Bernd Mark

Carotid artery stenting in clinical practice results from the Carotid Artery Stenting (CAS)-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).

Die stentgestützte Ballondilatation von symptomatischen und asymptomatischen Carotisstenosen (CAS) findet zunehmend Verbreitung im klinischen Alltag. Über die Machbarkeit und die Sicherheit der CAS in der täglichen Routine an einem Spektrum von verschiedenen Krankenhäusern liegen jedoch nur wenige Daten vor. Wir untersuchten die Daten des prospektiven multizentrischen Carotis-Stent (CAS) Registers der Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK). Zwischen 7/1996 und 5/2004 wurden 1888 Patienten an 28 Kliniken in das CAS-Register eingeschlossen. Die mediane Aufenthaltsdauer nach der Stentimplantation betrug 3 Tage (Quartile: 2–6 Tage). Die Patienten waren im Median 70 Jahre alt (Quartile: 64–76 Jahre) und in 72,1% der Fälle Männer. Die CAS wurde in 55% der Fälle bei symptomatischen Carotisstenosen durchgeführt. CAS-Patienten hatten in 66,5% der Fälle eine koronare Herzkrankheit, einen hohen Blutdruck in 91,7%, in 86,3% eine Hyperlipoproteinämie und waren zu 34,2% Diabetiker. Das CAS konnte in 98,1% erfolgreich zu Ende geführt werden, wobei eine Stentimplantation bei 97,3% der Patienten erfolgte. Die mediane Implantationszeit betrug 43 min (Quartile: 30–60 min). Während des Krankenhausaufenthaltes kam es in 0,3% (5/1888) zu Todesfällen und die ipsilaterale Insultrate betrug 3,2% (58/1840). In 1,4% (26/1840) der Patienten kam es zu einer kontralateralen Ischämie. Die kombinierte Rate aus Tod oder Apoplex betrug 3,8% (70/ 1841). Während des Beobachtungszeitraumes fand sich ein kontinuierlicher Anstieg der Rate des Einsatzes von Embolie-Protektionssystemen, der zuletzt 2004 97,9% betrug (p für Trend <0,0001). Wir beobachten ebenso einen Anstieg des Anteiles an behandelten asymptomatischen Carotisstenosen (p für Trend <0,0001) sowie einen Rückgang der Komplikationsraten bestehend aus Tod oder Apoplex von 6,3% 1996 auf 1,9% 2004 (p für Trend=0,021). Die CAS ist auch im klinischen Routineeinsatz eine bezüglich der Akutkomplikationen sichere und in einem hohen Maße erfolgreiche Prozedur. Im Laufe der letzten 8 Jahre konnte eine sehr starke Zunahme des Einsatzes von Embolie-Protektionssystemen bei gleichzeitigem Anstieg der Behandlung asymptomatischer Carotisstenosen und einem Rückgang in der akuten Komplikationsrate beobachtet werden. Carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis seems to be on the doorstep of more widespread use. However, its feasibility and safety in clinical practice at a broad spectrum of hospitals needs to be determined. We analyzed data of the prospective multi-centre Carotid Artery Stenting (CAS) Registry of the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK). From 7/1996 to 5/2004 1888 patients from 28 hospitals were included in the CAS Registry. The median hospital stay from CAS until hospital discharge was 3 days (quartiles: 2–6 days). Median patients age was 70 years (quartiles: 64–76 years) with 72.1% males. CAS for symptomatic stenosis was performed in 55% of cases. Patients treated with CAS suffered from coronary artery disease in 66.5%, had arterial hypertension in 91.7%, hyperlipidemia in 86.3% and 34.2% were diabetics. The intended CAS procedure was completed in 98.1% of cases. A stent was implanted in 97.3% of completed cases. The median intervention time was 43 min (quartiles: 30–60 min). During the hospital stay death rate was 0.3% (5/1888) and the rate of ipsilateral stroke 3.2% (58/1840). A contralateral ischemic event occurred in 1.4% (26/ 1840) of patients. The combined rate of all death or strokes was 3.8% (70/1841). Between 1996 and 2004 there was a steady increase in the use of protection devices during CAS (0% in 1996 and 97.9% in 2004; p for trend <0.0001). There was also an increase in the proportion of patients treated for asymptomatic stenoses (p for trend <0.0001). We observed a decrease of the combined endpoint of death or stroke from 6.3% in 1996 to 1.9% in 2004 (p for trend=0.021). The multi-centre ALKK CAS Registry data confirm the feasibility and shot-term safety of CAS even in daily clinical practice. There was a rapid penetration of the use of embolic protection devices, an increase in treatment of asymptomatic carotid stenoses and a decrease in acute complication rates from 1996 to 2004.

