Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials.
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Baber Usman, Giustino Gennaro, Sartori Samantha, Aquino Melissa, Stefanini Giulio G, Steg P Gabriel, Windecker Stephan, Leon Martin B, Wijns William, Serruys Patrick W, Valgimigli Marco, Stone Gregg W, Dangas George D, Morice Marie-Claude, Camenzind Edoardo, Weisz Giora, Smits Pieter C, Kandzari David, Von Birgelen Clemens, Mastoris Ioannis, Galatius Soren, Jeger Raban V, Kimura Takeshi, Mikhail Ghada W, Itchhaporia Dipti, Mehta Laxmi, Ortega Rebecca, Kim Hyo-Soo, Kastrati Adnan, Chieffo Alaide, Mehran Roxana
Аннотация
BACKGROUND: The prevalence and effect of CKD in women undergoing PCI with DES is unclear.
METHODS: We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl) <45 ml/min, 45 to 59 ml/min, and ≥60 ml/min. The primary endpoint was the 3-year rate of major adverse cardiovascular events (MACE). Participants for whom baseline creatinine was missing were excluded from the analysis.
RESULTS: Of 4,217 women included in the pooled cohort treated with DES and for whom serum creatinine was available, 603 (14%) had a CrCl <45 ml/min, 811 (19%) had a CrCl 45 to 59 ml/min, and 2,803 (66%) had a CrCl ≥60 ml/min. A significant stepwise gradient in risk for MACE was observed with worsening renal function (26.6% vs. 15.8% vs. 12.9%; p < 0.01). Following multivariable adjustment, CrCl <45 ml/min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction.
CONCLUSIONS: Among women undergoing PCI with DES, CKD is a common comorbidity associated with a strong and independent risk for MACE that is durable over 3 years. The benefits of newer-generation DES are uniform in women with or without CKD.