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Gold-coated stainless-steel stent materials elicit exaggerated cytokine levels from human monocytes–gaining biocompatibility insights with primary monocytes, platelets, endothelial-cells and surface analysis
Abstracts / Cardiovascular Revascularization Medicine 7 (2006) 81–126
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Fig. 1. PVC frequency, ST-segment changes, and injury score between thrombectomy systems.
Abstract 143 Effect of early heparin before primary angioplasty in patients with acute myocardial infarction Y-S Cho, K-I Kim, H-J Chang, W-Y Chung, T-J Youn, I-H Chae, D-J Choi, C-H Kim, B-H Oh, Y-B Park, Y-S Choi Cardiovascular Center, Seoul National University Bundang Hospital Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea Keywords: AMI, Angioplasty, Stents, Anticoagulants Background and Objectives: Although primary percutaneous coronary intervention (PCI) is highly effective reperfusion therapy in patients with acute myocardial infarction (AMI), delay in preparing for the procedure is inevitable. Heparin may facilitate primary PCI during this delay, but there is no established guideline regarding its use. We retrospectively evaluated the effect of early heparin administration at emergency room before primary PCI in Korean AMI patients. Methods: Consecutive 121 patients from January 2004 to August 2005 who presented with acute ST-segment elevation MI less than 12 hours from pain onset or persistent ischemia who were eligible for primary PCI were enrolled. There were no significant differences in age (61F13 vs. 60F 14 years, P=.750), sex (86% vs. 81% male, P=.513), door-to-balloon time (126F65 vs. 124F53 minutes, P=.842), and infarct-related artery (IRA) (LMCA:LAD:LCX:RCA; 4:52:5:39 vs. 0:52:9:39 %, P=.403) between early-heparin group (n=56) and heparin-during-PCI group (n=64). To all patients, 300 mg of aspirin was given at emergency room and 300-600mg of clopidogrel was given just after diagnostic coronary angiography. Glycoprotein IIb/IIIa inhibitors were given during the procedure as needed (9% vs. 16%, P=.268). In early-heparin group, conventional unfractionated heparin (36 patients, 4540F2853 IU) or low molecular weight heparin (20 patients, 64.2F5.7 mg) were given 144F95 minutes before PCI. Results: There was significant difference in TIMI flow of IRA between early-heparin and heparin-during-PCI group (TIMI 0:1:2:3 flow; 48:4:7:41 vs. 70:8:11:11 %, P=.002). In early heparin group, TIMI 3 flow was significantly more frequent (41% vs. 11%, P=.002), and TIMI 0 flow was significantly less frequent (48% vs. 70%, P=.002) than in heparin-during-PCI group. No significant difference in inhospital major adverse cardiac event including death, recurrent MI, and repeat target vessel revascularization (7% vs. 11%, P=.472), infarct size (peak CK; 2929F2472 vs. 3527F2467 IU/L, P=.188) and bleeding
tendency (TIMI major bleeding, 2% vs. 3%, P=.639) were noted between two groups. Conclusion: In Korean patients with AMI, early heparin therapy before primary angioplasty is safe and effective in achieving favorable coronary patency, although not resulted in clinical benefit. doi:10.1016/j.carrev.2006.03.054
Abstract 510 Gold-coated stainless-steel stent materials elicit exaggerated cytokine levels from human monocytes — gaining biocompatibility insights with primary monocytes, platelets, endothelial-cells and surface analysis R Ohri, E Bachili, G Sur, V Monni, C Szynal, J Lenz, T Jancaric, N Simons, T Gardener, D VanCamp, M Shen, R Radhakrishnan, A Whalen Boston Scientific Corporation, Natick, MA Keywords: Restenosis, Stents, Interleukins, Platelets Background: Historically, gold has been implanted as a biomaterial in several diseases, although side effects like toxicity and thrombocytopenia have been observed in certain applications. As a stent coating on stainless steel, gold has yielded negative clinical outcomes in terms of increased incidence of restenosis. Our objective was to determine if in vitro methods could be used to predict the potential for these negative clinical outcomes. Methods: The purpose of this study was to systematically study goldcoated 316L-grade stainless steel (SS) in cell-culture with primary human monocytes (cytokine expression), platelets (adhesion and activation), and endothelial cells (adhesion and proliferation). In addition, extensive surface characterization was carried out for correlation with the cell-culture outcomes, including surface roughness (white light interferometry), surface chemistry (XPS - X-ray Photoelectron Spectroscopy), surface-morphology (AFM - Atomic Force Microscopy), surfaceenergy (sessile drop static contact angle measurement), and SEM (Scanning Electron Microscopy). Comparison was made with uncoated 316L-grade SS. Results: With purified monocytes from 2 human blood-donors, significantly higher cytokine expression was obtained with gold-coated 316L SS, compared to 316L SS [as much as 33-fold for IL-8 (Fig. 1A), 19-fold for MCP-1, and 5-fold for TNF-a (Pb.05)-amongst 22 cytokines tested
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Abstracts / Cardiovascular Revascularization Medicine 7 (2006) 81–126
using Luminex-multiplexing]. Higher platelet adhesion was observed on gold-coated SS, compared to SS (2.5-fold). However, no differences were observed with platelet activation, as measured by p-selectin expression and PDGF-AB secretion. No significant differences were obtained with endothelial-cell adhesion and proliferation. Surface characterization indicated that gold-coated SS was rougher (P b.05, Fig. 1B), had modified surface morphology, and was more susceptible to hydrocarbon contamination. Conclusions: Our studies indicate a significantly higher inflammatory potential of gold-coated 316L-grade stainless steel, compared to uncoated 316L SS (as measured by induced cytokine expression in primary monocytes). These observations may help gain better understanding of the negative clinical outcomes associated with gold-coated stainless steel stents.
