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PBMC isolation
SEPARATION
After blood sampling in EDTA tubes, PBMCs were isolated from the whole blood by density gradient centrifugation (Lymphocyte Separation Medium, CMSMSL0101, Eurobio) with SepMate tubes (85460, STEMCELL Technologies). Whole blood was transferred into SepMate tubes at a rate of 17 ml of whole blood per tube and then centri...
PMC10427431
Cytometry analysis
At each blood sample, before or during the patient’s treatment, we performed immunophenotyping by flow cytometry.
PMC10427431
Blood count analysis
anti-CD15-PacificBlue
FLUOR, LYSIS
Antibodies for blood count analysis: multi-color flow cytometry was performed using Beckman Coulter’s custom design service and its dry coating technology, and custom tubes containing anti-CD16-FITC (clone 3G8), anti-CD56-PE (clone N901), anti-CD19-PE-Cy5.5 (clone J3-119), anti-CD14-PE-Cy7 (clone RMO52), anti-CD4-APC (...
PMC10427431
Immune cell populations identification
anti-PD1-PE-Cy7, anti-CD15-PacificBlue
FLUOR, LYSIS
To decipher the peripheral immune system, we performed five panels to identify and characterize the different lymphocyte and myeloid subpopulations.Antibodies for T cell analysis (first panel): using Beckman Coulter’s custom design service and its dry coating technology, custom tubes containing anti-CD183-FITC (clone G...
PMC10427431
Lymphocyte function analysis
FLUOR
Using Beckman Coulter’s custom design service and its dry coating technology, custom tubes containing anti-IFN-γ-FITC (clone 45.15), anti-CD25-PE (clone B1.49.9), anti-CD4-PE-Cy5.5 (clone 13B8.2), anti-IL-4-PE-Cy7 (clone MP4-25D2), anti-Foxp3-Alexa Fluor 647 (clone 259D), anti-TNF-α-Alexa Fluor 700 (clone IPM2), anti-C...
PMC10427431
DNA and RNA extraction
tumor, Tumor
BLOOD, TUMOR, TUMOR
After the evaluation of the tumor cell content in FFPE tumor specimens by a pathologist, samples were macro-dissected to obtain at least 80% tumor cell content for nucleic acid extraction. DNA was isolated from tumor tissue using the Maxwell 16 FFPE Plus LEV DNA Purification Kit (Promega). DNA from whole blood (germlin...
PMC10427431
Whole-exome capture and sequencing
Two hundred nanograms of genomic DNA was used for library preparation, using the Agilent SureSelectXT Reagent Kit. The totality of the enriched library was used in the hybridization and captured with SureSelect All Exon v5 or v6 (Agilent) baits. After hybridization, the captured libraries were purified according to the...
PMC10427431
RNA-seq
RNA depleted of ribosomal RNA was used for the library preparation with a NEBNext Ultra II RNA Directional Library Prep Kit for Illumina according to the manufacturer’s instructions (New England Biolabs). RNA-seq was performed on a NextSeq 500 device (Illumina). The libraries were sequenced with 76-bp paired-end reads.
PMC10427431
scRNA-seq
tumor, Tumor
TUMOR, TUMOR
This analysis was performed on one patient with complete response. Fresh tumor tissue was collected on the day of surgery for this patient. Tumor was mechanically and enzymatically dissociated using a human tumor dissociation kit, according to the manufacturer’s instructions (130-095-929, Miltenyi Biotec). In brief, tu...
PMC10427431
Immunohistology procedure
tumor
TUMOR, PATHOLOGY
Biopsies were collected before study entry (archival materials), at baseline or during treatment and were fixed after collection in paraformaldehyde and embedded in paraffin by the pathology laboratory. Four-micron slices were cut from FFPE tumor samples. The tissues embedded in paraffin were cut on a Leica rotary micr...
