OBJECTIVE: To compare in a randomised trial the procedural and clinical outcome and long term patency of conventional angioplasty with optional stent implantation versus direct stenting without predilatation. METHODS: Patients undergoing coronary intervention for symptomatic coronary artery disease were randomly assigned to conventional angioplasty with optional stenting or to direct stent implantation without predilatation. The post-stent treatment consisted of antiplatelets. Follow up angiography was performed six months after the initial procedure. RESULTS: Between December 1998 and August 1999, 181 of 190 eligible patients were randomly assigned to either optional stenting (n = 92) or direct stenting (n = 89). The procedural success was similar in both groups (87 (97.8%) in the optional v 87 (94.6%) in direct stenting group, p = 0.88). There were five cases of crossover from the direct stenting to the optional stenting group. Six patients experienced a Q wave myocardial infarction without further complications (4 in the optional v 2 in the direct stenting group, p = 0.36). One patient in whom coronary angioplasty failed underwent elective bypass surgery. No patients required urgent bypass surgery and no patients died. The reduction in late luminal loss (mean (SD) 1.19 (0.87) mm in the optional v 0.62 (0.69) mm in the direct stenting group, p = 0.004) led to a significant improvement in minimal luminal diameter at follow up (1.87 (0.93) mm in the optional v 2.56 (0.86) mm in the direct stenting group, p = 0.002), resulting in a significant reduction in restenosis rate, defined as > 50% diameter stenosis at follow up 6.5 (2.1) months after the initial procedure (28 (30.4%) in the optional v 14 (15.7%) in the direct stenting group, p = 0.019). Direct stenting significantly reduced the overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angioplasty catheters needed. The incidence of clinical events during the six month follow up did not differ significantly between the groups. No patient died during follow up. CONCLUSIONS: Direct stent implantation without predilatation significantly reduced late luminal loss, giving a better improvement in minimal luminal diameter and restenosis rate than with optional stenting. There were five patients in whom direct stenting failed who needed predilatation followed by stent implantation. However, in most patients direct stent implantation without predilatation is a feasible treatment option with a favourable long term outcome and a low incidence of complication. The procedure may help to reduce the cost of coronary interventions by reducing overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angiography catheters needed.

Angioplasty, Balloon, Coronary↗

PubMed2001

The Na(+)/H(+) exchange inhibitor eniporide as an adjunct to early reperfusion therapy for acute myocardial infarction. Results of the evaluation of the safety and cardioprotective effects of eniporide in acute myocardial infarction (ESCAMI) trial.

OBJECTIVES: We conducted an international, prospective, randomized, double-blind, placebo-controlled phase 2 trial in patients undergoing thrombolytic therapy or primary angioplasty for acute ST-elevation myocardial infarction (MI) to investigate the effect of eniporide on infarct size and clinical outcome. BACKGROUND: Experimental studies suggest that the activity of the Na(+)/H(+) exchange (NHE) plays an important role in the unfavorable sequels of myocardial ischemia and reperfusion. Eniporide specifically inhibits the NHE-1 isoform and has been shown to limit infarct size in experimental models. METHODS: The primary efficacy end point was the infarct size measured by the cumulative release of alpha-hydroxybutyrate dehydrogenase (alpha-HDBH) (area under the curve [AUC] 0 to 72 h). In stage 1, 50, 100, 150 or 200 mg eniporide given as a 10-min infusion before start of reperfusion therapy were compared with placebo in 430 patients, and in stage 2, 100 and 150 mg eniporide were compared with placebo in 959 patients. RESULTS: In stage 1, the administration of 100 mg and 150 mg eniporide resulted in smaller infarct sizes (mean alpha-HBDH AUC in U/ml x h, placebo: 44.2, 100 mg eniporide: 40.2, 150 mg eniporide: 33.9), especially in the angioplasty group. In contrast, in stage 2 there was no difference in the enzymatic infarct size between the three groups (placebo: 41.2, 100 mg eniporide: 43.0, 150 mg eniporide: 41.5). Overall there was no effect of eniporide on clinical outcome (death, cardiogenic shock, heart failure, life-threatening arrhythmias). However, there was a significant reduction of the incidence of heart failure in patients reperfused late (>4 h). CONCLUSIONS: In this large study administration of the NHE-1 inhibitor eniporide, before reperfusion therapy in patients with acute ST elevation MI, did not limit infarct size or improve clinical outcome.

