Percutaneous coronary interventions in cardiac allograft vasculopathy: a single-center experience.

OBJECTIVE: Cardiac allograft vasculopathy represents an accelerated form of obstructive coronary disease. It is the main cause of late death following heart transplantation. Percutaneous coronary intervention is considered a palliative procedure due to high restenosis rates. The aim of this study was to review our experience with percutaneous coronary interventions using stents in cardiac transplant recipients. METHODS: The present analysis included all primary adult heart transplanted patients who had been discharged from the hospital after transplantation, had a clinical follow-up of 12 months and underwent percutaneous coronary intervention (PCI). RESULTS: Seventy heart transplanted patients underwent percutaneous revascularization. Our analysis comprised 85 first-vessel procedures resulting in treatment of 135 lesions. The mean time from heart transplantation to first intervention was 9.3 +/- 4.8 years. Primary success was obtained in 96% lesions; at least 1 recurrent stenosis event occurred in 16 patients with primarily successful PCI. Lesions treated with drug-eluting stents experienced recurrent stenosis in 16% of cases. During a mean follow-up after PCI of 45.2 +/- 41.7 months, 27 deaths (19 cardiac) and 1 late re-transplantation occurred after PCI. CONCLUSION: In cardiac transplant recipients, percutaneous coronary intervention with stents can be performed safely with high rates of primary success. Restenosis rates were higher compared with coronary interventions in native coronary arteries. Drug-eluting stents seemed to favorably impact restenosis compared with bare-metal stents. The clinical benefit from percutaneous coronary intervention may be reduced due to disease progression in untreated coronary segments.

Urgent surgery in patients with a recently implanted coronary drug-eluting stent: a phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel.

BACKGROUND: Patients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding. METHODS: Phase II study with a Simon two-stage design. RESULTS: Thirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding. CONCLUSIONS: In patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.

[Limitations and usefulness of coronary stents in diverse clinical conditions. Long-term course]. / Limiti e utilità degli stent coronarici nelle varie condizioni cliniche. Decorso a lungo termine.

Since the introduction of balloon angioplasty, the acceptance and widespread application of coronary stents is the most important advance in interventional cardiology. The option of bail-out stenting has liberated interventionalists from the restrains of surgical stand-by. It has also allowed more aggressive balloon angioplasty and better short- and long-term results. This progress was enabled by improvements in deployment technique and antiplatelet therapy preventing most of the vexing problems of subacute stent thrombosis. Whereas initial registries and randomized trials focused on specific narrow patient populations, the clinical indications are broadening based on the results of new clinical trials that have focused on expanding populations, such as restenotic lesions, small vessels, total chronic occlusions, saphenous vein grafts stenoses, and acute ischemic syndromes. Despite this progress, a solution to the problem of in-stent restenosis, although less frequent than after balloon angioplasty alone, is still pending. In this review, we will discuss the process of restenosis which is the main indication for the use of stents, then we will analyze the application of stents in some particular clinical and anatomical situations and finally we will focus on in-stent restenosis which is the main limitation for stenting.

Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent.

UNLABELLED: Rapid technological developments have made new materials available for percutaneous coronary intervention procedures. The coronary stent in particular has undergone progressive structural improvements leading to the recent availability of a third generation of stents, namely, coated stents. The rapid evolution of the stent has often made its evaluation problematical, since trials are frequently confined to small groups of patients in single centers. The purpose of this registry was to verify the safety and efficacy of the BiodivYsio stent (a stent coated with phosphorylcholine polymer) in a broad population of patients who reflect the daily reality of coronary intervention in a cardiac catheterization laboratory. METHODS AND RESULTS: The registry was designed to collect the principal angiographic and clinical data of a consecutive series of Oreal worldO patients. Patients were treated with a BiodivYsio stent (Biocompatibles, Galway, United Kingdom) in 12 centers (11 Italian and 1 Swiss) between January 1998 and January 1999. Procedural, in-hospital, 30-day and six-month follow-up data were collected. The monitoring, data entry and statistical analyses were carried out by an independent center. During the study, 218 patients were enrolled; 165 (76%) male and 53 (24%) female, with an average age of 61.6 +/- 9.4 years (range, 36Eth 84 years). A total of 258 stents were implanted in 233 lesions (1.1 stents per lesion), of which 233 (90%) were the BiodivYsio PC coated stent, the remaining 25 implants were of other stent types. The percutaneous transluminal coronary angioplasty and stenting procedure were carried out in 109 (50%) patients with unstable angina, 65 (30%) with stable angina, 29 (13%) with acute myocardial infarction, and 15 (7%) patients with silent ischemia. Procedural success was achieved in 217/218 (99.5%) patients. Optimal results were achieved in 212 (97.7%) patients. In 34 (15.6%) cases, patients were treated with periprocedural abciximab. During the hospitalization period, one (0.4%) death occurred on day 7 due to subacute occlusion of the stent, and 3 (1.4%) myocardial infarctions were reported. At 30-day follow-up, 211 (97.2%) patients were asymptomatic, as were 189 (87%) patients at clinical follow-up at 6 months. CONCLUSIONS: This study evaluated the safety and efficacy of a third-generation stent. The results demonstrate a high procedural success rate and a low incidence of major adverse cardiac events at short- and medium-term follow-up. It appears that the BiodivYsio stent should be considered safe in clinical and/or anatomical situations with a high risk of complications, confirming the hypothesis that PC may have non-thrombogenic properties. To corroborate these results, an appropriately designed study would be required to measure the stentOs efficacy in the most suitable clinical context, i.e., clinical situations that are at the highest risk of ischemic relapse.