Carotid artery stenting in clinical practice

Die stentgestützte Ballondilatation von symptomatischen und asymptomatischen Carotisstenosen (CAS) findet zunehmend Verbreitung im klinischen Alltag. Über die Machbarkeit und die Sicherheit der CAS in der täglichen Routine an einem Spektrum von verschiedenen Krankenhäusern liegen jedoch nur wenige Daten vor. Wir untersuchten die Daten des prospektiven multizentrischen Carotis-Stent (CAS) Registers der Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK). Zwischen 7/1996 und 5/2004 wurden 1888 Patienten an 28 Kliniken in das CAS-Register eingeschlossen. Die mediane Aufenthaltsdauer nach der Stentimplantation betrug 3 Tage (Quartile: 2–6 Tage). Die Patienten waren im Median 70 Jahre alt (Quartile: 64–76 Jahre) und in 72,1% der Fälle Männer. Die CAS wurde in 55% der Fälle bei symptomatischen Carotisstenosen durchgeführt. CAS-Patienten hatten in 66,5% der Fälle eine koronare Herzkrankheit, einen hohen Blutdruck in 91,7%, in 86,3% eine Hyperlipoproteinämie und waren zu 34,2% Diabetiker. Das CAS konnte in 98,1% erfolgreich zu Ende geführt werden, wobei eine Stentimplantation bei 97,3% der Patienten erfolgte. Die mediane Implantationszeit betrug 43 min (Quartile: 30–60 min). Während des Krankenhausaufenthaltes kam es in 0,3% (5/1888) zu Todesfällen und die ipsilaterale Insultrate betrug 3,2% (58/1840). In 1,4% (26/1840) der Patienten kam es zu einer kontralateralen Ischämie. Die kombinierte Rate aus Tod oder Apoplex betrug 3,8% (70/ 1841). Während des Beobachtungszeitraumes fand sich ein kontinuierlicher Anstieg der Rate des Einsatzes von Embolie-Protektionssystemen, der zuletzt 2004 97,9% betrug (p für Trend <0,0001). Wir beobachten ebenso einen Anstieg des Anteiles an behandelten asymptomatischen Carotisstenosen (p für Trend <0,0001) sowie einen Rückgang der Komplikationsraten bestehend aus Tod oder Apoplex von 6,3% 1996 auf 1,9% 2004 (p für Trend=0,021). Die CAS ist auch im klinischen Routineeinsatz eine bezüglich der Akutkomplikationen sichere und in einem hohen Maße erfolgreiche Prozedur. Im Laufe der letzten 8 Jahre konnte eine sehr starke Zunahme des Einsatzes von Embolie-Protektionssystemen bei gleichzeitigem Anstieg der Behandlung asymptomatischer Carotisstenosen und einem Rückgang in der akuten Komplikationsrate beobachtet werden. Carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis seems to be on the doorstep of more widespread use. However, its feasibility and safety in clinical practice at a broad spectrum of hospitals needs to be determined. We analyzed data of the prospective multi-centre Carotid Artery Stenting (CAS) Registry of the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK). From 7/1996 to 5/2004 1888 patients from 28 hospitals were included in the CAS Registry. The median hospital stay from CAS until hospital discharge was 3 days (quartiles: 2–6 days). Median patients age was 70 years (quartiles: 64–76 years) with 72.1% males. CAS for symptomatic stenosis was performed in 55% of cases. Patients treated with CAS suffered from coronary artery disease in 66.5%, had arterial hypertension in 91.7%, hyperlipidemia in 86.3% and 34.2% were diabetics. The intended CAS procedure was completed in 98.1% of cases. A stent was implanted in 97.3% of completed cases. The median intervention time was 43 min (quartiles: 30–60 min). During the hospital stay death rate was 0.3% (5/1888) and the rate of ipsilateral stroke 3.2% (58/1840). A contralateral ischemic event occurred in 1.4% (26/ 1840) of patients. The combined rate of all death or strokes was 3.8% (70/1841). Between 1996 and 2004 there was a steady increase in the use of protection devices during CAS (0% in 1996 and 97.9% in 2004; p for trend <0.0001). There was also an increase in the proportion of patients treated for asymptomatic stenoses (p for trend <0.0001). We observed a decrease of the combined endpoint of death or stroke from 6.3% in 1996 to 1.9% in 2004 (p for trend=0.021). The multi-centre ALKK CAS Registry data confirm the feasibility and shot-term safety of CAS even in daily clinical practice. There was a rapid penetration of the use of embolic protection devices, an increase in treatment of asymptomatic carotid stenoses and a decrease in acute complication rates from 1996 to 2004.

