Projected inhibition of platelet aggregation with ticagrelor twice daily vs. clopidogrel once daily based on patient adherence data (the TWICE project)
Vrijens, Bernard ; ; LEGRAND, Victor et al
in British Journal of Clinical Pharmacology (2014), 77(5), 746-755
Abstract Aim Twice daily dosing is often perceived as inferior to once daily dosing due to a higher likelihood of missing a dose. However, more important is the extent to which drug action is maintained ... [more ▼]
Abstract Aim Twice daily dosing is often perceived as inferior to once daily dosing due to a higher likelihood of missing a dose. However, more important is the extent to which drug action is maintained when doses are delayed or missed. We compared the estimated inhibition of platelet aggregation (eIPA) for ticagrelor twice daily and clopidogrel once daily, based on their pharmacokinetic/ pharmacodynamic relationships and patient dosing history data. Methods Drug dosing histories of 5014 patients prescribed cardiovascular medications (primarily antihypertensive medicines) were extracted from an electronically compiled dosing history database. eIPA levels were simulated for 677 twice daily and 677 once daily dosing histories over a 30 day period, based on published onset/offset models for ticagrelor and clopidogrel IPA characteristics. Results While many patients treated twice daily missed at least one dose in 30 days, only 25.7% missed two consecutive doses. By comparison, 46.8% of patients treated once daily missed at least one dose. Simulations based on patient adherence over time showed that the average mean eIPA for ticagrelor twice daily remained significantly higher than for clopidogrel once daily (81.1% vs. 55.0%, P < 0.001). Ticagrelor twice daily patients had an eIPA below 10% for 0.20% of the 30 day period compared with 2.05% for clopidogrel once daily (P = 0.0001). Conclusions The projected level of platelet inhibition remained higher for ticagrelor twice daily than clopidogrel once daily, mainly due to the higher eIPA level achieved with ticagrelor and the relatively low likelihood of missing two consecutive twice daily doses. This modelling and simulation study suggests a therapeutic benefit of ticagrelor over clopidogrel when taking into account the most common dosing omissions. © 2013 The British Pharmacological Society. [less ▲]Detailed reference viewed: 13 (1 ULg)
Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study
; ; et al
in European Heart Journal (2014)
Aim Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following ... [more ▼]
Aim Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre ‘real-world’ patient population in highly experienced centres. Methods and results Patients with severe aortic stenosis at a higher surgical risk inwhomimplantation of theCoreValve Systemwas decided by the Heart Teamwere included. Endpointswere a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint- related eventswere independently adjudicated based on Valve AcademicResearch Consortiumdefinitions.Atotal of 1015 patients [mean logistic EuroSCORE 19.4+12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81+6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, theMACCErate was 8.0% (95% CI: 6.3–9.7%), all-cause mortalitywas 4.5% (3.2–5.8%), cardiovascular mortality was 3.4% (2.3–4.6%), and the rate of stroke was 3.0% (2.0–4.1%). The lifethreatening or disabling bleeding rate was 4.0% (2.8–6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4–24.1%), 17.9% (15.2–20.5%), 11.7% (9.4–14.1%), and 4.5% (2.9–6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic Euro- SCORE ≤10%, EuroSCORE 10–20%, and EuroSCORE .20% (P , 0.05), respectively. Conclusion The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis. [less ▲]Detailed reference viewed: 4 (0 ULg)
; ; et al
in JACC. Cardiovascular Interventions (2014)Detailed reference viewed: 9 (2 ULg)
High Prevalence of Abdominal Aortic Aneurysm in Patients with Three-vessel Coronary Artery Disease.
