CAD

Bypass Surgery for Multivessel CAD Reaffirmed in Newer Data

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Surgeons fire back at downgrading of CABG in recent guidelines

The recently weakened endorsement of coronary artery bypass grafting (CABG) for multivessel disease is not supported by contemporary real-world data, heart surgeons argued.

Based on over 100,000 Medicare beneficiaries presenting with acute coronary syndrome (ACS) who underwent revascularization, risk-adjusted rates of death, myocardial infarction (MI), heart failure, acute kidney injury, and readmissions at 30 days after discharge all favored CABG over multivessel percutaneous coronary intervention (PCI).

Moreover, CABG was associated with improved 3-year survival (HR 0.448, 95% CI 0.437-0.458) and the composite endpoint of reintervention, MI, and death (HR 0.476, 95% CI 0.46-0.493). Longitudinal outcomes favored CABG in key subgroups of patients older than 75 years and those with baseline diabetes, heart failure, or non-ST-segment elevation MI (NSTEMI).

Only stroke readmission rates did not significantly favor CABG over PCI after risk adjustment of longitudinal outcomes, reported J. Hunter Mehaffey, MD, MSc, a cardiac surgeon at West Virginia University in Morgantown, during this year’s meeting of the Society of Thoracic Surgeons (STS)opens in a new tab or window.

“These longitudinal data support the superiority of CABG compared to PCI and may have current and future policy and practice implications,” Mehaffey said, adding that he wished to “take back the narrative about bypass surgery to make sure patients are getting optimal treatment.”

Fellow surgeon Joseph Sabik, III, MD, of University Hospitals Cleveland Medical Center, called this an important study with “impressive” findings that should prompt reevaluation of the recent controversial guideline change that had not been endorsed by surgeon societies — namely the STS and the American Association for Thoracic Surgery.

The controversy erupted in 2021 when American guidelines downgraded CABG from class I to class IIbopens in a new tab or window, on par with PCI, in multivessel disease and normal left ventricular ejection fraction in stable ischemic heart disease. This change was attributed to the guideline writers considering only the most recent studies from the prior 5 years — meaning the downgrade of CABG was based largely on the ISCHEMIA trial that had found an initial invasive approach to be no better than medical therapy aloneopens in a new tab or window in stable coronary artery disease.

Yet ISCHEMIA was not representative of patients undergoing CABG and failed to capture those with multivessel disease in particular, Mehaffey argued.

Sabik, speaking as the STS session discussant, pointed out that the controversy is in stable ischemic disease, whereas the study by Mehaffey’s group covers an ACS population. Nevertheless, the results at least raise the question of whether CABG should be the preferred therapy for all patients with ACS, Sabik said.

Mehaffey acknowledged the disparate patient populations being discussed but warned of guideline creep as “many clinical providers do not read the fine print,” only reviewing the executive summary or a lay media report. He reminded the audience that his results persisted in NSTEMI.

Sabik also cautioned that the improved clinical outcomes after CABG surgery came at the cost of greater in-hospital morbidity: In-hospital outcome of death favored CABG, whereas PCI was associated with less bleeding, stroke, acute kidney injury, and acute renal failure.

Moreover, CABG was associated with significantly higher hospital cost compared with PCI ($57,189 vs $36,342, P< 0.001) and longer total hospital stays (11.9 days vs 5.8 days, P<0.001), the study authors found.

Aiming to give guideline committees the contemporary data that they want, Mehaffey and colleagues had limited their analysis to Medicare beneficiaries presenting from January 2018 to December 2020.

The observational study relied on a database of Centers for Medicare & Medicaid Services inpatient claims. Participants were people who underwent CABG (n=51,389) or multivessel PCI (n=52,738), excluding those with a history of concomitant valvular procedures, prior CABG, and heart transplantation.

Compared with the PCI arm, CABG recipients were younger (72.9 vs 75.2 years, P<0.001) but tended to have a higher Elixhauser Comorbidity Index (5.0 vs 4.2, P<0.001), and a higher likelihood of diabetes (48.5% vs 42.2%, P<0.001). The CABG cohort also had lower rates of ST elevation MI at presentation (14.4% vs 29.0%, P<0.001).

