ABSTRACT

BACKGROUND: Emulating randomized controlled trials (RCTs) by real-world evidence (RWE) studies would benefit future clinical and regulatory decision-making by balancing the limitations of RCT. We aimed to evaluate whether the findings from RWE studies can support regulatory decisions derived from RCTs of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with venous thromboembolism (VTE).

METHODS: Five landmark trials (AMPLIFY, RE-COVER II, Hokusai-VTE, EINSTEIN-DVT, and EINSTEIN-PE) of NOACs were emulated using the South Korean nationwide claims database (January 2012 to August 2020). We applied an active comparator and new-user design to include patients who initiated oral anticoagulants within 28 days from their VTE diagnoses. The prespecified eligibility criteria, exposure (each NOAC, such as apixaban, rivaroxaban, dabigatran, and edoxaban), comparator (conventional therapy, defined as subcutaneous heparin followed by warfarin), and the definition of outcomes from RCTs were emulated as closely as possible in each separate emulation cohort. The primary outcome was identical to each trial, which was defined as recurrent VTE or VTE-related death. The safety outcome was major bleeding. Propensity score matching was conducted to balance 69 covariates between the exposure groups. Effect estimates for outcomes were estimated using the Mantel-Haenszel method and Cox proportional hazards model and subsequently compared with the corresponding RCT estimates.

RESULTS: Compared to trial populations, real-world study populations were older (range: 63-69 years [RWE] vs. 54-59 years [RCT]), with more females (55-60.5% vs. 39-48.3%) and had a higher prevalence of active cancer (4.2-15.4% vs. 2.5-9.5%). The emulated estimates for effectiveness outcomes showed superior effectiveness of NOAC (AMPLIFY: relative risk 0.81, 95% confidence interval 0.70-0.94; RE-COVER II: hazard ratio [HR] 0.60, 0.37-0.96; Hokusai-VTE: 0.49, 0.31-0.78; EINSTEIN-DVT: 0.54, 0.33-0.89; EINSTEIN-PE: 0.50, 0.34-0.74), when contrasted with trials that showed non-inferiority. For safety outcomes, all emulations except for AMPLIFY and EINSTEIN-DVT yielded results consistent with their corresponding RCTs.

CONCLUSIONS: This study revealed the feasibility of complementing RCTs with RWE studies by using claims data in patients with VTE. Future studies to consider the different demographic characteristics between RCT and RWE populations are needed.

PMID:37775786 | PMC:PMC10542685 | DOI:10.1186/s12916-023-03069-1

21:55

PubMed articles on: Cancer & VTE/PE

A case report: A patient rescued by VA-ECMO after cardiac arrest triggered by trigeminocardiac reflex after nasal surgery

Medicine (Baltimore). 2023 Sep 29;102(39):e35226. doi: 10.1097/MD.0000000000035226.

ABSTRACT

RATIONALE: Cardiac arrest (CA) caused by trigeminocardiac reflex (TCR) after endoscopic nasal surgery is rare. Hence, when a patient suffers from TCR induced CA in the recovery room, most doctors may not be able to find the cause in a short time, and standard cardiopulmonary resuscitation and resuscitation measures may not be effective. Providing circulatory assistance through venous-arterial extracorporeal membrane oxygenation (VA-ECMO) can help healthcare providers gain time to identify the etiology and initiate symptom-specific treatment.

PATIENT CONCERNS: We report a rare case of CA after endoscopic nasal surgery treated with VA-ECMO.

DIAGNOSES: We excluded myocardial infarction, pulmonary embolism, allergies, hypoxia, and electrolyte abnormalities based on the relevant examination results. Following a multidisciplinary consultation, clinical manifestation and a review of previous literature, we reasoned that the CA was due to TCR.

INTERVENTIONS: VA-ECMO was established to resuscitate the patient successfully during effective cardiopulmonary resuscitation.

OUTCOMES: ECMO was successfully evacuated a period of 190 minutes of therapy. The patient was discharged home on day 8.

LESSONS: TCR is notable during endoscopic nasal surgery. Our case indicates that CA in operating room is worth prolonged CCPR. The ideal time for ECPR implementation should not be limited within 20 minutes after CCPR.

