Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: Results of the Randomized BIOFLOW-II Trial.

BACKGROUND Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. METHODS AND RESULTS A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm(2) versus X-EES, 0.43±0.56 mm(2); P=0.04). CONCLUSIONS Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. CLINICAL TRIAL REGISTRATION URL http://www.clinicaltrials.gov. Unique identifier: NCT01356888.

Clinical Use of Quantitative Computed Tomography–Based Finite Element Analysis of the Hip and Spine in the Management of Osteoporosis in Adults: the 2015 ISCD Official Positions—Part II

The International Society for Clinical Densitometry (ISCD) has developed new official positions for the clinical use of quantitative computed tomography (QCT)-based finite element analysis of the spine and hip. The ISCD task force for QCT reviewed the evidence for clinical applications and presented a report with recommendations at the 2015 ISCD Position Development Conference. Here we discuss the agreed upon ISCD official positions with supporting medical evidence, rationale, controversy, and suggestions for further study. Parts I and III address the clinical use of QCT of the hip, and the clinical feasibility of existing techniques for opportunistic screening of osteoporosis using CT scans obtained for other diagnosis such as colonography was addressed.

Genetic Resistance Determinants, In Vitro Time-Kill Curve Analysis and Pharmacodynamic Functions for the Novel Topoisomerase II Inhibitor ETX0914 (AZD0914) in Neisseria gonorrhoeae.

Resistance in Neisseria gonorrhoeae to all available therapeutic antimicrobials has emerged and new efficacious drugs for treatment of gonorrhea are essential. The topoisomerase II inhibitor ETX0914 (also known as AZD0914) is a new spiropyrimidinetrione antimicrobial that has different mechanisms of action from all previous and current gonorrhea treatment options. In this study, the N. gonorrhoeae resistance determinants for ETX0914 were further described and the effects of ETX0914 on the growth of N. gonorrhoeae (ETX0914 wild type, single step selected resistant mutants, and efflux pump mutants) were examined in a novel in vitro time-kill curve analysis to estimate pharmacodynamic parameters of the new antimicrobial. For comparison, ciprofloxacin, azithromycin, ceftriaxone, and tetracycline were also examined (separately and in combination with ETX0914). ETX0914 was rapidly bactericidal for all wild type strains and had similar pharmacodynamic properties to ciprofloxacin. All selected resistant mutants contained mutations in amino acid codons D429 or K450 of GyrB and inactivation of the MtrCDE efflux pump fully restored the susceptibility to ETX0914. ETX0914 alone and in combination with azithromycin and ceftriaxone was highly effective against N. gonorrhoeae and synergistic interaction with ciprofloxacin, particularly for ETX0914-resistant mutants, was found. ETX0914, monotherapy or in combination with azithromycin (to cover additional sexually transmitted infections), should be considered for phase III clinical trials and future gonorrhea treatment.

Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.

BACKGROUND Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. METHODS AND RESULTS Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. CONCLUSIONS In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.

Na 1 Nachlass Max Horkheimer, 75 - Korrespondenzen u.a. mit Armin Hodler (p. II 9, 1-88b)

37 Briefe und Beilage zwischen Armin Hodler und Max Horkheimer, 1935-1948; 14 Briefe und Beilage zwischen Hans Honegger und Max Horkheimer, 1941-1946; 1 Brief und Beilage von Max Horkheimer an Paul Honigsheim, 1943; 9 Briefe zwischen Hans Horkheimer und Max Horkheimer, 1945-1948 sowie 1 Reisebericht, Peru, 1939; 2 Briefe zwischen Susanna Huber-Weisser und Max Horkheimer, 1949; 5 Briefe zwischen Helen MacGill-Hughes vom The American Journal of Sociology und Max Horkheimer, 1949; 1 Briefabschrift von Max Horkheimer an Edmund Husserl, 28.10.1931; 1 Brief von Elizabeth Husserl-Rosenberg, 06.01.1948;

Na 1 Nachlass Max Horkheimer, 60 - Korrespondenzen u.a. mit der American Friends Service Committee (p. II 1, 226-453)

