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Introduction: This analysis examines the influence of age on antithrombotic therapy, success rate of percutaneous coronary intervention (PCI) and in-hospital mortality in patients with Acute Coronary Syndrome (ACS) and elective PCI., Methods: We analysed data of 26,795 unselected patients with ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable Angina (UA) and elective PCI from the ALKK-PCI Registry 2006, a German prospective, multicentre registry., Results: Elderly patients (>75) with ACS were significantly less often treated with acetylsalicylic acid intravenously and a clopidogrel loading dose of 600 mg. Moreover, the administration of GP IIb/IIIa antagonists was significantly lower in these patients. The rate of successful PCI (indicated as TIMI 3 flow) is comparable in younger and elderly patients with elective PCI, UA and NSTEMI, whereas there were more unsuccessful interventions in elderly patients with STEMI (13.2 vs. 11.0%, p < 0,033). In all indications elderly patients showed increased in-hospital mortality., Conclusion: In clinical practice, elderly patients with ACS undergoing PCI receive significantly less intensive antithrombotic treatment. In terms of successful PCI, there was no significant difference between the age groups in patients with elective PCI, UA and NSTEMI. The higher in-hospital mortality of the elderly in all patient groups is most likely due to a higher rate of comorbidities.

Aim of the Study: To examine the development of door-to-angiography time (DTA) and to evaluate the impact of door-to-angiography time in patients with ST-elevation myocardial infarction (STEMI) on hospital and one-year mortality., Methods and Results: From 1994 to 2008, 5078 patients (pts) and known DTA with acute ST-elevation myocardial infarction were enrolled into the MITRAplus and OPTAMI registry in Germany. Our data showed a reduction of the door-to- angiography time from 80 min to 64 min in the last 14 years (P < 0.001). Over 80% of patients received an angiography less than two hours after admission. The main predictor of a shorter door-to-balloon time was a hypotension with a blood pressure lower than 100 mmHg (OR 1.46, 95%CI: 1.08-1.91). Whereas a history of prior myocardial infarction (OR 0.61, 95%CI: 0.45-0.84), a previous coronary bypass grafting (OR 0.55, 95%CI: 0.33-0.91), age older than 75 years (OR 0.78, 95%CI: 0.62-0.99) and a pre-hospital delay more than three hours (OR 0.78, 95%CI: 0.66-0.93) were independent predictors for a longer of the door-to-balloon time. In the multivariate regression analysis no influence was detected of door-to-angiography time on hospital or one-year mortality., Conclusion: The DTA decreased in the last 14 years and is actually very short in Germany. We indentified predictors of a longer door-to-angiography time in clinical practice. Given the overall short in-hospital delay, the observed door-to-angiography time did not have influence on hospital and mid term mortality.

Background: Guidelines recommend on-site surgery backup (SB) when elective percutaneous coronary intervention (PCI) is performed. The evidence for this recommendation is however weak., Objectives: The objective of the present study was to compare clinical outcomes in patients undergoing PCI in hospitals with SB or without surgery backup (non-SB)., Methods: Prospective German PCI registry in 36 hospitals throughout Germany. Consecutive procedures were collected and analyzed centrally., Results: In 2006, a total of 23,148 patients were included; 12,465 patients (53.8%) in 11 hospitals with SB and 10,683 patients (46.2%) in 25 hospitals without on-site cardiac SB. Both patient groups were well-balanced with regard to age and gender. SB hospitals had more patients with ACS (OR 1.29; 95%CI 1.23-1.36) and less patients with stable angina (OR 0.78; 95%CI 0.74-0.82) than non-SB hospitals. There was no indication of a clinically relevant differential outcome for in-hospital death, MACE, non-fatal MI, non-fatal stroke/TIA, or emergency CABG between SB and non-SB hospitals for neither patients with ACS nor stable angina except for emergency CABG in ACS patients (more frequent in SB hospitals, OR 2.29; 95%CI 1.02-5.13)., Conclusions: There was no evidence of an excess risk associated with PCI-procedures performed in non-SB hospitals.

