High risk hypertensives: pre-hospital management of acute myocardial infarction--results from the French nationwide registry USIC 2000.

OBJECTIVE: To assess the use of mobile coronary care units (MCU) in hypertensive patients previously treated for cardiovascular diseases in comparison with those with no history of cardiovascular disease and to estimate the influence of the use of MCU on cardiovascular outcome in this population. PATIENTS: We used a nationwide prospective registry of all patients admitted for AMI in French intensive care units in 2000. Patients without history of hypertension or patients admitted with pulmonary oedema or cardiogenic shock were excluded. Men (N = 514) and women (N = 291) were analysed separately. RESULTS: The proportion of patients with history of myocardial infarction, peripheral artery disease and stroke was not significantly higher in subjects who used physician-staffed MCU as compared with patients with no history of myocardial infarction, peripheral artery disease or stroke. In each sex, revascularization (pre hospital fibrinolysis, in hospital fibrinolysis or coronary angioplasty) were more frequent in patients who used MCU. Also, one year cardiovascular mortality was lower in men who used MCU. CONCLUSION: Known high risk hypertensive patients did not use physician-staffed MCU more than subjects free of such condition. Education of hypertensive patients at risk during routine visits is required to increase of the use of physician-staffed MCU in case of symptoms suggestive of AMI.

Angiographically documented late reocclusion after successful coronary angioplasty of an infarct-related lesion is a powerful predictor of long-term mortality.

BACKGROUND: Late reocclusion of an infarct-related artery (IRA) that was patent in the early days after acute myocardial infarction (MI) is a frequent event; the reocclusion rate may be as high as 30%. Few studies have been designed to analyze the impact of late reocclusion of the IRA on late survival. METHODS AND RESULTS: We studied 528 patients who all had a patent IRA after a successful PTCA procedure 10+/-6 days after MI and who underwent systematic 6-month angiographic follow-up to assess late patency of the IRA. We compared long-term survival of patients with and without late reocclusion. Based on the results of 6-month follow-up angiography, 2 groups of patients were defined: (1) 90 patients (17%) with reocclusion (Thrombolysis In Myocardial Infarction [TIMI] flow 0 or 1) and (2) 438 patients (83%) without reocclusion. Long-term clinical follow-up was obtained for all 528 patients at a median of 5.7 years after follow-up angiography (6.4 years after PTCA). The overall actuarial 8-year total mortality rate was 13%. At the end of follow-up, there were 35 deaths (8%) among the 438 patients without reocclusion and 18 deaths (20%) among the 90 patients with reocclusion (P=0.002). The actuarial 8-year total mortality rate was 10% in patients without reocclusion and 28% in patients with reocclusion (P=0.0003). The actuarial cardiovascular mortality rate was 7% in patients without reocclusion and 25% in patients with reocclusion (P<0.0001). The impact of reocclusion on long-term mortality was greater in patients with anterior MI. CONCLUSIONS: Late IRA patency is strongly associated with long-term survival after MI. These observations should encourage prospective studies to evaluate the impact of strategies designed to prevent late reocclusion in postinfarction patients.

Patency of percutaneous transluminal coronary angioplasty sites at 6-month angiographic follow-up: A key determinant of survival in diabetics after coronary balloon angioplasty.

