Does a Carbon Ion-Implanted Surface Reduce the Restenosis Rate of Coronary Stents?
Jae-Hun JungPil‐Ki MinJong‐Youn KimSungha ParkEui‐Young ChoiYoung‐Guk KoDonghoon ChoiYangsoo JangWon-Heum ShimSeung-Yun Cho
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Neointimal hyperplasia and resulting restenosis limit the long-term success of coronary stenting. Heavy metal ions induce an inflammatory and allergic reaction, and result in in-stent restenosis. However, a carbon ion-implanted surface might prevent heavy metal ions from diffusing into surrounding tissue.140 lesions in 140 patients with coronary lesions underwent implantation of carbon-implanted surface stents (Arthos(inert) stent group, n=70) or control stents (Arthos stent group, n=70). The primary end point was the in-stent restenosis and the secondary end point was the value of hs-CRP at 48 h and 6 months after coronary stenting. Clinical and angiographic follow-ups were performed at 6 months.The rate of in-stent restenosis was lower in the Arthos(inert) stent group (15.9%, 10/63) than in the Arthos stent group (20.9%, 13/62), but there were no significant differences between both groups (p=0.56). The value of hs-CRP at 48 h was lower in the Arthos(inert) stent group (13.9+/-13.4 mg/dl) than in the Arthos stent group (24.5+/-26.0 mg/dl) with significant differences (p=0.04). However, the differences between two groups were not statistically significant at 6 months (p=0.76).As compared with a standard coronary stent, a carbon ion-implanted stent shows no considerable benefit for the prevention of in-stent restenosis within the range of this study. Despite all the limitations of this study, a positive effect of a carbon ion-implanted stent in reducing inflammatory reaction after coronary revascularization seems likely.Keywords:
Neointimal hyperplasia
Bare-metal stent
Neointimal hyperplasia and resulting restenosis limit the long-term success of coronary stenting. Heavy metal ions induce an inflammatory and allergic reaction, and result in in-stent restenosis. However, a carbon ion-implanted surface might prevent heavy metal ions from diffusing into surrounding tissue.140 lesions in 140 patients with coronary lesions underwent implantation of carbon-implanted surface stents (Arthos(inert) stent group, n=70) or control stents (Arthos stent group, n=70). The primary end point was the in-stent restenosis and the secondary end point was the value of hs-CRP at 48 h and 6 months after coronary stenting. Clinical and angiographic follow-ups were performed at 6 months.The rate of in-stent restenosis was lower in the Arthos(inert) stent group (15.9%, 10/63) than in the Arthos stent group (20.9%, 13/62), but there were no significant differences between both groups (p=0.56). The value of hs-CRP at 48 h was lower in the Arthos(inert) stent group (13.9+/-13.4 mg/dl) than in the Arthos stent group (24.5+/-26.0 mg/dl) with significant differences (p=0.04). However, the differences between two groups were not statistically significant at 6 months (p=0.76).As compared with a standard coronary stent, a carbon ion-implanted stent shows no considerable benefit for the prevention of in-stent restenosis within the range of this study. Despite all the limitations of this study, a positive effect of a carbon ion-implanted stent in reducing inflammatory reaction after coronary revascularization seems likely.
Neointimal hyperplasia
Bare-metal stent
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Objective Neointimal proliferation has played an important role in in-stent restenosis.Recent studies demonstrated that drug-eluting stents could prevent in-stent restenosis by inhibiting neointimal proliferation.The purpose of this study was to determine the efficacy of two different released rapamycin eluting stents to reduce in-stent neointimal hyperplasia.Methods Stents were coated with PLGA(poly/lactic-co-Gly-Colicacid)polymer containing 65～90 μg rapamycin(slow release)or 68～96 μg rapamycin(fast release)respectively.Twenty stents(metal group,n=8;slow released group,n=5;fast released group,n=7)were implanted in the coronary arteries of 20 pigs.Results After 28 days,the mean neointimal was 2.18±1.03 mm 2 for the metal group.Compared with metal group the mean neointimal was significantly decresed in the slow released group(1.09±0.82 mm 2,P=0.0450)and the fast released grpup(0.94±0.88 mm 2,P=0.0156).There is no difference between two Rapamycin groups(P=0.7692).The in-stent restenosis was 25% in metal group and 0% in two rapamycin groups 28 days later.Conclusion Stent-based delivery of Rapamycin is feasible and effectively reduces in-stent neointimal hyperplasia by inhibiting cellular proliferation and can be safely used.