The groups were relatively well-balanced after matching by inverse probability of treatment weighting propensity scores.

Nevertheless, the observational analysis remained subject to potential confounding and biases inherent in its nonrandomized design.

“The findings of our study were very convincing,” Mehaffey maintained in a press releaseopens in a new tab or window. “The singular message to the public is that the optimal treatment for multivessel coronary artery disease — to improve not only long-term survival but also lower your risk of complications — is coronary artery bypass surgery.”

“These contemporary real-world data support prior existing trials highlighting the benefits of CABG in multivessel coronary artery disease, urging a re-evaluation of recent guidelines,” he said.

Beetroot juice may aid people with coronary heart disease.

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https://www.theguardian.com/society/2022/jun/09/beetroot-juice-coronary-heart-disease-nitric-oxide-levels

Very high HDL ‘red flag’ for all-cause, CV death risk in adults with CAD

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In adults with CAD, those with HDL of 80 mg/dL or greater are nearly twice as likely to die of any cause compared with those with HDL between 40 mg/dL and 60 mg/dL, according to an analysis of two large biobank databases.

In an analysis of data from nearly 20,000 patients, researchers also found the higher risk for all-cause and CV death associated with very high HDL, typically considered protective, was independent of traditional CV risk factors and alcohol use.

Graphical depiction of source quote presented in the article
Quyyumi is professor of medicine, director of the Emory Clinical Cardiovascular Research Institute and the Bruce Logue Chair for Cardiovascular Research at Emory University School of Medicine.

“Very high HDL levels are associated with increased risk for adverse outcomes, not lower risk, as previously thought,” Arshed A. Quyyumi, MD, FRCP, professor of medicine, director of the Emory Clinical Cardiovascular Research Institute and the Bruce Logue Chair for Cardiovascular Research at Emory University School of Medicine, told Healio. “This is true not only in the general population but also in people with known coronary artery disease. The higher risk with very high HDL levels is particularly seen in men, although women also have higher risk at very high HDL levels.”

Prospective biobank data

In a prospective study, Quyyumi and colleagues analyzed data from patients with confirmed CAD and high HDL, defined as at least 80 mg/dL, using UK Biobank (2006-present; n = 14,478; mean age, 62 years; 76.2% men) and Emory Cardiovascular Biobank (2003-present; n = 5,467; mean age, 64 years; 66.4% men) data. Patients without confirmed CAD were excluded. The primary outcome was all-cause death; secondary outcome was CV death.

The findings were published in JAMA Cardiology.

During a median follow-up of 8.9 years in the UK Biobank and 6.7 years in the Emory Cardiovascular Biobank, researchers observed a U-shaped association between HDL level, all-cause death and CV death, with higher risk among patients with low and very high HDL vs. patients with midrange values.

For the UK Biobank analysis, compared with patients with an HDL between 40 mg/dL and 60 mg/dL, patients with an HDL of at least 80 mg/dL were nearly twice as likely to die of any cause during follow-up, with a HR of 1.96 (95% CI, 1.42-2.71; P < .001) and 71% more likely to die of CV causes, with an HR of 1.71 (95% CI, 1.09-2.68; P = .02). Results persisted after adjustment for other CV risk factors, including hypertension, diabetes and smoking.

Findings were similar for patients in the Emory Cardiovascular Biobank, with findings for the UK Biobank persisting after further adjustment for genetic risk score.

In sensitivity analyses, all-cause death risk among patients from the UK Biobank with very high HDL was greater among men (HR = 2.63; 95% CI, 1.75-3.95; P < .001) compared with women (HR = 1.39; 95% CI, 0.82-2.35; P = .23).

“Physicians have to be cognizant of the fact that, at levels of HDL above 80 mg/dL, they must be more aggressive with risk reduction and not believe that that the patient is at ‘low risk’ because of high levels of ‘good cholesterol,’” Quyyumi told Healio. “We need to understand what the mechanisms underlying this increased risk are. What are the functional changes in HDL that lead to this higher risk?”