Background: Percutaneous coronary intervention (PCI) early after thrombolysis (early PCI) in patients with ST-elevation myocardial infarction (STEMI) is currently advised by clinical guidelines, but little is known about its use in clinical practice., Methods: We analysed the MITRA (Maximal Individual Therapy of Acute Myocardial Infarction) plus registry., Results: Out of a total of 34276 patients with STEMI, 10600 (30.9%) were treated with intravenous thrombolysis. Out of these patients, 487 (4.6%) patients received an angioplasty between 61 min and 24 hours after thrombolysis. They were compared to 10113 (95.4%) patients who received PCI either later than 24 hours after thrombolysis or not at all. A continuous increase in the frequency of early PCI between the years 1994 (2%)-2002 (16.7%) was observed. After adjusting for confounding variables independent predictors to use early PCI were the increasing year of inclusion, the facility of the hospital to perform PCI, younger age and male gender. Hospital mortality was 7.2% in patients receiving early PCI, compared to 11.2% in the other group (<0.01). Independent predictors for a higher hospital mortality were shock, age >65 years, female gender, an anterior STEMI and a prehospital delay of >3 hours. However, early PCI was not longer associated with a lower mortality (OR 0.95, 95% CI 0.64-1.14)., Conclusion: Early PCI after thrombolysis is used infrequently in current clinical practice in Germany. Especially 'low risk' patients were treated with an early PCI, which may contribute to the missing effect on mortality compared to no or late PCI after thrombolysis.

Background: Studies about the influence of various factors on clinical therapy and course in acute coronary syndromes have shown that the outcome is related to admission time to the hospital, with an impaired prognosis in patients admitted out of regular working hours. However little is known about the impact of admission on weekend in hospitals with catheterisation laboratories., Methods: We analyzed data of the prospective MITRA-PLUS registry of 11,516 patients with ST-elevation myocardial infarction (STEMI) admitted to hospitals with catheterization facilities for differences of in-hospital mortality between patients admitted during regular working hours, at night and on weekends., Results: The prehospital delay and "door-to-balloon"-time were significantly longer on weekends and at nights than at regular working hours (median 196 Vs. 240 Vs. 155 min; P < 0.0001; 60 Vs. 84 min at weekends, resp. 75 min at nights; P < 0.0001). Reperfusion therapy was performed in 72.8% (8,248/11,332) patients, and there were less patients treated on weekend versus "on"-hours (69.7 Vs. 77 %, P < 0.0001). On weekends we found a significant higher in-hospital mortality (11.1 Vs. 9.4%, P = 0.01) and at night there was a trend to higher in-hospital mortality when compared with regular working hours (10.6 Vs. 9.4%, P = 0.07)., Conclusion: In patients with STEMI admitted to hospitals with catheterization facilities, admission during the "off"-hours is associated with higher in-hospital mortality. This may be due to lower rates of revascularization therapy and longer prehospital and in-hospital delays as compared to "on"-hours.

Background and Purpose: : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005., Methods: : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained., Results: : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3)., Conclusion: : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

Background: A meta-analysis of randomized trials has shown a significant reduction of mortality rate in patients receiving aspirin for secondary prevention after acute myocardial infarction (AMI). However, a significant number of patients do not receive aspirin after AMI. Little is known about why aspirin is withheld or the long-term outcome of these patients today., Methods: The Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) registry is a multicenter registry of patients with AMI in Germany., Results: Of 4902 patients, 509 (10%) did not receive aspirin at the time of discharge from the hospital. The mean follow-up period for these patients was 17 months. Relative contraindications to aspirin were significantly associated with the withholding of aspirin (in-hospital bleeding: odds ratio [OR], 3.56; 95% CI, 1.86-6.80; history of peptic ulcer: OR, 2.49; 95% CI, 1.62-3.83). Absolute contraindications to aspirin were rare (2.2%). Other medications of proven benefit were also given less often in these patients (beta-blockers: 49.0% vs 61.9%, P <.001; angiotensin-converting enzyme inhibitors: 65.6% vs 70.2%, P =.06; statins: 12.2% vs 15.1%, P =.10). Patients who were not given aspirin were at high risk for vascular events. They were more likely to have a history of prior AMI (OR, 1.34; 95% CI, 1.02-1.79), were in critical clinical condition at admission more often (cardiogenic shock: OR, 1.98; 95% CI, 1.09-3.56; overt heart failure: OR, 1.6; 95% CI, 1.05-2.3), and received acute revascularization less often (OR, 1.32; 95% CI, 1.05-1.67). The 1-year mortality was 2-times higher in patients who did not receive aspirin than in patients who did receive aspirin (16.5% vs 8.3%, P <.001). A significant association of withheld aspirin at discharge with a higher long-term mortality rate was confirmed with multivariate analysis (OR, 1.62; 95% CI, 1.15-2.29)., Conclusions: Ten percent of patients who sustained an AMI did not receive aspirin at the time of hospital discharge. Most of these patients were at high risk for cardiovascular events. Withheld aspirin was significantly associated with higher mortality rate during follow up.