BACKGROUND: Several reports have demonstrated a high mortality rate in diabetic patients treated by standard coronary balloon angioplasty. No clear explanation has been provided for this finding. METHODS AND RESULTS: Consecutive diabetic patients successfully treated by standard coronary balloon angioplasty (n=604) were enrolled in a follow-up program including repeated angiography at 6 months and long-term clinical follow-up. Clinical follow-up was available in 603 patients (99.8%). Twelve patients died, 2 underwent bypass surgery before scheduled repeated angiography, and 76 declined angiography. Determinants of long-term mortality were analyzed in the 513 patients with angiography at 6 months and long-term clinical follow-up (mean follow-up, 6.5+/-2.4 years). On the basis of the results of repeated angiography, 3 groups of patients were defined: group 1, 162 patients without restenosis (32%); group 2, 257 patients with nonocclusive restenosis (50%); and group 3, 94 patients with coronary occlusion (18%). Overall actuarial 10-year mortality rate was 36%. Actuarial 10-year mortality was 24% in group 1, 35% in group 2, and 59% in group 3 (P:<0.0001). Multivariate analysis demonstrated that coronary occlusion was a strong and independent correlate of long-term total mortality (hazard ratio, 2.16; 95% CI, 1.43 to 3.26; P:=0.0003) and cardiac mortality (hazard ratio, 2.38; 95% CI, 1.48 to 3.85; P:=0.0004). CONCLUSIONS: This study demonstrates that restenosis, especially in its occlusive form, is a major determinant of long-term mortality in diabetic patients after coronary balloon angioplasty.

Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) 11B trial.

BACKGROUND: Low-molecular-weight heparins are attractive alternatives to unfractionated heparin (UFH) for management of unstable angina/non-Q-wave myocardial infarction (UA/NQMI). METHODS AND RESULTS: Patients (n=3910) with UA/NQMI were randomized to intravenous UFH for >/=3 days followed by subcutaneous placebo injections or uninterrupted antithrombin therapy with enoxaparin during both the acute phase (initial 30 mg intravenous bolus followed by injections of 1.0 mg/kg every 12 hours) and outpatient phase (injections every 12 hours of 40 mg for patients weighing <65 kg and 60 mg for those weighing >/=65 kg). The primary end point (death, myocardial infarction, or urgent revascularization) occurred by 8 days in 14.5% of patients in the UFH group and 12.4% of patients in the enoxaparin group (OR 0.83; 95% CI 0.69 to 1.00; P=0. 048) and by 43 days in 19.7% of the UFH group and 17.3% of the enoxaparin group (OR 0.85; 95% CI 0.72 to 1.00; P=0.048). During the first 72 hours and also throughout the entire initial hospitalization, there was no difference in the rate of major hemorrhage in the treatment groups. During the outpatient phase, major hemorrhage occurred in 1.5% of the group treated with placebo and 2.9% of the group treated with enoxaparin (P=0.021). CONCLUSIONS: Enoxaparin is superior to UFH for reducing a composite of death and serious cardiac ischemic events during the acute management of UA/NQMI patients without causing a significant increase in the rate of major hemorrhage. No further relative decrease in events occurred with outpatient enoxaparin treatment, but there was an increase in the rate of major hemorrhage.

Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial.

BACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI. METHODS AND RESULTS: In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76+/-0.77 mm in the placebo group, which was not different from MLD in the tranilast groups (1.72 to 1.78+/-0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72). CONCLUSIONS: Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

Comparative results of percutaneous transluminal coronary angioplasty in patients with dynamic versus fixed coronary stenosis.

This study compares the results of percutaneous transluminal coronary angioplasty in a group of 132 patients (group A) with fixed atherosclerotic narrowing (no spontaneous or ergonovine-provoked spasm) and in a group of 97 patients (group B) with dynamic coronary stenosis (spasm superimposed on the stenosis). All these patients underwent complete follow-up angiography. The rate of restenosis (defined as a loss of 50% of the initial gain) was significantly higher in patients in group B (dynamic coronary stenosis) than in group A (fixed narrowing) (35 versus 22%, p less than 0.05). Despite treatment with a calcium antagonist, coronary artery spasm persisted in 44% of the patients in group B and was detected for the first time in 15% of the patients in group A. Thus, in patients with dynamic coronary stenosis, the results of coronary angioplasty were less satisfactory than in patients with fixed narrowing, and in both groups coronary artery spasm was frequently (64%) superimposed on the restenosis.

Clinical characteristics and angiographic follow-up of patients undergoing early or late repeat dilation for a first restenosis.

