HOT UNE
Hot line 11
Stockholm, 5 September 2005
Five important studies were presented in the second hot line session, which was chaired by C.W. Hamm (Bad Nauheim, Germany) and RJ.C. Hall (Norwich, UK). The first speaker, M. Brignoke (Lavagna, Italy), presented the ISSUE II (The International Study of Syncope of Uncertain Etiology) study. The implantable loop recorder allows a mechanism-based effective therapy in patients with recurrent suspected or certain neurally mediated syncope. This study was made possible by a grant from Medtronic Inc. An implantable loop recorder was used to determine the most appropriate treatment for patients suffering from syncope. Patients with significant electrocardiographic or cardiac abnormalities, as well as patients with orthostatic hypotension and carotid sinus syndrome were excluded. In 422 patients with three or more episodes of syncope within two years, a loop recorder was implanted. In 103 patients the type of syncope was documented, of which 47 had pacemakers implanted and six underwent antiarrhythmic therapy. Fifty patients were left untreated. The burden of syncope decreased from 0.83 episodes to 0.07 per treated patient per year. The discussant J.J. Blanc (Brest, France) pointed out that you would need to implant 700 loop recorders and 100 pacemakers to avoid 28 episodes of syncope. In conclusion, the implantable loop recorder is a valuable diagnostic tool in patients with syncope. However, large numbers ofrecorders were required per successful treatment.
W.H. van Gilst (Groningen, the Netherlands) presented the IMAGINE (Ischaemic Management with Accupril Post Bypass Graft via Inhibition of the Converting Enzyme) trial. The trial was set up to test whether ACE inhibition therapy with accupril instituted early after coronary arterial bypass grafting (CABG) had beneficial cardiovascular effects. In the IMAGINE B. Hooft van Huysduynen Leiden University Medical Center, Leiden E-mail: [email protected]
6
study 2553 patients, who had undergone CABG in the previous seven days, were randomised to receive either quinapril (titrated up to maxinmally 40 mg/day) or placebo. The patients were at relatively low risk, as they had a left ventricular ejection fraction of at least 40%. Furthermore, all patients were on optimal therapy of 5-blockers, statins and aspirin and had no indication for the use ofACE inhibition according to guidelines. After 43 months no benefits were demonstrated for the quinapril-treated group regarding cardiovascular death,
resusctated cardiac arst; nonfatal myocial infirction,
coronary revascularisation, hospitalisation for unstable angina, documented angina, stroke or heart failure requiring hospitalisation. The side effects hypotension and cough were reported more often in the quinapril group. Lack ofpositive outcome was probably related to the very low risk ofthe study population. The discussant, M.E. Bertrand (Lille, France), stated that the conclusions from the previous HOPE (Heart Outcomes Prevention Evaluation) and EUROPA (European Trial on Reduction ofCardiac Events with Perindopril in Stable Coronary Artery Disease) studies, which showed excellent results for the use of ACE inhibitors in patients with stable coronary artery disease, remained undisputed. In conclusion, ACE inhibitors should not be given immediately after CABG. Next, S. Tusufand S.R. Mebta (Hamilton, Canada) discussed the efficacy and safety of fondaparinux compared with enoxaparin in 20,000 high-risk patients with ACS without ST elevation in the OASIS 5 (Organisation to Assess Strategies for Ischaemic Syndromes) Michelangelo programme. OASIS 5 was set up to determine the effectivity and safety of the new antithrombotic drug fondaparinux compared with the currently used enoxaparin in patients with acute coronary syndrome without ST elevation. Altogether, 20,000 patients with unstable angina or non-STsegment myocardial infarction were enrolled in 578 centres in 41 countries. Patients were randomised to either fondaparinux (2.5 mg subcutaneously daily) or enoxaparin (1 mg/kg subcutaneously twice daily). This study was supported by grants from Sanofi-Synthelabo, Organon, and Glaxo-Smith Kline. Duration oftherapy Netherlands Heart Journal, Volume 13, Supplement 2, Novanber 2005
fi
27th Congress of the European Society of Cardiology
was 5.2 days in the enoxaparin group and 5.4 days in the fondaparinux group. PCI was performed in 31% of patients. The primary endpoint of death, MI, or refractory ischaemia at day 9 occurred in 5.8% of the enoxaparin group and 5.9% of the fondaparinux group, showing that fondaparinux was non-inferior compared with enoxaparin. Major bleeding by day 9 was lower in the fondaparinux group (2.1 vs. 4.0%, HR 0.53, p
