Drug-Eluting Stents ; adverse effects ; Humans ; Middle Aged ; Myocardial Infarction ; etiology ; Sirolimus ; administration & dosage ; Thrombosis ; etiology

OBJECTIVETo analyse the impact of sirolimus-eluting stents (SES) on long-term outcomes in patients with coronary artery disease (CAD) and diabetes.

METHODSAmong 1004 patients with CAD undergone percutaneous coronary intervention (PCI), 84 diabetic and 250 non-diabetic patients received SES, 168 diabetic and 502 non-diabetic patients had bare metal stent (BMS) implantation. Baseline clinical characteristics, interventional procedures (coronary angiography and PCI), occurrence of major adverse cardiac events (MACE), and MACE-free survival rates at one year during follow-up were compared.

RESULTSDuring follow-up (average 16.2 months), patients (with and without diabetes mellitus) who received SES had similar occurrence of MACE (4.8% vs. 3.6%, P = 0.744) and MACE-free survival rates at one year (95.0% vs. 96.7%, P = 0.602). However those received BMS had a higher occurrence of MACE in diabetes mellitus than that in non-diabetic patients (31.0% vs. 21.7%, P = 0.015). MACE-free survival rate at one year was lower in diabetic patients with BMS than that in non-diabetic patients with BMS (74.2% vs. 86.8%, P = 0.001).

CONCLUSIONImplantation of sirolimus-eluting stents may reduce the major adverse cardiac events and the frequency of repeat intervention in patients with diabetes mellitus.

Coronary Disease ; therapy ; Diabetic Angiopathies ; therapy ; Female ; Humans ; Male ; Retrospective Studies ; Sirolimus ; administration & dosage ; Stents

Adult ; Benzamides ; administration & dosage ; Drug Therapy, Combination ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; Male ; Piperazines ; administration & dosage ; Pyrimidines ; administration & dosage ; Sirolimus ; administration & dosage

BACKGROUNDFirst generation drug-eluting stents (DESs) were based on 316L stainless steel and coated with a permanent polymer. The vessel wall of these DESs was inflammatory and late in-stent thrombosis was reported. Hence, cobalt chromium based DES coated with a bioabsorbable polymer was an alternate choice.

METHODSCobalt chromium based DES with bioabsorbable polymer (Simrex stent) as well as control stents (Polymer stent and EXCEL(TM) stent) were implanted into porcine arteries. At a designated time, angiography, quantitative coronary angiography (QCA) analysis, histomorphometry, and electron-microscopical follow-up were performed.

RESULTSA total of 98 stents of all the three groups were harvested. At week 24, percent diameter stenosis (%DS), late loss (LL), and percent area stenosis (%AS) of Simrex was (12.9 ± 0.4)%, (0.35 ± 0.02) mm, and (24.5 ± 4.2)%, respectively, without significant difference in comparison to commercialized EXCEL(TM) stent. Slight inflammatory reaction was seen around the stent strut of Simrex, just as in the other two groups. Electron-microscopical follow-up suggested that it might take 4 - 12 weeks for Simrex to complete its re-endothelialization process.

CONCLUSIONSCobalt chromium based, bioabsorbable polymer coated sirolimus-eluting stent showed excellent biocompatibility. During 24 weeks observation in porcine model, it was proved that this novel DES system successfully inhibited neointima hyperplasia and decreased in-stent stenosis. It is feasible to launch a clinical evaluation to improve the current prognosis of DES implantation.

Angioplasty, Balloon, Coronary ; Animals ; Chromium Alloys ; administration & dosage ; Coronary Angiography ; Drug-Eluting Stents ; adverse effects ; Polymers ; administration & dosage ; Sirolimus ; administration & dosage ; Swine ; Swine, Miniature

Drug-coated stent play an important role in percutaneous transluminal coronary angioplasty (PTCA), and it constitutes an innovation to further reduce the incidence of restenosis. In this paper, the mechanisms and the process of endovascular stent implantation,and the principles of drug release of drug-coated stent are reviewed. Especially, polymer coated design and the further development of drug eluting stents are discussed.
Angioplasty, Balloon, Coronary ; instrumentation ; Coronary Restenosis ; prevention & control ; Drug Delivery Systems ; Drug-Eluting Stents ; Heparin ; administration & dosage ; Humans ; Paclitaxel ; administration & dosage ; Sirolimus ; administration & dosage

OBJECTIVETo compare the clinical outcomes between China made sirolimus-eluting stents (SES) and bare metal stents (BMS) implantation in patients with acute myocardial infarction (AMI).

