PURPOSE: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. RESULTS: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). CONCLUSION: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.
Acute Coronary Syndrome/drug therapy ; Aged ; Drug-Eluting Stents/adverse effects ; Female ; Humans ; Incidence ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multivariate Analysis ; Proportional Hazards Models ; Republic of Korea ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives ; Sirolimus/therapeutic use ; Time Factors ; Treatment Outcome

BACKGROUNDDrug-eluting stents represent a major advance in interventional cardiology. However, the current drug-eluting stents have significant limitations. One of the major problems is very late stent thrombosis, which is likely caused by inflammation and a hypersensitivity reaction related to a polymer on the stent. A polymer-free sirolimus-eluting stent with a unique nano-porous surface has been developed. This study aimed to evaluate this novel polymer-free sirolimus-eluting stent for its efficacy and safety in a pig model.

METHODSStents were directly coated with sirolimus (a drug concentration of 2.2 µg/mm(2) on the stent surface). The polymer-free sirolimus-eluting stents (PFSES) were compared to standard polymer-coated sirolimus-eluting stents (PCSES) and bare-metal stents (BMS) in 18 pigs.

RESULTSAt one month the degree of neointimal hyperplasia was similar between the two sirolimus-eluting stent groups and was significantly less compared to BMS ((1.93 ± 0.51) mm(2), (1.57 ± 0.69) mm(2) vs. (4.45 ± 1.05) mm(2), P < 0.05) At three months, PFSES maintained the low level of neointima ((2.41 ± 0.99) mm(2) vs. (4.32 ± 1.16) mm(2), P < 0.05), whereas PCSES had developed significant neointimal proliferation similar to BMS. The inflammation level was significantly higher in PCSES when compared with BMS three months post-implantation (2.50 ± 0.55 vs. 0.83 ± 0.75, P < 0.05) whereas PFSES showed a low level of inflammation comparable to PCSES (1.33 ± 0.52 vs. 2.50 ± 0.55, P < 0.05).

CONCLUSIONThe PFSES is effective and safe, and appears to be superior to standard PCSEs.

Animals ; Drug-Eluting Stents ; adverse effects ; Neointima ; prevention & control ; Polymers ; chemistry ; Sirolimus ; therapeutic use ; Swine

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

Anti-Bacterial Agents ; adverse effects ; Coronary Aneurysm ; etiology ; Drug-Eluting Stents ; adverse effects ; Humans ; Male ; Middle Aged ; Sirolimus ; adverse effects ; Thrombosis ; etiology

BACKGROUNDThe benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue percutaneous coronary intervention (PCI). A meta-analysis of randomised trials comparing SES and bare-metal stent (BMS) was performed.

METHODSA systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events (MACEs). The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.

RESULTSTotally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group (9.7% vs 20.3%, OR 2.45, 95% CI 1.88-3.19, P < 0.00001). No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group (5.1% vs 14.8%, OR 3.30, 95% CI 2.37-4.60, P < 0.00001). No significant difference was found between the pooled rates of stent thrombosis (1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95% CI 0.79-3.26, P = 0.19).

CONCLUSIONSSES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.

Drug-Eluting Stents ; adverse effects ; Humans ; Immunosuppressive Agents ; administration & dosage ; adverse effects ; chemistry ; Myocardial Infarction ; therapy ; Randomized Controlled Trials as Topic ; Sirolimus ; administration & dosage ; adverse effects ; chemistry ; Stents ; adverse effects ; Treatment Outcome

BACKGROUNDPrevious studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK(®) stent in long coronary artery disease.

METHODSThe long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention (PCI) for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion(s) with diameter stenosis ≥ 70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month.

RESULTSFifty patients (mean age (57.6 ± 10.2) years) with 59 de novo long lesions (reference vessel diameter (2.85 ± 0.44) mm, lesion length (35.2 ± 9.4) mm, and stent length (41.8 ± 11.3) mm) were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was (0.16 ± 0.16) mm. Proximal edge, distal edge and in-segment late loss (mm) were 0.21 ± 0.35, 0.03 ± 0.33, and 0.07 ± 0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction (MI), or stent thrombosis occurred. Non-Q-wave MI occurred in two patients (4%) due to procedural complications.

CONCLUSIONSTreatment of long coronary lesions with the FIREHAWK(®) stent is able to produce similar results as observed in the FIREHAWK(®) FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK(®) for long coronary lesions.

Aged ; Coronary Artery Disease ; drug therapy ; therapy ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Sirolimus ; adverse effects ; therapeutic use ; Treatment Outcome

Adult ; Coronary Angiography ; Drug-Eluting Stents ; adverse effects ; Humans ; Male ; Multidetector Computed Tomography ; Percutaneous Coronary Intervention ; adverse effects ; Sirolimus ; Thrombosis ; diagnosis ; etiology ; Ultrasonography, Interventional

BACKGROUNDThe zotarolimus-eluting stent has shown larger in-stent late lumen loss compared to sirolimus-eluting stents in previous studies. However, this has not been thoroughly evaluated in ST elevation myocardial infarction.