Neointimal hyperplasia
Bare-metal stent
Sirolimus
PLGA
Bare metal
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Coronary restenosis
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Objective To determine the efficacy of stent based rapamycin (Rapa) and methotrexate (MTX) alone or in combination of them to reduce in stent neointimal hyperplasia Rapamycin is a potent immunosuppressive agent that inhibits smooth muscle cell (SMC) proliferation by blocking cell cycle progression Methods Stents were coated with PLGA (poly/lactic co glycolic acid) polymer containing 68-96 μg Rapa or 250-300 μg MTX or 58-81 μg Rapa and 120-170 μg MTX respectively Twenty five stents (metal, n =8; MTX, n =5; Rapa, n =7; Rapa and MTX, n =5) were implanted in the coronary arteries of 25 pigs Results After 28 days, the mean neointimal thickness was (2 18±1 03) mm 2 in the bare metal stent group; (0 94±0 88) mm 2 in the Rapa group; (0 47±0 24) mm 2 in the combination Rapa and MTX group, (3 93±1 48) mm 2 in the MTX group Compared with metal group the mean neointimal thickness was significantly decresed in Rapa groups and combined group The in stent restenosis was 25% (2/8) in metal group and 80% (4/5) in MTX group after 28 days, and there was no restenosis in the other two groups Conclusion Stent based delivery of Rapa via PLGA polymer can feasibly and effectively reduce in stent neointimal hyperplasia by inhibiting cellular proliferation However there are no effects to reduce in stent neointimal hyperplasia by MTX eluting stents in this study
Neointimal hyperplasia
PLGA
Neointima
Sirolimus
Bare-metal stent
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The development of coronary artery stents that release (elute) a drug locally into the diseased vasculature has revolutionized the practice of interventional cardiology. These devices were designed to minimize the incidence of in-stent restenosis that may occur with bare metal stents. The paclitaxel-eluting stent is the most recent drug-eluting stent approved for use in the United States and is a bare metal stent coated with paclitaxel that is gradually released from the stent into the vessel wall with undetectable systemic concentrations of the drug. Paclitaxel functions to stabilize the assembly of microtubules, thereby interfering with cell division, motility, and shape, and ultimately inhibiting smooth muscle cell proliferation and migration, key processes in the development of neointimal hyperplasia during in-stent restenosis. Clinical trials have repeatedly demonstrated the superiority of the paclitaxel-eluting stent over the bare metal stent in terms of reducing restenosis rates and percent stenosis diameter as well as other angiographic end points. Although the rates of major adverse cardiac events are reduced with the paclitaxel-eluting stent compared with the bare metal stent, this is primarily the result of a reduction in the need for target vessel revascularization, whereas rates of myocardial infarction and death have not been shown to be significantly affected.
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After a study comparing drug-eluting stents (DESs) to sequential treatment with drug-eluting balloons (DEBs) and bare metal stents (BMSs), we retrospectively analysed strut malapposition and neointimal hyperplasia in de novo coronary lesions using optical coherence tomography (OCT) or intravascular ultrasonography (IVUS).We obtained OCT data from 16 patients (eight per group) and IVUS data from 40 patients (20 per group). OCT or IVUS was performed after the index procedure and after 9 months. Parameters including obstruction volume due to neointimal hyperplasia (neointimal hyperplasia volume/stent volume, %), strut malapposition (% of malapposed struts), and intra-individual inhomogeneity of in-stent restenosis were compared.Although obstruction volume due to neointimal hyperplasia was significantly higher in the DEB-BMS group (14.90 ± 15.36 vs. DES 7.03 ± 11.39, p = 0.025), there was no difference in strut malapposition between the two groups (DEB-BMS 1.99 ± 5.37 vs. DES 0.88 ± 2.22, p = 0.856). The DEB-BMS group showed greater intra-individual inhomogeneity of in-stent restenosis pattern than the DES group.Treatment with DEB followed by BMS failed to improve strut malapposition despite higher in-stent neointimal growth, probably because of the inhomogeneous inhibition of in-stent neointimal hyperplasia by DEB. DEB technology should be improved to obtain even drug delivery to the vessel wall and homogeneous prevention of neointimal growth comparable to contemporary DES.
Neointimal hyperplasia
Intravascular Ultrasound
Neointima
Bare-metal stent
Bare metal
Coronary restenosis
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Objective:Determine the efficacy of two diffient released rapamycin coated stents via PLGA (poly/lactic-co-glycolic acid) polymer to reduce in-stent neointimal hyperplasia. Method: Stents were coated with PLGA polymer containing 65～90 μg(1 μg/mm 2) rapamycin (slow release) or 68～96 μg (1 μg/mm 2) rapamycin (fast release) respectively. Twenty stents (metal group, n=8; slow released group, n=5; fast released group, n=7) were implanted in the coronary arteries of 20 pigs. Result:After 28 days, the mean neointimal was ( 2.18± 1.03)mm 2 for the metal group. Compared with metal group the mean neointimal was significantly decresed in the slow released group [( 1.09± 0.82)mm 2, P 0.05] and the fast released group [( 0.94± 0.88)mm 2, P 0.05]. The in-stent restenosis was 25% in metal group and 0% in two rapamycin group after 28 days. Conclusion:Stent-based delivery of Rapa via PLGA polymer is feasible and effectively reduces in-stent neointimal hyperplasia by inhibiting cellular proliferation.
Neointimal hyperplasia
PLGA
Glycolic acid
Bare-metal stent
Biodegradable polymer
Sirolimus
Bare metal
Intimal hyperplasia
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Background:A novel bare metal stent with an SiO2coating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device.
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Bare-metal stent
Inert
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Neointimal 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. We 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. Experimental 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. Clinicaltrials.gov NCT01057563.
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Balloon dilation
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Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors).In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response.According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS.The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies.
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Bare-metal stent
Sirolimus
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Coronary arteries
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