PMC10427431
Imaging mass cytometry
PMC10427431
Antibodies and metal conjugation
Antibodies other than provided ready to use by Standard BioTools were conjugated to purified lanthanide metals and eluted in antibody stabilizer buffer (CANDOR Bioscience) using the Maxpar X8 Antibody Labeling Kit according to the manufacturer’s instructions (PRD002 Rev 14, Fluidigm, Standard BioTools). CD15 was labele...
PMC10427431
Antibody staining
SECONDARY
After deparaffinization and antigen retrieval using Dako Target Retrieval Solution at pH 9 (S236784-2, Agilent) in a water bath (96 °C for 30 min), 3-µm tissue sections were encircled with a Dako Pen and incubated with SuperBlock (37515, Thermo Fisher Scientific) at room temperature for 45 min and then with FcR Blockin...
PMC10427431
Data acquisition
Images were acquired with the Hyperion Imaging System (Fluidigm, Standard BioTools) according to the manufacturer’s instructions. After choosing the region of interest (ROI) in the section, the ROI was ablated with a UV laser at 200 Hz. Data were exported as .mcd files and visualized using Fluidigm MCD viewer 1.0.560.6...
PMC10427431
Imaging mass cytometry data pre-processing and cell segmentation
The raw data (.mcd files) were processed with the Steinbock pipeline (version 0.15.0)
PMC10427431
Cytokine measurement
tumor necrosis
TUMOR NECROSIS
Forty-five analytes were quantified in the plasma using Human XL Cytokine Magnetic 45-plex Luminex Assay (898855, R&D Systems) according to the manufacturer’s instructions: C-C motif chemokine ligand 2 (CCL2), CCL3, CCL4, CCL5, CCL11, CCL19, CCL20, CD40 ligand, fractalkine, C-X-C motif chemokine ligand 1 (CXCL1), CXCL2...
PMC10427431
ELISpot assay
tumor
TUMOR
Circulating tumor-specific T cell responses were assessed by IFN-γ ELISpot after short-term in vitro stimulation of PBMCs with a mixture of eight TERT-derived MHC class II-binding peptides (pool of HLA-DR and HLA-DP-restricted TERT peptidesThe same experiment was conducted after synthesis of 14 neopeptides identified f...
PMC10427431
Whole-exome sequencing data analysis
Cancer
MUTANT, CANCER
Reads in the FASTQ format were aligned to the reference human genome GRCh37 using the Burrows–Wheeler aligner (BWA version 0.7.17). Local realignment was performed using the Genome Analysis Toolkit (GATK version 4.13.0). Duplicate reads were removed using Picard version 2.5. In case of matched tumor-normal samples, som...
PMC10427431
RNA-seq data analysis
Raw FASTQ data were pseudo-aligned, and gene counts as well as transcripts per kilobase million (TPM) were quantified using Kallisto softwareTumor microenvironment (TME)-associated transcriptomic elements were quantified using MCP-counter, ImmuCellAI and tools, following respective guidelines. The MCP-counterThe CMScal...
PMC10427431
Single-cell data analysis
Cell Ranger (version 3.1.0) was used for raw data pre-processing. Each library was aligned to an indexed hg19 genome using Cell Ranger count. Output from Cell Ranger was loaded into R and further analyzed using the Seurat pipeline (version 3.1.2). Dimensional reduction, clustering and differential expression analysis o...
PMC10427431
TCR sequence analysis
TCR sequencing was used to count clonotypes detected in more than two cells per sample. A cell’s clonotype was defined as the combined alpha and beta chain CDR3 nucleotide sequences for that cell. As it was not possible to deduce beta and alpha chain pairing for partitions with multiple beta chains, these partitions we...
PMC10427431
Statistical analysis
death
DISEASE PROGRESSION, EVENT, METASTASIS
The efficacy population included all participants who met the eligibility criteria and who received at least one complete or two incomplete treatment cycles. All enrolled patients who initiated the study treatment were included in the safety analysis.PFS was defined as the time from the date of metastasis diagnosis to ...