; VAN DAMME, Hendrik ; et al
in European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery (2014)
OBJECTIVES: Currently, the prevalence of abdominal aortic aneurysm (AAA) in patients with coronary artery disease (CAD) and the correlation between CAD severity and AAA prevalence are not clearly known ... [more ▼]
OBJECTIVES: Currently, the prevalence of abdominal aortic aneurysm (AAA) in patients with coronary artery disease (CAD) and the correlation between CAD severity and AAA prevalence are not clearly known. We conducted a prospective study to determine the prevalence of AAA in patients undergoing coronary angiography and to determine the risk factors and a coronary profile associated with AAA. METHODS: Over an 18-month period, abdominal aortic ultrasound was performed on 1,000 patients undergoing coronary angiography for suspected or known CAD, or prior to valve surgery. Clinical characteristics and coronary profile were collected from the patients. RESULTS: The overall number of previously repaired, already diagnosed, and new cases of AAA in the study population was 42, yielding a prevalence of 4.2%. Among the patients with newly detected AAAs, only two had an AAA diameter of >54 mm and were therefore treated surgically. In men aged >/=65 years, the prevalence reached 8.6%, while in men with three-vessel CAD it was 14.4%. Multivariate analysis showed that age >/=65 years (p = .003), male gender (p = .003), family history of AAA (p = .01), current smoking (p = .002), and three-vessel CAD (p < .001) were significantly associated with a higher prevalence of AAA. CONCLUSION: The prevalence of AAA was high in men aged >/=65 years and in those with three-vessel CAD regardless of age. While our findings do not prove the cost-effectiveness of screening for AAA in these high risk patients, they do support the usefulness of a quick ultrasound examination of the abdominal aorta during routine transthoracic echocardiography in such patients. [less ▲]Detailed reference viewed: 17 (7 ULg)
New Insights Into Aortic Diseases A Report From the Third International Meeting on Aortic Diseases (IMAD3)
; SAKALIHASAN, Natzi ; et al
in AORTA (2013), 1Detailed reference viewed: 25 (4 ULg)
Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry.
; ; et al
in International journal of cardiology (2013), 168(3), 2522-7
BACKGROUND: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. METHODS: A total of 7651 patients were selected among 15,147 ... [more ▼]
BACKGROUND: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. METHODS: A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. RESULTS: The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 +/- 9.9 vs.62.9 +/- 10.7, P<0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P<0.04 and P<0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p=0.4). CONCLUSIONS: Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB. [less ▲]Detailed reference viewed: 5 (0 ULg)
One-year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-SELECT registry.
; ; et al
in Journal of interventional cardiology (2013), 26(2), 163-72
OBJECTIVES: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the ... [more ▼]
OBJECTIVES: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the international e-SELECT registry. BACKGROUND: Large-scale registry data are lacking on DES outcomes in SmVD treatment. METHODS: There were 4,700 SmVD (at least one vessel with estimated reference vessel diameter [RVD] < 2.5 mm, excluding 283 patients with unknown RVD vessels) and 10,139 NSmVD only patients. RESULTS: The SmVD population was older, with more women, diabetics, and vessels treated, higher mean Charlson Comorbidity Index score (CCI), shorter lesions, and less STEMI presentation. The 1-year stent thrombosis (ST) rate (primary end-point), was significantly higher (1.3% vs. 0.7%) in SmVD versus NSmVD, mainly driven by early events. One-year major adverse cardiac event (MACE), myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) rates were significantly higher in SmVD although death and major bleeding rates were similar in both groups. Complication rates were similar between pure (3,188 patients; only RVD < 2.5 mm) and mixed (1,795 patients; some RVD < 2.5 mm or unknown RVD) SmVD. Multivariate predictors for 1-year MACE in SmVD included saphenous vein graft or bifurcation lesions, major bleeding, any antiplatelet therapy discontinuation within 1 month, age, number of stents implanted, CCI, acute coronary syndrome, and insulin-dependent diabetes mellitus. CONCLUSION: SES implantation for SmVD occurs more frequently in women, diabetics, and those with multivessel disease and comorbidities. One-year ST, MACE, MI, and clinically indicated TLR rates are higher, although low overall, in SmVD or mixed SmVD patients while death rates are similar to NSmVD. [less ▲]Detailed reference viewed: 6 (0 ULg)
Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics.
