Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 5-year results of the TARGET Ⅱ trial / 中华心血管病杂志

Objective@#This study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) in patients with moderate-complex coronary lesions (including patients with small vessel disease, long lesion and multi vessel disease), and to validate the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with FIREHAWK stent. @*Methods@#TARGETⅡ was a prospective, multicenter, single-arm clinical trial, a total of 730 patients who underwent percutaneous coronary intervention (PCI) of de novo lesions in native coronary arteries in 24 medical centers in China from August 2011 to February 2012 were enrolled in this study. All patients were exclusively treated with the FIREHAWK stent. Clinical data including patients with diabetes, small vessel disease, long lesion and multi vessel disease were analyzed. The primary composite endpoint was the target lesion failure (TLF) of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR). The secondary composite endpoint was patient-oriented endpoint (PoCE), a composite of all death, all myocardial in farction (MI), or any repeat revascularization; definite/probable stent thrombosis (ST) (including acute, late, and very late thrombosis) . SS was calculated in lesions with stenosis more than 50% with coronary artery diameter greater than 1.5 mm. Patients were grouped by tertiles of SS (≤7, >7 to ≤12, >12). Follow-up was performed up to 5 years. @*Results@#A total of 730 patients were enrolled in the TARGET Ⅱ trial. The average SS was 10.9±6.9. 683 (93.6%) patients completed 5-year clinical follow-up. The 5-year incidence of TLF was 8.5%(58/683). The incidence of TLF components was as follows: cardiac death 2.0%(14/683), TV-MI 4.4%(30/683), TLR 3.4%(23/683). The incidence of PoCE was 16.4%(112/683). The incidence of definite/probable stent thrombosis was 0.7%(5/683).Multivariable Cox regression analysis showed that the diabetes subgroup (HR=1.123, 95%CI 0.623-2.026, P=0.699), the small vessel disease subgroup (HR=0.909, 95%CI 0.526-1.570, P=0.732), the long lesion subgroup (HR=1.561, 95%CI 0.922-2.640, P=0.097), and the multi vessel disease subgroup (HR=1.062, 95%CI 0.611-1.846, P=0.830) did not increase the HR of TLF compared with the counterpart subgroups. Multivariable Cox regression analysis showed that the hazard of TLF was not increased in the middle and high SS groups as compared with the low SS group (HR=1.203,95%CI 0.607-2.385,P=0.597;HR=1.548,95%CI 0.829-2.892,P=0.171). @*Conclusions@#The 5 years follow-up results of TARGET Ⅱ trial shows that the biodegradable polymer of FIREHAWK stents have long-lasting safety and efficacy for patients with moderate-complex coronary lesions. SS is not the predicting factor for the occurrence of TLF in FIREHAWK treated patients with moderate-complex coronary lesions. Trial Registration Clinical Trials.gov, NCT0141264.

Should antiplatelet therapy be interrupted in drug eluting stent recipients throughout the periendoscopic period? A very late stent thrombosis case re-port and review of the literature / 老年心脏病学杂志（英文版）

In-stent thrombosis after cessation of antiplatelet medications in patients with drug-eluting stents (DES) is a significant problem in medical practice, particularly in the perioperative period. We report a case of an 87-year-old man with a medical history of hypertension, coronary artery disease and chronic atrophic gastritis. Very late thrombosis of a sirolimus-eluting stent occurred 1207 days after implantation, seven months after discontinuation of clopidogrel, and the interruption of aspirin 13 days in preparation of an elective endoscopic gastroin-testinal procedure presented with acute myocardial infarction. The patient was treated with thrombectomy and successfully revascularized with superimposition of two sirolimus-eluting stents. Medications administered in the catheterization laboratory included low molecular weight heparin and nitroglycerin. Flow was defined as grade 2 according to the thrombolysis in myocardial infarction scale. Electrocardio-gram after the procedure revealed persistent, but decreased, ST-segment elevation in the anterolateral leads. The patient recovered and was discharged on aspirin and clopidogrel indefinitely. There was no cardiac event during the two year follow-up period. This case underlines the importance of maintaining the balance of thrombosis and bleeding during perioperation of non-cardiac procedure and the possible need for continuation of aspirin therapy during periendoscopic procedures among patients with low bleeding risks who received DES.

Migration of a sirolimus-eluting stent from the ostium of the left main coronary artery to the right deep femoral artery

No abstract available.

Comparison of long-term efficacy of Simultaneous kissing stent technique versus single stent technique in true coronary bifurcations / 中国综合临床

Objective To evaluate long-term outcome of simultaneous kissing sirolimus-eluting stent (SKS) technique versus single sirolimus-eluting stent (SSS) technique for percutaneous treatment of true coronary bifurcation lesions in large-size vessels.Methods This randomized study assigned 190 patients with a coronary bifurcation lesion to simultaneous kissing stenting (SKS) in both main and side branches and 190 patients to main vessel stenting only (SSS).The endpoints included restenosis,death,non-fatal myocardial infarction,target-lesion revascularization (TLR),stent thrombosis,success rate of percutaneous coronary intervention (PCI) and the operation duration.Results During 1-year follow-up,the SKS group and the SSS group had similar incidences of overall re stenosis [30 ( 15.8 ％ ) vs.24 ( 15.2 ％ ),x2=0.000,P＜0.05],mainbranch restenosis [20 ( 10.5％ ) vs.16 ( 10.1％ ),x2=0.003,P ＞ 0.05];side-branch restenosis [13 ( 6.8％ )vs.23 ( 14.6％ );x2=4.73,P＜0.05];death [2 ( 1.1％ ) vs.1 ( 0.6％ ),x2=0.026,P ＞ 0.05],non-fatal myocardial infarction [4 (2.1％ ) vs.2 ( 1.3％ ),x2=0.034,P ＞ 0.05],TLR [23 ( 12.1％ ) vs.20 ( 12.7％ ),x2=0.000,P ＞ 0.05] and stent thrombosis [4 (2.1％ ) vs.2 ( 1.3 ％ ),x2=0.034,P ＞ 0.05] and a shorter operation duration[(20 ± 8) min vs.(45 ± 9) min,t=1.98,P＜0.05] than the SSS group.Conclusion For true coronary bifurcation lesions in large-size vessels,SKS and SSS have similar long-term outcomes.The SKS group has a higher success rate of PCI and shorter operation duration.

