Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of
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ORIGINAL INVESTIGATION
Cardiovascular Diabetology Open Access
Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial Chao Gao1,2,15†, Mariusz Tomaniak3,4†, Kuniaki Takahashi5, Hideyuki Kawashima5,15, Rutao Wang1,2,15, Hironori Hara5,15, Masafumi Ono5,15, Gilles Montalescot6, Scot Garg7, Michael Haude8, Ton Slagboom9, Pascal Vranckx10, Marco Valgimigli11, Stephan Windecker11, Robert‑Jan van Geuns2, Christian Hamm12, Philippe Gabriel Steg13,14, Yoshinobu Onuma15, Dominick J. Angiolillo16 and Patrick W. Serruys15,17,18*
Abstract Background: Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation char‑ acterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients. Methods: In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (onemonth dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regi‑ men (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patientoriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events. Results: At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66–2.80], p 60 mm Total Stent Length (SD)
323/10,513 (3.1%)
88/3189 (2.8%)
31/1332 (2.3%)
28/838 (3.3%)
1346/10,513 (12.8%)
437/3189 (13.7%)
180/1332 (13.5%)
106/838 (12.7%)
35.2 (25.1)
36.0 (25.2)
35.7 (25.8)
36.3 (26.2)
Medications on discharge ACE-inhibition and/or ARB
6346/10,450 (60.4%)
1986/3162 (62.3%)
730/1320 (54.8%)
457/826 (54.5%)
Beta-blockade
8194/10,452 (77.9%)
2577/3163 (80.8%)
1069/1321 (80.3%)
669/826 (79.8%)
Statin
9718/10,459 (92.4%)
2916/3168 (91.4%)
1212/1322 (91.0%)
764/827 (91.2%)
Paris bleeding risk score [31] (IQR)
3 (2,4)
3 (2,4)
6 (5,7)
6 (5,7)*
Paris thrombotic risk score (IQR)
2 (0,4)
3 (2,4)
4 (2,7)
5 (4,7)*
Paris bleeding risk score ≥ 8
100/10,039 (1.0%)
41/3060 (1.3%)
269/1288 (20.9%)
189/803 (23.5%)*
Paris thrombotic risk score ≥ 5
140/10,506 (1.3%)
655/3185 (20.8%)
243/1331 (18.3%)
615/838 (73.4%)*
PRECISE DAPT score [15] (IQR)
14 (9,19)
15 (10,20)
27 (23,32)
29 (24,34)*
731/9849 (7.4%)
323/3007 (10.7%)
846/1266 (66.8%)
567/799 (71.0%)*
PRECISE DAPT score ≥ 25 Antiplatelet therapy Reference treatment strategy
5297/10,513 (50.4%)
1575/3189 (49.4%)
662/1332 (49.7%)
410/838 (48.9%)
Experimental treatment strategy
5216/10,513 (49.6%)
1614/3189 (50.6%)
670/1332 (50.3%)
428/838 (51.1%)
Data are n
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