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Biomedical subjects

K L Neuhaus

Publications and source records attributed to K L Neuhaus.

At least 19 recordsLinked to original sources
PubMed1997

Influence of the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-1) trial on the use of thrombolytics in Germany. ALKK Study Group. Arbeitsgemeinschaft der Leitenden Kardiologischen Krankenhausärtze.

Our results show significant and independent influence of the GUSTO-1 trial on the use of recombinant tissue plasminogen activator in acute myocardial infarction in Germany. This influence started soon after the publication of the trial and was not restricted to subgroups who benefitted most from recombinant tissue plasminogen activator.

Aged↗
PubMed1997

Primary angioplasty versus thrombolysis in the treatment of acute myocardial infarction. ALKK Study Group.

This study investigates the hypothesis if primary angioplasty is superior to intravenous thrombolysis in the treatment of acute myocardial infarction (AMI). Small prospective randomized studies did not demonstrate a significant benefit regarding total mortality. A total of 14,980 patients with AMI were registered by "The 60-Minutes Myocardial Infarction Project," a prospective multicenter observational study: 210 of these patients were treated with primary angioplasty. A matched pair analysis comparing 1 primary angioplasty patient with 3 intravenous thrombolysis patients could be performed in 156 primary angioplasty patients. Criteria for matching were age, sex, location of AMI, systolic blood pressure, previous AMI, and prehospital delay. Patients with a bundle branch block or requiring resuscitation were excluded from analysis. Because of matching, both groups showed similar baseline characteristics. Patients with primary angioplasty had more relative contraindications for thrombolysis (ulcers: 10.3% vs 2.3%, recent intramuscular injections: 6.4% vs 1.6%, recent surgical interventions: 5.1% vs 1.1%, central punctures: 9% vs 3.9%). There was a tendency toward less combined adverse events in the primary angioplasty group (3.2% vs 5.7%, odds ratio [OR] = 0.55, 95% confidence interval [CI] = 0.21 to 1.44). In-hospital mortality rates in the primary angioplasty group and thrombolysis group were 4.3% and 10.3%, respectively (OR = 0.39, 95% CI = 0.17 to 0.92). The difference in mortality could already be demonstrated within the first 48 hours with 1.9% versus 5.3% deaths (OR = 0.35, 95% CI = 0.11 to 1.14). Thus this study indicates a superiority of primary angioplasty in comparison to intravenous thrombolysis in AMI even in a clinical routine setting, with a reduction of hospital mortality of about 60%.

Aged↗
PubMed1997

PTCA registry of German community hospitals. Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK) Study Group.

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) is widely used, but no quality control has been systematically performed as yet. METHODS: A registry of all PTCA procedures has been established since October 1992 for the majority of the German community hospitals performing PTCA, representing about one third of all PTCA activity in Germany. Baseline demographic data, indication for PTCA, primary success and in-hospital clinical events were recorded. Each centre was visited at regular intervals to assure completeness and reliability of the data. RESULTS: Of 52453 procedures performed from October 1992 to December 1994 the catheter laboratory and discharge forms were 99.7% and 98.1% complete, respectively. In 85.9% a single lesion was dilated per procedure, but 48.7% of the patients had multivessel disease. The success rate was 66.5% in complete occlusions (residual stenosis < 70%) and 91.2% in non-occluded vessels (residual stenosis < 50%). Abrupt vessel closure occurred in 3.4%, of which 77.5% could be recanalized by repeat intervention. In procedures not done for acute myocardial infarction, the in-hospital mortality was 0.52%, the procedure-related mortality 0.37%. In 3.02% of all patients a severe complication occurred (procedure-related death, myocardial infarction or emergency bypass surgery). CONCLUSION: Complete recording of all PTCA procedures is feasible even on a nationwide basis. This is a pre-requisite for continuous quality control. The reporting of the procedures by itself very probably, has an impact on the quality which is, however, not measurable quantitatively.

Aged↗
PubMed1997

The 60 minutes myocardial infarction project. Treatment and clinical outcome of patients with acute myocardial infarction in Germany.

