatelet treatment for acute coronary syndromes) trial 717 , an approach of DAPT de-escalation guided by platelet function testing may be considered in ACS patients (NSTE-ACS and STEMI) as an alternative to 12 months potent platelet inhibition, especially for patients deemed unsuitable for maintained potent platelet inhibition.…”

Section: Peri-interventional Treatmentmentioning

confidence: 99%

2018 ESC/EACTS Guidelines on myocardial revascularization

Neumann¹,

Ahlsson²,

Alfonso³

et al. 2018

European Heart Journal

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Section: Peri-interventional Treatmentmentioning

confidence: 99%

2018 ESC/EACTS Guidelines on myocardial revascularization

Neumann¹,

Ahlsson²,

Alfonso³

et al. 2018

European Heart Journal

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5,048

2,078

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“…73,74 The randomized TOPIC trial (Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome) showed that in patients who have been event free for the first month after an ACS on a combination of aspirin plus a new-generation P2Y 12 inhibitor, de-escalation to aspirin plus clopidogrel was associated with reduced bleeding complications, mostly minor. 73 Although this study did not show any differences in ischemic events between groups, play of chance cannot be ruled out given the limited sample size of the trial.…”

Section: De-escalation (Switching From Prasugrel or Ticagrelor To Clomentioning

confidence: 99%

“…The TROP-ICAL-ACS trial (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for ACS) randomized patients with ACS undergoing PCI to either standard treatment with prasugrel for 12 months or a de-escalation regimen (1 week of prasugrel followed by 1 week of clopidogrel and platelet function testing-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge). 74 The trial showed that a strategy of guided de-escalation of antiplatelet treatment was noninferior to standard treatment with prasugrel at 1 year in terms of net clinical benefit. The strategy did not show any increase in ischemic events, although there was a numeric but not statistically significant reduction in bleeding.…”

Section: De-escalation (Switching From Prasugrel or Ticagrelor To Clomentioning

confidence: 99%

International Expert Consensus on Switching Platelet P2Y ₁₂ Receptor–Inhibiting Therapies

et al. 2017

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Dual antiplatelet therapy with aspirin and a P2Y 12 inhibitor is the treatment of choice for the prevention of atherothrombotic events in patients with acute coronary syndromes and for those undergoing percutaneous coronary interventions. The availability of different oral P2Y 12 inhibitors (clopidogrel, prasugrel, ticagrelor) has enabled physicians to contemplate switching among therapies because of specific clinical scenarios. The recent introduction of an intravenous P2Y 12 inhibitor (cangrelor) further adds to the multitude of modalities and settings in which switching therapies may occur. In clinical practice, it is not uncommon to switch P2Y 12 inhibitor, and switching may be attributed to a variety of factors. However, concerns about the safety of switching between these agents have emerged. Practice guidelines have not fully elaborated on how to switch therapies, leaving clinicians with limited guidance on when and how to switch therapies when needed. This prompted the development of this expert consensus document by key leaders from North America and Europe with expertise in basic, translational, and clinical sciences in the field of antiplatelet therapy. This expert consensus provides an overview of the pharmacology of P2Y 12 inhibitors, different modalities and definitions of switching, and available literature and recommendations for switching between P2Y 12 inhibitors. Dual antiplatelet therapy with aspirin and a platelet P2Y 12 receptor antagonist (P2Y 12 inhibitor) is the treatment of choice for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) and for those undergoing percutaneous coronary intervention (PCI).1,2 Clopidogrel, prasugrel, and ticagrelor are the most commonly used oral platelet P2Y 12 inhibitors; the use of ticlopidine, the first available P2Y 12 inhibitor, has been largely abandoned. 3Clopidogrel is the only oral P2Y 12 inhibitor indicated for the treatment of patients with stable coronary artery disease.1,2 Although all 3 agents have an indication for use in ACS, current guidelines support the preferential use of prasugrel and ticagrelor over clopidogrel because of their superior net clinical benefits.1,2,4-6 Nevertheless, clopidogrel remains widely prescribed. 7,8 The availability of different oral P2Y 12 inhibitors has enabled physicians to contemplate switching among therapies because of specific clinical scenarios. 9 The recent introduction of an intravenous P2Y 12 inhibitor (ie, cangrelor) further adds to the multitude of modalities and settings in which switching therapies may occur. 6 A variety of factors may contribute to the decision to switch, including the clinical setting, patient characteristics, concomitant therapies, costs, social issues, development of side effects, medication adherence, and patient/physician preference. Therefore, it is not uncommon to change P2Y 12 inhibitor. However, concerns about the safety of switching between these agents have emerged. At present, data from large-scale clinical studie...