; ; et al
in Journal of the American College of Cardiology (2013), 61(23), 2329-38
OBJECTIVES: This study sought to evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in ... [more ▼]
OBJECTIVES: This study sought to evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in patients with chronic heart failure. BACKGROUND: In pre-clinical heart failure models, cardiopoietic stem cell therapy improves left ventricular function and blunts pathological remodeling. METHODS: The C-CURE (Cardiopoietic stem Cell therapy in heart failURE) trial, a prospective, multicenter, randomized trial, was conducted in patients with heart failure of ischemic origin who received standard of care or standard of care plus lineage-specified stem cells. In the cell therapy arm, bone marrow was harvested and isolated mesenchymal stem cells were exposed to a cardiogenic cocktail. Derived cardiopoietic stem cells, meeting release criteria under Good Manufacturing Practice, were delivered by endomyocardial injections guided by left ventricular electromechanical mapping. Data acquisition and analysis were performed in blinded fashion. The primary endpoint was feasibility/safety at 2-year follow-up. Secondary endpoints included cardiac structure/function and measures of global clinical performance 6 months post-therapy. RESULTS: Mesenchymal stem cell cocktail-based priming was achieved for each patient with the dose attained in 75% and delivery without complications in 100% of cases. There was no evidence of increased cardiac or systemic toxicity induced by cardiopoietic cell therapy. Left ventricular ejection fraction was improved by cell therapy (from 27.5 +/- 1.0% to 34.5 +/- 1.1%) versus standard of care alone (from 27.8 +/- 2.0% to 28.0 +/- 1.8%, p < 0.0001) and was associated with a reduction in left ventricular end-systolic volume (-24.8 +/- 3.0 ml vs. -8.8 +/- 3.9 ml, p < 0.001). Cell therapy also improved the 6-min walk distance (+62 +/- 18 m vs. -15 +/- 20 m, p < 0.01) and provided a superior composite clinical score encompassing cardiac parameters in tandem with New York Heart Association functional class, quality of life, physical performance, hospitalization, and event-free survival. CONCLUSIONS: The C-CURE trial implements the paradigm of lineage guidance in cell therapy. Cardiopoietic stem cell therapy was found feasible and safe with signs of benefit in chronic heart failure, meriting definitive clinical evaluation. (C-Cure Clinical Trial; NCT00810238). [less ▲]Detailed reference viewed: 7 (0 ULg)
Reply: The C-CURE Randomized Clinical Trial (Cardiopoietic stem Cell therapy in heart failURE).
; ; et al
in Journal of the American College of Cardiology (2013), 62(25), 2454-6Detailed reference viewed: 5 (0 ULg)
Identification of protein biomarkers associated with cardiac ischemia by a proteomic approach.
Fillet, Marianne ; Deroyer, Céline ; et al
in Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals (2013), 18(7), 614-24
Angina is chest pain induced by ischemia of the heart muscle, generally due to obstruction or spasm of the coronary arteries. People that suffer from average to severe cases of angina have an increased ... [more ▼]
Angina is chest pain induced by ischemia of the heart muscle, generally due to obstruction or spasm of the coronary arteries. People that suffer from average to severe cases of angina have an increased percentage of death before the age of 55, usually around 60%. Therefore, prevention of major complications, optimizing diagnosis, prognosis and therapeutics are of primary importance. The main objective of this study was to uncover biomarkers by comparing serum protein profiles of patients suffering from stable or unstable angina and controls. We identified by non-targeted proteomic approach and confirmed by the means of independent techniques, the differential expression of several proteins indicating significantly increased vascular inflammation response, disturbance in the lipid metabolism and in atherogenic plaques stability. [less ▲]Detailed reference viewed: 15 (4 ULg)
L'imagerie cardiovasculaire multimodalites avant l'implantation d'une prothese valvulaire aortique par voie percutanee.
