Search

OBJECTIVES We sought to determine the effectiveness of primary angioplasty compared with thrombolysis in clinical practice. BACKGROUND In clinical practice, primary angioplasty for the treatment of acute myocardial infarction (AMI) has not yet been proven more effective than intravenous thrombolysis, nor have subgroups of patients been identified who would perhaps benefit from primary angioplasty. METHODS The pooled data of two AMI registries—the Maximal Individual TheRapy in Acute myocardial infarction (MITRA) study and the Myocardial Infarction Registry (MIR)—were analyzed. A total of 9,906 lytic-eligible patients with AMI, with a pre-hospital delay of ≤12 h, were treated with either primary angioplasty (n = 1,327) or thrombolysis (n = 8,579). RESULTS Despite differences in the patients’ characteristics and concomitant diseases between the two groups, the prevalence of adverse risk factors was balanced. Univariate analysis of hospital mortality showed a more favorable course for patients treated with primary angioplasty: 6.4% versus 11.3% (odds ratio [OR] 0.54, 95% confidence interval [CI] 0.43 to 0.67). This was confirmed by logistic regression analysis (multivariate OR 0.58, 95% CI 0.44 to 0.77). Primary angioplasty was associated with a lower mortality in all subgroups analyzed. We observed a significant correlation between mortality and absolute risk reduction (r = 0.82, p CONCLUSIONS These large registry data showed the effect of primary angioplasty to be more favorable than thrombolysis for the treatment of patients with AMI in clinical practice. This effect was not restricted to special subgroups of patients. As mortality increased, the absolute benefit of primary angioplasty also increased.

OBJECTIVES We describe the baseline characteristics and clinical course of patients who had an acute myocardial infarction (AMI) during their hospital stay. BACKGROUND In comparison with patients who had an AMI outside of the hospital (prehospital AMI), the data on patients who had an AMI in the hospital are poorly described. METHODS Patients with an in-hospital AMI were prospectively registered in the Southwest German Maximal Individual TheRapy in Acute myocardial infarction (MITRA) study and compared with patients with prehospital AMI. RESULTS Of 5,888 patients with AMI, 403 patients (6.8%) had an in-hospital AMI. These patients were older, more often male and sicker as compared with the patients with a prehospital AMI. They also showed a higher prevalence of concomitant diseases, such as arterial hypertension, diabetes mellitus, renal insufficiency and contraindications for thrombolysis. There was no significant difference regarding the use of reperfusion therapy, either thrombolysis (in-hospital AMI 44.2% vs. prehospital AMI 49.1%; odds ratio [OR] 0.86, 95% confidence interval [CI] 0.70 to 1.05) or primary angioplasty (9.9% vs. 8.2%; OR 1.23, 95% CI 0.88 to 1.73), or a combination of both, between the two groups. The interval from symptom onset to the start of treatment in patients receiving reperfusion therapy was 55 min for patients with an in-hospital AMI versus 180 min for patients with a prehospital AMI (p = 0.001). In-hospital death occurred in 110 (27.3%) of 403 patients with an in-hospital versus 762 (13.9%) of 5,485 patients with a prehospital AMI (OR 2.33, 95% CI 1.85 to 2.94). This was confirmed by logistic regression analysis after adjusting for other confounding variables (OR 1.67, 95% CI 1.23 to 2.24). CONCLUSIONS In-hospital AMI occurred in 6.8% of patients. Time to intervention was shorter; however, the use of reperfusion therapy for in-hospital AMI was not different from that for prehospital AMI. In particular, primary angioplasty seems to be underused in these patients. This, as well as the selection of patients, may result in the high hospital mortality rate of 27.3%.

