Hotline update of clinical trials and registries presented at the German Cardiac Society meeting 2008

Maier, Lars S.; Maack, Christoph; Ritter, Oliver; Böhm, Michael

doi:10.1007/s00392-008-0664-7

Cited by 30 publications

(7 citation statements)

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“…The data were presented by leading experts in the field with relevant positions in the trials and registries. These comprehensive summaries should provide the readers with the most recent data on diagnostic and therapeutic developments in cardiovascular medicine similar as previously reported (Rosenkranz et al in Clin Res Cardiol 96:457–468, 9; Maier et al in Clin Res Cardiol 97:356–363, 3). …”

supporting

confidence: 57%

“…The objective of the GERSHWIN (German stent health outcome and economics within normal practice) study was to study clinical benefit (MACE: death, myocardial infarction, bypass therapy, re-PCI in the target vessel), costs, and quality of life using SES or BMS [3]. Patients were allocated in a 2:1 fashion to SES or BMS from 2003 to 2005 in 35 centers across Germany.…”

Section: Gershwinmentioning

confidence: 99%

“…Böhm [9] and L.S. Maier [3, 9] are funded by the Deutsche Forschungsgemeinschaft (DFG, Klinische Forschergruppe (KFO 115 [3], Maier; KFO 196 [9], Böhm), Heisenberg-Program [3]).…”

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confidence: 99%

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Hotline update of clinical trials and registries presented at the German Cardiac Society Meeting 2009

et al. 2009

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This review article gives an overview on a number of novel clinical trials and registries in the field of cardiovascular medicine. Key presentations made at the 75th annual meeting of the German Cardiac Society, held in Mannheim, Germany, in April 2009 are reported. The data were presented by leading experts in the field with relevant positions in the trials and registries. These comprehensive summaries should provide the readers with the most recent data on diagnostic and therapeutic developments in cardiovascular medicine similar as previously reported (Rosenkranz et al. in Clin Res Cardiol 96:457–468, 9; Maier et al. in Clin Res Cardiol 97:356–363, 3).

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confidence: 57%

Section: Gershwinmentioning

confidence: 99%

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Hotline update of clinical trials and registries presented at the German Cardiac Society Meeting 2009

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Hotline Update of Clinical Trials and Registries presented at the German Cardiac Society Meeting 2007

et al. 2007

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This article summarizes the results of a number of new clinical trials, registries and metaanalyses in the field of cardiovascular medicine. Key presentations made at the 73(rd) annual meeting of the German Cardiac Society, held in Mannheim, Germany, in April 2007 are reported. The data were presented by leading experts in the field with relevant positions in the trials, registries or metaanalyses. These comprehensive summaries should provide the readers with the most recent data on diagnostic and therapeutic developments in cardiovascular medicine.

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“…Most of the scientific evidence regarding DEB efficacy is actually concentrated in the treatment of patients with in-stent restenosis; there are some data about use of DEBs for de novo lesions and for bifurcation lesions [9]. For de novo lesions the only registry available is the Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease (PEPCAD I), which concluded that DEBs are associated with a high procedural success rate in small de novo lesions, while DEBs in conjunction with a bare-metal stent (BMS) remains a concern because of high restenosis rate [10]. Until now, DEBs failed to show equivalence to DES regarding angiographic endpoints during PCI of small coronary arteries [11].…”

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confidence: 99%

INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial

Burzotta

Brancati

Trani

et al. 2012

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BackgroundNeointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies.Methods/DesignWe present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months.DiscussionExperimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia.Trial registrationClinicaltrials.gov NCT01057563.

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Hotline update of clinical trials and registries presented at the German Cardiac Society meeting 2008

Cited by 30 publications

References 14 publications

Hotline update of clinical trials and registries presented at the German Cardiac Society Meeting 2009

Hotline update of clinical trials and registries presented at the German Cardiac Society Meeting 2009

Hotline Update of Clinical Trials and Registries presented at the German Cardiac Society Meeting 2007

INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial

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