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The CIS was undertaken with the aim to evaluate the effects of lipid modifications on angiographic progression and regression of CAD in patients with CAD and hypercholesterolemia. The design included a multicenter randomized, double-blind, parallel, placebo-controlled comparison, with target and safety limits for adjusting the trial medication depending on the LDL cholesterol level (LDL-C) achieved, i.e., up to 40 mg of simvastatin (S) or placebo (P) daily, add-on medication (up to 3 x 4 g Colestyramin), and diet counselling. Male patients, average age 49 (or = 56) years, were included with angiographic CAD and a screening total cholesterol of 207-350 mg/dl, who were not due to undergo coronary bypass surgery or PTCA, who did not suffer from serious other disease (e.g., diabetes mellitus), and who had not undergone coronary bypass surgery previously.All baseline variables were comparable in the treatment groups, with 129 patients taking S and 125 taking P. Of these 254 patients 217 had their final study visit and 207 underwent a second angiography after an average treatment time of 2.3 years under an average daily dose of 37 mg S. 205 pairs of films were available for analysis. Vital information was obtained of all patients until closure of the data bank, half a year after the last study angiography. Five deaths occurred within the study period, 12 through March 15, 1995 (S: 1/6, P: 4/6). 37 patients (S: 18, P: 19) discontinued trial drug and protocol. Concomitant CAD medication was comparable in both groups, except lipid-lowering add-on medication which was significantly higher in the P group (38% versus 13%). Significant changes in lipid levels, on treatment, were observed in the S group amounting to a mean difference in LDL-C of -35%, in Apo-Protein B (ApoB) of -30%, in VLDL-C of -37%, and in triglycerides (TG) of -27%, and in HDL-C of +6%, in comparison to the control group; these differences were even greater in 137 fully compliant patients: -41, -36, -39, -31, and +7%, respectively. Progression in the S group was significantly less, as defined by the two primary target criteria: 1) the minimum obstruction diameter (MOD), determined by quantitative coronary angiography (QCA), decreased about five times less in comparison to the control group (S: by -0.017; P: -0.0954 mm), and 2) the standardized visual global change score (GCS) deteriorated almost three times less in the S group (by +0.20) than in the P group (+0.58). Of the secondary target criteria, the mean lumen diameter (QCA) also developed a significant difference (S: -0.20; P: +0.23 mm; p = 0.0006) with a trend toward regression in the S group. The QCA-%-stenosis deteriorated three- to four-times less in the S group as compared to the control group (S: by 0.69%; P: by 2.73%; p = 0.0022), and the number of patients with angiographic progression was nearly halved (S: 30%; P: 56%; p0.0000). These differences were determined by intention to treat analysis (ITT), and they were obtained in spite of lipid lowering add-on medication in 38% of the P patients; they turned out to be more pronounced in 137 fully compliant patients, in an analysis "as treated". The mean decrease in LDL-C serum level caused by S was significantly correlated to the decrease in progression, and multivariate regression analysis of both treatment groups identified LDL-C (or ApoB) and TG as independent predictors of progression. Progression appeared to be most pronounced in low and medium sized lesions, and the beneficial effect of lipid intervention dominated in lesions with 12-56% QCA stenosis severity. A small fraction of patients who suffered from exercise-induced angina, with ST-segment-depression at the beginning of the study, experienced a significant improvement under S as compared to P treatment. Although the study was not designed to show differences in clinical events, the combined number of all major cardiovascular events tended to be less frequent in the S than in the C gr

Vocational and social reintegration is one of the main targets of cardiac rehabilitation programs. As prognosis bases on objective pathophysiological data and psychosocial data, those data have to be used in the practice of cardiologists and rehabilitation workers. The relevant diagnostic parameters are demonstrated in this publication.