Background Concern exists regarding the results of primary angioplasty for acute myocardial infarction when the procedure is performed during night hours. Methods and Results Between June 1994 and January 1997, 491 patients with acute myocardial infarction who underwent primary angioplasty procedures were consecutive registered in the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Three hundred seventy-eight patients (77%) were treated during the day and 113 (23%) at night. Baseline characteristics showed no major differences between the 2 groups. Prehospital delay time was 60 minutes shorter during the night (median value 180 minutes for day, 120 minutes for night, P = .005), and in-hospital time to treatment was 9 minutes longer (median value 85 minutes day, 94 minutes night, P = .037). Patients treated during the night more often received angiotensin-converting enzyme blockers (61.4% day, 76.1% night, P = .004) and the so-called optimal adjunctive therapy (54% day, 64.6% night, P = .045). There were no differences concerning clinical events between the 2 groups. Hospital mortality was 8.7% during the day and 5.3% during the night (univariate analysis P = .238; logistic regression P = .653). Conclusions In a clinical setting, primary angioplasty for acute myocardial infarction can be performed safely during the night with a clinically insignificant prolongation of in-hospital time to reperfusion compared with practice during the day. (Am Heart J 1999;138:1111-7.)

Background —We prospectively investigated lepirudin for further parenteral anticoagulation in patients with heparin-induced thrombocytopenia (HIT). Methods and Results —Patients with confirmed HIT (n=112) received lepirudin according to need for 2 to 10 days (longer if necessary): A1, treatment: 0.4 mg/kg IV bolus, followed by 0.15 mg · kg −1 · h −1 intravenous infusion, n=65; A2, treatment in conjunction with thrombolysis: 0.2 mg/kg, followed by 0.10 mg · kg −1 · h −1 , n=4; and B, prophylaxis: 0.10 mg · kg −1 · h −1 , n=43. Outcomes from 95 eligible lepirudin-treated patients were compared with those of historical control patients (n=120). Complete laboratory response (activated partial thromboplastin time ratio >1.5 with ≤2 dose increases and platelet count normalization by day 10) was achieved in 65 lepirudin-treated patients (69.1%; 95% CI, 59.3% to 78.3%). At 2 weeks after cessation of lepirudin, 11 patients died (9.8%), 10 underwent limb amputation (8.9%), and 20 suffered a new thromboembolic complication (17.9%). The average combined event rate per patient-day decreased from 5.1% in the pretreatment period to 1.5% in the treatment period. Thirty-five days after HIT confirmation, fewer lepirudin-treated patients than historical control patients had experienced ≥1 outcome (cumulative incidence 30.9% versus 52.1%; relative risk [RR] 0.71; P =0.12, log-rank test). Bleeding events were more frequent in the lepirudin group than the historical control group (cumulative incidence at 35 days, 44.6% versus 27.2%; RR 2.57; P =0.0001, log-rank test). No difference was observed in bleeding events requiring transfusion (cumulative incidence at 35 days, 12.9% versus 9.1%; RR 1.66; P =0.23, log-rank test); no intracranial bleeding was observed in the lepirudin group. Conclusions —Lepirudin effectively prevents death, limb amputations, and new thromboembolic complications and has an acceptable safety profile in HIT patients. Treatment should be initiated as soon as possible if HIT is suspected.

Background Thrombolytic agents are given in massive pulmonary embolism to dissolve or reduce the clot and normalize hemodynamics. Comparative clinical studies have shown that administration of a 2-hour infusion of alteplase is more effective than urokinase over a 12-hour period. Reteplase is a new generation thrombolytic with a longer half-life that can be administered more conveniently as a double bolus. We compared efficacy and safety of reteplase with the approved regimen of alteplase in massive pulmonary embolism. Methods Thirty-six patients were enrolled and randomly assigned: 23 received reteplase and 13 received alteplase along with intravenous heparin. Reteplase was administered as 2 intravenous bolus injections of 10 U 30 minutes apart, and alteplase was administered as an intravenous infusion of a total dose of 100 mg over a 2-hour period, including an initial 10-mg bolus. Diagnosis of pulmonary embolism was confirmed by selective pulmonary angiography. Hemodynamic monitoring was conducted during the first 24 hours after administration. The primary end point was change in total pulmonary resistance. Secondary variables were pulmonary pressure, cardiac index, clinical parameters, and adverse events. Results The primary parameter of total pulmonary resistance showed a significant decrease after just 0.5 hours in the reteplase group and after 2 hours in the alteplase group, with a further decrease persisting for up to 24 hours in both treatment groups. A similar pattern was seen in other directly measured hemodynamic parameters, especially mean pulmonary artery pressure and cardiac index; there was no significant difference between reteplase and alteplase. There was also no apparent difference between the treatment groups with respect to safety, and no stroke or intracranial hemorrhage occurred. The rate of bleedings and the incidence of nonhemorrhagic adverse events were as expected for patients with pulmonary embolism treated with a thrombolytic agent. Conclusions Reteplase is suitable for treatment of massive pulmonary embolism with a standard double bolus 10 + 10 U. Efficacy of reteplase appeared to be at least as good at decreasing pulmonary vascular resistance as that of the approved alteplase regimen of 100 mg infusion over a 2-hour period. (Am Heart J 1999;138:39-44.)

