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PubMed1992

Potency assays for Anistreplase: comparison of the fibrin plate assay and a 96-well plate assay.

Several production lots of Anistreplase (Eminase) were assayed for potency by either two fibrin plate assays or a clot lysis assay performed in 96-well microtiter plates. The 96-well plate assay yielded comparable data to the fibrin plate assays and had the advantage of greater efficiency with respect to both time and reagents. As a result the newer method appears to be a suitable alternative to the fibrin plate assays for lot release of Anistreplase.

Analysis of Variance↗
PubMed1993

Cost effectiveness of thrombolytic treatment for myocardial infarction: comparison of anistreplase, alteplase and streptokinase in 270 patients treated within 4 hours.

Two hundred and seventy patients, under 71 years of age and suffering from a less than 4 h infarction diagnosed according to clinical and electrocardiographic criteria, were included: two 90-patient groups were randomized and then treated with either anistreplase (30 mg iv over 5 min) or alteplase (10 mg bolus injection + 5000 IU heparin bolus injection, followed by 90 mg alteplase over 3 h), and compared with a consecutive control series of 90 patients treated with streptokinase (1.5 million U over 1 h). Intravenous heparin and aspirin (250 mg day-1) were then prescribed routinely. The three groups were comparable as regards age (55.2 +/- 10 years), male/female ratio (10.4), the site of the infarction (42% anterior, 55% inferior) and initial clinical seriousness (Killip I = 90%, II = 8%, III = 2%). The patients were thrombolysed in 17 community hospitals, and then referred to a university hospital with catheterization facilities. An efficacy score was determined, based on four parameters: two obtained from coronary angiography and left ventriculography performed on day 6 +/- 2 (N = 252) (asynergic score and patency of the infarct-related artery), one from Tl-tomography performed at rest (infarct size) and one from radionuclide angiography (global left ventricular ejection fraction) performed between day 15 and day 21 (N = 242). The score (range: 0-24 per patient) was 17.8 +/- 6.4 for alteplase, 17.7 +/- 6.0 for anistreplase and 18.1 +/- 6.0 for streptokinase respectively (NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Recovery of left ventricular function after acute myocardial infarction: efficacy of domiciliary thrombolysis in the Grampian Region Early Anistreplase Trial.

BACKGROUND: The objective was to compare the effect of thrombolytic therapy given either at home or in hospital on the recovery of left ventricular function after acute myocardial infarction. METHODS: In a randomized double-blind trial, 311 patients with suspected acute myocardial infarction were given 30 units anistreplase intravenously either at home, or later, in hospital. The median time-saving made with domiciliary thrombolysis was 130 min. All patients were admitted to hospital where left ventricular stroke distance was measured daily using a simple bedside ultrasound technique, and expressed as a percentage of the age-predicted normal value. The last recorded inpatient stroke distance measurement was used to assess residual left ventricular function after recovery from myocardial infarction. RESULTS: The mean stroke distance in patients with confirmed myocardial infarction was 74% on the day of admission, rising to 83% on the last inpatient day; it did not change between discharge and 3 months after admission. For 180 patients assigned randomly to treatment within 2 h of the onset of symptoms, mean stroke distance was greater by 6.8% in those given active anistreplase at home rather than in hospital (95% confidence interval 1.0 to 12.7%, P = 0.02), but there was no significant difference in stroke distance following home or hospital thrombolysis in 111 patients assigned treatment after that time (difference -2.0%, 95% confidence interval -8.4 to 4.5%, P = 0.54). CONCLUSIONS: The efficacy of thrombolytic therapy is enhanced when administered within 2 h of the onset of symptoms.

Adult↗
PubMed1991

SWIFT trial of delayed elective intervention v conservative treatment after thrombolysis with anistreplase in acute myocardial infarction. SWIFT (Should We Intervene Following Thrombolysis?) Trial Study Group.

