Drug-coated balloon strategy following orbital atherectomy for calcified coronary artery compared with drug-eluting stent: One-year outcomes and optical coherence tomography assessment.

BACKGROUND: Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug-eluting stent (DES) era. While recent studies reported the efficacy of orbital atherectomy (OA) combined with DES for calcified lesion, the effectiveness of drug-coated balloon (DCB) following OA has not been fully elucidated. METHODS: Between June 2018 and June 2021, 135 patients who received PCI for calcified de novo coronary lesions with OA were enrolled and divided into two groups; OA followed by DCB (n = 43) if the target lesion achieved acceptable preparation, or second- or third-generation DESs (n = 92) if the target lesion showed suboptimal preparation between June 2018 and June 2021. All patients underwent PCI with optical coherence tomography (OCT) imaging. The primary endpoint was 1-year major adverse cardiac event (MACE), that was a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: Mean age was 73 years and 82% was male. In OCT analysis, maximum calcium plaque was thicker (median: 1050 µm [interquartile range (IQR): 945-1175 µm] vs. 960 µm [808-1100 µm], p = 0.017), calcification arc tended to larger (median: 265° [IQR: 209-360°] vs. 222° [162-305°], p = 0.058) in patients with DCB than in DES, and the postprocedure minimum lumen area was smaller in DCB compared with minimum stent area in DES (median: 3.83 mm2 [IQR: 3.30-4.52 mm2 ] vs. 4.86 mm2 [4.05-5.82 mm2 ], p < 0.001). However, 1 year MACE free rate was not significantly different between 2 groups (90.3% in DCB vs. 96.6% in DES, log-rank p = 0.136). In the subgroup analysis of 14 patients who underwent follow-up OCT imaging, late lumen area loss was lower in patients with DCB than DES, despite lower lesion expansion rate in DCB than DES. CONCLUSIONS: In calcified coronary artery disease, DCB alone strategy (if acceptable lesion preparation was performed with OA) was feasible compared with DES following OA with respect to 1-year clinical outcomes. Our finding indicated using DCB with OA might be reduce late lumen area loss for severe calcified lesion.

Sex differences in Japanese patients with ruptured aortic aneurysms.

OBJECTIVE: This study aimed to assess the sex differences in clinical presentation and outcomes of Japanese patients with ruptured aortic aneurysm (rAA) using a large nationwide claims-based database in Japan. METHODS: We identified patients hospitalized in certified teaching hospitals in Japan with rAA between April 1, 2012, and March 31, 2015. Patients' characteristics and in-hospital outcomes were compared between men and women. The Barthel index was used for evaluating functional status at discharge by examining the ability to perform basic daily activities. RESULTS: Of 7086 eligible patients, 32.3% (2291/7086) were women. Women were older than men (81.9 years vs 76.1 years; P < .001), had higher prevalence of coma at admission (33.2% vs 25.2%; P < .001), and were less likely to undergo emergency operation including endovascular aneurysm repair (35.7% vs 51.1%; P < .001). The unadjusted mortality rate (62.5% vs 52.0%; P < .001) and Barthel index at discharge (78.7 vs 86.1; P < .001) were significantly worse in women than in men. However, multilevel mixed-effect logistic regression analyses showed that female sex itself was not an independent predictor for in-hospital death (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.78-1.04; P = .17). Older age, coma at admission, and vasopressor use were detected as independent predictors for in-hospital death. The same results were confirmed for each rupture site. Stratified analyses showed that older women (threshold, 80 years; OR, 0.81; 95% CI, 0.66-0.98; P = .028) and those who underwent emergency operation (OR, 0.75; 95% CI, 0.61-0.93; P = .009) showed significantly better outcomes than men. CONCLUSIONS: In a univariate analysis, female patients with rAA showed worse mortality than men because of their older age, more severe clinical presentation, and low emergency operation rate. However, after adjustment for covariates, female sex itself was not associated with increased mortality.

Editor's Choice - Endovascular Repair Versus Surgical Repair for Japanese Patients With Ruptured Thoracic and Abdominal Aortic Aneurysms: A Nationwide Study.