Comparison of efficacy and complication rates after percutaneous coronary interventions in patients with and without renal insufficiency treated with abciximab.

Risk factors for bleeding were found in varying rates in both groups of patients. Neither adjunctive heparin therapy nor risk factors for bleeding complications could sufficiently explain the significantly higher rates of peri-interventional bleeding among patients with impaired renal function. Multivariate analysis of the registry data showed an independent association of renal insufficiency with bleeding complications under abciximab (odds ratio 5.1; 95% confidence interval 1.9 to 13.8). Success rates after PCI under abciximab were comparable in patients with normal and impaired renal function. These data suggest that the effects of abciximab are not entirely independent of renal function. Further investigation of this subject is necessary to find the optimal regimen for patients with impaired renal funtion receiving this highly effective drug.

Double-Blind, Randomized, Prospective Comparison of Loading Doses of 600 mg Clopidogrel Versus 60 mg Prasugrel in Patients With Acute ST-Segment Elevation Myocardial Infarction Scheduled for Primary Percutaneous Intervention: The ETAMI Trial (Early Thienopyridine treatment to improve primary PCI in Patients with Acute Myocardial Infarction)

OBJECTIVES This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (PPCI). BACKGROUND Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention (PCI) loading dose of clopidogrel or prasugrel in patients with STEMI. METHODS This double-blind, prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel (n = 31) or 600 mg clopidogrel (n = 31). The primary endpoint was the platelet reactivity index (PRI) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication. Secondary endpoints were PRI after 4 h, TIMI (Thrombolysis In Myocardial Infarction) patency of the infarct-related artery before and after PCI, and clinical events until day 30. RESULTS The PRI after 2 h (50.4 ± 32.7% vs. 66.3 ± 22.2%; p = 0.035) and after 4 h (39.1 ± 27.5% vs. 54.5 ± 49.3%; p = 0.038) were significantly lower with prasugrel compared with clopidogrel. In addition, the rate of patients with a PRI <50% tended to be higher with prasugrel compared with clopidogrel after 2 h (46.7% vs. 28.6%; p = 0.15) and after 4 h (63.0% vs. 38.9%; p = 0.06). There were no significant differences in TIMI 2/3 patency before PCI (39.2% vs. 31.0%; p = 0.43) and TIMI 3 patency after PCI (88.5% vs. 89.3%; p = 0.92). CONCLUSIONS The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel. Therefore, prasugrel should be preferred to clopidogrel in this setting. (ETAMI-Study: Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction; NCT01327534).

Clopidogrel in addition to aspirin reduces in-hospital major cardiac and cerebrovascular events in unselected patients with acute ST segment elevation myocardial

We sought to assess the effect of clopidogrel on in-hospital events in unselected patients with acute ST elevation myocardial infarction (STEMI). In a retrospective analysis of consecutive patients enrolled in the Acute Coronary Syndromes (ACOS) registry with acute STEMI we compared outcomes of either adjunctive therapy with aspirin alone or aspirin plus clopidogrel within 24 hours after admission.A total of 7,559 patients were included in this analysis, of whom 3,541 were treated with aspirin alone, and 4,018 with dual antiplatelet therapy. The multivariable analysis with adjustment for baseline characteristics and treatments showed that the rate of in-hospital MACCE (death, non-fatal reinfarction, non-fatal stroke) was significantly lower in the aspirin plus clopidogrel group,compared to the aspirin alone group in the entire cohort and all three reperfusion strategy groups (entire group odds ratio 0.60, 95% CI 0.49-0.72 , no reperfusion OR 0.69,95% CI 0.51-0.94,fibrinolysis OR 0.62,95% CI 0.44-0.88, primary PCI OR 0.54, 95% CI 0.39-0.74). There was a significant increase in major bleeding complications with clopidogrel (7.1% vs. 3.4%, p<0.001). In clinical practice early adjunctive therapy with clopidogrel in addition to aspirin in patients with STEMI is associated with a significant reduction of in-hospital MACCE regardless of the initial reperfusion strategy. This advantage was associated with an increase in major bleeding complications.