Adult↗

PubMed2001

Extent of ST-segment deviation in a single electrocardiogram lead 90 min after thrombolysis as a predictor of medium-term mortality in acute myocardial infarction.

BACKGROUND: In evolving myocardial infarction, assessment of the sum of early resolution of ST-segment elevation (sumSTR) has become an established method to predict outcome. We have found previously that mortality is predicted more accurately by the existing ST-segment deviation in the single electrocardiograph (ECG) lead with maximum deviation (maxSTE) 90 min after start of thrombolysis. This report compares the power to predict medium-term mortality by these two approaches. METHODS: An ST-segment resolution substudy was done in conjunction with the Intravenous nPA for Treatment of Infarcting Myocardium Early (InTIME) II Study, which compared mortality in patients with acute myocardial infarction randomly assigned lanoteplase or alteplase. In 2719 patients, a 12-lead ECG was assessed at baseline and 90 min after the start of thrombolytic therapy. FINDINGS: MaxSTE achieved a better combination of sensitivities and specificities for mortality prediction than sumSTR. The area under the receiver-operating characteristic curves for 180-day mortality prediction was 0.680 for maxSTE and 0.622 for sumSTR (difference 0.058; 95% CI 0.027-0.088). Risk groups categorised at low, medium, or high risk by maxSTE comprised 43%, 32%, and 24% of patients and those by complete, partial, or no sumSTR comprised 40%, 36%, and 24% of all patients. The 180-day mortality rates for the three maxSTE risk groups were 3.1%, 7.1%, and 16.2%, and those for the sumSTR groups were 4.8%, 8.1%, and 11.7%. The 12-month Kaplan-Meier estimates were 4.1%, 8.8%, and 18.6%, and 5.9%, 9.9%, and 13.7%, respectively. INTERPRETATION: MaxSTE predicts early and medium-term mortality more accurately than does sumSTR. The prognosis for an individual patient can be accurately estimated simply by the ST-segment deviation present in one ECG lead recorded 90 min after thrombolysis.

Electrocardiography↗

PubMed2001

[Leading symptoms of chest pain in the emergency room. Using cardiac markers for risk stratification].

BACKGROUND AND OBJECTIVE: The acute coronary syndrome (ACS)--acute infarction or unstable angina pectoris--requires special monitoring and differentiated treatment. A prospective trial was undertaken to determine (1) clinical characteristics of patients with chest pain; (2) value of cardiac markers troponin T, myoglobin and CK-MB mass in differentiating cardiac and noncardiac chest pain; (3) the proportion of patients with ACS in whom these markers provided helpful additional information on admission and afterwards. PATIENTS AND METHODS: 233 consecutive patients (134 men, 99 women; aged 18-98 years), presenting in 1998 with nontraumatic chest pain at the emergency unit of the Lippe-Detmold Hospital were prospectively enrolled in the study. Levels of troponin T, myoglobin, CK-MB mass and activity and creatine kinase were measured on admission and after 2, 4 and 12-24 hours. RESULTS: ACS was ultimately diagnosed in 73 patients (31%). These were significantly older (p = 0.0015) and more often male (p = 0.046). 91% of patients with ACS but only 68% of those without described the chest pain as a sense of pressure or stabbing (p = 0.0002). Measurement of troponin T and myoglobin on admission was helpful in 39% of those with ACS, compared with 15% of those without. When the admission ECG was normal or nonspecific in patients with ACS, troponin T was elevated in 16%, CK-MB mass in 24%. In patients with unstable angina no single marker was associated with an increased risk (high rate of special supervision and intervention). CONCLUSION: In the assessment of patients with acute chest pain clinical judgement plays the predominant role. In the mostly elderly and male patients with ACS (31% of the cohort) feeling of pressure or stabbing chest pain were most prominent (91%). Cardiac markers troponin T, CK-MB mass and myoglobin were helpful in the differential diagnosis of chest pain, even when the ECG was unremarkable or nonspecific. At the time of admission myoglobin was the most significant marker for acute myocardial infarction or unstable angina.

Adolescent↗

PubMed2001

[Position paper on intracoronary brachytherapy].

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Angioplasty, Balloon, Coronary↗

PubMed2001

Non-invasive detection of early infarct vessel patency by resolution of ST-segment elevation in patients with thrombolysis for acute myocardial infarction; results of the angiographic substudy of the Hirudin for Improvement of Thrombolysis (HIT)-4 trial.