Very high HDL as ‘red flag’

Sadiya S. Khan

Gregg C. Fonarow

In a related editorial, Sadiya S. Khan, MD, MSc, assistant professor of preventive medicine (epidemiology) and medicine (cardiology) at Northwestern University Feinberg School of Medicine, and Gregg C. Fonarow, MD, FACC, FAHA, FHFSA, director of the Ahmanson-UCLA Cardiomyopathy Center, co-director of the UCLA Preventive Cardiology Program, co-chief of the division of cardiology at UCLA and the Eliot Corday Chair in Cardiovascular Medicine and Science, wrote that emerging data from healthy populations suggest a “paradoxical association” may be present, with higher mortality observed among people with very high HDL.

“Although the present findings may be related to residual confounding, high HDL-C levels should not automatically be assumed to be protective,” Khan and Fonarow wrote. “Clinicians should use HDL-C levels as a surrogate marker with very low and very high levels as a red flag to target for more intensive primary and secondary prevention, as the maxim for HDL-C as ‘good’ cholesterol only holds for HDL-C levels of 80 mg/dL or less.”

Previous analyses have suggested very high HDL may be a risk factor for all-cause death. As Healio previously reported, patients with HDL levels greater than 60 mg/dL in the Emory Cardiovascular Biobank had a nearly 50% increased risk for all-cause mortality, CV mortality and MI compared with those with HDL levels of 41 mg/dL to 60 mg/dL.

Reference:

Repeat Measures of Lipoprotein(a) Molar Concentration and Cardiovascular Risk

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Abstract

Background

When indicated, guidelines recommend measurement of lipoprotein(a) for cardiovascular risk assessment. However, temporal variability in lipoprotein(a) is not well understood, and it is unclear if repeat testing may help refine risk prediction of coronary artery disease (CAD).

Objectives

The authors examined the stability of repeat lipoprotein(a) measurements and the association between instability in lipoprotein(a) molar concentration with incident CAD.

Methods

The authors assessed the correlation between baseline and first follow-up measurements of lipoprotein(a) in the UK Biobank (n = 16,017 unrelated individuals). The association between change in lipoprotein(a) molar concentration and incident CAD was assessed among 15,432 participants using Cox proportional hazards models.

Results

Baseline and follow-up lipoprotein(a) molar concentration were significantly correlated over a median of 4.42 years (IQR: 3.69-4.93 years; Spearman rho = 0.96; P < 0.0001). The correlation between baseline and follow-up lipoprotein(a) molar concentration were stable across time between measurements of ❤ (rho = 0.96), 3-4 (rho = 0.97), 4-5 (rho = 0.96), and >5 years (rho = 0.96). Although there were negligible-to-modest associations between statin use and changes in lipoprotein(a) molar concentration, statin usage was associated with a significant increase in lipoprotein(a) among individuals with baseline levels ≥70 nmol/L. Follow-up lipoprotein(a) molar concentration was significantly associated with risk of incident CAD (HR per 120 nmol/L: 1.32 [95% CI: 1.16-1.50]; P = 0.0002). However, the delta between follow-up and baseline lipoprotein(a) molar concentration was not significantly associated with incident CAD independent of follow-up lipoprotein(a) (P = 0.98).

Conclusions

These findings suggest that, in the absence of therapies substantially altering lipoprotein(a), a single accurate measurement of lipoprotein(a) molar concentration is an efficient method to inform CAD risk.

CAD: Striving for Better Lung Ca Imaging Reports

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Swiss researchers aim to make radiology reports more meaningful by extracting TNM staging data

Computer-aided detection (CAD) has made its mark in the cancer field, most notably for breast cancer detection. In lung cancer, the use of CAD systems can improve the performance of radiologists in pinpointing pulmonary nodules. But CAD systems in lung cancer have suffered from some shortcomings, such as only little to modest improvement in sensitivity, an increase in false positives, and issues with the level of automation as well as the ability to detect different types and shapes of nodules.

Another potential pitfall: How can CAD results, which are rendered in the language of radiologists, be matched with the language of oncologists?

Bram Stieltjes, MD, PhD, of the University Hospital Basel in Switzerland, and colleagues sought to answer that question by developing an in-house CAD image-processing software for PET/CT lung studies. The goal with a study they presented at the 2017 Radiological Society of North America (RSNA) meeting in Chicago was to decrease tumor, node, distant metastasis (TNM) misstaging, and subsequent erroneous treatment planning for lung cancer patients.

