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https://www.readbyqxmd.com/read/28317458/use-of-the-instantaneous-wave-free-ratio-or-fractional-flow-reserve-in-pci
#1
Justin E Davies, Sayan Sen, Hakim-Moulay Dehbi, Rasha Al-Lamee, Ricardo Petraco, Sukhjinder S Nijjer, Ravinay Bhindi, Sam J Lehman, Darren Walters, James Sapontis, Luc Janssens, Christiaan J Vrints, Ahmed Khashaba, Mika Laine, Eric Van Belle, Florian Krackhardt, Waldemar Bojara, Olaf Going, Tobias Härle, Ciro Indolfi, Giampaolo Niccoli, Flavo Ribichini, Nobuhiro Tanaka, Hiroyoshi Yokoi, Hiroaki Takashima, Yuetsu Kikuta, Andrejs Erglis, Hugo Vinhas, Pedro Canas Silva, Sérgio B Baptista, Ali Alghamdi, Farrel Hellig, Bon-Kwon Koo, Chang-Wook Nam, Eun-Seok Shin, Joon-Hyung Doh, Salvatore Brugaletta, Eduardo Alegria-Barrero, Martijin Meuwissen, Jan J Piek, Niels van Royen, Murat Sezer, Carlo Di Mario, Robert T Gerber, Iqbal S Malik, Andrew S P Sharp, Suneel Talwar, Kare Tang, Habib Samady, John Altman, Arnold H Seto, Jasvindar Singh, Allen Jeremias, Hitoshi Matsuo, Rajesh K Kharbanda, Manesh R Patel, Patrick Serruys, Javier Escaned
Background Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. Methods We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization...
March 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28317438/instantaneous-wave-free-ratio-versus-fractional-flow-reserve-to-guide-pci
#2
Matthias Götberg, Evald H Christiansen, Ingibjörg J Gudmundsdottir, Lennart Sandhall, Mikael Danielewicz, Lars Jakobsen, Sven-Erik Olsson, Patrik Öhagen, Hans Olsson, Elmir Omerovic, Fredrik Calais, Pontus Lindroos, Michael Maeng, Tim Tödt, Dimitrios Venetsanos, Stefan K James, Amra Kåregren, Margareta Nilsson, Jörg Carlsson, Dario Hauer, Jens Jensen, Ann-Charlotte Karlsson, Georgios Panayi, David Erlinge, Ole Fröbert
Background The instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events. Methods We conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment...
March 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28314920/-new-antibiotics-standstill-or-progress
#3
J Rademacher, T Welte
The development of resistance to antibiotics has been ignored for a long time. But nowadays, increasing resistance is an important topic. For a decade no new antibiotics had been developed and it is not possible to quickly close this gap of new resistance and no new drugs. This work presents six new antibiotics (ceftaroline, ceftobiprole, solithromycin, tedizolid, ceftolozane/tazobactam, ceftazidime/avibactam). In part, only expert opinions are given due to lack of study results.The two 5th generation cephalosporins ceftaroline and ceftobiprole have beside their equivalent efficacy to ceftriaxone (ceftaroline) and cefipim (ceftobiprole) high activity against MRSA...
March 17, 2017: Medizinische Klinik, Intensivmedizin und Notfallmedizin
https://www.readbyqxmd.com/read/28304237/cervical-disc-arthroplasty-with-the-prestige-lp-disc-versus-anterior-cervical-discectomy-and-fusion-at-2-levels-results-of-a-prospective-multicenter-randomized-controlled-clinical-trial-at-24-months
#4
Matthew F Gornet, Todd H Lanman, J Kenneth Burkus, Scott D Hodges, Jeffrey R McConnell, Randall F Dryer, Anne G Copay, Hui Nian, Frank E Harrell
OBJECTIVE The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels. METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate...
March 17, 2017: Journal of Neurosurgery. Spine
https://www.readbyqxmd.com/read/28304219/surgical-or-transcatheter-aortic-valve-replacement-in-intermediate-risk-patients
#5
Michael J Reardon, Nicolas M Van Mieghem, Jeffrey J Popma, Neal S Kleiman, Lars Søndergaard, Mubashir Mumtaz, David H Adams, G Michael Deeb, Brijeshwar Maini, Hemal Gada, Stanley Chetcuti, Thomas Gleason, John Heiser, Rüdiger Lange, William Merhi, Jae K Oh, Peter S Olsen, Nicolo Piazza, Mathew Williams, Stephan Windecker, Steven J Yakubov, Eberhard Grube, Raj Makkar, Joon S Lee, John Conte, Eric Vang, Hang Nguyen, Yanping Chang, Andrew S Mugglin, Patrick W J C Serruys, Arie P Kappetein
Background Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. Methods We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement...