PMC10427431
Reporting summary
Further information on research design is available in the
PMC10427431
Online content
Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02497-z.
PMC10427431
Supplementary information
Supplementary Figs. 1–8, Supplementary Tables 1–8, Protocol Clinical Study and CONSORT 2010 Checklist.Reporting Summary
PMC10427431
Source data
Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statistical source data.Statist...
PMC10427431
Extended data
PMC10427431
Extended data
is available for this paper at 10.1038/s41591-023-02497-z.
PMC10427431
Supplementary information
The online version contains supplementary material available at 10.1038/s41591-023-02497-z.
PMC10427431
Acknowledgements
Cancer
CANCER
We acknowledge O. Jaen (Beckman Coulter) for the help with flow cytometry panel design. We thank the GenomEast platform, a member of the ‘France Génomique’ consortium (ANR-10-INBS- 0009) for scRNA-seq and RNA-seq. We also thank the Cytometry platform (IGBMC, Strasbourg) for the sorting experiments related to scRNA-seq....
PMC10427431
Author contributions
RECRUITMENT
F.G. was the coordinating investigator of the study and was responsible for study conception and design and acquisition of funding and approvals. He also contributed as an investigator and medical monitor and to patient recruitment, data collection and data interpretation. The paper was written by F.G., M.T. and C.T., ...
PMC10427431
Peer review
PMC10427431
Data availability
The RNA-seq and single-cell data generated in this study have been deposited in the Gene Expression Omnibus database under accession number
PMC10427431
Competing interests
Pierre, J.B.
ONCOLOGY
F.G. received fees for oral communication from Eli Lilly, Sanofi, Bristol Myers Squibb, AstraZeneca and Amgen, received funding for clinical trials from AstraZeneca, received travel grants from Roche France, Amgen and Servier and is an advisory board member for Merck Serano, Amgen, Roche France and Sanofi, all outside ...
PMC10427431
References
PMC10427431
Abstract
Serban Stoica and Helena J M Smartt contributed equally to this work.
PMC10097434
OBJECTIVES
COLD
Intermittent cold blood cardioplegia is commonly used in children, whereas intermittent warm blood cardioplegia is widely used in adults. We aimed to compare clinical and biochemical outcomes with these 2 methods.
PMC10097434
METHODS
A single-centre, randomized controlled trial was conducted to compare the effectiveness of warm (≥34
PMC10097434
RESULTS
deaths
COLD
97 participants with median age of 1.2 years were randomized (49 to warm, 48 to cold cardioplegia); 59 participants (61%) had a risk-adjusted congenital heart surgery score of 3 or above. There were no deaths and 92 participants were followed to 3-months. Troponin release was similar in both groups [geometric mean rati...
PMC10097434
CONCLUSIONS
arrest
ARREST
Warm blood cardioplegia is a safe and reproducible technique but does not provide superior myocardial protection in paediatric heart surgery.Myocardial protection is typically achieved via cardioplegic arrest.
PMC10097434
INTRODUCTION
low cardiac output syndrome, arrest
DEL, ARREST, COMPLICATIONS, LOW CARDIAC OUTPUT SYNDROME
Myocardial protection is typically achieved via cardioplegic arrest. Several variables affect myocardial protection, including the type of crystalloid solution, mixing with blood, dose and frequency of delivery, and temperature. Sound protection and a technically adequate repair are cornerstones of surgery. Minimizing ...
PMC10097434
MATERIALS AND METHODS
PMC10097434
Ethical approval
Ethical approval was granted by the London—Central Ethics Service Committee (reference 18/LO/0205, 7 March 2018). Patients and/or parents/guardians provided written informed consent for randomization and use of their data.