Background: Percutaneous transluminal coronary angioplasty of the infarct-related artery in stable survivors of acute myocardial infarction is often performed, even in patients without any symptoms or residual ischemia. Despite the lack of randomized studies, it is widely believed that this intervention will improve the clinical outcome of these patients., Methods and Results: Three hundred patients with single vessel disease of the infarct vessel and no or minor angina pectoris in the subacute phase (1 to 6 weeks) after an acute myocardial infarction were randomized to angioplasty (n=149) or medical therapy (n=151). Primary end point was the survival free of reinfarction, (re)intervention, coronary artery bypass surgery, or readmission for severe angina pectoris at 1 year. The event-free survival at 1 year was 82% in the medical group and 90% in the angioplasty group (P=0.06). This difference was mainly driven by the difference in the need for (re)interventions (20 versus 8, P=0.03). At long-term follow-up (mean, 56 months), survival was 89% and 96% (P=0.02). Survival free of reinfarction, (re)intervention, or coronary artery bypass surgery was 66% and 80% in the medically and interventionally treated patients, respectively (P=0.05). The use of nitrates was significantly lower in the angioplasty group, both at 1 year (38% versus 67%, P=0.001) and at long-term follow-up (36% versus 55%, P=0.006)., Conclusions: Percutaneous revascularization of the infarct-related coronary artery in stable patients with single vessel disease improves clinical outcome at long-term follow-up and reduces the use of nitrates. The results of our study should be reproduced in a confirmatory study with a larger sample size before percutaneous coronary intervention in this low-risk patient subgroup, after myocardial infarction can be recommended as routine treatment in clinical practice.

Objective Among other adjunctive medication, heparin is widely used in the therapy of acute myocardial infarction (AMI) today. Large randomized trials, however, have shown inconclusive data on the benefit of adjunctive heparin therapy for patients with AMI. The aim of this study was to describe the use of heparin and complication rates in routine clinical practice today. Methods MITRA and MIR were multicenter registries of AMI patients in Germany. During the years 1994 to 1998, 22697 patients were registered with MITRA and MIR. Of these patients 49.9% received reperfusion therapy. Results 21004 patients (92%) received heparin during acute therapy of AMI. The following factors were associated with withholding heparin: Bleeding at admission (OR 4.7; CI 3.2-6.8), cardiogenic shock (OR 1.8; CI 1.4-2.3) and fibrinolytic therapy with streptokinase (OR 2.1; CI 1.8-2.3). Complication rates of patients with heparin were only slightly higher than among those without heparin: 1.7% strokes and 1.9% bleedings were reported among the patients with fibrinolysis and heparin compared to 1.3% strokes and 1.4% bleedings among patients without heparin (p=ns). Mortality rates were 14.1% for patients with and 27.3% for patients without heparin (p<0.001). Conclusions Of the patients in MITRA and MIR 92% received heparin during AMI. Patients with active bleeding or in critical condition received heparin significantly less often. The selection of critically ill patients may have contributed to the high mortality of patients without heparin for AMI. Bleeding complication rates of patients with adjunctive heparin were only sightly higher than reported in randomized trials.