Aims The purpose of this study was to validate ST segment resolution as a non-invasive marker for patency of the infarct-related artery 90 min after the start of streptokinase therapy in patients with acute myocardial infarction. Methods and Results In the HIT-4 angiographic substudy, 447 patients with acute myocardial infarction </=6 h received 1.5 million IU streptokinase. Angiograms of the infarct vessel were obtained after 90 min and 12-lead ECGs at baseline and after 90 min. The best cut-off points for a correct prediction of 90 min infarct vessel patency (TIMI 2/3 flow) and complete patency (TIMI 3) were 30% ST resolution and 40% ST resolution, respectively (specificity 68% and 69%, sensitivity 76% and 75%). Prediction of infarct vessel patency by ST resolution in steps of 10% displayed a gradual increase in patency rates. Patients with > or =70% ST resolution (n=70) had a 92% probability of TIMI 2/3 flow, while <30% ST resolution (n=172) was associated with the absence of TIMI 3 flow in 84% of patients. Conclusions Despite fairly good sensitivities and specificities the prediction of infarct vessel patency by ST resolution in the individual patient is limited. However, patients with > or =70% ST resolution are likely to have a patent infarct artery and <30% ST resolution predicts epicardial vessel occlusion or, since persistent ST elevation reflects the existing ischaemic myocardial injury, absence of myocardial perfusion.

Double-Blind Method↗

PubMed2001

Availability of on-site catheterization and clinical outcomes in patients receiving fibrinolysis for ST-elevation myocardial infarction.

AIMS: To compare management and clinical outcomes in hospitals stratified by the availability of on-site catheterization in InTIME-II, a multicentre trial comparing alteplase with lanoteplase for acute myocardial infarction. METHODS AND RESULTS: We studied 15,078 patients enrolled in 35 countries and 855 hospitals. Thirty-one percent of hospitals had 24-h, 25% day-only, and 44% no on-site catheterization facilities. Rates of cardiac angiography (57%, 38%, 26%) and revascularization (37%, 21%, 17%) were higher in hospitals with increasing access to on-site facilities(P<0.0001). The presence of a 24-h on-site facility was the strongest predictor of angiography during the index admission (odds ratio 4.17, 95% CI 3.85-4.54). There were no major differences in patient outcomes at 30 days when hospitals were stratified by availability of on-site catheterization. Adjusted 1-year mortality was similar between groups of hospitals (odds ratio for day-only 0.94 [0.80-1.09] and odds ratio for no availability 0.95 [0.83-1.10] compared to hospitals with 24-h facilities). CONCLUSIONS: There is a marked variation in procedure use by the availability of on-site catheterization with no major differences in patient outcomes. There is a need for additional randomized trials in the current era to address both the appropriate selection of patients and timing of invasive procedures in ST-elevation acute myocardial infarction.

Adolescent↗

PubMed2001

Randomized comparison of J&J Crown stent versus NIR stent after routine coronary angioplasty.

BACKGROUND: Coronary artery stents are used for the treatment of acute or threatening vessel occlusion complicating coronary angioplasty or for prevention of restenosis after angioplasty. The current randomized trial compared the procedural outcome and long-term patency of 2 different flexible stents in unselected lesion morphology. METHODS: The study population consisted of consecutive patients undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure stent implantation. The poststent treatment consisted of antiplatelet therapy. The primary hypothesis was an assumed restenosis rate of 30% in the group receiving NIR stents (Boston Scientific Europe SPRL, Parc Industriel de Petit-Rechain, Belgium) and a reduction of the restenosis rate (defined as >50% vessel diameter at follow-up) by 50% in the group undergoing J&J Crown stent (Cordis, Johnson & Johnson Interventional Systems, Warren, NJ) implantation: the restenosis rate and minimal luminal diameter at follow-up. Follow-up angiography was performed 6 months after the initial procedure. RESULTS: A total of 203 patients were randomized to receive either the J&J Crown stent (n = 103) or the NIR stent (n = 100). The procedural success was similar in both groups (96.1% vs 99% in the NIR stent group, respectively; P =.19). There were 4 cases of crossover from the J&J Crown to the NIR stent group. In one patient, stent implantation of either stent model did not succeed. One patient died from fulminant pulmonary embolism. Restenosis, defined as >50% diameter stenosis at follow-up 5.8 +/- 1.3 months after the initial procedure occurred in 19 patients (18.4%) in the J&J Crown stent group compared with 22 patients (22.0%) in the NIR stent group (P =.42). There was a significantly higher rate of crossover from the J&J Crown stent to the NIR stent (3.9% vs 0%, respectively, P =.047), whereas reverse crossover did not occur. The one lesion in which NIR stent implantation was not successful had an extremely tortuous proximal part. This patient underwent only balloon angioplasty. Clinical events were rare during 6 months of follow-up and the incidence did not differ between both groups (nonfatal myocardial infarction: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32; all-cause mortality: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32). CONCLUSIONS: There were no significant angiographic and clinical differences between the J&J Crown and NIR stents. Both stents had a similar procedural success rate, although the implantation of NIR stents was successful even in vessels in which previous attempts at J&J Crown stent placement had failed.