Wenn man berucksichtigt, welche unterschiedlichen Intentionen mit einer Reha-Masnahme verknupft sind, wird deutlich, wie vielschichtig die Frage nach dem Nutzen einer Reha ist. Es lassen sich 4 verschiedene Perspektiven nennen, aus denen der Nutzen einer Reha-Masnahme betrachtet werden kann: 1. Aus der Zielsetzung des Reha-Auftrages der Reha-Klinik 2. Aus der Sicht des Patienten 3. Aus der Sicht des Rentenversicherungstragers 4. Aus der Sicht des Arbeitsamtes Dabei spielen objektive Aspekte (Frage nach der Wiederherstellung oder der Verbesserung der Erwerbsfahigkeit eines Patienten) und subjektive Aspekte (Wohlbefinden des Patienten) eine Rolle.

Die Zusammenfassung, Beurteilung und Interpretation der Untersuchungsergebnisse erfolgt jeweils in der chronologischen Reihenfolge des Inhaltsverzeichnisses. Dabei wird fur jeden Punkt auf die unter I.1 — Hintergrund, Ziel und Hypothesen der Untersuchung — aufgefuhrten Kriterien eingegangen werden.

Quasi als Vorarbeit fur die nunmehr zu publizierende epidemiologische Studie, welche in einem 2-teiligen Forschungsvorhaben 1990 und 1991 insgesamt 1120 Patienten erfaste, haben wir ein umfangreiches Literaturstudium zum Thema „Qualitatssicherung in der kardiologischen Rehabilitation“ durchgefuhrt, auf deren Ergebnis wir den Leser als Basislekture verweisen mochten. Es handelt sich um eine Ubersichtsarbeit „Anschlusheilbehandlung bei kardiologischer Indikation — Standard und Qualitatssicherung aus Sicht der Rehabilitationsklinik“ (Weidemann, H. — Perfusion 40/1990) und um die offiziellen Mitteilungen der Deutschen Gesellschaft fur Pravention und Rehabilitation von Herz-Kreislauf-Erkrankungen e.V. „Die Komponenten einer umfassenden kardiologischen Rehabilitation in der Phase II nach WHO“ (Weidemann, H., M.J. Halhuber, J. Gehring, M. Keck, P. Mathes, H. Hofmann, O. Brusis, K. Held — Herz/Kreislauf 23 (10/1991).

Fur die Uberprufung der folgenden Fragestellungen ist es zumeist unerheblich, ob die Patienten der Reha-Kommission vorgestellt wurden oder nicht. Es handelt sich um allgemeine Aussagen zu bestimmten Wirkungszusammenhangen. Deshalb beziehen sich die folgenden Darstellungen i.d.R. auf die Gesamtgruppe.

Die umfassende kardiologische Rehabilitation setzt heute einen Standard voraus, der nach Auffassung der Deutschen Gesellschaft fur Pravention und Rehabilitation von Herz-Kreislaufkrankheiten bisher nur in speziellen medizinischen Institutionen und im Rahmen eines stationaren Aufenthaltes gewahrleistet werden konnte. Anliegen einer stationaren Rehabilitation ist die Verbesserung der Lebenserwartung und Lebensqualitat eines Herzpatienten sowie die krankheits- und behindertengerechte Reintegration in sein soziales und berufliches Umfeld — Rehabilitation vor Rente.

Kardiologische Rehabilitation im Phase II WHO erfordert sozialmedizinische, berufsfordernde und psychologische Strukturen und Inhalte zur Beurteilung der beruflichen und sozialen Reintegration chronisch Herzkranker. Charakteristisches Merkmal: Interdisziplinare Rehabilitationsteamarbeit unter arztlicher Leitung. Der Gesetzgeber raumt auch in Zukunft der beruflichen Rehabilitation Herzkranker einen hohen Stellenwert ein. Dies ist nach Auffassung der LVA-Reha-Studie Baden uneingeschrankt der Fall, wenn sie feststellt, das es das Ziel der Rehabilitation durch die gesetzlichen Rentenversicherungstrager ist, den behinderten Versicherten auf Dauer in die Lage zu versetzen, seiner Berufs- und Erwerbstatigkeit nachzugehen. Auch die BfA last keinen Zweifel daran, das das Ziel der Rehabilitation, zum Beispiel Herzinfarktkranker, mittels Anschlusheilbehandlung die Wiedereingliederung in das Erwerbsleben ist. Damit gilt weiterhin der Grundgedanke des Gesetzgebers „Rehabilitation vor Rente“, der als wesentlichsten Punkt „die Entwicklung eines umfassenden diagnostischen und therapeutischen Programms in der medizinischen sowie eines dem Einzelschicksal gerecht werdenden Programms in der beruflichen Rehabilitation“ enthalt.

