Diagnostic value of stress thallium-201/rest technetium-99m-sestamibi sequential dual isotope high-speed myocardial perfusion imaging for the detection of haemodynamically relevant coronary artery stenosis.

BACKGROUND: The aim of this study was to determine the diagnostic accuracy of stress thallium-201/rest technetium-99m-sestamibi sequential dual-isotope high-speed myocardial perfusion imaging (DI-HS-MPI) against invasively determined fractional flow reserve (FFR). METHODS: Fifty-four consecutive patients prospectively underwent DI-HS-MPI before invasive coronary angiography. Perfusion was scored visually by summed stress score on a patient and coronary territory basis. Significant coronary artery disease (CAD) was defined by the presence of ≥ 90% stenosis/occlusion or fractional flow reserve ≤ 0.80 for coronary stenosis ≥ 50%. RESULTS: FFR was measured in 69 of 162 coronary vessels, with 1.28 ± 0.56 vessels assessed/patient. Sensitivity, specificity, and diagnostic accuracy of MPI for the detection of significant CAD were 92.8%, 69.2%, and 81.4%, on a patient basis, and 83.7%, 90.4%, and 88.8% by coronary territory. CONCLUSIONS: DI-HS-MPI accurately detects functionally significant CAD as defined by using FFR.

SPECT myocardial ischemia in the absence of obstructive CAD: Contribution of the invasive assessment of microvascular dysfunction.

Coronary microvascular dysfunction has recently emerged as a major independent prognostic factor and can be invasively assessed by coronary flow reserve (CFR) and the index of microvascular resistance (IMR). The incremental prognostic value of myocardial ischemia from SPECT myocardial perfusion imaging (MPI) over clinical characteristics, cardiac risk factors, and stress test data for the prediction of hard cardiac events (myocardial infarction and cardiac death) has been well demonstrated over the last two decades regardless of the absence or presence of epicardial CAD. Recently developed semi-conductor, cardiac-dedicated cameras allow for decreased acquisition times and systematic procubitus and decubitus acquisitions thereby limiting the occurrence of false positives historically attributable to artefactual motion, attenuation, and digestive artifacts. It is therefore likely that pathophysiological causes rather than acquisition artifacts might underlie SPECT perfusion abnormalities. Here, we report four representative examples of patients presenting with ischemia in the setting of no obstructive CAD and normal fractional flow reserve together with elevated IMR and low CFR. The results indicate that ischemia from SPECT MPI could result from microvascular dysfunction in patients without obstructive CAD and should be considered as a prognostic factor for hard cardiac events.

Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography.

BACKGROUND: Recent advances in nuclear myocardial perfusion imaging (MPI) have made it possible to develop a dual-isotope protocol for high-speed acquisition with image quality and radiation delivery comparable to that obtained with conventional single isotope protocols. So far, no study has compared dual-isotope high-speed MPI to invasive coronary angiography (ICA) in a large cohort using a Cadmium-zinc-telluride SPECT system. METHODS: Over a 1-year period (May 2011 to April 2012), 1366 patients underwent dual-isotope high-speed MPI. Patients with ICA within 3 months after dual-isotope high-speed MPI were included together with patients with a low likelihood of coronary artery disease (CAD) in order to assess normalcy rate. Global summed stress score (SSS) and summed rest score (SRS) were calculated, and ICA results were analyzed independently. The main end point was a patient-based assessment of the diagnostic performance of dual-isotope high-speed MPI in detecting or ruling out significant CAD (>70% reduction in lumen diameter). RESULTS: Inclusion criteria were fulfilled for 214 patients (143 men; age 60 ± 14 years; ICA, n = 104; low likelihood for CAD, n = 110). An exercise stress test was performed in 62% of patients and a pharmacological stress test was performed with either dipyridamole (32%) or dobutamine (6%). Average examination duration was 22.4 ± 4.5 minutes. Mean SSS, SRS, and SDS were 8.0 ± 4.9, 3.1 ± 4.3, and 5.0 ± 3.2, respectively. Prevalence of angiographic CAD was 75%. ICA detected stenosis in the left main trunk, left anterior descending artery, left circumflex artery, and right coronary artery in 4, 33, 31, and 42 patients, respectively. Sensitivity of dual-isotope high-speed MPI was 94%, normalcy rate was 92%, and accuracy was 83% for detecting CAD. CONCLUSION: Dual-isotope high-speed MPI is reliable at detecting or ruling out CAD. NCT01785589.