OBJECTIVE: To see whether early elective angiography with a view to coronary angioplasty or bypass grafting of a stenosed infarct related vessel would improve outcome in acute myocardial infarction treated by thrombolysis with anistreplase. DESIGN: Randomised study of two treatment strategies with analysis of results over 12 months. SETTING: 21 district hospitals and regional cardiac centres in Britain and Ireland. SUBJECTS: 800 of 993 patients presenting with clinical and electrocardiographic features of acute myocardial infarction up to three hours after the onset of major symptoms. TREATMENT STRATEGIES: Intravenous anistreplase 30 units followed by a standard regimen of heparin, warfarin, and timolol and (in patients so randomised) early angiography plus appropriate intervention. MAIN OUTCOME MEASURE: Death or reinfarction within 12 months. RESULTS: 397 patients were randomised to receive early angiography plus appropriate intervention (coronary angioplasty in 169 cases, coronary grafting in 59) and 403 patients to receive conservative care (of these, 12 had angioplasty and seven bypass grafting during the initial admission). By 12 months mortality (5.8% (23 patients) in the intervention group v 5.0% (20) in the conservative care group; p = 0.6) and rates of reinfarction (15.1% (60 patients) v 12.9% (52); p = 0.4) were similar in the two groups. No significant differences in rates of angina or rest pain were found at 12 months. Left ventricular ejection fraction at three and 12 months was the same in both groups. Median hospital stay was longer in the intervention group (11 days v 10 days; p less than 0.0001). CONCLUSION: For most patients given thrombolytic treatment for acute myocardial infarction a strategy of angiography and intervention is appropriate only when required for clinical indications.

Angioplasty, Balloon, Coronary↗
PubMed1993

Loss of quality adjusted days as a trial endpoint: effect of early thrombolytic treatment in suspected myocardial infarction. Grampion Region Early Anistreplase Trial (GREAT).

STUDY OBJECTIVES: (1) To measure the quality of life and the loss of quality adjusted days (QADS) after suspected acute myocardial infarction in patients who received thrombolytic treatment either at home or in hospital. (2) To compare the loss of QADS as a trial endpoint with the conventional endpoints of mortality and Q-wave infarction. DESIGN: Randomised double blind parallel group trial of anistreplase (30 U given intravenously) and placebo given either at home or in hospital. SETTING: Rural practices in Grampian admitting patients to teaching hospitals in Aberdeen. PATIENTS: A total of 311 patients with suspected acute myocardial infarction and no contraindications to thrombolytic treatment seen at home within four hours of the onset of symptoms. MEASUREMENTS AND MAIN RESULTS: Loss of quality adjusted days (QADS) in the first 100 days after suspected myocardial infarction (365 QADS = 1 QALY) was the main outcome measure. Compared with later administration in hospital, anistreplase at home resulted in a relative reduction of mortality of 49% (95% confidence interval 3.95%, 2p = 0.04), and a relative reduction of 26% in the proportion of survivors with infarction who had Q-waves (95% CI 7.44%, 2p = 0.007). During the 100 day follow up, the median loss of QADS was 25 for all patients. This loss was significantly greater in those who died than in survivors (65 v 18, 2p < 0.001), and in survivors with infarction than in survivors without infarction (26 v 13, 2p < 0.01). However, there was no significant difference in loss of QADS in those with infarction with or without Q-waves (29 v 21, NS), and the median loss of QADS was not significantly different in those who had thrombolytic treatment at home or in hospital (median difference 0, 95% CI -5, +4 QADS). CONCLUSIONS: Loss of QADS had two serious limitations as an outcome measure: it was less sensitive than mortality and it failed to reflect physiological benefit. Palliative treatment with no physiological effect would have resulted in a greater gain in QADS (or QALYs) than did early thrombolytic treatment. Extreme caution is required in accepting a gain in QALYs as a valid outcome measure for health care.

Anistreplase↗
PubMed1990

Pharmacology of anistreplase.

Eminase (anistreplase), or anisoylated plasminogen streptokinase activator complex (APSAC), is a reversibly inactivated lys-plasminogen-streptokinase activator complex that is given rapidly over a period of 2-5 minutes, and has a half-life in the circulation of 90-105 min. Eminase represents a significant advance in drug design for therapeutic thrombolysis based on convenience in administration, high gradient (especially initially) for diffusion into thrombus, improved fibrin binding, ability to lyse fibrin rapidly, improved stability in the circulation, long duration of action, and production of an antithrombotic state.

Anistreplase↗
PubMed1989

Reperfusion, patency and reocclusion with anistreplase (APSAC) in acute myocardial infarction.

