Everolimus-Stent PCI Effective in Most CKD Patients: Analysis

September 18, 2015

NEW YORK, NY — In patients with chronic kidney disease (CKD) undergoing coronary revascularization, those who received an everolimus-eluting stent (EES) had a significantly lower risk of death, stroke, and need for repeat revascularization at 30 days compared with patients who underwent CABG surgery, according to the results of a new observational study[1].

In follow-up out to nearly 3 years, though, patients who underwent PCI with EES had a similar mortality risk and a lower risk of stroke as those undergoing CABG but significantly higher risks of MI and repeat revascularization. A subgroup analysis of CKD patients on hemodialysis showed these patients had a significantly increased risk of death and repeat revascularization with PCI compared with CABG surgery.

"The vast majority of cardiovascular trials exclude patients with CKD," lead investigator Dr Sripal Bangalore (New York University School of Medicine) told heartwire from Medscape. "There is such an explosion of diabetes and obesity that we're going to see a lot of these CKD patients in our clinical practice, and the number-one cause of mortality in these patients is coronary artery disease. But since the trials exclude patients with CKD, we have no idea how to best manage them."

The European guidelines recommend CABG over PCI (class IIa) in patients with moderate to severe CKD and multivessel disease if the surgical risk profile is acceptable and the patient is expected to live beyond 1 year. Similarly, the American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend CABG over PCI in patients with end-stage renal disease and three-vessel coronary disease/disease in the proximal left-anterior descending (LAD) artery plus one other major artery.

The recommendations, said Bangalore, are fairly "weak" in favoring CABG over PCI in the CKD setting and are based on observational studies comparing bypass surgery with first-generation drug-eluting stents or bare-metal stents.

Published in the September 15, 2015 issue of the Journal of the American College of Cardiology, the analysis included 11,305 patients with CKD and multivessel coronary disease. Of these, 5028 underwent PCI with EES and 6247 underwent CABG surgery. Given differences in baseline characteristics, 2960 patients in the EES arm were propensity-matched with 2960 patients in the CABG arm.

Overall, patients who received the latest-generation EES had a 45% lower relative risk of death at 30 days compared with the CABG-treated patients. The risk of stroke and repeat revascularization was reduced 78% and 52%, respectively, relative to those who underwent CABG surgery. By nearly 3 years, there remained a benefit in terms of stroke reduction with PCI, but rates of MI and repeat revascularization were higher in the PCI-treated patients. All-cause mortality at 2.9 years was similar in the two treatment arms.

Short- and Long-Term Outcome in Propensity-Matched Cohort

Outcome EES, n=2960 (%) CABG, n=2960 (%) Hazard ratio (95% CI)
30 days
Death 1.0 1.7 0.55 (0.35–0.87)
MI 0.7 0.5 1.33 (0.68–2.60)
Stroke 0.4 1.7 0.22 (0.12–0.42)
Repeat revascularization 0.4 0.8 0.48 (0.23–0.98)
2.9 years
Death 22.7 20.5 1.07 (0.92–1.24)
MI 10.7 7.0 1.76 (1.40–2.23)
Stroke 4.5 6.4 0.56 (0.41–0.76)
Repeat revascularization 26.1 13.1 2.42 (2.05–2.85)

Regarding the increase in MI at 2.9 years with PCI, the researchers say the increase was driven by patients with three-vessel coronary artery disease and by patients who underwent incomplete revascularization. To heartwire , Bangalore said the increase in MI among patients who were incompletely revascularized might be the result of greater atherosclerotic burden, which would increase their risk of ischemic events.

EES Implantation as an Alternative to CABG

In an editorial[2], Dr John Bittl (Munroe Regional Medical Center, Ocala, FL) said the study gives "relevant and timely guidance for revascularization decisions" in patients with CKD and multivessel coronary artery disease.

"The results suggest that patients with CKD stage 3 or 4 and multivessel coronary artery disease can undergo EES implantation as an alternative to CABG, particularly if there are mitigating factors against CABG such as frailty or significantly reduced life expectancy," writes Bittl. "However, surgical candidates with CKD stage 3 or 4 and multivessel coronary artery disease involving the proximal LAD should probably be given the option of CABG, because longer follow-up may show a survival advantage with surgery."

Regarding the patients with advanced CKD on hemodialysis, Bittl said that despite the data showing an advantage of CABG surgery over PCI, revascularization decisions need to be made on an individual basis. He added that the observational study highlights the need for a randomized, controlled trial comparing CABG surgery and PCI in patients with CKD.

Bangalore said while there are debates over which revascularization is best for CKD patients, the real question is whether these patients should even undergo coronary revascularization at all. To address this gap in knowledge, Bangalore is leading the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches—Chronic Kidney Disease trial (ISCHEMIA-CKD), an international comparative effectiveness study in stable ischemic heart disease in patients with advanced chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2 or on dialysis).

For these CKD patients with moderate to severe ischemia on stress imaging, the investigators will test a routine invasive strategy with cardiac catheterization followed by coronary revascularization plus optimal medical therapy (OMT) against a conservative strategy of OMT alone (reserving revascularization for patients who fail medical therapy).

"COURAGE and BARI-2D largely excluded patients with chronic kidney disease or included only a very small group of patients," said Bangalore. "We just don't know how to treat them. Hopefully ISCHEMIA-CKD will provide more insight."

The study was funded by Abbott Vascular. Bangalore has served as an ad hoc consultant/speaker for Abbott Vascular; has received research grants from Abbott Vascular and the National Heart, Lung, and Blood Institute; and has received honoraria from Abbott Vascular. Disclosures for the coauthors are listed in the paper. Bittl has no relevant financial relationships. 

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