4

CONGRESS DAILYThrombosis 2010

Milan, July 9th

realized with the contribution of

The scientific handing over has been tak-en by Jacqueline Conard, who will chairthe 22nd Congress scheduled on October6-9, 2012 in Nice, France. “We have cho-sen a very good, charming and easy toreach venue which boasts a great aca-demic tradition and an excellent congressreceptivity”, states Conard. Focus of the scientific programme of thenext Congress will be the new anticoagu-lant drugs again, which will be providedwith more literature on the first applica-tive phase in two years. “Apart from thiswide theme - Canard explains - we willprovide attention to woman's wealthwho, due to pregnancy, contraceptivesand vitro fecondation is at thromboticrisk. Furthermore, another importanttheme will be represented by biomarkersconcerning the specific thrombotic risk”.Young investigators’ generations and stu-dents will have the chance to attend spe-cific congress sessions as well. The Spanish experts Monreal, Vicente,Badimon e Paramo and the secretary ofthe League Maria Teresa Santos were inMilan as well: actually the Iberian coun-try will be the organizer of the Congressin 2014. In four years the impact on ther-apeutic aspects is expected to be relevant

- Vicente Vicente explains: “There willbe a consolidation with registration of thenew drugs, with more experiences and

new directions (infarction and acutecoronary syndromes, stroke and rarethrombosis). The new oral anticoagulantwhich will enter the market in two orthree years will provide experienced da-ta, together with the results of actual ap-plication, dosing, need of monitoring, sideeffects and check”.

The coffee? It would enable the reduc-tion of venous thrombosis as well as amoderate consumption of wine would.Chocolate increases the anti-plateletproperty of aspirin, fish is important inthe reduction of thrombotic diseases ingeneral. Over the years numer-ous studies have shownthat the Mediterraneandiet reduces cardiovas-cular risk. As it is wellknown, the Medite-rranean diet entails eat-ing fresh food such asvegetables and fruits inseason, grains, fish,especially oily fish, oliveoil, especially extra vir-gin olive oil, drinkingwine in moderation, andreining in meat and ani-mal fats. The resultsfrom the latest meta-analyses presented atthe 21st InternationalThrombosis Congressconfirmed past findingsand revealed new bene-fits of a healthy diet interms of protectionagainst thrombotic dis-eases.“There is evidence thatseveral coagulation fac-tors are influenced bydiet - said Mannucci - Ithas been proven thanomega-3 (n-3) polyunsat-urated fatty acids (PUFA) have bene-ficial effects on platelet function.Although there is not yet direct evi-dence of the benefits of monounsatu-rated fatty acids (MUFA) on coagula-tion, the vast majority of studies onthrombotic diseases suggest that the

Mediterranean diet may reduce therisk of thrombosis”.The Mediterranean diet is healthyaltogether. It helps maintain a bal-anced metabolic function and henceprevent overweight and obesity. Most

importantly, numerousfoods in the Mediter-ranean diet are rich invitamins and antioxi-dants which counteractthe action of free radi-cals that, when inexcess, damage cellularmembranes and DNAby altering cellularfunction and gene infor-mation. Further con-sensus for wine, con-sumed in moderateamounts (no more than2 glasses a day). Unlikespirits, wine is thoughtto protect againstvenous thrombosis as itreduces the levels of fib-rinogen and factor VIIcurrently considered tobe markers of cardio-vascular risk.Specialists also con-firmed that fish protectsagainst thrombotic dis-eases, although a recentTromsø Universitystudy in Norway sug-gested that the reduc-tion in thrombotic

events associated witheating fish regularly may be greater inwomen than in men.Finally, five or sixsmall cups of coffee a day may reducethe risk of venous thrombosis by 35%,while chocolate plays a significant rolein enhancing the antiplatelet effects ofaspirin.