PMC10097434
Trial design
Thermic-3 is a single-centre, parallel-group RCT. Participants were allocated in a 1:1 ratio to receive either antegrade ICBC or IWBC. Participants were followed-up for 3 months after randomization. Details of the study rationale and design are reported elsewhere [
PMC10097434
Participants and setting
arrest, atrial septal defect
CIRCULATORY ARREST, ARREST
Patients aged ≤18 years undergoing congenital heart surgery requiring CPB and cardioplegic arrest at the Bristol Royal Hospital for Children, a regional congenital cardiac surgery centre in the UK, were screened for eligibility. Patients weighing <3 kg, those requiring emergency surgery or secundum atrial septal defect...
PMC10097434
Interventions
electromechanical arrest of the heart
STERILE
Participants received either IWBC (blood cardioplegia at the same temperature as the body, ≥34°C) or ICBC (blood cardioplegia at 4–6°C) during surgery.The route of cardioplegia infusion for both groups was usually into the aortic root, or selectively into the coronary arteries. All surgeons used the same established ca...
PMC10097434
Outcomes
The primary outcome was cardiac troponin T (cTnT) over the 1st 48 postoperative hours. Secondary outcomes were cardiac function (left and right ventricular function by echocardiography), circulatory function [central venous saturations (CVS), arterial saturations, base deficit, blood lactate], blood gas and blood sampl...
PMC10097434
Sample size
The sample size was 94 patients (47/group), which provided 80% power to detect a difference of 0.46 standard deviations in cTnT, assuming correlations between pre- and post-surgery measures of 0.3 and between the post-surgery measures of 0.5, 5% statistical significance (2-tailed) and allowing for up to 15% missing dat...
PMC10097434
Randomization
HEART
Randomization was stratified by surgical complexity [Risk Adjustment for Congenital Heart Surgery (RACHS) score <3 vs ≥3]. Random allocations were computer-generated using blocks with varying sizes, prepared by a statistician independent of the study team. Allocations were concealed until a patient was recruited and re...
PMC10097434
Blinding
Staff providing postoperative care were blinded to the participants’ allocation. Documents containing allocation information (e.g. anaesthetic and perfusion charts) were placed in a sealed envelope within the medical notes. Staff accessing the contents of the sealed envelope were asked to record their name and reason f...
PMC10097434
Statistical methods
REGRESSION, EVENT
Analyses were based on a pre-specified statistical analysis plan and performed on an intention-to-treat basis. Continuous outcomes were compared using linear regression, time to event outcomes using Cox regression, categorical/ordinal outcomes using logistic regression and continuous longitudinal outcomes using linear ...
PMC10097434
RESULTS
PMC10097434
Recruitment
MAY
Between May 2018 and April 2020, 479 patients were screened for inclusion and 234 (49%) were eligible (There were 29 protocol deviations (12 ICBC versus 17 IWBC,
PMC10097434
Baseline data
mitral valve replacement, tricuspid valve repair and right ventricular, ventricular septal defect, Ebstein’s repair, pulmonary and tricuspid valve, atrioventricular septal defect
HEART, COLD
The median age was 1.2 years (range <1 month to 16.3 years): patients allocated IWBC were, on average, 7 months older than those allocated ICBC (median 11 and 18 months, respectively; Table Demography and intraoperative detailsData missing for 1 patient (ICBC).Other procedures were: ICBC group—double outlet right ventr...
PMC10097434
Operative details
Operative characteristics were similar in the 2 groups; the median duration of cross-clamp and CPB was 70 min and 100 min respectively, with 3- and 5-min difference between groups. The overall median duration of surgery was 225 min and blood product use was similar (Table 
PMC10097434
Primary outcome
cTnT concentrations are illustrated in Fig. (
PMC10097434
Secondary outcomes
BLOOD
The median postoperative chest drain loss was 75 ml in both groups (GMR 1.04; 95% CI 0.82–1.32; Electrical activity is shown in Cardiac function data are shown in Figs Blood gas levels over time. Geometric mean and 95% CI at each time point and GMR and 95% CI for the effect of IWBC versus ICBC on lactate (
PMC10097434
Complications and hospital readmissions
death, low cardiac output, stroke, Low cardiac output, neurological defects, paraplegia, Hirschsprung’s disease, disability
TRANSIENT ISCHAEMIC ATTACK, STROKE, RECURRENT LARYNGEAL NERVE PALSY, PARAPLEGIA, COLD, COMPLICATIONS, COMPLICATIONS
In the period from surgery to hospital discharge, there were 185 complications reported (69 ICBC, 116 IWBC), of which 30 (5 ICBC vs 25 IWBC) were classified as serious (Table Complications following surgeryComplications that were life-threatening or that caused hospitalization, increased length of hospital admission, p...
