A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.

OBJECTIVES: To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results. METHODS: We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding. RESULTS: The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32). CONCLUSION: Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

The Impact of Age and Sex on In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention.

OBJECTIVES: We sought to determine the effect of age and sex on procedural outcomes and efficiency of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical and angiographic characteristics and outcomes of 1675 CTO-PCIs performed in 1644 patients between 2012 and 2016 at 15 United States centers. RESULTS: Mean age was 65.3 ± 10 years and 1408 (86%) were men. Overall technical and procedural success rates were 88% and 87%, respectively. Increasing age was associated with more comorbidities (dyslipidemia, hypertension, prior coronary artery bypass graft surgery, prior stroke, peripheral arterial disease, and chronic lung disease) and more lesion calcification. As compared with the reference age of <65 years, age >75 years was independently associated with technical failure (odds ratio [OR], 2.28; 95% confidence interval [CI], 1.20-4.28). Increasing age was also independently associated with the incidence of major adverse cardiovascular events (MACEs; OR, 2.93; 95% CI, 1.10-9.23 for 65-75 years and OR, 5.71; 95% CI, 1.89-19.60 for >75 years). Compared with men, women (n = 236; 14%) were older (66.8 ± 11.1 years vs 65.0 ± 9.8 years; P=.02), but had similar clinical characteristics and lower J-CTO scores (2.3 ± 1.3 vs 2.5 ± 1.2; P=.02). Although crude technical success rate was higher in women compared with men (92% vs 87%; P=.04), multivariable analysis did not show independent association between sex and technical failure (OR, men/women, 1.66; 95% CI, 0.86-3.50) or MACE (OR, 0.61; 95% CI, 0.25-1.73). CONCLUSIONS: Older age, but not sex, is associated with lower technical success and higher in-hospital complication rate for CTO-PCI. CTO-PCI is relatively infrequently attempted in women, despite high technical success and acceptable complication rates.

Saphenous vein graft near-infrared spectroscopy imaging insights from the lipid core plaque association with clinical events near-infrared spectroscopy (ORACLE-NIRS) registry.

OBJECTIVES: We sought to examine near-infrared spectroscopy (NIRS) imaging findings of aortocoronary saphenous vein grafts (SVGs). BACKGROUND: SVGs are prone to develop atherosclerosis similar to native coronary arteries. They have received little study using NIRS. METHODS: We examined the clinical characteristics and imaging findings from 43 patients who underwent NIRS imaging of 45 SVGs at our institution between 2009 and 2016. RESULTS: The mean patient age was 67 ± 7 years and 98% were men, with high prevalence of diabetes mellitus (56%), hypertension (95%), and dyslipidemia (95%). Mean SVG age was 7 ± 7 years, mean SVG lipid core burden index (LCBI) was 53 ± 60 and mean maxLCBI4 mm was 194 ± 234. Twelve SVGs (27%) had lipid core plaques (2 yellow blocks on the block chemogram), with a higher prevalence in SVGs older than 5 years (46% vs. 5%, P = 0.002). Older SVG age was associated with higher LCBI (r = 0.480, P < 0.001) and higher maxLCBI4 mm (r = 0.567, P < 0.001). On univariate analysis, greater annual total cholesterol exposure was associated with higher SVG LCBI (r = 0.30, P = 0.042) and annual LDL-cholesterol and triglyceride exposure were associated with higher SVG maxLCBI4 mm (LDL-C: r = 0.41, P = 0.020; triglycerides: r = 0.36, P = 0.043). On multivariate analysis, the only independent predictor of SVG LCBI and maxLCBI4mm was SVG age. SVG percutaneous coronary intervention was performed in 63% of the patients. An embolic protection device was used in 96% of SVG PCIs. Periprocedural myocardial infarction occurred in one patient. CONCLUSIONS: Older SVG age and greater lipid exposure are associated with higher SVG lipid burden. © 2016 Wiley Periodicals, Inc.

Characterization of the etiological agents of tuberculous lymphadenitis in Dera Woreda, North Showa, Ethiopia.