The 22nd edition will be heldin Nice, France, 6-9 October

at the Acropolis Congress Centre

New anticoagulants, woman’s healthand bio-markers in the agenda of 2012

Diet and thrombotic diseases: coffee,chocolate&wine helpful in prevention

CONGRESS DAILY is a special edition of NTR - Notiziario in Tempo Reale by e.press® srl - registration Trib. NA no. 4560Editor and Director Enrico Sbandi Professional journalist Claudio Ravel - Translation Giovanna Basilio - direct printing at Marriot Hotel, Milan

Exclusive distributor for medical and health sector: VALUE RELATIONS INTERNATIONAL srl, via G. B. Morgagni, 30 - 20129 Milan, Italy

"We hand over highly interesting andconstantly developing themes toFrance and Spain, two great Mediter-ranean Countries which will be en-charged toorganize thetwo next edi-tions of theCongress”.With thesewords PierMannuccioMannucci,President ofthe 21st In-ternationalCongress onThrombosis of the MediterraneanLeague Against ThromboembolicDiseases, comments satisfied the de-velopment of the Milanese edition ofthe congress among the most renownworldwide sectional experts.Figures are excellent, more than1,200 participant and high is the qual-ity of the 736 presented works, as re-ported in this newsletter yesterday.These are results which qualify theorganization of this congress whosemerit is that of having focused its top-ics on the great chances supplied bythe new molecules. Actually, Milan2010 has inhaugurated “a new era inantithrombotics”, as stated by thecongress claim.

Arrivederciin Nice 2012

Jacqueline Conard, President of the 22nd International Congress on Thrombo-sis that will be held on 6-9 October 2012 in Nice, France.

further in page 4In the photo: Pier Mannuccio

Mannucci, President of 21st Congress

“The long-term risk of cancer in patientswith venous thromboembolism” is thetheme of the work tha will be presentedthis morning by Paolo Prandoni.Venous thromboembolism (VTE) is awell known marker of occult malignan-cy. Indeed, during the initial six monthsfollowing a thrombotic episode a newcancer is diagnosed in up to 10% of pa-tients, especially in those with idiopathicVTE. While it would be of interest toknow whether this increased risk forcancer persists over the long-term, be-yond this initial 6-month period, availableinformation is controversial.To determine whether and to what ex-tent the long-term risk of cancer exceedsthat expected in the general population,we assessed the risk of subsequent overt

malignancy in 1,495 patients who re-mained cancer free during the initial sixmonths after the thrombotic episode, andin 1,495 age- and sex-matched controlsubjects derived from the general popula-

tion of three regions in northern Italy.For both studies patients and controlsthe mean age was 60.0 ± 16.8 years, and46% were males. In 825 (55%) patientswith VTE, the episode was consideredidiopathic. All patients and controls had

follow-up for 30 months, which began atthe 6-month point after VTE. Results:during the 30-month follow-up period,new objectively-confirmed cancer devel-oped in 48 patients with VTE and in 43control subjects, resulting in a cumula-tive incidence of 3.2% (95% CI, 2.3 to4.4) and 2.9% (95% CI, 2.0 to 4.0), re-spectively. The HR for new cancer in pa-tients with VTE as compared to controlswas 1.09 (95% CI, 0.59 - 1.34). When theanalysis was confined to the 825 patientswith idiopathic VTE and their controls,the HR for cancer was 1.12 (95% CI,0.61 - 1.36).The conclusion, according to the wordsof Prandoni, are that in patients with afirst VTE, including those with idiopa-thic thrombosis, the risk for subsequentcancer beyond the initial six months doesnot appear to exceed that expected in thegeneral population.

In the photo:Paolo Prandoni

Patients with VTE: no long term risk of cancer Beyond the initial six monthsdoes not appear to exceed that

expected in the general population

2 3

Simposia, lectures and oral communication. Every daymany simultaneous sessions in the numerous halls ofthe Marriott Hotel, all featured by a particular, as wellas flattering, peculiarity: they have all begun on timeand ended by the established terms. Of course the participants have their merit but the

organizing secretary ARSeducandi has played thelion’s share above all.The whole staff has showed courtesy and profession-ality and even Prof. Mannuccio Mannucci stopped fora cheese with the secretary members at the end of anexacting day.