PMC10097434
DISCUSSION
Cardiac and renal function
EVENTS, COMPLICATIONS
Our results show that there is no difference in myocardial protection in the 1st 48 h when ICBC and IWBC are used, as evidenced by the similar cTnT profiles in the 2 groups. Cardiac and renal function were also comparable. However, participants in the IWBC group had on average a longer stay in PICU and experienced more...
PMC10097434
Strengths and limitations
myocardial damage
SEPARATION, COLD
This is one of few adequately powered RCTs focused on paediatric myocardial protection. Strengths are: inclusivity of the eligibility criteria; concealed allocation to minimize selection bias; objective outcomes and blinding to minimize detection bias, and minimal attrition. Stratification by RACHS score ensured the mo...
PMC10097434
CONCLUSION
In this single-centre trial of myocardial protection with St Thomas’ solution and normothermic bypass, IWBC is a safe and reproducible technique, but it does not provide superior myocardial protection to ICBC. Whether IWBC is advantageous for the most complex patients is uncertain as they are not represented in suffici...
PMC10097434
Supplementary Material
Click here for additional data file.
PMC10097434
ACKNOWLEDGEMENTS
We thank the research nurses, intensive care unit staff, anaesthetists, cardiologists and perfusionists who supported this research.
PMC10097434
SUPPLEMENTARY MATERIAL
PMC10097434
Funding
HEART
This work was supported by the British Heart Foundation (PG/15/33/31394/BHF, CH/1992027/7163/BHF, CH/17/1/32804/BHF) and the National Institute for Health Research (NIHR) Bristol Biomedical Research Centre. The funders played no role in the design, collection, analysis and interpretation of data. This trial was designe...
PMC10097434
DATA AVAILABILITY
SECONDARY
Anonymized individual patient data will be made available upon request to the corresponding author for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the Medical Research Council Policy on Data Sharing regarding scientific quality, ethical ...
PMC10097434
Author contributions
PMC10097434
Reviewer information
European Journal of Cardio-Thoracic Surgery thanks Rodrigo Soto and the other anonymous reviewer(s) for their contribution to the peer review process of this article.
PMC10097434
MAY, THORACIC
Presented at the American Association of Thoracic Surgery 102nd Annual Meeting, Boston, MA, USA, 14–17 May 2022.
PMC10097434
REFERENCES
PMC10097434
ABBREVIATIONS
HEART
Confidence intervalsCardiopulmonary bypassCardiac troponin TCentral venous saturationsGeometric mean ratioHazard ratioIntermittent cold blood cardioplegiaIntermittent warm blood cardioplegiaPaediatric Intensive Care UnitRisk Adjustment for Congenital Heart SurgeryRandomized controlled trialsVasoactive-inotrope score
PMC10097434
Key Points
PMC10687657
Question
chronic kidney disease
Is intravascular imaging beneficial in patients with complex coronary lesions and chronic kidney disease?
PMC10687657
Findings
vessel failure, cardiac death, chronic kidney disease
MYOCARDIAL INFARCTION, CARDIAC DEATH
In this prespecified cohort substudy of the RENOVATE-COMPLEX-PCI trial with 1639 patients with or without chronic kidney disease, intravascular imaging–guided revascularization was associated with significantly lower incidence of the target vessel failure (a composite of cardiac death, myocardial infarction, or target ...