PMID:37773828 | PMC:PMC10545381 | DOI:10.1097/MD.0000000000035226

21:55

PubMed articles on: Cancer & VTE/PE

ASO Visual Abstract: In-Hospital Venous Thromboembolism and Pulmonary Embolism After Major Urological Cancer Surgery

Ann Surg Oncol. 2023 Sep 25. doi: 10.1245/s10434-023-14315-4. Online ahead of print.

NO ABSTRACT

PMID:37743458 | DOI:10.1245/s10434-023-14315-4

21:55

PubMed articles on: Cancer & VTE/PE

Baicalin and lung diseases

Naunyn Schmiedebergs Arch Pharmacol. 2023 Sep 19. doi: 10.1007/s00210-023-02704-1. Online ahead of print.

ABSTRACT

Studies focusing on natural products have been conducted worldwide, and the results suggest that their natural ingredients effectively treat a wide range of illnesses. Baicalin (BIA) is a glycoside derived from the flavonoid baicalein present in Scutellaria baicalensis of the Lamiaceae family. Interestingly, BIA has been shown to protect the lungs in several animal models used in numerous studies. Therefore, we fully analyzed the data of the studies that focused on BIA's lung protective function against various injuries and included them in this review. Interestingly, BIA exhibits promising effects against acute lung injury, lung fibrosis, pulmonary embolism, and lung remodelling associated with COPD, LPS, and paraquat insecticide. BAI exhibits anticancer activity against lung cancer. Additionally, BIA potently attenuates lung damage associated with infections. BIA primarily exerts its therapeutic effects by suppressing inflammation, oxidative stress immune response, and apoptosis pathways. Nrf2/HO-1, PI3K/Akt, NF-κB, STAT3, MAPKs, TLR4, and NLRP3 are important targets in the pulmonary therapeutic effects of BIA on different lung disease models. Consequently, we recommend using it in future potential clinical applications, its contribution to treatment guidelines, and translating its promising effects to clinical practice in lung diseases.

PMID:37725153 | DOI:10.1007/s00210-023-02704-1

21:56

PubMed articles on: Cancer & VTE/PE

9 October 2023

C

01:51

Cardiotoxicity News

PubMed articles on: Cardio-Oncology

Development and Validation of a Nomogram Model for the Risk of Cardiac Death in Patients Treated with Chemotherapy for Esophageal Cancer

Cardiovasc Toxicol. 2023 Oct 7. doi: 10.1007/s12012-023-09807-4. Online ahead of print.

ABSTRACT

The primary cause of mortality in esophageal cancer survivors is cardiac death. Early identification of cardiac mortality risk during chemotherapy for esophageal cancer is crucial for improving the prognosis. We developed and validated a nomogram model to identify patients with high cardiac mortality risk after chemotherapy for esophageal cancer for early screening and clinical decision-making. We randomly allocated 37,994 patients with chemotherapy-treated esophageal cancer into two groups using a 7:3 split ratio: model training (n = 26,598) and validation (n = 11,396). 5- and 10-year survival rates were used as endpoints for model training and validation. Decision curve analysis and the consistency index (C-index) were used to evaluate the model's net clinical advantage. Model performance was evaluated using receiver operating characteristic curves and computing the area under the curve (AUC). Kaplan-Meier survival analysis based on the prognostic index was performed. Patient risk was stratified according to the death probability. Age, surgery, sex, and year were most closely related to cardiac death and used to plot the nomograms. The C-index for the training and validation datasets were 0.669 and 0.698, respectively, indicating the nomogram's net clinical advantage in predicting cardiac death risk at 5 and 10 years. The 5- and 10-year AUCs were 0.753 and 0.772 for the training dataset and 0.778 and 0.789 for the validation dataset, respectively. The accuracy of the model in predicting cardiac death risk was moderate. This nomogram can identify patients at risk of cardiac death after chemotherapy for esophageal cancer at an early stage.

PMID:37804372 | DOI:10.1007/s12012-023-09807-4

01:51

PubMed articles on: Cardio-Oncology

Outcomes of patients with active cancers and pre-existing cardiovascular diseases infected with SARS-CoV-2

Cardiooncology. 2023 Oct 6;9(1):36. doi: 10.1186/s40959-023-00187-w.

ABSTRACT

OBJECTIVE: To determine the impact of acute SARS-CoV-2 infection on patient with concomitant active cancer and CVD.

