Study: Paclitaxel-eluting stent showed lower rates of restenosis compared to BMS
The CoStar paclitaxel-eluting stent was proven to be just as safe and effective as a bare-metal stent with the same design, and also had lower rates of restenosis, revascularization and less late lumin loss at eight months, according to the results to the EUROSTAR-II study published ahead of print in the April issue of EuroIntervention.
“Patients receiving bare metal stents (BMS) suffer from restenosis in 20-50.3 percent due to excessive neointimal proliferation,” the authors wrote. “The purpose of this study was to compare the performance of the CoStar reservoirs DES [drug-eluting stent] vs. a BMS of identical design with empty reservoirs.”
Sigmund Silber, MD, of the Heart Centre at the Isar in Munich, Germany, and colleagues set out to compare the angiographic and clinical performance of the paclitaxel-eluting stent (Taxus Express, Boston Scientific) and a bioabsorbable polymer with surface coating (CoStar, Cordis) vs. a bare-metal stent (BMS) with a metallic platform.
The authors identified 303 patients with a total of 335 lesions who had de novo coronary artery stenosis and were eligible for elective PCI treatment. Patients were randomized to receive the CoStar stent (152 patients) or BMS (151 patients).
The primary endpoint used during the study was in-segment binary restenosis at eight months by quantitative coronary angiography.
The researchers reported that at eight months, the primary endpoint of in-segment binary restenosis was lower in patients treated with the CoStar device compared with those treated with BMS, 17.6 percent vs. 30.3 percent. Rates of in-stent late loss were also higher in the CoStar arm.
The composite endpoint of cardiac death, MI related to target vessel and target lesion revascularization (TLR) was less in patients treated with the CoStar device compared with BMS at eight months, 19.7 percent vs. 29.1 percent.
The rates of target lesion revascularization (TLR) were 15.1 percent in the CoStar device and 26.5 percent in the BMS arm.
The authors noted that the results of the COSTAR-II study failed to prove non-inferiority with the CoStar stent when compared to the first-generation paclitaxel-eluting stent (Taxus Express). However, “The results of this EUROSTAR-II trial prove the efficacy of reservoirs technology for inhibition of neointimal hyperplasia and clinically relevant prevention of retenosis, compared to an identical BMS platform,” the authors wrote.
The current study shows that the CoStar DES device prevented restenosis compared to the BMS; however, major adverse cardiovascular event (MACE) rates were higher than in any previous study. The authors suggested that these higher rates may be due to the higher incidence of revascularization found during the study.
The authors concluded,“As compared with an equivalent bare-metal stent, paclitaxel elution from reservoirs resulted in significantly less binary restenosis, less late loss and lower revascularization rates at eight months.” No safety concerns were observed during the study, added the authors.
The study was funded by a grant from Berlin, Germany-based Biotronik.
“Patients receiving bare metal stents (BMS) suffer from restenosis in 20-50.3 percent due to excessive neointimal proliferation,” the authors wrote. “The purpose of this study was to compare the performance of the CoStar reservoirs DES [drug-eluting stent] vs. a BMS of identical design with empty reservoirs.”
Sigmund Silber, MD, of the Heart Centre at the Isar in Munich, Germany, and colleagues set out to compare the angiographic and clinical performance of the paclitaxel-eluting stent (Taxus Express, Boston Scientific) and a bioabsorbable polymer with surface coating (CoStar, Cordis) vs. a bare-metal stent (BMS) with a metallic platform.
The authors identified 303 patients with a total of 335 lesions who had de novo coronary artery stenosis and were eligible for elective PCI treatment. Patients were randomized to receive the CoStar stent (152 patients) or BMS (151 patients).
The primary endpoint used during the study was in-segment binary restenosis at eight months by quantitative coronary angiography.
The researchers reported that at eight months, the primary endpoint of in-segment binary restenosis was lower in patients treated with the CoStar device compared with those treated with BMS, 17.6 percent vs. 30.3 percent. Rates of in-stent late loss were also higher in the CoStar arm.
The composite endpoint of cardiac death, MI related to target vessel and target lesion revascularization (TLR) was less in patients treated with the CoStar device compared with BMS at eight months, 19.7 percent vs. 29.1 percent.
The rates of target lesion revascularization (TLR) were 15.1 percent in the CoStar device and 26.5 percent in the BMS arm.
The authors noted that the results of the COSTAR-II study failed to prove non-inferiority with the CoStar stent when compared to the first-generation paclitaxel-eluting stent (Taxus Express). However, “The results of this EUROSTAR-II trial prove the efficacy of reservoirs technology for inhibition of neointimal hyperplasia and clinically relevant prevention of retenosis, compared to an identical BMS platform,” the authors wrote.
The current study shows that the CoStar DES device prevented restenosis compared to the BMS; however, major adverse cardiovascular event (MACE) rates were higher than in any previous study. The authors suggested that these higher rates may be due to the higher incidence of revascularization found during the study.
The authors concluded,“As compared with an equivalent bare-metal stent, paclitaxel elution from reservoirs resulted in significantly less binary restenosis, less late loss and lower revascularization rates at eight months.” No safety concerns were observed during the study, added the authors.
The study was funded by a grant from Berlin, Germany-based Biotronik.