AIMS: To describe patient characteristics, pre-hospital delay, treatment, complications and outcome in patients with acute myocardial infarction admitted to hospitals in Germany. METHODS AND RESULTS: The study was of prospective observational multicentre design. Those involved were consecutive patients with acute Q-wave myocardial infarction admitted within 96 h of onset of symptoms to 136 German hospitals between July 1992 and September 1994 (n = 14980, median age 66 (quartiles 57, 74) years, 68% male, 48% anterior wall infarction). Median pre-hospital delay was 170 (90, 475) min, with 17% arriving within the first hour and 61% within 4 h of onset of symptoms. The following patient groups had a short pre-hospital delay: males, those aged less than 65 years, those admitted at night or the weekend, those with a previous myocardial infarction, those in need of cardiopulmonary resuscitation, and those with a diagnostic first ECG. The first ECG was diagnostic in 67.6% of cases. Reperfusion therapy was used in 53%, with thrombolytic therapy in 51.6%. Median time from admission to initiation of treatment was 30 (20, 55) min. Respective rates of treatment with aspirin, nitrates, and beta-blockers were 81%, 83%, and 16%. Major complications were cerebral bleeding (0.4%), bleeding requiring transfusions (0.9%), left ventricular rupture (0.6%) and anaphylactic shock (0.1%). Median hospital stay was 20 (13, 26) days. In-hospital death rate was 17.2%. Increased hospital mortality was observed with female gender, an unknown or long pre-hospital delay, a diagnostic first ECG, anterior wall infarction, trauma or major operation within the last 14 days, renal insufficiency and malignoma. CONCLUSIONS: 'Real-life' hospital mortality is much higher than previously reported in clinical trials. To reduce hospital mortality, the efficacy of thrombolysis should be increased by shortening the pre-hospital delay, and the use of concomitant therapy, especially beta-blockers, should be increased.

Aged↗
PubMed1997

Significance of initial ST segment changes for thrombolytic treatment in first inferior myocardial infarction.

OBJECTIVE: To evaluate the benefit to risk ratio of thrombolytic treatment in patients with small inferior acute myocardial infarction (AMI). Controlled studies relating the benefit from thrombolysis with initial electrocardiographic features are scarce and of limited sample size. DESIGN: Retrospective study of 728 patients with a first inferior AMI of six hours' duration from the Intravenous Streptokinase in Acute Myocardial Infarction (ISAM) study comparing streptokinase with placebo stratified by the initial sum ST segment elevation (sigma ST) of 0.8 mV or less and greater than 0.8 mV, and 636 patients from the International Joint Efficacy Comparison of Thrombolytics (INJECT) trial comparing double blind streptokinase with reteplase stratified by either sigma ST or the presence of precordial ST segment depression. RESULTS: ISAM study patients with an sigma ST of greater than 0.8 mV had a significant mortality benefit from streptokinase throughout six years, while those with an sigma ST of 0.8 mV or less showed a trend to higher mortality at six months (6.3% streptokinase v 5.1% placebo). Despite significantly smaller infarcts and fewer clinical complications in patients with an sigma ST of 0.8 mV or less (ISAM and INJECT) or the absence of precordial ST segment depression (INJECT) thrombolytic treatment was associated with higher early mortality than in those with initially larger ST segment deviations. CONCLUSION: Thrombolytic treatment in patients with inferior AMI presenting with larger ST segment deviations is associated with improved survival throughout six years. The risk to benefit ratio, however, in terms of early mortality in patients who have an sigma ST of 0.8 mV or less and no precordial ST segment depression may be unfavourable.

Electrocardiography↗
PubMed1996

Cardioversion of atrial fibrillation in the elderly. ALKK-Study Group. Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte.

The purpose of this investigation was to define cardioversion success rates, frequency of complications of cardioversion, and current treatment practices in elderly patients (aged > or = 65 years) with atrial fibrillation (AF). The results were compared with those in younger patients (aged < 65 years). The investigation was a prospective multicenter observational study with 61 participating cardiology clinics. Consecutive patients in whom cardioversion of AF was planned had to be prospectively registered. Of 1,152 patients registered, 570 (49.5%) were < 65 years old (group 1) and 582 (50.5%) were > or = 65 years (group 2). The overall success rate of cardioversion on an intention-to-treat basis was 76.1% in group 1 and 72.7% in group 2 (p = 0.18). In multivariate analysis, left atrial size and New York Heart Association functional class before cardioversion were identified as predictors of success (p < 0.001, respectively; p = 0.025). These clinical factors were not equally distributed between the age groups: Left atrial size was larger in the elderly than in younger patients (44.0 +/- 6.4 mm vs 42.8 +/- 6.4 mm; p = 0.006) and a New York Heart Association functional class > or = II was more prevalent in group 2 than in group 1 (48.6% vs 29.6%; p < 0.001). The overall complication rates were not significantly different between the 2 groups (4.2% in group 1 vs 5.3% in group 2; p = 0.37). The frequency of patients who were adequately anticoagulated for cardioversion was 56.9% in age group 1 and 39.6% in age group 2 (p < 0.001). In chronic AF the same trend for age-dependent underuse of anticoagulation was observed. Age itself was not a predictor of cardioversion success and did not predispose to higher complication rates. Therefore, cardioversion should be considered in older patients with the same criteria and emphasis as in younger patients. Anticoagulation and antithrombotic medication is underused for cardioversion and in treating chronic AF, especially in elderly patients.

