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Current status of percutaneous coronary interventions in diabetics with multivessel disease - is it time to challenge FREEDOM?
Kaul, Upendra; Sudhir, Krishnankutty; Bangalore, Sripal
Diabetes mellitus (DM) and coronary artery disease (CAD) are the leading causes of death in the world. Over the last two decades, clinical trials have indicated that DM patients with CAD have poorer cardiac outcomes than non-diabetic patients with CAD. The pivotal findings of the FREEDOM trial greatly impacted the way clinicians approached revascularisation in diabetic patients with multivessel disease (MVD). However, since the publication of the FREEDOM trial, much has changed both in percutaneous coronary intervention (PCI) technology, as well as in the management of diabetes. This review provides insights into advancements in stent technology, enhanced patient management strategies, improved clinical outcomes with newer hypoglycaemic agents, current approaches to antiplatelet therapy, and advances in lipid management in diabetic patients. The influence of patient-specific factors such as comorbidities and anatomical complexities on treatment decisions in diabetic patients with MVD is also discussed. The ongoing TUXEDO-2 India trial was designed to primarily compare the clinical outcomes of PCI with the new-generation ultrathin-strut Supraflex Cruz stent, compared to the second-generation XIENCE stent in the setting of contemporary optimal medical therapy in Indian diabetic patients with MVD. The secondary objective of this study is to compare clinical outcomes in the combined group from both study arms against a performance goal derived from the coronary artery bypass grafting (CABG) arm of the FREEDOM trial (historical cohort). The tertiary objective is to compare the efficacy and safety of ticagrelor versus prasugrel in diabetic patients with MVD. In view of recent advances in PCI and medical therapy since the FREEDOM trial, now is an appropriate time to revisit the results of CABG versus PCI in diabetic patients with MVD.
PMCID:11261656
PMID: 39070972
ISSN: 2491-0929
CID: 5731252
SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions
Riley, Robert F; Patel, Mitul P; Abbott, J Dawn; Bangalore, Sripal; Brilakis, Emanouil S; Croce, Kevin J; Doshi, Darshan; Kaul, Prashant; Kearney, Kathleen E; Kerrigan, Jimmy L; McEntegart, Margaret; Maehara, Akiko; Rymer, Jennifer A; Sutton, Nadia R; Shah, Binita
The prevalence of calcification in obstructive coronary artery disease is on the rise. Percutaneous coronary intervention of these calcified lesions is associated with increased short-term and long-term risks. To optimize percutaneous coronary intervention results, there is an expanding array of treatment modalities geared toward calcium modification prior to stent implantation. The Society for Cardiovascular Angiography and Interventions, herein, puts forth an expert consensus document regarding methods to identify types of calcified coronary lesions, a central algorithm to help guide use of the various calcium modification strategies, tips for when using each treatment modality, and a look at future studies and trials for treating this challenging lesion subset.
PMCID:11307856
PMID: 39132214
ISSN: 2772-9303
CID: 5726702
Percutaneous Mechanical Aspiration in Infective Endocarditis: Applications, Technical Considerations, and Future Directions
El Sabbagh, Abdallah; Yucel, Evin; Zlotnick, David; Moriarty, John M; Younes, Stephanie; Hamid, Nadira; Akhtar, Yasir; Baddour, Larry M; O'Gara, Patrick; Starck, Christoph; Bangalore, Sripal; Parikh, Sahil A; Rosenfield, Kenneth; Sethi, Sanjum S
In recent years, there has been a shift in the epidemiology of patients with infective endocarditis (IE). This has been characterized by an alarming increase in IE in patients who inject drugs, cardiac implantable electronic device-related IE, and those with comorbid conditions and high surgical risk. This unmet need has mandated a reevaluation of complex management strategies in these patients and introduction of unconventional approaches in treatment. Percutaneous mechanical aspiration has emerged as both a diagnostic and therapeutic option in selected patients with IE. In this review, the authors discuss the gaps in care of IE, rationale, device armamentarium, procedural, and technical considerations and applications of percutaneous mechanical aspiration in IE.