Angioplasty, Balloon, Coronary↗

PubMed2001

Anticoagulation: the present and future.

Thrombin is a central bioregulator of coagulation and is therefore a key target in the therapeutic prevention and treatment of thromboembolic disorders, including deep vein thrombosis and pulmonary embolism. The current mainstays of anticoagulation treatment are heparins, which are indirect thrombin inhibitors, and coumarins, such as warfarin, which modulate the synthesis of vitamin K-dependent proteins. Although efficacious and widely used, heparins and coumarins have limitations because their pharmacokinetics and anticoagulant effects are unpredictable, with the risk of bleeding and other complications resulting in the need for close monitoring with their use. Low-molecular-weight heparins (LMWHs) provide a more predictable anticoagulant response, but their use is limited by the need for subcutaneous administration. In addition, discontinuation of heparin treatment can result in a thrombotic rebound due to the inability of these compounds to inhibit clot-bound thrombin. Direct thrombin inhibitors (DTI) are able to target both free and clot-bound thrombin. The first to be used was hirudin, but DTIs with lower molecular weights, such as DuP 714, PPACK, and efegatran, have subsequently been developed, and these agents are better able to inhibit clot-bound thrombin and the thrombotic processes that take place at sites of arterial damage. Such compounds inhibit thrombin by covalently binding to it, but this can result in toxicity and nonspecific binding. The development of reversible noncovalent DTIs, such as inogatran and melagatran, has resulted in safer, more specific and predictable anticoagulant treatment. Oral DTIs, such as ximelagatran, are set to provide a further breakthrough in the prophylaxis and treatment of thrombosis.

Administration, Oral↗

PubMed2000

Prior cytomegalovirus, Chlamydia pneumoniae or Helicobacter pylori infection and the risk of restenosis after percutaneous transluminal coronary angioplasty.

We investigated a possible correlation between the serologic status concerning Cytomegalovirus (CMV), Chlamydia pneumoniae (CP) and Helicobacter pylori (HP) and the occurrence of restenosis in patients undergoing percutaneous transluminal coronary angioplasty for symptomatic coronary artery disease. Tests for anti-CMV IgG, anti-Chlamydia pneumoniae IgG and IgA and HP IgG and IgA were performed with an enzyme-linked immunosorbent assay (ELISA). Restenosis was defined as >/=50% stenosis at follow-up angiography in a vessel with less than 50% stenosis immediately after PTCA. Of 148 patients, 112 (75.7%) were seropositive for CMV, 75 (50.7%) were seropositive for CP and 78 (52.7%) were seropositive for HP. Restenosis occured in 31.8% of patients. CMV seropositivity was established in 74.5% of patients with restenosis versus 76.2% without restenosis (P=0.82), CP seropositivity was established in 44. 7% of patients with restenosis versus 53.5% without restenosis (P=0. 32), HP seropositivity was established in 53.2% of patients with restenosis versus 52.5% without restenosis (P=0.94). In contrast to some earlier studies CMV or HP seropositivity could not be found to be associated with the risk of restenosis after coronary intervention. An association between the serological status of CP and restenosis could also not be established.

Angioplasty, Balloon, Coronary↗

PubMed2000

[Current guidelines for cardiopulmonary resuscitation].

Explore the source record for details and available documents.

Cardiopulmonary Resuscitation↗

PubMed2000

[Ticlopidine-associated thrombotic thrombocytopenic purpura (Morbus Moschcowitz)].