DAVIN, Laurent ; BRUYERE, Pierre-Julien ; LANCELLOTTI, Patrizio et al
in Revue Médicale de Liège (2013), 68(2), 86-93
Calcified aortic valve stenosis is the most frequent valvular heart disease in developed countries with a very poor outcome when symptoms develop. However, several of these patients are denied for surgery ... [more ▼]
Calcified aortic valve stenosis is the most frequent valvular heart disease in developed countries with a very poor outcome when symptoms develop. However, several of these patients are denied for surgery. The main reasons are their advanced age (elderly patient), co-morbidities, technical limitations and a very high surgical risk. It is currently possible to propose a Transcatheter Aortic Valve Implantation (TAVI). After selection of candidates, the feasibility of the intervention is analysed. The size of the aortic bioprosthesis must be selected according to the cardiac anatomy. Several cardiac imaging modalities (echocardiography, computed tomography and cardiac MRI) can be used to identify unsuitable situations. Heavy calcifications or tortuosity can thwart the retrograde approach use. The sub-clavian arteries (for the CoreValve) and trans-apical approach (for the Edwards-Sapien) constitute alternatives ways. [less ▲]Detailed reference viewed: 43 (8 ULg)
Subacute Transcatheter CoreValve Thrombotic Obstruction.
LANCELLOTTI, Patrizio ; Radermecker, Marc ; et al
in Circulation: Cardiovascular Interventions (2013), 6(3), 32-3Detailed reference viewed: 20 (2 ULg)
Nursing Care Plan for Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving® system
ERPICUM, Marie ; Defraigne, Jean-Olivier ; LARBUISSON, Robert et al
Report (2012)Detailed reference viewed: 34 (6 ULg)
One-year clinical outcomes after sirolimus-eluting coronary stent implantation for acute myocardial infarction in the worldwide e-SELECT registry.
; ; et al
in Journal of interventional cardiology (2012), 25(3), 253-61
BACKGROUND: The aim was to ascertain the 1-year clinical outcomes of 1,234 patients who underwent implantations of sirolimus-eluting stents (SES) for acute myocardial infarction (MI) in the multinational ... [more ▼]
BACKGROUND: The aim was to ascertain the 1-year clinical outcomes of 1,234 patients who underwent implantations of sirolimus-eluting stents (SES) for acute myocardial infarction (MI) in the multinational e-SELECT registry. METHODS: Fifteen thousand and one hundred and forty-seven patients treated with SES were entered in the e-SELECT registry, of whom 1,234 presented within <24 hours of onset of acute MI. RESULTS: At 1 year, the rates of major adverse cardiac events (MACE) (5.5% vs. 4.8%; P = 0.28) were similarly low in the acute and no acute MI groups. The rates of definite/probable stent thrombosis (ST) were higher in the acute MI group (2.1%vs; 0.88%, P < 0.001). ST was a strong independent predictor of death at 1 year (HR 13.4; 95% CI 5.0, 36.0; P < 0.001) and MI (HR 58.9; 95% CI 26.9, 129.1; P < 0.001). Dual antiplatelet therapy (DAPT) compliance at 6 months was 96.0% in the acute MI versus 94.5% in the no acute MI group (P = 0.03). CONCLUSION: In selected patients presenting within <24 hours of acute MI onset and highly compliant with DAPT, SES implantation was associated with similar rates of MACE, though higher rates of ST, as compared to no acute MI patients. [less ▲]Detailed reference viewed: 9 (1 ULg)
Endovascular repair of the left subclavian artery after gunshot wound: an alternative to surgical treatment.
; ; et al
in Acta cardiologica (2012), 67(5), 609-12
Penetrating injuries of the subclavian artery are associated with a high morbidity and mortality rate. Endovascular treatment with covered stents (stent grafts) has emerged as an effective alternative to ... [more ▼]
Penetrating injuries of the subclavian artery are associated with a high morbidity and mortality rate. Endovascular treatment with covered stents (stent grafts) has emerged as an effective alternative to surgery, but this new technique is not exempt from complications. We report the case of a male gunshot victim, treated by a covered stent for haemorrhagic shock due to partial subclavian rupture. [less ▲]Detailed reference viewed: 6 (0 ULg)
The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.
; ; et al
in JACC. Cardiovascular Interventions (2012), 5(1), 64-71
OBJECTIVES: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the ... [more ▼]
OBJECTIVES: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. BACKGROUND: There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. METHODS: The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. RESULTS: Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). CONCLUSIONS: Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. [less ▲]Detailed reference viewed: 9 (0 ULg)
Management of patent foramen ovale in cryptogenic stroke.
