Daily Archives: September 7, 2024
Cohort Study: Lower Risk of Cardiovascular Complications in Post–COVID-19 Vaccine Myocarditis Compared to Conventional Etiologies
7 Sep, 2024 | 20:36h | UTCStudy Design and Population: This French nationwide cohort study included 4,635 individuals aged 12-49 hospitalized for myocarditis between December 2020 and June 2022. The cohort was divided into three groups: 558 patients with post–COVID-19 mRNA vaccine myocarditis, 298 with post–COVID-19 infection myocarditis, and 3,779 with conventional myocarditis.
Main Findings: At 18 months of follow-up, the frequency of cardiovascular events was significantly lower in the postvaccine myocarditis group (5.7%) compared to conventional myocarditis (13.2%) with a weighted hazard ratio (wHR) of 0.55 (95% CI, 0.36-0.86). Hospital readmission for myopericarditis occurred in 3.2% of postvaccine cases, 4.0% of post–COVID-19 cases, and 5.8% of conventional cases. The all-cause mortality rate was 0.2% for postvaccine myocarditis, 1.3% for post–COVID-19 myocarditis, and 1.3% for conventional myocarditis.
Implications for Practice: Postvaccine myocarditis patients, primarily young males, experience fewer complications compared to conventional myocarditis, but long-term follow-up is still needed. These findings should guide future mRNA vaccine recommendations and clinical management for myocarditis patients.
Reference: Semenzato L. et al. (2024). Long-term Prognosis of Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2, or Conventional Etiologies. JAMA, Online. DOI: http://doi.org/10.1001/jama.2024.16380
Link: https://jamanetwork.com/journals/jama/fullarticle/2822933
RCT: Olanzapine Improves Nausea and Vomiting Control in Moderately Emetogenic Chemotherapy but Increases Somnolence
7 Sep, 2024 | 19:28h | UTCStudy Design and Population: This phase 3, multicenter, open-label randomized clinical trial involved 560 chemotherapy-naive patients aged 18 years or older with solid malignant tumors. The trial, conducted at three institutes in India, compared the efficacy of adding olanzapine to standard antiemetic therapy in patients receiving moderately emetogenic chemotherapy (MEC) based on oxaliplatin, carboplatin, or irinotecan.
Main Findings: The group receiving olanzapine in addition to standard antiemetic therapy showed significantly higher complete response (CR) rates (91% vs 82%, P = .005) compared to the observation group. The olanzapine group also demonstrated superior control of nausea (96% vs 87%, P < .001) and chemotherapy-induced nausea and vomiting (CINV) (96% vs 91%, P = .02). The use of rescue medications was significantly lower in the olanzapine group. Grade 1 somnolence occurred in 10% of patients receiving olanzapine but was absent in the observation group.
Implications for Practice: The results support the inclusion of olanzapine in antiemetic regimens for MEC to improve CINV outcomes. However, mild somnolence should be considered when prescribing olanzapine as part of antiemetic prophylaxis. Further research could explore dose optimization to minimize adverse effects.
Reference: Ostwal, V. et al. (2024). Olanzapine as antiemetic prophylaxis in moderately emetogenic chemotherapy: a phase 3 randomized clinical trial. JAMA Network Open. DOI: http://doi.org/10.1001/jamanetworkopen.2024.26076
Link: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822027
RCT: Pulmonary Vein Isolation Reduces Atrial Fibrillation Burden and Improves Quality of Life vs. Sham Procedure
7 Sep, 2024 | 17:24h | UTCStudy Design and Population: This double-blind, randomized clinical trial (SHAM-PVI) compared pulmonary vein isolation (PVI) via cryoablation to a sham procedure in 126 patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). The study, conducted in two UK tertiary centers, enrolled patients between January 2020 and March 2024. Major exclusions included long-standing persistent AF, prior left atrial ablation, and ejection fraction below 35%. Patients were monitored using implantable loop recorders.