Circulating levels of secretory- and lipoprotein-associated phospholipase A2 activities: relation to atherosclerotic plaques and future all-cause mortality.

AIMS: Secretory- and lipoprotein-associated phospholipases A2 (sPLA2 and Lp-PLA2) are enzymes both suggested to be of importance for atherosclerosis. We investigated relationships between the activities of these enzymes in the circulation and atherosclerosis as well as future clinical events. METHODS AND RESULTS: The population-based Prospective Investigation of the Vasculature in Uppsala Seniors (PIVUS) study included 1016 randomly selected subjects, all aged 70. The prevalence of carotid artery plaques was recorded by ultrasound (n= 954), and arterial stenosis was assessed by whole-body magnetic resonance angiography (WBMRA, n= 302). Secretory-associated phospholipase A2 [odds ratio 1.23 for 1 SD increase, 95% confidence interval (CI): 1.05-1.44, P= 0.007], but not Lp-PLA2 (P= 0.26), activity was significantly related to carotid atherosclerosis and to the amount of stenosis at WBMRA (P= 0.006) following adjustment for multiple risk factors (waist circumference, serum triglycerides, body mass index, C-reactive protein, high density lipoprotein-C, low density lipoprotein-C, triglycerides, GFR, fasting glucose, blood pressure, statin use, and exercise habits). Secretory-associated phospholipase A2 [hazard ratio (HR) 1.45 for 1 SD increase, 95% CI: 1.15-1.84, P= 0.001], but not Lp-PLA2 (HR 0.95, P= 0.55), activity was a significant risk factor for all-cause mortality (114 had died) during 7.0 years follow-up after adjustment for the risk factors described above. In a sample of 1029 post-myocardial infarction (MI) patients (French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction), sPLA2 (adjusted HR 1.32 for 1 unit increase, 95% CI: 1.02-1.71, P= 0.036), but not Lp-PLA2 (HR 1.03, P= 0.90), activity predicted death or recurrent MI during 1-year follow-up (n= 136 cases). CONCLUSION: sPLA2 activity was related to atherosclerosis and predicted all-cause mortality in a sample of elderly subjects, as well as death or MI in post-MI patients.

Cluster-randomized trial to evaluate the effects of a quality improvement program on management of non-ST-elevation acute coronary syndromes: The European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS).

BACKGROUND: Registries have shown that quality of care for acute coronary syndromes (ACS) often falls below the standards recommended in professional guidelines. Quality improvement (QI) is a strategy to improve standards of clinical care for patients, but the efficacy of QI for ACS has not been tested in randomized trials. METHODS: We undertook a prospective, cluster-randomized, multicenter, multinational study to evaluate the efficacy of a QI program for ACS. Participating centers collected data on consecutive admissions for non-ST-elevation ACS for 4 months before the QI intervention and 3 months after. Thirty-eight hospitals in France, Italy, Poland, Spain, and the United Kingdom were randomized to receive the QI program or not, 19 in each group. We measured 8 in-hospital quality indicators (risk stratification, coronary angiography, anticoagulation, ß-blockers, statins, angiotensin-converting enzyme inhibitors, and clopidogrel loading and maintenance) before and after the intervention and compared composite changes between the QI and non-QI groups. RESULTS: A total of 2604 patients were enrolled. The absolute overall change in use of quality indicators in the QI group was 8.5% compared with 0.8% in the non-QI group (odds ratio for achieving a quality indicator in QI versus non-QI 1.66, 95% CI 1.43-1.94; P < .001). The main changes were observed in the use of risk stratification and clopidogrel loading dose. CONCLUSIONS: The QI strategy resulted in a significant improvement in the quality indicators measured. This type of QI intervention can lead to useful changes in health care practice for ACS in a wide range of settings.

Drug-eluting stents in patients at high risk of restenosis: assessment for France.