Firebird stent for the treatment of patients with coronary heart disease: short-term clinical outcome / 老年心脏病学杂志（英文版）

Objective The sirolimus-eluting stent (SES) has dramatically reduced the rate ofrestenosis in comparison to that with the bare-metal stent (BMS).This study aimed to evaluate the short-term efficacy and safety of Firebird stent implantation for patients with coronary heart disease (CHD). Methods From Apri12006 through July 2007, 155 patients (mean age 58.93～10.27 years) with CHD were implanted with Firebird stent or Cypher select stent at Daxing Hospital. Patients were followed up for one year. All-cause mortality, major adverse cardiac events (MACE, including cardiac death, myocardial infarction, recurrence of angina pectoris, heart failure, revascularization, and adverse arrhythmia) and stent thrombosis were compared between the 2 groups. Results Of the 155 consecutive patients, 147 patients were revascularized completely. Of these patients, 48 (with 59 lesions) were treated with Firebird stent, 59 patients (with 75 lesions) with Cypher select stent. The demographic characteristics were similar in the 2 groups. All the angiographic and procedural results were not significantly different between the 2 groups. All-cause mortality, myocardial infarction, recurrence of angina pectoris, MACE and stent thrombosis were almost identical between the 2 groups before discharge, at 6 months and at one year .Conclusion The short-term efficacy and safety of Firebird stent are similar to that of the cypher select stent for the treatment of patients with CHD.

A Safety and Effectiveness of High Pressure Balloon Dilatation for Sirolimus-Eluting Stent Implantation in the Ischemic Heart Disease

BACKGROUND: We have no information about the safety and effectiveness when we perform overdilating a sirolimuseluting stent(SES) with high pressure. In some specific animal model, the study reported overdilatation of SES with high pressure resulted in increase of restenosis. The aim of this study was to evaluate the safety and effectiveness of overdilatation of SES with high pressure. METHODS: 97 patients underwent PCI using SES between August 2003 and July 2005 were divided into two group(high pressure group, low pressure group), stents were implanted with high pressure(>18 atm) and low pressure(<12 atm). We compared between the two group of safety of stents, major adverse cardiac events(MACE), rate of restenosis, late loss. RESULTS: In high pressure group, there are more type C lesion(51% vs 38%, p<0.01). There were no significant differences between the two groups regarding MACE(12.8% vs 17.2%, p=0.78), in-stent restenosis rate(2.6 % vs 5.2%, p=0.65). There are small increasing of late loss in high pressure group, but no statistically significant difference(0.30 vs 0.15, p=0.05). CONCLUSION: Implantation of SES overdilated with high pressure is able to be performed safely to obtain wider inner lumen of stents.

Clinical observation on sirolimus-eluting stent implantation in left main coronary artery bifurcation lesions / 中国医师进修杂志

Objective To evaluate the acute and long-term results of stenting for left main coronary artery (LMCA) bifurcation lesions. Methods Forty consecutive patients with LMCA bifurcation lesion and normal left ventricular function were included. Sirolimus-eluting stents were performed in all patients. Results (1)The average diameter of LMCA was (0.81?0.48)mm before stenting and increased to (3.53?0.22)mm after stenting.(2)The procedural success rate was 100.0%. In-hospital events including stent thrombosis,Q-wave myocardial infarction,and emergency bypass surgery did not occur in any patients,and non-Q-wave MI in one patient (2.5%).(3)Clinical follow-up was obtained in all patients at (8.43?3.24) months. There were no death and no myocardial infarction during follow-up. The major adverse cardis events rate was 20.0%.(4)The angiographic follow-up rate was 67.5% (27 of the 40 eligible patients),and the restenosis rate was 18.5% (parent vessel only 11.1%,side branch only 3.7%,and both 3.7%).(5)Different type of operation had no influence on restenosis rate during angiographic follow-up. Conclusion Sirolimus-eluting stent implantation for LMCA bifurcation stenosis appears safe and effective with regard to acute and midterm complications.

Clinical efficacy of coronary sirolimus-eluting stenting in patients with type 2 diabetes / 介入放射学杂志

Objective To evaluate the clinical outcomes of sirolimus-eluting stenting in patients with coronary artery disease and type 2 diabetes.Methods Among 101 patients with coronary artery disease and type 2 diabetes who underwent percutaneous coronary intervention, 67 received sirolimus-eluting stents (SES group) and 34 were treated only with bare metal stents (BMS group). Baseline clinical characteristics, procedural success rate, occurrence of cardiac events during follow-up were recorded and compared between the two groups. Results The procedural success rate was 100% in both groups. During follow-up(average one year), the SES group patients had significantly lower occurrence of cardiac events than those in the BMS group ( 7.5% vs. 32.4%, P= 0.001).Conclusions Sirolimus-eluting stent implantation for patients with coronary artery disease and type 2 diabetes is safe and can reduce major adverse cardiac events in long-term follow-up.