March 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28303753/efficacy-and-safety-of-emtricitabine-tenofovir-alafenamide-ftc-taf-vs-emtricitabine-tenofovir-disoproxil-fumarate-ftc-tdf-as-a-backbone-for-treatment-of-hiv-1-infection-in-virologically-suppressed-adults-subgroup-analysis-by-third-agent-of-a-randomized-double
#6
Frank A Post, Yazdan Yazdanpanah, Gabriel Schembri, Adriano Lazzarin, Jacques Reynes, Franco Maggiolo, Mingjin Yan, Michael E Abram, Cecilia Tran-Muchowski, Andrew Cheng, Martin S Rhee
BACKGROUND: FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety. OBJECTIVE: To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third agent). METHODS: We conducted a 48-week subgroup analysis based on third agent from a randomized, double blind study in virologically suppressed adults on a FTC/TDF-containing regimen who switched to FTC/TAF vs...
March 17, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28302411/immunogenicity-and-safety-of-a-quadrivalent-inactivated-influenza-vaccine-compared-with-two-trivalent-inactivated-influenza-vaccines-containing-alternate-b-strains-in-adults-a-phase-3-randomized-noninferiority-study
#7
John T Treanor, Frank R Albano, Daphne C Sawlwin, Alison Graves Jones, Jolanta Airey, Neil Formica, Vince Matassa, Jane Leong
BACKGROUND: Vaccination is the most effective means of influenza prevention. Efficacy of trivalent vaccines may be enhanced by including both B strain lineages. This phase 3, double-blind study assessed the immunogenicity and safety/tolerability of a quadrivalent inactivated influenza vaccine (IIV4) versus the United States (US)-licensed 2014-2015 trivalent inactivated influenza vaccine (IIV3-Yamagata [IIV3-YAM]; Afluria) and IIV3 containing the alternate Victoria B strain (IIV3-VIC) in adults ≥18years...
March 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28301705/reprioritizing-research-activity-for-the-post-antibiotic-era-ethical-legal-and-social-considerations
#8
Spencer Phillips Hey, Aaron S Kesselheim
Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research-including clinical trials and regulatory requirements-to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 21st Century Cures Act...
March 2017: Hastings Center Report
https://www.readbyqxmd.com/read/28298277/supplementation-of-infant-formula-with-bovine-milk-fat-globule-membranes
#9
REVIEW
Niklas Timby, Magnus Domellöf, Bo Lönnerdal, Olle Hernell
Studies have shown that supplementation of infant formula with bovine milk fat globule membranes (MFGMs) may substantially narrow the gap in health outcomes between formula-fed and breastfed infants. In one study, consumption of a formula supplemented with a lipid-rich MFGM concentrate between 2 and 6 mo of age improved cognitive performance at 24 wk of age. In another study, a formula supplemented with a protein-rich MFGM concentrate given between 2 and 6 mo of age improved cognitive performance at 12 mo of age, decreased infectious morbidity until 6 mo of age, and yielded serum cholesterol concentrations closer to those of breastfed infants...
March 2017: Advances in Nutrition
https://www.readbyqxmd.com/read/28296721/single-pemetrexed-is-noninferior-to-platinum-based-pemetrexed-doublet-as-first-line-treatment-on-elderly-chinese-patients-with-advanced-nonsquamous-nonsmall-cell-lung-cancer
#10
Xiaolin Pu, Wei Li, Binbin Lu, Zhaoxia Wang, Min Yang, Weifei Fan, Lijuan Meng, Zhigang Lv, Yuchun Xie, Jun Wang
BACKGROUND: To evaluate the clinical efficacy and toxicity of single pemetrexed treatment compared with platinum-based pemetrexed doublet pemetrexed-based as first-line treatment for advanced nonsquamous nonsmall cell lung cancer (NS-NSCLC) in elderly Chinese patients. METHODS: The study retrospectively reviewed 175 elderly Chinese patients with NS-NSCLC from June 2010 to September 2013: 90 patients received single pemetrexed treatment, 45 received pemetrexed plus oxaliplatin, and 40 received pemetrexed plus carboplatin...
