Endoscopic submucosal dissection (ESD) is a minimally invasive treatment for early gastric cancer that enables the en bloc resection of large lesions. However, it is associated with a significant risk of delayed bleeding, particularly in patients receiving antithrombotic therapy. Delayed bleeding after ESD causes anemia and serious systemic complications, including cardiovascular events. Here, we report a rare case of Takotsubo syndrome triggered by delayed bleeding after gastric ESD that culminated in cardiac arrest. A man in his 70s who underwent gastric ESD experienced delayed bleeding six days after the treatment, requiring emergency endoscopic hemostasis. The following day, the patient developed sudden ventricular fibrillation without prior chest symptoms. After resuscitation with electrical defibrillation, left ventriculography revealed apical ballooning consistent with Takotsubo syndrome. With intensive care, cardiac function recovered, and the patient was discharged ambulatory. Takotsubo syndrome is typically induced by stress, and often triggers psychological and physical stimuli. Although most patients present with chest pain or discomfort, our patient showed no preceding symptoms and developed sudden arrhythmia and cardiac arrest. This case highlights the need for aggressive bleeding prevention and enhanced post-ESD cardiac surveillance to mitigate rare but potentially fatal complications.
Abstract Background This study aimed to evaluate the safety and effectiveness of the Kanshas drug-coated balloon (DCB) with paclitaxel for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA) over a 3-year period. Results A prospective, multicenter, single-arm trial enrolled 121 patients with symptomatic lower extremity artery disease (LEAD). At 3 years, the primary patency rate was 63.4%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 83.2%. Sustained improvements were observed in Rutherford classification, ankle brachial index (ABI), and walking impairment questionnaire (WIQ) scores. No device- or procedure-related deaths or major amputations occurred. Conclusions The Kanshas DCB showed favorable safety and effectiveness for treating atherosclerotic lesions in the SFA and/or proximal PA over 3 years. Trail registration Registration ID: UMIN000034122. Registration Date: September 13, 2018. Registration site URL: https://center6.umin.ac.jp/cgi-openbin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J . Graphical Abstract
In the Phase III TASUKI-52 trial, nivolumab with carboplatin, paclitaxel (CP), plus bevacizumab significantly prolonged progression-free survival (PFS), and resulted in longer overall survival (OS) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). This final analysis evaluated 4-year treatment outcomes in terms of OS, PFS and duration of response (DOR) by investigator assessment and safety, as well as the background characteristics and treatment courses associated with 4-year survivors. Patients were randomized 1:1 to receive nivolumab (n = 275) or placebo (n = 275) in addition to CP plus bevacizumab. With a minimum follow-up of 53.1 months, nivolumab with CP plus bevacizumab continued to show improvement in OS (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.58-0.88) and PFS (HR: 0.61; 95% CI: 0.50-0.74) compared to placebo with CP plus bevacizumab. The 4-year OS rate was 34.7% in the nivolumab arm versus 22.1% in the placebo arm, and the 4-year PFS rate was 13.7% in the nivolumab arm versus 3.3% in the placebo arm. Among 4-year survivors, the median DOR was numerically longer in the nivolumab arm than in the placebo arm (34.7 vs. 13.5 months). No new safety signals were observed. Four-year survival in the nivolumab arm was associated with the absence of bone metastases and age < 65, but not with PD-L1 status and tumor size. In conclusion, treatment with nivolumab demonstrated long-term survival benefit and durable response, which supports nivolumab with CP plus bevacizumab as a first-line treatment option for advanced nonsquamous NSCLC. Trial Registration: ClinicalTrials.gov identifier: NCT03117049.
Background: No studies have compared aspirin to P2Y12 inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients with diabetes. Methods and Results: We conducted a prespecified diabetes subgroup analysis of the 1-year STOPDAPT-3 trial; patients were randomized at the time of index PCI, and outcomes from 30 days to 1 year were assessed using a 30-day landmark analysis comparing 1-month DAPT followed by aspirin monotherapy (aspirin group) to 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). The effect of aspirin relative to clopidogrel was not significant for the coprimary cardiovascular endpoint (composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) regardless of diabetes (aspirin/clopidogrel 5.3/5.6 vs. 3.9/3.7 per 100 person-years for diabetes vs. non-diabetes, respectively; hazard ratios [HRs] 0.96 [95% confidence interval {CI} 0.67-1.37] and 1.06 [95% CI 0.72-1.55], respectively; Pinteraction=0.71), but there was a significant interaction between diabetes and the effect of aspirin relative to clopidogrel for the coprimary bleeding endpoint (Bleeding Academic Research Consortium 3 or 5; aspirin/clopidogrel 2.8/1.8 vs. 1.3/2.0 per 100 person-years diabetes vs. non-diabetes, respectively; HR 1.54 [95% CI 0.88-2.71] vs. 0.65 [95% CI 0.36-1.17], respectively; Pinteraction=0.04). Conclusions: From 30 days to 1 year after PCI, cardiovascular outcomes were similar between aspirin and clopidogrel regardless of diabetes. A nominal bleeding interaction was observed; given the exploratory and underpowered subgroup analyses, this finding should be interpreted cautiously.
OBJECTIVE:While drug-eluting treatment is a first-line therapy for femoropopliteal (FP) lesions, long-term comparative data between drug-eluting stents (DES) and drug-coated balloons (DCB) in real-world practice are scarce. We aimed to compare the 3-year outcomes of DES versus DCB for symptomatic FP disease. METHODS:We conducted a retrospective analysis of the CILANTRO study, a multicenter registry combining data from the CAPSICUM, POPCORN, and POPCORN Type R studies. Patients treated with either DES or DCB for symptomatic FP lesions were included. To minimize selection bias, we performed 1:1 propensity score matching. The primary outcome was clinically driven target lesion revascularization (TLR), while secondary outcomes included restenosis. RESULTS:A total of 2651 patients treated with DCB and 972 with DES were identified. Propensity score matching extracted 912 pairs with well-balanced baseline characteristics. The median follow-up period was 31.6 months. The 3-year rate of TLR was not significantly different between the DCB and DES groups (23.3% vs. 18.8%; hazard ratio, 1.19 [95% confidence interval, 0.93-1.53]; p = 0.16). Interaction analysis revealed that a more marked increased risk of TLR in the DCB group in patients with semi-compliant balloon use or without non-compliant balloon use (p = 0.017 and 0.018). The 3-year rate of restenosis was significantly higher in the DCB group than in the DES group (38.1% vs. 26.3%; hazard ratio, 1.77 [1.43-2.19]; p < 0.001). CONCLUSIONS:In this propensity score-matched analysis, the 3-year rate of TLR was not significantly different between DCB and DES, although DES demonstrated lower restenosis rate. Nevertheless, DCB remains a clinically viable option, and our sub-analysis suggests that balloon selection for pre-dilatation may influence its efficacy.