Adjunctive thrombus aspiration and mechanical protection from distal embolization in primary percutaneous intervention for acute myocardial infarction.

Primary percutaneous intervention for acute occlusion of a native coronary artery may be complicated by distal embolization of plaque or thrombotic debris, with infarct extension. We tested the clinical application of a new therapeutic strategy combining maximal antiplatelet therapy, with glycoprotein IIb/IIIa inhibition, and adjunctive mechanical protection from distal embolization and direct aspiration of thrombus with a new balloon and catheter system (PercuSurgetrade mark). Successful aspiration of thrombus could be obtained in 7 out of 8 attempted procedures, with inability to negotiate the angulated take-off of the circumflex coronary artery in one patient. The current mechanical characteristics of the device, primarily developed for use in larger saphenous vein grafts, and certain caveats and limitations are discussed. New dedicated systems should be available in the near future for the native coronary circulation. Excellent immediate angiographic results were obtained in all treated patients, without evidence of loss of distal branches and no intraprocedural complications.

[The initial experience of the use of ReoPro in high-risk coronary angioplasty in Italy: the Italian Registry on the Conditions for the Use of ReoPro during Angioplasty (R.I.CO.R.D.A.)]. / Esperienza iniziale sull'impiego di ReoPro nell'angioplastica coronarica ad alto rischio in Italia: Registro Italiano sulle Condizioni d'Uso di ReoPro durante Angioplastica (R.I.CO.R.D.A.).

BACKGROUND: The R.I.CO.R.D.A. Registry was created with the aim of monitoring early Italian experience on the use of abciximab (ReoPro) in the setting of high-risk coronary angioplasty (PTCA). Indication for enrollment included abciximab administration either on an elective basis (i.e. preprocedural or planned) or as bailout for complicated PTCA (i.e. intraprocedural, as a rescue treatment). METHODS: From June 1996 to January 1998, 359 patients undergoing PTCA on 443 lesions were enrolled in 24 Italian catheterization laboratories. In 91/359 patients (25%) abciximab was administered as bailout, and in the remaining cases on an elective basis as a pre-PTCA treatment. RESULTS: The incidence of death, coronary artery bypass grafting, Q wave and large non-Q wave myocardial infarction, small non-Q wave myocardial infarction and recurrent ischemia in the elective group were 1.9, 1.9, 2.6, 6.7 and 3.4%, respectively. In the bailout group corresponding figures were 4.4 (p = NS), 3.3 (p = NS), 16.5 (p < 0.01), 16.5 (p < 0.01) and 12.1% (p < 0.01), respectively. The heparin dose during PTCA was quite variable, particularly in the very early stages. Overall, 46% of patients received a heparin dose of < or = 5000 IU, and the remaining a higher dose, more often 10,000 IU. The latter group showed a significantly higher incidence of bleeding complications (25 vs 10%, p < 0.01). The incidence of bleeding was almost double in patients treated with bailout abciximab as compared with the elective group (29 vs 15%, p < 0.01), according to the higher heparin dose administered (9253 +/- 3341 vs 6649 +/- 3156 IU, p < 0.01). Overall, the incidence of red blood cell transfusions was 5.8%. CONCLUSIONS: The results of this Registry shed light on the actual use of abciximab in the setting of high-risk PTCA in Italy. The incidence of cardiac events and bleeding complications in the group of patients treated on an elective basis is comparable to that reported in the main large-scale international trials. The bailout abciximab group showed a higher incidence of both cardiac events and bleeding complications.

