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Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial

White, Harvey D; O'Brien, Sean M; Alexander, Karen P; Boden, William E; Bangalore, Sripal; Li, Jianghao; Manjunath, Cholenahally N; Lopez-Sendon, Jose Luis; Peteiro, Jesus; Gosselin, Gilbert; Berger, Jeffrey S; Maggioni, Aldo Pietro; Reynolds, Harmony R; Hochman, Judith S; Maron, David J
Importance/UNASSIGNED:Traditional time-to-event analyses rate events occurring early as more important than later events, even if later events are more severe, eg, death. Days alive out of hospital (DAOH) adds a patient-focused perspective beyond trial end points. Objective/UNASSIGNED:To compare DAOH between invasive management and conservative management, including invasive protocol-assigned stays, in the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) randomized clinical trial. Design, Setting, and Participants/UNASSIGNED:In this prespecified analysis of the ISCHEMIA trial, DAOH was compared between 5179 patients with stable coronary disease and moderate or severe ischemia randomized to invasive management or conservative management. Participants were recruited from 320 sites in 37 countries. Stays included overnight stays in hospital or extended care facility (skilled nursing facility, rehabilitation, or nursing home). DAOH was separately analyzed excluding invasive protocol-assigned procedures. Data were collected from July 2012 to June 2019, and data were analyzed from July 2020 to April 2021. Interventions/UNASSIGNED:Invasive management with angiography and revascularization if feasible or conservative management, with both groups receiving optimal medical therapy. Main Outcomes and Measures/UNASSIGNED:The hypothesis was formulated before data lock in July 2020. The primary end point was mean DAOH per patient between randomization and 4 years. Initial stays for invasive protocol-assigned procedures were prespecified to be excluded. Results/UNASSIGNED:Of 5179 included patients, 1168 (22.6%) were female, and the median (interquartile range) age was 64 (58-70) years. The average DAOH was higher in the conservative management group compared with the invasive management group at 1 month (30.8 vs 28.4 days; P < .001), 1 year (362.2 vs 355.9 days; P < .001), and 2 years (718.4 vs 712.1 days; P = .001). At 4 years, the 2 groups' DAOH were not significantly different (1415.0 vs 1412.2 days; P = .65). In the invasive management group, 2434 of 4002 stays (60.8%) were for protocol-assigned procedures. There were no clear differences at any time point in DAOH when protocol-assigned procedures were excluded from the invasive management group. There were more hospital and extended care stays in the invasive management vs conservative management group during follow-up (4002 vs 1897; P < .001). Excluding protocol-assigned procedures, there were fewer stays in the invasive vs conservative group (1568 vs 1897; P = .001). Cardiovascular stays following the initial assigned procedures were lower in the invasive management group (685 of 4002 [17.1%] vs 1095 of 1897 [57.8%]; P < .001) due to decreased spontaneous myocardial infarction stays (65 [1.6%] vs 123 [6.5%]; P < .001) and unstable angina stays (119 [3.0%] vs 216 [11.4%]; P < .001). Conclusions and Relevance/UNASSIGNED:DAOH was higher for patients in the conservative management group in the first 2 years but not different at 4 years. DAOH was decreased early in the invasive management group due to protocol-assigned procedures. Hospital stays for myocardial infarction and unstable angina during follow-up were lower in the invasive management group. DAOH provides a patient-focused metric that can be used by clinicians and patients in shared decision-making for management of stable coronary artery disease. Trial Registration/ Identifier: NCT01471522.
PMID: 33938917
ISSN: 2380-6591
CID: 4865992

Tricuspid valve vegetation debulking using the AngioVac system [Case Report]

Bangalore, Sripal; Alviar, Carlos L; Vlahakis, Susan; Keller, Norma
Tricuspid valve endocarditis with recurrent septic pulmonary emboli is an indication for surgery. We present the case of a 36-year old man with tricuspid valve endocarditis and septic pulmonary emboli with percutaneous extraction of the vegetation. We discuss the nuances of such an approach and the need for more evidence in the management of these complex patients.
PMID: 33565679
ISSN: 1522-726x
CID: 4779782

Impact of COVID-19 pandemic on STEMI care: An expanded analysis from the United States

Garcia, Santiago; Stanberry, Larissa; Schmidt, Christian; Sharkey, Scott; Megaly, Michael; Albaghdadi, Mazen S; Meraj, Perwaiz M; Garberich, Ross; Jaffer, Farouc A; Stefanescu Schmidt, Ada C; Dixon, Simon R; Rade, Jeffrey J; Smith, Timothy; Tannenbaum, Mark; Chambers, Jenny; Aguirre, Frank; Huang, Paul P; Kumbhani, Dharam J; Koshy, Thomas; Feldman, Dmitriy N; Giri, Jay; Kaul, Prashant; Thompson, Craig; Khalili, Houman; Maini, Brij; Nayak, Keshav R; Cohen, Mauricio G; Bangalore, Sripal; Shah, Binita; Henry, Timothy D
OBJECTIVE:To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care. BACKGROUND:We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data. METHODS:Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC. RESULTS:Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05). CONCLUSIONS:The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI.
PMID: 32767652
ISSN: 1522-726x
CID: 4555742