OBJECTIVE: The aim of this study was to analyze the angiographic rate of recurrent restenosis in patients who underwent repeat coronary angioplasty for a first restenosis within 3 months or greater than 3 months after the first procedure. BACKGROUND: Several studies that have examined risk factors for restenosis after coronary angioplasty have suggested that a short interval between a first angioplasty and a repeat procedure is associated with an increased risk for a second restenosis. METHODS: Between January 1981 and December 1990, 423 patients underwent a repeat coronary angioplasty procedure because restenosis had occurred at the site of a successful first angioplasty procedure. The clinical characteristics, immediate outcome and angiographic rate of recurrent restenosis were compared in patients who underwent repeat dilation within 3 months (early redilation group, n = 77) or greater than 3 months (late redilation group, n = 346) after the first procedure. RESULTS: The incidence of unstable angina at the time of the repeat procedure was significantly higher in the patients who underwent early redilation (42% vs. 8%, p = 0.0001). The procedural success rate (95%) and complication rate were similar in both groups. Follow-up angiography was performed in 86% of patients with an initially successful procedure. The incidence of restenosis was significantly higher in the group that underwent early redilation (56% vs. 37%, p = 0.007) and was similar in patients in this group who presented with stable (55%) or unstable (57%) angina. CONCLUSIONS: Rapidly recurring coronary stenoses have an extremely high rate of restenosis when again treated by coronary angioplasty, irrespective of the clinical presentation at the time of repeat dilation. The outcome in patients with early restenosis who have stable angina might be improved by delaying the repeat procedure.

Percutaneous coronary rotational angioplasty in humans: preliminary report.

Percutaneous coronary rotational angioplasty was attempted in 12 patients. The procedure was performed with a flexible rotating shaft with an abrasive tip, varying in diameter from 1.25 to 3.5 mm, tracking along a central guide wire. Among the 12 patients (mean age 58 years), 4 had a stenosis in the left anterior descending coronary artery and 8 a stenosis in the right coronary artery. After the guide wire crossed the stenosis, the abrasive tip was slowly advanced and several passes across the stenosis were made. The residual stenosis was measured with computerized automatic quantitative coronary angiography. Success was defined as a reduction of percent stenosis by greater than 20%. If residual stenosis remained significant (greater than 50%), the procedure was completed by balloon dilation. The device could not be inserted in 2 of the 12 patients. Five of the 10 patients underwent rotational angioplasty alone, and 5 had the procedure completed by balloon dilation. The stenosis was significantly enlarged from 0.56 +/- 0.31 mm to 1.26 +/- 0.28 mm. The outline of the vessel appeared smooth and regular. There were no complications related to the procedure and all patients were free of symptoms when discharged 2 to 3 days after the procedure. Thus, coronary rotational angioplasty is a simple and safe procedure allowing marked dilation of the narrowed segment. However, long-term follow-up is required for further evaluation.

Left ventricular systolic and diastolic function during acute coronary artery balloon occlusion in humans.

Left ventricular function during percutaneous transluminal coronary angioplasty was studied in 16 patients undergoing the procedure. All measurements were performed before and during the first episode of balloon coronary occlusion. In 16 patients (Group A), data were recorded before and 30 or 50 s after balloon inflation, and in 8 of these patients (Group B) data were also recorded 15 min after the complete procedure. Left ventriculograms indicated a marked dyskinesia of the anterior and apical wall in all patients. After balloon inflation, there was a marked depression in stroke index and ejection fraction and an increase in left ventricular end-diastolic pressure and the time constants of relaxation in all patients. Simultaneous recording of left ventricular pressure (Millar micromanometer) during cineangiography permitted the assessment of myocardial and chamber stiffness. Although there was a strong tendency for both myocardial and chamber stiffness to increase after 30 to 50 s of occlusion, these increases were statistically insignificant. In Group B, a third set of angiographic and pressure measurements obtained 15 min after completion of the coronary angioplasty procedure indicated no residual left ventricular dysfunction, and in this respect, the results are of added clinical importance.

Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure.

OBJECTIVES: We sought to study the relationship between survival and right ventricular ejection fraction (RVEF) in a subgroup of patients with moderate congestive heart failure (CHF). BACKGROUND: It has been demonstrated that RVEF is an independent predictor of survival in patients with advanced CHF. METHODS: Cardiopulmonary exercise testing and radionuclide angiography (to determine right and left ventricular ejection fraction) were prospectively performed in 205 consecutive patients with moderate CHF (140 patients in New York Heart Association [NYHA] class II, 65 in class III). RESULTS: Left ventricular ejection fraction was 29.3%+/-10.1%, RVEF was 37.5%+/-14.6% and peak oxygen consumption (VO2) was 16.2+/-5.4 ml/min/kg (60.2%+/-19% of maximal predicted VO2). After a median follow-up period of 755 days, there were 44 cardiac-related deaths, 3 deaths from noncardiac causes and 15 transplantations of whom 2 were urgent; 1 patient was lost to follow-up. Multivariate analysis showed that three variables-NYHA classification, percent of maximal predicted VO2 and RVEF-were independent predictors of both survival and event-free cardiac survival. Left ventricular ejection fraction and peak VO2 normalized to body weight had no predictive value. The event-free survival rates from cardiovascular mortality and urgent transplantation at 1 year were 80%, 90% and 95% in patients with an RVEF <25%, with a RVEF > or =25% and <35% and with a RVEF > or =35%, respectively. At 2 years, survival rates were 59%, 77% and 93% in the same subgroups, respectively. CONCLUSIONS: In addition to the NYHA classification and to the percent of maximal predicted VO2, RVEF is an independent predictor of survival in patients with moderate CHF.

Restenosis, late vessel occlusion and left ventricular function six months after balloon angioplasty in diabetic patients.

OBJECTIVES: We studied angiographic outcome and its predictors after traditional coronary balloon angioplasty in diabetics. We further examined whether changes in ejection fraction were influenced by the status of the dilated site(s) at follow-up. BACKGROUND: Recent studies have suggested that diabetics have a particularly poor outcome after balloon angioplasty. The reasons for this observation are not known. METHODS: We investigated procedural and six-month angiographic outcome, analyzed by quantitative coronary angiography, and left ventricular function in 485 consecutive diabetics (627 lesions) treated by balloon angioplasty without stent implantation. RESULTS: The procedure was successful in 455 (94%) patients; angiographic follow-up was available in 377 patients (83%). At follow-up, the rates of restenosis and total occlusion were 62% and 13%, respectively. Five independent predictors of restenosis were identified: the presence of organ damage, a saphenous vein graft (SVG) angioplasty, a bifurcation lesion, a Thrombolysis in Myocardial Infarction (TIMI) flow <3 preprocedure and the degree of residual stenosis. Four independent predictors of vessel occlusion were identified: treatment with insulin, a SVG angioplasty, a TIMI flow <3 preprocedure and the degree of residual stenosis after angioplasty. Late vessel occlusion at angioplasty site(s) was observed in 15% of patients, ranging from 11% for a one-site procedure to 37% for a three-site procedure. This complication was associated with a decrease in ejection fraction at follow-up (-6.2 +/- 9.9%, p = 0.0001), whereas no significant change was observed in patients without occlusion. CONCLUSIONS: This study shows that late vessel occlusion is a frequent mode of restenosis in diabetic patients and is associated with a significant decrease in ejection fraction. This could partly explain the poor long-term clinical outcome reported in such patients after traditional balloon angioplasty.

The angiotensin II type 1 receptor gene polymorphism is associated with coronary artery vasoconstriction.

