Bivalirudin use in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Insights from the prospective, multi-centre EUROVISION registry.

BACKGROUND: The effectiveness of bivalirudin in patients undergoing percutaneous coronary intervention for acute myocardial infarction has been tested in clinical trials, but its use in a real-world scenario has never been reported. METHODS: From the total number of patients enrolled in the EUROVISION registry, 678 subjects affected by ST-elevation myocardial infarction were selected and included in the analysis. Posology and usage patterns of bivalirudin, as evaluated by dose and time of drug bolus and infusion administered, were evaluated. The 30-day outcome has been assessed by efficacy and safety endpoints. RESULTS: All patients received an initial intravenous bolus of bivalirudin (0.70±0.25 mg/kg) followed by an infusion (1.58±0.47 mg/kg/h; duration: 60 [30, 107] min) in 99.3% of cases. An additional bolus (0.49±0.06 mg/kg) was administered in 9.3% of patients. Bivalirudin infusion was prolonged after procedure in 62.2%. Death occurred in 2.1% of patients, non-fatal myocardial reinfarction in 0.3%, unplanned revascularization in 0.6% and non-fatal stroke in 0.4%. Acute stent thrombosis was not observed. Major bleeding occurred in 1.5% of patients. CONCLUSIONS: Bivalirudin usage in the setting of primary PCI provided excellent results in terms of 30-day outcome even in a real-world population.

Assessment of left ventricular volumes and function by cine-MR imaging depending on the investigator's experience.

AIMS: To analyze the reproducibility of LV volumes calculated by cardiac magnetic resonance imaging (CMRI) and to compare them to those obtained by conventional ventriculography. METHODS: A total of 30 patients with stable ischemic heart disease were prospectively included. Each underwent CMRI twice and ventriculography. Left ventricular end diastolic volume (EDV), end systolic volume (ESV) and LV ejection fraction (EF) were calculated by two radiologists at different level of experience. Intraobserver, interobserver and interstudy variabilities were assessed. RESULTS: The cut off values were: intraobserver variability (EDV, ESV, EF): 9.4 ml, 5.3 ml, 3.3% for well-trained radiologist; 13.1 ml, 7.5 ml, 4.1% for less-trained radiologist. interobserver variability: EDV: 11.7 and 10.4 ml; ESV: 7.0 and 6.6 ml; EF: 3.9 and 4.2%. interstudy variability (EDV, ESV, EF): 11.6 and 12.6 ml, 7.1 and 7.4 ml, 3.9 and 3.5%, for experienced and less-trained observers. Statistical differences were found between CMRI and ventriculography: CMRI underestimation of EDV and EF, overestimation of ESV. CONCLUSIONS: CMRI volumetric quantification of LV volumes and function is highly reproducible at different levels of experience, but not interchangeable with those obtained by ventriculography.

[Transient left ventricular apical ballooning or the tako-tsubo syndrome]. / Ballonisation apicale transitoire du ventricule gauche ou syndrome du tako-tsubo. A propos de 10 nouveaux cas.

Recently, Japanese authors have described a new clinical entity associating apical akidyskinesia and basal hyperkinesias without significant coronary artery disease under the name of the tako-tsubo syndrome. This syndrome is usually observed in elderly women and the clinical presentation is usually that of an acute coronary syndrome. The authors report 10 cases of patients investigated between June 2003 and August 2004. All patients were women with an average age of 66 +/- 15 years. Seven patients had chest pain on admission with, in three cases, signs of cardiac failure. In 8 patients, a causal factor was identified: emotional stress in 7 cases and anaphylactic shock in one case. All patients underwent coronary angiography and ventriculography which showed typical changes in left ventricular contractility without significant coronary disease. The peak CPK and troponin values were 222 +/- 115 UI/l and 3.32 +/- 1.50 microg/l, respectively. One patient died in cardiogenic shock. In the other cases, normalisation of wall motion was observed in the month following the onset of symptoms. One patient developed 3rd degree atrioventricular block and required implantation of a pacemaker. This clinical entity must be taken into consideration in elderly women with acute coronary syndromes.