Objective: Among other adjunctive medication, heparin is widely used in the therapy of acute myocardial infarction (AMI) today. Large randomized trials, however, have shown inconclusive data on the benefit of adjunctive heparin therapy for patients with AMI. The aim of this study was to describe the use of heparin and complication rates in routine clinical practice today., Methods: MITRA and MIR were multicenter registries of AMI patients in Germany. During the years 1994 to 1998, 22,697 patients were registered with MITRA and MIR. Of these patients 49.9% received reperfusion therapy., Results: 21,004 patients (92%) received heparin during acute therapy of AMI. The following factors were associated with withholding heparin: Bleeding at admission (OR 4.7; CI 3.2-6.8), cardiogenic shock (OR 1.8; CI 1.4-2.3) and fibrinolytic therapy with streptokinase (OR 2.1; CI 1.8-2.3). Complication rates of patients with heparin were only slightly higher than among those without heparin: 1.7% strokes and 1.9% bleedings were reported among the patients with fibrinolysis and heparin compared to 1.3% strokes and 1.4% bleedings among patients without heparin (p = ns). Mortality rates were 14.1% for patients with and 27.3% for patients without heparin (p < 0.001)., Conclusions: Of the patients in MITRA and MIR 92% received heparin during AMI. Patients with active bleeding or in critical condition received heparin significantly less often. The selection of critically ill patients may have contributed to the high mortality of patients without heparin for AMI. Bleeding complication rates of patients with adjunctive heparin were only slightly higher than reported in randomized trials.

Long-term follow-up after treatment with primary angioplasty compared to treatment with thrombolysis in patients with acute myocardial infarction (AMI) remains still to be determined. We therefore analyzed the data of the "Maximal Individual Therapy" in Acute Myocardial Infarction (MITRA-1) Registry. Follow-up data for a median of 17 months after discharge were available in 2090 out of 2195 (95%) AMI patients treated with thrombolysis, as well as 293 out of 312 patients (94%) treated with primary angioplasty. There were only small differences in patient characteristics between the two treatment groups. Compared to patients treated with thrombolysis, those treated with primary angioplasty had a higher prevalence of prior myocardial infarction (16.4% versus 12.2%, p = 0.04), longer prehospital delay: 10 minutes (130 minutes versus 120 minutes, p = 0.002), and a longer door-to-treatment time: 45 minutes (p < 0.001). Primary angioplasty patients were more likely to be treated with beta-blockers (primary angioplasty 79.8% versus thrombolysis 66.2%, p < 0.001) or statins (24.5% versus 16.5%, p < 0.001). There was no difference between the treatment groups for total mortality (p = 0.90) nor for the combined endpoint of death or re-infarction (p = 0.85). However, the combined endpoint of death, re-infarction or percutaneous coronary intervention or coronary bypass surgery was significantly lower in the primary angioplasty group (primary angioplasty 25.6% versus thrombolysis 32.3%, univariate odds ratio 0.72, 95% CI: 0.55-0.95, p = 0.02). This result was confirmed by multivariate analysis after adjusting for confounding parameters (multivariate odds ratio: 0.62, 95% CI: 0.42-0.91). The beneficial effect of primary angioplasty compared to thrombolysis achieved during the hospital stay after an AMI is maintained during a 17 month follow-up. AMI patients treated with thrombolysis were more likely to be treated with either percutaneous coronary intervention or coronary bypass surgery after discharge.

Aims: The specialty of the admitting physician may influence treatment and outcome in patients with acute myocardial infarction., Methods and Results: The pooled data of three German acute myocardial infarction registries: the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) 1+2 studies and the Myocardial Infarction Registry (MIR) were analysed. Patients admitted to hospitals with departments of cardiology were compared to hospitals without such departments. A total of 24 814 acute myocardial infarction patients were included, 9020 (36%) patients at 91 (29.8%) hospitals with departments of cardiology and 15 794 (64%) at 214 (70.2%) hospitals without cardiology departments. There were only minor differences in patient characteristics and prevalence of concomitant diseases between the two types of hospital. The first electrocardiogram was more often diagnostic at hospitals with cardiology departments (71.8% vs 66.5%, P<0.001). Reperfusion therapy and adjunctive medical therapy, such as aspirin, beta-blockers and ACE-inhibitors were used more often at cardiology departments (all P -values <0.001), even after adjustment for confounding parameters. Treatment improved at both types of hospital over time. Admission to a hospital with a department of cardiology was independently associated with a lower hospital mortality (14.2% vs 15.4%, adjusted OR=0.91; 95%CI: 0.83-0.99). Additional logistic regression models showed that the higher use of reperfusion therapy and recommended concomitant medical therapy was responsible for most of the survival benefit at such hospitals., Conclusion: Treatment of acute myocardial infarction patients at hospitals with departments of cardiology was independently associated with a higher use of recommended therapy and a lower hospital mortality compared to hospitals without such departments., (Copyright 2001 The European Society of Cardiology.)