PMC10687657
Meaning
coronary artery lesions, vessel failure
These findings suggest that in patients with complex coronary artery lesions, intravascular imaging–guided revascularization was superior to angiography-guided revascularization in reducing the risk of target vessel failure, regardless of kidney function.
PMC10687657
Importance
coronary lesions, CKD, chronic kidney disease
As patients with chronic kidney disease (CKD) are more likely to have complex coronary lesions, intravascular imaging guidance in percutaneous coronary intervention (PCI) for this population could be potentially beneficial.
PMC10687657
Objectives
CKD
To investigate whether the outcomes of intravascular imaging–guided procedural optimization would be different according to the presence of CKD.
PMC10687657
Design, Setting, and Participants
CKD
MAY
This was a prespecified substudy of RENOVATE-COMPLEX-PCI, a recently published multicenter randomized clinical trial in Korea studying the benefits of intravascular imaging for complex coronary lesions. Patients with complex coronary lesions, with or without CKD, were enrolled between May 2018 and May 2021. Data were a...
PMC10687657
Interventions
PCI in each group was done either under the guidance of intravascular imaging or angiography alone.
PMC10687657
Main Outcomes and Measures
vessel failure, TVF
MYOCARDIAL INFARCTION, CARDIAC DEATH
The primary end point was target vessel failure (TVF) at the 3-year point, defined as a composite of cardiac death, target vessel–related myocardial infarction, or clinically driven target vessel revascularization.
PMC10687657
Results
CKD, non-CKD
A total of 1639 patients (1300 male [79.3%]) treated with PCI for complex coronary lesions were stratified into CKD (296 participants) and non-CKD (1343 participants) groups. The mean (SD) age of each group was 70.3 (9.4) and 64.5 (10.1) years, and mean (SD) estimated serum creatinine was 2.9 (5.3) and 0.8 (0.2) mg/dL ...
PMC10687657
Conclusions and Relevance
CKD
In this prespecified cohort substudy of the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention trial, intravascular imaging guidance showed clinical benefit over angiography guidance in reducing the risk of TVF,...
PMC10687657
Trial Registration
ClinicalTrials.gov Identifier:
PMC10687657
Introduction
AIDS, CHRONIC KIDNEY DISEASE (CKD), CARDIOVASCULAR MORBIDITY
Chronic kidney disease (CKD) is a prevalent condition associated with increased cardiovascular morbidity and mortality.Intravascular imaging tools, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), are useful aids in optimizing stent implantation and securing positive clinical outcomes.
PMC10687657
Methods
PMC10687657
Trial Design and Patient Selection
The RENOVATE-COMPLEX-PCI was an investigator-initiated, randomized, open-label, multicenter, superiority trial at 20 sites in Korea. The design and primary results have been described previously.
PMC10687657
Randomization and Treatment
coronary artery lesions
Eligible patients with amenable complex coronary artery lesions were randomized in a 2:1 ratio to the intravascular imaging–guided PCI group or the angiography-guided PCI group. Randomization was performed by a web-based program run by an independent organization and stratified according to clinical presentation and pa...
PMC10687657
Definitions and End Points
CKD
MAY
CKD was defined if the patient previously received a diagnosis of CKD (supported either by medical record or history-taking) or if the estimated glomerular filtration rate (GFR) was below 60mL/min/1.73mPatient follow-up was conducted at 1, 6, and 12 months and annually thereafter. The clinical follow-up was completed i...
PMC10687657
Statistical Analysis
The full statistical analysis plan and sample size calculation of the RENOVATE-COMPLEX-PCI were previously described in detail.
PMC10687657
Results
PMC10687657
Baseline Demographics
CKD
Of the 1639 patients (1300 male [79.3%]) enrolled in this trial, 296 patients (mean [SD] age, 70.3 [9.4] years) had CKD (203 patients undergoing imaging-guided PCI and 93 patients undergoing angiography-guided PCI) and 1343 patients (mean [SD] age, 64.5 [10.1] years) did not have CKD (889 patients undergoing imaging-gu...
PMC10687657
Baseline Characteristics Stratified by Presence of Chronic Kidney Disease (CKD) and Allocation Group
Abbreviations: GFR, glomerular filtration rate; LV, left ventricle; PCI, percutaneous coronary intervention.SI conversion factor: To convert creatinine to micromoles per liter, multiply by 76.25.Of the total 1639 patients, 104 (6.3%) had no LV ejection fraction.
PMC10687657
Angiographic and Procedural Characteristics
CKD, non-CKD
A comparison of angiographic and procedural characteristics between CKD and non-CKD groups is shown in eTable 2 in Angiographic characteristics and lesion complexity between the 2 randomly assigned strategies were generally well balanced, regardless of the presence of CKD (In lesion-level analysis, the location of the ...
PMC10687657
Comparison of Primary End Points According to Chronic Kidney Disease (CKD) and Glomerular Filtration Rate (GFR)
vessel failure, CKD, diabetes
HYPERTENSION, DYSLIPIDEMIA, ACUTE CORONARY SYNDROME, DIABETES
A, The Kaplan-Meier curve shows the cumulative incidence of target vessel failure in patients with (orange line) or without (blue line) CKD who underwent complex percutaneous coronary intervention. B, Continuous association of GFR with cumulative hazard of the target vessel failure is presented. Adjusted variables incl...
PMC10687657
Primary and Secondary End Points in Patients With Chronic Kidney Disease
MYOCARDIAL INFARCTION, ACUTE CORONARY SYNDROME
Abbreviations: HR, hazard ratio; MI, myocardial infarction; NA, not applicable.Percentages are 3-year Kaplan-Meier estimates.Adjusted variables for multivariable analysis were age, sex, acute coronary syndrome, history of percutaneous coronary intervention, 3 or more complex coronary lesions, use of adjunctive noncompl...
PMC10687657
Comparison of Target Vessel Failure Between Imaging-Guided and Angiography-Guided Percutaneous Coronary Intervention (PCI), Stratified by the Presence of Chronic Kidney Disease (CKD)
vessel failure
The Kaplan-Meier curve shows the cumulative incidence of target vessel failure in intravascular imaging-guided PCI (orange line) and angiography-guided PCI (blue line) for patients with (A) or without (B) CKD.Among the non-CKD population, the primary end point occurred in 54 of 889 patients in the intravascular imaging...
PMC10687657
Primary and Secondary End Points in Patients Without Chronic Kidney Disease
MYOCARDIAL INFARCTION, ACUTE CORONARY SYNDROME
Abbreviations: HR, hazard ratio; MI, myocardial infarction; NA, not applicable.Percentages are 3-year Kaplan-Meier estimates.Adjusted variables for multivariable analysis were age, sex, acute coronary syndrome, history of percutaneous coronary intervention, 3 or more complex coronary lesions, and use of adjunctive nonc...
PMC10687657
Outcome Differences Between Intravascular Imaging- and Angiography-Guided PCI According to GFR
eFigure 5 in
PMC10687657
Discussion
coronary artery lesions, cardiac death, CKD, uremia
CARDIAC DEATH, ISCHEMIC HEART DISEASE, UREMIA
In this prespecified substudy of the RENOVATE-COMPLEX-PCI, we aimed to investigate whether the benefit of intravascular imaging–guided PCI differs according to the presence of CKD. A summary of the findings is as follows. First, patients with CKD had a 2-fold higher risk of TVF than those without CKD after PCI for comp...
PMC10687657
Limitations
bleeding, CKD
EVENT, BLEEDING
This study has several limitations. First, an uneven proportion of choice for intravascular imaging devices resulted in only a small fraction of OCT, and its benefit and harm could not be accurately compared with IVUS or angiography alone. A relatively small CKD population also limits interpretation from the comparison...
PMC10687657