Main Findings: At 6 months, the PVI group demonstrated a significant reduction in AF burden (60.31%) compared to the sham group (35.0%), with a geometric mean difference of 0.25 (95% CI, 0.15-0.42; P < .001). Quality-of-life scores also improved more in the PVI group, with an 18.39-point difference (95% CI, 11.48-25.30). Symptom improvement was also marked, with a reduction in the Mayo AF-Specific Symptom Inventory frequency score of −6.36 points (95% CI, −8.46 to −4.26).
Implications for Practice: PVI significantly reduces AF burden and improves both symptoms and quality of life in patients with symptomatic AF, compared to a sham procedure. These findings support the efficacy of PVI beyond a placebo effect, making it a compelling option for managing AF in patients not responsive to antiarrhythmic drugs.
Reference: Dulai, R., Sulke, N., Freemantle, N., Lambiase, P. D., Farwell, D., Srinivasan, N. T., et al. (2024). Pulmonary vein isolation vs sham intervention in symptomatic atrial fibrillation: The SHAM-PVI randomized clinical trial. JAMA. http://doi.org/10.1001/jama.2024.17921
Link: https://jamanetwork.com/journals/jama/fullarticle/2823283
RCT: Optical Coherence Tomography (OCT)-Guided PCI Lowers Adverse Cardiac Events Compared to Angiography in Complex Lesions
7 Sep, 2024 | 17:08h | UTCStudy Design and Population: This multicenter, randomized, open-label superiority trial (OCCUPI) compared optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with angiography-guided PCI in patients with complex coronary lesions. The trial was conducted across 20 hospitals in South Korea, enrolling 1,604 patients aged 19–85 years requiring drug-eluting stents. Participants were randomized into OCT-guided PCI (n=803) or angiography-guided PCI (n=801), with outcomes assessed over 1 year.
Main Findings: At 1 year, major adverse cardiac events (MACE), including cardiac death, myocardial infarction, stent thrombosis, and ischemia-driven target-vessel revascularization, occurred in 5% of patients in the OCT-guided group compared to 7% in the angiography-guided group. The reduction in events was mainly driven by lower rates of spontaneous myocardial infarction and target-vessel revascularization in the OCT group. Secondary outcomes, such as stroke or contrast-induced nephropathy, showed no significant differences between groups.
Implications for Practice: OCT-guided PCI was associated with a lower incidence of MACE in patients with complex coronary lesions. These findings suggest that OCT guidance may provide additional benefit in stent optimization compared to angiography alone.
Reference: Hong SJ et al. (2024). Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea. The Lancet. DOI: https://doi.org/10.1016/S0140-6736(24)01454-5
link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01454-5/fulltext
Meta-Analysis: Ticagrelor Monotherapy Reduces Bleeding Without Increasing Ischemic Risk in Coronary Stent Patients
7 Sep, 2024 | 15:06h | UTCStudy Design and Population: This systematic review and individual patient-level meta-analysis pooled data from six randomized trials, comparing ticagrelor monotherapy after short-term dual antiplatelet therapy (DAPT) with standard 12-month DAPT in patients who underwent percutaneous coronary intervention with drug-eluting stents. The analysis included 23,256 patients in the per-protocol population and 24,407 in the intention-to-treat population, excluding those requiring long-term anticoagulants.
Main Findings: Ticagrelor monotherapy was found to be noninferior to 12-month DAPT for major adverse cardiovascular or cerebrovascular events (MACCE), with a hazard ratio (HR) of 0.91 (95% CI 0.78-1.07). It also reduced the risk of major bleeding (HR 0.43, p<0.0001) and all-cause mortality (HR 0.76, p=0.034). Subgroup analyses suggested possible benefits in women for mortality and in patients with acute coronary syndrome (ACS) for bleeding reduction.
Implications for Practice: Ticagrelor monotherapy may offer a safer alternative to prolonged DAPT by reducing bleeding risks without increasing ischemic events, particularly in ACS patients. Further research is needed to fully explore potential survival benefits, especially in women.