Results: The abciximab-treated group had a lower rate of new revascularization (26.8% vs. 15.8%. P=.02). The results by subgroups were: noninsulin-dependent non-abciximab-treated: 23.5%; non-insulin-dependent abciximab-treated 19% (p=ns); insulin-dependent non-abciximab-treated: 32.7%; insulin-dependent abciximab-treated: 12.2% ( P=.05). In the DES subgroup, clinical restenosis was reduced from 13% to 3% when abciximab was used ( P=.03). From a multivariant analysis the restenosis predictors were: insulin-dependence (OR: 2.7), abciximab use (OR: 0.18), stent diameter (OR: 0.18). Conclusions: 1) Abciximab use in diabetics with stent implantation has a favorable effect by reducing the need for new revascularization. This benefit is more evident in insulin-dependent patients as it eliminates the negative prognosis effect of being insulin-dependent, and levels the percentage of events in this population to that of non-insulin-dependents in a long follow-up period. 2) Abciximab use, gives an extra benefit to that of DES-use by reducing once again restenosis. doi:10.1016/j.carrev.2006.03.056 Abstract 611 Sirolimus-eluting stents versus paclitaxel-eluting stents for saphenous vein graft intervention WW Chu, PK Kuchulakanti, B Wang, WO Suddath, AD Pichard, LF Satler, KM Kent, R Waksman
Fig. 1. A, Cytokine expression levels for IL-8. B, White-light interterometry generated roughness maps (color-coded) for 1 mm2 area.
doi:10.1016/j.carrev.2006.03.055
Abstract 511 Abciximab offers greater benefit to insulin-dependent diabetic patients undergoing coronary stent implantation: this benefit is maintained even after dug-eluting stents utilization JR Lo´pez-Mı´nguez, JM Nogales, A Morales, R Gonza´lez, R Alonso, F Gime´nez, A Vaello, A Mercha´n Keywords: Stents, Diabetes Introduction and Objectives: Abciximab use does not reach 25% in most studies on diabetic patients undergoing stent implantation. The aim of this study is to evaluate whether it could be more beneficial in different subgroups such as insulin-dependent patients and whether its use adds some extra benefit to that of the drug-eluting stents (DES) in these patients. Patients and Method: A total of 373 consecutive diabetics (223 noninsulin-dependents and 150 insulin-dependents) who had undergone stent implantation were examined with a follow-up of 25.6F16.2 months. Abciximab was used in 21.7%.
Keywords: Angioplasty, Drug-eluting stents Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) in SVG intervention is currently unknown. We conducted this retrospective analysis to investigate this issue. Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared to 42 patients with 45 SVG lesions treated with PES (PES group). All patients received distal protection devices during the interventions. The in-hospital, 30-day and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MI) during the index hospitalization. Non-Q-wave MI was similar between the two groups. At 30-day and 6-month follow-up, all the clinical outcomes were similar between the two groups. There was no subacute stent thrombosis (SAT) or late thrombosis (LT) in either group. The event-free survival at 6 months was also similar between both groups ( P=.75). Conclusions: The use of DES in patients undergoing SVG intervention with a distal protection device is clinically feasible, safe and effective up to 6 months. As compared to SES, PES has similar efficacy and clinical outcomes in SVG interventions. doi:10.1016/j.carrev.2006.03.057 Abstract 612 The impact of overlapping drug-eluting stents in patients undergoing percutaneous coronary intervention WW Chu, PK Kuchulakanti, R Torguson, B Wang, LC Clavijo, WO Suddath, AD Pichard, LF Satler, KM Kent, R Waksman Washington Hospital Center, Washington, DC Keywords: Angioplasty, Drug-eluting stents Background: Sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping
107
Fig. 1. PVC frequency, ST-segment changes, and injury score between thrombectomy systems.