Adult↗
PubMed1996

Recombinant hirudin (HBW 023) produces stable anticoagulation unaffected by circadian variation in patients with thrombolysis for acute myocardial infarction.

BACKGROUND: Circadian variations have been described for a number of haemostatic and physiological factors, all of which might predispose towards clotting in the late morning. The anticoagulation effect of heparin has been shown to respond in a circadian manner, resulting in minimal prolongation of the activated partial thromboplastin time (aPTT) in the morning. METHODS: Recombinant hirudin (HBW 023) given as a bolus of 0.07, 0.1, 0.2 or 0.4 mg.kg-1 followed by an infusion of 0.05, 0.06, 0.1 or 0.15 mg.kg-1 over 48 h was used as conjunctive therapy to thrombolysis with front-loaded recombinant tissue-type plasminogen activator (100 mg.90 min-1) in 40 patients with acute myocardial infarction. APTT, activated clotting time and free hirudin plasma levels were determined at baseline and at 8, 12, 16, 20, 24, 32, 40 and 48 h. RESULTS: The prolongation of aPTT and activated clotting time was dose-dependent and stable. In 82.5% of the patients, aPTT values were ranged between the highest and the lowest aPTT of < 30 s. When the results were divided into four time intervals (0000-0600, 0600-1200, 1200-1800, 1800-2400) neither in the individual patients nor in the mean values of the four different dose groups was any significant circadian variation in aPTT or activated clotting time prolongation observed. The pharmacokinetic studies of free hirudin plasma levels revealed no circadian rhythm either. All but one patient (97.5%) had a patent vessel (TIMI grade 2/3) at the end of the hirudin infusion. CONCLUSIONS: Recombinant hirudin, in contrast to heparin, does not show any circadian variation in its anticoagulation effect. This might, in part, explain the more stable and predictable anticoagulation achieved by hirudin, which is associated with a reduced rate of reocclusions after thrombolysis.

Adult↗
PubMed1995

[Cardioversion in atrial fibrillation. Results and complications in 1,152 prospective patients. Study Group of the Working Society of Leading Cardiologic Hospital Physicians].

BACKGROUND: Pharmacological and direct-current cardioversion of atrial fibrillation are often performed interventions. Little is known about results and complications of cardioversion in daily practise. PATIENTS AND METHODS: Demographic, procedural and outcome data from patients with cardioversion of atrial fibrillation were collected in a prospective, multicenter registry of 61 hospitals. RESULTS: Between July 1994 and December 1994 1152 patients with a mean age of 64 +/- 11 years were registered on an intention-to-treat basis. 62% were male. The most prevalent underlying disorders were coronary artery disease (34.7%), valvular heart disease (18.1%), and cardiomyopathy (6.9%). 16.4% of patients had lone atrial fibrillation. New onset atrial fibrillation was reported in 21%, paroxysmal in 32% and chronic in 47% of patients. The mean duration of atrial fibrillation was 7 +/- 26 weeks (range 1 day to 7 years, median 5 days). In 3.8% of patients no cardioversion attempt was made and follow-up was not possible in another 5.5%. 19.2% of patients cardioverted spontaneously. Direct current cardioversion was attempted in 39.7% and pharmacological cardioversion in 31.8% of patients. Cardioversion was successful (sinus rhythm at discharge) in 96.4% of spontaneous cardioversion, in 73.1% of direct current cardioversion and in 84.4% of pharmacological cardioversion. Success of cardioversion was significantly related to duration of atrial fibrillation, NYHA functional class and left atrial diameter (p < 0.001). In 55 (4.8%) cases complications were reported of which 14 were fatal. Five cases of sudden death occurred, all of which were related to quinidine therapy for pharmacological cardioversion. Five cases of embolism were reported. Two were not associated with cardioversion attempts and 3 occurred within 24 hours after successful direct current cardioversion. Two of these patients were effectively anticoagulated at the time of cardioversion. A total of only 62% of patients with atrial fibrillation of more than 48 hours duration were anticoagulated for cardioversion with coumadine or i.v. heparin. CONCLUSIONS: The main risks of cardioversion are fatal proarrhythmic events in pharmacological attempts to restore sinus rhythm. The risk of embolism is despite low rates of effective anticoagulation low.

