Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Jul;17(7):e013503.
doi: 10.1161/CIRCINTERVENTIONS.123.013503. Epub 2024 May 6.

Angiographic Characteristics and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study

Aditya S Bharadwaj  1 , Arsalan Abu-Much  2 , Aneel S Maini  2 , Zhipeng Zhou  2 , Yanru Li  2 , Wayne B Batchelor  3 , Cindy L Grines  4 , Suzanne J Baron  5   6 , Björn Redfors  2   7 , Alexandra J Lansky  8   9 , Mir B Basir  10 , William W O'Neill  10
Affiliations
Randomized Controlled Trial

Angiographic Characteristics and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study

Aditya S Bharadwaj et al. Circ Cardiovasc Interv. 2024 Jul.

Abstract

Background: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI).

Methods: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization).

Results: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m2, 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis.

Conclusions: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.

Keywords: coronary artery disease; glomerular filtration rate; hypertension; percutaneous coronary intervention; renal insufficiency, chronic.

PubMed Disclaimer

Conflict of interest statement

Dr Bharadwaj reports consulting and speaker fees from Abiomed, Shockwave Medical, and Cardiovascular Systems, Inc. Dr Batchelor reports consulting for Abbott, Medtronic, and Boston Scientific. Dr Grines reports participation on the advisory boards for Philips and Abiomed. Dr Baron reports receiving institutional research support from Boston Scientific Corporation, Acarix, and Abiomed; speaker fees from Medtronic, Edwards Lifesciences, Shockwave, and Zoll Medical; and consulting fees/advisory board membership from Medtronic, Boston Scientific Corporation, Zoll Medical, and Abiomed. Dr Redfors reports consultant fees from Pfizer and Boehringer Ingelheim. Dr Lansky received speaker fees from Abiomed. M.B. Basir has been a consultant/speaker for Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Dr O’Neill reports grant/research support from St. Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Study flowchart. The estimated glomerular filtration rate (eGFR) was calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation. PROTECT III indicates A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI.
Figure 2.
Figure 2.
Kaplan-Meier curves for major adverse cardiovascular and cerebrovascular events (MACCEs) at 30 and 90 d stratified by the estimated glomerular filtration rate (eGFR). eGFR was calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation.
Figure 3.
Figure 3.
Kaplan-Meier curves for all-cause death and cardiovascular death at 30 and 90 d stratified by the estimated glomerular filtration rate (eGFR). A, All-cause death. B, Cardiovascular death. eGFR was calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation.
Figure 4.
Figure 4.
Kaplan-Meier curves for all-cause death at 1-y stratified by the estimated glomerular filtration rate (eGFR). eGFR was calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Sarnak MJ, Amann K, Bangalore S, Cavalcante JL, Charytan DM, Craig JC, Gill JS, Hlatky MA, Jardine AG, Landmesser U, et al. ; Conference Participants. Chronic kidney disease and coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol. 2019;74:1823–1838. doi: 10.1016/j.jacc.2019.08.1017 - PubMed
    1. Bundy JD, Chen J, Yang W, Budoff M, Go AS, Grunwald JE, Kallem RR, Post WS, Reilly MP, Ricardo AC, et al. . Risk factors for progression of coronary artery calcification in patients with chronic kidney disease: the CRIC study. Atheroscler. 2018;271:53–60. doi: 10.1016/j.atherosclerosis.2018.02.009 - PMC - PubMed
    1. Coca SG, Krumholz HM, Garg AX, Parikh CR. Underrepresentation of renal disease in randomized controlled trials of cardiovascular disease. JAMA. 2006;296:1377–1384. doi: 10.1001/jama.296.11.1377 - PubMed
    1. Maini R, Wong DB, Addison D, Chiang E, Weisbord SD, Jneid H. Persistent underrepresentation of kidney disease in randomized, controlled trials of cardiovascular disease in the contemporary era. J Am Soc Nephrol. 2018;29:2782–2786. doi: 10.1681/ASN.2018070674 - PMC - PubMed
    1. Smilowitz NR, Gupta N, Guo Y, Mauricio R, Bangalore S. Management and outcomes of acute myocardial infarction in patients with chronic kidney disease. Int J Cardiol. 2017;227:1–7. doi: 10.1016/j.ijcard.2016.11.026 - PubMed

Publication types

MeSH terms

Associated data