Abstract 143 Effect of early heparin before primary angioplasty in patients with acute myocardial infarction Y-S Cho, K-I Kim, H-J Chang, W-Y Chung, T-J Youn, I-H Chae, D-J Choi, C-H Kim, B-H Oh, Y-B Park, Y-S Choi Cardiovascular Center, Seoul National University Bundang Hospital Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea Keywords: AMI, Angioplasty, Stents, Anticoagulants Background and Objectives: Although primary percutaneous coronary intervention (PCI) is highly effective reperfusion therapy in patients with acute myocardial infarction (AMI), delay in preparing for the procedure is inevitable. Heparin may facilitate primary PCI during this delay, but there is no established guideline regarding its use. We retrospectively evaluated the effect of early heparin administration at emergency room before primary PCI in Korean AMI patients. Methods: Consecutive 121 patients from January 2004 to August 2005 who presented with acute ST-segment elevation MI less than 12 hours from pain onset or persistent ischemia who were eligible for primary PCI were enrolled. There were no significant differences in age (61F13 vs. 60F 14 years, P=.750), sex (86% vs. 81% male, P=.513), door-to-balloon time (126F65 vs. 124F53 minutes, P=.842), and infarct-related artery (IRA) (LMCA:LAD:LCX:RCA; 4:52:5:39 vs. 0:52:9:39 %, P=.403) between early-heparin group (n=56) and heparin-during-PCI group (n=64). To all patients, 300 mg of aspirin was given at emergency room and 300-600mg of clopidogrel was given just after diagnostic coronary angiography. Glycoprotein IIb/IIIa inhibitors were given during the procedure as needed (9% vs. 16%, P=.268). In early-heparin group, conventional unfractionated heparin (36 patients, 4540F2853 IU) or low molecular weight heparin (20 patients, 64.2F5.7 mg) were given 144F95 minutes before PCI. Results: There was significant difference in TIMI flow of IRA between early-heparin and heparin-during-PCI group (TIMI 0:1:2:3 flow; 48:4:7:41 vs. 70:8:11:11 %, P=.002). In early heparin group, TIMI 3 flow was significantly more frequent (41% vs. 11%, P=.002), and TIMI 0 flow was significantly less frequent (48% vs. 70%, P=.002) than in heparin-during-PCI group. No significant difference in inhospital major adverse cardiac event including death, recurrent MI, and repeat target vessel revascularization (7% vs. 11%, P=.472), infarct size (peak CK; 2929F2472 vs. 3527F2467 IU/L, P=.188) and bleeding
tendency (TIMI major bleeding, 2% vs. 3%, P=.639) were noted between two groups. Conclusion: In Korean patients with AMI, early heparin therapy before primary angioplasty is safe and effective in achieving favorable coronary patency, although not resulted in clinical benefit. doi:10.1016/j.carrev.2006.03.054
Abstract 510 Gold-coated stainless-steel stent materials elicit exaggerated cytokine levels from human monocytes — gaining biocompatibility insights with primary monocytes, platelets, endothelial-cells and surface analysis R Ohri, E Bachili, G Sur, V Monni, C Szynal, J Lenz, T Jancaric, N Simons, T Gardener, D VanCamp, M Shen, R Radhakrishnan, A Whalen Boston Scientific Corporation, Natick, MA Keywords: Restenosis, Stents, Interleukins, Platelets Background: Historically, gold has been implanted as a biomaterial in several diseases, although side effects like toxicity and thrombocytopenia have been observed in certain applications. As a stent coating on stainless steel, gold has yielded negative clinical outcomes in terms of increased incidence of restenosis. Our objective was to determine if in vitro methods could be used to predict the potential for these negative clinical outcomes. Methods: The purpose of this study was to systematically study goldcoated 316L-grade stainless steel (SS) in cell-culture with primary human monocytes (cytokine expression), platelets (adhesion and activation), and endothelial cells (adhesion and proliferation). In addition, extensive surface characterization was carried out for correlation with the cell-culture outcomes, including surface roughness (white light interferometry), surface chemistry (XPS - X-ray Photoelectron Spectroscopy), surface-morphology (AFM - Atomic Force Microscopy), surfaceenergy (sessile drop static contact angle measurement), and SEM (Scanning Electron Microscopy). Comparison was made with uncoated 316L-grade SS. Results: With purified monocytes from 2 human blood-donors, significantly higher cytokine expression was obtained with gold-coated 316L SS, compared to 316L SS [as much as 33-fold for IL-8 (Fig. 1A), 19-fold for MCP-1, and 5-fold for TNF-a (Pb.05)-amongst 22 cytokines tested
108
Abstracts / Cardiovascular Revascularization Medicine 7 (2006) 81–126
using Luminex-multiplexing]. Higher platelet adhesion was observed on gold-coated SS, compared to SS (2.5-fold). However, no differences were observed with platelet activation, as measured by p-selectin expression and PDGF-AB secretion. No significant differences were obtained with endothelial-cell adhesion and proliferation. Surface characterization indicated that gold-coated SS was rougher (P b.05, Fig. 1B), had modified surface morphology, and was more susceptible to hydrocarbon contamination. Conclusions: Our studies indicate a significantly higher inflammatory potential of gold-coated 316L-grade stainless steel, compared to uncoated 316L SS (as measured by induced cytokine expression in primary monocytes). These observations may help gain better understanding of the negative clinical outcomes associated with gold-coated stainless steel stents.
