EuroPCR 2019 | Global Leaders: Ticagrelor Monotherapy at Long Term Could Have a Role in Complex PCI

This post hoc analysis of what had been a trial with negative outcomes should be considered only as a hypothesis generator.

Patients receiving complex PCI treated with ticagrelor monotherapy after one-month dual antiaggregation therapy (DAPT) showed better results at 2 years when compared against patients receiving a conventional DAPT scheme.

In the global analysis, this trial did not show significant differences in primary end point (composite of all-cause mortality or non-fatal MI at 2 years).

This new analysis focuses on more complex patients, where leaving aspirin after one month and following with ticagrelor for 23 more months was associated with a 36% relative risk reduction of death or non-fatal MI, compared against patients receiving DAPT for 12 months followed by aspirin alone for 12 more months.

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This benefit of ticagrelor was not observed in non-complex PCI procedures.

The GLOBAL LEADERS was an open study carried out in 130 centers in 18 countries. It compared patients receiving PCI with Biolimus A9 (Biomatrix) DES in the context of acute coronary syndrome or stable chronic angina randomized to 75 or 100 mg of aspirin plus 90 mg ticagrelor twice a day for one month followed by ticagrelor as monotherapy for 23 more months vs. DAPT with clopidogrel (for stable patients) or ticagrelor (for acute patients) for 12 months, followed by aspirin as monotherapy.

Of the total study, some 4570 patients receiving complex PCI defined as diffuse multivessel disease, treating 3 or more lesions, interventions requiring 3 or more stents, bifurcations with 2 or more stents and a total stent length over 60 mm. These definitions are considered complex PCI by the European guidelines, and these are the patients at higher risk of ischemic events.

Bleeding risk with ticagrelor monotherapy was not higher than with conventional DAPT, both in complex and non-complex PCI.

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Net adverse clinical events (death, MI, stroke, revascularization plus BARC 3 to 5 bleeding) favored ticagrelor as monotherapy in complex PCI.

The higher the number of high- risk features, the higher the benefit of ticagrelor monotherapy.

Original Title: Effect of ticagrelor monotherapy for 23 months following 1-month DAPT vs. standard DAPT for 12 months followed by 12 months of aspirin monotherapy in patients undergoing complex PCI.

Presenter: Serruys PW.

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