A rare case: surviving acute left main coronary artery occlusion in Kawasaki's disease.

We present a case of cardiogenic shock due to acute thrombotic occlusion of the left main coronary artery in Kawasaki's aneurysmal coronary artery disease. The patient was treated with PTCA as a bridge to CABG. Because of a persistent low-output syndrome, orthotopic heart transplantation was successfully performed three days later. The patient is alive and well one year after the event.

Coronary angioplasty and coronary artery remodeling.

Coronary artery remodeling is an active process of structural changes in vascular wall structures, in response to varied physiologic or pathologic stimuli. In the past few years, the advent of a new imaging modality such as intravascular ultrasound has allowed in vivo studies, increasing our understanding of this phenomenon. This article reviews some fundamental concepts of coronary vascular remodeling in atherosclerosis and after angioplasty.

Long-term effects of carvedilol in idiopathic dilated cardiomyopathy with persistent left ventricular dysfunction despite chronic metoprolol. The Heart-Muscle Disease Study Group.

OBJECTIVES: The purpose of this study was to analyze whether long-term treatment with the nonselective beta-adrenergic blocking agent carvedilol may have beneficial effects in patients with dilated cardiomyopathy (DCM), who are poor responders in terms of left ventricular (LV) function and exercise tolerance to chronic treatment with the selective beta-blocker metoprolol. BACKGROUND: Although metoprolol has been proven to be beneficial in the majority of patients with heart failure, a subset of the remaining patients shows long-term survival without satisfactory clinical improvement. METHODS: Thirty consecutive DCM patients with persistent LV dysfunction (ejection fraction < or =40%) and reduced exercise tolerance (peak oxygen consumption <25 ml/kg/min) despite chronic (>1 year) tailored treatment with metoprolol and angiotensin-converting enzyme inhibitors were enrolled in a 12-month, open-label, parallel trial and were randomized either to continue on metoprolol (n = 16, mean dosage 142+/-44 mg/day) or to cross over to maximum tolerated dosage of carvedilol (n = 14, mean dosage 74+/-23 mg/day). RESULTS: At 12 months, patients on carvedilol, compared with those continuing on metoprolol, showed a decrease in LV dimensions (end-diastolic volume -8+/-7 vs. +7+/-6 ml/m2, p = 0.053; end-systolic volume -7+/-5 vs. +6+/-4 ml/m2, p = 0.047), an improvement in LV ejection fraction (+7+/-3% vs. -1+/-2%, p = 0.045), a reduction in ventricular ectopic beats (-12+/-9 vs. +62+/-50 n/h, p = 0.05) and couplets (-0.5+/-0.4 vs. +1.5+/-0.6 n/h, p = 0.048), no significant benefit on symptoms and quality of life and a negative effect on peak oxygen consumption (-0.6+/-0.6 vs. +1.3+/-0.5 ml/kg/min, p = 0.03). CONCLUSIONS: In DCM patients who were poor responders to chronic metoprolol, carvedilol treatment was associated with favorable effects on LV systolic function and remodeling as well as on ventricular arrhythmias, whereas it had a negative effect on peak oxygen consumption.

Stent thrombosis: incidence and related factors in the R.I.S.E. Registry(Registro Impianto Stent Endocoronarico)