A “cheese” to farewell the 21st Congress

The oral communications programmeschedules, this morning, the session“New Anticoagulants 2”, in whichGiancarlo Agnelli, who’s also chair-man, presents “The ultra-low-molecu-lar-weight heparin (ULMWH) semu-loparin for prevention of venousthromboembolism (VTE) after elec-tive knee replacement surgery”. Thework is signed by M. R. Lassen, W.Fisher, D. George, A. Kakkar, P.Mismetti, P. Mouret, F. Lawson, A.G. G. Turpie, together with Agnelli. Semuloparin is a new ULMWHunder development for prevention ofVTE in patients with cancer, and alsoin patients undergoing major abdomi-nal or orthopaedic surgery. This studyaimed to compare the efficacy andsafety of semuloparin versus enoxa-

parin after elective knee replacementsurgery.Material and methods. In this multi-national, double-blind, double-dummystudy, patients were randomized tosemuloparin 20 mg once-daily orenoxaparin 30 mg twice-daily for 7-10days after surgery. Bilateral ascendingcontrast venography was performedbetween day 7 and 11. SymptomaticVTE and death were recorded.Results: of 1150 patients randomized,

855 patients (74.3%) were evaluablefor the primary efficacy analysis. Theoccurrence of the primary efficacyendpoint of any VTE or all-causedeath was lower in the semuloparingroup compared to the enoxaparingroup, but the difference did not reachstatistical significance, the odds ratiowas 0.83, 95% confidence interval[CI] 0.60-1.14. Major bleeding rateswere similar in the 2 treatment groupswhile the rates of non-major bleedingand all clinically-relevant bleedingwere slightly higher in the semu-loparin group compared with those inthe enoxaparin group. No case ofdrug-induced liver injury was identi-fied. Thrombocytopenia rates weresimilar in the 2 groups.Overall, these results suggest thatsemuloparin 20 mg once-daily andenoxaparin 30 mg twice-daily exhibitsimilar efficacy and safety profiles inVTE prevention after elective kneereplacement surgery.

In the photo:Giancarlo Agnelli

Preventive drugs in orthopedic surgeryThe semuloparin for prevention

of venous thromboembolismemployed after elective

knee replacement surgery

Recent meta-analyses and randomized trials have put intoquestion the role of aspirin for primary prevention of ma-jor cardiovascular events, suggesting that the benefit maybe lower than previously hypothesized. Giovanni Tognoniwill present today the study “Ongoing trials on aspirin forprimary prevention: will they deliver?”.Given the persisting uncertainties regarding the role of as-pirin, ongoing trials are of utmost importance to clarify itsriskbenefit profile, particularly among individuals at mod-erate risk of cardiovascular events. In the absence of con-clusive evidence, existing data have been interpreted bymajor scientific societies with a high level of inconsistency.Guidelines on the use of aspirin in individuals with dia-betes are a clear example in this sense: while antiplatelettherapy is still recommended for the vast majority of indi-viduals by some key guideline agencies, it is not recom-mended at all by others. Delivering positive or negativerecommendations, rather than acknowledging the exis-tence of a genuine uncertainty, can represent a majorthreat to the enrollment of patients in ongoing trials, asdocumented by the slow rate of accrual in some studies.The societies who have so beautifully documented that weare facing a perfect case of uncertainty would greatly con-tribute to the credibility of the scientific methods in guidingpractice if they would agree on a joint, sobering statementrecommending that all diabetic patients with no history ofCV disease should be considered (except those with docu-mented contraindications, or perceived indications) ascandidates for randomized clinical trials.