Impact of renal function in high bleeding risk patients undergoing percutaneous coronary intervention: a patient-level stratified analysis from four post-approval studies

Kuno, Toshiki; Claessen, Bimmer; Cao, Davide; Chandiramani, Rishi; Guedeney, Paul; Sorrentino, Sabato; Krucoff, Mitchell; Kozuma, Ken; Ge, Junbo; Seth, Ashok; Makkar, Raj; Bangalore, Sripal; Bhatt, Deepak L; Angiolillo, Dominick J; Saito, Shigeru; Neumann, Franz-Josef; Hermiller, James; Rau, Vinuta; Ruster, Karine; Wang, Jin; Valgimigli, Marco; Mehran, Roxana
Data on ischemic and bleeding outcomes after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with chronic kidney disease (CKD) are scarce. We aimed to evaluate the association between CKD and ischemic and bleeding outcomes in HBR patients who underwent PCI. Among 10,502 patients in the four post-approval registries evaluating patients undergoing PCI, 2,300 patients presented with at least one major or two minor ARC-HBR criteria. CKD was defined as eGFR < 60 mL/min/1.73 m2. These HBR patients were divided into 3 groups: eGFR < 30 mL/min/1.73 m2 defined as severe CKD (N = 221), eGFR 30- < 60 mL/min/1.73 m2 defined as moderate CKD (N = 970), eGFR ≥ 60 mL/min/1.73 m2 defined as no CKD (N = 1,109). The primary endpoint was the composite of cardiac death, myocardial infarction, or stent thrombosis, and the safety endpoint was major bleeding up to 4-year follow-up. HBR patients with CKD were more often female and had higher rates of comorbidities compared to those without CKD. Reduced renal function was associated with higher rates of the primary endpoint (severe CKD vs. moderate CKD vs. no CKD: 30.2% vs. 12.5% vs. 9.1%, P < 0.01) as well as major bleeding (10.3% vs. 8.9% vs. 6.4%, P = 0.03). After adjustment, severe CKD and moderate CKD in HBR patients remained independent predictors for the primary endpoint (HR [95%CI] 2.84 [1.94-4.16], P < 0.01, 1.48 [1.10-2.00], P < 0.01) compared to those with no CKD. However, decreased renal function was no longer significantly associated with major bleeding after adjustment. In conclusions, in HBR patients undergoing PCI, CKD has an important impact on major ischemic events after PCI.
PMID: 33709255
ISSN: 1573-742x
CID: 4809572

Kidney Transplant List Status and Outcomes in the ISCHEMIA-CKD Trial

Herzog, Charles A; Simegn, Mengistu A; Xu, Yifan; Costa, Salvatore R; Mathew, Roy O; El-Hajjar, Mohammad C; Gulati, Sanjeev; Maldonado, Rafael A; Daugas, Eric; Madero, Magdelena; Fleg, Jerome L; Anthopolos, Rebecca; Stone, Gregg W; Sidhu, Mandeep S; Maron, David J; Hochman, Judith S; Bangalore, Sripal
BACKGROUND:Patients with chronic kidney disease (CKD) and coronary artery disease frequently undergo preemptive revascularization before kidney transplant listing. OBJECTIVES/OBJECTIVE:In this post-hoc analysis from ISCHEMIA-CKD, we compared outcomes of patients not listed versus those listed according to management strategy. METHODS:In ISCHEMIA-CKD (n=777), 194 patients (25%) with chronic coronary syndromes and at least moderate ischemia were listed for transplant. The primary (all-cause mortality or nonfatal myocardial infarction [MI]) and secondary (death, nonfatal MI, hospitalization for unstable angina, heart failure, resuscitated cardiac arrest, or stroke) outcomes were analyzed using Cox multivariable modeling. Heterogeneity of randomized treatment effect between listed versus not listed groups was assessed. RESULTS:Compared with those not listed, listed patients were younger (60 versus 65 years), less likely of Asian race (15% versus 29%), more likely on dialysis (83% versus 44%), had fewer anginal symptoms, and more likely to have coronary angiography and coronary revascularization irrespective of treatment assignment. Among patients assigned to an invasive strategy versus conservative strategy, the adjusted hazard ratios (aHR) (95% confidence interval [CI]) for the primary outcome were 0.91 (0.54-1.54) and 1.03 (0.78-1.37) for those listed and not listed, respectively (pinteraction=0.68). Adjusted HR for secondary outcomes were 0.89 (0.55-1.46) in listed and 1.17 (0.89-1.53) in those not listed (pinteraction=0.35). CONCLUSIONS:In ISCHEMIA-CKD, an invasive strategy in kidney transplant candidates did not improve outcomes compared with conservative management. These data do not support routine coronary angiography or revascularization in patients with advanced CKD and chronic coronary syndromes listed for transplant.
PMID: 33989711
ISSN: 1558-3597
CID: 4867872

Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials

Madhavan, Mahesh V; Howard, James P; Naqvi, Azim; Ben-Yehuda, Ori; Redfors, Bjorn; Prasad, Megha; Shahim, Bahira; Leon, Martin B; Bangalore, Sripal; Stone, Gregg W; Ahmad, Yousif
AIMS /UNASSIGNED:Contemporary 2nd-generation thin-strut drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. A previous meta-analysis of 10 randomized controlled trials (RCTs) with 11 658 patients demonstrated a 16% reduction in the 1-year risk of target lesion failure (TLF) with ultrathin-strut DES compared with conventional 2nd-generation thin-strut DES. Whether this benefit is sustained longer term is not known, and newer trial data may inform these relative outcomes. We therefore sought to perform an updated systematic review and meta-analysis of RCTs comparing clinical outcomes with ultrathin-strut DES (≤70 µm strut thickness) with conventional 2nd-generation thin-strut DES. METHODS AND RESULTS /UNASSIGNED:We performed a random-effects meta-analysis of all RCTs comparing ultrathin-strut DES to conventional 2nd-generation thin-strut DES. The pre-specified primary endpoint was long-term TLF, a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included the components of TLF, stent thrombosis (ST), and all-cause death. There were 16 eligible trials in which 20 701 patients were randomized. The weighted mean follow-up duration was 2.5 years. Ultrathin-strut DES were associated with a 15% reduction in long-term TLF compared with conventional 2nd-generation thin-strut DES [relative risk (RR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.008] driven by a 25% reduction in CD-TLR (RR 0.75, 95% CI 0.62-0.92, P = 0.005). There were no significant differences between stent types in the risks of MI, ST, cardiac death, or all-cause mortality. CONCLUSIONS /UNASSIGNED:At a mean follow-up of 2.5 years, ultrathin-strut DES reduced the risk of TLF, driven by less CD-TLR compared with conventional 2nd-generation thin-strut DES, with similar risks of MI, ST, cardiac death, and all-cause mortality.
PMID: 34002202
ISSN: 1522-9645
CID: 4876882

Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome: Insights from a network meta-analysis of randomized trials

Kuno, Toshiki; Ueyama, Hiroki; Takagi, Hisato; Fox, John; Bangalore, Sripal
BACKGROUND:With newer generation drug eluting stents (DES), the minimal duration of dual antiplatelet therapy (DAPT) recommended by guidelines has been reduced to 6 months in patients with stable coronary artery disease. Whether shorter duration of DAPT is safe in patients presenting with acute coronary syndrome (ACS) remains controversial. Our aim of this study was to investigate the optimal DAPT duration (≤3 months vs. 6 months vs. 12 months vs. >12 months) among patients with ACS undergoing percutaneous coronary intervention (PCI). METHODS:PUBMED and EMBASE were searched through January 2020 for randomized controlled trials of DAPT duration in patients with ACS. The ischemic outcomes were all-cause death, myocardial infarction, and stent thrombosis. The safety outcome was major and/or clinically relevant bleeding. RESULTS:Our search identified 14 eligible trials enrolling a total of 31,837 patients comparing different DAPT duration in patients with ACS. Short-term DAPT (≤3 months or 6 months) did not increase ischemic outcomes compared to long-term DAPT (12 months and >12 months). For bleeding outcomes, ≤3 months DAPT was associated with significant reduction in bleeding compared to 6 months, 12 months or >12 months DAPT (OR [95% CI]: 0.60 [0.37-0.98]; 0.68 [0.54-0.85] and 0.43 [0.34-0.54], respectively). These findings were similar when limited to 2nd generation DES. CONCLUSIONS:Data from this meta-analysis of randomized trials support short-term (≤3 months and 6 months) DAPT in patients with ACS undergoing PCI. Guidelines might need to consider short-term DAPT even in patients presenting with ACS, especially in this era of newer generation DES.
PMID: 32893157
ISSN: 1878-0938
CID: 4588732

Coronary CT Angiography Followed by Invasive Angiography in Patients With Moderate or Severe Ischemia-Insights From the ISCHEMIA Trial