OBJECTIVES: This study sought to assess the potential association of the angiotensin-converting enzyme (ACE) and angiotensin II type 1 (AT1) receptor gene polymorphisms on coronary vasomotion in humans. BACKGROUND: Abnormal coronary vasomotion plays a role in the clinical expression of coronary atherosclerosis. The components of the renin-angiotensin system are important determinants of vasomotor tone. Furthermore, epidemiologic evidence suggests that these components are involved in the pathogenesis of coronary artery disease. Indeed, two genetic polymorphisms of the ACE and AT1 receptor genes were synergistically associated with the occurrence of myocardial infarction. The influence of these genetic polymorphisms on the risk of myocardial infarction may be related, at least in part, to a deleterious effect on coronary vasomotion. METHODS: We studied the response of angiographically normal human coronary arteries after intravenous injection of methylergonovine maleate, a potent vasoconstrictor whose effects have been previously explored in various aspects of coronary artery disease. We characterized the ACE and AT1 receptor genotypes in a consecutive series of 140 patients with normal coronary arteries. Coronary vasomotion was assessed with quantitative coronary angiography. RESULTS: No effect of the ACE gene polymorphism was detected. Conversely, the patients carrying the AT1 receptor CC genotype (n = 13) had significantly greater vasoconstriction in distal coronary vessels (p < 0.009). CONCLUSIONS: The AT1 receptor gene polymorphism is associated with coronary vasomotion in humans.

Effect of mitral valve surgery on exercise capacity, ventricular ejection fraction and neurohormonal activation in patients with severe mitral regurgitation.

OBJECTIVES: The purpose of this study was to prospectively investigate the effects of surgical correction of mitral regurgitation (MR) on exercise performance, cardiac function and neurohormonal activation. BACKGROUND: Little is known about the effect of surgical correction of MR on functional status or on neurohormonal activation. METHODS: Cardiopulmonary exercise test, radionuclide angiography and blood samples for assessment of neurohormonal status were obtained in 40 patients with nonischemic MR before and within one year (216+/-80 days) after surgery. Twenty-four patients underwent mitral valve repair (MVr), and 16 underwent valve replacement (VR) with anterior chordal transection. RESULTS: Despite an improvement in New York Heart Association functional class, exercise performance did not change (peak oxygen consumption: 19.3+/-6.1 to 18.5+/-5.6 ml/kg/min, percentage of maximal predicted oxygen consumption: 79.5+/-18.2% to 76.8+/-16.9%). After surgery, left ventricular (LV) ejection fraction (EF) decreased (64.2+/-10.3% to 59.9+/-11.4%, p = 0.003) while right ventricular (RV) EF increased (41.4+/-9.6% to 44.7+/-9.5%, p = 0.03). Left ventricular EF did not change after MVr (64.3+/-11.5% to 61.5+/-12.2%), but RVEF improved (40.4+/-9.2% to 46.0+/-10.0%, p = 0.02). In contrast, VR was associated with an impairment of LV function in the apicolateral area and a decrease in LVEF (64.1+/-8.5% to 57.4+/-10.0%, p = 0.01), whereas RVEF did not change (42.9+/-10.3% to 42.8+/-8.6%). Moreover, there was only a slight decrease in neurohormonal activation after surgery. CONCLUSIONS: Despite an improvement in symptomatic status, exercise performance was not improved seven months after either MVr or VR for MR, and neurohormonal activation persisted. Compared with MVr, VR resulted in a significant impairment of cardiac function in this study.

Predictors of restenosis after coronary stent implantation.