Aged↗
PubMed1995

Frequency of "optimal anticoagulation" for acute myocardial infarction after thrombolysis with front-loaded recombinant tissue-type plasminogen activator and conjunctive therapy with recombinant hirudin (HBW 023). ALKK Study Group.

This retrospective analysis reviewed 183 patients with acute myocardial infarction who were given front-loaded recombinant tissue-type plasminogen activator (rt-PA) and r-hirudin (HBW 023) in 1 of 4 dose groups (bolus dose of 0.07, 0.1, 0.2, or 0.4 mg/kg, followed by an infusion of 0.05, 0.06, 0.1, or 0.15 mg/kg/hour over 48 hours). Activated partial thromboplastin time (aPTT) levels were determined at baseline and at 4, 8, 12, 16, 20, 24, 32, 40, and 48 hours. Of the 178 patients with r-hirudin treatment for > or = 12 hours, anticoagulation was optimal in 55.1% (all aPTTs > 2 x baseline), suboptimal in 33.7% (lowest aPTT > 1.5 but < 2 x baseline), and inadequate in 11.2% (> or = 1 aPTT but < 1.5 x baseline). Optimal anticoagulation was observed more frequently in the higher dose groups (dose 1, 15%; dose 2, 44.4%; dose 3, 63.4%; dose 4, 73.4%; p for trend < 0.0001). Patency (according to Thrombolysis in Myocardial Infarction trial grade 2 or 3) of the infarct artery after 36 to 48 hours was higher in the group with optimal anticoagulation compared with those with suboptimal or inadequate anticoagulation: 97.9%, 88.4%, and 85%, respectively (p = 0.03 optimal vs suboptimal or inadequate anticoagulation). In conclusion, r-hirudin in a dose of 0.1 or 0.15 mg/kg/hour achieves an optimal anticoagulation in about 63% or 74% of patients, which is associated with an enhanced patency 24 to 48 hours after rt-PA. A subsequent study revealed that this effective anticoagulation may be accompanied by an increased risk of severe bleeding complications after thrombolysis.

Adult↗
PubMed1995

[Percutaneous extracorporeal circulation in cardiogenic shock caused by combined poisoning with methyldigoxin, nifedipine and indapamide].

HISTORY AND FINDINGS: A 38-year-old man with endogenous depression was found comatose and with gasping respiration. Empty packets of tablets pointed to poisoning with methyldigoxin, nifedipine and indapamide. Pupils reacted slowly to light and no peripheral blood pressure could be measured. TREATMENT AND COURSE: Routine resuscitation measures (intubation, mechanical ventilation, external cardiac massage and drugs) were undertaken during transport to hospital where, in addition to further symptomatic treatment, digoxin antibodies were administered, but without noticeable effect. Percutaneous cardiopulmonary bypass was therefore undertaken. It achieved a cardiac output of 3.2l and a systolic pressure of 80 mm Hg: a stable rhythm and circulation were obtained within 15 hours indicating that electromechanical uncoupling had for the time being been overcome. The EEG suggested a midbrain syndrome. After another 18 hours of mechanical ventilation and symptomatic treatment asystole suddenly occurred. Renewed resuscitation procedures were not undertaken because of the very poor neurological state and prognosis. CONCLUSION: Although haemodynamic stabilization was only temporarily achieved and the patient's death could not be prevented because of adverse pretreatment conditions, the application of percutaneously implantable, transportable heart-lung machine appears to be justified in cases of intoxication with cardio- and vasodepressive substances.

Adult↗
PubMed1995

Recombinant hirudin and front-loaded alteplase in acute myocardial infarction: final results of a pilot study. HIT-I (hirudin for the improvement of thrombolysis).