Mancini, G B John; Leipsic, Jonathan; Budoff, Matthew J; Hague, Cameron J; Min, James K; Stevens, Susanna R; Reynolds, Harmony R; O'Brien, Sean M; Shaw, Leslee J; Manjunath, Cholenahally N; Mavromatis, Kreton; Demkow, Marcin; Lopez-Sendon, Jose Luis; Chernavskiy, Alexander M; Gosselin, Gilbert; Schuchlenz, Herwig; Devlin, Gerard P; Chauhan, Anoop; Bangalore, Sripal; Hochman, Judith S; Maron, David J
OBJECTIVES/OBJECTIVE:This study aimed to examine the concordance of coronary computed tomographic angiography (CCTA) assessment of coronary anatomy and invasive coronary angiography (ICA) as the reference standard in patients enrolled in the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA). BACKGROUND:Performance of CCTA compared with ICA has not been assessed in patients with very high burdens of stress-induced ischemia and a high likelihood of anatomically significant coronary artery disease (CAD). A blinded CCTA was performed after enrollment to exclude patients with left main (LM) disease or no obstructive CAD before randomization to an initial conservative or invasive strategy, the latter guided by ICA and optimal revascularization. METHODS:Rates of concordance were calculated on a per-patient basis in patients randomized to the invasive strategy. Anatomic significance was defined as ≥50% diameter stenosis (DS) for both modalities. Sensitivity analyses using a threshold of ≥70% DS for CCTA or considering only CCTA images of good-to-excellent quality were performed. RESULTS:In 1,728 patients identified by CCTA as having no LM disease ≥50% and at least single-vessel CAD, ICA confirmed 97.1% without LM disease ≥50%, 92.2% with at least single-vessel CAD and no LM disease ≥50%, and only 4.9% without anatomically significant CAD. Results using a ≥70% DS threshold or only CCTA of good-to-excellent quality showed similar overall performance. CONCLUSIONS:CCTA before randomization in ISCHEMIA demonstrated high concordance with subsequent ICA for identification of patients with angiographically significant disease without LM disease.
PMID: 33454249
ISSN: 1876-7591
CID: 4760142

Chronic Inflammation in Chronic Kidney Disease Progression: Role of Nrf2

Stenvinkel, Peter; Chertow, Glenn M; Devarajan, Prasad; Levin, Adeera; Andreoli, Sharon P; Bangalore, Sripal; Warady, Bradley A
Despite recent advances in the management of chronic kidney disease (CKD), morbidity and mortality rates in these patients remain high. Although pressure-mediated injury is a well-recognized mechanism of disease progression in CKD, emerging data indicate that an intermediate phenotype involving chronic inflammation, oxidative stress, hypoxia, senescence, and mitochondrial dysfunction plays a key role in the etiology, progression, and pathophysiology of CKD. A variety of factors promote chronic inflammation in CKD, including oxidative stress and the adoption of a proinflammatory phenotype by resident kidney cells. Regulation of proinflammatory and anti-inflammatory factors through NF-κB- and nuclear factor, erythroid 2 like 2 (Nrf2)-mediated gene transcription, respectively, plays a critical role in the glomerular and tubular cell response to kidney injury. Chronic inflammation contributes to the decline in glomerular filtration rate (GFR) in CKD. Whereas the role of chronic inflammation in diabetic kidney disease (DKD) has been well-elucidated, there is now substantial evidence indicating unresolved inflammatory processes lead to fibrosis and eventual end-stage kidney disease (ESKD) in several other diseases, such as Alport syndrome, autosomal-dominant polycystic kidney disease (ADPKD), IgA nephropathy (IgAN), and focal segmental glomerulosclerosis (FSGS). In this review, we aim to clarify the mechanisms of chronic inflammation in the pathophysiology and disease progression across the spectrum of kidney diseases, with a focus on Nrf2.
PMID: 34307974
ISSN: 2468-0249
CID: 4949052

Evidence-Based Practices in the Cardiac Catheterization Laboratory: A Scientific Statement From the American Heart Association

Bangalore, Sripal; Barsness, Gregory W; Dangas, George D; Kern, Morton J; Rao, Sunil V; Shore-Lesserson, Linda; Tamis-Holland, Jacqueline E
Cardiac catheterization procedures have rapidly evolved and expanded in scope and techniques over the past few decades. However, although some practices have emerged based on evidence, many traditions have persisted based on beliefs and theoretical concerns. The aim of this review is to highlight common preprocedure, intraprocedure, and postprocedure catheterization laboratory practices where evidence has accumulated over the past few decades to support or discount traditionally held practices.
PMID: 34187171
ISSN: 1524-4539
CID: 4926482