OBJECTIVES: We sought to determine predictors of restenosis after coronary stenting (CS) in a consecutive series of patients. BACKGROUND: Although stenting in highly selected patient groups reduces restenosis, the results of stenting in a heterogeneous patient group and the effects of clinical and procedural factors on stent restenosis are currently unclear. METHODS: We analyzed the 6-month angiographic outcome of 500 lesions in 463 consecutive patients undergoing successful CS. Clinical, qualitative and quantitative angiographic variables were correlated with restenosis assessed as both a binary and a continuous variable. RESULTS: Restenosis, defined as the presence of >50% diameter stenosis in the dilated segment, was present in 105 (26%) of the 405 lesions with angiographic follow-up. The mean late lumen loss during the follow-up period was 0.79+/-0.64 mm. Implantation of multiple stents (p < 0.0001) and a high acute gain (p < 0.0002) were independently associated with a higher late lumen loss. In contrast, the use of high inflation pressure (p < 0.02) and Palmaz-Schatz stents (p < 0.005) was independently associated with a lower late lumen loss. When restenosis was defined as a qualitative variable, implantation of multiple stents (p < 0.001), stenosis length (p < 0.01), small reference diameter (p < 0.02) and stent type other than Palmaz-Schatz (p < 0.01) were independent predictors of restenosis. None of the clinical variables tested was associated with restenosis. CONCLUSIONS: Coronary stenting in an unselected patient group is associated with an acceptable restenosis rate. Although some risk factors were identified, the risk of restenosis was not related to most of the variables tested. This suggests that the superiority of CS over balloon angioplasty, in terms of restenosis, might also apply to subgroups of patients that were not included in the recent randomized studies.

Role of nitric oxide in restenosis after experimental balloon angioplasty in the hypercholesterolemic rabbit: effects on neointimal hyperplasia and vascular remodeling.

OBJECTIVES: The purpose of this study was to assess the effects of L-arginine and N(G)-nitro-L-arginine methyl ester (L-NAME) on neointimal hyperplasia and vascular remodeling after balloon angioplasty in the hypercholesterolemic rabbit. BACKGROUND: Restenosis after balloon angioplasty is a consequence of both neointimal hyperplasia and vessel remodeling. Nitric oxide inhibits neointimal hyperplasia, but its effect on vessel remodeling is unknown. METHODS: Six weeks after induction of bilateral iliac atherosclerosis, 48 rabbits underwent successful angioplasty in 75 vessels. Eight rabbits (acute group) were sacrificed immediately after angioplasty. The remaining animals received either placebo (chronic control group), or a diet supplemented with either L-arginine (1.5 g/kg/day), or L-NAME (15 mg/kg/day) for 4 weeks after angioplasty. RESULTS: The intimal area was significantly greater in the chronic control group compared to the acute group (2.60+/-1.03 mm2 vs. 1.35+/-0.62 mm2). This increase in intimal area was lower in the L-arginine group (1.79+/-0.61 mm2), and greater in the L-NAME group (3.23+/-0.92 mm2). The area circumscribed by the internal elastic lamina (IEL) increased significantly in the control group compared to the acute group (from 2.52+/-0.66 to 3.33+/-0.85 mm2); a more marked increase occurred in the L-NAME group (3.90+/-0.85 mm2). By contrast, IEL area was unchanged in the L-arginine group (2.41+/-0.62 mm2). As a result, there was no significant difference in lumen area after 4 weeks in the chronic groups (control: 0.74+/-0.38 mm2; L-arginine: 0.50+/-0.43 mm2; L-NAME: 0.48+/-0.42 mm2). CONCLUSIONS: Our results demonstrate that L-arginine inhibits whereas L-NAME stimulates neointimal hyperplasia after experimental balloon angioplasty in the hypercholesterolemic rabbit. However, the lack of vessel enlargement in the L-arginine group resulted in a similar final lumen size in the L-NAME and L-arginine groups.

Effect of pravastatin on angiographic restenosis after coronary balloon angioplasty. The PREDICT Trial Investigators. Prevention of Restenosis by Elisor after Transluminal Coronary Angioplasty.