Bei der Entscheidung, ob ein Patient der Reha-Kommission vorgestellt wird, spielen verschiedene Faktoren, die eine Wiedereingliederung erschweren oder verhindern konnten, eine Rolle. Als wichtigste sind zu nennen: 1. korperliche Berufstatigkeit 2. ungunstige funktions- und leistungsdiagnostische Befunde 3. psychosoziale Probleme

Plasma levels of atrial natriuretic peptide (ANP) were determined in 34 male patients undergoing diagnostic right heart catheterization. Patients with effort angina exhibited significant higher ANP levels at rest (259 +/- 42 pg/ml; n = 7) than patients without signs of coronary heart disease (78 +/- 30 pg/ml; n = 8). Patients with effort angina also had higher ANP levels at rest than patients exhibiting impaired cardiac function on exertion without signs of ischemia (105 +/- 15 pg/ml; n = 4), patients with only minimal functional alterations due to infarction residues (95 +/- 27 pg/ml; n = 7), or patients with only borderline changes of ST-segments during exertion (61 +/- 19 pg/ml; n = 8). In contrast, mean pulmonary capillary or right atrial pressures were not significantly different between the various groups of patients. The patients with effort angina also exhibited the highest ANP levels during bicycle exercise (846 +/- 238 pg/ml). There was only a weak to moderate linear correlation between ANP levels and pulmonary or right atrial pressures in the whole group of patients (r = 0.1-0.6). The plasma levels of epinephrine and norepinephrine and of ANP were not significantly correlated, with the exception of norepinephrine levels during exercise (r = 0.54). Our observations suggest that in patients with effort angina there may exist additional stretch-independent factors stimulating the release of ANP, possibly associated with repetitive myocardial ischemia.

UNLABELLED The CIS was undertaken with the aim to evaluate the effects of lipid modifications on angiographic progression and regression of CAD in patients with CAD and hypercholesterolemia. The design included a multicenter randomized, double-blind, parallel, placebo-controlled comparison, with target and safety limits for adjusting the trial medication depending on the LDL cholesterol level (LDL-C) achieved, i.e., up to 40 mg of simvastatin (S) or placebo (P) daily, add-on medication (up to 3 x 4 g Colestyramin), and diet counselling. Male patients, average age 49 (< or = 56) years, were included with angiographic CAD and a screening total cholesterol of 207-350 mg/dl, who were not due to undergo coronary bypass surgery or PTCA, who did not suffer from serious other disease (e.g., diabetes mellitus), and who had not undergone coronary bypass surgery previously. RESULTS All baseline variables were comparable in the treatment groups, with 129 patients taking S and 125 taking P. Of these 254 patients 217 had their final study visit and 207 underwent a second angiography after an average treatment time of 2.3 years under an average daily dose of 37 mg S. 205 pairs of films were available for analysis. Vital information was obtained of all patients until closure of the data bank, half a year after the last study angiography. Five deaths occurred within the study period, 12 through March 15, 1995 (S: 1/6, P: 4/6). 37 patients (S: 18, P: 19) discontinued trial drug and protocol. Concomitant CAD medication was comparable in both groups, except lipid-lowering add-on medication which was significantly higher in the P group (38% versus 13%). Significant changes in lipid levels, on treatment, were observed in the S group amounting to a mean difference in LDL-C of -35%, in Apo-Protein B (ApoB) of -30%, in VLDL-C of -37%, and in triglycerides (TG) of -27%, and in HDL-C of +6%, in comparison to the control group; these differences were even greater in 137 fully compliant patients: -41, -36, -39, -31, and +7%, respectively. Progression in the S group was significantly less, as defined by the two primary target criteria: 1) the minimum obstruction diameter (MOD), determined by quantitative coronary angiography (QCA), decreased about five times less in comparison to the control group (S: by -0.017; P: -0.0954 mm), and 2) the standardized visual global change score (GCS) deteriorated almost three times less in the S group (by +0.20) than in the P group (+0.58). Of the secondary target criteria, the mean lumen diameter (QCA) also developed a significant difference (S: -0.20; P: +0.23 mm; p = 0.0006) with a trend toward regression in the S group. The QCA-%-stenosis deteriorated three- to four-times less in the S group as compared to the control group (S: by 0.69%; P: by 2.73%; p = 0.0022), and the number of patients with angiographic progression was nearly halved (S: 30%; P: 56%; p < 0.0000). These differences were determined by intention to treat analysis (ITT), and they were obtained in spite of lipid lowering add-on medication in 38% of the P patients; they turned out to be more pronounced in 137 fully compliant patients, in an analysis "as treated". The mean decrease in LDL-C serum level caused by S was significantly correlated to the decrease in progression, and multivariate regression analysis of both treatment groups identified LDL-C (or ApoB) and TG as independent predictors of progression. Progression appeared to be most pronounced in low and medium sized lesions, and the beneficial effect of lipid intervention dominated in lesions with 12-56% QCA stenosis severity. A small fraction of patients who suffered from exercise-induced angina, with ST-segment-depression at the beginning of the study, experienced a significant improvement under S as compared to P treatment. Although the study was not designed to show differences in clinical events, the combined number of all major cardiovascular events tended to be less frequent in the S than in the C gr