Because the reestablishment of coronary blood flow is believed to be central to the benefit of thrombolytic therapy, measurements of reperfusion (i.e., angiography before and after therapy), patency (i.e., angiography after therapy) and reocclusion rates are important to the evaluation of new thrombolytic therapies. For anisoylated plasminogen streptokinase activator complex (APSAC, anistreplase), comparisons have been made with control or placebo therapies to assess absolute efficacy, and with streptokinase to assess relative efficacy. In pooled experience from reperfusion studies, APSAC (30 U over 2 to 5 minutes) led to angiographic reperfusion in 55% of patients (98 of 177) who had symptoms of acute myocardial infarction (MI) for less than 6 hours. Among 107 patients treated with APSAC in angiographic patency studies, 69% (74) showed an open infarct-related artery 1 to 4 hours after therapy. (Patency rates are generally 10 to 20% greater than reperfusion rates, because some patients with acute MI may have a patent [subtotally occluded or spontaneously reperfused] infarct-related artery when entered into patency studies.) Using early peaking (less than or equal to 15 hours) of the creatine kinase curve as an indicator, a patency rate of 63% was observed among 387 patients treated with APSAC. The initial success rate with thrombolytic therapies is diminished by the rates of reocclusion and reinfarction, which must be accounted for in determining the net success of therapy. In 6 studies, a total of 87 patients with initially patent arteries after APSAC returned for reevaluation in 1 to 3 days.(ABSTRACT TRUNCATED AT 250 WORDS)

Anistreplase↗
PubMed1994

Relation of reperfusion success with anistreplase or alteplase in acute myocardial infarction to body weight. The TEAM-3 investigators.

Adjustment in dose based on body size is not recommended currently for thrombolytic regimens, except for a reduction in alteplase (recombinant tissue-type plasminogen activator [rt-PA]) dose for safety reasons in patients with low body weight. It is unresolved how to dose thrombolytic agents in very heavy patients. The study objective was to assess whether patency of the infarct-related artery at 1 day after therapy with anistreplase (anisoylated plasminogen streptokinase activator complex [APSAC]) or rt-PA is adversely affected by increased body weight. Data were analyzed from a double-blind, randomized, comparative study of APSAC (30 U/5 min) versus rt-PA (100 mg/3 hours, adjusted downward for body weight < 65 kg), together with heparin and aspirin, in patients with acute myocardial infarction presenting within 4 hours of symptom onset. Coronary patency, determined at 1 day, was assessed in a blinded fashion, and patency success was correlated with body weight, divided into quintiles. In patients treated with APSAC, coronary patency rates were similar in those in the upper quintile of body weight (> 94 kg; n = 22) and in the low-normal weight group (n = 126) (86 and 90%, respectively, for perfusion grade 2/3 [p = 0.64]; and 82 and 74%, respectively, for grade 3 [p = 0.42]). In contrast, for the rt-PA group, heavy patients (n = 34) achieved significantly lower patency rates (74 vs 89% for grade 2/3 [p = 0.02]; and 59 vs 77% for grade 3 [p = 0.03]). The dose of heparin administered, adjusted to maintain a therapeutic partial thromboplastin time until the 1-day (mean 28 hours) angiogram, was greater in the heavy than in the low-normal weight group (mean +/- SE 39,680 +/- 4,818 vs 30,027 +/- 1,177 U; p = 0.007).(ABSTRACT TRUNCATED AT 250 WORDS)

Anistreplase↗
PubMed1994

Comparison of front-loaded recombinant tissue-type plasminogen activator, anistreplase and combination thrombolytic therapy for acute myocardial infarction: results of the Thrombolysis in Myocardial Infarction (TIMI) 4 trial.

OBJECTIVES: The aim of our study was to determine a superior thrombolytic regimen from three: anistreplase (APSAC), front-loaded recombinant tissue-type plasminogen activator (rt-PA) or combination thrombolytic therapy. BACKGROUND: Although thrombolytic therapy has been shown to reduce mortality and morbidity after acute myocardial infarction, it has not been clear whether more aggressive thrombolytic-antithrombotic regimens could improve the outcome achieved with standard regimens. METHODS: To address this issue, 382 patients with acute myocardial infarction were randomized to receive in a double-blind fashion (along with intravenous heparin and aspirin) APSAC, front-loaded rt-PA or a combination of both agents. The primary end point "unsatisfactory outcome" was a composite clinical end point assessed through hospital discharge. RESULTS: Patency of the infarct-related artery (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3 flow) at 60 min after the start of thrombolysis was significantly higher in rt-PA-treated patients (77.8% vs. 59.5% for APSAC-treated patients and 59.3% for combination-treated patients [rt-PA vs. APSAC, p = 0.02; rt-PA vs. combination, p = 0.03]). At 90 min, the incidence of both infarct-related artery patency and TIMI grade 3 flow was significantly higher in rt-PA-treated patients (60.2% had TIMI grade 3 flow vs. 42.9% and 44.8% of APSAC- and combination-treated patients, respectively [rt-PA vs. APSAC, p < 0.01; rt-PA vs. combination, p = 0.02]). The incidence of unsatisfactory outcome was 41.3% for rt-PA compared with 49% for APSAC and 53.6% for the combination (rt-PA vs. APSAC, p = 0.19; rt-PA vs. combination, p = 0.06). The mortality rate at 6 weeks was lowest in the rt-PA-treated patients (2.2% vs. 8.8% for APSAC and 7.2% for combination thrombolytic therapy [rt-PA vs. APSAC, p = 0.02; rt-PA vs. combination, p = 0.06]). CONCLUSIONS: Front-loaded rt-PA achieved significantly higher rates of early reperfusion and was associated with trends toward better overall clinical benefit and survival than those achieved with a standard thrombolytic agent or combination thrombolytic therapy. These findings support the concept that more rapid reperfusion of the infarct-related artery is associated with improved clinical outcome.

