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Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial

Pracoń, Radosław; Spertus, John A; Broderick, Samuel; Bangalore, Sripal; Rockhold, Frank W; Ruzyllo, Witold; Demchenko, Elena; Nageh, Thuraia; Grossman, Gabriel Blacher; Mavromatis, Kreton; Manjunath, Cholenahally N; Smanio, Paola E P; Stone, Gregg W; Mancini, G B John; Boden, William E; Newman, Jonathan D; Reynolds, Harmony R; Hochman, Judith S; Maron, David J; ,
BACKGROUND/UNASSIGNED:ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease. METHODS/UNASSIGNED:Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use. RESULTS/UNASSIGNED:Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14-2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78-12.86] and 2.63 [95% CI, 1.51-4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23-3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34-2.40]). Baseline low-density lipoprotein cholesterol <70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46-0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis >70% on coronary computed tomography angiography. CONCLUSIONS/UNASSIGNED:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
PMCID:11187765
PMID: 38629312
ISSN: 1941-7632
CID: 5671492

Outcomes with treatment interventions for clot-in-transit in patients with pulmonary embolism: a meta-analysis

Maqsood, Muhammad Haisum; Zhang, Robert S; Zlotnick, David M; Parikh, Sahil A; Bangalore, Sripal
OBJECTIVES:Clot-in-transit (CIT) in patients with pulmonary embolism (PE) has been associated with a high mortality rate and poor prognosis. The aim of this study was to evaluate the pooled efficacy of each of the 4 interventions (anticoagulation [AC] alone, systemic thrombolytic [ST] therapy, surgical thrombectomy, and catheter-based thrombectomy [CBT]) using mortality as the primary outcome. METHODS:A time limited search until March 28, 2024 was conducted using PubMed (National Institutes of Health) and EMBASE (Elsevier) databases. RESULTS:Thirteen studies (6 retrospective, 4 non-randomized prospective, and 3 pooled studies of case-reports) were included in the calculation of weighted proportion of mortality, including a total of 492 patients with CIT and PE with a mean age of 60.6 years; 50.1% were males. ST was the most frequently used treatment intervention (38.2%), followed by surgical thrombectomy (33.8%), AC alone (22.6%), and CBT (5.9%). The unweighted mortality was highest with AC alone 32.4% (36/111), followed by surgical thrombectomy 23.2% (38/164), CBT 20.7% (6/29), and ST 13.8% (26/188). The weighted mortality for AC alone was 35% (95% CI, 21% to 49%; 12 studies), surgical thrombectomy was 31% (95% CI, 16% to 47%; 12 studies), CBT was 20% (95% CI, 6% to 34%; 3 studies), and ST was 12% (95% CI, 5% to 19%; 12 studies). CONCLUSIONS:In this meta-analysis of patients with CIT and PE, the highest mortality was observed with AC alone, followed by surgical thrombectomy, CBT, and ST therapy. However, there remains a need for randomized clinical trial data to determine the best treatment.
PMID: 38776476
ISSN: 1557-2501
CID: 5654692

Is this the end of the ultrathin-strut hypothesis? [Editorial]

Bangalore, Sripal; Finn, Aloke V
PMCID:11100498
PMID: 39230273
ISSN: 1969-6213
CID: 5687942

One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes

Cao, Davide; Vranckx, Pascal; Valgimigli, Marco; Sartori, Samantha; Angiolillo, Dominick J; Bangalore, Sripal; Bhatt, Deepak L; Feng, Yihan; Ge, Junbo; Hermiller, James; Makkar, Raj R; Neumann, Franz-Josef; Saito, Shigeru; Picon, Hector; Toelg, Ralph; Maksoud, Aziz; Chehab, Bassem M; Choi, James W; Campo, Gianluca; De la Torre Hernandez, José M; Krucoff, Mitchell W; Kunadian, Vijay; Sardella, Gennaro; Spirito, Alessandro; Thiele, Holger; Varenne, Olivier; Vogel, Birgit; Zhou, Yujie; Windecker, Stephan; Mehran, Roxana
BACKGROUND:A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. AIMS/OBJECTIVE:We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. METHODS:This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. RESULTS:Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. CONCLUSIONS:Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.
PMCID:11100501
PMID: 38776146
ISSN: 1969-6213
CID: 5654662

Percutaneous mechanical thrombectomy in acute pulmonary embolism: Outcomes from a safety-net hospital