OBJECTIVE: This study compared outcomes after endovascular aneurysm repair (ER) and open surgical repair (OR) of ruptured descending thoracic aortic aneurysms (rDTAA) and ruptured abdominal aortic aneurysms (rAAA) through a nationwide analysis performed in Japan. METHODS: This was a national registry based retrospective comparative study using data from the Japanese Registry of all Cardiac and Vascular Diseases Diagnostic Procedure Combination (JROAD-DPC) database, a nationwide claim based database from more than 600 hospitals. Patients admitted to certificated teaching hospitals with rDTAA and rAAA and treated by either ER or OR between 1 April 2012 and 31 March 2015 were identified. A propensity score matched analysis was performed to compare ER and OR. RESULTS: About 40% of the total cohort (n = 8,302) were managed conservatively for various reasons, including limited options in primary care facilities in certain areas. In total, 983 patients had rDTAA (OR = 511; ER = 472) and 2,320 (OR = 1,754; ER = 566) had rAAA. Altogether, 604 and 1,080 patients were matched with rDTAA and rAAA, respectively. Compared with OR, ER was associated with significantly better in hospital mortality in patients with rDTAA (ER = 22.5%; OR = 29.8% [p < .001]) and similar mortality for those with rAAA (ER = 25.7%; OR = 24.3% [p = .57]). ER involved significantly shorter hospital stays for rDTAA (ER = 25.5; OR = 32 days [p < .001]) and rAAA (ER = 16; OR = 21 days [p < .001]). The median Barthel Index at discharge was ≥75/100 for all groups, and there were no differences between ER and OR. Total medical costs were significantly lower for ER for rDTAA (ER = ¥6.47 million, OR = ¥7.28 million [p < .001]) but were higher for rAAA (ER = ¥4.65 million; OR = ¥3.43 million [p < .001]). CONCLUSION: A Japanese nationwide observational study showed that in hospital outcomes for ER vs. OR were more favourable for rDTAA and comparable for rAAA. ER resulted in an equivalently favourable functional status at discharge and significantly shorter hospital stays.

Assessment of the Safety and Efficacy of Edoxaban for the Treatment of Venous Thromboembolism Secondary to Active Malignancy.

Objective: To assess the safety and efficacy of edoxaban for the treatment of venous thromboembolism (VTE) secondary to active malignancy. Materials and Methods: We enrolled 48 patients with newly diagnosed VTE secondary to active malignancy that was treated with oral edoxaban for 1 year between September 2014 and August 2015. We retrospectively examined the presence or absence of recurrent symptomatic VTE, VTE-related mortality, and bleeding events. Results: No recurrent symptomatic VTE or VTE-related deaths were recorded, enabling efficient assessment. Treatment safety was determined based on the reports of bleeding. Bleeding was reported in two patients, with serious bleeding in one of them. Conclusion: Edoxaban is safe and effective for the treatment of VTE secondary to active malignancy.

Early validation study of 64-slice multidetector computed tomography for the assessment of myocardial viability and the prediction of left ventricular remodelling after acute myocardial infarction.

AIMS: We aim to validate the ability of multidetector computed tomography (MDCT) for assessing myocardial viability and predicting left ventricular (LV) remodelling after acute myocardial infarction (AMI). METHODS AND RESULTS: In 52 consecutive patients with first AMI, 64-slice MDCT without iodine re-injection was performed immediately following coronary stenting. Electrocardiogram-gated thallium-201 single-photon emission tomography was performed using QGS programs within 5 days and 6 months after onset. Among the 52 patients, 18 patients (Group A) showed transmural contrast-delayed enhancement on MDCT images, 20 patients (Group B) showed subendocardial contrast-delayed enhancement, and 14 patients (Group C) had no contrast-delayed enhancement. In the acute phase, peak creatine kinase-MB [497 (189-744), 182 (90-358), 85 (40-204) IU/mL, respectively, P = 0.0004] was significantly higher in Group A, while the incidence of myocardial blush grade 3 (22, 67, 75%, respectively, P = 0.001) and LV ejection fraction (41 +/- 7, 53 +/- 12, 62 +/- 11%, respectively, P < 0.0001) were significantly lower in Group A. During the 6-month period, LV remodelling (P = 0.001) and the number of rehospitalization for heart failure (P = 0.0017) were more significantly observed in Group A. CONCLUSION: Myocardial contrast-delayed enhancement patterns provide promising information regarding myocardial viability, LV remodelling, and prognosis in AMI.