Reference: Valgimigli M, Hong S-J, Gragnano F, et al. (2024). De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials. Lancet. http://doi.org/10.1016/S0140-6736(24)01616-7
Link: https://www.sciencedirect.com/science/article/pii/S0140673624016167
RCT: Renal Denervation Reduces Blood Pressure in Chinese Patients With Uncontrolled Hypertension
7 Sep, 2024 | 14:57h | UTCStudy Design and Population: This was a prospective, multicenter, randomized, sham-controlled trial investigating the efficacy and safety of catheter-based radiofrequency renal denervation (RDN) in Chinese patients with uncontrolled hypertension despite standardized triple antihypertensive therapy. A total of 217 patients (mean age 45.3 years, 21% female) were randomized 1:1 to receive RDN or a sham procedure.
Main Findings: At 6 months, patients who underwent RDN showed a significantly greater reduction in 24-hour ambulatory systolic blood pressure (−13.0 mm Hg) compared to the sham group (−3.0 mm Hg), with a baseline-adjusted difference of −9.4 mm Hg (P<0.001). Significant reductions were also observed in 24-hour diastolic BP and office systolic and diastolic BP. One access site complication occurred in the RDN group but resolved without further issues.
Implications for Practice: This trial demonstrates that RDN is an effective and safe option for reducing blood pressure in patients with uncontrolled hypertension, offering a potential adjunct to antihypertensive therapy in this population. Further research may solidify its role in managing resistant hypertension.
Reference: Jiang X et al. (2024). Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. https://doi.org/10.1161/CIRCULATIONAHA.124.069215
Link: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069215
RCT: Invasive Strategy Does Not Significantly Improve Cardiovascular Outcomes Over Conservative Management in Older Adults with NSTEMI
7 Sep, 2024 | 13:25h | UTCStudy Design and Population: This was a prospective, multicenter, randomized trial conducted across 48 sites in the UK, enrolling 1,518 patients aged 75 years or older with non-ST-segment elevation myocardial infarction (NSTEMI). Patients were randomly assigned to receive either the best available medical therapy alone (conservative strategy) or in combination with invasive treatment (coronary angiography and revascularization). The population included individuals who were frail or had high comorbidities, with a mean age of 82 years.
Main Findings: Over a median follow-up of 4.1 years, the primary outcome (a composite of cardiovascular death or nonfatal myocardial infarction) occurred in 25.6% of the invasive-strategy group and 26.3% of the conservative-strategy group (HR, 0.94; 95% CI, 0.77–1.14; P=0.53), showing no significant difference. Cardiovascular death rates were similar between the two groups, but nonfatal myocardial infarction was lower in the invasive group (11.7% vs. 15.0%; HR, 0.75; 95% CI, 0.57–0.99). Procedural complications were rare, affecting less than 1% of patients.
Implications for Practice: This trial suggests that in older adults with NSTEMI, an invasive strategy does not significantly reduce the risk of cardiovascular death or nonfatal myocardial infarction compared to a conservative approach. The findings support the consideration of conservative management in frail elderly patients or those with significant comorbidities, given the minimal additional benefit of invasive treatment.
Reference: Kunadian, V., Mossop, H., Shields, C., Bardgett, M., Watts, P., Teare, M. D., Pritchard, J., et al. (2024). Invasive treatment strategy for older patients with myocardial infarction. New England Journal of Medicine. http://doi.org/10.1056/NEJMoa2407791
Link: https://www.nejm.org/doi/10.1056/NEJMoa2407791
RCT: Edoxaban Monotherapy Reduces Bleeding Events in Atrial Fibrillation with Stable CAD Compared to Dual Therapy
7 Sep, 2024 | 13:03h | UTCStudy Design and Population: This multicenter, open-label, adjudicator-masked randomized trial enrolled 1,040 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) across 18 sites in South Korea. Patients were randomly assigned to receive either edoxaban monotherapy (n=524) or dual antithrombotic therapy (edoxaban plus a single antiplatelet agent; n=516). The mean age was 72.1 years, with a mean CHA2DS2-VASc score of 4.3, reflecting a moderate to high stroke risk.