Although stent thrombosis has been greatly reduced by adequate stent expansion with high-pressure balloon inflations and by the use of antiplatelet drugs, this event is still frightening, as it may lead to acute myocardial ischemia resulting in acute myocardial infarction or sudden death. Therefore, the definition of factors associated with stent thrombosis may provide a better understanding of the mechanisms underlying this phenomenon and may permit us to define therapeutic strategies to further reduce its occurrence. The purpose of this study was to assess factors responsible for the occurrence of stent thrombosis after coronary stent implantation in 939 consecutive patients enrolled in the Registro Impianto Stent Endocoronarico (R.I.S.E. Study Group). Consecutive patients undergoing coronary stent implantation at 16 medical centers in Italy were prospectively enrolled in the registry. Clinical data, and qualitative and quantitative angiographic findings were obtained from data collected in case report forms at each investigator site. The study group consisted of 781 men and 158 women with a mean age of 59 yr: 1,392 stents were implanted in 1,006 lesions and expanded at a maximal inflation pressure of 14.7 +/- 3 atm. The great majority of patients (92%) received only antiplatelet drugs after coronary stenting. During hospitalization there were 45 major ischemic complications in 39 patients (4.2%): 13 events were related to acute or subacute thrombosis (1.4%). Another stent thrombotic event occurred in the first month of follow-up. On multivariate logistic regression analysis, stent thrombosis was related to the following factors: unplanned stenting (OR 3.46, 95% CI 1.65-7.23), unstable angina (OR 3.37, 95% CI 1.11-10.14) and maximal inflation pressure (OR 0.83, 95% CI 0.75-0.93). In conclusion, this registry shows that in an unselected population of patients undergoing coronary stenting, stent thrombosis occurs in less than 2% of patients and is significantly related to unplanned stent implantation, unstable angina, and maximal inflation pressure. The incidence of this phenomenon is likely to be further reduced by the use of new potent antiplatelet drugs, such as platelet glycoprotein IIb/IIIa antagonists.

Treatment of a native right coronary artery with the PercuSurge Guardwire protection system during PTCA and stenting.

Cardiac catheterization in a patient with recent-onset unstable angina demonstrated a suboccluded dominant right coronary artery (RCA), with angiographic evidence of a large thrombus load and a severe focal stenosis of the left anterior descending (LAD) coronary artery. After abciximab, uneventful PTCA and stenting of the LAD was performed. The thrombus containing lesion of RCA was treated with balloon predilatation and stent deployment, and the whole procedure was accomplished with protection of the distal vessel by means of PercuSurge. This device was planned to avoid distal debris migration during percutaneous interventions of saphenous bypass grafts. The system is designed to allow the placement of a temporary occlusion device, a low-profile balloon, distal to the lesion to be treated during the procedure. The occlusive balloon is kept inflated during the treatment of the lesion. Before deflating the balloon and allowing blood to reach the distal vessel, whenever it is necessary, the material proximal to the balloon is aspirated through a monorail catheter. This aspiration removes blood and thrombi proximal to the occlusive balloon from the treated coronary artery. The case we present first reports the application of the device in a large native coronary artery, with an optimal distal flow restoring and no evidence of thrombus embolization. This type of protection of distal coronary vessels towards micro- and macroembolization of thrombi is a promising system of performing safer percutaneous interventions, even in acute ischemic syndromes.

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Predictors of major in-hospital ischemic complications and length of hospital stay after coronary stenting.

Although recent data show that coronary stenting reduces procedural complications and late restenosis, major concern has been expressed about the greater hospital cost associated with the use of this device as compared to conventional coronary angioplasty. Since length of hospital stay after surgical procedures is a major determinant of resource use, the identification of variables associated with an excessively long hospital stay after intracoronary stent placement may have important practical consequences. The purpose of this study was to assess factors responsible for the occurrence of in-hospital complications and prolonged hospital stay after coronary stenting in 939 consecutive patients enrolled in the Registro Impianto Stent Endocoronarico (RISE Study Group). Consecutive patients undergoing coronary stent implantation at 16 medical centers in Italy were prospectively enrolled in the Registry. Clinical data, qualitative and quantitative angiographic findings were obtained from data collected in case report forms at each investigator site. Major ischemic complications were considered death, Q-wave myocardial infarction, emergency bypass surgery and emergency repeat angioplasty. The study group consisted of 939 patients (781 men, 158 women with a mean age of 59 years) in whom 1392 stents were implanted in 1006 lesions and expanded at a maximal inflation pressure of 14.7 +/- 3 atmospheres. The great majority of patients (92%) received only antiplatelet drugs after coronary stenting. During hospitalization, there were 45 major ischemic complications in 39 patients (4.2%): 13 events were related to acute or subacute thrombosis (1.4%). On multivariate logistic regression analysis, the following factors were predictive of in-hospital complications: increasing age (OR 2.19, 95% CI 1.18-4.07), unplanned stenting (OR 3.46, 95% CI 1.65-7.23) and maximal inflation pressure (OR 0.83, 95% CI 0.75-0.93). Mean hospital stay after stent implantation was 4.1 +/- 4.4 days and was related, by multivariate regression analysis, to female sex (p = 0.0001), prior bypass surgery (p = 0.03), non-elective stenting (p = 0.0001), use of anticoagulation (p = 0.0001) and development of major ischemic complications (p = 0.0001). This Registry shows that in an unselected population of patients undergoing coronary stenting, major ischemic complications occur at a relatively low rate (4.2%) and thrombotic events can be kept at 1.4%, despite the omission of anticoagulation in the great majority of patients. Length of hospital stay was affected by the occurrence of major ischemic complications, unplanned stenting, use of anticoagulation, female sex and prior bypass surgery. Accumulating experience, further reduction in complications and complete omission of anticoagulation may decrease length of hospital stay, thus reducing the use of resources after coronary stenting.