Aspirin for primary prevention A still open debate

2 3

Simposia, lectures and oral communication. Every daymany simultaneous sessions in the numerous halls ofthe Marriott Hotel, all featured by a particular, as wellas flattering, peculiarity: they have all begun on timeand ended by the established terms. Of course the participants have their merit but the

organizing secretary ARSeducandi has played thelion’s share above all.The whole staff has showed courtesy and profession-ality and even Prof. Mannuccio Mannucci stopped fora cheese with the secretary members at the end of anexacting day.

A “cheese” to farewell the 21st Congress

The oral communications programmeschedules, this morning, the session“New Anticoagulants 2”, in whichGiancarlo Agnelli, who’s also chair-man, presents “The ultra-low-molecu-lar-weight heparin (ULMWH) semu-loparin for prevention of venousthromboembolism (VTE) after elec-tive knee replacement surgery”. Thework is signed by M. R. Lassen, W.Fisher, D. George, A. Kakkar, P.Mismetti, P. Mouret, F. Lawson, A.G. G. Turpie, together with Agnelli. Semuloparin is a new ULMWHunder development for prevention ofVTE in patients with cancer, and alsoin patients undergoing major abdomi-nal or orthopaedic surgery. This studyaimed to compare the efficacy andsafety of semuloparin versus enoxa-

parin after elective knee replacementsurgery.Material and methods. In this multi-national, double-blind, double-dummystudy, patients were randomized tosemuloparin 20 mg once-daily orenoxaparin 30 mg twice-daily for 7-10days after surgery. Bilateral ascendingcontrast venography was performedbetween day 7 and 11. SymptomaticVTE and death were recorded.Results: of 1150 patients randomized,

855 patients (74.3%) were evaluablefor the primary efficacy analysis. Theoccurrence of the primary efficacyendpoint of any VTE or all-causedeath was lower in the semuloparingroup compared to the enoxaparingroup, but the difference did not reachstatistical significance, the odds ratiowas 0.83, 95% confidence interval[CI] 0.60-1.14. Major bleeding rateswere similar in the 2 treatment groupswhile the rates of non-major bleedingand all clinically-relevant bleedingwere slightly higher in the semu-loparin group compared with those inthe enoxaparin group. No case ofdrug-induced liver injury was identi-fied. Thrombocytopenia rates weresimilar in the 2 groups.Overall, these results suggest thatsemuloparin 20 mg once-daily andenoxaparin 30 mg twice-daily exhibitsimilar efficacy and safety profiles inVTE prevention after elective kneereplacement surgery.

In the photo:Giancarlo Agnelli

Preventive drugs in orthopedic surgeryThe semuloparin for prevention

of venous thromboembolismemployed after elective

knee replacement surgery

Recent meta-analyses and randomized trials have put intoquestion the role of aspirin for primary prevention of ma-jor cardiovascular events, suggesting that the benefit maybe lower than previously hypothesized. Giovanni Tognoniwill present today the study “Ongoing trials on aspirin forprimary prevention: will they deliver?”.Given the persisting uncertainties regarding the role of as-pirin, ongoing trials are of utmost importance to clarify itsriskbenefit profile, particularly among individuals at mod-erate risk of cardiovascular events. In the absence of con-clusive evidence, existing data have been interpreted bymajor scientific societies with a high level of inconsistency.Guidelines on the use of aspirin in individuals with dia-betes are a clear example in this sense: while antiplatelettherapy is still recommended for the vast majority of indi-viduals by some key guideline agencies, it is not recom-mended at all by others. Delivering positive or negativerecommendations, rather than acknowledging the exis-tence of a genuine uncertainty, can represent a majorthreat to the enrollment of patients in ongoing trials, asdocumented by the slow rate of accrual in some studies.The societies who have so beautifully documented that weare facing a perfect case of uncertainty would greatly con-tribute to the credibility of the scientific methods in guidingpractice if they would agree on a joint, sobering statementrecommending that all diabetic patients with no history ofCV disease should be considered (except those with docu-mented contraindications, or perceived indications) ascandidates for randomized clinical trials.

