In a randomized cross-over study, the effect of PGE(1) and iloprost on microcirculation as well as the tolerability was investigated in 36 patients with peripheral arterial occlusive disease stage III and IV according to Fontaine. Patients received PGE(1) and iloprost by single 3-h i.v. infusions on two different days at doses recommended by the manufacturers or in previous studies (PGE(1): first hour 20 mug, next 2 h 30 mug each. Iloprost: first hour 0.5 ng/kg/min, next 2 h 1.0 ng/kg/min).Transcutancous oxygen pressure (tcPO(2)) values increased much more with PGE(1). Median tcPO(2) increase over baseline 30 min after the end of infusion was 9 and 2 mmHg for PGE(1) and iloprost, respectively, corresponding to median AUC differences from baseline of 1050 and 210 min mmHg. Because of its exploratory character, the study was not powered to test for significance. Adverse effects occurred in 19.4% (PGE(1)) and 30.6% (iloprost) of patients. Dose reduction was required in 3 patients receiving iloprost (hypotension, nausea, irritation of the infused vein), and in none receiving PGE(1). (C) 2003 Elsevier Ltd. All rights reserved.

BACKGROUND:Infection with Chlamydia pneumoniae is suspected to contribute to the pathogenesis of human atherosclerosis. We investigated whether treatment with the macrolide antibiotic roxithromycin would reduce mortality or morbidity in patients with an acute myocardial infarction.METHODS AND RESULTS:Eight hundred seventy-two patients with an acute myocardial infarction (AMI) were randomly assigned to receive double-blind treatment with either 300 mg roxithromycin or placebo daily for 6 weeks. Primary end point was total mortality during 12-month follow-up. Four hundred thirty-three patients were treated with roxithromycin and 439 with placebo. With the exception of a higher proportion of patients suffering an anterior wall AMI (48.1% in the roxithromycin group versus 40.2% in the placebo group; P=0.027) and a lower prevalence of chronic obstructive pulmonary disease in the roxithromycin group (3.5% versus 6.9%, P=0.028), baseline characteristics, reperfusion therapy, and medical treatment were well balanced between the two groups. More patients in the roxithromycin group interrupted their study medication before completion of at least 4 weeks of treatment (78 of 433 [18%] versus 48 of 439 [11%]; P=0.003; odds ratio, 1.8; 95% CI, 1.2 to 2.6). Follow-up at 12 months was achieved in 868 of 872 (99.5%) patients. Total mortality at 12 months was 6.5% (28 of 431) in the roxithromycin group compared with 6.0% (26 of 437) in the placebo group (odds ratio, 1.1; 95% CI, 0.6 to 1.9; P=0.739). There were also no differences in the secondary combined end points at 12 months.CONCLUSIONS:Treatment of AMI patients with roxithromycin did not reduce event rates during 12 months of follow-up. Therefore, our findings do not support the routine use of antibiotic treatment with a macrolide in patients with AMI.

UNLABELLED:DRG-based cost analysis of inpatient conservative treatment of PAD stage III/IV BACKGROUND: In a prospective study carried out by the German Society of Angiology and the DRG Competence Center, Munich, the question was investigated whether the costs of conservative treatment of patients with PAOD stage III/IV (DRG F65) are adequately represented within the current G-DRG system. METHODS UND PATIENTS: Between September 1 and December 16, 2002, a total of 704 patients with DRG F65 (peripheral vascular diseases) were evaluated at 8 angiologic centers in Germany. Apart from the length of hospital stay, the total costs (cost equivalents) were calculated using a method developed by the DRG Research Group at the University of Münster. Moreover, the study population was compared with a German calculation sample for the DRGs F65A/B, as published by InEK.RESULTS:As it turned out, conservatively treated patients with PAOD stage III or IV (DRGs F65A/B) cause significantly (p < 0.001) higher costs and have significantly (p < 0.001) greater lengths of hospital stay than patients who were also assigned to DRG F65 because of other vascular diseases. At the same time it became clear that angiologic centers treat twice as many patients with critical limb ischemia in comparison with the German average. The reimbursement hitherto estimated by InEK covers not even half the cost actually produced by conservative treatment of PAD stage III/IV.CONCLUSION:To ensure a performance-related reimbursement, a new basis DRG for patients with PAD stage III/IV has to be created, as has ben proposed by the German Society of Angiology. Otherwise, adequate conservative therapy in accordance with existing guidelines, of patients who cannot be treated surgically or interventionally will not be possible any more in the future.