1 Brief von Max Horkheimer an die Commerzbank Stuttgart, 1947; 2 Briefe von Max Horkheimer an die United States Lines, 1946-1947; 4 Brief und Beilage von Max Horkheimer an das American Consulate General Stuttgart, 1940-1941, 1946; 1 Brief von Max Horkheimer an das Hebrew Sheltering and Immigrant Aid, 1946; 1 Brief von Max Horkheimer an Lilly Straus, 1945; 2 Briefe von Max Horkheimer an Herbert S. Eskin, 1945; 3 Briefe von Max Horkheimer an State of New York, 1939-1941; 5 Briefe von Max Horkheimer an das American Friends Service Committee, 1940-1941; 2 Briefe von Max Horkheimer an Elisabeth Kunz, 1941;

Na 1 Nachlass Max Horkheimer, 77 - Korrespondenzen u.a. mit Siegfried Kander (p. II 9, 223-402)

31 Briefe zwischen Siegfried Kander und Max Horkheimer, 1941-1949; 2 Briefe zwischen Harold H. Shaper und Max Horkheimer, 1945 siehe auch Siegfried Kander; 2 Briefe und Beilagen zwischen H. M. Kallen und Max Horkheimer, 1944; 17 Briefe und Beilage zwischen Erika Kickton und Max Horkheimer, 1946-1949; 9 Briefe zwischen Christa Kerti und Max Horkheimer, 1948-1949; 25 Briefe zwischen Else Klee-Hausmann und Max Horkheimer, 1947-1949; 18 Briefe und Beilage zwischen Philip Klein von The New York School of Social Work, American Jewish Committee und Max Horkheimer, 1944-1947; 2 Briefe zwischen Otto Klineberg und Max Horkheimer, 1949;

Na 1 Nachlass Max Horkheimer, 76 - Korrespondenzen u.a. mit Hermann Igersheimer (p. II 9, 89-222c)

1 Brief und Beilage vom Institut für sozialwissenschaftliche Forschung Darmstadt an Max Horkheimer, 1949; 82 Briefe zwischen Hermann Igersheimer und Max Horkheimer, 1941-1950; 5 Briefe zwischen Harold E. Jones von der University of California und Max Horkheimer, 1947; 1 Brief von Morris Janowitz an Max Horkheimer, 1948; 2 Briefe vom Jewish Community Center an Max Horkheimer, 1948; 7 Briefe zwischen Robert P. St.John und Max Horkheimer, 1945; 2 Briefe zwischen Erich von Kahler und Max Horkheimer, 1945; 2 Briefe und Beilage zwischen Anselm Kahn und Max Horkheimer, 04.07.1945, 19.07.1945;

Na 1 Nachlass Max Horkheimer, 63 - Korrespondenzen u.a. mit der American Philosophical Association (p. II 3, 1-132)

Drucksachen und Briefwechsel von der American Philosophical Association, 1942-1949; 2 Briefe von Max Horkheimer an Eugene N. Anderson, 25.05.1942; 1 Briefabschrift an Franz Neumann, 29.04.1942; 3 Briefe zwischen Walter L. Arensberg und Max Horkheimer, 1941; 17 Brief und Beilagen zwischen Aufbau [Zeitschrift] und Max Horkheimer, 1942-1948; 8 Briefe und Beilage ziwschen Bruno Franco Avardi und Max Horkheimer [Pollock], 1942-1943; 21 Briefe und Beilage zwischen Edward N. Barnhart von der University of California und Max Horkheimer, 1947-1949; 5 Briefe zwischen Salo W. Baron und Max Horkheimer, 1945; 5 Briefe zwischen Gertrude Bauer und Max Horkheimer, 1941-1946; 1 Brief und Beilage von Ralph L. Beals von der University of California an Max Horkheimer, 1947-1948; 5 Briefe zwischen Howard Becker und Max Horkheimer, 1948; 1 Brief und Beilage von Frank Beckwith an Max Horkheimer, 1944; 1 Brief zwischen Bruno Bettelheim und Max Horkheimer, 1944-1949 sowie 1 Manuskript von Bruno Bettelheim: The Thematic Apperception Test as an Educational and Therapeutic Device;