Stieltjes spoke with ASCO Reading Room about the impetus for this research, and the plans for launching the CAD program at his institution as soon as early 2018.

Study Details

The group evaluated reports from the radiology information system (RIS) of 145 non-small cell lung cancer (NSCLC) patients who underwent a primary staging FDG-PET/CT exam at the facility. TNM (edition 7) was determined according to the text information in the reports by a radiologist and a nuclear medicine physician.

The team then downloaded the corresponding PET and CT image data sets from the university’s picture archiving and communication system (PACS). These data sets were transferred to 3D-slicer-based prototype software. As the authors explained, the image-processing application allows for manual segmentation of tumors, lymph nodes, and metastasis using a set of labels including location information and morphological TNM features.

Stieltjes et al reported that in a substantial number of patients, not enough information was provided by the original report to extract a distinct TNM stage:

  • T: 18.6% (27/145)
  • N: 10.3% (15/145)
  • M: 2.1% (3/145)

“Furthermore, in 29 cases, there was a considerable discrepancy between the report and annotation: upstaging due to the annotations: T: n=11, N: n=6, M: n=4; downstaging due to the annotations: T: n=3; N: n=4; M: n=1.”

Applying the image-processing tool and using a segmentation-based approach to the image data sets allowed the team to extract TNM information in all patients, the researchers explained, adding that their approach with tumor labels allows for a clear definition of cancerous lesions in a standardized and reproducible manner.

“We could demonstrate that the proper TNM stage could not be derived from unstructured PET/CT reports in a roughly 30% of the cases. This commonly affects the T-stage because of missing diameter measurements, but also the N and M stage.”

The investigators concluded that the labels generated using this image-processing tool could be directly translated into clinical decision-making, such as tumor boards, and were less prone to interpretation.

The following interview with Stieltjes, who is the head of research coordination for radiologist and nuclear medicine at the Basel institution, has been edited for length and clarity.

Why did your group decide to undertake this study?

Stieltjes: We were trying to standardize our output, and perhaps implement the much-hyped machine learning — what some might call a type of artificial intelligence inroutine clinical practice. I’ve been [at Basel] about 3 years, and our first year we looked for projects that might be suitable to achieve this goal. Lung tumor staging was one such project where the data was there, and there was a substantial number of patients.

The clinical work time that is done on preparing a lung PET/CT report is very high; we [radiologists] take about an hour per report. So there is much that can be gained in terms of efficiency. My gut feeling was that … even when we put in the work on interpretation and reporting, we don’t always deliver the information that is necessary for the oncologists.

There’s an ongoing conversation in radiology about the usefulness of structured reporting versus the free-text reporting described in your study. Do you see structured reporting being of some benefit along with the image-processing tool used in your research?

Stieltjes: Structured reporting does not touch on the radiological workflow as it is right now; it is only formalizing the way text is inputted. Radiology is still interpreting the image and generating a report. However the link between the text and the image is very weak.

What we are presenting is a sort of third way: You first define all the important anatomical features in a structured way with labels. Then the job of the radiologist is not scrolling and talking, but scrolling and clicking, labeling — to place a label on an image in the study series. This then goes to a database.

As a recipient of the report, I can learn and understand what the radiologist sees; I’m able to have a direct link between his or her knowledge and the actual place in the image where their skills have seen an area of importance.

Is the system described in the study ready for clinical deployment?

Stieltjes: We’re on the brink of putting the annotation portion for lung tumors into clinical routine — not the decision-making part. What we’re trying to do is change the radiologist workflow, so that they’re labeling as part of their report — so we focused on getting the annotation part done first. We hope to have it into practice in the early part of 2018.

The next part is the capability to detect all lung lesions, which the radiologist will review, and we’re confident that we’ll have that in the next generation of the application.

What feedback have you received from oncologists and other clinical colleagues about this system?

