[Temporal trends in the use of drug-eluting stents in German clinical practice]. / Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in Deutschland. Daten des ALKK-Registers.

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.

Randomized comparison of percutaneous transluminal coronary angioplasty and medical therapy in stable survivors of acute myocardial infarction with single vessel disease: a study of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte.

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.

Too little aspirin for secondary prevention after acute myocardial infarction in patients at high risk for cardiovascular events: Results from the MITRA study.

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.

Age-related differences in antithrombotic therapy, success rate and in-hospital mortality in patients undergoing percutaneous coronary intervention: results of the quality control registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

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.

The development of door-to-angiography time in the last 14 years for patients with acute ST-elevation myocardial infarction treated with primary coronary intervention: Determinants and outcome. Results from the MITRAplus and OPTAMI registry.

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.

Angioplasty within 24 h after thrombolysis in patients with acute ST-elevation myocardial infarction: current use, predictors and outcome. Results of the MITRA plus registry.

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.

In-hospital outcomes after elective and non-elective percutaneous coronary interventions in hospitals with and without on-site cardiac surgery backup.

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.

Influence of presentation at the weekend on treatment and outcome in ST-elevation myocardial infarction in hospitals with catheterization laboratories.

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.