OBJECTIVES: This study sought to determine whether pravastatin affects clinical or angiographic restenosis after coronary balloon angioplasty. BACKGROUND: Experimental data and preliminary clinical studies suggest that lipid-lowering drugs might have a beneficial effect on restenosis after coronary angioplasty. METHODS: In a multicenter, randomized, double-blind trial, 695 patients were randomized to receive pravastatin (40 mg/day) or placebo for 6 months after successful balloon angioplasty. All patients received aspirin (100 mg/day). The primary angiographic end point was minimal lumen diameter (MLD) at follow-up, assessed by quantitative coronary angiography. A sample size of 313 patients per group was required to demonstrate a difference of 0.13 mm in MLD between groups (allowing for a two-tailed alpha error of 0.05 and a beta error of 0.20). To allow for incomplete angiographic follow-up (estimated lost to follow-up rate of 10%), 690 randomized patients were required. Secondary end points were angiographic restenosis rate (restenosis assessed as a categoric variable, > 50% stenosis) and clinical events (death, myocardial infarction, target vessel revascularization). RESULTS: At baseline, clinical, demographic, angiographic and lipid variables did not differ significantly between groups. In patients treated with pravastatin, there was a significant reduction in total and low density lipoprotein cholesterol and triglyceride levels and a significant increase in high density lipoprotein cholesterol levels. At follow-up the MLD (mean +/- SD) was 1.47 +/- 0.62 mm in the placebo group and 1.54 +/- 0.66 mm in the pravastatin group (p = 0.21). Similarly, late loss and net gain did not differ significantly between groups. The restenosis rate (recurrence > 50% stenosis) was 43.8% in the placebo group and 39.2% in the pravastatin group (p = 0.26). Clinical restenosis did not differ significantly between groups. CONCLUSIONS: Although pravastatin has documented efficacy in reducing clinical events and angiographic disease progression in patients with coronary atherosclerosis, this study shows that it has no effect on angiographic outcome at the target site 6 months after coronary angioplasty.

Prevention of restenosis future directions.

Restenosis remains the major limitation of percutaneous transluminal coronary angioplasty. Restenosis after balloon angioplasty is due to vascular remodeling and neointimal hyperplasia. In spite of encouraging results in animal models, most of the pharmacological trials of prevention of restenosis in humans have produced negative results. This has prompted interest in the potential role of locally delivered drugs and various balloon catheter systems that are now available to achieve local delivery of therapeutic agents at the site of arterial injury. In 1997, implantation of a coronary stent in conjunction with balloon angioplasty is performed in an increasing number of patients. Randomized studies have shown that coronary stenting may reduce the risk of restenosis. In addition, restenosis after coronary stenting is mainly due to neointimal hyperplasia. Restenosis within coronary stents might thus be much more sensitive to therapies designed to inhibit neointimal hyperplasia than restenosis after balloon angioplasty. Thus, the future prevention of restenosis might well be the combination of a mechanical device that produces the widest possible lumen and prevents vessel constriction with a pharmacologic approach to inhibit the proliferative process. (Trends Cardiovasc Med 1997;7:90-94). © 1997, Elsevier Science Inc.

[Biochemical evaluation of the results of lipid regulating treatment in France]. / Evaluation biologique des résultats du traitement hypolipémiant en France. Etude SPOT.

The objective of the SPOT study (Study of Practice versus Objectives of Treatment) was the biochemical evaluation of the results of long term lipid regulating treatment in France, compared to the objectives defined by AFSSAPS (French regulatory agency for the safety of medical products) in 2000. A random sample of doctors was recruited in 21 French regions by the Regional Health Observation service. To be included in the SPOT study, the patients had to be on lipid regulating medication for at least six months and consent to biochemical evaluation following a consultation. A sample of 641 doctors examined 2,479 patients treated for 7 years on average. These middle aged patients (aged 63 +/- 11 years) were mostly taking statins (72%). They had an average total cholesterol level of 5.41 +/- 1.01 mmol/L (2.10 +/- 0.39 g/L). and LDL of 3.25 +/- 0.93 mmol/L (1.26 +/- 0.36 g/L), reflecting previous results and confirming the stability of their treatment. In primary prevention and in low risk subjects (with less than 2 associated risk factors), the AFSSAPS objectives were achieved in 95% of cases. In secondary prevention or in very high risk subjects (at least 3 associated risk factors 0), 35% of patients had LDL cholesterol greater than 3.4 mmol/L (1.30 g/L). The SPOT study, performed on subjects who had in theory been stabilised with lipid regulating medication, gave two conclusions: cardiovascular prevention with lipid regulating medication is improving in France, and the subjects at greatest risk attain the recommended objectives less often despite the expected benefit of treatment being higher.

