TY - JOUR
T1 - Guided de-escalation of DAPT in acute coronary syndrome patients undergoing percutaneous coronary intervention with BVS implantation
T2 - a post-hoc analysis from the randomized TROPICAL-ACS trial
AU - Koltowski, Lukasz
AU - Tomaniak, Mariusz
AU - Gross, Lisa
AU - Rymuza, Bartosz
AU - Kowara, Michal
AU - Parma, Radoslaw
AU - Komosa, Anna
AU - Klopotowski, Mariusz
AU - Jacobshagen, Claudius
AU - Gori, Tommaso
AU - Aradi, Daniel
AU - Huber, Kurt
AU - Hadamitzky, Martin
AU - Massberg, Steffen
AU - Lesiak, Maciej
AU - Filipiak, Krzysztof J.
AU - Witkowski, Adam
AU - Opolski, Grzegorz
AU - Huczek, Zenon
AU - Sibbing, Dirk
N1 - Publisher Copyright:
© The Author(s) 2019.
PY - 2019/4
Y1 - 2019/4
N2 - To 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 hypothesisgenerating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.
AB - To 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 hypothesisgenerating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.
KW - Bioresorbable vascular scaffold
KW - Clopidogrel
KW - Platelet function testing
KW - Prasugrel
UR - http://www.scopus.com/inward/record.url?scp=85061297788&partnerID=8YFLogxK
U2 - 10.1007/s11239-019-01811-2
DO - 10.1007/s11239-019-01811-2
M3 - Article
C2 - 30739305
AN - SCOPUS:85061297788
SN - 0929-5305
VL - 47
SP - 427
EP - 435
JO - Journal of Thrombosis and Thrombolysis
JF - Journal of Thrombosis and Thrombolysis
IS - 3
ER -