METHODSConsecutive patients with AMI underwent primary percutaneous coronary intervention (PCI) were randomly divided into SES group (n = 87) and BMS group (n = 86). The incidence of major adverse cardiac events (MACE including death, reinfarction, in-stent thrombosis, restenosis rate, target vessel revascularization) up to 6 months post PCI were assessed.

RESULTSPostprocedure vessel patency, enzymatic release, cardiac function, and the incidence of short-term MACE were similar between the two groups (all P > 0.05). Two in-stent thrombosis was diagnosed in the SES group and bare stents group respectively (2.4% vs. 2.3%, P > 0.05). At 6 months, In-stent restenosis rate (4.5% vs. 40.0%, P < 0.01) and the in-segment restenosis rate (6.8% vs. 44.9%, P < 0.01) as well as MACE (8.0% vs. 24.4%, P < 0.01), which is mainly due to a marked reduction in the risk of target vessel revascularization (3.4% vs. 11.6%, P < 0.05) were significantly lower in SES group compared to BMS group.

CONCLUSIONThe China made SES were not associated with an increased risk of in-stent thrombosis but significantly reduced restenosis rate and MACE at 6 months post primary angioplasty in patients with AMI.

Aged ; Angioplasty, Balloon, Coronary ; Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; Sirolimus ; administration & dosage

Coronary Occlusion ; surgery ; Drug-Eluting Stents ; adverse effects ; Humans ; Male ; Middle Aged ; Sirolimus ; administration & dosage ; Thrombosis ; complications

Emplacing a stent in the coronary artery has many characteristics. The installation is easy to do and the stent has evident curative effect. However, it will cause thrombosis and immunoreaction because it is metal. So suburgent thrombosis and restenosis after surgeries are still two major complications. The drug-coated stent is one kind of the drug-eluting stents, whose metal surface is coated by some polymer that combines with a sort of effective drug or antibody. It can transport the drug or antibody to the localily of pathological changes and there in it improves the local drug concentration. In this paper the research progress of interrelated issues about the drug-coated stent is reviewed.
Angioplasty, Balloon, Coronary ; instrumentation ; Coated Materials, Biocompatible ; Coronary Restenosis ; prevention & control ; Drug Delivery Systems ; instrumentation ; Humans ; Lactic Acid ; administration & dosage ; Paclitaxel ; administration & dosage ; Pharmaceutical Preparations ; administration & dosage ; Polyesters ; Polymers ; administration & dosage ; Sirolimus ; administration & dosage ; Stents ; adverse effects

OBJECTIVETo Compare the efficacy and safety of Rapamycin (Cypher) and Paclitaxel (TAXUS) eluting stents for multi-vessel coronary diseases.

METHODSFrom June 2003 to December 2004, a total of 416 patients with multi-vessel coronary diseases were randomly treated with Rapamycin (n = 210) and Paclitaxel (n = 206) eluting stents. Patients with left main lesion, acute myocardial infarction, revascularization were not included. Acute and long-term outcomes were compared between the two groups.

RESULTSBaseline clinical characteristics, including risk factors of coronary heart disease, coronary lesion type, heart function, rates of success and complication of percutaneous coronary intervention procedure in the two groups were comparable. Number of stents implanted was not significantly different between the two groups (3.24 +/- 1.25 vs 3.19 +/- 1.38, P > 0.05). Mean follow-up duration was (19.5 +/- 8.9) months. Follow-up rate (96.2 vs 95.1%), angina pectoris reoccurrence (4.0 vs 6.1%), restenosis (7.1 vs 9.6%), major adverse cardiac event (6.4 vs 8.8%) and event free survival (93.1 vs 91.3%) during follow-up were not significantly different between the two groups. Subacute stent thrombosis rate tended to be higher in Paclitaxel eluting stent group compared with Rapamycin eluting stent group (1.0% vs 0.5%, P > 0.05). At 6 to 9 months angiographic follow-up, the in-stent minimal lumen diameter (MLD) and the in-segment MLD were similar between the two groups.

CONCLUSIONSSatisfactory acute and long term outcomes for patients with multi-vessel coronary disease were achieved by both Cypher and TAXUS stent implantation and the safety and efficacy of the two kinds of stents were comparable.

Angioplasty, Balloon, Coronary ; methods ; Constriction, Pathologic ; Coronary Disease ; therapy ; Drug-Eluting Stents ; Follow-Up Studies ; Humans ; Paclitaxel ; administration & dosage ; Sirolimus ; administration & dosage ; Treatment Outcome

BACKGROUNDDrug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with complex lesion.

METHODSThis is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were in CYPHER group, and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.

RESULTSSuccess rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group (P < 0.05).

CONCLUSIONSCYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.

Coronary Disease ; therapy ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Paclitaxel ; administration & dosage ; Retrospective Studies ; Sirolimus ; administration & dosage ; Stents ; adverse effects