PMCID:11307789
PMID: 39130180
ISSN: 2772-9303
CID: 5726562
Variation in Health Status With Invasive vs Conservative Management of Chronic Coronary Disease
Arnold, Suzanne V; Jones, Philip G; Maron, David J; Cohen, David J; Mark, Daniel B; Reynolds, Harmony R; Bangalore, Sripal; Chen, Jiyan; Newman, Jonathan D; Harrington, Robert A; Stone, Gregg W; Hochman, Judith S; Spertus, John A; ,
BACKGROUND:The ISCHEMIA trial found that patients with chronic coronary disease randomized to invasive strategy had better health status than those randomized to conservative strategy. It is unclear how best to translate these population-level results to individual patients. OBJECTIVES/OBJECTIVE:The authors sought to identify patient characteristics associated with health status from invasive and conservative strategies, and develop a prediction algorithm for shared decision-making. METHODS:One-year disease-specific health status was assessed in ISCHEMIA with the Seattle Angina Questionnaire (SAQ) Summary Score (SAQ SS) and Angina Frequency, Physical Limitations (PL), and Quality of Life (QL) domains (range 0-100, higher = less angina/better health status). RESULTS:Among 4,617 patients from 320 sites in 37 countries, mean SAQ SS was 74.1 ± 18.9 at baseline and 85.7 ± 15.6 at 1 year. Lower baseline SAQ SS and younger age were associated with better 1-year health status with invasive strategy (P interaction = 0.009 and P interaction = 0.004, respectively). For the individual domains, there were significant treatment interactions for baseline SAQ score (Angina Frequency, PL), age (PL, QL), anterior ischemia (PL), and number of baseline antianginal medications (QL), with more benefit of invasive in patients with worse baseline health status, younger age, anterior ischemia, and on more antianginal medications. Parsimonious prediction models were developed for 1-year SAQ domains with invasive or conservative strategies to support shared decision-making. CONCLUSIONS:In the management of chronic coronary disease, individual patient characteristics are associated with 1-year health status, with younger age and poorer angina-related health status showing greater benefit from invasive management. This prediction algorithm can support the translation of the ISCHEMIA trial results to individual patients. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
PMID: 38599711
ISSN: 1558-3597
CID: 5725862
Relationship between the mixed venous-to-arterial carbon dioxide gradient and the cardiac index in acute pulmonary embolism
Yuriditsky, Eugene; Zhang, Robert S; Bakker, Jan; Horowitz, James M; Zhang, Peter; Bernard, Samuel; Greco, Allison A; Postelnicu, Radu; Mukherjee, Vikramjit; Hena, Kerry; Elbaum, Lindsay; Alviar, Carlos L; Keller, Norma M; Bangalore, Sripal
AIMS/OBJECTIVE:Among patients with acute pulmonary embolism (PE) undergoing mechanical thrombectomy, the cardiac index (CI) is frequently reduced even among those without a clinically apparent shock. The purpose of this study is to describe the mixed venous-to-arterial carbon dioxide gradient (CO2 gap), a surrogate of perfusion adequacy, among patients with acute PE undergoing mechanical thrombectomy. METHODS AND RESULTS/RESULTS:This was a single-centre retrospective study of consecutive patients with PE undergoing mechanical thrombectomy and simultaneous pulmonary artery catheterization over a 3-year period. Of 107 patients, 97 had simultaneous mixed venous and arterial blood gas measurements available. The CO2 gap was elevated (>6 mmHg) in 51% of the cohort and in 49% of patients with intermediate-risk PE. A reduced CI (≤2.2 L/min/m2) was associated with an increased odds [odds ratio = 7.9; 95% confidence interval (CI) 3.49-18.1, P < 0.001] for an elevated CO2 gap. There was an inverse relationship between the CI and the CO2 gap. For every 1 L/min/m2 decrease in the CI, the CO2 gap increased by 1.3 mmHg (P = 0.001). Among patients with an elevated baseline CO2 gap >6 mmHg, thrombectomy improved the CO2 gap, CI, and mixed venous oxygen saturation. When the CO2 gap was dichotomized above and below 6, there was no difference in the in-hospital mortality rate (9 vs. 0%; P = 0.10; hazard ratio: 1.24; 95% CI 0.97-1.60; P = 0.085). CONCLUSION/CONCLUSIONS:Among patients with acute PE undergoing mechanical thrombectomy, the CO2 gap is abnormal in nearly 50% of patients and inversely related to the CI. Further studies should examine the relationship between markers of perfusion and outcomes in this population to refine risk stratification.