Stieltjes: This project has been conducted in partnership with our oncology department. The oncologists are really looking forward to having all the TNM information in our reports for two reasons: One, TNM information was not always included in reports; and two, images were not always included in reports. Now labeled images and TNM stage will be part of every report.

Of course, oncologists want to have pathology for correlation, so our TNM stage will be provisional until they get a pathological confirmation.

Should We Set a Higher Bar for Coronary Angiography?

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Compared with Ontario, obstructive disease is less common in patients who undergo catheterization in New York.

A recent study indicated that more cardiac catheterizations are performed per capita in New York State than in Ontario, Canada). Now, the same investigators have compared the prevalence of obstructive coronary artery disease (CAD) — defined as diameter stenosis ≥50% in the left main or ≥70% in a major epicardial vessel — in patients undergoing the procedure in the two regions.

Obstructive CAD was found in significantly more of approximately 55,000 patients undergoing a first elective cardiac catheterization during 2008–2011 in Ontario than in some 18,000 such patients in New York (45% and 30%, respectively). Compared with the Canadian patients, the New Yorkers were younger and more likely to be women or to have no or atypical symptoms; the prevalence of several other risk factors also differed significantly between the two groups. Fewer patients in New York than in Ontario had noninvasive evaluations (63% vs. 75%, P<0.001), and the predicted preprocedure probability of obstructive CAD was significantly lower in New York.

Among patients with obstructive CAD, those in New York were significantly more likely than those in Ontario to undergo revascularization (percutaneous coronary intervention, 55% vs. 35%; coronary artery bypass grafting, 20% vs. 14%). Higher crude 30-day mortality in New York than in Ontario was mainly attributable to higher mortality in patients without obstructive CAD.

COMMENT

These findings suggest that the relatively high cardiac catheterization rate in New York results primarily from selecting patients at lower predicted probabilities of obstructive coronary artery disease. The investigators could not control for regional differences in patient, societal, and physician characteristics, preferences, and expectations; nor could they assess which catheterization rate is more appropriate. Nonetheless, the higher prevalence of interventionalists and cardiac invasive capabilities — as well as market-oriented financing — in New York seems likely to account for much, if not all, of the disparity; if so, these data illuminate an opportunity to reduce unnecessary healthcare expenditures.

Source: NEJM

FDA approves first drug-eluting stent for treatment of CAD in patients with diabetes.

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Medtronic has announced FDA approval of the Resolute Integrity drug-eluting stent for the treatment of coronary artery disease, which is also the first stent approved for coronary artery disease patients with diabetes.

The agency’s approval was based on results from the global RESOLUTE clinical program, consisting of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. The program enrolled more than 5,100 patients who received the drug-eluting stent — about one-third of whom had diabetes.

The RESOLUTE US program enrolled 1,402 patients (34% with diabetes) from 128 US-based clinical trial sites. At 1-year follow-up, researchers found low rates of target lesion failure (4.7%), clinically driven target lesion revascularization (2.8%) and definite/probable stent thrombosis (0.1%). A prespecified analysis of patients with diabetes who received the Resolute drug-eluting stent at 1 year also showed low rates of target lesion failure (6.6%), target lesion revascularization (3.4%) and definite/probable stent thrombosis (0.3%). Further, the Resolute drug-eluting stent matched the safety and efficacy of the Xience V drug-eluting stent (Abbott) in two separate large randomized controlled trials.

Additionally, 1- and 2-year data from the Resolute All-Comers study, which enrolled nearly 2,300 patients at 17 centers, were published in The New England Journal of Medicine and The Lancet, respectively.

Similar to Medtronic’s Integrity bare metal stent, the Resolute Integrity drug-eluting stent uses continuous sinusoid technology, which encompasses one continuous single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points.

“The Resolute Integrity drug-eluting stent offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” Martin B. Leon, MD, director of the center for interventional vascular therapy at New York-Presbyterian/Columbia University Medical Center and principal investigator of the RESOLUTE US clinical study, said in a press release. “Its approval by the FDA is based on the impressive performance of the Resolute drug-eluting stent in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first drug-eluting stent approved for patients with diabetes, the Resolute Integrity drug-eluting stent promises to gain rapid acceptance in cath labs nationwide.”

Source: Endocrine Today.Cardiology.