Carotid artery stenting: do procedural complications relate to the side intervened upon?: results from the Carotid Artery Stent (CAS)-Registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

Objectives: To determine the influence of the side intervened upon on outcomes during carotid artery stenting (CAS). Background: Anatomic and technical aspects may influence the results of CAS. The value of the side intervened upon has not been analyzed yet. Methods: We analyzed data from the Carotid Artery Stent (CAS) – Registry. Results: A total of 3,165 CAS procedures, 1,613 (51%) at the left and 1,552 (49%) at the right carotid artery were included. There was a higher proportion of patients treated for symptomatic stenoses when CAS was performed at the left carotid artery (50.1% versus 45.8%, P = 0.016) and more patients already had prior carotid endarterectomy (8.5% versus 5.8%, P = 0.003). Interventions at the left side took 3 min longer than interventions at the right side (46.6 ± 24.3 versus 43.8 ± 23.6, P = 0.003). In patients treated at the left carotid artery amaurosis fugax (0.7% versus 0.1%, P = 0.005), ipsilateral stroke (3.1% versus 1.8%, P = 0.017), and the primary endpoint of in‐hospital death or stroke (4.1% versus 2.3%, P = 0.005) occurred significantly more often. Even after adjusting for confounding parameters, CAS procedures performed at the left carotid arteries remained an independent predictor of death or stroke (OR = 1.77, 95% CI: 1.15–2.72, P = 0.009). Conclusions: In current clinical practice, CAS is performed frequently at the right carotid artery as at the left carotid artery. CAS interventions have a higher in‐hospital complication rate if performed at the left carotid artery. Technical improvements might help to overcome this situation.

Midventricular form of takotsubo cardiomyopathy as a recurrence 1 year after typical apical ballooning: a case report

Takotsubo cardiomyopathy was first described in Japan and is characterized by transient left ventricular apical ballooning in the absence of a significant coronary artery disease.Caused by the clinical presentation including chest pain, electrocardiographic changes and elevated myocardial markers this syndrome is frequently misdiagnosed as an acute coronary syndrome. Recurrences of Takotsubo Cardiomyopathy, especially in variant regions of the left ventricle are rareWe describe a midventricular form of Takotsubo Cardiomyopathy as a recurrence 1 year after typical apical ballooning.

Glycoprotein IIb/IIIa antagonists during carotid artery stenting : Results from the Carotid Artery Stenting (CAS) registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK)

BackgroundGlycoprotein II b/IIIa antagonists (GPII b/IIIa-A) lower the periprocedural rate of ischemic events during high risk percutaneous coronary interventions. Their clinical impact on carotid artery stenting (CAS) remains to be determined.MethodsWe analyzed data from the Carotid Artery Stent (CAS) Registry.ResultsFrom 01/ 2000 to 06/2005 1322 CAS interventions were registered. In 94 (7.1%) procedures a GPII b/IIIa-A was used: abciximab in 8 cases (8.6%), tirofiban in 53 cases (57%) and eptifibatide in 32 cases (34.4%). The use of a GPII b/IIIa-A during CAS decreased significantly over time: from 17.6% in 2000 to 3% in 2005, p for trend <0.0001. The mean use of a GPII b/IIIa-A at the hospitals was 5.2%. More than 50% of the hospitals never used a GPII b/IIIa-A. There were no significant differences in baseline characteristics and concomitant diseases in CAS patients treated with GPII b/IIIa-A compared to those without GPII b/IIIa-A. A bilateral intervention was performed more often in patients treated with GPII b/IIIa-A (2.1 vs 0.2%, p=0.04), a thrombus was more often visible (27 vs 12.4%, p<0.001) and an ulcer more frequently diagnosed (50 vs 37.5%, p=0.03). There was no significant difference in the combined death or stroke rate between the two groups (5.3 vs 3.0%, p=0.22, OR=1.81, 95% CI: 0.69–4.72), which was confirmed by logistic regression analysis after adjusting for possible confounders (OR=1.67, 95% CI: 0.62–4.46, p=0.31).ConclusionsOur data neither demonstrate a significant benefit nor a significant risk with the use of GPIIb/IIIa-A during CAS. However, only an adequately sized randomized controlled clinical trial could establish the real value of GPII b/IIIa-A during CAS. Until then, considering the potential increase in cerebral hemorrhage, we should not use GPII b/ IIIa-A routinely during CAS.

Reperfusion therapy for acute ST-elevation and non ST-elevation myocardial infarction: what can be achieved in daily clinical practice in unselected patients at an interventional center?