March 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28296582/randomized-trial-of-a-hypofractionated-radiation-regimen-for-the-treatment-of-localized-prostate-cancer
#11
Charles N Catton, Himu Lukka, Chu-Shu Gu, Jarad M Martin, Stéphane Supiot, Peter W M Chung, Glenn S Bauman, Jean-Paul Bahary, Shahida Ahmed, Patrick Cheung, Keen Hun Tai, Jackson S Wu, Matthew B Parliament, Theodoros Tsakiridis, Tom B Corbett, Colin Tang, Ian S Dayes, Padraig Warde, Tim K Craig, Jim A Julian, Mark N Levine
Purpose Men with localized prostate cancer often are treated with external radiotherapy (RT) over 8 to 9 weeks. Hypofractionated RT is given over a shorter time with larger doses per treatment than standard RT. We hypothesized that hypofractionation versus conventional fractionation is similar in efficacy without increased toxicity. Patients and Methods We conducted a multicenter randomized noninferiority trial in intermediate-risk prostate cancer (T1 to 2a, Gleason score ≤ 6, and prostate-specific antigen [PSA] 10...
March 15, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28296570/statistical-design-of-noninferiority-multiple-region-clinical-trials-to-assess-global-and-consistent-treatment-effects
#12
Guoqing Diao, Donglin Zeng, Joseph G Ibrahim, Alan Rong, Oliver Lee, Kathy Zhang, Qingxia Chen
Noninferiority multiregional clinical trials (MRCTs) have recently received increasing attention in drug development. While a major goal in an MRCT is to estimate the global treatment effect, it is also important to assess the consistency of treatment effects across multiple regions. In this paper, we propose an intuitive definition of consistency of noninferior treatment effects across regions under the random-effects modeling framework. Specifically, we quantify the consistency of treatment effects by the percentage of regions that meet a predefined treatment margin...
February 13, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28292339/comparison-of-ferric-sulfate-combined-mineral-trioxide-aggregate-pulpotomy-and-zinc-oxide-eugenol-pulpectomy-of-primary-maxillary-incisors-an-18-month-randomized-controlled-trial
#13
Trang D Nguyen, Peter L Judd, Edward J Barrett, Nicole Sidhu, Michael J Casas
PURPOSE: The purpose of this study was to compare outcomes and survival of ferric sulfate with mineral trioxide aggregate (FS+MTA) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors. METHODS: In this parallel group noninferiority trial, asymptomatic carious vital primary incisors with pulp exposure in healthy 18- to 46-month-olds were allocated randomly to receive FS+MTA pulpotomy or RCT between September 2010 and September 2012. Each incisor was classified into one of the following radiographic outcomes: N (incisor without pathologic change); Po (pathologic change present, follow-up recommended); Px (pathologic change present, extract...
January 15, 2017: Pediatric Dentistry
https://www.readbyqxmd.com/read/28291393/early-positron-emission-tomography-response-adapted-treatment-in-stage-i-and-ii-hodgkin-lymphoma-final-results-of-the-randomized-eortc-lysa-fil-h10-trial
#14
Marc P E André, Théodore Girinsky, Massimo Federico, Oumédaly Reman, Catherine Fortpied, Manuel Gotti, Olivier Casasnovas, Pauline Brice, Richard van der Maazen, Alessandro Re, Véronique Edeline, Christophe Fermé, Gustaaf van Imhoff, Francesco Merli, Réda Bouabdallah, Catherine Sebban, Lena Specht, Aspasia Stamatoullas, Richard Delarue, Valeria Fiaccadori, Monica Bellei, Tiana Raveloarivahy, Annibale Versari, Martin Hutchings, Michel Meignan, John Raemaekers
Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated-according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)-stage I and II HL...
March 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28288057/mesorectal-excision-with-or-without-lateral-lymph-node-dissection-for-clinical-stage-ii-iii-lower-rectal-cancer-jcog0212-a-multicenter-randomized-controlled-noninferiority-trial
#15
Shin Fujita, Junki Mizusawa, Yukihide Kanemitsu, Masaaki Ito, Yusuke Kinugasa, Koji Komori, Masayuki Ohue, Mitsuyoshi Ota, Yoshihiro Akazai, Manabu Shiozawa, Takashi Yamaguchi, Hiroyuki Bandou, Kenji Katsumata, Kohei Murata, Yoshihito Akagi, Nobuhiro Takiguchi, Yoshihisa Saida, Kenichi Nakamura, Haruhiko Fukuda, Takayuki Akasu, Yoshihiro Moriya
OBJECTIVE: The aim of the study was to confirm the noninferiority of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) in terms of efficacy. BACKGROUND: Lateral pelvic lymph node metastasis is occasionally found in clinical stage II or III lower rectal cancer, and ME with LLND is the standard procedure in Japan. ME alone, however, is the international standard surgical procedure for rectal cancer. METHODS: Eligibility criteria included histologically proven rectal cancer at clinical stage II/III; main lesion located in the rectum, with the lower margin below the peritoneal reflection; no lateral pelvic lymph node enlargement; Peformance Status of 0 or 1; and age 20 to 75 years...