In patients with acute myocardial infarction (AMI) admitted at hospitals without angioplasty facilities there are some subgroups of patients which seem to profit from a transfer to primary or acute angioplasty. However, current clinical practice at such hospitals is unknown. We analyzed the pooled data of the german acute myocardial infarction registries MITRA and the MIR. Angioplasty was not available at 221/271 hospitals (81.5%). Out of 14,487 patients with acute myocardial infarction admitted to these hospitals, 50.1% (7,259/14,487) received thrombolysis at the initial hospital and 3.6% (523/14,487) were transferred. Out of the transferred patients, 55.3% (289/523) were treated with primary angioplasty and 44.7% (234/523) received a combination of thrombolysis and angioplasty. The proportion of transferred patients increased from 1.1% in 1994 to 5.5% in 1998 (p for trend = 0.001). One hundred and four hospitals (47.1%) never transferred patients. Patients transferred for primary angioplasty (289 patients) were compared to patients treated with thrombolysis at the initial hospitals (7,259 patients). Multivariate analysis showed the following independent predictors for transfer of patients for primary angioplasty: contraindications for thrombolysis (OR = 17.9), a non-diagnostic first ECG (OR = 4.0), pre-hospital delay ≥ 6 hours (OR = 2.5), unknown symptom onset of the acute myocardial infarction (OR = 2.0) and anterior wall acute myocardial infarction (OR = 1.6). Heart failure at admission was the only dependent predictor not to transfer patients (OR = 0.40). In Germany only 47.1% of hospitals without angioplasty facilities transfer patients with acute myocardial infarction to primary or acute angioplasty. The proportion of transferred patients increased from 1.1% in 1994 to 5.5% in 1998. Contraindications for thrombolysis were the strongest predictor to transfer patients to primary angioplasty.

Background: Clinical studies oil the efficacy and tolerability of prostaglandin E-1 (PGE(1)) in the treatment of stage III/IV PAOD have so far reported only the effect of a single course of treatment lasting an average of 3-4 weeks. In view of the progressive nature of PAOD, however, worsening of the symptoms may again occur during the further course of the disease. The aim of the present retrospective study was, therefore, to investigate the question whether, under the conditions usually met with in the doctor's office or hospital, patients with stage III/IV PA OD also benefit over the long-term, that is, from repeated treatment with PGE(1) (Prostavasin(R)). Patients and Methods: In 13 angiological centers, the data of 277 patients (mean age 67 +/- 11 years) with the typical profile of instable stage III (n = 93) or stage IV (n = 184) PAOD who underwent more than one course of PGE(1) treatment were analysed. The mean daily dose and duration of the initial Prostavasin(R) treatment in the 169 hospitalized patients were 2 x 40 mu g PGE(1) i.v. for 21 days, and in the 108 ambulatory patients 1 x 60 mu g PGE(1) i.v. for 20 days. Results: Following the first course of treatment, 46% of the patients were returned from stage III/IV to stage II. On the occasion of the second course of treatment, 32% of these patients were still in stage II, while in the remaining patients, after an average treatment-free period of 342 days, the condition had deteriorated. Among this latter group, however, the renewed course of treatment resulted in renewed down-grading to stage II in 67% of the cases. The results seen after a third or fourth course of treatment were similarly positive. However, the success of treatment in patients with US Doppler pressures <50 mmHg was less favorable in comparison with higher Doppler pressures. Here, only 39% as compared with 62% of the cases were down-graded to stage II by the initial treatment. In all 4 courses of treatment, the tolerability of PGE(1) was equally good. Conclusions: In the usual office or hospital setting, intravenous Prostavasin(R) administered to patients with stage III/IV PAOD produces a long-lasting clinical improvement. Even in cases subsequently experiencing clinical deterioration, a renewed course of Prostavasin(R) treatment is successful, and the tolerability of the substance remains good.

Zusammenfassung Es wird ein Fall von rudimentärer erster Brustrippe mit einem typischen Halsrippensyndrom mitgeteilt, dessen Seltenheit betont und in Anlehnung an die bisher bei der Halsrippe gewonnenen Forschungsergebnisse eine Deutung der Symptome versucht.

Background: In a prospective study carried out by the German Society of Angiology and the DRG Competence Center, Munich, the question was investigated whether the costs of conservative treatment of patients with PAOD stage III/IV (DRG F65) are adequately represented within the current G-DRG system. Methods und patients: Between September 1 and December 16, 2002, a total of 704 patients with DRG F65 (peripheral vascular diseases) were evaluated at 8 angiologic centers in Germany. Apart from the length of hospital stay, the total costs (cost equivalents) were calculated using a method developed by the DRG Research Group at the University of Munster. Moreover, the study population was compared with a German calculation sample for the DRGs F65A/B, as published by InEK. Results: As it turned out, conservatively treated patients with PAOD stage III or IV (DRGs F65A/B) cause significantly (p < 0.001) higher costs and have significantly (p < 0.001) greater lengths of hospital stay than patients who were also assigned to DRG F65 because of other vascular diseases. At the same time it became clear that angiologic centers treat twice as many patients with critical limb ischemia in comparison with the German average. The reimbursement hitherto estimated by InEK covers not even half the cost actually produced by conservative treatment of PAD stage III/IV. Conclusion: To ensure a performance-related reimbursement, a new basis DRG for patients with PAD stage III/IV has to be created, as has been proposed by the German Society of Angiology. Otherwise, adequate conservative therapy in accordance with existing guidelines, of patients who cannot be treated surgically or interventionally will not be possible any more in the future.

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