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

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

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

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 investigate the impact of the stents coated with sirolimus and anti-CD34 antibody on the short-term re-endothelialization and the long-term restenosis in Chinese Minipigs.

METHODSThree different types of stents [bare-metal stent (BMS), sirolimus-eluting stent (SES) and anti-CD34 antibody and sirolimus-coated stent (ASES)] were randomly implanted in the coronary arteries of 22 Chinese Minipigs. At two weeks after stenting, coronary angiography and optical coherence tomography (OCT) were performed in 10 experimental animals. At three months after stenting, coronary angiography and OCT were performed in the remaining 12 experimental animals. Histopathologic examination was performed on the coronary artery segments containing stent after the animals were executed.

RESULTS(1) No in-stent thrombosis and parietal thrombus were found by coronary angiography, OCT and histopathologic examination at two weeks post stenting. OCT analysis showed that the covered ratio of stent struts by neointima in ASES group was higher than in SES group [(55.56 ± 35.27)% vs. (41.82 ± 23.28)%, P < 0.05]. The mean thickness of neointima in ASES group was significantly higher than in SES group [(89.0 ± 5.0) µm vs. (32.0 ± 4.9) µm, P < 0.01] and BMS group [(89.0 ± 5.0) µm vs. (44.0 ± 7.2) µm, P < 0.01]. Histopathologic and scanning electron microscopy examinations demonstrated that the covering level and quality of stent struts by neointima in BMS and ASES group were both better than in SES group. (2) At three months follow-up, quantitative coronary angiography analysis found that late in-stent lumen loss in ASES group was significantly lower than in BMS group [(0.18 ± 0.06) mm vs.(0.35 ± 0.06) mm, P < 0.05]. OCT analysis showed that the percent neointimal hyperplasia in ASES and SES group was significantly lower than in BMS group [(34.75 ± 2.64)% and (35.63 ± 2.07)% vs. (48.28 ± 3.25)%, both P < 0.01]. Histopathologic analysis demonstrated that the percent areal restenosis of ASES and SES group were both significantly lower than that of BMS group [(28.65 ± 5.64)% and (29.33 ± 6.07)% vs. (46.18 ± 8.25)%, both P < 0.05].

CONCLUSIONThe stents coated with anti-CD34 antibody and sirolimus can attenuate the inhibitory effect of sirolimus on the re-endothelialization at two weeks after stenting and the anti-hyperplasia effect of sirolimus at three months after stenting.

Animals ; Antibodies ; administration & dosage ; therapeutic use ; Antigens, CD34 ; immunology ; Drug-Eluting Stents ; Male ; Sirolimus ; administration & dosage ; therapeutic use ; Swine ; Swine, Miniature ; Treatment Outcome

BACKGROUNDIn-stent restenosis (ISR) remains a challenge for interventional cardiologists. Some data suggest that drug-eluting stents (DES) represent a promising new option for the treatment of patients with ISR. Currently, 2 DES platforms are available [sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)], but the superiority of either approach for treating ISR has not been convincingly demonstrated. The aim of the present study was to retrospectively compare angiographic and clinical outcomes after treatment of ISR with SES or PES in a series of consecutive patients with ISR.

METHODSA total of 745 consecutive patients were treated with bare metal stents from April 12, 2004 to December 31, 2004 in our center. Of these, clinically driven target lesion revascularization (TLR) was performed in 54 ISR from 54 patients at 7 months. Of the 54 patients with ISR, 36 received SES and 18 received PES. Follow-up included angiography and assessment of clinical outcome, both performed 7 months after DES implantation.

RESULTSThere were no significant differences in baseline clinical data (including medication usage and lesion characteristics) between the two groups. Except for overlapping of multiple stents, procedural parameters were also similar in both groups. Seven-month angiographic follow-up showed that the binary restenosis rate was higher in patients treated with PES than that in patients treated with SES (in-stent binary restenosis: 27.8% vs 5.6%, P < 0.023; In-segment binary restenosis: 44.4% vs 13.9%, P < 0.014). Major adverse cardiac events (MACE) occurring during hospitalization or during the follow-up period including thrombosis and TLR was similar in both groups (22.2% vs 8.3%, P > 0.05).

CONCLUSIONSResults from this small sample size, retrospective, single-center study showed that SES might be superior to PES in treating ISR because of lower 7-month restenosis rates (both in-stent and in-segment binary restenosis) with no increased incidence of MACE.

Adult ; Aged ; Coronary Angiography ; Coronary Restenosis ; diagnostic imaging ; therapy ; Drug Delivery Systems ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel ; administration & dosage ; Sirolimus ; administration & dosage ; Stents