Main Findings: At 12 months, the primary composite outcome occurred in fewer patients in the edoxaban monotherapy group (6.8%) than in the dual therapy group (16.2%) (HR, 0.44; 95% CI, 0.30–0.65; P<0.001). The reduction was largely driven by a significantly lower incidence of major bleeding or clinically relevant non-major bleeding (4.7% vs. 14.2%; HR, 0.34; 95% CI, 0.22–0.53). In contrast, the incidence of major ischemic events was similar between the two groups.
Implications for Practice: Edoxaban monotherapy provides a safer antithrombotic option for patients with AF and stable CAD by significantly reducing bleeding without increasing ischemic events compared to dual therapy. These findings suggest that monotherapy could be a preferable long-term treatment strategy in this population.
RCT: Interruption of Oral Anticoagulation during TAVI Reduces Bleeding Without Increasing Thromboembolic Events
7 Sep, 2024 | 12:43h | UTCStudy Design and Population: This international, open-label, randomized noninferiority trial examined 858 patients undergoing transcatheter aortic-valve implantation (TAVI) who had an indication for oral anticoagulation due to concomitant diseases. Patients were randomized 1:1 to either continue or interrupt their oral anticoagulation during the procedure, with the primary outcome being a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days.
Main Findings: Primary outcome events occurred in 16.5% of the continuation group and 14.8% of the interruption group, showing a non-significant risk difference of 1.7 percentage points (95% CI, -3.1 to 6.6). Thromboembolic events were similar between groups (8.8% in continuation vs. 8.2% in interruption). However, bleeding events were significantly higher in the continuation group (31.1% vs. 21.3%; risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).
Implications for Practice: Interrupting oral anticoagulation during TAVI significantly reduces bleeding without increasing thromboembolic risks, suggesting it may be a safer strategy for patients undergoing TAVI. These findings could influence clinical decision-making regarding anticoagulation management in this population.
Reference: van Ginkel, D.J. et al. (2024). Continuation versus Interruption of Oral Anticoagulation during TAVI. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2407794
RCT: Continuing Aspirin vs. Antiplatelet Cessation Before Surgery Did Not Reduce Ischemic Events in Patients With Coronary Stents Over 1 Year Post-Implantation
7 Sep, 2024 | 12:29h | UTCStudy Design and Population: This randomized controlled trial (ASSURE-DES) investigated the perioperative management of antiplatelet therapy in 926 patients with coronary drug-eluting stents (DES) undergoing low-to-intermediate-risk noncardiac surgery. The patients, at least one year post-stent implantation, were randomized to continue aspirin monotherapy or stop all antiplatelet therapy five days prior to surgery.
Main Findings: The study found no significant difference in the primary composite outcome (death, myocardial infarction, stent thrombosis, or stroke) between the aspirin monotherapy group (0.6%) and the no antiplatelet group (0.9%). However, minor bleeding was more frequent in the aspirin group (14.9% vs 10.1%, P=0.027), with no difference in major bleeding.
Implications for Practice: These results suggest that for stable patients with DES undergoing noncardiac surgery, temporarily discontinuing aspirin may be a safe option, as continuing aspirin did not reduce ischemic events but did increase minor bleeding risk. Further research is needed to assess outcomes in higher-risk surgical settings.
News Release: SCOFF Trial Confirms Fasting Not Necessary Before Cardiac Catheterisation Procedures
7 Sep, 2024 | 10:10h | UTC1 September 2024 – London, United Kingdom – New findings from the SCOFF trial, presented at ESC Congress 2024, suggest that fasting prior to minimally invasive cardiac catheterisation procedures under conscious sedation does not increase the risk of complications. The trial supports reconsidering current guidelines on pre-procedural fasting.
