Regional variation in patients and outcomes in the GLOBAL LEADERS trial.

Gao, Chao; Takahashi, Kuniaki; Garg, Scot; Hara, Hironori; Wang, Rutao; Kawashima, Hideyuki; Ono, Masafumi; Montalescot, Gilles; Haude, Michael; Slagboom, Ton; Vranckx, Pascal; Valgimigli, Marco; Windecker, Stephan; Hamm, Christian; Steg, Philippe Gabriel; Storey, Robert; van Geuns, Robert-Jan; Tao, Ling; Onuma, Yoshinobu and Serruys, Patrick W (2021). Regional variation in patients and outcomes in the GLOBAL LEADERS trial. International journal of cardiology, 324, pp. 30-37. Elsevier 10.1016/j.ijcard.2020.09.039

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BACKGROUND

Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy.

METHODS

Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years.

RESULTS

Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (Pinteraction = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction.

CONCLUSIONS

Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT01813435).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Valgimigli, Marco and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0167-5273

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

30 Nov 2020 14:14

Last Modified:

18 Jan 2021 01:32

Publisher DOI:

10.1016/j.ijcard.2020.09.039

PubMed ID:

32941872

Uncontrolled Keywords:

Aspirin-free antiplatelet strategies DAPT Percutaneous coronary intervention Ticagrelor

BORIS DOI:

10.7892/boris.147497

URI:

https://boris.unibe.ch/id/eprint/147497

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