Background Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. Methods We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. Results The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting ...

https://www.nejm.org/doi/pdf/10.1056/NEJMoa035071

Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

/pdf/a-randomized-comparison-of-a-sirolimus-eluting-stent-with-a-3h78nze073.pdf

A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization

Pathology of Drug-Eluting Stents in Humans: Delayed Healing and Late Thrombotic Risk

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material positioned over the structure 12; and at least one porous layer 20 positioned over the bioactive material layer 18. Preferably, the structure 12 is a coronary stent, and the bioactive material is at least one of heparin, dexamethasone or a dexamethasone derivative. The device 10 includes layers 18 and 22 of heparin and dexamethasone, the layer 22 of dexamethasone being positioned above the layer 18 of heparin. The layers of bioactive material also can be individual materials or a combination of different materials. Unexpectedly, the more soluble heparin markedly promotes the release of the less soluble dexamethasone above it. The porous layer 20 is composed of a polymer applied by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyimide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor.

Coated implantable medical device

Background— The US Food and Drug Administration recently issued a warning of subacute thrombosis and hypersensitivity reactions to sirolimus-eluting stents (Cypher). The cause and incidence of these events have not been determined. Methods and Results— We present findings of a 58-year-old man who died of late stent thrombosis 18 months after receiving 2 Cypher stents for unstable angina. Although angiographic and intravascular ultrasound results at 8 months demonstrated the absence of neointimal formation, vessel enlargement was present. An autopsy showed aneurysmal dilation of the stented arterial segments with a severe localized hypersensitivity reaction consisting predominantly of T lymphocytes and eosinophils. Conclusions— The known pharmacokinetic elution profile of Cypher stents and the presence of polymer fragments surrounded by giant cells and eosinophils suggest that a reaction to the polymer may have caused late stent thrombosis. Careful long-term follow-up of patients with vessel enlargement af...

Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious?

Background— The purpose of this study was to determine the efficacy of stent-based delivery of sirolimus (SRL) alone or in combination with dexamethasone (DEX) to reduce in-stent neointimal hyperpl...

Stent-Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model

An intralumen medical device comprising anti-proliferative and anti-thrombotic or anti-coagulant drugs, agents or compounds may be utilized in the treatment of vascular disease. The intralumen medical device is selectively coated with the drugs, agents or compounds for local delivery, thereby increasing their effectiveness and reducing potential toxicity associated with systemic use. The selective coating is utilized to ensure that the specific drugs, agents or compounds come into contact with or are delivered to the appropriate tissues and/or fluids for maximum effectiveness.

Drug combinations and delivery devices for the prevention and treatment of vascular disease

An implantable intraluminal device is described. The device comprises a stent having a substantially tubular body defining a luminal surface and an abluminal surface. A coating including a polymeric matrix and at least one therapeutic agent is affixed to at least one of the luminal and abluminal surfaces. A diffusion barrier is affixed to the coating and configured to control the elution rate of the at least one therapeutic agent, the diffusion barrier including a complex of heparin, polyethylenimine and dextran.

Heparin barrier coating for controlled drug release

The preparation and use of medical devices are described. A thiol group agent is loaded onto a medical device such as a stent or a catheter. Preferably, the loading is accomplished onto a polymeric surface that had been activated by water vapor RF plasma treatment. The thiol group agent is structured to exhibit sulfhydryl groups. These sulfhydryl groups are available for interaction with NO carriers such as nitrovasodilators. This interaction can take place in situ at an in vivo location within a vascular system, for example, in which event the sulfhydryl groups would be delivered by the medical device while the NO carrier will be delivered by suitable pharmaceutical administration means. Alternatively, the NO carrier can be loaded onto the treated medical device surface at a suitable time prior to insertion of the medical device into the body, such as immediately before the initiation of a medical procedure such as stent delivery and implantation.

Method for targeting in vivo nitric oxide release

The preparation and use of medical devices are described. A thiol group agent is loaded onto a medical device such as a stent or a catheter. Preferably, the loading is accomplished onto a polymeric surface (22) that had been activated by water vapor RF plasma treatment. The thiol group agent is structured to exhibit sulfhydryl groups. These sulfhydryl groups are available for interaction with nitric oxide (NO) carriers such as nitrovasodilators. This interaction can take place in situ at an in vivo location within a vascular system, for example, in which the sulfhydryl groups would be delivered by the medical device while the NO carrier will be delivered by suitable pharmaceutical administration means. Alternatively, the NO carrier can be loaded onto the treated medical device surface at a suitable time prior to insertion of the medical device into the body, such as immediately before the initiation of a medical procedure such as stent delivery and implantation.

MEDICAL DEVICE FOR $i(IN VIVO) NITRIC OXIDE RELEASE

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