There are few data about the incidence, determinants, and clinical course of in-hospital repeat acute myocardial infarction (RE-AMI) after an index AMI. From June 1994 to June 1998, 22,613 patients with AMI as an index event were registered by the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) and Myocardial Infarction Registries (MIR). Of these, 1,071 (4.7%) had a RE-AMI. For the index event, 9,143 patients (40.5%) were treated with thrombolysis, 1,707 (7.5%) with primary angioplasty, and 443 (2.0%) with a combination of both. Multivariate analysis showed that previous AMI (odds ratio [OR] 1.59; 95% confidence intervals [CI] 1.35 to 1.86), age >70 years (OR 1.57; 95% CI 1.36 to 1.81), diagnostic first electrocardiogram (OR 1.37; 95% CI 1.19 to 1.59), and female gender (OR 1.14; 95% CI 1.05 to 1.32) were independently associated with a higher incidence of RE-AMI. The incidence of RE-AMI was higher when patients received thrombolysis (OR 1.36; 95% CI 1.15 to 1.61), and it was lower when they underwent primary angioplasty (OR 0.74; 95% CI 0.53 to 1.03) or received beta blockers (OR 0.84; 95% CI 0.72 to 0.97). Patients with RE-AMI had higher hospital mortality compared with those without RE-AMI (OR 4.35; 95% CI 3.83 to 4.95). Multivariate logistic regression analysis showed an independent association of RE-AMI with in-hospital death (OR 6.60; 95% CI 5.61 to 7.70), repeat revascularization (OR 2.91; 95% CI 2.42 to 3.50), low workload capacity on the bicycle ergometry test (OR 2.17; 95% CI 1.71 to 2.76), and ejection fraction <40% (OR 1.72; 95% CI 1.38 to 2.14) at discharge. Thus, RE-AMI occurs in 4.7% of patients after an AMI. Previous AMI, age >70 years, diagnostic first electrocardiogram, and female gender are independent determinants for RE-AMI. Thrombolysis is associated with a higher and beta blockers with a lower incidence of RE-AMI. Once a RE-AMI occurs, it is a strong predictor of in-hospital mortality and morbidity.

Background: Clinical trials have shown the efficacy of aspirin for acute myocardial infarction (AMI). However, not all patients receive aspirin for AMI. The aim of this study was to provide information on characteristics and clinical course of patients not treated with aspirin for AMI., Methods: We analyzed the data of the Myocardial Infarction Registry (MIR) and the Maximal Individual Therapy of Acute Myocardial Infarction (MITRA) registry. MITRA and MIR were prospective multicenter registries of patients with ST segment elevation myocardial infarction in Germany., Results: Of 22,572 patients registered from 1994 to 1998, 1767 (7.8%) did not receive aspirin within the first 48 hours after admission. Multivariate analysis revealed two main factors associated with withholding aspirin for AMI: relative contraindications to aspirin (gastric ulcer [odds ratio (OR) 4.9, 95% confidence interval (CI) 3.7-5.7], renal insufficiency [OR 1.4, 95% CI 1.1-1.8]), and critical clinical state at admission (cardiogenic shock [OR 1.5, 95% CI 1.2-2.1] and prehospital resuscitation [OR 1.8, 95% CI 1.4-2.2]). In addition, these patients were significantly less likely to receive reperfusion therapy and adjunctive medical therapy such as beta-blockers and angiotensin-converting enzyme inhibitors. In-hospital mortality after adjustment for baseline characteristics was 27.2% in patients without aspirin compared with 11.1% in patients treated with aspirin., Conclusions: Only a minority of AMI patients (7.8%) did not receive aspirin. Relative contraindications to aspirin and a critical clinical state at admission were the main factors associated with withholding aspirin for AMI. Even after adjustment for patient characteristics, the mortality of patients without aspirin was almost three times higher.