Background Little is known about the differences in patients with acute myocardial infarction (AMI) treated with primary angioplasty or intravenous thrombolysis in clinical practice. Methods In all, 5,906 patients with AMI were registered by the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Of these, 491 (8.3%) patients were treated with primary angioplasty and 2,817 (47.7%) with intravenous thrombolysis. Results There were only minor differences in baseline characteristics between the two groups. Prehospital delay time (median) was longer in the angioplasty group than in the thrombolysis group (161 vs. 120, p = 0.001), as was door-to-treatment time (88 vs. 30 min; p = 0.001). Patients treated with primary angioplasty more often had contraindications for thrombolytic therapy (12.9 vs. 6%, p = 0.001) and received beta blockers (65 vs. 58.1%, p = 0.004), heparin (98.2 vs. 91.6%, p = 0.001), angiotensin-converting enzyme (ACE) inhibitors (64.8 vs. 50%, p = 0.001) and "optimal" concomitant medication (56.4 vs. 42.9%, p = 0.001) more often. Univariate analysis showed a significant lower incidence of heart failure (5.3 vs. 16.5%, p = 0.001), postinfarct angina (7.3 vs. 16.4%, p = 0.001), in-hospital death (7.9 vs. 11.7%, p = 0.015) and the combined end point (21.6 vs. 40.3%, p = 0.001) in these patients. Stepwise logistic regression analysis revealed optimal concomitant medication [odds ratio (OR) = 0.94, 95% confidence interval (CI): 0.89-0.98) and the type of revascularization (OR = 0.65, 95% CI: 0.58-0.73) to be associated with a significant reduction in the incidence of the combined end point. Similar results were obtained in all predefined subgroups. Conclusions In clinical practice, patients treated with primary angioplasty are more often treated with beta blockers and ACE inhibitors than patients treated with intravenous thrombolysis. Thus, the selection of patients and the type of revascularization contributes to the reduction in mortality, overt heart failure, and postinfarct angina in these patients.

The benefit of primary angioplasty in patients with acute myocardial infarction (AMI) and contraindications for thrombolysis compared to a conservative regimen is still unclear. Out of 5,869 patients with AMI registered by the MITRA trial, 337 (5.7%) patients had at least one strong contraindication for thrombolytic therapy. Out of these 337 patients 46 (13.6%) were treated with primary angioplasty and 276 (86.4%) were treated conservatively. Patients treated conservatively were older (70 years vs. 60 years; P = 0.001), had a higher rate of a history with chronic heart failure (14.8% vs. 4.4%; P = 0.053), a higher heart rate at admission (86 beats/min vs. 74 beats/min; P = 0.001), and a higher prevalence of diabetes mellitus (27.1% vs. 12.8%; P = 0.056). Patients treated with primary angioplasty received more often aspirin (91.3% vs. 74.6%; P = 0.012), β-blockers (60.9% vs. 46.1%; P = 0.062), angiotensin converting enzyme (ACE) inhibitors (71.7% vs. 44%; P = 0.001), and the so-called optimal adjunctive medication (54.4% vs. 32.3%; P = 0.004). Hospital mortality was significantly lower in patients who received primary angioplasty (univariate: 2.2% vs. 24.7%; P = 0.001; multivariate: OR = 0.46; P = 0.0230). In patients with AMI and contraindications for thrombolytic therapy, primary angioplasty was associated with a significantly lower mortality compared to conservative treatment. Therefore, hospitals without the facilities to perform primary angioplasty should try to refer such patients to centers with the facilities for such a service, if this is possible in an acceptable time.Cathet. Cardiovasc. Intervent. 46:127–133, 1999. © 1999 Wiley-Liss, Inc.