Zhang, Robert S; Alviar, Carlos L; Yuriditsky, Eugene; Alam, Usman; Zhang, Peter S; Elbaum, Lindsay; Grossman, Kelsey; Singh, Arushi; Maqsood, Muhammad H; Greco, Allison A; Postelnicu, Radu; Mukherjee, Vikramjit; Horowitz, James; Keller, Norma; Bangalore, Sripal
BACKGROUND:Our study aims to present clinical outcomes of mechanical thrombectomy (MT) in a safety-net hospital. METHODS:This is a retrospective study of intermediate or high-risk pulmonary embolism (PE) patients who underwent MT between October 2020 and May 2023. The primary outcome was 30-day mortality. RESULTS:Among 61 patients (mean age 57.6 years, 47% women, 57% Black) analyzed, 12 (19.7%) were classified as high-risk PE, and 49 (80.3%) were intermediate-risk PE. Of these patients, 62.3% had Medicaid or were uninsured, 50.8% lived in a high poverty zip code. The prevalence of normotensive shock in intermediate-risk PE patients was 62%. Immediate hemodynamic improvements included 7.4 mmHg mean drop in mean pulmonary artery pressure (-21.7%, p < 0.001) and 93% had normalization of their cardiac index postprocedure. Thirty-day mortality for the entire cohort was 5% (3 patients) and 0% when restricted to the intermediate-risk group. All 3 patients who died at 30 days presented with cardiac arrest. There were no differences in short-term mortality based on race, insurance type, citizenship status, or socioeconomic status. All-cause mortality at most recent follow up was 13.1% (mean follow up time of 13.4 ± 8.5 months). CONCLUSION:We extend the findings from prior studies that MT demonstrates a favorable safety profile with immediate improvement in hemodynamics and a low 30-day mortality in patients with acute PE, holding true even with relatively higher risk and more vulnerable population within a safety-net hospital.
PMID: 38577945
ISSN: 1522-726x
CID: 5931202

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

A case report of sodium azide-induced myopericarditis [Case Report]

Tarabanis, Constantine; Banco, Darcy; Keller, Norma M; Bangalore, Sripal; Alviar, Carlos L
BACKGROUND/UNASSIGNED:Sodium azide exposures are rare but can be lethal as the substance inhibits complex IV in the electron transport chain, blocking adenosine-triphosphate (ATP) synthesis. Sodium azide is mostly used as a propellant in vehicular airbags but is also used in laboratory, pharmacy, and industrial settings. No known antidote exists and its cardiotoxic effects are poorly described in the literature. CASE SUMMARY/UNASSIGNED:We describe the case of a 31-year-old patient with major depressive disorder presenting with altered mental status after ingestion of an unknown amount of sodium azide. Although initially chest pain free, she developed pleuritic chest pain 48 h after ingestion. This was accompanied by new diffuse ST elevations on the electrocardiogram and serum troponin elevations concerning for myopericarditis. Treatment was pursued with a 14-day course of colchicine resulting in complete symptom resolution within 4 days of treatment initiation. The patient's transthoracic echocardiogram was only notable for a preserved left ventricular ejection fraction (LVEF). DISCUSSION/UNASSIGNED:Cardiac toxicity after sodium azide ingestion usually occurs days after ingestion and has been previously described in the forms of heart failure with reduced ejection fraction complicated by cardiogenic shock. We describe the first case of sodium azide-induced myopericarditis with a preserved LVEF treated with colchicine. Colchicine is an established treatment for pericarditis, but its inhibition of endocytosis, an ATP-dependent cellular function, could be mechanistically relevant to this case.
PMCID:10986400
PMID: 38567268
ISSN: 2514-2119
CID: 5729062

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

Balloon-Assisted Coronary Intravascular Lithotripsy for Large Severely Calcified Coronary Artery Stenosis [Case Report]

Yarusi, Brett; Mustehsan, Mohammad Hashim; Bangalore, Sripal
We present a patient with in-stent restenosis due to severe coronary calcification with asymmetric stent expansion and resulting stent eccentricity in a very large (6.0 mm) caliber coronary artery. We demonstrate the feasibility of using the largest commercially available coronary intravascular lithotripsy balloon (4.0 mm) along with a "buddy" balloon inflated simultaneously to treat focal coronary artery calcification in a vessel with a diameter significantly larger than the largest commercially available coronary intravascular lithotripsy balloon. To our knowledge, this is the first demonstration of this technique in coronary artery intervention.
PMCID:11307760
PMID: 39130170
ISSN: 2772-9303
CID: 5726552

Sex Differences in Revascularization, Treatment Goals, and Outcomes of Patients With Chronic Coronary Disease: Insights From the ISCHEMIA Trial

Reynolds, Harmony R; Cyr, Derek D; Merz, C Noel Bairey; Shaw, Leslee J; Chaitman, Bernard R; Boden, William E; Alexander, Karen P; Rosenberg, Yves D; Bangalore, Sripal; Stone, Gregg W; Held, Claes; Spertus, John; Goetschalckx, Kaatje; Bockeria, Olga; Newman, Jonathan D; Berger, Jeffrey S; Elghamaz, Ahmed; Lopes, Renato D; Min, James K; Berman, Daniel S; Picard, Michael H; Kwong, Raymond Y; Harrington, Robert A; Thomas, Boban; O'Brien, Sean M; Maron, David J; Hochman, Judith S; ,
BACKGROUND:Women with chronic coronary disease are generally older than men and have more comorbidities but less atherosclerosis. We explored sex differences in revascularization, guideline-directed medical therapy, and outcomes among patients with chronic coronary disease with ischemia on stress testing, with and without invasive management. METHODS AND RESULTS/RESULTS:=0.49), with no significant sex-by-treatment-group interactions. CONCLUSIONS:Women had less extensive coronary artery disease and, therefore, lower revascularization rates in the invasive group. Despite lower risk factor goal attainment, women with chronic coronary disease experienced similar risk-adjusted outcomes to men in the ISCHEMIA trial. REGISTRATION/BACKGROUND:URL: http://wwwclinicaltrials.gov. Unique identifier: NCT01471522.
PMCID:10944079
PMID: 38410945
ISSN: 2047-9980
CID: 5645612