[Prevalence of renal artery stenosis in patients undergoing cardiac catheterization: when should abdominal aortography be performed? Results in 467 patients]. / Prévalence des sténoses des artères rénales dépistées au cours de coronarographies diagnostiques: dans quels cas doit-on réaliser une aortographie abdominale? A propos de 467 patients.

PURPOSE: To define a subgroup of patients at increased risk of renal artery stenosis (RAS) in a population of patients undergoing cardiac catheterization. MATERIALS AND METHODS: A total of 467 patients (mean age of 64 Years +/-11) underwent cardiac catheterization and aortography Results were evaluated to detect correlations between the presence or absence of RAS and clinical and biological parameters. RESULTS: A total of 42 (9%) patients had a renal artery stenosis. Univariate analysis defined parameters correlated with the presence of RAS: systolic blood pressure (p=0.03), pulse pressure (p=0.005), age (p<0.0001), creatinine clearance (p<0.0001), 2-vessel (p=0.028) and 3-vessel (p=0.037) coronary artery diseases. Multivariate analysis showed that the presence of RAS correlated to creatinine clearance (p=0.02) and 2-vessel coronary artery disease. A creatinine clearance between 30 and 60 ml/min and multi-vessel coronary artery disease defined a subgroup at increased risk of RAS with sensitivity, specificity, positive and negative predictive values of: 47.6, 90.1, 32.3 and 94.6%. The prevalence of renal artery stenosis was 5.2% when both parameters were absent. CONCLUSION: Patients with mild renal insufficiency and multi-vessel coronary artery disease defined a subgroup of patients at increased risk of RAS (32.5%) that may benefit from abdominal aortography performed at the time of cardiac catheterization.

Stent placement compared with balloon angioplasty for small coronary arteries: in-hospital and 6-month clinical and angiographic results.

BACKGROUND: Stenting has been demonstrated to be superior to balloon angioplasty in de novo focal lesions located in large native vessels. However, in small vessels, the benefit of stenting remains questionable. METHODS AND RESULTS: A total of 381 symptomatic patients with de novo focal lesion located on a small coronary segment vessel (<3 mm) were randomly assigned to either stent implantation (192 patients; 197 lesions) or standard balloon angioplasty (189 patients; 198 lesions). The primary end point was the angiographic restenosis rate at 6 months, as determined by quantitative coronary angiography. On intention-to-treat analysis, angiographic success rate and major adverse cardiac events were comparable: 97.9% and 4.6% versus 93.9% and 5.8% in the stent group and the balloon group, respectively. After the procedure, a larger acute gain was achieved with stent placement (1.35+/-0.45 versus 0.94+/-0.47 mm, P=0.0001), resulting in a larger minimal lumen diameter (2.06+/-0.42 versus 1.70+/-0.46 mm, P=0.0001). At follow-up (obtained in 91% of patients), angiographic restenosis rate was 21% in the stent group versus 47% in the balloon group (P=0.0001), a risk reduction of 55%. Repeat target lesion revascularization was less frequent in the stent group (13% versus 25%, P=0.0006). CONCLUSIONS: Elective stent placement in small coronary arteries with focal de novo lesions is safe and associated with a marked reduction in restenosis rate and subsequent target lesion revascularization rate at 6 months.

Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. BET (Benefit Evaluation of Direct Coronary Stenting) Study Group.

The purpose of this study was to compare the effects of stent placement with and without balloon predilatation on duration of the procedure, reduction of procedure-related costs, and clinical outcomes. Although preliminary trials of direct coronary stenting have demonstrated promising results, the lack of randomized studies with long-term follow-up has limited the critical evaluation of the role of direct stenting in the treatment of obstructive coronary artery disease. Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+; 173 patients) or standard stent implantation with balloon predilatation (DS-; 165 patients). Baseline clinical and angiographic characteristics were similar in the 2 groups. Procedural success was achieved in 98.3% of patients assigned to DS+ and 97.5% of patients assigned to DS- (p = NS), with a crossover rate of 13.9%. Compared with DS-, DS+ conferred a dramatic reduction in procedure-related cost ($956.4 +/- $352.2 vs $1,164.6 +/- $383.9, p <0.0001) and duration of the procedure (424.2 +/- 412.1 vs 634.5 +/- 390.1 seconds, p < 0.0001). At 6-month follow-up, the incidence of major adverse cardiac events including death, angina pectoris, myocardial infarction, congestive heart failure, repeat angioplasty, or coronary artery bypass graft surgery was 5.3% in DS+ and 11.4% in DS- (p = NS). Multivariate analysis demonstrated that major adverse cardiac events rates were related to stent length of 10 mm (relative risk [RR] 3.25, 95% confidence intervals [CI] 1.36 to 7.78; p = 0.008), stent diameter of 3 mm (RR 2.69, 95% CI 1.03 to 7.06; p = 0.043), and complex lesion type C (RR 2.83, 95% CI 1.02 to 7.85; p = 0.045). Thus, in selected patients, this prospective randomized study shows the feasibility of DS+ with reduction in procedural cost and length, and without an increase in in-hospital clinical events and major adverse cardiac events at 6-month follow-up.