Key Points for Physicians:
– No increased complications: The SCOFF trial found no significant difference in adverse outcomes, such as aspiration pneumonia or hypoglycemia, between patients who fasted and those who ate normally before cardiac catheterisation.
– Improved patient satisfaction: Patients who did not fast reported higher satisfaction, with fewer complaints of discomfort and hunger.
– Potential guideline change: These findings, in line with previous studies like CHOW-NOW and TONIC, challenge the necessity of fasting before such procedures.
The trial’s lead investigator, Dr. David Ferreira (John Hunter Hospital, Australia), emphasized that avoiding fasting may improve patient experience without increasing risks, making it time to reconsider fasting guidelines for these procedures.
Study Overview:
– Trial design: Prospective, randomized, open-label, with blinded endpoint assessment.
– Participants: 716 patients undergoing coronary angiography, coronary intervention, or cardiac implantable electronic device procedures.
– Primary endpoint: Composite of hypotension, aspiration pneumonia, hyperglycemia, and hypoglycemia, showing a lower event rate in the non-fasting group (12.0%) compared to the fasting group (19.1%).
These results are likely to influence future clinical practice, providing greater flexibility for both patients and healthcare systems.
RCT: More Extensive Lymph Node Removal Does Not Improve Outcomes in Right-Sided Colon Cancer Surgery
7 Sep, 2024 | 09:56h | UTCStudy Design and Population: This multicenter, open-label, randomized controlled trial (RELARC) evaluated the efficacy of complete mesocolic excision (CME) versus D2 lymphadenectomy for right-sided colon cancer. Conducted across 17 hospitals in China, the study enrolled 1,072 patients with stage T2-T4aNanyM0 or TanyN+M0 disease. Participants were randomized (1:1) to undergo either CME or D2 dissection, and the primary outcome was 3-year disease-free survival (DFS), with 3-year overall survival (OS) as the main secondary outcome.
Main Findings: Among 995 analyzed patients, no significant differences were observed between CME and D2 groups in 3-year DFS (86.1% vs. 81.9%, HR 0.74, P = 0.06) or 3-year OS (94.7% vs. 92.6%, HR 0.70, P = 0.17). While CME trended toward better DFS, the results were not statistically significant.
Implications for Practice: Given the lack of significant survival benefit, the trial supports D2 dissection as the standard surgical approach for right-sided colon cancer. CME may be reserved for cases with evident mesocolic lymph node involvement.
Cohort Study: Short-Course Radiotherapy with CAPOX Shows Favorable Outcomes in High-Risk Locally Advanced Rectal Cancer
7 Sep, 2024 | 09:38h | UTCStudy Design and Population: This Swedish nationwide cohort study examined total neoadjuvant treatment (TNT) for 273 patients with high-risk locally advanced rectal cancer (LARC) using short-course radiotherapy (5×5 Gy) followed by four cycles of CAPOX chemotherapy. Patients were treated between July 2016 and June 2020 across 16 hospitals, with 189 additional patients treated off-study. The study aimed to evaluate the complete response (CR) rate, comparing outcomes with the RAPIDO trial.
Main Findings: The CR rate, including both pathological complete response (pCR) and clinical complete response (cCR), was 24% (LARCT-US group) and 23% (AdmL group), comparable to the RAPIDO trial’s results. Locoregional recurrences were low (6% and 5%, respectively) after 3 years. Neurotoxicity was lower than in RAPIDO, and overall, the treatment was well tolerated. Notably, two fewer chemotherapy cycles did not compromise the CR rate.
Implications for Practice: While the study demonstrates promising outcomes using short-course radiotherapy and four CAPOX cycles for locally advanced rectal cancer (LARC), these findings are based on an observational study, which inherently limits the ability to draw definitive causal conclusions. Despite this, the real-world data suggests that a shorter chemotherapy regimen may be both feasible and effective. Further randomized trials are needed to confirm these results and assess long-term outcomes. Clinicians should cautiously apply this regimen, considering both the evidence and individual patient factors.