METHODSThis was a prospective, randomized, controlled trial evaluating angiographic outcomes in patients presenting with ST elevation myocardial infarction, treated with zotarolimus-eluting stents or sirolimus-eluting stents. From March 2007 to February 2009, 122 patients were randomized to zotarolimus-eluting stents or sirolimus-eluting stents in a 1:1 fashion. The primary endpoint was 9-month in-stent late lumen loss confirmed by coronary angiography, and secondary endpoints were percent diameter stenosis, binary restenosis rate, major adverse cardiac events (a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization), and late-acquired incomplete stent apposition.

RESULTSAngiographic in-stent late lumen loss was significantly higher in the zotarolimus-eluting stent group compared to the sirolimus-eluting stent group ((0.49 ± 0.65) mm vs. (0.10 ± 0.46) mm, P = 0.001). Percent diameter stenosis at 9-month follow-up was also larger in the zotarolimus-eluting stent group ((30.0 ± 17.9)% vs. (17.6 ± 14.0)%, P < 0.001). In-segment analysis showed similar findings. There were no significant differences in binary restenosis rate, major adverse cardiac events, and late-acquired incomplete stent apposition.

CONCLUSIONSCompared to sirolimus-eluting stents, the zotarolimus-eluting stent is associated with significantly higher in-stent late lumen loss at 9-month angiographic follow-up in the treatment of ST elevation myocardial infarction. Although there was no significant difference in 1-year clinical outcomes, the clinical implication of increased late lumen loss should be further studied.

Aged ; Angioplasty, Balloon, Coronary ; adverse effects ; methods ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; Sirolimus ; analogs & derivatives ; therapeutic use ; Treatment Outcome

BACKGROUNDEarly clinical trials with the Endeavor zotarolimus eluting stent (ZES) in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 5 years of follow-up. The aim of this clinical registry study was to evaluate real world clinical performance of the ZES coronary system in Chinese patients.

METHODSThe China Endeavor Registry is a prospective, multicenter registry assessing the safety of the ZES system in a real world patient population. It was conducted at 46 centers in China in routine treatment of patients with coronary artery stenosis, including patients with clinical characteristics or lesion types that are often excluded from randomized controlled trials. The registry included 2210 adult patients who underwent single-vessel or multi-vessel percutaneous coronary intervention. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months.

RESULTSThe 12-month rate of MACE for all patients in the registry was 3.03%. Cardiac death or myocardial infarction rate was 1.28% and target lesion revascularization rate was 1.66%, non-target lesion target vessel revascularization (TVR) was 0.52%, TVR was 2.18%, and target vessel failure was 3.22%. There was only one case of emergent cardiac bypass surgery. The 12-month overall incidence of all Academic Research Consortium (ARC)-defined stent thrombosis was 0.43%.

CONCLUSIONMid-term results from the real-world China Endeavor Registry suggest that Endeavor ZES was safe and effective in Chinese patients.

Aged ; Angioplasty, Balloon, Coronary ; adverse effects ; Asian Continental Ancestry Group ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Sirolimus ; analogs & derivatives ; therapeutic use

OBJECTIVETo analyze the clinical date of 4 patients who developed very late stent thrombosis after implantation of sirolimus eluting stents.

METHODSFrom Oct. 2002 to Aug. 2006, 835 sirolimus eluting stents were implanted in 612 patients. From Jan. 2006 to Aug. 2006, very late thrombosis in sirolimus eluting stents occurred in 4 patients (0.65%), and which caused acute myocardial infarction in anterior wall. Emergency percutaneous coronary interventions (PCIs) were performed in 4 patients immediately after re-admission. The clinical date of the 4 cases were analyzed retrospectively.

RESULTSThese 4 patients were male with the age of 40-69 years. Very late stent thrombosis occurred 31-37 months after successful implantation of sirolimus eluting stents. Application of clopidogrel was stopped 7-12 months after first stents implantation. Aspirin was continued in 3 patients, while the other patient discontinued taking aspirin 18 moths before thrombosis occurred. Emergency coronary angiogram showed that sirolimus eluting stents in LADs were all occlude by thrombosis with TIMI 0 flow. All 4 patients survived after successfully primary PCIs.

CONCLUSIONSOur report presents evidence of very late thrombosis in sirolimus eluting coronary stents, and more careful and prolonged flow-up was required in patients after implantation of drug eluting stents.

Adult ; Aged ; Angioplasty, Balloon, Coronary ; adverse effects ; Drug-Eluting Stents ; adverse effects ; Humans ; Male ; Middle Aged ; Sirolimus ; administration & dosage ; Thrombosis ; etiology