Abstract
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 hypothesis-generating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.
Highlights
In the randomized Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes (TROPICAL-ACS) trial, a platelet function testing (PFT)-guided dual antiplatelet therapy1 3 Vol.:(0123456789)(DAPT) de-escalation strategy with an early switch from prasugrel to clopidogrel was found to be effective and safe when compared to standard treatment with uniform and potent platelet inhibition in biomarker positive acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) [1, 2]
Among younger ACS patients, there was a net clinical benefit from PFT-guided dual antiplatelet treatment (DAPT) de-escalation, driven by a reduction in bleeding events during long-term treatment [3]. Those observations were mainly derived from a study population treated with latest generation drug eluting stents (DES) in whom the largest benefits of potent platelet inhibition for protection against ischemic complications are observed early after PCI, while the risk of bleeding events persists during chronic antiplatelet treatment [4,5,6]
We analysed the safety and efficacy of a PFT-guided DAPT de-escalation strategy in ACS patients treated with bioresorbable vascular scaffold (BVS) implantation that were enrolled in the TROPICAL-ACS study
Summary
In the randomized Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes (TROPICAL-ACS) trial, a platelet function testing (PFT)-guided dual antiplatelet therapy1 3 Vol.:(0123456789)(DAPT) de-escalation strategy with an early switch from prasugrel to clopidogrel was found to be effective and safe when compared to standard treatment with uniform and potent platelet inhibition in biomarker positive acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) [1, 2]. A PFT-guided de-escalation of DAPT from a potent P2Y12 inhibitor to clopidogrel may offer an attractive alternative DAPT strategy especially for patients with BVS implantation and in whom sufficient and supposedly extended (> 12 months) dual platelet inhibition seems mandatory In this respect, the recently released 2018 ESC/EACTS Guidelines on myocardial revascularization have included a PFT-guided DAPT de-escalation as a treatment concept that may be considered (class IIb, LOE B) as an alternative DAPT strategy for ACS patients [14]. We analysed the safety and efficacy of a PFT-guided DAPT de-escalation strategy in ACS patients treated with BVS implantation that were enrolled in the TROPICAL-ACS study
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