Recent studies on antiplatelet antiaggregation support the use of short dual antiaggregation therapy (DAPT), even in unforeseen scenarios, such as complex PCI.
On the contrary, in patients with high ischemic risk, there is still evidence in favor of prolonged antiaggregation, mainly through the DAPT study, which showed lower risk of major ischemic events with DAPT prolonged after one year.
Another recent study was the HOST-EXAM, which showed ─ in a select Asian population ─ reduced cardiovascular events with clopidogrel monotherapy longer than a year, compared against aspirin monotherapy.
However, it has not been established yet whether a more potent antiaggregant such as ticagrelor might bring more benefits. The aim of this study, which looked at data from the main GLOBAL-LEADERS trial, was to compare the efficacy and safety of ticagrelor vs aspirin monotherapy after one year.
The Global Leaders included patients with chronic and acute coronary syndromes. It used biolimus eluting stents (BioMatrix), one month DAPT with ticagrelor and aspirin followed by 90 mg ticagrelor monotherapy every 12 hours for 23 months, or aspirin monotherapy after 12 month DAPT. The analysis included all patients that did not have events during their first year of DAPT aster stenting.
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Primary end point was a composite of death, acute myocardial infarction, and any stroke. Secondary safety end point was presence of BARC major bleeding (typo 3, 4 and 5), other outcomes were any revascularization, a combined outcome oriented to the patient (POCE [primary end point + new revascularization]) and net clinical events (NCE [POCE + bleeding BARC 3 or 5]).
The study looked at data from 11121 patients with similar baseline characteristics, primary end point was significantly lower in patients treated with ticagrelor (adjusted HR: 0.74, CI 95% 0.58-0.96; P=0.022), mainly driven by reduced rate of new AMI (adjusted HR 0.54, CI 95% 0.36-0.82; P=0.003). The risk of new revascularization was also lower with ticagrelor (adjusted HR 0.80, CI 95% 0.64-0.99; p=0.037), with no differences in stent thrombosis. When looking at safety outcomes, there was BARC major bleeding type 3 or 5 (HR 1.80, CI 95%: 0.99-3.30; p=0.055) and type 2 (adjusted HR 1.47, CI 95%: 1.02-2.11; p=0.027). Also, in combined primary end points, POCE showed significant reduction (HR 0.82, CI 95%: 0.69-0.98; p=0.027), but not NCE (adjusted HR 0.85, CI 95%: 0.72-1.01; p=0.069).
Conclusions
The main findings of this study were lower events rate with ticagrelor monotherapy after one year, at the expense of higher bleeding risk. It has the limitations of any sub-study, not prespecified, which means it will only be useful as a hypothesis generator.
When looking at the number needed to treat to reduce primary end point (it was 145, associated to higher risk of bleeding) the use of this strategy is not justified against the use of aspirin, even less when you take into account the cost of ticagrelor vs. aspirin.
Dr. Omar Tupayachi.
Member of the editorial board of SOLACI.org.
Original Title: Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.
Reference: Ono, Masafumi et al. “Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.” EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology vol. 18,5 e377-e388. 5 Aug. 2022, doi:10.4244/EIJ-D-21-00870.
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