BACKGROUND: Tuberculous lymphadenitis (TBLN) is a common form of extra pulmonary tuberculosis where lymph nodes particularly from cervical, axillary and inguinal sites are mostly involved, however, its diagnosis poses a major challenge in resource limited settings. OBJECTIVE: To identify the etiological species of Mycobacteria responsible for TBLN in Derra area, a rural district in Ethiopia, where the status of TBLN is unknown. MATERIALS AND METHODS: A total of 153 patients who were clinically suspected for TBLN, between the periods of August 2004 and February 2005 were included in the study. Fine needle aspirates (FNA) were collected and processed from 145 participants and further analyzed using Ziehl Neelsen staining, culture, cytology and polymerase chain reaction (PCR) using sets of primers, targeting the IS6110 insertion sequence and the pncA gene allelic variation at position 169. RESULTS: Out of the 145 FNA samples, 66 (45.5%) demonstrated growth on Lowenstein-Jensen (LJ) medium and 115 (79.3%) cases were confirmed as TBLN by a combination of results from acid fast bacilli (AFB) smear examination, culture, cytology and PCR. From the 145 clinically suspected TBLN cases, 108 (75%) were identified by PCR at complex level of which 107/108 (99.1%) were positive for M. tuberculosis and 1/108 (0.9%) was positive for M. bovis using pncA primers. CONCLUSION: The study indicates that M. tuberculosis is the major cause of tuberculous lymphadenitis in Dera area.

Bovine tuberculosis at a cattle-small ruminant-human interface in Meskan, Gurage region, Central Ethiopia.

BACKGROUND: Bovine tuberculosis (BTB) is endemic in Ethiopian cattle. The aim of this study was to assess BTB prevalence at an intensive contact interface in Meskan Woreda (district) in cattle, small ruminants and suspected TB-lymphadenitis (TBLN) human patients. METHODS: The comparative intradermal test (CIDT) was carried out for all animals involved in the cross-sectional study and results interpreted using a > 4 mm and a > 2 mm cut-off. One PPD positive goat was slaughtered and lymph nodes subjected to culture and molecular typing. In the same villages, people with lymphadenitis were subjected to clinical examination. Fine needle aspirates (FNA) were taken from suspected TBLN and analyzed by smear microscopy and molecular typing. RESULTS: A total of 1214 cattle and 406 small ruminants were tested for BTB. In cattle, overall individual prevalence (> 2 mm cut-off) was 6.8% (CI: 5.4-8.5%) with 100% herd prevalence. Only three small ruminants (2 sheep and 1 goat) were reactors. The overall individual prevalence in small ruminants (> 2 mm cut-off) was 0.4% (CI: 0.03-5.1%) with 25% herd prevalence. Cattle from owners with PPD positive small ruminants were all PPD negative. 83% of the owners kept their sheep and goats inside their house at night and 5% drank regularly goat milk.FNAs were taken from 33 TBLN suspected cases out of a total of 127 screened individuals with lymph node swellings. Based on cytology results, 12 were confirmed TBLN cases. Nine out of 33 cultures were AFB positive. Culture positive samples were subjected to molecular typing and they all yielded M. tuberculosis. M. tuberculosis was also isolated from the goat that was slaughtered. CONCLUSIONS: This study highlighted a low BTB prevalence in sheep and goats despite intensive contact with cattle reactors. TBLN in humans was caused entirely by M. tuberculosis, the human pathogen. M. tuberculosis seems to circulate also in livestock but their role at the interface is unknown.

Is tuberculous lymphadenitis over-diagnosed in Ethiopia? Comparative performance of diagnostic tests for mycobacterial lymphadenitis in a high-burden country.

Ethiopia reports the third highest number of extrapulmonary TB cases globally, most of which are lymph node TB (TBLN). We investigated the performance of the available diagnostic tests for TBLN. Fine needle aspirate (FNA) and excision biopsy samples from affected lymph nodes were collected from 150 consenting patients with suspected TBLN visiting regional hospitals in Ethiopia. The sensitivity, specificity, positive (PPV) and negative predictive value (NPV) of histopathology against culture as reference was 92%, 88%, 97% and 77% and of FNA cytology (FNAC) 76%, 88%, 100% and 55%, respectively. Naked eye examination of FNA had 67% sensitivity and 64% specificity. HIV coinfection did not diminish the performance of macroscopic examination, Ziehl-Neelsen stain, histology or cytology examinations. When any positive result in ZN, histopathology or culture was considered confirmatory, clinical diagnosis could be confirmed in 85% of the patients, suggesting that TBLN is over-diagnosed in up to 15% of cases. With combined criteria as reference standard, the sensitivity, specificity, PPV and NPV of FNAC was 72%, 100%, 100% and 55%, respectively. FNAC is a practical tool that can improve the diagnosis of TBLN in high-burden settings. Over-diagnosis alone cannot explain the high burden of LNTB in Ethiopia.