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“…Bleeding Academic Research Consortium 2 or higher bleeding events were similar between groups. 48 Although costly and time-consuming, early deescalation of antiplatelet treatment guided by platelet function testing may be an alternative approach in some patients. On a similar subject but with no use of platelet function testing guidance, the TOPIC (timing of platelet inhibition after acute coronary syndrome) trial showed that de-escalation from prasugrel or ticagrelor to clopidogrel after 30 days from the ACS may achieve lower bleeding rates than standard therapy with the more potent P2Y12 inhibitors for 12 months.…”

Section: Platelet Testingmentioning

confidence: 99%

The year in cardiology 2017: coronary interventions

Kristensen

Mæng

Capodanno

et al. 2018

European Heart Journal

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PreambleThe first balloon coronary angioplasty was performed in Zurich by Andreas Grüntzig in 1977. The patient, a 38-year-old man with severe angina and a tight stenosis on the left anterior descending artery, is still alive, is doing well, and he celebrated the 40-year anniversary of his percutaneous coronary interventions (PCI) in 2017 ( Figure 1). During the last decades, PCI techniques have undergone major improvements with the first real game changer being the introduction of bare metal stents, which made PCI safer and improved longer-term outcomes. Later on, drug-eluting stents (DESs) were introduced, which resulted in a major reduction in restenosis and also-with the newer generation DES-a low rate of stent thrombosis. Further, the introduction of intracoronary pressure measurements for assessment of severity of coronary stenoses [fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR)] and intracoronary imaging [intravascular ultrasound (IVUS) and optical coherence tomography (OCT)] for lesion assessment has refined lesion and procedure assessment. Improved outcomes were also fostered by development of better and safer adjunctive antithrombotic drugs and secondary prevention, optimizing drug-device synergy. Still, 40 years later the research in the coronary interventional field is very intense, and we aim here to summarize major developments in PCI published in 2017. Myocardial revascularization Percutaneous coronary intervention techniqueThe SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) II study investigated the impact of a contemporary PCI strategy on clinical outcomes of 454 patients with three-vessel disease. 1Characteristics of the SYNTAX II strategy that captures all components of today's 'best of PCI practice' are summarized in Figure 2. Following this approach systematically, the authors demonstrated major adverse cardiac and cerebrovascular events (MACCE) at 1 year to be much improved with respect to a matched historical PCI cohort from the SYNTAX I trial (10.6% vs. 17.4%; P = 0.006). The better result of the contemporary PCI strategy compared with the procedural technique followed at the time of the SYNTAX I trial was driven by a lower risk of myocardial infarction (MI) and revascularization, with a parallel reduction in stent thrombosis. Overall, the SYNTAX II study suggests that the combination of best practice components in PCI technique portends improved patient outcomes beyond what can be achieved by introducing one single new element. Because these results outperform PCI results obtained in the earlier SYNTAX I trial, the hypothesis was generated that a new randomized study of modern best PCI practice in patients with three-vessel disease might show non-inferiority vs. coronary artery bypass grafting (CABG). 1Glimpsing to the future, the feasibility and technical success of robotically-assisted PCI for complex coronary lesions were investigated in 334 procedures from 315 patients included in the Complex Robotically Assisted Percutaneous Coronary Intervention (...

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Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial

Cited by 485 publications

References 41 publications

2018 ESC/EACTS Guidelines on myocardial revascularization

2018 ESC/EACTS Guidelines on myocardial revascularization

International Expert Consensus on Switching Platelet P2Y ₁₂ Receptor–Inhibiting Therapies

The year in cardiology 2017: coronary interventions

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Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial

Cited by 485 publications

References 41 publications

2018 ESC/EACTS Guidelines on myocardial revascularization

2018 ESC/EACTS Guidelines on myocardial revascularization

International Expert Consensus on Switching Platelet P2Y 12 Receptor–Inhibiting Therapies

The year in cardiology 2017: coronary interventions

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Product

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International Expert Consensus on Switching Platelet P2Y ₁₂ Receptor–Inhibiting Therapies