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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

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Abstract

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.

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Dr. Tomaniak reports lecture fee from Astra Zeneca, outside the submitted work. Dr. Chichareon reports Grants from biosensons, outside the submitted work. Dr. Modolo reports Grants from Biosensors, outside the submitted work. Dr. Curzen reports Grants and personal fees from Boston Scientific, Grants and personal fees from Heartflow, Grants and personal fees from Haemonetics, outside the submitted work. Dr. Haude reports institutional Grant/research support from Biotronik AG, Abbott Vascular, Cardiac Dimensions, Volcano, Lilly and consultant/speaker´s bureau: Biotronik AG, Abbott Vascular, Cardiac Dimensions. Dr. Montalescot has received research Grants to the institution or consulting/lecture fees from Abbott, Amgen, Actelion, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Cardiovascular Research Foundation, Daiichi-Sankyo, Idorsia, Lilly, Europa, Elsevier, Fédération Française de Cardiologie, ICAN, Medtronic, Journal of the American College of Cardiology, Lead-Up, Menarini, Merck Sharp & Dohme, Novo Nordisk, Pfizer, Sanofi, Servier, The Mount Sinai School, TIMI Study Group, and WebMD. Dr. Angiolillo reports Grants and personal fees from Amgen, Grants and personal fees from Aralez, Grants and personal fees from Bayer, Grants and personal fees from Biosensors, Grants and personal fees from Boehringer Ingelheim, Grants and personal fees from Bristol-Myers Squibb, Grants and personal fees from Chiesi, Grants and personal fees from Daiichi-Sankyo, Grants and personal fees from Eli Lilly, personal fees from Haemonetics, Grants and personal fees from Janssen, Grants and personal fees from Merck, personal fees from PhaseBio, personal fees from PLx Pharma, personal fees from Pfizer, Grants and personal fees from Sanofi, personal fees from The Medicines company, Grants and personal fees from CeloNova, personal fees from St Jude Medical, Grants from CSL Behring, Grants from Eisai, Grants from Gilead, Grants from Idorsia Pharmaceuticals Ltd, Grants from Matsutani Chemical Industry Co., Grants from Novartis, Grants from Osprey Medical, Grants from Renal Guard Solutions, Grants from Scott R. MacKenzie Foundation, Grants from NIH/NCATS Clinical and Translational Science Award to the University of Florida UL1 TR000064 and NIH/NHGRI U01 HG007269, Grants and personal fees from Astra Zeneca, outside the submitted work. Dr. Capodanno reports personal fees from Bayer, personal fees from AstraZeneca, personal fees from Sanofi Aventis, personal fees from Baehringer, personal fees from Daiichi Sankyo, outside the submitted work. Dr. Storey reports personal fees from Bayer, personal fees from Bristol-Myers Squibb/Pfizer, Grants and personal fees from AstraZeneca, personal fees from Novartis, personal fees from Idorsia, Grants and personal fees from Thromboserin, personal fees from Haemonetics, personal fees from Amgen, Grants and personal fees from Glycardial Diagnostics, outside the submitted work. Dr. Hamm reports personal fees from AstraZeneca, outside the submitted work. Dr. Vranckx reports personal fees from AstraZeneca and the Medicines Company during the conduct of the study and personal fees from Bayer Health Care, Terumo, and Daiichi-Sankyo outside the submitted work. Dr. Valgimigli reports Grants and personal fees from Abbott, personal fees from Chiesi, personal fees from Bayer, personal fees from Daiichi Sankyo, personal fees from Amgen, Grants and personal fees from Terumo, personal fees from Alvimedica, Grants from Medicure, Grants and personal fees from AstraZeneca, personal fees from Biosensors, outside the submitted work. Dr. Windecker’s institution has research contracts with Abbott, Amgen, Bayer, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, St Jude Medical, Symetis SA, and Terumo outside the submitted work. Dr. Onuma has received consultancy fees from Abbott Vascular outside the submitted work. Dr. Serruys has received personal fees from Abbot Laboratories, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital Publishing, Stentys France, Svelte Medical Systems, Philips/Volcano, St Jude Medical, Qualimed, and Xeltis, outside the submitted work.

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Tomaniak, M., Chichareon, P., Klimczak-Tomaniak, D. et al. 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. Clin Res Cardiol (2020) doi:10.1007/s00392-019-01586-9

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Keywords

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