Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study

Selected in EuroIntervention Journal by E. Asher

The aim of the current trial was to explore if direct P2Y12 inhibitor monotherapy was feasible and safe in patients with NSTEMI undergoing PCI.

Reviewer

Elad Asher

@AsherElad

Interventional cardiologist / Cardiologist

Jerusalem, Israel

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My Comment

Why this study – the rationale/objective? 

In patients with non-ST-segment elevation (NSTEMI) who undergo percutaneous coronary intervention (PCI), 12 months of dual antiplatelet therapy (DAPT) is the current standard of care.

However, long-term DAPT may increase bleeding, which is associated with increased mortality. In recent years, several large-scale randomized controlled trials have demonstrated that early aspirin withdrawal can significantly reduce bleeding without an increase in either stent-related or non-stent-related ischemic events. Yet, all these trials included at least 1 to 3 months of DAPT before switching to P2Y12 inhibitor monotherapy.

Hence, the aim of the current trial was to explore if direct P2Y12 inhibitor monotherapy was feasible and safe in patients with NSTEMI undergoing PCI.

How was it executed? - the methodology

Source: EuroIntervention

Source: EuroIntervention

The Optical Coherence Tomography (OCT) - Guided PCI with Single- Antiplatelet Therapy (OPTICA) study (ClinicalTrials.gov: NCT04766437) was a single-arm pilot study with 75 patients aimed to evaluate the feasibility and safety of P2Y12 inhibitor monotherapy using ticagrelor or prasugrel directly following PCI, using new generation drug-eluting stents (DES).

The study was conducted between March 2021 and March 2022, in 2 affiliated hospitals of the Amsterdam University Medical Center.

Inclusion criteria:

Patients diagnosed with NSTEMI or unstable angina were included after providing an informed consent.

Exclusion criteria:

• Patients on chronic oral anticoagulant therapy or with an allergy or contraindication to both ticagrelor and prasugrel were excluded.
• Patients who had an overriding indication for DAPT (e.g., recent PCI or ACS).
• Patients requiring complex PCI (PCI of left main disease, chronic total occlusion, a bifurcation lesion requiring two-stent treatment, a saphenous or arterial graft lesion, or severely calcified lesions) were also excluded.

Safety

• To enhance patient safety, all patients underwent platelet function testing before PCI, and the first 35 patients underwent OCT imaging after PCI.
• A stopping rule based on the occurrence of stent thrombosis was incorporated into the study design. If ≥ 2 cases of stent thrombosis occurred, patient enrolment would be halted, and patients would be switched to the current standard of care: 12 months of DAPT.

Antiplatelet therapy pre-PCI

• Patients received a loading dose of 180 mg ticagrelor or 60 mg prasugrel at least two hours prior to the index PCI (patients aged ≥ 75 years or with a body weight < 60 kg) were solely treated with ticagrelor.
• If patients were on a chronic aspirin regimen or received an aspirin loading dose (e.g. in the ambulance) prior to inclusion in the study, aspirin was discontinued on the day of the index PCI at the latest.

PCI

• All patients were treated with unfractionated heparin during coronary angiography.
• Index PCI was performed with the intention to treat the culprit vessel using new-generation DES. In case of multiple lesions, the decision for direct revascularization of non-culprit lesions or a staged approach was at the discretion of the treating physician.
• OCT was performed in the first 35 patients. The use of OCT imaging in the remaining 40 patients was at the discretion of the treating physician.

Antiplatelet therapy post-PCI

• Patients with adequate inhibition of platelet reactivity and an optimal stent result continued to receive 90 mg ticagrelor twice daily or 10 mg prasugrel once daily without concurrent aspirin for up to 12 months.
• In the case of high platelet reactivity or a suboptimal stent result, aspirin was added to the antiplatelet regimen.
• If patients developed atrial fibrillation or another indication for chronic oral anticoagulant therapy during follow-up, an oral anticoagulant in combination with clopidogrel for up to 12 months was recommended.

Study endpoints

Clinical follow-up was performed at 1, 3, 6 and 12 months by telephone contact.

• Primary ischemic endpoint: composite of all-cause mortality, MI, definite or probable stent thrombosis, or stroke within 6 months following PCI.
• Primary bleeding endpoint was major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding within 6 months following PCI.
• Secondary endpoints included any repeat revascularization and the individual components of the primary endpoints within 6 months following PCI

What is the main result?