PMID: 38454794
ISSN: 2048-8734
CID: 5723232
Atherosclerosis quantification and cardiovascular risk: the ISCHEMIA trial
Nurmohamed, Nick S; Min, James K; Anthopolos, Rebecca; Reynolds, Harmony R; Earls, James P; Crabtree, Tami; Mancini, G B John; Leipsic, Jonathon; Budoff, Matthew J; Hague, Cameron J; O'Brien, Sean M; Stone, Gregg W; Berger, Jeffrey S; Donnino, Robert; Sidhu, Mandeep S; Newman, Jonathan D; Boden, William E; Chaitman, Bernard R; Stone, Peter H; Bangalore, Sripal; Spertus, John A; Mark, Daniel B; Shaw, Leslee J; Hochman, Judith S; Maron, David J
BACKGROUND AND AIMS/OBJECTIVE:The aim of this study was to determine the prognostic value of coronary computed tomography angiography (CCTA)-derived atherosclerotic plaque analysis in ISCHEMIA. METHODS:Atherosclerosis imaging quantitative computed tomography (AI-QCT) was performed on all available baseline CCTAs to quantify plaque volume, composition, and distribution. Multivariable Cox regression was used to examine the association between baseline risk factors (age, sex, smoking, diabetes, hypertension, ejection fraction, prior coronary disease, estimated glomerular filtration rate, and statin use), number of diseased vessels, atherosclerotic plaque characteristics determined by AI-QCT, and a composite primary outcome of cardiovascular death or myocardial infarction over a median follow-up of 3.3 (interquartile range 2.2-4.4) years. The predictive value of plaque quantification over risk factors was compared in an area under the curve (AUC) analysis. RESULTS:Analysable CCTA data were available from 3711 participants (mean age 64 years, 21% female, 79% multivessel coronary artery disease). Amongst the AI-QCT variables, total plaque volume was most strongly associated with the primary outcome (adjusted hazard ratio 1.56, 95% confidence interval 1.25-1.97 per interquartile range increase [559 mm3]; P = .001). The addition of AI-QCT plaque quantification and characterization to baseline risk factors improved the model's predictive value for the primary outcome at 6 months (AUC 0.688 vs. 0.637; P = .006), at 2 years (AUC 0.660 vs. 0.617; P = .003), and at 4 years of follow-up (AUC 0.654 vs. 0.608; P = .002). The findings were similar for the other reported outcomes. CONCLUSIONS:In ISCHEMIA, total plaque volume was associated with cardiovascular death or myocardial infarction. In this highly diseased, high-risk population, enhanced assessment of atherosclerotic burden using AI-QCT-derived measures of plaque volume and composition modestly improved event prediction.
PMID: 39101625
ISSN: 1522-9645
CID: 5714002
International Variation in Health Status Benefits in Patients Undergoing Initial Invasive Versus Conservative Management for Chronic Coronary Disease: Insights From the ISCHEMIA Trial
Ikemura, Nobuhiro; Spertus, John A; Nguyen, Dan; Fu, Zhuxuan; Jones, Philip G; Reynolds, Harmony R; Bangalore, Sripal; Bhargava, Balram; Senior, Roxy; Elghamaz, Ahmed; Goodman, Shaun G; Lopes, Renato D; Pracoń, Radoslaw; López-Sendón, José; Maggioni, Aldo P; Kohsaka, Shun; Roth, Gregory A; White, Harvey D; Mavromatis, Kreton; Boden, William E; Rodriguez, Fatima; Hochman, Judith S; Maron, David J; ,
BACKGROUND/UNASSIGNED:The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated greater health status benefits with an initial invasive strategy, as compared with a conservative one, for patients with chronic coronary disease and moderate or severe ischemia. Whether these benefits vary globally is important to understand to support global adoption of the results. METHODS/UNASSIGNED:We analyzed participants' disease-specific health status using the validated 7-item Seattle Angina Questionnaire (SAQ: >5-point differences are clinically important) at baseline and over 1-year follow-up across 37 countries in 6 international regions. The average effect of initial invasive versus conservative strategies on 1-year SAQ scores was estimated using Bayesian proportional odds regression and compared across regions. RESULTS/UNASSIGNED:Considerable regional variation in baseline health status was observed among 4617 participants (mean age=64.4±9.5 years, 24% women), with the mean SAQ summary scores of 67.4±19.5 in Eastern Europe participants (17% of the total), 71.4±15.4 in Asia-Pacific (18%), 74.9±16.7 in Central and South America (10%), 75.5±19.5 in Western Europe (26%), and 78.6±19.2 in North America (28%). One-year improvements in SAQ scores were greater in regions with lower baseline scores with initial invasive management (17.7±20.9 in Eastern Europe and 11.4±19.3 in North America), but similar in the conservative arm. Adjusting for baseline SAQ scores, similar health status benefits of an initial invasive strategy on 1-year SAQ scores were observed (ranging from 2.38 points [95% CI, 0.04-4.50] in North America to 4.66 points [95% CI, 2.46-6.94] in Eastern Europe), with an 88.3% probability that the difference in benefit across regions was <5 points. CONCLUSIONS/UNASSIGNED:In patients with chronic coronary disease and moderate or severe ischemia, initial invasive management was associated with a consistent health status benefit across regions, with modest regional variability, supporting the international generalizability of health status benefits from invasive management of chronic coronary disease. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