March 10, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28285463/video-assisted-thoracoscopic-surgery-node-dissection-for-lung-cancer-treatment
#16
REVIEW
Atsushi Watanabe, Masahiro Miyajima, Taijiro Mishina, Kodai Tsuruta, Yuki Takahashi, Ryunosuke Maki, Makoto Tada
PURPOSE: Mediastinal node dissection (MND) is an integral component of the surgical treatment for non-small cell lung cancer (NSCLC). Although video-assisted thoracoscopic surgery (VATS) has been used increasingly for lung cancer treatment, the accuracy of by VATS MND still remains controversial. We reviewed the surgical results of VATS MND for NSCLC. METHODS: A systematic review of literature was performed, and articles that fully described the surgical procedure, devices, and results of VATS MND were selected to compare the efficacy of MND by VATS and thoracotomy...
March 11, 2017: Surgery Today
https://www.readbyqxmd.com/read/28282359/locoregional-therapy-with-curative-intent-versus-primary-liver-transplant-for-hepatocellular-carcinoma-systematic-review-and-meta-analysis
#17
A R Murali, S Patil, K T Phillips, M Voigt
BACKGROUND: Loco-regional therapy with curative intent (CLRT) followed by salvage liver transplant (SLT) in case of HCC recurrence is an alternative to primary liver transplant (LT) in selected patients with HCC. METHODS: We performed a systematic review and meta-analysis of studies comparing the survival of patients treated with CLRT versus LT, stratified by the stage of liver disease, extent of cancer, and whether SLT was offered or not. RESULTS: We included 48 studies involving 9835 patients (5736 patients with CLRT and 4119 patients with primary LT)...
March 10, 2017: Transplantation
https://www.readbyqxmd.com/read/28277409/randomized-controlled-trial-of-two-alcohol-based-preparations-for-surgical-site-antisepsis-in-colorectal-surgery
#18
Robyn B Broach, Emily C Paulson, Charles Scott, Najjia N Mahmoud
OBJECTIVE: To compare 2 alcohol-based, dual-action skin preparations for surgical site infection (SSI) prevention in elective colorectal surgery. BACKGROUND: Colorectal surgery is associated with the highest SSI rate among elective surgical procedures. Although evidence indicates that alcohol-based skin preparations are superior in SSI prevention, it is not clear if different alcohol-based preparations are equivalent in clean-contaminated colorectal procedures. METHODS: We performed a blinded, randomized, noninferiority trial comparing iodine povacrylex-alcohol (IPA) and chlorhexidine-alcohol for elective, clean-contaminated colorectal surgery...
March 8, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28272925/a-biomechanical-comparison-of-allograft-tendons-for-ligament-reconstruction
#19
Jeremiah E Palmer, Joseph P Russell, Jason Grieshober, Abigail Iacangelo, Benjamin A Ellison, T Dylan Lease, Hyunchul Kim, R Frank Henn, Adam H Hsieh
BACKGROUND: Allograft tendons are frequently used for ligament reconstruction about the knee, but they entail availability and cost challenges. The identification of other tissues that demonstrate equivalent performance to preferred tendons would improve limitations. Hypothesis/Purpose: We compared the biomechanical properties of 4 soft tissue allograft tendons: tibialis anterior (TA), tibialis posterior (TP), peroneus longus (PL), and semitendinosus (ST). We hypothesized that allograft properties would be similar when standardized by the looped diameter...
March 2017: American Journal of Sports Medicine
https://www.readbyqxmd.com/read/28270723/a-canadian-perspective-on-the-subcutaneous-administration-of-rituximab-in-non-hodgkin-lymphoma
#20
REVIEW
D MacDonald, T Crosbie, A Christofides, W Assaily, J Wiernikowski
Rituximab is widely used for the treatment of non-Hodgkin lymphoma, being a key component in most therapeutic regimens. Administration of the intravenous (IV) formulation is lengthy and places a significant burden on health care resources and patient quality of life. A subcutaneous (sc) formulation that provides a fixed dose of rituximab is being examined in a number of studies. Results indicate that the pharmacokinetics are noninferior and response rates are comparable to those obtained with the IV formulation...
February 2017: Current Oncology
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