[Clinical polymorphic presentation and natural history of active myocarditis: experience in 60 cases]. / Polimorfismo clinico di presentazione e storia naturale della miocardite attiva: esperienza su 60 casi.

Eight-hundred thirty patients (pts) with suspected myocardial disease of undefined etiology were observed from 1978 to 1996. In 350 pts, the clinical diagnosis was of dilated cardiomyopathy (DCM) or myocarditis. An endomyocardial biopsy was performed on all patients and in 54 of them (15%), an active myocarditis was identified. In six cases, myocarditis was detected at autopsy. There were 37 male patients and 23 females, with an average age of 35.5 +/- 15 years (range 1.67). Mean time interval between clinical onset and diagnosis was 4 +/- 10 months. Clinical presentation was characterized in 4 cases by fulminant myocarditis (Group I), in 8 cases by chest pain (Group II), in 14 cases by arrhythmia (Group III: hypokinetic in 9 pts and hyperkinetic in 5) and, in the last 34 pts, by congestive heart failure (CHF) (Group IV). Improvement was defined at 9 +/- 3 months according to a clinical score based on left ventricular shortening fraction (increase > or = 5 units), New York Heart Association Class improvement by (at least one Class) and left ventricular end-diastolic diameter (decrease > or = 10%). The main clinical and instrumental parameters characterizing the groups were: a more severe dilatation and left ventricular dysfunction in the pts belonging to Group I or IV with respect to those in Group II and III; a significantly worse prognosis in terms of evolution in DCM or death/cardiac transplantation (CT) in the pts from the Group II and III. After a follow-up period of 48 +/- 46 months, the mortality in the four groups was: 100% (4/4), 0% (0/8), 21% (3/14), 38% (13/34). Fifty percent of deaths were concentrated in the first 2 years of follow-up. Left ventricular end-diastolic diameter (OR 1.09, p < 0.05), age (OR 0.95), presence of left ventricular bundle branch block (OR 2.32), right ventricular function (OR 2.43) at clinical onset and the status of improvement at 9 +/- 3 months of follow-up (OR 0.24, p < 0.05) are predictors of evolution in DCM or death/CT for the pts with onset from CHF (Group IV). Immunosuppressive treatment has been utilized for the 76% of the pts. No conclusion can be drawn on the efficacy of this therapy, but no adverse events significantly related to therapy have been observed in a 9 +/- 3 months follow-up period. In conclusion, myocarditis can show a clinical presentation polymorphism, which influences the prognosis and natural history of the disease. Evolution in DCM and adverse events (death/CT) are more common in Groups I and IV. Some simple parameters evaluated at clinical presentation and the proposed classification as "improved" or "not improved" after a short-term follow-up (9 +/- 3 months) show good predictive accuracy. The present study does not allow us to draw any conclusion about the efficacy of immunosuppressive treatment. A randomized, controlled, large-scale trial, with adequate follow-up and advanced histological diagnosis techniques will help define the role of immunosuppressive therapy and patient eligibility criteria for this treatment.

[Effectiveness of the Palmaz Schatz stent in elderly patients with unstable angina: factors predictive of short-term and long-term events]. / Efficacia dello stent di Palmaz Schatz nel paziente anziano con angina instabile: fattori predittivi di eventi a breve e lungo termine.