Aged↗
PubMed1994

A randomized trial of intravenous heparin in conjunction with anistreplase (anisoylated plasminogen streptokinase activator complex) in acute myocardial infarction: the Duke University Clinical Cardiology Study (DUCCS) 1.

OBJECTIVES: We designed a randomized trial to evaluate the effects of heparin administration in conjunction with anistreplase (anisoylated plasminogen streptokinase activator complex [APSAC]) on arterial patency and clinical end points. BACKGROUND: The role of conjunctive intravenous heparin therapy with APSAC has not been tested despite the recommendations that intravenous heparin should be used. METHODS: Four hours after APSAC administration, 250 patients with acute myocardial infarction were randomly assigned to receive 325 mg of either aspirin alone or aspirin and a continuous infusion of heparin (15 IU/kg body weight per h). Clinical ischemic events and bleeding complications were monitored. On hospital day 5, coronary arteriography and left ventriculography were performed. RESULTS: The primary end point of the trial (the combined outcome of death, reinfarction, recurrent ischemia and occlusion of the infarct-related artery) occurred in 42% of the heparin-treated group versus 43% of the group treated without heparin (p = 0.94). A patent infarct-related artery was present in 80% of the patients treated with heparin and in 73% of those treated without heparin (p = 0.26). Left ventricular function, as measured by ejection fraction, was well preserved in both groups (52% vs. 50.5%, respectively, p = 0.29). The overall bleeding rate was higher in patients with (32%) than without (17.2%) heparin (p = 0.006). CONCLUSIONS: Weight-adjusted intravenous heparin therapy after APSAC in acute myocardial infarction does not reduce the combined incidence of death, reinfarction, recurrent ischemia and occlusion of the infarct-related artery. Furthermore, withholding intravenous heparin therapy is associated with a 46% reduction in bleeding complications. Our findings do not support the addition of intravenous heparin after APSAC therapy, as currently recommended, and suggest that a strategy of withholding heparin is simpler and safer and does not place the patient at increased risk for ischemic complications after myocardial infarction.

Aged↗
PubMed1995

Drug eruptions and isotypic antibody responses to streptokinase after infusions of anisoylated plasminogen-streptokinase complex (APSAC, anistreplase).

BACKGROUND: Anisoylated plasminogen-streptokinase complex (APSAC, anistreplase) is a thrombolytic agent (131 kd) used for treatment of myocardial infarction. Like its principal antigenic determinant, streptokinase, APSAC has been reported to cause a variety of allergic reactions. OBJECTIVE: This study was intended to determine any association between isotypic antibody responses to streptokinase and observed allergic reactions to APSAC. METHODS: We measured sequential IgM, IgG, IgA, and IgE antistreptokinase serum levels in 21 patients who received APSAC or tissue-type plasminogen activator in a prospective, double-blind study. RESULTS: Of 11 patients who received APSAC, four had maculopapular rashes and one had urticaria; those with maculopapular rashes had significantly higher rises in serum IgM, IgG, IgA, and IgE antistreptokinase levels. We could not, however, define a temporal relationship between rises in antistreptokinase levels of a particular isotype and the onset of maculopapular rashes. The patient who had urticaria had no antistreptokinase responses but had also received several other potentially causal drugs. None of 10 patients who received tissue-type plasminogen activator had allergic reactions or significant rises in serum antistreptokinase levels. CONCLUSION: The more vigorous panisotypic antistreptokinase responses observed in patients who received APSAC and had maculopapular rashes may reflect generalized immune system activation that included other immune responses (such as cell-mediated hypersensitivity) that were responsible for these reactions.