Hot line 11
Stockholm, 5 September 2005
Five important studies were presented in the second hot line session, which was chaired by C.W. Hamm (Bad Nauheim, Germany) and RJ.C. Hall (Norwich, UK). The first speaker, M. Brignoke (Lavagna, Italy), presented the ISSUE II (The International Study of Syncope of Uncertain Etiology) study. The implantable loop recorder allows a mechanism-based effective therapy in patients with recurrent suspected or certain neurally mediated syncope. This study was made possible by a grant from Medtronic Inc. An implantable loop recorder was used to determine the most appropriate treatment for patients suffering from syncope. Patients with significant electrocardiographic or cardiac abnormalities, as well as patients with orthostatic hypotension and carotid sinus syndrome were excluded. In 422 patients with three or more episodes of syncope within two years, a loop recorder was implanted. In 103 patients the type of syncope was documented, of which 47 had pacemakers implanted and six underwent antiarrhythmic therapy. Fifty patients were left untreated. The burden of syncope decreased from 0.83 episodes to 0.07 per treated patient per year. The discussant J.J. Blanc (Brest, France) pointed out that you would need to implant 700 loop recorders and 100 pacemakers to avoid 28 episodes of syncope. In conclusion, the implantable loop recorder is a valuable diagnostic tool in patients with syncope. However, large numbers ofrecorders were required per successful treatment.
W.H. van Gilst (Groningen, the Netherlands) presented the IMAGINE (Ischaemic Management with Accupril Post Bypass Graft via Inhibition of the Converting Enzyme) trial. The trial was set up to test whether ACE inhibition therapy with accupril instituted early after coronary arterial bypass grafting (CABG) had beneficial cardiovascular effects. In the IMAGINE B. Hooft van Huysduynen Leiden University Medical Center, Leiden E-mail: [email protected]
6
study 2553 patients, who had undergone CABG in the previous seven days, were randomised to receive either quinapril (titrated up to maxinmally 40 mg/day) or placebo. The patients were at relatively low risk, as they had a left ventricular ejection fraction of at least 40%. Furthermore, all patients were on optimal therapy of 5-blockers, statins and aspirin and had no indication for the use ofACE inhibition according to guidelines. After 43 months no benefits were demonstrated for the quinapril-treated group regarding cardiovascular death,
resusctated cardiac arst; nonfatal myocial infirction,
coronary revascularisation, hospitalisation for unstable angina, documented angina, stroke or heart failure requiring hospitalisation. The side effects hypotension and cough were reported more often in the quinapril group. Lack ofpositive outcome was probably related to the very low risk ofthe study population. The discussant, M.E. Bertrand (Lille, France), stated that the conclusions from the previous HOPE (Heart Outcomes Prevention Evaluation) and EUROPA (European Trial on Reduction ofCardiac Events with Perindopril in Stable Coronary Artery Disease) studies, which showed excellent results for the use of ACE inhibitors in patients with stable coronary artery disease, remained undisputed. In conclusion, ACE inhibitors should not be given immediately after CABG. Next, S. Tusufand S.R. Mebta (Hamilton, Canada) discussed the efficacy and safety of fondaparinux compared with enoxaparin in 20,000 high-risk patients with ACS without ST elevation in the OASIS 5 (Organisation to Assess Strategies for Ischaemic Syndromes) Michelangelo programme. OASIS 5 was set up to determine the effectivity and safety of the new antithrombotic drug fondaparinux compared with the currently used enoxaparin in patients with acute coronary syndrome without ST elevation. Altogether, 20,000 patients with unstable angina or non-STsegment myocardial infarction were enrolled in 578 centres in 41 countries. Patients were randomised to either fondaparinux (2.5 mg subcutaneously daily) or enoxaparin (1 mg/kg subcutaneously twice daily). This study was supported by grants from Sanofi-Synthelabo, Organon, and Glaxo-Smith Kline. Duration oftherapy Netherlands Heart Journal, Volume 13, Supplement 2, Novanber 2005
fi
27th Congress of the European Society of Cardiology
was 5.2 days in the enoxaparin group and 5.4 days in the fondaparinux group. PCI was performed in 31% of patients. The primary endpoint of death, MI, or refractory ischaemia at day 9 occurred in 5.8% of the enoxaparin group and 5.9% of the fondaparinux group, showing that fondaparinux was non-inferior compared with enoxaparin. Major bleeding by day 9 was lower in the fondaparinux group (2.1 vs. 4.0%, HR 0.53, p