Aspirin for primary prevention A still open debate

4

CONGRESS DAILYThrombosis 2010

Milan, July 9th

realized with the contribution of

The scientific handing over has been tak-en by Jacqueline Conard, who will chairthe 22nd Congress scheduled on October6-9, 2012 in Nice, France. “We have cho-sen a very good, charming and easy toreach venue which boasts a great aca-demic tradition and an excellent congressreceptivity”, states Conard. Focus of the scientific programme of thenext Congress will be the new anticoagu-lant drugs again, which will be providedwith more literature on the first applica-tive phase in two years. “Apart from thiswide theme - Canard explains - we willprovide attention to woman's wealthwho, due to pregnancy, contraceptivesand vitro fecondation is at thromboticrisk. Furthermore, another importanttheme will be represented by biomarkersconcerning the specific thrombotic risk”.Young investigators’ generations and stu-dents will have the chance to attend spe-cific congress sessions as well. The Spanish experts Monreal, Vicente,Badimon e Paramo and the secretary ofthe League Maria Teresa Santos were inMilan as well: actually the Iberian coun-try will be the organizer of the Congressin 2014. In four years the impact on ther-apeutic aspects is expected to be relevant

- Vicente Vicente explains: “There willbe a consolidation with registration of thenew drugs, with more experiences and

new directions (infarction and acutecoronary syndromes, stroke and rarethrombosis). The new oral anticoagulantwhich will enter the market in two orthree years will provide experienced da-ta, together with the results of actual ap-plication, dosing, need of monitoring, sideeffects and check”.

The coffee? It would enable the reduc-tion of venous thrombosis as well as amoderate consumption of wine would.Chocolate increases the anti-plateletproperty of aspirin, fish is important inthe reduction of thrombotic diseases ingeneral. Over the years numer-ous studies have shownthat the Mediterraneandiet reduces cardiovas-cular risk. As it is wellknown, the Medite-rranean diet entails eat-ing fresh food such asvegetables and fruits inseason, grains, fish,especially oily fish, oliveoil, especially extra vir-gin olive oil, drinkingwine in moderation, andreining in meat and ani-mal fats. The resultsfrom the latest meta-analyses presented atthe 21st InternationalThrombosis Congressconfirmed past findingsand revealed new bene-fits of a healthy diet interms of protectionagainst thrombotic dis-eases.“There is evidence thatseveral coagulation fac-tors are influenced bydiet - said Mannucci - Ithas been proven thanomega-3 (n-3) polyunsat-urated fatty acids (PUFA) have bene-ficial effects on platelet function.Although there is not yet direct evi-dence of the benefits of monounsatu-rated fatty acids (MUFA) on coagula-tion, the vast majority of studies onthrombotic diseases suggest that the

Mediterranean diet may reduce therisk of thrombosis”.The Mediterranean diet is healthyaltogether. It helps maintain a bal-anced metabolic function and henceprevent overweight and obesity. Most

importantly, numerousfoods in the Mediter-ranean diet are rich invitamins and antioxi-dants which counteractthe action of free radi-cals that, when inexcess, damage cellularmembranes and DNAby altering cellularfunction and gene infor-mation. Further con-sensus for wine, con-sumed in moderateamounts (no more than2 glasses a day). Unlikespirits, wine is thoughtto protect againstvenous thrombosis as itreduces the levels of fib-rinogen and factor VIIcurrently considered tobe markers of cardio-vascular risk.Specialists also con-firmed that fish protectsagainst thrombotic dis-eases, although a recentTromsø Universitystudy in Norway sug-gested that the reduc-tion in thrombotic

events associated witheating fish regularly may be greater inwomen than in men.Finally, five or sixsmall cups of coffee a day may reducethe risk of venous thrombosis by 35%,while chocolate plays a significant rolein enhancing the antiplatelet effects ofaspirin.