Aged↗
PubMed1993

Raised levels of antistreptokinase antibody and neutralization titres from 4 days to 54 months after administration of streptokinase or anistreplase.

Streptokinase and anistreplase are antigenic and their administration often leads to antibody formation. These can cause allergic reactions and/or neutralization of streptokinase with resulting suboptimal treatment. Currently, streptokinase re-administration is considered appropriate for up to 5 days and from 1 year after a previous dose. Antistreptokinase antibody and neutralization titres (NT) were measured in three groups of patients to determine if this practice is appropriate: 1. (early)--36 patients whose titres were measured for at least 5 days after thrombolysis; 2. (late)--57 patients who received thrombolysis 12-54 months previously; 3. (controls)--182 consecutive suspected myocardial infarction patients (without previous exposure to thrombolysis). Results were as follows (mean +/- SEM): 1. (early)--the antibody and/or NT were raised by day 4 in 19.4% of the patients. One patient could have neutralized 1.97 million units (MU) of streptokinase by day 4. (Day 4--antibody 1:39 +/- 11, NT 0.19 +/- 0.05 MU; day 5--1:136 +/- 41 and NT 0.7 +/- 0.43 MU respectively.) 2. (late)--23 patients (40%) had either antibody titres > or = 1:160 and/or NT > 1.5 MU. (12-23 months--antibody 1:243 +/- 43, NT 0.63 +/- 0.15 MU; 24-35 months--1:98 +/- 31 and 0.69 +/- 0.22 MU; 36-54 months--1:87 +/- 14 and 0.54 +/- 0.12 MU.) All titres were significantly higher than the controls (antibody 1:25 +/- 3, NT 0.14 +/- 0.01 MU, P < 0.01). After streptokinase or antistreplase, antibodies are raised from 4 days to at least 54 months. It would seem prudent to avoid their re-administration during this time interval.

Anistreplase↗
PubMed1994

Electrocardiographic evidence of reperfusion occurring before hospital admission. A Grampian Region Early Anistreplase Trial (GREAT) sub-study.

The benefits of thrombolysis are believed to be related to the speed of reperfusion of the infarct-related artery. In this sub-study, evidence for the occurrence of reperfusion before admission to hospital has been sought. In a randomized double-blind controlled trial, 311 patients with suspected acute myocardial infarction were given anistreplase 30 units i.v., either at home at a median 101 min (early group, n = 163), or in hospital at a median 240 min after symptom onset (large group, n = 148). Paired electrocardiograms recorded at home and on admission to hospital were available for study in 143 and 137 patients in early and late groups. Reduction in ST elevation between home and hospital electrocardiograms of > 25% in a single lead was taken as evidence of reperfusion. Patients with significant ST elevation in either electrocardiogram comprised the sub-study groups, and numbered 63/143 (44%) and 68/137 (50%) in early and late groups respectively. A reduction of > 25% in the single lead demonstrating greatest ST elevation on the presenting electrocardiogram was observed in 37/63 (59%) and 23/68 (34%) patients in the early and late sub-study groups (difference 25%, 95% confidence interval 8% to 42%, P = 0.003). It was found that domiciliary thrombolysis was associated with electrocardiographic evidence of an increased rate of reperfusion occurring before admission to hospital. Evidence of reperfusion occurring pre-hospital, whether spontaneous or following thrombolytic therapy, was associated with a better outcome.

Anistreplase↗
PubMed1996

Magnitude of benefit from earlier thrombolytic treatment in acute myocardial infarction: new evidence from Grampian region early anistreplase trial (GREAT)

OBJECTIVE: To generalise from the results of the Grampian region early anistreplase trial (GREAT) and to express the benefit of earlier thrombolysis in terms of lives saved per hour of earlier treatment. DESIGN: Multivariate analysis of a randomised double blind trial. SETTING: 29 rural practices in Grampian region and teaching hospitals in Aberdeen. SUBJECTS: 311 patients with suspected acute myocardial infarction and without contraindications to thrombolysis who were seen by their general practitioners within four hours of the start of symptoms. INTERVENTIONS: Anisterplase 30 units given intravenously, either by general practitioners before hospitalisation or later in hospital. MAIN OUTCOME MEASURE: Death within 30 months of entry into trial. RESULTS: Death within 30 months was positively related to age (P < 0.0001) and to delay between start of symptoms and thrombolytic treatment (P = 0.0004). However, the probability of dying rose exponentially with earlier presentation, so death within 30 months was negatively related to the logarithm of the time of randomisation (P = 0.0163). In patients presenting two hours after start of symptoms each hour's delay in receiving thrombolysis led to the loss of 21 lives per 1000 within 30 days (95% confidence interval 1 to 94 lives per 1000) (P = 0.03) and 69 lives per 1000 within 30 months (16 to 141 lives per 1000) (P = 0.0004). CONCLUSIONS: The magnitude of the benefit from earlier thrombolysis is such that giving thrombolytic treatment to patients with acute myocardial infarction should be accorded the same degree of urgency as the treatment of cardiac arrest.

Anistreplase↗
PubMed1990

Rash after treatment with anistreplase.

A palpable purpura developed on the legs and lower abdomen of a woman of 54 five days after she was treated with anistreplase anisoylated plasminogen streptokinase activator complex (APSAC) for an acute myocardial infarction. Histological examination of a skin biopsy specimen taken 6 days after treatment showed leucocytoclastic vasculitis. The rash resolved within two weeks and there were no other complications.

Anistreplase↗
PubMed1992

ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group.

41,299 patients entering 914 hospitals up to 24 h (median 4 h) after the onset of suspected acute myocardial infarction were randomised between streptokinase (SK: 1.5 MU infused over about 1 h), tissue plasminogen activator (tPA, duteplase: 0.60 MU/kg infused over about 4 h), or anisoylated plasminogen-streptokinase activator complex (APSAC), anistreplase: 30 U over about 3 min). All patients were to receive aspirin (162 mg/day enteric-coated), with the first tablet chewed for rapid and full antiplatelet effect. Half of all patients were randomly allocated subcutaneous calcium heparin (12,500 IU starting at 4 h and given twice daily for 7 days or until prior discharge) in addition to aspirin, and the other half were to receive aspirin alone. ASPIRIN PLUS HEPARIN VERSUS ASPIRIN ALONE--The addition of heparin to aspirin was associated with an excess of transfused or other major non-cerebral bleeds (1.0% aspirin plus heparin vs 0.8% aspirin alone; 2p < 0.01) and of definite or probable cerebral haemorrhage (0.56% vs 0.40%; 2p < 0.05), but with no significnat differences in total stroke (1.28% vs 1.18%). Reinfarctions were slightly less common among those allocated aspirin plus heparin (3.16% vs 3.47%; 2p = 0.09). There was no signficant difference in the pre-specified endpoint of 35-day mortality (2132 [10.3%] aspirin plus heparin vs 2189 [10.6%] aspirin alone). During the scheduled heparin treatment period there were slightly fewer deaths in the aspirin plus heparin group (days 0-7 in hospital: 1534 [7.4%] vs 1633 [7.9%]; 2 p = 0.06), with a slight convergence by day 35 (598 further deaths [3.1% of survivors] vs 556 [2.9%]). The pattern was similar to that observed in the GISSI-2 trial, so that in both trials combined there was a significant reduction in mortality during the scheduled treatment period (2071 [6.8%] vs 2239 [7.3%]; 2p < 0.01). This indicates avoidance of 5 deaths (SD 2) per 1000 patients allocated this high-dose subcutaneous heparin regimen in addition to aspirin, but some of any early benefit may be lost after heparin ceases, with no significant mortality advantage in days 0-35 (both trials: 3100 [10.0%] vs 3172 [10.2%]) or during follow-up to 6 months. SK VERSUS APSAC--APSAC was associated with significantly more reports of allergy causing persistent symptoms and of non-cerebral bleeds, but not of transfused bleeds or of reinfarctions. There was a slight excess of strokes with APSAC (1.04% SK vs 1.26% APSAC; 2p = 0.08), much of it appearing soon after treatment started (strokes during days 0-1: 0.50% SK vs 0.73% APSAC; 2p < 0.02) and being attributed to cerebral haemorrhage (0.24% SK vs 0.55% APSAC; 2p < 0.0001). No significant difference was observed in reinfarction (3.47% SK vs 3.55% APSAC). There was no significant mortality difference during days 0-35, either among all randomised patients (1455 [10.6%] SK vs 1448 [10.5%] APSAC) or among the pre-specified subset presenting within 0-6 h of pain onset and with ST elevation on the electrocardiogram in whom fibrinolytic treatment may have most to offer (861 [10.0%] SK vs 855 [9.9%] APSAC). No significant difference in 6-month survival was apparent overall or in the subset.(ABSTRACT TRUNCATED AT 400 WORDS)

Aged↗