• Seventy-five patients comprised the study population, of them, 85.3 % presented with NSTEMI, while 14.7 % were diagnosed with unstable angina.
• At the time of admission, 15 patients (20.0 %) were on a chronic aspirin regimen, and 55 patients (73.3 %) received an aspirin loading dose, most often in the ambulance, before undergoing PCI.
• The mean age was 64.5 ± 11.6 years, and 29.3 % of patients were female. Eighteen patients (24.0 %) had DM, and 28.0 % of patients were active smokers.
• Only 16.0 % of patients had undergone a PCI prior to the index procedure.
• Patients were discharged from the hospital after a median of 3 days (IQR: 2 to 5).

Platelet function testing

• Before the index procedure, 67 (89.3 %) and 8 (10.7 %) patients received loading dose of ticagrelor or prasugrel, respectively. All patients, with the exception of one, had adequate inhibition of platelet reactivity with a median PRU value of 6 (IQR: 2 to 28).

Procedural characteristics

• 96 % of patients underwent PCI via radial access.
• 24.0 % underwent multivessel PCI and 29.3 % of patients had more than one treated lesion during the index procedure [median number of implanted stents per patient was 1 (IQR: 1 to 2); median total stent length was 33 mm (IQR: 20 to 46); median minimum stent diameter was 3.00 mm (IQR: 2.75 to 3.50)].
• 45.3 % underwent OCT imaging during the index procedure.
• Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 was achieved in 106 out of 106 of lesions (100 %).
• 4 patients (5.3 %) had a suboptimal stent result or were otherwise deemed unsuitable for ticagrelor or prasugrel monotherapy by the treating physician.
• After excluding the above 4 patients and the patients which was poor responder to prasugrel, 70 (93.3 %) patients were treated with ticagrelor or prasugrel monotherapy directly following PCI.

Outcomes

• Primary ischemic endpoint occurred in 3 patients (4.0 %) within 6 months following PCI. (Two patients suffered from Type 4a MI due to temporary occlusion of a septal and diagonal side branch, respectively, during the index PCI and 1 patient suffered from a Type 2 MI due to severe hypertension).
• No cases of stent thrombosis or spontaneous MI (i.e., Type 1 MI) occurred within 6 months.
• Primary bleeding endpoint occurred in 7 (9.3 %) patients within 6 months (2 patients had a major bleeding event).
• Four patients (5.3 %) underwent repeat revascularization within 6 months.

Adherence to medication

• Directly following PCI, 93.3 % of patients were on ticagrelor or prasugrel monotherapy.
• At 1, 3 and 6 months, 89.3 %, 85.3 % and 82.7 % of patients remained on ticagrelor or prasugrel monotherapy, respectively.
• During follow-up, 11 (14.7 %) patients switched from ticagrelor to prasugrel monotherapy; 4. (5.3 %) switched from ticagrelor monotherapy to clopidogrel and aspirin; 2 (2.7 %) switched from ticagrelor monotherapy to ticagrelor and aspirin after complex, non-target vessel revascularization during follow-up, and 2 (2.7 %) switched to clopidogrel and an oral anticoagulant due to new onset atrial fibrillation.

Critical reading and the relevance for clinical practice

This pilot study was the first to demonstrate that monotherapy using ticagrelor or prasugrel directly after PCI in patients with NSTEMI was feasible in most patients and, more importantly, not associated with any overt safety concerns, given the absence of stent thrombosis and spontaneous MI within the first six months of follow-up.

The authors speculate that, in the present era, stent thrombosis is most often a consequence of suboptimal stent deployment and not device thrombogenicity, limiting the need for prolonged DAPT after successful stent implantation.

Pharmacological studies have previously demonstrated that the antithrombotic potency of ticagrelor and prasugrel alone is similar to the potency of ticagrelor or prasugrel combined with aspirin, providing a mechanistic rationale for P2Y12 inhibitor monotherapy.

The authors concluded that: Completely omitting aspirin after successful PCI in NSTE-ACS is feasible and not associated with any overt safety concerns given the absence of stent thrombosis and spontaneous MI within the first six months of follow-up. Ultimately, large-scale randomized controlled trials will need to examine the efficacy and safety of direct P2Y12 inhibitor monotherapy compared to the current standard of care; 12 months of DAPT.

Should common practice and guidelines be changed?

The current study has several limitations. a) there was no comparator or control group; b) important exclusion criteria such as the exclusion of complex PCI should be considered when extrapolating the results to a more general population; c) all patients in the present study underwent platelet function testing, which is not reflective of daily clinical practice and d) almost half of the patients in the present study underwent OCT-guided PCI, minimizing the risk of ischemic events post-PCI. Moreover, there was a routine preloading of P2Y12 inh. prior to PCI which is not according to the guidelines, as well as loading with prasugrel prior to knowing the coronary anatomy in NSTEMI patients.

What is your practice regarding P2Y12 inhibitors monotherapy in NSTEMI/ACS patients?