Na 1 Nachlass Max Horkheimer, 68 - Korrespondenzen u.a. mit Gretl Dupont (p. II 5, 220-439)

6 Briefe zwischen Max Horkheimer und F. Pollock mit Einbezug von Arthur G. Coons vom Occidental College Los Angeles, 1947; 4 Briefe zwischen Kathleen Costello und Max Horkheimer, 1945-1946; 8 Briefe und Beilage zwischen Edward M. David und Max Horkheimer, 24.11.1941-1942; 11 Briefe zwischen dem United States of America, Department of States und Max Horkheimer, 1942-1949; 3 Briefe zwischen Monroe E. Deutsch und Max Horkheimer, 1946; 12 Briefe und Beilage zwischen dem Dictionary of the Arts und Max Horkheimer, 1941-1944 sowie 1 Manuskrip: Sociology of Arts von Max Horkheimer; 2 Briefe zwischen Robert Disraeli und Max Horkheimer, 1945; 21 Briefe und Beilage zwischen Ria Drevermann und Max Horkheimer, 1948-1950; 6 Briefe zwischen Wolf Drewermann und Max Horkheimer, 1948-1949; 2 Briefe von Stephen Duggan vom Institute of International Education an Max Horkheimer, 1942-1947; 6 Briefe zwischen Joseph Dunner und Max Horkheimer, 1945-1947; 24 Briefe und Beilage zwischen Gretl Dupont und Max Horkheimer, 1942-1948; 3 Briefe zwischen Clarence A. Dykstra und Max Horkheimer, 1946-1947, 1947;

Na 1 Nachlass Max Horkheimer, 66 - Korrespondenzen u.a. mit Ermin Cahn und Max Cahn (p. II 4, 256 - 433)

3 Briefe zwischen Charlotte Bühler und Max Horkheimer, 1946 sowie 4 Papers von Charlotte Bühler zum Antisemitismus; 55 Briefe zwischen Ermin Cahn, Max Cahn und Max Horkheimer, 1941-1949; 1 Brief und Beilage von Max Horkheimer an Max L. Cahn, 1948; 6 Briefe zwischen der Society for the Protection of Science and Learning und Max Horkheimer, 1944-1948; 16 Briefe zwischen Hadley Cantril und Max Horkheimer, 1948-1949 sowie 2 Manuskripte von Hadley Cantril : The Development od a Scientific Morality; Trends of Opinion During World War II; 12 Briefe und Beilage zwischen Charles Carlé und Max Horkheimer, 1942-1943;

Na 1 Nachlass Max Horkheimer, 74 - Korrespondenzen u.a. mit Käte von Hirsch (p. II 8, 232-369)

1 Brief von F. Pollock an Frederick J. Hacker, 1945; 1 Brief von Frederick J. Hacker an Max Horkheimer, sowie 2 Memoranden von Max Horkheimer; 5 Briefe zwischen Willy Hartner und Max Horkheimer, 1948; 3 Briefe und eine Drucksache von Fred Herzberg an Max Horkheimer, 1947; 1 Brief und 3 Memoranden von Max Horkheimer an Fred Herzberg, 1947; 2 Briefe von Heinz Herald an Max Horkheimer, 1946 sowie 1 Gutachten und Beilage von Max Horkheimer an Heinz Herald, 1946; 2 Briefe zwischen Josef Haurand und Max Horkheimer, 1949, 1950; 3 Briefe und Beilage zwischen Herta Herzog und Max Horkheimer, 1949; 23 Briefe zwischen dem Hessischen Staatsministerium für Kultus und Unterricht und Max Horkheimer, 1948-1949 siehe auch Hessischer Minister für Erziehung und Volkdsbildung; 2 Briefe von Eduard Heumann an Max Horkheimer, 1948-1949; 1 Brief und Beilage von George J. Hexter an A. Lourie; 35 Briefe zwischen Käte von Hirsch und Max Horkheimer, 1941-1948;

Shakers : compendium of the origin, history, princicples, rules and regulations, government, and doctrines of the United Society of Believers in Christ's Second Appearing : with biographies of Ann Lee, William Lee, Jas. Whittaker, J. Hocknell, J. Meacham, and Lucy Wright

by F. W. Evans