PMID: 39301726
ISSN: 1941-7705
CID: 5711452
Inferior vena cava contrast reflux grade is associated with a reduced cardiac index in acute pulmonary embolism
Yuriditsky, Eugene; Zhang, Robert S; Zhang, Peter; Horowitz, James M; Bernard, Samuel; Greco, Allison A; Postelnicu, Radu; Mukherjee, Vikramjit; Hena, Kerry; Elbaum, Lindsay; Alviar, Carlos L; Keller, Norma M; Bangalore, Sripal
BACKGROUND AND AIMS/OBJECTIVE:Patients with intermediate-risk pulmonary embolism (PE) commonly present with a significantly reduced cardiac index (CI). However, the identification of this more severe profile requires invasive hemodynamic monitoring. Whether inferior vena cava (IVC) contrast reflux, as a marker of worse right ventricular function, can predict invasive hemodynamics has not been explored. METHODS:This was a single-center retrospective study over a 3-year period of consecutive patients with PE undergoing mechanical thrombectomy and simultaneous pulmonary artery catheterization. CT pulmonary angiograms were reviewed, and contrast reflux was graded as no/minimal reflux (limited to the IVC) or substantial (opacification including hepatic veins) based on an established scale. RESULTS:were 62.6 %, 93.1 %, 94.6 %, and 56.2 %, respectively. These findings remained significant in a multivariable model and were similar when isolating for intermediate-risk patients (n = 72, 85 %). CONCLUSIONS:The degree of contrast reflux is highly specific for a reduced cardiac index in PE even when isolating for intermediate-risk patients. Real-time prediction of a hemodynamic profile may have added value in the risk-stratification of PE.
PMID: 39369656
ISSN: 1879-2472
CID: 5705862
Procedural Outcomes With Femoral, Radial, Distal Radial, and Ulnar Access for Coronary Angiography: A Network Meta-Analysis
Maqsood, M Haisum; Yong, Celina M; Rao, Sunil V; Cohen, Mauricio G; Pancholy, Samir; Bangalore, Sripal
BACKGROUND/UNASSIGNED:Radial artery access for coronary angiography or percutaneous coronary intervention (PCI) reduces the risk of death, bleeding, and vascular complications and is preferred over femoral artery access, leading to a class 1 indication by clinical practice guidelines. However, alternate upper extremity access such as distal radial and ulnar access are not mentioned in the guidelines despite randomized trials. We aimed to evaluate procedural outcomes with femoral, radial, distal radial, and ulnar access sites in patients undergoing coronary angiography or PCI. METHODS/UNASSIGNED:PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials that compared at least 2 of the 4 access sites in patients undergoing PCI or angiography. Primary outcomes were major bleeding and access site hematoma. Intention-to-treat mixed treatment comparison meta-analysis was performed. RESULTS/UNASSIGNED:From 47 randomized clinical trials that randomized 38 924 patients undergoing coronary angiography or PCI, when compared with femoral access, there was a lower risk of major bleeding with radial access (odds ratio [OR], 0.46 [95% CI, 0.35-0.59]) and lower risk of access site hematoma with radial (OR, 0.34 [95% CI, 0.24-0.48]), distal radial (OR, 0.33 [95% CI, 0.20-0.56]), and ulnar (OR, 0.50 [95% CI, 0.31-0.83]) access. However, when compared with radial access, there was higher risk of hematoma with ulnar access (OR, 1.48 [95% CI, 1.03-2.14]). CONCLUSIONS/UNASSIGNED:Data from randomized trials support guideline recommendation of class 1 for the preference of radial access over femoral access in patients undergoing coronary angiography or PCI. Moreover, distal radial and ulnar access can be considered as a default secondary access site before considering femoral access. REGISTRATION/UNASSIGNED:URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 42024512365.
PMID: 39027936
ISSN: 1941-7632
CID: 5699452
Ischemia Severity, Coronary Artery Disease Extent, and Exercise Capacity in ISCHEMIA [Letter]
Fleg, Jerome L; Huang, Zhen; Reynolds, Harmony R; Shaw, Leslee J; Chaitman, Bernard R; O'Brien, Sean M; Berstein, Leonid; Peteiro, Jesus; Smanio, Paola E P; Wander, Gurpreet S; Berger, Jeffrey S; Berman, Daniel S; Picard, Michael H; Kwong, Raymond Y; Min, James K; Phillips, Lawrence M; Bangalore, Sripal; Maron, David J; Hochman, Judith S; ,
PMCID:11232923
PMID: 38976607
ISSN: 1524-4539
CID: 5698702