Effects of Plasma Tainted with CJD Still Under Scrutiny in U.K
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Tuesday, July 14 BOSTON, MASSACHUSETTS ISTH 2009 DAILY XXII CONGRESS INTERNATIONAL SOCIETY ON THROMBOsis AND HAEMOSTAsis Dr. Hill cautioned against making INSIDE Effects of Plasma Tainted with too much of these findings. “There are many uncertainties about this data, and LATE-BREAKING RESULTS there are questions about the current Latest data released on five trials risk assessment. page 2 CJD Still Under Scrutiny in U.K. “We possibly don’t know the full ex- bout half of the 8,730 people in Among those 792 patients, 1,157 tent of contaminated batches. The pat- HISTORY FROM THE the United Kingdom who were have had treatment or exposure epi- terning incubation of time of variant BEGINNING Aexposed to plasma tainted with sodes with 12.7 million units of the im- CJD following exposure to plasma prod- variant Creutzfeldt-Jacob disease have plicated product. That is about half of uct may well be different even to expo- ISTH was founded 40 years ago not yet been treated. the 23 million that have been issued. sure through cellular product.” page 4 Physicians are trying to assess the risk Sixty-seven percent of this cohort had Finding answers to these questions to the patients who received the tainted received only one batch from an im- may involve better recruitment, post SNAKE BITE TREATMENT plasma from 1987 to 1999. Frank G. H. plicated donor, “but all have received mortem, results of longitudinal studies Research ongoing about when, if to Hill, MB, ChB, FRCPath, FRCPCH, other batches which may add to their involving these patients and the devel- administer fresh frozen plasma at Birmingham Children’s Hospital NHS cumulative risk.” opment of a blood test. page 6 Trust and the U.K. Haemophilia Centre Directors Organization, discussed the ex- Opening tent of exposure and risk stratification dur- YOUNG INVESTIGATORS ing a plenary session Monday morning. Ceremony Four Pier M. Mannucci Awards “Information on the National Haemo- announced Draws Large, page 8 philia Database shows us we have in ex- cess of 23,000 registered patients; 8,730 Festive Crowd of those have been treated,” said Hill. Hundreds of delegates “From annual return data, we can iden- gathered Sunday night tify 4,580 patients who have received to celebrate the opening U.K. plasma products and therefore are of the XXII ISTH at risk of variant CJD and require public Congress. TUESDAY health precautions with certain opera- AT A GLANCE tive procedures. Of those, 792 have been positively notified as having received an Ongoing implicated batch,” Dr. Hill said. Oral Communications, State- of-the-Art Lectures, Abstract Symposia, Nurses’ Sessions 9:45 a.m. – 10:30 a.m. PrPSC Detected in Spleen of Adult Hemophilic Patient in U.K. Plenary Lecture: Contribution nalyses of tissues from 17 Unit, said Monday products. All we can say we know for of Allosteric Disulfide Bonds patients exposed to variant that the patient “like- sure is that there was an infected donor to Regulation of Hemostasis Creutzfeldt-Jakob disease in ly” contracted the in this pool.” (Philip Hogg) A the United Kingdom showed that one disease from an un- Investigators performed prospective 3:00 p.m. – 3:15 p.m. patient with hemophilia had disease-as- identified source. and retrospective analyses on tissues ISTH General Membership sociated prion protein – PrPSC - in his “Because of the collected from biopsies or autopsies, Assembly spleen tissues. large volume of non- searching for the presence of disease-as- It is not yet known whether the pa- implicated products Dr. James W. sociated prion protein. All patients had 3:15 p.m. – 4:00 p.m. tient came in contact with the disease received, it is likely Ironside, FRCPath been treated with U.K.-sourced pooled Presidential Plenary through diet, blood transfusion or this could be the source of the infec- factor concentrates for bleeding disor- Abstracts pooled clotting factor concentrate. Dr. tion,” he said. “On the relative risk, it ders from 1980 and 2001. That pool is James W. Ironside, FRCPath, director is very difficult to discriminate between known to contain tainted plasma from 4:00 p.m. – 4:15 p.m. of the U.K.’s National CJD Surveillance the implicated and non-implicated (Ironside, continued on page 11) ISTH 2009 Congress Awards Presentation Tuesday, July 14, 6:30 PM – 7:30 PM 4:15 p.m. – 5:00 p.m. Industry Sponsored Technical Sessions TIPS OF THE DAY Presidential Plenary Abstracts Add future professional conferences to your calendar after • Network for Continuing • Rovi stopping by the Future Events Kiosk. 