Ralf Zahn

Hemodynamic effects of double bolus reteplase versus alteplase infusion in massive pulmonary embolism

BACKGROUNDnThrombolytic agents are given in massive pulmonary embolism to dissolve or reduce the clot and normalize hemodynamics. Comparative clinical studies have shown that administration of a 2-hour infusion of alteplase is more effective than urokinase over a 12-hour period. Reteplase is a new generation thrombolytic with a longer half-life that can be administered more conveniently as a double bolus. We compared efficacy and safety of reteplase with the approved regimen of alteplase in massive pulmonary embolism.nnnMETHODSnThirty-six patients were enrolled and randomly assigned: 23 received reteplase and 13 received alteplase along with intravenous heparin. Reteplase was administered as 2 intravenous bolus injections of 10 U 30 minutes apart, and alteplase was administered as an intravenous infusion of a total dose of 100 mg over a 2-hour period, including an initial 10-mg bolus. Diagnosis of pulmonary embolism was confirmed by selective pulmonary angiography. Hemodynamic monitoring was conducted during the first 24 hours after administration. The primary end point was change in total pulmonary resistance. Secondary variables were pulmonary pressure, cardiac index, clinical parameters, and adverse events.nnnRESULTSnThe primary parameter of total pulmonary resistance showed a significant decrease after just 0.5 hours in the reteplase group and after 2 hours in the alteplase group, with a further decrease persisting for up to 24 hours in both treatment groups. A similar pattern was seen in other directly measured hemodynamic parameters, especially mean pulmonary artery pressure and cardiac index; there was no significant difference between reteplase and alteplase. There was also no apparent difference between the treatment groups with respect to safety, and no stroke or intracranial hemorrhage occurred. The rate of bleedings and the incidence of nonhemorrhagic adverse events were as expected for patients with pulmonary embolism treated with a thrombolytic agent.nnnCONCLUSIONSnReteplase is suitable for treatment of massive pulmonary embolism with a standard double bolus 10 + 10 U. Efficacy of reteplase appeared to be at least as good at decreasing pulmonary vascular resistance as that of the approved alteplase regimen of 100 mg infusion over a 2-hour period.

Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in DeutschlandTemporal Trends in the Use of Drug-Eluting Stents in German Clinical Practice

BACKGROUND AND PURPOSEn: 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.nnnMETHODSn: 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.nnnRESULTSn: 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).nnnCONCLUSIONn: DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.ZusammenfassungHintergrund und Ziel:Medikamente freisetzende Stents („drug-eluting stents“ [DES]) zeichnen sich im Vergleich zu unbeschichteten Metallstents durch eine niedrigere Restenoserate aus. Seit 2002 sind sie in Deutschland zugelassen. Die folgende Analyse zeigt die Verwendung von DES im klinischen Alltag sowie Determinanten des Einsatzes in den Jahren 2003 und 2005 in Deutschland.Methodik:Das ALKK-Register (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) erfasst konsekutiv klinische und prozedurale Parameter interventionell behandelter Patienten mittels standardisierter Fragebögen, welche zur Datenzentrale des KL-Neuhaus Datenzentrums (Ludwigshafen) weitergeleitet werden. Die folgende Analyse umfasst die Daten von 40 434 Koronarinterventionen (PCIs), welche in den Jahren 2003 und 2005 an 32 Kliniken durchgeführt wurden.Ergebnisse:Insgesamt wurden 2003 18 564 PCIs und 2005 21 870 PCIs erfasst. Der Anteil von DES lag 2003 bei 4,3% und stieg bis 2005 auf 19,1% an. Die Hauptindikation für die Implantation eines DES war die stabile Angina pectoris (2003: 68,4%, 2005: 55,3%); DES wurden vor allem bei Patienten mit bekannter PCI eingesetzt (2003: 42,5%, 2005: 48,1%) . Der Anteil von DES bei komplexen Prozeduren war besonders hoch bei Interventionen am ungeschützten Hauptstamm (DES 2003: 15,6%, 2005: 35,9%), einer Ostiumstenose (DES 2003: 6,4%, 2005: 32,7%), bei In-Stent-Stenose (DES 2003: 9,5%, 2005: 40,6%) und Interventionen an mehr als einem Versorgungsgebiet (DES 2003: 7,6%, 2005: 29,3%).Schlussfolgerung:DES wurden vorwiegend bei stabiler Angina pectoris eingesetzt, allerdings mit zunehmendem Anteil auch bei komplexen Koronarläsionen im Off-Label-Bereich.AbstractBackground 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.