Recombinant hirudin, a specific thrombin inhibitor, has been shown to accelerate thrombolysis and reduce reocclusions in experimental models. In a pilot trial recombinant hirudin (HBW 023) was used as an adjunctive therapy to thrombolysis with front-loaded tissue plasminogen activator (t-PA) (100 mg.90 min-1) in 40 patients with acute myocardial infarction whose duration of symptoms was less than 6 h. Patients received a bolus of r-hirudin of 0.07 mg.kg-1 b.w. followed by an infusion of 0.05 mg.kg-1.h-1 over 48 h. Complete patency (TIMI grade 3) of the infarct-related artery at 30, 60 and 90 min after the start of thrombolytic therapy was seen in 38.5%, 64.1% and 71.0% of patients, respectively. After 24-48 h, 80% of patients had a complete patent infarct vessel. A very early, complete and sustained patency (TIMI grade 3 at 60 and 90 min and at 24-48 h) was observed in 55% of patients. Reocclusions during the hirudin therapy appeared in six (16.1%) patients, two of whom had a PTCA at 90 min. The only reinfarction was seen after 6 h; this was successfully treated with additional thrombolysis. Major bleedings, mostly related to the invasive procedure, were observed in three patients. Spontaneous organ bleedings and intracerebral haemorrhages did not occur. There was one in-hospital death due to a late retroperitoneal bleeding. In was concluded that, with regard to safety and efficacy, the general feasibility of r-hirudin as adjunctive therapy to thrombolysis with front-loaded t-PA, has been demonstrated.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1995

Prevention and management of thrombotic complications during coronary interventions. Combination therapy with antithrombins, antiplatelets, and/or thrombolytics: risks and benefits.

Acute occlusions after percutaneous transluminal coronary intervention occur in about 5% of cases. The incidence of these serious adverse events may be reduced by the identification of risk factors, appropriate indication for the intervention, and by medical therapy with antiplatelets and antithrombins. The medical management of complications during percutaneous transluminal interventions also may include thrombolytics. Aspirin has been shown to significantly reduce the incidence of procedure-related coronary occlusion and ischaemic events. Available data suggest pre-treatment with 250-500 mg followed by 100-300 mg aspirin after the intervention. Ticlopidine seems to be equally effective; however, because of its side effects it should be used only in cases of a contra-indication to aspirin. The second indispensable therapeutic concept in the prevention of acute thrombotic events during PTCA is thrombin inhibition. The level of anticoagulation achieved by heparin seems to be critically important. Therefore the recommendation for heparin dosing is a bolus of 10,000 U followed by an intravenous infusion over 24 h of either 1000 U.h-1 or an infusion adjusted to keep the aPTT above 3 times control, but lower doses of shorter duration may be equally effective in uncomplicated cases. Prolonged pre-treatment with heparin may be useful if the pre-intervention angiogram is suggestive of intracoronary thrombus. Thrombolysis as an adjunct to PTCA did not reduce the rate of periprocedural coronary occlusions, but pre-treatment with thrombolysis may be useful in patients with recanalization of occluded vein grafts or in patients with large amounts of thrombotic material. In acute coronary occlusion, thrombolysis has rarely been used as a sole rescue therapy and results have not been encouraging, although a thrombotic process often is involved. Thrombolysis as an adjunct to rescue angioplasty showed no better clinical outcome than prolonged balloon inflation or stenting. Because of serious bleeding complications, thrombolysis should only be considered as a treatment option if thrombosis is unequivocally the major cause of the acute occlusion.

Angioplasty, Balloon, Coronary↗
PubMed1994

Frequency of achieving optimal reperfusion with thrombolysis in acute myocardial infarction (analysis of four German multicenter studies).

Patients from 4 German multicenter studies on thrombolysis in acute myocardial infarction (AMI) were retrospectively evaluated to assess the incidence of optimal reperfusion, defined as a completely perfused infarct vessel after 90 minutes, without subsequent death or reinfarction, and without reocclusion or deterioration of flow in control angiograms. Of 907 patients with a 90-minute angiogram, 75% had an open infarct vessel by conventional definition (perfusion grade 2 or 3 according to the criteria of the Thrombolysis in Myocardial Infarction [TIMI] study). However, only 62% had TIMI grade 3 complete perfusion. Of the 561 patients with such primary treatment success, 106 (19%) had secondary treatment failure by death, reinfarction, or subtotal or total reocclusion of the infarct vessel. In a subset of 668 patients with a first angiogram after 60 minutes, conventional patency was 70%, complete perfusion 51%, and an optimal perfusion result was achieved in only 42%. The efficacy of thrombolysis in AMI is substantially overestimated by conventional 90-minute patency rates.