METHODS: The researchers extracted and analyzed data from the National COVID Cohort Collaborative (N3C) database between January 1, 2020, and July 22, 2022. They included only patients with acute SARS-CoV-2 infection, defined as a positive test by PCR 21 days before and 5 days after the day of index hospitalization. Active cancers were defined as last cancer drug administered within 30 days of index admission. The "Cardioonc" group consisted of patients with CVD and active cancers. The cohort was divided into four groups: (1) CVD (-), (2) CVD ( +), (3) Cardioonc (-), and (4) Cardioonc ( +), where (-) or ( +) denotes acute SARS-CoV-2 infection status. The primary outcome of the study was major adverse cardiovascular events (MACE), including acute stroke, acute heart failure, myocardial infarction, or all-cause mortality. The researchers analyzed the outcomes by different phases of the pandemic and performed competing-risk analysis for other MACE components and death as a competing event.

RESULTS: The study analyzed 418,306 patients, of which 74%, 10%, 15.7%, and 0.3% had CVD (-), CVD ( +), Cardioonc (-), and Cardioonc ( +), respectively. The Cardioonc ( +) group had the highest MACE events in all four phases of the pandemic. Compared to CVD (-), the Cardioonc ( +) group had an odds ratio of 1.66 for MACE. However, during the Omicron era, there was a statistically significant increased risk for MACE in the Cardioonc ( +) group compared to CVD (-). Competing risk analysis showed that all-cause mortality was significantly higher in the Cardioonc ( +) group and limited other MACE events from occurring. When the researchers identified specific cancer types, patients with colon cancer had higher MACE.

CONCLUSION: In conclusion, the study found that patients with both CVD and active cancer suffered relatively worse outcomes when they had acute SARS-CoV-2 infection during early and alpha surges in the United States. These findings highlight the need for improved management strategies and further research to better understand the impact of the virus on vulnerable populations during the COVID-19 pandemic.

PMID:37803479 | PMC:PMC10557272 | DOI:10.1186/s40959-023-00187-w

01:51

PubMed articles on: Cardio-Oncology

Editorial: Cancer treatment-related cardiovascular disease - real world data in cardio-oncology

Front Oncol. 2023 Sep 20;13:1277042. doi: 10.3389/fonc.2023.1277042. eCollection 2023.

NO ABSTRACT

PMID:37799461 | PMC:PMC10548460 | DOI:10.3389/fonc.2023.1277042

01:51

PubMed articles on: Cardio-Oncology

Clinical Utility and Prognostic Value of Coronary Computed Tomography Angiography in Patients With Cancer

Am J Cardiol. 2023 Oct 3;207:448-454. doi: 10.1016/j.amjcard.2023.08.121. Online ahead of print.

ABSTRACT

There is growing interest in the role of coronary computed tomography angiography (CTA) in cardio-oncology. However, there is a paucity of real-world experience and outcome data for patients with cancer. This study sought to determine the clinical utility and prognostic value of coronary CTA in patients with cancer. In this prospective, single-center study, we recruited patients with cancer who underwent coronary CTA. Coronary artery disease (CAD) extent was classified as normal, nonobstructive (1% to 49% stenosis), and potentially obstructive (≥50% stenosis). Patients were followed up for a median of 9 months (interquartile range 3 to 30 months) for cancer-related deaths and major adverse cardiovascular events (MACEs) defined as nonfatal myocardial infarction, urgent unplanned revascularization, or cardiovascular death. The mean age of patients (n = 113) was 61 ± 12 years, and 68 were female (60%). The most common underlying cancers were breast (29%) and lymphoma (13%). A total of 25 patients had potentially obstructive CAD, most commonly of the left anterior descending artery. After coronary CTA, 88% statin-naive patients with potentially obstructive CAD were initiated on statin therapy. A total of 28/32 patients who were taking fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) continued therapy, of whom none had MACEs. Overall, there were no episodes of MACEs in this cohort and 11% had cancer-related deaths. Coronary CTA has an important role in the clinical decision-making in patients with cancer to detect CAD, initiate primary preventative therapy, and guide coronary revascularization. No MACEs occurred. Using this coronary CTA-guided approach, preventative therapy was initiated, and most patients continued prognostically important cancer therapy.

PMID:37797552 | DOI:10.1016/j.amjcard.2023.08.121

01:51

PubMed articles on: Cardio-Oncology

Advances in Screening for Radiation-Associated Cardiotoxicity in Cancer Patients

Curr Cardiol Rep. 2023 Oct 5. doi: 10.1007/s11886-023-01971-x. Online ahead of print.