By Ripal T. Gandhi, MD, and Suvranu Ganguli, MD Summer 2017
This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at firstname.lastname@example.org or email@example.com.
N Engl J Med. 2017 Jan 5;376(1):32-40. doi: 10.1056/NEJMoa1611688. Epub 2016 Nov 13.
Hiatt WR, Fowkes FG, Heizer G, Berger JS, Baumgartner I, Held P, Katona BG, Mahaffey KW, Norgren L, Jones WS, Blomster J, Millegård M, Reist C, Patel MR; EUCLID Trial Steering Committee and Investigators.
BACKGROUND: Peripheral artery disease is considered to be a manifestation of systemic atherosclerosis with associated adverse cardiovascular and limb events. Data from previous trials have suggested that patients receiving Clopidogrel monotherapy had a lower risk of cardiovascular events than those receiving aspirin. We wanted to compare Clopidogrel with ticagrelor, a potent antiplatelet agent, in patients with peripheral artery disease.
METHODS In this double-blind, event-driven trial, we randomly assigned 13,885 patients with symptomatic peripheral artery disease to receive monotherapy with ticagrelor (90 mg twice daily) or Clopidogrel (75 mg once daily). Patients were eligible if they had an ankle-brachial index (ABI) of 0.80 or less or had undergone previous revascularization of the lower limbs. The primary efficacy end point was a composite of adjudicated cardiovascular death, myocardial infarction or ischemic stroke. The primary safety end point was major bleeding. The median follow-up was 30 months.
RESULTS: The median age of the patients was 66 years, and 72 percent were men; 43 percent were enrolled on the basis of the ABI and 57 percent on the basis of previous revascularization. The mean baseline ABI in all patients was 0.71; 76.6 percent of the patients had claudication and 4.6 percent had critical limb ischemia. The primary efficacy end point occurred in 751 of 6,930 patients (10.8 percent) receiving ticagrelor and in 740 of 6,955 (10.6 percent) receiving Clopidogrel (hazard ratio, 1.02; 95 percent confidence interval [CI], 0.92 to 1.13; P=0.65). In each group, acute limb ischemia occurred in 1.7 percent of the patients (hazard ratio, 1.03; 95 percent CI, 0.79 to 1.33; P=0.85) and major bleeding in 1.6 percent (hazard ratio, 1.10; 95 percent CI, 0.84 to 1.43; P=0.49).
CONCLUSIONS In patients with symptomatic peripheral artery disease, ticagrelor was not shown to be superior to Clopidogrel for the reduction of cardiovascular events. Major bleeding occurred at similar rates among the patients in the two trial groups. (Funded by AstraZeneca; EUCLID ClinicalTrials.gov number, NCT01732822.)
Chest. 2017 Mar;151(3):626-635. doi: 10.1016/j.chest.2016.10.052. Epub 2016 Nov 11.
Patil M, Dhillon SS, Attwood K, Saoud M, Alraiyes AH, Harris K.
BACKGROUND: The indwelling pleural catheter (IPC), which was initially introduced for the management of recurrent malignant effusions, could be a valuable management option for recurrent benign pleural effusion (BPE), replacing chemical pleurodesis. The purpose of this study is to analyze the efficacy and safety of IPC use in the management of refractory nonmalignant effusions.
METHODS: We conducted a systematic review and meta-analysis on the published literature. Retrospective cohort studies, case series and reports that used IPCs for the management of pleural effusion were included in the study.
RESULTS: Thirteen studies were included in the analysis, with a total of 325 patients. Congestive heart failure (49.8 percent) was the most common cause of BPE requiring IPC placement. The estimated average rate of spontaneous pleurodesis was 51.3 percent (95 percent CI, 37.1–65.6 percent). The estimated average rate of all complications was 17.2 percent (95 percent CI, 9.8–24.5 percent) for the entire group. The estimated average rate of major complications included the following: empyema, 2.3 percent (95 percent CI, 0.0–4.7 percent); loculation, 2.0 percent (95 percent CI, 0.0–4.7 percent); dislodgement, 1.3 percent (95 percent CI, 0.0–3.7 percent); leakage, 1.3 percent (95 percent CI, 0.0–3.5 percent); and pneumothorax, 1.2 percent (95 percent CI, 0.0–4.1 percent). The estimated average rate of minor complications included the following: skin infection, 2.7 percent (95 percent CI, 0.6–4.9 percent); blockage and drainage failure, 1.1 percent (95 percent CI, 0.0–3.5 percent); subcutaneous emphysema, 1.1 percent (95 percent CI, 0.0–4.0 percent); and other, 2.5 percent (95 percent CI, 0.0–5.2 percent). One death was directly related to IPC use.
CONCLUSIONS: IPCs are an effective and viable option in the management of patients with refractory BPE. The quality of evidence to support IPC use for BPE remains low and high-quality studies such as randomized controlled trials are needed.
Journal of Trauma and Acute Care Surgery. 82(1):138-140, January 2017.
Juern JS, Milia D, Codner P; More
INTRODUCTION: Blunt pelvic fractures can be associated with major pelvic bleeding. The significance of contrast extravasation (CE) on computed tomography (CT) is debated. We sought to update our experience with CE on CT scan for the years 2009–2014 to determine the accuracy of CE in predicting the need for angioembolization.