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: Mortality from cardiac surgery is an essential indicator of quality and forms the basis of treatment strategy decisions in eligible patients. No contemporary complete data on unselected adult cardiac surgery patients are available in Germany., Methods and Results: A registry was started in June 1997 of all patients referred to surgery from 85 cardiology centres in Germany. The registry was intended to include 10 000 patients and this number was reached in March 1998. Follow-up of the patients was by simple questionnaire, reporting the date of surgery, major complications, and symptomatic improvement. If the questionnaire was not returned, a reminder letter was sent and, if necessary, further telephone investigations were performed. This resulted in 99.9% complete data. Of 10 525 patients operated on, 3.91% had died by 30 days after surgery. The overall operative mortality was 4.57%, which included 69 patients who died after more than 30 days from complications related to surgery. By multivariate analysis, the following predictors of mortality were identified: previous surgery, emergency or complex operation; age >75 years, female gender, cardiac failure, angina CCS class IV, and three-vessel coronary disease. An integral part of the registry was a pre-operative prediction of surgical risk in five categories. This risk estimate revealed a surprisingly correct prediction of the mortality observed., Conclusions: In a representative unselected group of cardiac surgery patients, operative mortality was 4.57%. Several procedural and clinical parameters were significantly correlated with mortality, but the risk increment by each of these factors was small. Unstructured clinical judgement reliably predicted the operative risk.

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.

Objectives: Two third of patients with acute myocardial infarction are admitted to hospitals without cardiac catheterization facilities. Whether a postinfarction patient will undergo cardiac catheterization or not is more often decided by general physicians than by cardiologists. The purpose of this presentation is to investigate the determinants for decision making to use cardiac catheterization in patients after myocardial infarction., Methods: MITRA is a prospective, multicenter registry, which enrolls all consecutive patients with acute Q wave infarction admitted to 54 hospitals in Southwestern Germany. During the pilot phase 949 consecutive survivors of acute myocardial infarction were included, and inhospital outcome as well as therapeutic strategies were registered., Results: Only half of the patients underwent cardiac catheterization regardless of whether a catheterization facility was available or not. In 63% of the patients under 65 years of age coronary angiography was performed; however, every fourth patient with age above 70 years was transferred to an invasive therapeutic strategy. The percentage of male patients was twice a high in the invasive group, whereas patients with prior infarction, clinical signs of congestive heart failure, patients with moderately or severely impaired left ventricular function, and finally patients with a prehospital delay of more than 4 hours were more frequent in the conservative group. The following three parameters were calculated to be independent determinants of an invasive strategy: pathological stress ECG (OR: 2.8; CI: 1.80-4.60), patients < 70 years without stress ECG (OR: 2.18; CI: 1.5-3.18), and male gender (OR: 1.45: CI: 1.10-2.00). Independent factors of a conservative strategy were primary PTCA (OR: 0.2; CI: 0.09-0.46), prehospital delay > 4 hours (OR: 0.71; CI: 0.51-0.97), and the combination of age > 70 years and the absence of a stress ECG (OR: 0.78; CI: 0.55-1.11)., Conclusions: In Germany, patients with acute myocardial infarction are less likely to undergo cardiac catheterization compared to patients in other Western countries (e.g. , the United States). Despite recommended guidelines, invasive strategies are more frequent in low risk groups (younger patients, male gender) than in postinfarction patients at high risk (severely impaired left ventricular function, clinical signs of congestive heart failure, the elderly).

Objective: To determine the frequency of the use of primary angioplasty in patients with acute myocardial infarction and the factors influencing its indications in hospitals with the facilities to perform this treatment., Design: Data from the maximal individual therapy in acute myocardial infarction (MITRA) trial were analysed, concerning the effects of the decisions of individual hospitals, the time of admission of patients, and the effects of patient characteristics on the selection of reperfusion treatment., Patients: Between June 1994 and January 1997 eight hospitals treated 1532 patients with acute myocardial infarction. 418 (27.3%) were treated conservatively, 641 (41.8%) were treated using intravenous thrombolysis, 387 (25.3%) were treated using primary angioplasty, and 86 (5.6%) received a combination of thrombolysis and angioplasty., Results: The proportion of patients treated with primary angioplasty varied from 1.8% to 57.7% among the eight hospitals. The use of primary angioplasty during non-office hours also showed wide variation, ranging from 20% to 54% between centres. The use of thrombolysis was comparatively evenly distributed during the non-office hours, ranging from 50-69%. Four hospitals with a primary angioplasty use rate > 30% showed no difference in the proportion of patients with contraindications for thrombolysis, high risk patients, or a combination of both, when compared with four hospitals with a lower rate of primary angioplasty use (98/322 (30.4%) v 19/65 (29. 2%), respectively, p = 0.847)., Conclusions: In hospitals with the facilities for performing primary angioplasty the most important factors influencing its use were the discretion of the individual hospital and the time of patient admission. Characteristics of patients did not influence the choice of reperfusion treatment