A comparison of systematic stenting and conventional balloon angioplasty during primary percutaneous transluminal coronary angioplasty for acute myocardial infarction. STENTIM-2 Investigators.

OBJECTIVES: In a multicenter, randomized trial, systematic stenting using the Wiktor stent was compared to conventional balloon angioplasty with provisional stenting for the treatment of acute myocardial infarction (AMI). BACKGROUND: Primary angioplasty in AMI is limited by in-hospital recurrent ischemia and a high restenosis rate. METHODS: A total of 211 patients with AMI <12 h from symptom onset, with an occluded native coronary artery, were randomly assigned to systematic stenting (n = 101) or balloon angioplasty (n = 110). The primary end point was the binary six-month restenosis rate determined by core laboratory quantitative angiographic analysis. RESULTS: Angiographic success (Thrombolysis in Myocardial Infarction [TIMI] flow grade 3 and residual diameter stenosis <50%) was achieved in 86% of the patients in the stent group and in 82.7% of those in the balloon angioplasty group (p = 0.5). Compared with the 3% cross-over in the stent group, cross-over to stenting was required in 36.4% of patients in the balloon angioplasty group (p = 0.0001). Six-month binary restenosis (> or = 50% residual stenosis) rates were 25.3% in the stent group and 39.6% in the balloon angioplasty group (p = 0.04). At six months, the event-free survival rates were 81.2% in the stent group and 72.7% in the balloon angioplasty group (p = 0.14), and the repeat revascularization rates were 16.8% and 26.4%, respectively (p = 0.1). At one year, the event-free survival rates were 80.2% in the stent group and 71.8% in the balloon angioplasty group (p = 0.16), and the repeat revascularization rates were 17.8% and 28.2%, respectively (p = 0.1). CONCLUSIONS: In the setting of primary angioplasty for AMI, as compared with a strategy of conventional balloon angioplasty, systematic stenting using the Wiktor stent results in lower rates of angiographic restenosis.

Comparable uptake of thallium-201 and technetium-99m MIBI in hibernating and "maimed" myocardium.

Thallium-201 and technetium-99m-MIBI uptake are comparable in "maimed" (i.e., partially viable) and hibernating myocardium. The appreciation of myocardial viability should be based not only on the presence of a regional contractility improvement, but also on the evaluation of the initial level of contractility and of tracer uptake in the concerned area.

[Identification of hibernating myocardium using 99m sestamibi tomoscintigraphy at rest]. / Identification du myocarde hibernant par la tomoscintigraphie de repos au technétium 99m sestamibi.

The aim of this study was to assess the value of resting 99m Tc-Sestamibi scintigraphy for the detection of hibernating myocardium in zones of contractile dysfunction. Based on a series of 25 patients, 27 segments of supposedly hibernating myocardium were identified. All these segments corresponded to left ventricular wall motion abnormalities confirmed by contrast angiography and were perfused by a stenosed coronary artery: none of these zones were infarcted. Before revascularisation, comparison of the results of ventriculography and scintigraphy showed a correlation (p < 0.001) between the severity of regional contractile dysfunction appreciated by the center line method and the degree of myocardial hypofixation of 99m Tc MIBI. Three months after revascularisation, improvement of regional wall motion, assessed by control contrast angiography, was observed in 21 of the 27 segments studied (78%). Of these 21 segments, the viability of which was confirmed, 13 had a non-transmural uptake defect and 8 were normal on pre-revascularisation scintigraphy. The 6 segments without improvement at the 3 month control, had a transmural uptake defect on scintigraphy in 67% of cases. The authors concluded that when a residual uptake defect of 99m Tc sestamibi is present, viable myocardium may also be present.