INTRODUCTION: To evaluate clinical, procedural and therapeutical predictors of in- and out-hospital events in the elderly, we analyzed 69 consecutive patients (age: 74, range: 70-87) with unstable angina who successfully underwent Palmaz Schatz coronary stenting. METHODS: Between March 1991 and March 1994, after the stenting procedure, a cohort of 38 patients (AC) was treated with iv heparin for 48 hours, warfarin (dosage titrated on INR) and dipiridamole (75 mg tid) for 3 months, aspirin (325 mg a day) chronically; between April 1994 and April 1995, after 48 hours of iv heparin, a second cohort of 31 patients (NO AC) received subcutaneous low molecular weight heparin (4000 U a day) for a week, ticlopidine (250 bid) for 1 month, and aspirin (100 mg a day) chronically. NO AC patients showed, by protocol, a higher postdilatation pressure (14 +/- 2 vs 9 +/- 3 atm, p < 0.0001). RESULTS: The 2 cohorts of patients were similar with respect to baseline clinical and angiographic findings. A shorter hospital stay (5 +/- 2 vs 10 +/- 6 days, p < 0.0001) and a lower incidence of in-hospital events were seen in the NO AC group (3.2 vs 24%, p = 0.028), both by a reduction of ischaemic events (3.2 vs 10.5%, p = ns) and hemorrhagic events (0 vs 13.2%, p = 0.03). During a mean follow-up of 21 +/- 13 months, NO AC patients did not show a significant lower rate of out-hospital events (1 year event-free survival respectively 94.7% in NO AC cohort vs 85.7% in AC cohort, p = ns). At logistic regression model, anticoagulant therapy (OR 10.89, Cl 1.39-85.28, p < 0.05) and refractory angina (Braunwald C3) (OR 5.70, Cl 1.12-29.03, p < 0.05) were significantly related to the incidence of acute events, while refractory angina (OR 5.76, Cl 1.27-26.00, p = 0.02) and multivessel disease (OR 3.31, Cl 0.89-12.20, p = 0.07) to the occurrence of late cardiac events, particularly for a higher risk of non-target site new revascularizations. Stent implantation on saphenous vein graft was also associated to a higher risk of repeating a revascularization of non-treated sites (20 vs 4%, p = 0.021). CONCLUSIONS: In elderly with unstable angina treated with Palmaz Schatz stenting, NO AC patients showed a significant reduction of in-hospital events without a subsequent higher risk of late events. In addition, refractory angina, multivessel disease and stent implantation on saphenous vein graft were the other main clinical variables predictive of out-hospital events particularly for higher risk of non-target site new revascularizations.

Predictive value of heart rate in dilated cardiomyopathy treated with metoprolol.

UNLABELLED: Predictive factors of a favourable response to beta-blocker therapy are still unknown and the role of heart rate remains controversial. AIM: To investigate the relation between heart rate and the response to chronic metoprolol treatment in patients with dilated cardiomyopathy (DCM). METHODS: Ninety-eight consecutive patients with DCM, left ventricular ejection fraction (LVEF) < or = 0.40 and blood pressure < or = 140/90 mmHg were treated with metoprolol, associated with digitalis, diuretics and ACE-inhibitors. After 24 +/- 6 months, 48 patients (49%) were classified as "improved" on the basis of a clinical/instrumental score. RESULTS: Rest, mean 24-hour and maximal exercise heart rate were all significantly and directly related to the probability of improvement, but heart rate at rest, supine and in upright position, showed the highest predictive power. The relationship between heart rate and improvement with metoprolol appeared to be non-linear, with an increasing probability in patients with higher heart rate, but with a fall of the slope in cases with extreme tachycardia. By dividing our study population on the basis of the most important clinical variables, this complex relation was evident only in patients at a more advanced stage of the disease. CONCLUSION: Our analysis confirms the strict relationship between heart rate and improvement with chronic metoprolol therapy in patients with DCM. This relation seems to be non-linear and is influenced by the severity of the disease.

Optimised method for determination of ticlopidine in serum by high performance liquid chromatography.

In this study we verified whether high performance liquid chromatography with UV detection (HPLC-UV) could be optimised and hence become a useful method for measuring ticlopidine concentrations in patient blood. The extraction step was improved by adding isoamylic alcohol in the extraction mixture, resulting in a better recovery. Moreover, the extraction efficiency was consistently ameliorated by evaporation to dryness of the organic extract; we could therefore utilise a lower (213 nm) wavelength, corresponding to the maximum of absorption, achieving a better sensitivity. With these technical improvements, the limit of quantitation is 0.02 microgram/ml, and the limit of detection is 0.01 microgram/ml, hence comparable to levels obtained with gas-liquid chromatography with nitrogen detection (GC-NPD). In addition, HPLC method, if compared with GC-NPD, is simpler and can be easily used for routine determinations of a lot of serum samples.

Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group.

OBJECTIVES: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.