Background and Objective: 30-day mortality after operation is generally accepted as a central standard of quality, especially in regard to cardiac operations. The Working Party of Directors of Hospital Cardiology Departments (Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte, ALKK) in Germany set up a pilot project to analyse whether by direct communication with patients by a database centre the expenditure incurred in collecting complete data can be decisively reduced and full documentation of outcome can in this way be obtained even for a large multi-centre patient cohort., Patients and Methods: Between 1.6.1997 and 31.3.1998, data were consecutively collected by questionnaire on all patients registered for a cardiac operation at 85 of the 135 ALKK centres. The questionnaire included data about each patient and the indication for operation as well as the estimate of operative risk, assigned to one of five risk categories by the referring cardiologist either alone or in conjunction with the cardiac surgeon., Results: Until 30.9.1998, the data were obtained on 11,349 patients who had given informed consent (response rate 99.99%), including survival figures. 824 (7.3%) patients had not undergone the planned cardiac surgery, 134 having died before the data of operation. The 30-day postoperative mortality, obtained in 99.99% of the 10,525 patients, was 3.92%. The operative mortality was lowest, at 3.73%, for aortocoronary bypass only (n = 7932), highest for aortocoronary bypass plus valvular operation (n = 785), at 8.04%. There was good agreement between the cardiologists' preoperative risk assessment and the observed mortality., Conclusions: The 30-day mortality after cardiac operation can be obtained almost completely and with reasonable expenditure even for a large patient cohort. The results confirm that hospital mortality data definitely understate the overall operative risk. The methodology used in this pilot project, namely the inclusion of information from the patients by questionnaire, can also be applied to clinical results in other areas.

There have been some prospective randomized studies which compared primary angioplasty with intravenous thrombolysis in patients with an acute myocardial infarction (AMI). However, a substantial number of patients with AMI who would not have been included in those trials are treated with one of these two therapeutic options. To describe the proportions, characteristics, and outcome of these patients treated with primary angioplasty or thrombolysis we analyzed the data of the prospective "Maximal Individual Optimized Therapy for Acute Myocardial Infarction" (MITRA) trial. Out of 3308 patients treated with primary angioplasty or thrombolysis, 737 (22.3%) belonged to one of the following groups, not included in current randomized trials: Left bundle branch block, non-diagnostic first ECG, pre-hospital delay > 12 hours or unknown pre-hospital delay. Primary angioplasty was performed in 158/737 (21.4%) and thrombolysis received 579/737 (78.6%) of the patients. There were only minor differences regarding patients' characteristics and concomitant diseases between the two groups. Patients treated with primary angioplasty were 3 years younger (62 years median versus 65 years median (p < 0.036). They also more often showed overt heart failure at admission compared to patients treated with thrombolysis (primary angioplasty: 3.2% versus thrombolysis: 8.9%, OR = 0.34, 95% CI: 0.13-0.86). In-hospital time to intervention was 1 1/2 hours longer in patients treated with primary angioplasty (156 minutes median versus 47 minutes median, p = 0.001). beta-blockers were more often used with primary angioplasty compared to thrombolysis (70.31% versus 55.9%; OR = 1.87, 95% CI: 1.28-2.72), as well as ACE inhibitors (62% versus 49.9%; OR = 1.64, 95% CI: 1.14-2.35). Hospital mortality (8.2% versus 16.4%; OR = 0.46, 95% CI: 0.25-0.84), as well as a combined endpoint of death, reinfarction, postinfarction angina, advanced heart failure, and stroke (24.1% versus 42.3%, OR = 0.43, 95% CI: 0.29-0.64) were lower in patients treated with primary angioplasty compared to those treated with thrombolysis. Logistic regression analysis showed primary angioplasty to be independently associated with a lower rate of the combined endpoint (OR = 0.73, 95% CI: 0.59-0.91), after adjusting for confounding parameters. All subgroups showed a more favorable outcome in patients treated with primary angioplasty. In clinical practice, patients with AMI, not included in current randomized trials comparing primary angioplasty with thrombolysis, account for 22% of all patients with AMI treated with one of those two therapies. Primary angioplasty seems to be associated with a lower event rate compared to thrombolysis in these patients. This has to be confirmed by a prospective randomized trial.

Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of > 12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.

Background: Primary angioplasty for acute myocardial infarction (AMI) can only be performed in a limited number of centers. Therefore, some patients will be referred for this procedure., Design: We analyzed the data of the prospective observational MITRA trial, which took place at 54 hospitals in southwest Germany, to describe current practices and outcomes in referred patients compared to patients treated on-site., Results: Out of 491 patients treated with primary angioplasty, 63 (12.8%) were referred. Out of 46 hospitals without facilities to perform primary angioplasty, 29 (63%) never referred patients. Referred patients were less often male (60.3% versus 75.9%; p = 0.013), suffered more often from anterior wall infarction (62.9% versus 45.8%; p = 0.014), and more often had absolute contraindications against thrombolysis (11.1% versus 2.8%; p = 0.006). In-hospital time to treatment was 80 minutes in patients treated on-site compared to 190 minutes in referred patients (p = 0.001). There was a non-significant difference of in-hospital mortality between the two groups (11.1% for referred versus 7.5% on-site; p = 0.319). Referred patients had a higher hospital morbidity as expressed by a higher proportion of post-infarction angina (28.6% versus 4.2%; p = 0.001), a more frequent need for urgent revascularization (43.8% versus 16.4%; p = 0.001) and a higher proportion of advanced heart failure (11.1% versus 4.4%; p = 0.062)., Conclusions: Referral of patients with AMI for primary angioplasty is used only in a minority of hospitals. The referred patients represent a selected, more ill subgroup, resulting in a higher hospital morbidity compared to patients treated on-site. Continuous efforts should be undertaken to decrease the time delay from admission at the initial hospital to the beginning of revascularization.

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.

The prognostic value of thrombolytics, aspirin, beta-blockers and ACE-inhibitors has been well documented in large clinical trials, but the application of these drugs in clinical practice is not known. MITRA is a multicenter study of 54 hospitals in a defined region in southwest Germany. The aim is to document actual clinical practice (pilot phase) and to establish an individually optimised prognostic therapy for acute myocardial infarction, considering only the absolute contraindications for each drug. In the pilot phase, 1303 consecutive patients with acute transmural myocardial infarction were enrolled. The median age was 66 years, the prehospital time was 2.7 hours. 47% had an anterior infarction. In the subgroup of patients without absolute contraindications, only 53.4% were treated with thrombolytics, 87.6% with aspirin, 37.1% with beta-blocker, and 17.4% with ACE-inhibitor. Out of these, patients were classified as "optimally treated" if they received thrombolysis, aspirin as well as beta-blocker. Patients were also included if any of these medications was withheld in the presence of absolute contraindications. Treatment was defined suboptimal, if the patients did not receive any of these three medications despite the absence of absolute contraindications. Only 29% (n = 383) received an optimal post-infarction therapy and 71% (n = 775) a suboptimal treatment. The univariate analysis revealed 10 variables influencing optimal therapy. In this subgroup patients were younger, they more often had clear ECG-findings or left bundle branch block, an anterior infarction, acute cardiac failure, AV-block, bradycardia, recent trauma or surgery (less then 2 weeks) and a severe chronic obstructive lung disease. The prehospital time was more often available. Early mortality after 2 days was 5.0% versus 9.3% in the suboptimal treated patients (OR: 0.5, CI: 0.30-0.86) the total inhospital mortality was 10.9% in the optimal versus 17.7% in the suboptimal group (OR: 0.6, CI: 0.38-0.84). In a multivariate analysis the parameter "optimal treatment" was found to be an independent predictor of the early (OR = 0.4; CI: 0.20-0.69) and the inhospital mortality (OR = 0.4; CI: 0.25-0.64). The following in-hospital events occurred: stroke 2.8%, reinfarction 12.9%, cardiac failure 21.5%, cardiogenic shock 10.4% and in-hospital mortality 18.1% (2-days mortality 9.5%). Pharmacological therapy for acute myocardial infarction is inconsistent with the recommendations suggested in recent clinical trials and needs to be individually optimised. Optimal treatment is an independent predictor of early and inhospital mortality.