Rest technetium 99m-sestamibi tomoscintigraphy in hibernating myocardium.

The myocardial uptake of rest-injected technetium 99m sestamibi on single-photon-emission computed tomographic images was assessed in 25 patients. All had an area of myocardial dysfunction that could be related to a coronary artery stenosis. None of the patients had clinical evidence of a myocardial infarction. Three months after revascularization, viability was demonstrated by contrast angiography and center-line analysis in 21 (78%) of the 27 formerly hibernating territories. Among these, none had a transmural defect, and 38% had a normal technetium 99m-sestamibi uptake. The four transmural preoperative defects were located in territories without viability. Eight of the 9 territories that were normal at scintigraphy proved to be viable postoperatively. It is concluded that as long as some residual technetium 99m-sestamibi uptake is present, viable myocardium is also present.

Reinjection as an alternative to rest imaging for detection of exercise-induced ischemia with thallium-201 emission tomography.

Exercise thallium-201 single photon emission computed tomography images were compared prospectively with 4-hour redistribution images, with 4-hour reinjection images, and with images obtained at rest on a separate day in 37 patients with documented coronary artery disease. Exercise images were abnormal in 35 patients (95%). On the basis of an improvement in thallium-201 distribution between exercise and nonexercise images, overall sensitivity for the detection of coronary artery stenosis was significantly higher with reinjection at 4 hours (p < 0.05) or with a rest injection on a separate day (p < 0.05) than with redistribution imaging (84%, 83%, and 70%, respectively). Reinjection and rest injection were positive more frequently in patients with a wall-motion abnormality (76% and 80%, respectively, vs 64% at redistribution; p < 0.05 for both) or with > 90% stenosis (77% and 76%, respectively, vs 58% at redistribution; p < 0.05 for both). Among the 11 patients who had no evidence of redistribution at 4 hours, five (45%) demonstrated ischemia with reinjection and five demonstrated ischemia in the separate rest study; a total of seven patients showed improvement either at reinjection or rest. Among these 86% had a wall-motion abnormality associated with stenosis of > 90%, whereas in the other 30 patients these two conditions were observed concomitantly in only 43%. This study demonstrates that the thallium-201 4-hour postexercise reinjection technique is as sensitive as the 2-day rest/exercise method for the detection of coronary artery stenosis and provides additional information when a severe stenosis is associated with a wall-motion abnormality.

[Silent ischemic heart diseases in patients with peripheral arterial diseases. Screening and 5-year prognosis in a population of 418 patients]. / Les cardiopathies ischémiques silencieuses chez l'artéritique. Dépistage et pronostic à 5 ans dans une population de 418 patients.

Silent ischaemic heart disease was looked for by exercise stress testing in 418 patients with chronic obliterative arterial disease of the lower limbs with no clinical or electrocardiographic signs of myocardial ischaemia. In the initial work-up, 6.2% of patients had a positive exercise test and the results were suspect in 9.2% of patients. These patients were followed up for 5 years. There were 42 deaths (10%). The cause of death was cardiovascular in 53.7% of cases (myocardial infarction 40.4%) and malignant disease in 35.7%. During the 5 year follow-up, ischaemic heart disease present as angina pectoris or myocardial infarction in 115 cases (27.5%). Patients who had a positive exercise stress test initially had a particularly high death rate (23%) and developed clinical signs of coronary insufficiency in 57.5% of cases. On the other hand, the peripheral vascular complications were relatively rare in this series: cerebrovascular accidents: 1.4%; retinal vascular accident: 1.1%; carotid surgery: 1.6%; lower limb amputation: 1.9%; lower limb vascular surgery: 17.7%. Silent ischaemic heart disease is very prevalent in patients with obliterative arterial disease of the lower limbs and is a main vital prognostic factor in these patients. These results confirm the need for a complete cardiovascular check-up in all patients with peripheral arterial disease.