[Management of patients admitted for acute myocardial infarction in France from 1995 to 2000: time to admission dependent improvement in outcome]. / Prise en charge de l'infarctus du myocarde en France dans les études USIK 1995 et USIC 2000: amélioration pronoslique et rôle du délai d'admission.

The in-hospital management and short- and long-term outcomes was assessed in 2 registries of consecutive patients admitted for acute myocardial infarction, 5 years apart, in France. The 2000 cohort was younger and with a less frequent history of cardiac diseases, but was more often diabetic and with anterior infarcts. Time to admission was actually longer in 2000 than in 1995 (median 5.25 hours vs 4.00 hours). Overall, reperfusion therapy was used in 43% of the patients in both registries. However, the use of reperfusion therapy increased from 1995 to 2000 in patients admitted within 6 hours of symptom onset (64 vs 58%), with an increasing use of primary angioplasty (from 12 to 30%). Five-day mortality significantly improved from 7.7 to 6.1% (p < 0.03) and one-year survival was also less in the most recent period (85 vs 81%, p < 0.01). Multivariate analyses showed that the period of inclusion (2000 vs 1995) was an independent predictor of both short- and long-term mortality in patients admitted within 6 hours of symptom onset. Thus, in the real world setting, a continued decline in one-year mortality was observed in patients admitted to intensive care units for recent acute myocardial infarction, especially for patients admitted early. This goes along with a shift in reperfusion therapy towards a broader use of primary angioplasty, and with an increased use of the early prescription of recognised secondary prevention medications.

[Clinical and therapeutic specificities of myocardial infarction in patients with peripheral arterial disease: the USIC 2000 registry]. / Particularités cliniques et thérapeutiques de l'infarctus du myocarde chez l'artéritique: etude à partir du registre USIC 2000.

OBJECTIVE: Several studies underlined the worse prognosis of myocardial infarction (MI) among patients with peripheral arterial disease (PAD). We sought to describe the presentation and management modalities of a cohort of PAD patients presenting an acute MI, compared to those without PAD. MATERIALS AND METHODS: The USIC 2000 registry, a nationwide database on all patients admitted to a CCU for an acute MI < 48 hours in France in November 2000 was used for this study. RESULTS: Among the 2311 patients included, PAD was reported in 215 subjects (9.3%). In multivariate analysis, the following factors were positively related to the presence of PAD (P < or = 0.05): age >75 y (OR = 2.3), diabetes (OR = 2.0), hypertension (OR = 1.4), active smoking (OR = 4.6), renal failure (OR =3.1), and treatments with antiplatelets (OR = 3.9), anti-vitamin K (OR = 1.9), statins (OR = 1.7) and low molecular weight heparins (OR = 6.8). By introducing the data concerning the arrival in CCUs in the model, the following factors were also significantly more frequent among PAD patients: male sex (OR = 1.6), past history of coronary artery disease (OR = 2.2), left bundle branch block (OR = 1.8) and late management >6 hours (OR = 1.4). Conversely, ST-segment elevation was less frequent (OR = 0.7). When the CCU stay data were introduced in the model, a lower rate of coronary stenting (OR = 0.7) and betablockers use within 48 hours of admission (OR = 0.6) were noted. CONCLUSION: Beyond the presence of PAD per se, several particularities do exist, especially the coexistence of a high number of pejorative factors and an under-utilization of treatments presenting prognostic benefits.