BACKGROUND: In unselected patients, the incidence of restenosis is lower after placement of drug-eluting stents (DES) than bare-metal stents (BMS) without difference in safety at a time horizon of 4 years. However, DES appears less effective in "off label" patients. OBJECTIVES: The aim of the study was to assess available evidence of DES efficacy and safety by patient category to establish when DES placement may be recommended for reimbursement by the French national health insurance. METHODS: Based on a systematic review by patient category (January 2002 to August 2009), two health technology assessment (HTA) reports and thirty-eight clinical studies not covered by the HTA reports (eleven meta-analysis including ours, eleven randomized trials and sixteen cohort studies) were selected. After assessment of the methodological quality, the studies mostly comparing DES with BMS were reviewed by a panel of health professionals who defined a priori the most relevant end points of safety and efficacy. RESULTS: Seven to fourteen patients treated with DES were needed to avoid one target lesion revascularization (TLR) in patients with lesions >15 mm long, vessel diameter <3 mm, or diabetes, and with some complex lesions (total coronary occlusion, BMS in-stent restenosis multivessel disease, unprotected left main stenosis). DES appeared as safe as other alternatives over a follow-up of up to 4 years when dual antiplatelet therapy was continued for at least 1 year, but statistical power remains limited to conclude for some clinical features. CONCLUSIONS: For reimbursement, DES use should be limited to certain categories of patients. Treatment of particular cases requires a multidisciplinary approach.

Rationale for an early aldosterone blockade in acute myocardial infarction and design of the ALBATROSS trial.

BACKGROUND: Aldosterone is at its highest levels at presentation for acute myocardial infarction (AMI). High aldosterone levels are predictive of poor outcome regardless of heart failure. Angiotensin-converting enzyme inhibitors have delayed partial and temporary effects on aldosterone levels. We hypothesize that aldosterone receptor blockade, early after AMI onset on top of standard therapy, may improve clinical outcome. STUDY DESIGN: ALBATROSS is a nationwide, multicenter, open-labeled, randomized trial designed to assess the superiority of aldosterone blockade by a 200-mg intravenous bolus of potassium canrenoate followed by a daily 25-mg dose of spirinolactone for 6 months, on top of standard therapy compared to standard therapy alone among 1,600 patients admitted for ST-segment elevation or high risk non-ST-segment elevation acute AMI -TIMI score ≥3-within 72 hours after symptom onset regardless of heart failure and treatment strategy. The primary efficacy end point of the study is the 6-month rate of the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, class IA American College of Cardiology/American Heart Association/European Society of Cardiology indication for implantable cardioverter device, and new or worsening heart failure. Secondary end points include each of the components of the primary end point, different combinations of such components, the primary end point assessed at hospital discharge and 30-day follow-up, and rates of acute renal failure. Safety end points include rates of hyperkalemia and premature drug discontinuation. CONCLUSIONS: ALBATROSS will assess the cardiovascular benefit of a low-cost aldosterone receptor blocker on top of standard therapy in all-coming AMI patients.

Platelet hyperactivity during exercise leading to iterative coronary stent thrombosis: clinical implications.

Exercise may induce platelet activation in spite of using antiplatelet treatment. We present a case where the initial acute coronary syndrome and the iterative stent thrombosis always occurred after intense and prolonged physical effort. For this patient the at rest response to platelet inhibition with antiplatelet treatments was assessed as adequate, but after exercise the patient developed platelet activation which could be the trigger of his stent thrombosis.

Individual participant data analysis of two trials on aldosterone blockade in myocardial infarction.

BACKGROUND: Two recent randomised trials studied the benefit of mineralocorticoid receptor antagonists (MRAs) in ST-segment elevation myocardial infarction (STEMI) irrespective or in absence of heart failure. The studies were both undersized to assess hard clinical endpoints. A pooled analysis was preplanned by the steering committees. METHODS: We conducted a prespecified meta-analysis of patient-level data of patients with STEMI recruited in two multicentre superiority trials, randomised within 72 hours after symptom onset. Patients were allocated (1:1) to two MRA regimens: (1) an intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) versus standard therapy or (2) oral eplerenone (25-50 mg) versus placebo. The primary and key secondary outcomes, all-cause death and the composite of all-cause death or resuscitated sudden death, respectively, were assessed in the intention-to-treat population using a Cox model stratified on the study identifier. RESULTS: Patients were randomly assigned to receive (n=1118) or not the MRA regimen (n=1123). After a median follow-up time of 188 days, the primary and secondary outcomes occurred in 5 (0.4%) and 17 (1.5%) patients (adjusted HR (adjHR) 0.31, 95% CI 0.11 to 0.86, p=0.03) and 6 (0.5%) and 22 (2%) patients (adjHR 0.26, 95% CI 0.10 to 0.65, p=0.004) in the MRA and control groups, respectively. There were also trends towards lower rates of cardiovascular death (p=0.06) and ventricular fibrillation (p=0.08) in the MRA group. CONCLUSION: Our analysis suggests that compared with standard therapy, MRA regimens are associated with a reduction of death and death or resuscitated sudden death in STEMI.

N-terminal pro-brain natriuretic peptide predicts myocardial ischemia and is related to postischemic left-ventricular dysfunction in patients with stable coronary artery disease.

BACKGROUND: The N-terminal-pro-B natriuretic peptide (Nt-pro-BNP) is of diagnostic and prognostic value in coronary artery disease (CAD). We assessed the relationship between Nt-pro-BNP and (1) the extent of ischemia on stress myocardial perfusion imaging (MPI), and (2) changes between the basal and postexercise ejection fraction (EF), in stable patients with a normal EF. METHODS AND RESULTS: One hundred and two patients with stable, documented CAD (EF, 62% +/- 8%) underwent an exercise-rest thallium-201 gated-MPI and serial Nt-pro-BNP assays. Myocardial perfusion imaging produced abnormal results in 57 patients (56%; group 1), and normal results in 45 patients (44%; group 2). Median baseline, immediate postexercise, and 3-hour postexercise Nt-pro-BNP values were higher in group 1 than in group 2: 182 vs 85, 201 vs 86, and 212 vs 99 pg/mL, respectively (P < .001 for all). Postexercise EF decreased in group 1 (53% +/- 11% vs 62% +/- 10%, P < .001), but not in group 2 (61% +/- 9% vs 62% +/- 7%, NS). The Nt-pro-BNP ruled out significant ischemia with a negative predictive value of 0.90, whereas patients within the higher tertile of Nt-pro-BNP had a fivefold higher risk of ischemia compared with patients within the lower tertile. CONCLUSIONS: The post-stress increase in Nt-pro-BNP is related to myocardial ischemia and to postischemic left-ventricular dysfunction, and accurately predicts the presence or absence of myocardial perfusion defects.

Primary angioplasty is cost-minimizing compared with pre-hospital thrombolysis for patients within 60 min of a percutaneous coronary intervention center: the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) cost-efficacy sub-study.

OBJECTIVES: This ancillary study of the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) trial sought to assess the cost-efficacy ratio of primary coronary angioplasty (PCA) and pre-hospital thrombolysis (PHT) in patients suffering from an acute myocardial infarction (AMI) (<6 h) close to (<60 min journey) a percutaneous coronary intervention (PCI) center. BACKGROUND: In the CAPTIM study, at 30 days follow-up PCA was as equally effective as PHT with rescue angioplasty if needed. The cost efficacy of these two strategies has not yet been compared. METHODS: Data were prospectively collected for 299 patients in three centers. The efficacy analysis was extended at one-year follow-up for those patients. Direct fixed and variable actual costs were assessed with a piggyback data collection. RESULTS: The one-year primary end point event-rate (death, non-fatal myocardial infarction, and stroke) was not different after PCA or PHT (14% vs. 16. 4%, p = NS). Costs were lower in the PCA group either during the in-hospital period (8,287 vs. 9,170 $, p = 0.0001) and after one-year follow-up, in relation to a higher rate of subsequent revascularizations in the PHT group (49% vs. 23%, p < 0. 01), leading to a longer hospital stay (10 vs. 9.1 days, p = 0. 03). CONCLUSIONS: After AMI in patients less than 1 h from a PCI center, PCA is as effective and less costly than a combined strategy of PHT followed by rescue angioplasty.

Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial.

BACKGROUND: Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF). OBJECTIVES: The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction. METHODS: We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months. RESULTS: The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001). CONCLUSIONS: The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136).

[Which indications and access routes for transcatheter aortic valve implantation? Health technology assessment from HAS]. / Quelles indications et quelles voies d'abord pour l'implantation des valves aortiques percutanées ? Évaluation technologique menée par la Haute Autorité de santé (HAS).

The transcatheter aortic valve implantation should be restricted to patients with severe symptomatic aortic stenosis with a contraindication for a surgical replacement (taking into account surgical risk scores, comorbidities, anatomical conditions, life expectancy and frailty). Patient eligibility should be performed by a heart team with the involvement of a cardiac surgeon, an interventional cardiologist, a clinical cardiologist and an anaesthetist/resuscitation specialist. The advice of a geriatrician is strongly recommended. The long-term efficacy remains unknown. The French National Authority for Health (Haute Autorité de santé [HAS]) reminds that contraindications in the CE mark should be strictly respected (i.e.instructions for use). Extension of current indications should be conditional to the presentation of clinical evidence. Thus, implantation in patients at lower surgical risk or the use of direct transaortic route are not eligible for reimbursement given the current state of knowledge.

The favorable price evolution between bare metal stents and drug eluting stents increases the cost effectiveness of drug eluting stents.

AIMS: We aimed to assess the cost effectiveness of the sirolimus-eluting stent (SES) in diabetic and non-diabetic patients vs. bare metal stents (BMS). METHODS: EVASTENT was a matched cohort registry of patients undergoing revascularization exclusively with SES; for each diabetic patient (db+) included, stratified according to single (SVD) or multiple (MVD) vessel disease, a non-diabetic patient (db-) was subsequently included. Efficacy, safety and cost data were obtained from the SES database, and then data from the BMS group were derived by using an original method of transition probabilities of events (Markov model and Monte Carlo simulations) if BMS had been implanted in the same patient, over a 3-year time period. Sensitivity analysis was performed by varying the price difference between BMS and SES from 2008 to 2012. RESULTS: In this study, 1731 patients were included with 97% complete follow-up at 3-years. In 2008, compared to BMS the SES was cost effective only in MVD db+ (7494€ per avoided revascularization (PAR) vs. >10,000€ in other groups). In 2012, after a reduction in the price difference between SES and BMS, SES were cost effective in MVD db+ (-891), SVD db+ (3519), MVD db- (3050), and SVD db- (6329) patients. Otherwise, the cardiovascular mortality rate was higher (p<0.0001) in MVD db+ than in SVD db+, MVD db- and SVD db-. CONCLUSION: The SES is now cost effective in diabetic and non-diabetic patients, after a favorable price evolution between drug eluting and bare metal stents.

Stent-related cardiac events beyond three years after implantation of the sirolimus-eluting stent (from the EVASTENT Patients).

The frequency of very late stent thrombosis (VLST) up to 3 years after sirolimus-eluting stent implantation is 0.5% to 0.6%/year but incertitude remains about the frequency of VLAST after 3 years. Diabetic (db+) and nondiabetic (db-) patients with or without multiple diseased vessels included in the EVASTENT matched-cohort registry were followed up to 6 years after stent implantation. Long-term follow-up was obtained for 1,564 of the 1,731 included patients. All-cause deaths (including cancer and complications of diabetes) occurred at steady rates of 2.5%/year up to 3 years and 1.2%/year after 3 years (difference not significant). In contrast, VLST (any Academic Research Consortium definition) was only 0.18%/year (95% confidence interval 0.08 to 0.39) after 3 years versus 0.63%/year (confidence interval 0.41 to 0.98) from 1 year to 3 years (p = 0.03). Target lesion revascularization rates were also lower after 3 years than before 3 years (1.9% vs 7%, p ≤ 0.01) with 66% of revascularization procedures after 3 years being for nontarget lesions. Six-year all-cause death and cardiac death cumulative rates were higher in db+ than in db- patients. However, after 3 years compared to before 3 years, no differences between db+ and db- patients were observed for target lesion revascularization and ST rates. It is noteworthy that 51% of patients continued to be on clopidogrel therapy nearly 6 years after receiving ≥ 1 sirolimus-eluting stent. In conclusion, all-cause deaths continued at a steady rate over 6 years. However, cardiac deaths and "very" VLST leveled out beyond 3 years.

Characteristics and management of acute ST-segment elevation myocardial infarctions occurring in ski resorts in the French Alps: Impact of an acute coronary care network.

BACKGROUND: Compliance with guidelines for the management of ST-segment elevation myocardial infarction (STEMI) may be difficult in hard-to-access areas. AIMS: to analyse the characteristics, management and outcome of STEMIs occurring at altitude in the French Alps and managed by mobile medical emergency units. METHODS: From January 2006 to December 2008, from the prospective RESURCOR registry, 114 patients with a STEMI of less than 12 hours' duration, occurring in a ski resort or at high altitude and managed by the RESURCOR care system, were identified. Baseline characteristics, treatments and in-hospital outcomes were analysed. RESULTS: Ninety-three per cent of patients were men; the mean age was 57 years. STEMIs occurred during or less than 1 hour after physical activity in 76.3% of cases (mainly during or after alpine/cross-country skiing). Killip class greater or equal to 2 and cardiac arrest were observed in 35% and 7.9% of cases, respectively. Fifty-two (45.6%) patients underwent thrombolysis and 62 (54.4%) had percutaneous coronary intervention (PCI). Median delays were: first call to treatment, 82 min (17-230 min); symptoms to treatment, 165 min (52-770 min). All delays were significantly longer for PCI than for thrombolysis. First call to treatment delay was less than 120 min in 98.1% of patients who underwent thrombolysis and in 51.6% who had PCI (P<0.0001). In-hospital survival was 96.5%. CONCLUSION: Altitude STEMIs happen mainly during sporting activities. Clinical presentation is often severe, but an emergency coronary care network allows rapid reperfusion. These findings emphasize the need for an efficient network for STEMI management in geographically difficult-to-access areas.

Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: the EQUIP-ACS project protocol and design.

BACKGROUND: Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe. METHODS/DESIGN: This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge). After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect. DISCUSSION: If we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers. TRIAL REGISTRATION: Clinicaltrials.gov NCT00716430.

Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction.

BACKGROUND: The impact of antidiabetic medications on clinical outcomes in patients developing acute myocardial infarction (MI) is controversial. We sought to determine whether in-hospital outcomes in patients who were on sulfonylureas (SUs) when they developed their MIs differed from that of diabetic patients not receiving SUs and whether clinical outcomes were related to the pancreatic cells specificity of SUs. METHODS AND RESULTS: We analyzed the outcomes of the 1310 diabetic patients included in the nationwide French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction in 2005. Medications used before the acute episode were recorded. In-hospital complications were analyzed according to prior antidiabetic treatment. Mortality was lower in patients previously treated with SUs (3.9%) vs. those on other oral medications (6.4%), insulin (9.4%), or no medication (8.4%) (P = 0.014). Among SU-treated patients, in-hospital mortality was lower in patients receiving pancreatic cells-specific SUs (gliclazide or glimepiride) (2.7%), compared with glibenclamide (7.5%) (P = 0.019). Arrhythmias and ischemic complications were also less frequent in patients receiving gliclazide/glimepiride. The lower risk in patients receiving gliclazide/glimepiride vs. glibenclamide persisted after multivariate adjustment (odds ratio 0.15; 95% confidence interval 0.04-0.56) and in propensity score-matched cohorts. CONCLUSION: In this nationwide registry of patients hospitalized for acute MI, no hazard was associated with the use of SUs before the acute episode. In addition, patients previously receiving gliclazide/glimepiride had improved in-hospital outcomes, compared with those on glibenclamide.

Prevalence, therapeutic management and medium-term prognosis of spontaneous coronary artery dissection: results from a database of 11,605 patients.

OBJECTIVE: To assess the prevalence, clinical presentation, therapeutic management and medium-term prognosis of spontaneous coronary artery dissection (SCAD). METHODS: Over a 5-year period, and out of a cath-lab database of 11,605 files, 23 cases of SCAD were confirmed by re-analysis of angiograms. Therapeutic management and in-hospital outcome were obtained from medical files and prospective follow-up was performed. RESULTS: The population consisted of 17 women and 6 men (mean age 45 years). A total of 83% of men had >/=2 cardiovascular risk factors versus only 35% of women (p=0.07). Acute coronary syndrome (ACS) was the clinical presentation in 21 cases (ST+ 61%). The prevalence of SCAD was: 0.2% in the whole population (men: 0.07%, women: 0.6%, p<0.001), and 8.7% and 10.8% in women <50 years with ACS and ST+ ACS, respectively. Left and right coronary arteries were involved in 20 (87%) and 3 (13%) cases, respectively. Coronary stenting alone was performed in 8 (35%), bypass surgery alone in 2 (9%), and both in 3 (13%) cases. Ten patients (44%) were medically managed. One patient died during hospitalization. At 1-year follow-up (100%), 77% of discharged patients were event-free. One patient died, four experienced heart failure, and none had angina or new ACS. CONCLUSION: SCAD is observed in as much as 1 out 10 women <50 years presenting with ACS. After immediate coronary angiography, medical therapy is the chosen strategy in half of cases. Most patients who survive the acute phase are free from coronary events at 1 year.