Results: The abciximab-treated group had a lower rate of new revascularization (26.8% vs. 15.8%. P=.02). The results by subgroups were: noninsulin-dependent non-abciximab-treated: 23.5%; non-insulin-dependent abciximab-treated 19% (p=ns); insulin-dependent non-abciximab-treated: 32.7%; insulin-dependent abciximab-treated: 12.2% ( P=.05). In the DES subgroup, clinical restenosis was reduced from 13% to 3% when abciximab was used ( P=.03). From a multivariant analysis the restenosis predictors were: insulin-dependence (OR: 2.7), abciximab use (OR: 0.18), stent diameter (OR: 0.18). Conclusions: 1) Abciximab use in diabetics with stent implantation has a favorable effect by reducing the need for new revascularization. This benefit is more evident in insulin-dependent patients as it eliminates the negative prognosis effect of being insulin-dependent, and levels the percentage of events in this population to that of non-insulin-dependents in a long follow-up period. 2) Abciximab use, gives an extra benefit to that of DES-use by reducing once again restenosis. doi:10.1016/j.carrev.2006.03.056 Abstract 611 Sirolimus-eluting stents versus paclitaxel-eluting stents for saphenous vein graft intervention WW Chu, PK Kuchulakanti, B Wang, WO Suddath, AD Pichard, LF Satler, KM Kent, R Waksman
Fig. 1. A, Cytokine expression levels for IL-8. B, White-light interterometry generated roughness maps (color-coded) for 1 mm2 area.
doi:10.1016/j.carrev.2006.03.055
Abstract 511 Abciximab offers greater benefit to insulin-dependent diabetic patients undergoing coronary stent implantation: this benefit is maintained even after dug-eluting stents utilization JR Lo´pez-Mı´nguez, JM Nogales, A Morales, R Gonza´lez, R Alonso, F Gime´nez, A Vaello, A Mercha´n Keywords: Stents, Diabetes Introduction and Objectives: Abciximab use does not reach 25% in most studies on diabetic patients undergoing stent implantation. The aim of this study is to evaluate whether it could be more beneficial in different subgroups such as insulin-dependent patients and whether its use adds some extra benefit to that of the drug-eluting stents (DES) in these patients. Patients and Method: A total of 373 consecutive diabetics (223 noninsulin-dependents and 150 insulin-dependents) who had undergone stent implantation were examined with a follow-up of 25.6F16.2 months. Abciximab was used in 21.7%.
Keywords: Angioplasty, Drug-eluting stents Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) in SVG intervention is currently unknown. We conducted this retrospective analysis to investigate this issue. Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared to 42 patients with 45 SVG lesions treated with PES (PES group). All patients received distal protection devices during the interventions. The in-hospital, 30-day and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MI) during the index hospitalization. Non-Q-wave MI was similar between the two groups. At 30-day and 6-month follow-up, all the clinical outcomes were similar between the two groups. There was no subacute stent thrombosis (SAT) or late thrombosis (LT) in either group. The event-free survival at 6 months was also similar between both groups ( P=.75). Conclusions: The use of DES in patients undergoing SVG intervention with a distal protection device is clinically feasible, safe and effective up to 6 months. As compared to SES, PES has similar efficacy and clinical outcomes in SVG interventions. doi:10.1016/j.carrev.2006.03.057 Abstract 612 The impact of overlapping drug-eluting stents in patients undergoing percutaneous coronary intervention WW Chu, PK Kuchulakanti, R Torguson, B Wang, LC Clavijo, WO Suddath, AD Pichard, LF Satler, KM Kent, R Waksman Washington Hospital Center, Washington, DC Keywords: Angioplasty, Drug-eluting stents Background: Sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping