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Invasive Versus Medical Management in Patients With Chronic Kidney Disease and Non-ST-Segment-Elevation Myocardial Infarction
Majmundar, Monil; Ibarra, Gabriel; Kumar, Ashish; Doshi, Rajkumar; Shah, Palak; Mehran, Roxana; Reed, Grant W; Puri, Rishi; Kapadia, Samir R; Bangalore, Sripal; Kalra, Ankur
Background The role of invasive management compared with medical management in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) and advanced chronic kidney disease (CKD) is uncertain, given the increased risk of procedural complications in patients with CKD. We aimed to compare clinical outcomes of invasive management with medical management in patients with NSTEMI-CKD. Methods and Results We identified NSTEMI and CKD stages 3, 4, 5, and end-stage renal disease admissions using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes from the Nationwide Readmission Database 2016 to 2018. Patients were stratified into invasive and medical management. Primary outcome was mortality (in-hospital and 6 months after discharge). Secondary outcomes were in-hospital postprocedural complications (acute kidney injury requiring dialysis, major bleeding) and postdischarge 6-month safety and major adverse cardiovascular events. Out of 141Â 052 patients with NSTEMI-CKD, 85Â 875 (60.9%) were treated with invasive management, whereas 55Â 177 (39.1%) patients were managed medically. In propensity-score matched cohorts, invasive strategy was associated with lower in-hospital (CKD 3: odds ratio [OR], 0.47 [95% CI, 0.43-0.51]; P<0.001; CKD 4: OR, 0.79 [95% CI, 0.69-0.89]; P<0.001; CKD 5: OR, 0.72 [95% CI, 0.49-1.06]; P=0.096; end-stage renal disease: OR, 0.51 [95% CI, 0.46-0.56]; P<0.001) and 6-month mortality. Invasive management was associated with higher in-hospital postprocedural complications but no difference in postdischarge safety outcomes. Invasive management was associated with a lower hazard of major adverse cardiovascular events at 6Â months in all CKD groups compared with medical management. Conclusions Invasive management was associated with lower mortality and major adverse cardiovascular events but minimal increased in-hospital complications in patients with NSTEMI-CKD compared with medical management, suggesting patients with NSTEMI-CKD should be offered invasive management.
PMCID:9238658
PMID: 35713283
ISSN: 2047-9980
CID: 5282792
Clinical and Quality-of-Life Outcomes Following Invasive vs Conservative Treatment of Patients With Chronic Coronary Disease Across the Spectrum of Kidney Function
Bangalore, Sripal; Hochman, Judith S; Stevens, Susanna R; Jones, Philip G; Spertus, John A; O'Brien, Sean M; Reynolds, Harmony R; Boden, William E; Fleg, Jerome L; Williams, David O; Stone, Gregg W; Sidhu, Mandeep S; Mathew, Roy O; Chertow, Glenn M; Maron, David J
Importance/UNASSIGNED:Prior trials of invasive vs conservative management of chronic coronary disease (CCD) have not enrolled patients with severe chronic kidney disease (CKD). As such, outcomes across kidney function are not well characterized. Objectives/UNASSIGNED:To evaluate clinical and quality-of-life (QoL) outcomes across the spectrum of CKD following conservative and invasive treatment strategies. Design, Setting, and Participants/UNASSIGNED:Participants from the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) and ISCHEMIA-Chronic Kidney Disease (CKD) trials were categorized by CKD stage: stage 1 (estimated glomerular filtration rate [eGFR] 90 mL/min/1.73m2 or greater), stage 2 (eGFR 60-89 mL/min/1.73m2), stage 3 (eGFR 30-59 mL/min/1.73m2), stage 4 (eGFR 15-29 mL/min/1.73m2), or stage 5 (eGFR less than 15 mL/min/1.73m2 or receiving dialysis). Enrollment took place from July 26, 2012, through January 31, 2018, with a median follow-up of 3.1 years. Data were analyzed from January 2020 to May 2021. Interventions/UNASSIGNED:Initial invasive management of coronary angiography and revascularization with guideline-directed medical therapy (GDMT) vs initial conservative management of GDMT alone. Main Outcomes and Measures/UNASSIGNED:The primary clinical outcome was a composite of death or nonfatal myocardial infarction (MI). The primary QoL outcome was the Seattle Angina Questionnaire (SAQ) summary score. Results/UNASSIGNED:Among the 5956 participants included in this analysis (mean [SD] age, 64 [10] years; 1410 [24%] female and 4546 [76%] male), 1889 (32%), 2551 (43%), 738 (12%), 311 (5%), and 467 (8%) were in CKD stages 1, 2, 3, 4, and 5, respectively. By self-report, 18 participants (<1%) were American Indian or Alaska Native; 1676 (29%), Asian; 267 (5%), Black; 861 (16%), Hispanic or Latino; 18 (<1%), Native Hawaiian or Other Pacific Islander; 3884 (66%), White; and 13 (<1%), multiple races or ethnicities. There was a monotonic increase in risk of the primary composite end point (3-year rates, 9.52%, 10.72%, 18.42%, 34.21%, and 38.01% respectively), death, cardiovascular death, MI, and stroke in individuals with higher CKD stages. Invasive management was associated with an increase in stroke (3-year event rate difference, 1%; 95% CI, 0.3 to 1.7) and procedural MI (1.6%; 95% CI, 0.9 to 2.3) and a decrease in spontaneous MI (-2.5%; 95% CI, -3.9 to -1.1) with no difference in other outcomes; the effect was similar across CKD stages. There was heterogeneity of treatment effect for QoL outcomes such that invasive management was associated with an improvement in angina-related QoL in individuals with CKD stages 1 to 3 and not in those with CKD stages 4 to 5. Conclusions and Relevance/UNASSIGNED:Among participants with CCD, event rates were inversely proportional to kidney function. Invasive management was associated with an increase in stroke and procedural MI and a reduced risk in spontaneous MI, and the effect was similar across CKD stages with no difference in other outcomes, including death. The benefit for QoL with invasive management was not observed in individuals with poorer kidney function.
PMCID:9244774
PMID: 35767253
ISSN: 2380-6591
CID: 5281172
Cardiovascular and Venous Thromboembolic Risk With Janus Kinase Inhibitors in Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis of Randomized Trials
Maqsood, Muhammad Haisum; Weber, Brittany N; Haberman, Rebecca H; Lo Sicco, Kristen I; Bangalore, Sripal; Garshick, Michael S
OBJECTIVE:Janus kinase (JAK) inhibition effectively treats immune-mediated inflammatory diseases (IMIDs); however, concern over the risk of major adverse cardiac events (MACE) and venous thromboembolism (VTE) remains. We aimed to evaluate the safety (VTE and MACE outcomes) of JAK inhibitors in the treatment of IMIDs. METHODS:A search in PubMed, Embase, and ClinicalTrials.gov databases was conducted for randomized clinical trials (RCTs) of JAK inhibitors across IMIDs. Primary outcomes were VTE and MACE with JAK inhibitors compared with placebo and active comparator arms stratified by follow-up time. RESULTS: = 0.01). No increased risk of VTE was seen when comparing JAK inhibitors with placebo arms. For the outcome of MACE, the results were largely similar but did not reach statistical significance (OR 1.19; 95% CI: 0.86-1.64). CONCLUSION/CONCLUSIONS:JAK inhibitors when compared with active comparator arms increased the risk of VTE, which was dependent on duration of exposure. Future clinical trials with extended follow-up are needed to clarify the safety profiles of JAK inhibitors.
PMID: 35903881
ISSN: 2578-5745
CID: 5276932
Crush techniques for percutaneous coronary intervention of bifurcation lesions
Moroni, Francesco; Shue-Min Yeh, James; Attallah, Antonious; Santiago, Ricardo; Martins Filho, Evandro; Hall, Jack; Bangalore, Sripal; Azzalini, Lorenzo
Percutaneous coronary intervention (PCI) of coronary artery bifurcation lesions entails technical challenges and carries a higher risk of adverse events on follow-up, driven by repeat revascularisation and stent thrombosis. While most bifurcations can be tackled with a provisional (single-stent) approach, more complex lesions involving both branches (true bifurcation lesions) require a two-stent approach. In the latter context, several techniques have been proposed. Among them, the crush technique has dramatically evolved in recent years, and its more recent iterations have been shown to provide excellent and durable results, both for left main and non-left main bifurcations. The aim of the present work is to discuss the technical aspects and outcomes of the variants of the crush technique from the first description in the early 2000s to the present day.
PMID: 34794934
ISSN: 1969-6213
CID: 5234652
2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Lawton, Jennifer S; Tamis-Holland, Jacqueline E; Bangalore, Sripal; Bates, Eric R; Beckie, Theresa M; Bischoff, James M; Bittl, John A; Cohen, Mauricio G; DiMaio, J Michael; Don, Creighton W; Fremes, Stephen E; Gaudino, Mario F; Goldberger, Zachary D; Grant, Michael C; Jaswal, Jang B; Kurlansky, Paul A; Mehran, Roxana; Metkus, Thomas S; Nnacheta, Lorraine C; Rao, Sunil V; Sellke, Frank W; Sharma, Garima; Yong, Celina M; Zwischenberger, Brittany A
AIM:The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS:A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. STRUCTURE:Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.
PMID: 34895951
ISSN: 1558-3597
CID: 5223212
2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Lawton, Jennifer S; Tamis-Holland, Jacqueline E; Bangalore, Sripal; Bates, Eric R; Beckie, Theresa M; Bischoff, James M; Bittl, John A; Cohen, Mauricio G; DiMaio, J Michael; Don, Creighton W; Fremes, Stephen E; Gaudino, Mario F; Goldberger, Zachary D; Grant, Michael C; Jaswal, Jang B; Kurlansky, Paul A; Mehran, Roxana; Metkus, Thomas S; Nnacheta, Lorraine C; Rao, Sunil V; Sellke, Frank W; Sharma, Garima; Yong, Celina M; Zwischenberger, Brittany A
AIM:The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS:A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.
PMID: 34882436
ISSN: 1524-4539
CID: 5223192
2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Lawton, Jennifer S; Tamis-Holland, Jacqueline E; Bangalore, Sripal; Bates, Eric R; Beckie, Theresa M; Bischoff, James M; Bittl, John A; Cohen, Mauricio G; DiMaio, J Michael; Don, Creighton W; Fremes, Stephen E; Gaudino, Mario F; Goldberger, Zachary D; Grant, Michael C; Jaswal, Jang B; Kurlansky, Paul A; Mehran, Roxana; Metkus, Thomas S; Nnacheta, Lorraine C; Rao, Sunil V; Sellke, Frank W; Sharma, Garima; Yong, Celina M; Zwischenberger, Brittany A
PMID: 34882435
ISSN: 1524-4539
CID: 5223182
2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
Lawton, Jennifer S; Tamis-Holland, Jacqueline E; Bangalore, Sripal; Bates, Eric R; Beckie, Theresa M; Bischoff, James M; Bittl, John A; Cohen, Mauricio G; DiMaio, J Michael; Don, Creighton W; Fremes, Stephen E; Gaudino, Mario F; Goldberger, Zachary D; Grant, Michael C; Jaswal, Jang B; Kurlansky, Paul A; Mehran, Roxana; Metkus, Thomas S; Nnacheta, Lorraine C; Rao, Sunil V; Sellke, Frank W; Sharma, Garima; Yong, Celina M; Zwischenberger, Brittany A
AIM:The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization as well as the supporting documentation to encourage their use. METHODS:A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. STRUCTURE:Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests.
PMID: 34895950
ISSN: 1558-3597
CID: 5223202
Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA
Mark, Daniel B; Spertus, John A; Bigelow, Robert; Anderson, Sophia; Daniels, Melanie R; Anstrom, Kevin J; Baloch, Khaula N; Cohen, David J; Held, Claes; Goodman, Shaun G; Bangalore, Sripal; Cyr, Derek; Reynolds, Harmony R; Alexander, Karen P; Rosenberg, Yves; Stone, Gregg W; Maron, David J; Hochman, Judith S
BACKGROUND:ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) compared an initial invasive treatment strategy (INV) with an initial conservative strategy in 5179 participants with chronic coronary disease and moderate or severe ischemia. The ISCHEMIA research program included a comprehensive quality-of-life (QOL) substudy. METHODS:In 1819 participants (907 INV, 912 conservative strategy), we collected a battery of disease-specific and generic QOL instruments by structured interviews at baseline; at 3, 12, 24, and 36 months postrandomization; and at study closeout. Assessments included angina-related QOL (19-item Seattle Angina Questionnaire), generic health status (EQ-5D), depressive symptoms (Patient Health Questionnaire-8), and, for North American patients, cardiac functional status (Duke Activity Status Index). RESULTS:Median age was 67 years, 19.2% were female, and 15.9% were non-White. The estimated mean difference for the 19-item Seattle Angina Questionnaire Summary score favored INV (1.4 points [95% CI, 0.2-2.5] over all follow-up). No differences were observed in patients with rare/absent baseline angina (SAQ Angina Frequency score >80). Among patients with more frequent angina at baseline (SAQ Angina Frequency score <80, 744 patients, 41%), those randomly assigned to INV had a mean 3.7-point higher 19-item Seattle Angina Questionnaire Summary score than conservative strategy (95% CI, 1.6-5.8) with consistent effects across SAQ subscales: Physical Limitations 3.2 points (95% CI, 0.2-6.1), Angina Frequency 3.2 points (95% CI, 1.2-5.1), Quality of Life/Health Perceptions 5.3 points (95% CI, 2.8-7.8). For the Duke Activity Status Index, no difference was estimated overall by treatment, but in patients with baseline SAQ Angina Frequency scores <80, Duke Activity Status Index scores were higher for INV (3.2 points [95% CI, 0.6-5.7]), whereas patients with rare/absent baseline angina showed no treatment-related differences. Moderate to severe depression was infrequent at randomization (11.5%-12.8%) and was unaffected by treatment assignment. CONCLUSIONS:In the ISCHEMIA comprehensive QOL substudy, patients with more frequent baseline angina reported greater improvements in the symptom, physical functioning, and psychological well-being dimensions of QOL when treated with an invasive strategy, whereas patients who had rare/absent angina at baseline reported no consistent treatment-related QOL differences. REGISTRATION/BACKGROUND:URL: https://www. CLINICALTRIALS/RESULTS:gov; Unique identifier: NCT01471522.
PMCID:9044280
PMID: 35259918
ISSN: 1524-4539
CID: 5216792
Timing of Statin Dose: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Haisum Maqsood, Muhammad; Messerli, Franz H; Waters, David; Skolnick, Adam H; Maron, David J; Bangalore, Sripal
PMID: 35512427
ISSN: 2047-4881
CID: 5216352