Background: In the year 2000 a new definition of acute myocardial infarction (AMI) was introduced, now differentiating ST segment elevation AMI (STEMI) from non-ST segment elevation AMI (NSTEMI). The characterization of AMI patients according to this definition is still incomplete. Methods and results: 888 consecutive AMI patients at a single interventional center were included: 493 (55.5%) STEMI and 395 (44.5%) NSTEMI patients. Median age of STEMI patients was four years lower compared to NSTEMI patients (62.8 versus 66.6 years, P<0.001). STEMI patients more often presented in cardiogenic shock (11.0% versus 2.0%, P<0.001) and after pre-hospital resuscitation (4.9% versus 0.8%, P<0.001). Catheterization was performed in 98.4% of STEMI and in 95.9% of NSTEMI patients (P<0.001). The circumflex artery was more often the culprit lesion in NSTEMI patients compared to STEMI patients (58.3% versus 48%, P=0.003). They also showed significantly more often a 3 vessel disease (41.4% versus 29.9%, P=0.002). Out of STEMI patients 10.1% were treated with medical therapy only compared to 27.2% of NSTEMI patients (P<0.001). Whereas PCI was performed more often in STEMI patients (84.3% versus 57.8%, P<0.001), CABG was used more often in NSTEMI patients (21.6% versus 9.1%, P<0.001). In-hospital death was 8.7% in STEMI compared to 4.8% in NSTEMI patients (P<0.001). Conclusions: In clinical practice STEMI and NSTEMI seem to occur with similar frequency. Invasive strategies were applied in a high percentage in both groups, however with different therapeutic consequences. In-hospital mortality was twice as high in STEMI compared to NSTEMI patients.

Comparison of different cardiac markers in monitoring percutaneous coronary interventions with frequent use of stents and gpIIbIIIa-antagonists.

Studien aus den frühen 90er Jahren fanden in 5–30% erhöhte Werte der CK und ihrer Isoform CK-MB nach perkutaner Koronarintervention (PCI) als Zeichen eines kleinen Myokardschadens. Über die Häufigkeit kardialer Markererhöhungen unter modernen, verbesserten PCI-Techniken sowie die Korrelation zwischen den verschiedenen häufig eingesetzten Markern, vor allem den kardialen Troponinen, ist wenig bekannt. Von 1997–2001 wurden 1486 Patienten, die sich einer PCI innerhalb der Regelarbeitszeit unterzogen, in ein prospektives Register eingeschlossen. Ein Infarkt in den letzten 48 Stunden war ein Ausschlusskriterium. Klinische und prozedurale Basisdaten sowie Verlaufsdaten von Entlassung bis zu einem Jahr wurden erhoben. Ein PCI-assoziierter Anstieg des Troponin T (cTnT) fand sich in 18%, der Gesamt-CK in 11%, der CK-MB in 33% und des Myoglobins in 23% der Fälle. Die Korrelation zwischen den Markern war gering. Verglichen mit cTnT zeigten die anderen Marker eine niedrige Sensitivität (Gesamt-CK 58%, CK-MB 27%, Myoglobin 22%) und, vor allem die Gesamt-CK, eine niedrige Spezifität. Die Stentimplantation, ein Seitastverschluss oder schwere Dissektion, eine komplexe Stenosemorphologie, der Einsatz eines GpIIbIIIa-Antagonisten, eine proximale Stenose und instabile Angina waren unabhängige Prädiktoren für einen Anstieg des cTnT in der multivariaten Analyse. In Anbetracht der schwachen Korrelation zwischen dem spezifischeren und sensitiveren cTnT und den anderen Markern sollte in erster Linie das cTnT zur Überwachung nach PCI eingesetzt werden. Neben der Stenosemorphologie war vor allem die Stentimplantation mit einem häufigeren Troponin-Anstieg assoziiert. Studies from the early 1990s found elevations of creatine kinase (CK) and its isoform CK-MB in 5–30% of patients after PCI, indicating minor myocardial damage. Less is known about the influence of modern improved PCI-techniques on the frequency of elevated cardiac markers and the correlation between different commonly used markers, especially cardiac troponins. From 1997 to 2001, 1486 patients undergoing PCI during the regular working hours were included in the prospective ”Ludwigshafen Infarctlet Registry”. Myocardial infarction in the past 48 hours was an exclusion criterion. Clinical and procedural data were documented. Follow-up data were obtained from discharge up to one year. PCI-related elevations of troponin T were found in 18%, of total-CK in 11%, of CK-MB in 33% and of myoglobin in 23% of cases. The correlation between the different markers was poor. Compared with troponin T, other markers showed low sensitivity (total-CK 58%, CK-MB 27%, myoglobin 22%) and, especially total-CK, low specificity. Stenting, side branch occlusion or major dissection, complex lesion morphology, gpIIbIIIa-antagonist application, proximal stenosis and unstable angina were independent predictors of an elevated troponin T in multivariate analysis. Due to this weak correlation between more specific and sensitive troponins and the other markers, troponins are preferred in monitoring after PCI. In addition to lesion characteristics, particularly stenting is associated with an increased rate of elevated troponin.