Ann Intern Med. 2022 Nov 1. doi: 10.7326/M22-1667. Online ahead of print.
ABSTRACT
BACKGROUND: Evidence on the risk-benefit ratio of dual antiplatelet therapies among patients with stroke and impaired renal function is limited and inconsistent.
OBJECTIVE: To investigate the effect of renal function on the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin treatment.
DESIGN: Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04078737).
SETTING: 202 centers in China.
PATIENTS: CYP2C19 loss-of-function allele carriers with minor stroke or transient ischemic attack.
INTERVENTION: Ticagrelor-aspirin and clopidogrel-aspirin.
MEASUREMENTS: Renal function was evaluated by estimated glomerular filtration rate (eGFR) levels. The primary efficacy and safety outcomes were recurrent stroke and severe or moderate bleeding within 90 days, respectively.
RESULTS: Among 6378 patients, 4050 (63.5%) had normal (eGFR ≥90 mL/min/1.73 m2), 2010 (31.5%) had mildly decreased (eGFR 60 to 89 mL/min/1.73 m2), and 318 (5.0%) had moderately to severely decreased (eGFR <60 mL/min/1.73 m2) renal function. The corresponding differences in recurrent stroke between ticagrelor-aspirin and clopidogrel-aspirin for normal, mildly decreased, and moderately to severely decreased renal function was -2.8 percentage points (95% CI, -4.4 to -1.3 percentage points) (hazard ratio [HR], 0.63 [CI, 0.49 to 0.81]), -0.2 percentage point (CI, -2.4 to 2.0 percentage points) (HR, 0.98 [CI, 0.69 to 1.39]), and 3.7 percentage points (CI, -2.3 to 10.1 percentage points) (HR, 1.31 [CI, 0.48 to 3.55]), respectively. Rates of severe or moderate bleeding did not substantially differ by treatment assignments across eGFR categories.
LIMITATION: Renal function was only evaluated by using eGFR, and the proportion of patients with severely decreased renal function was low.
CONCLUSION: Patients with normal, rather than impaired, renal function received greater benefit from ticagrelor-aspirin versus clopidogrel-aspirin.
PRIMARY FUNDING SOURCE: Ministry of Science and Technology of the People’s Republic of China.
PMID:36315949 | DOI:10.7326/M22-1667