The 22nd edition will be heldin Nice, France, 6-9 October

at the Acropolis Congress Centre

New anticoagulants, woman’s healthand bio-markers in the agenda of 2012

Diet and thrombotic diseases: coffee,chocolate&wine helpful in prevention

CONGRESS DAILY is a special edition of NTR - Notiziario in Tempo Reale by e.press® srl - registration Trib. NA no. 4560Editor and Director Enrico Sbandi Professional journalist Claudio Ravel - Translation Giovanna Basilio - direct printing at Marriot Hotel, Milan

Exclusive distributor for medical and health sector: VALUE RELATIONS INTERNATIONAL srl, via G. B. Morgagni, 30 - 20129 Milan, Italy

"We hand over highly interesting andconstantly developing themes toFrance and Spain, two great Mediter-ranean Countries which will be en-charged toorganize thetwo next edi-tions of theCongress”.With thesewords PierMannuccioMannucci,President ofthe 21st In-ternationalCongress onThrombosis of the MediterraneanLeague Against ThromboembolicDiseases, comments satisfied the de-velopment of the Milanese edition ofthe congress among the most renownworldwide sectional experts.Figures are excellent, more than1,200 participant and high is the qual-ity of the 736 presented works, as re-ported in this newsletter yesterday.These are results which qualify theorganization of this congress whosemerit is that of having focused its top-ics on the great chances supplied bythe new molecules. Actually, Milan2010 has inhaugurated “a new era inantithrombotics”, as stated by thecongress claim.

Arrivederciin Nice 2012

Jacqueline Conard, President of the 22nd International Congress on Thrombo-sis that will be held on 6-9 October 2012 in Nice, France.

further in page 4In the photo: Pier Mannuccio

Mannucci, President of 21st Congress

“The long-term risk of cancer in patientswith venous thromboembolism” is thetheme of the work tha will be presentedthis morning by Paolo Prandoni.Venous thromboembolism (VTE) is awell known marker of occult malignan-cy. Indeed, during the initial six monthsfollowing a thrombotic episode a newcancer is diagnosed in up to 10% of pa-tients, especially in those with idiopathicVTE. While it would be of interest toknow whether this increased risk forcancer persists over the long-term, be-yond this initial 6-month period, availableinformation is controversial.To determine whether and to what ex-tent the long-term risk of cancer exceedsthat expected in the general population,we assessed the risk of subsequent overt

malignancy in 1,495 patients who re-mained cancer free during the initial sixmonths after the thrombotic episode, andin 1,495 age- and sex-matched controlsubjects derived from the general popula-

tion of three regions in northern Italy.For both studies patients and controlsthe mean age was 60.0 ± 16.8 years, and46% were males. In 825 (55%) patientswith VTE, the episode was consideredidiopathic. All patients and controls had

follow-up for 30 months, which began atthe 6-month point after VTE. Results:during the 30-month follow-up period,new objectively-confirmed cancer devel-oped in 48 patients with VTE and in 43control subjects, resulting in a cumula-tive incidence of 3.2% (95% CI, 2.3 to4.4) and 2.9% (95% CI, 2.0 to 4.0), re-spectively. The HR for new cancer in pa-tients with VTE as compared to controlswas 1.09 (95% CI, 0.59 - 1.34). When theanalysis was confined to the 825 patientswith idiopathic VTE and their controls,the HR for cancer was 1.12 (95% CI,0.61 - 1.36).The conclusion, according to the wordsof Prandoni, are that in patients with afirst VTE, including those with idiopa-thic thrombosis, the risk for subsequentcancer beyond the initial six months doesnot appear to exceed that expected in thegeneral population.

In the photo:Paolo Prandoni

Patients with VTE: no long term risk of cancer Beyond the initial six monthsdoes not appear to exceed that

expected in the general population