• J. Thromb. Thrombolysis · Apr 2019

    Randomized Controlled Trial Multicenter Study

    Guided de-escalation of DAPT in acute coronary syndrome patients undergoing percutaneous coronary intervention with BVS implantation: a post-hoc analysis from the randomized TROPICAL-ACS trial.

    • Lukasz Koltowski, Mariusz Tomaniak, Lisa Gross, Bartosz Rymuza, Michal Kowara, Radoslaw Parma, Anna Komosa, Mariusz Klopotowski, Claudius Jacobshagen, Tommaso Gori, Daniel Aradi, Kurt Huber, Martin Hadamitzky, Steffen Massberg, Maciej Lesiak, Krzysztof J Filipiak, Adam Witkowski, Grzegorz Opolski, Zenon Huczek, and Dirk Sibbing.
    • 1st Department of Cardiology, Medical University of Warsaw, ul. Banacha 1a, 02-097, Warsaw, Poland. lukasz.koltowski@wum.edu.pl.
    • J. Thromb. Thrombolysis. 2019 Apr 1; 47 (3): 427-435.

    AbstractTo investigate the safety and efficacy of an early platelet function testing (PFT)-guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVS). Early DAPT de-escalation is a new non-inferior alternative to 12-months DAPT in patients with biomarker positive ACS treated with stent implantation. In this post-hoc analysis of the TROPICAL-ACS trial, which randomized 2610 ACS patients to a PFT-guided DAPT de-escalation (switch from prasugrel to clopidogrel) or to control group (uniform prasugrel), we compared clinical outcomes of patients (n = 151) who received a BVS during the index PCI. The frequency of the primary endpoint (cardiovascular death, myocardial infarction, stroke or BARC ≥ 2 bleeding) was 8.8% (n = 6) in the de-escalation group vs. 12.0% (n = 10) in the control group (HR 0.72, 95% CI 0.26-1.98, p = 0.52) at 12 months. One early definite stent thrombosis (ST) occurred in the control group (day 19) and 1 possible ST (sudden cardiovascular death) in the de-escalation group (day 86), both despite prasugrel treatment and in a background of high on-treatment platelet reactivity assessed at day 14 after randomization (ADP-induced platelet aggregation values of 108 U and 59 U, respectively). A PFT-guided DAPT de-escalation strategy could potentially be a safe and effective strategy in ACS patients with BVS implantation but the level of platelet inhibition may be of particular importance. This hypothesis-generating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.

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