METHODS: This is a retrospective review of the trauma registry and our electronic medical record from a Level I trauma center. Patients seen from July 1, 2009, to Sept. 7, 2014, with blunt pelvic fractures and contrast-enhanced CT were included. Standard demographic, clinical, and injury data were obtained. Patient records were queried for CE, performance of angiography, and angioembolization. Positive patients were those where CE was associated with active bleeding requiring angioembolization. All other patients were considered negative.
RESULTS: There were 497 patients during the study time period with blunt pelvic fracture meeting inclusion criteria, and 75 patients (15 percent) had CE. Of those patients with CE, 30 patients (40 percent) underwent angiography, and 17 patients (23 percent) required angioembolization. The sensitivity, specificity, positive predictive value, and negative predictive value of CE on CT were 100 percent, 87.9 percent, 22.7 percent, and 100 percent, respectively. Two patients without CE underwent angiography but did not undergo embolization. Patients with CE had higher mortality (13 vs. 6 percent, p < 0.05) despite not having higher ISS scores.
CONCLUSIONS: This study reinforces that CE on CT pelvis with blunt trauma is common, but many patients will not require angioembolization. The negative predictive value of 100 percent should be reassuring to trauma surgeons such that if a modern CT scanner is used, and there is no CE seen on CT, then the pelvis will not be a source of hemorrhagic shock. All of these findings are likely due to both increased comfort with observing CEs and the increased sensitivity of modern CT scanners.
LEVEL OF EVIDENCE: Therapeutic/care management study, level IV.
JAMA Surg. 2017;152(1):55-64. doi:10.1001/jamasurg.2016.3310
Agopian VG, Harlander-Locke MP, Markovic D, Zarrinpar A, Kaldas FM, Cheng EY, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW
IMPORTANCE: Serum α-fetoprotein (AFP) is a biomarker for hepatocellular carcinomas (HCCs) associated with a more aggressive tumor phenotype and inferior outcomes after a liver transplant (LT). Data on the outcomes for patients with HCCs that do not produce AFP are limited.
OBJECTIVE: To compare characteristics and outcomes among LT recipients with radiographically apparent HCC lesions with AFP-producing tumors or with tumors that do not produce AFP (hereafter referred to as non-AFP–producing tumors), and to identify factors influencing recurrence in LT recipients with non-AFP–producing tumors.
DESIGN, SETTING AND PARTICIPANTS: Retrospective analysis at a university transplant center of 665 adults with HCC who underwent an LT during the period from 1989 to 2013. Of the 665 LT recipients, 457 (68.7 percent) had AFP-producing tumors, and 208 (31.3 percent) had non-AFP–producing tumors (the maximum AFP level before an LT was ≤10 ng/mL). Dates of study analysis were from August 2015 to June 2016.
INTERVENTION: Liver transplant.
MAIN OUTCOMES AND MEASURES: Recurrence-free survival and recurrence rates.
RESULTS: Patients with non-AFP–producing tumors had radiographic tumor characteristics similar to those of patients with AFP-producing tumors, but, pathologically, they had fewer lesions (25 percent vs. 35 percent with >2 lesions; P=.03), smaller cumulative tumor diameters (4.2 vs. 5.0 cm; P=.02), fewer microvascular (17 percent vs. 22 percent) and macrovascular (2 percent vs. 9 percent) invasions (P < .001), and fewer poorly differentiated tumors (15 percent vs. 28 percent; P < .001). Patients with non-AFP–producing tumors also had significantly superior recurrence-free survival at 1, 3, and 5 years (88 percent, 74 percent, and 67 percent vs. 76 percent, 59 percent, and 51 percent, respectively; P=.002) and lower 5-year recurrence rates (8.8 percent vs. 22 percent; P < .001) than patients with AFP-producing tumors. When stratified by radiologic Milan criteria, 5-year survival was better, and recurrence lowest, among patients with non-AFP–producing tumors within the Milan criteria (71 percent survival and 6 percent recurrence), and survival was worse, and recurrence highest, for patients with AFP-producing tumors outside the Milan criteria (40 percent survival and 42 percent recurrence; P < .001). Significant predictors of recurrence among patients with non-AFP–producing tumors include radiologic (>2 tumors [HR, 4.98; 95 percent CI, 1.72–14.4; P=.003]; cumulative diameter [1.70 per log SD; 1.12–2.59; P < .001]; outside the Milan criteria [10.0; 3.7–33.3; P < .001) and pathologic factors (>2 tumors [4.39; 1.32–14.6; P=.02]; cumulative diameter [2.32 per log SD; 1.43–3.77; P=.001]; microvascular [3.07; 1.02–9.24; P=.05] and macrovascular invasion [8.75; 2.15–35.6; P=.002]).
CONCLUSIONS AND RELEVANCE: Nearly one-third of patients with radiographically apparent HCC have non-AFP–producing tumors that have more favorable pathologic characteristics, lower posttransplant recurrence, and superior survival compared with patients with AFP-producing tumors. Posttransplant HCC recurrence for patients with non-AFP–producing tumors is predicted by important radiologic and pathologic factors, and is negligible for patients within the Milan criteria. Stratifying patients by AFP status in addition to radiological criteria may improve the selection process for and the prioritization of transplant candidates.