Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial.

Tomaniak, Mariusz; Chichareon, Ply; Klimczak-Tomaniak, Dominika; Takahashi, Kuniaki; Kogame, Norihiro; Modolo, Rodrigo; Wang, Rutao; Ono, Masafumi; Hara, Hironori; Gao, Chao; Kawashima, Hideyuki; Rademaker-Havinga, Tessa; Garg, Scot; Curzen, Nick; Haude, Michael; Kochman, Janusz; Gori, Tommaso; Montalescot, Gilles; Angiolillo, Dominick J; Capodanno, Davide; ... (2020). Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clinical research in cardiology, 109(7), pp. 930-943. Springer-Verlag 10.1007/s00392-019-01586-9

[img]
Preview
Text
Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor.pdf - Published Version
Available under License Publisher holds Copyright.

Download (2MB) | Preview

BACKGROUND

Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF.

METHODS

A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m2).

RESULTS

At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF.

CONCLUSIONS

IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy.

CLINICAL TRIAL REGISTRATION

The trial has been registered with ClinicalTrials.gov, number NCT01813435.

Item Type:

Journal Article (Original Article)

Division/Institute:

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

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1861-0684

Publisher:

Springer-Verlag

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

19 Nov 2020 15:17

Last Modified:

12 Jan 2024 00:25

Publisher DOI:

10.1007/s00392-019-01586-9

PubMed ID:

31925529

Uncontrolled Keywords:

Aspirin-free antiplatelet strategies Chronic kidney disease DAPT Impaired renal function Percutaneous coronary intervention Ticagrelor

BORIS DOI:

10.7892/boris.147462

URI:

https://boris.unibe.ch/id/eprint/147462

Actions (login required)

Edit item Edit item
Provide Feedback