The results of a randomized double-blind study with two comparable treatment groups are reported. In the course of treatment the frequency of angina pectoris during exercise as measured by a 4-point rating scale of symptom intensity decreased significantly for both groups. In comparison to the base line data the mean total workload increased significantly in both treatment groups (Molsidomin from 379 to 526 watt min; ISDN from 382 to 524 watt min-1). The product of systolic blood pressure and heart rate (BP X HR) under maximal workload increased significantly in both groups (Molsidomin from 17.5 to 20.9 mmHg min-1 1000(-1); ISDN from 17.7 to 20.2 mmHg min-1 1000(-1). The decrease in the ischaemic ST-segment depression on the level of maximal workload of the base line test was significant for both groups for all measures (Molsidomin from 0.27 to 0.08 mV; ISDN from 0.28 to 0.07 mV). The decrease of the ST-segment depression on the individual maximal workload level was significant for all measures in the Molsidomin group, but only on the first day of treatment in the ISDN group.

Hemodynamic measurements were carried out during exercise testing with floating catheterization in 12 male patients with multiple-vessel disease and stable angina pectoris after placebo, after acute treatment with 60 mg ISDN, and after 4 weeks treatment with 4 X 60 mg ISDN. The acute effects of ISDN at the maximal comparable workload were a 32% decrease in PAd, a 41% decrease in ST-segment depression, and a 35% increase in maximal workload. After 4 weeks therapy we found an attenuation of the efficacy of ISDN, with only a 12% decrease in PAd, a 33% decrease in ST-segment depression, and an 18% increase in maximal workload.

Durch die Untersuchungen von Rotta und Mitarb. (14), Grover und Mitarb. (5, 6), Fishman und Mitarb. (4), sowie zahlreicher weiterer Autoren wissen wir, das es unter chronischen Hypoxiebedingungen in der Hohe bei Tieren und Menschen zum Auftreten einer pulmonalen Hypertonie kommt; durch Einatmung reinen Sauerstoffes waren diese Veranderungen teilweise reversibel (5a, 6, 7, 8, 14). Das Auftreten einer pulmonalen Hypertonie wurde ebenfalls durch experimentelle Untersuchungen mit akuter Hypoxieexposition bestatigt (3, 5a, 5b), so das heute an einem ursachlichen Zusammenhang zwischen chronischer und akuter Hypoxie und einer pulmonalen Hypertonie kein Zwiefel mehr besteht. Sicher spielen auch bei zahlreichen Lungenerkrankungen, welche mit einer pulmonalen Hypertonie einhergehen, funktionelle Faktoren eine wesentliche, die rein anatomischen Veranderungen noch ubertreffende Rolle (6, 15).