ANAMNESIS AND CLINICAL FINDINGS: A 75-year-old woman with a history of recurrent ischemic cerebral events was admitted with acute unspecific neurological symptoms and fever. EXAMINATION: Intracerebral hemorrhage due to hypertension and antithrombotic therapy with ticlopidine was ruled out with cranial computed tomography. Laboratory findings on admission included thrombocytopenia (12/nl), renal insufficiency (serum creatinine 1.6 mg/dl) and LDH elevation (1,218 U/l). The hemoglobin on admission was normal. THERAPY AND CLINICAL COURSE: In the presence of rapidly declining hemoglobin values and fragmentation of red cells thrombotic-thrombocytopenic purpura (TTP) was diagnosed and the patient received fresh frozen plasma. Shortly after the plasma infusion the patient's condition deteriorated rapidly showing clinical signs of an allergic shock. In the sequel of 24 to 48 hours the patient developed renal failure, severe anemia and the thrombocyte count fell to 5/nl. The patient was mechanically ventilated during the next 48 hours and needed intravenous catecholamines. Even after restoration of spontaneous respiration and cessation of pharmacological sedation the patient remained comatose. Cranial computed tomography on the fourth day after admission showed multiple infarction syndrome. The patient died on the ninth day after admission in status epilepticus which could not be stopped with pharmacological means. CONCLUSIONS: The combination of neurological symptoms, thrombocytopenia, fever, renal failure and hemolytic anemia in a patient taking ticlopidine points to a diagnosis of TTP. The high mortality of TTP can probably only be reduced by early plasmapheresis.

Aged↗

PubMed2000

[Importance of acute PTCA in the treatment of perioperative myocardial infarction].

The mortality of perioperative myocardial infarction is still high and according to recently published data amounts to 17 to 42%. In the seventies introduction of thrombolytic therapy has led to a dramatic reduction in mortality of non-perioperative myocardial infarction. However, in the perioperative situation thrombolytic therapy remains to be problematic in most cases because of expected severe bleeding complications. In the last 4-6 years acute-PTCA has been established in the therapy of acute myocardial infarction. Up to date no data are available concerning the effect of acute-PTCA on mortality of perioperative myocardial infarction. Nevertheless it can be assumed, that acute-PTCA will lead to a considerable reduction in mortality of perioperative myocardial infarction. Therefore, in patients with significant perioperative myocardial infarction immediate coronary angiography and, if indicated, acute-PTCA should be performed. In principle, thrombolytic therapy is considered to be contraindicated in the intra- or postoperative situation. However, if coronary angiography and PTCA are not possible, thrombolysis might be taken into consideration, in particular if the expected bleeding complications are small in relation to the expected benefit of thrombolysis. Since acute-PTCA has been shown to remarkably reduce mortality in patients with cardiogenic shock after acute myocardial infarction, this group of patients should be especially considered.

Angioplasty, Balloon, Coronary↗

PubMed2000

[Acute myocardial infarction in patients with angiographically normal coronary arteries: clinical features and medium term follow-up].

BACKGROUND: Acute myocardial infarction (MI) in patients with normal coronary arteries has been recognized for several years. In most cases its etiology is unknown. The objective of the present study was to describe clinical features and medium term follow-up of those patients. PATIENTS AND METHODS: Between April 1991 and December 1996, 9860 coronary angiographies were performed in our hospital. During this period 17 patients with documented myocardial infarction and completely normal coronary arteries were identified. Acute myocardial infarction was defined as the clinical event with acute angina pectoris, ST-elevation typical for myocardial infarction, and an increase in serum creatinine phosphokinase (CPK) above 125 U/l. RESULTS: The mean peak CPK was 675 U/l (range: 129-1760 U/l). All 17 patients revealed significant ST-segment elevation. According to the ECG criteria there was no predilection for a specific location of MI (9 anterior MIs and 8 inferior MIs). Thrombolytic therapy was performed in 9 patients. In 12 patients areas of localized hypo- or akinesia were shown on left ventricular cineangiography. The mean ejection fraction was 61.5+/-10.3%. The age and sex distribution revealed a bimodel character: there was a younger age group of 9 patients, all men with a mean age of 35.9 years (31-43) and all strong cigarette smokers (mean 28 cigarettes/day) and there was an older group of 7 patients (1 man, 6 women) with a mean age of 56,4 years (47-68) and no significant association with cigarette smoking. During a mean follow-up period of 48.6 months (31-85 months) no patient died and no patient suffered from recurrent chest pain and used nitroglycerin occasionally. CONCLUSION: Patients with acute MI and angiographically normal coronary arteries show a bimodal sex and age distribution: a younger age group, all men and uniformly strong cigarette smokers and an older group predominantly women with no significant association with cigarette smoking. Both groups seem to have a favorable prognosis.

Adult↗