Adult↗
PubMed1994

Extent of early ST segment elevation resolution: a simple but strong predictor of outcome in patients with acute myocardial infarction.

OBJECTIVES: This study proposed to verify the prognostic power of early ST segment elevation resolution in patients with acute myocardial infarction from the Intravenous Streptokinase in Acute Myocardial Infarction study data base. BACKGROUND: Data from a small prospective study suggested that use of two cutoff points for three different levels of ST segment resolution 3 h after the start of thrombolysis may be an efficient way to predict outcome in an individual patient. METHODS: The three groups of ST segment resolution were defined as 1) complete resolution (> or = 70% [552 patients]) or only slight ST segment elevation (127 patients); 2) partial resolution (< 70% to 30% [475 patients]); 3) no resolution (< 30% to > 0% [362 patients]). Infarct size was measured from creatine kinase isoenzyme, MB fraction, release and from the number of Q waves. Left ventricular function was assessed in 818 patients 1 month after infarction. RESULTS: For complete, partial and no ST segment resolution 3 h after the start of streptokinase or placebo infusion, enzyme release was 1.2, 1.8 and 2.1 IU/ml x h; number of Q waves 1.7, 2.5 and 3.0; and ejection fraction 60%, 53% and 49%, respectively (all adjusted p = 0.0000). Mortality rate at 21 days was 2.2%, 3.4% and 8.6%, respectively. No ST segment resolution was the most powerful independent predictor of early mortality (p = 0.0001). Survival rate curves at 6-year follow-up showed significant mortality differences with increasing divergence (p = 0.0003 anterior infarction; p = 0.005 inferior infarction). In subgroups with an overall higher risk of dying, mortality was strongly determined by the extent of early ST segment resolution. CONCLUSIONS: The extent of ST segment elevation resolution conveys useful early information about outcome in an individual patient after acute myocardial infarction.

Aged↗
PubMed1994

Dose finding with a novel recombinant plasminogen activator (BM 06.022) in patients with acute myocardial infarction: results of the German Recombinant Plasminogen Activator Study. A study of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK).

OBJECTIVES: The aim of this study was to determine the appropriate dose of a novel recombinant tissue-type plasminogen activator (BM 06.022) for thrombolysis in patients with acute myocardial infarction. BACKGROUND: BM 06.022 is a mutant of tissue-type plasminogen activator expressed in Escherichia coli that can be given as a single bolus because of a prolonged half-life, which might obviate the need for complicated regimens. METHODS: BM 06.022 given as a single bolus was investigated in 142 patients in a multicenter sequential dose-finding study. Efficacy of the drug was assessed from infarct-related artery patency by coronary angiography. RESULTS: With the first dose of 10 MU of BM 06.022, the predefined minimal 90-min patency of 70% was not achieved, as indicated by the sequential probability ratio test after treatment of 42 patients (group A). The second dose of 15 MU of BM 06.022 was given subsequently in the preset maximum of 100 patients (group B). Angiography 30, 60 and 90 min after the bolus injection of BM 06.022 revealed a patent infarct-related artery (Thrombolysis in Myocardial Infarction trial [TIMI] grade 2 or 3) in 65% and 66%, 73% and 74% and 66% and 75% of patients in groups A and B, respectively. Very early reocclusion up to the 90-min angiogram occurred in 17% and 13%, late reocclusion until predischarge angiography occurred in 7% and 5%, and rescue percutaneous transluminal coronary angioplasty after the 90-min angiogram was performed in 6 and 14 patients in groups A and B, respectively. Plasma fibrinogen decreased from 2.79 g/liter (range 0.94 to 4.75) to 1.69 g/liter (range 0.0 to 3.95) in group A and from 2.54 g/liter (range 0.0 to 5.02) to 0.92 g/liter (range 0.0 to 2.68) in group B. Two bleeding complications requiring transfusion or surgical intervention and one nonfatal intracranial hemorrhage were encountered. Eight patients had a reinfarction, and five patients died, all of cardiac causes. CONCLUSIONS: With BM 06.022 given as a single bolus, a high early patency rate of the infarct-related coronary artery can be achieved. The speed of thrombolysis seems to be superior to standard thrombolytic drugs. The compound warrants further evaluation with respect to safety and efficacy by clinical end points.

Adult↗