; Legrand, Victor ; et al
in Acta cardiologica (2012), 67(1), 3-9
There is currently no consensus on the optimal management of cryptogenic stroke in the presence of a patent foramen ovale (PFO). Some physicians do not believe in the added value of PFO closure in ... [more ▼]
There is currently no consensus on the optimal management of cryptogenic stroke in the presence of a patent foramen ovale (PFO). Some physicians do not believe in the added value of PFO closure in cryptogenic stroke, whereas, for others, cryptogenic stroke represents a situation where PFO closure would be the best management. Because of a lack of well-designed randomized trials, guidelines do not provide a clear answer. Therefore, the cardiological and neurovascular societies in Belgium decided to write an attempt at an expert opinion paper. [less ▲]Detailed reference viewed: 7 (0 ULg)
Une entite electrocardiographique peu connue, mais pourtant importante aux urgences ... le syndrome de Wellens.
; ; Legrand, Victor
in Revue medicale de Liege (2012), 67(10), 527-30
We report the case of a 54-year-old patient admitted to an emergency department, because of a thoracic pain suspicious for angina pectoris. Although the patient had become asymptomatic on admission, his ... [more ▼]
We report the case of a 54-year-old patient admitted to an emergency department, because of a thoracic pain suspicious for angina pectoris. Although the patient had become asymptomatic on admission, his electrocardiogram presented abnormalities (biphasic T waves in V1 to V4 ) which prompted a diagnosis of unstable angina.This electrocardiophic pattern is known as Wellens' syndrome. [less ▲]Detailed reference viewed: 8 (1 ULg)
Nursing care after Transcatheter Aortic Valve Implantation with the Medtronic CoreValve Revalving® system
ERPICUM, Marie ; RADERMECKER, Marc ; DEFRAIGNE, Jean et al
Poster (2011, April 02)
The risks, complications and results of the transcatheter aortic valve implantation (TAVI) are widely described. But to our knowledge, no one has yet defined the nursing cares required after this ... [more ▼]
The risks, complications and results of the transcatheter aortic valve implantation (TAVI) are widely described. But to our knowledge, no one has yet defined the nursing cares required after this procedure and their effects on the TAVI results. The aims of this review are to describe the nursing cares required after TAVI and to determine which aspects of the management could be optimized to improve the results of the procedure. [less ▲]Detailed reference viewed: 177 (10 ULg)
Final results of a phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: the SEISMIC trial.
; ; et al
in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (2011), 6(7), 805-12
AIMS: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter ... [more ▼]
AIMS: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter-defibrillators (ICD). METHODS AND RESULTS: Patients were randomised 2:1 to autologous skeletal myoblast therapy vs. optimal medical treatment. The primary safety end-point was defined as the incidence of procedural and device related serious adverse events, whereas the efficacy endpoints were defined as the change in global LVEF by MUGA scan, change in NYHA classification of heart failure and in the distance achieved during a six-minute walk test (6MW) at 6-month follow-up. Forty subjects were randomised to the treatment arm (n=26), or to the control arm (n=14). There were 12 sustained arrhythmic events and one death after episodes of ventricular tachycardia (VT) in the treatment group and 14 events in the control group (P=ns). At 6-month follow-up, 6MW distance improved by 60.3+/-54.1?meters in the treated group as compared to no improvement in the control group (0.4+/-185.7?meters; P=ns). In the control group, 28.6% experienced worsening of heart failure status (4/14), while 14.3% experienced an improvement in NYHA classification (2/14). In the myoblast-treatment arm, one patient experienced a deterioration in NYHA classification (8.0%), whereas five patients improved one or two classes (20.0%; P=0.06). However, therapy did not improve global LVEF measured by MUGA at 6-month follow-up. CONCLUSIONS: These data indicate that implantation of myoblasts in patients with HF is feasible, appears to be safe and may provide symptomatic relief, though no significant effect was detected on global LVEF. [less ▲]Detailed reference viewed: 4 (0 ULg)