6:30 p.m. – 7:30 p.m. Medical Education (Novo Room 104 ABC Technical Sessions Nordisk) Stay connected at the Cyber Café & Message Center in the (Industry Sponsored) Room 107 ABC Exhibition Area. The ISTH 2009 Daily Congress news will also appear on the ISTH website at www.isth.org. TUESDAY • JULY 14, 2009 LATE BREAKING TRIAL ADVANCE-2: Favorable Risk-Benefit Profile With Apixaban pixaban for thromboprophy- lower major and paring efficacy and safety of 2.5 mg bleeding (major and clinically rel- laxis after total knee replace- clinically relevant apixaban twice daily for preventing evant nonmajor). A ment had better efficacy and non-major bleed- VTE vs. the current European stan- The primary outcome occurred safety compared to the current stan- ing rates in patients dard of care, 40 mg subcutaneous in 15.1% of patients in the apixaban dard of care enoxaparin, according to undergoing total enoxaparin once daily, said Michael group vs. 24.4% in the enoxaparin late-breaking results of ADVANCE-2 knee replacement. Lassen, MD, of the University of Co- group (P,.001). Major VTE oc- presented Monday. A D V A N C E - 1 penhagen, Hørsholm, Denmark. curred in 1.1% of apixaban patients ADVANCE-1 results, presented in compared apixa- Michael Primary efficacy outcome was the treated with apixaban vs. 2.2% of December 2008 at the 50th ASH An- ban with the North Lassen, MD composite of DVT by venography, patients treated with enoxaparin, Dr. nual Meeting, showed that apixaban American dosage symptomatic objectively confirmed Lassen said. failed to meet one of two prespeci- of enoxaparin 30 mg twice daily. DVT or pulmonary embolism, or Apixaban also conferred a better fied noninferiority criteria margins ADVANCE-2 was a randomized, death from any cause during treat- safety profile compared with apixaban in reducing rates of VTE but showed double blind, multicenter trial com- ment. Primary safety outcome was (3.5% vs.4.8%; respectively; P=.09). LATE BREAKING TRIAL dependent radiologists. The primary efficacy endpoint Four-Week Prophylaxis Better Than One Week was the combined incidence of to- tal documented symptomatic and After Abdominal, Pelvic Surgery asymptomatic DVT, nonfatal pul- monary embolism and deaths due to hen compared with a tients undergoing cancer abdominal patients; the efficacy analysis, 488. any cause. Primary safety endpoint one-week prophylaxis, or pelvic surgery. Prior to randomization, all patients was major hemorrhage, according to W four weeks with the low These results were part of the CAN- received 3,500 IU bemiparin starting six Dr. Kakkar. molecular weight heparin bemiparin BESURE trial presented Monday by hours postsurgery for eight days. They Patients assigned bemiparin had significantly reduced the rate of ma- Dr. Vijay V. Kakkar, MD, director were then randomly assigned 3,500 IU a 24.4% relative risk reduction for jor venous thromboembolism with- of the Thrombosis Research Institute, bemiparin once daily or placebo for 20 the primary endpoint and a 82.4% out increased complications in pa- London, as part of the late-breaking more days, Dr. Kakkar said. relative risk reduction for incidence abstracts session. Follow-up was three months. of major VTE (see chart). C A N B E S U R E Twenty-eight days after surgery, bi- Rates of major bleeding were simi- was a multicenter, lateral ascending venography was lar in both groups (0.6% vs. 0.3%, re- randomized, double performed and examined by five in- spectively; P=.572). blind parallel group trial. The study in- cluded 703 patients LATE BREAKING TRIAL aged 40 or older who were undergoing sur- gery on the gastroin- Better Anticoagulant Control testinal or genitouri- nary tract, or female With Warfarin reproductive organs. The safety analysis atients who switched from were randomly assigned to warfa- included data on 625 acenocoumarol to warfa- rin and 254 to phenprocoumon. P rin spent more time within An equal number of patients initiat- therapeutic ranges than those who ing and switching therapies were in switched to phenprocoumon, ac- both groups. LATE BREAKING TRIAL cording to late-breaking After six months’ follow- results presented Monday. up, the overall mean per- Enoxaparin Effective for VTE Prevention The trial compared warfa- centage of time spent within rin and phenprocoumon therapeutic ranges was in Advanced Pancreatic Cancer in patients who were ei- 74.6% for the warfarin group ther initiating anticoagulant and 65.3% for the phen- ONKO 004 trial results sug- CONKO 004 trial. treatment or switching from procoumon group (95% CI, gest that the low molecular In an intent-to-treat analysis, the vitamin K antagonist 5.8-12.8), she said. C weight heparin enoxaparin enoxaparin reduced the risk of VTE acenocoumarol to a new Yvonne van The difference in mean helped prevent symptomatic ve- by 65% with no increased safety com- therapy. Leeuwen, MSc percentage of time spent nous thromboembolism in patients plications, Dr. Reiss said. Yvonne van Leeuwen, within therapeutic ranges undergoing chemotherapy for ad- From April 2004 to January 2009, MSc, from the department of clini- was more substantial in patients vanced pancreatic cancer. 312 VTE- and chemotherapy-naive cal epidemiology at Leiden Univer- who switched therapies: 78.3% for H.B.