Within 1 year, 434 patients were admitted to 14 hospitals with suspected acute myocardial infarction (AMI)or = 4 hours after the onset of symptoms. Group A consisted of 171 patients (39%) treated with thrombolysis, and group B consisted of 263 patients (61%) with contraindications. Patients in group A more likely had a "definite AMI" (92%; group A1) than patients in group B (67%; group B1). Group B1 had 277 contraindications (1.6/per patient) with increased risk for life-threatening bleeding being the most frequently recorded at admission. The in-hospital mortality in group A1 was 7% (11 of 158) and in group B1, 27% (47 of 177) (p0.0001). Age and type of therapy (thrombolysis or no thrombolysis) were identified as independent predictors of increased mortality (p0.0001 and0.05, respectively). Thus, although most patients with an AMI are excluded from thrombolytic therapy because of contraindications, our data suggest that their in-hospital mortality is unexpectedly high. Further evaluation of this group of patients is warranted to define the impact of contraindications as an independent factor of mortality.

Unstable angina pectoris is used to describe accelerated angina, new onset of angina, or prolonged angina. The natural history of the angina varies according to clinical presentation. The 1-year mortality rate ranges from 2% to nearly 40%. Specific therapy includes nitrates, beta-adrenergic blockers, and/or calcium antagonists as well as antithrombotic therapy in the form of aspirin. Patients with severe angina at rest and ST- and T-wave changes should be admitted to a coronary care unit where full-dose heparin is administered. Coronary angiography should be performed in individuals who fail to respond to the conventional therapy in order to evaluate other therapeutic options, including percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery. In some cases, especially in patients with intracoronary thrombus, thrombolytic therapy may be beneficial.

If a stroke occurs during cardiac catheterization, immediate application of rt-PA in the involved carotid artery should be considered as an alternative to conventional therapy.

324 pts with acute myocardial infarction were treated with intravenous Streptokinase (l4 hrs after onset of symptoms, 1.500.000 U/1 hr) in 13 acute care hospitals and were centrally randomized by phone call to the university hospital in two groups during fibrinolysis. Group A (invasive strategy) CA with PTCA/CABS 14 to 48 hours after start of treatment and predischarge control CA. Group B (control group) no CA within the first 21 days, unless there is evidence for ischemia and predischarge control CA. In Gr-A 14/158 (=9%) pts, in Gr-B 10/166 (=6%) pts died before hospital discharge (n.s.). In a follow-up period of at least 24 months (Median 35 months) 13/144(=9%) pts of Gr-A and 14/156 (=9%) pts of Gr-B died (n.s.). All other patients (n = 273; Gr-A: 131, Gr-B: 142) were followed for a median time of 76 months (30–89 months, 1723 patient years). In Gr-A 20/131 (= 15%) pts and in Gr-B 7/142 (=5%) pts died during this period (p l 0.008). Cumulative number of deaths in Gr-A and Gr-B Time Gr-A Gr-B p-value l14 hrs 3 (=2%) 3 (=2%) n.s. 14–48 hrs 9 (=6%) 8 (=5%) n.s. in-hospital 14 (=9%) 10 (=6%) n.s. 3-year-FU 27 (=17%) 24 (=14%) n.s. 6-year-FU 47 (=30%) 31 (=19%) l0.03 Conclusion This data exclude even a long-term superiority of an invasive approach to patients with fibrinolytic treated acute myocardial infarction. A detailed stratification to identify patients who will benefit from coronary intervention is needed.