P2Y₁₂ inhibitor monotherapy, no aspirin, after PCI for NSTE-ACS
Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study
Introduction and methods
Background
Several large-scale RCTs have shown that early switching from dual antiplatelet therapy (DAPT) to P2Y₁₂ inhibitor monotherapy can reduce bleeding risk in patients with non–ST-segment elevation ACS (NSTE-ACS) undergoing PCI, without increasing ischemic events [1-6]. Before the switch, however, all these trials included ≥1–3 months of DAPT, a period in which the average daily bleeding risk following PCI is highest [7].
Aim of the study
The authors evaluated the feasibility and safety of P2Y₁₂ inhibitor monotherapy directly following PCI in patients with NSTE-ACS.
Methods
The OPTICA (Optical Coherence Tomography-Guided PCI with Single-Antiplatelet Therapy) study was a single-arm pilot study conducted at the 2 affiliated hospitals of the Amsterdam University Medical Centers in the Netherlands. In this study, 75 patients with NSTE-ACS (NSTEMI or unstable angina) received a loading dose of ticagrelor 180 mg or prasugrel 60 mg (at the treating physician’s discretion) PCI using new-generation drug-eluting stents. Exclusion criteria were, among others, overriding indication for DAPT (f.e., recent PCI or ACS) and need for complex PCI.
In the first 35 patients, the stent result was adjudicated per protocol with optical coherence tomography (OCT); use of OCT imaging in the remaining 40 patients was at the discretion of the treating physician. Monotherapy with ticagrelor (90 mg twice daily ) or prasugrel (10 mg once daily) was continued for up to 12 months.
Outcomes
The primary ischemic endpoint was a composite outcome of all-cause mortality, MI, definite or probable stent thrombosis, or stroke within 6 months following PCI. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) bleeding type 2, 3, or 5 within 6 months.
Main results
- Overall, 70 of the 75 patients (93.3%) were treated with ticagrelor or prasugrel monotherapy directly following PCI. Medication adherence at 1, 3, and 6 months was 89.3%, 85.3%, and 82.7%, respectively.
- In the intention-to-treat analysis, 3 patients (4.0%) met the primary ischemic endpoint within 6 months, of whom 2 suffered a coronary intervention–related (type 4a) MI and 1 suffered a type 2 MI due to severe hypertension. There were no cases of death, spontaneous (type 1) MI, stent thrombosis, or stroke.
- The primary bleeding endpoint occurred in 7 patients (9.3%), of whom 2 had a major bleeding event (BARC type 3) and 5 a minor bleeding event (BARC type 2).
- During follow-up, 11 patients (14.7%) switched from ticagrelor to prasugrel monotherapy, mainly due to presumed side effects of ticagrelor.
Conclusion
This Dutch, bicenter, single-arm, pilot study in 75 NSTE-ACS patients showed that P2Y₁₂ inhibitor monotherapy with ticagrelor or prasugrel directly following PCI was feasible in most patients and was not associated with any overt safety concerns within the first 6 months. The authors stress they are the first to investigate aspirin withdrawal directly following PCI in NSTE-ACS patients and that “[t]his pilot study was only possible because of the recent advances made in stent technology and the advent of potent P2Y₁₂ inhibitors.”
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