Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result A prospective, historically controlled, multi-center clinical study

Background  The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. This study was conducted to evaluate the safety and efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.
Methods  Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) within the previous six months and served as historical controls (control group). Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.
Results  The demographic characteristics were similar between the two groups despite more patients in the Firebird 2 group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P=0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P=0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller ((2.79±0.46) mm vs (2.98±0.49) mm, P=0.0175) and more stents were implanted for each lesion (1.28±0.52 vs 1.10±0.30, P=0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2 group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P=0.0168; 1.5% vs 26.5% at 12 month, P<0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05±0.09) mm vs (0.98±0.61) mm; in-segment: (0.05±0.18) mm vs (0.72±0.59) mm; P<0.0001) than the control group. One patient in the Firebird 2 group had in-segment restenosis (1.3%) while the rate in the control group (38.1%) was significantly higher, P<0.0001. Intravascular ultrasound examination was performed in 70.1% of patients in the Firebird 2 group and revealed that the percentage of volumetric obstruction was (1.26±1.05) %. No stent thrombosis was observed in either group at 12-month follow-up.
Conclusion  The Firebird 2 sirolimus-eluting cobalt alloyed stent is safe and feasible in treating patients with coronary artery disease.

     

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

Background  The Firebird 2^TM sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2^TM cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.

Methods  The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry. Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.

Results  Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events (MACE) was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction (MI), and 6 target vessel revascularization (TVR). At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis (ST) occurred in 0.43% (22/5058) of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.

Conclusion  The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

     

Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction

Background There are few evidences about the value of drug eluting stent in patients with ST-segment elevation myocardial infarction （STEMI）. We prospectively designed a randomized controlled trial to compare the safety and efficacy of Firebird sirolimus eluting stent （Firebird stent） and bare metal stent （BMS）. Methods Patients with STEMI enrolled during one year period were randomized to undergo implantation of Firebird stent or BMS, and clinical and angiographic follow-up. The primary endpoint of the present study was in-lesion late lumen loss （LLL） at 6 months, and secondary endpoint includes stent thrombosis and major adverse cardiac events （MACE） at 6 months. Results During one year period, 156 patients were randomized into the Firebird stent group （101 patients with an average age of 57.8 years） or the BMS group （55 patients with 59.7 years on average）. Six-month angiographic follow-up was available in 66.3% and 63.7% of patients assigned to Firebird stent and BMS, respectively. At 6-month follow-up, mortality, target vessel revascularization （TVR） and MACE were 2.0%, 6.9% and 9.9% in the Firebird stent group, while 3.6%, 30.9% and 36.4% in the BMS group （P〈0.05）. Subacute thrombosis occurred in 1 patient in both groups, respectively. The mean LLL was 0.18 mm in the Firebird stent group versus 0.72 mm in the BMS group. Conclusion Implantation of Firebird sirolimus eluting stent for STEMI may greatly reduce TVR and MACE at 6 months with low incidence of acute/subacute stent thrombosis compared with BMS.     

Comparison of long-term clinical outcome after successful implantation of Firebird sirolimus- and Taxus paclitaxel-eluting stents in Chinese population: analysis of a large single center registry

Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.Methods From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird group.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.     

Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent

Background  Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of drug-eluting stents (DES) has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available (sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)). However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions.
Methods  In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES (n=68) and PES (n=83). Quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 2.5 mm measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups.
Results  Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups (0 vs 1.2%, P>0.05). The TLR and in-segment restenosis were not significantly different (19.1% vs 25.3%; 10.3% vs 10.8%, P=0.365 and P=0.913 respectively) between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group (4.4% vs 21.7%; P=0.002). Similarly, the late loss was significantly higher in the PES group ((0.140.38) mm vs (0.490.61) mm; P<0.001).
Conclusions  In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.

     

Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years

Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent （SES） in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease （CAD） who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events （MACE） and Academic Research Consortium defined stent thrombosis （ST） were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients （65. 4%） were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year＇s and 3 years＇ clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE （13.7% vs 6.4%, P 〈0.05） and TVR （9.8% vs 4.0%, P 〈0.05） and the cumulative MACE free survival rate was very significantly lower in the DM group （86.4% vs 93;6%, P 〈0.05）. ST occurred in 7 patients （1.4%） at the end of 3 years＇ follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label （1.5%） and on label groups （1.1%, P=-0.07）. Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.     

Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease

Background Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents （DES） implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease （CAD） in China.
Methods From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up： 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird, After two years of follow-up, there were 2176 patients （1245 Cypher, 558 Taxus and 373 Firebird）. All patients were treated with aspirin and clopidogrel over at least 9 months.
Results Among 8190 patients, 17 patients had acute stent thrombosis （0.24%）： 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis： 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%： 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%： 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%： 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.
Conclusion The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.     

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease

Background  The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conduced to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes.
Methods  One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC).
Results  The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P>0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P=0.524), re-MI (0 vs 2.0%, P=0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P=0.299) and very late thrombosis (0 vs 3.0%, P=0.295) between 1-year and 3-year follow-up.
Conclusion  The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

     

Firebird and Cypher sirolimus-eluting stents and bare metal stents in treatment of very long coronary lesions

Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion （VLCL）. The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion （≥ 30 mm） between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event （MACE） that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 （41 lesions） were treated with Firebird SES, 37 （39 lesions） with Cypher SES, and 37 （37 lesions） with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group （in-segment： 14.6% vs 12.8%, relative risk （RR）1.14, P=0.81; in-stent： 9.8% vs 10.3%, RR 0.95, P=0.94）, and significantly lower than those in the B     

A comparison of angiographic and clinical outcomes after sirolimus-eluting versus paclitaxel-eluting stents for the treatment of in-stent restenosis

Background In-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.     

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a “real world” setting: six-month follow-up results

Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n=93, Firebird group) or Excel stents (n=97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups.Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P﹥0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 ± 0.21) mm versus (0.14 ± 0.20) mm (P=0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.     

Long-term clinical outcomes after bioabsorbable polymer- and durable polymer-based sirolimus-eluting stents implantation: two-year follow-up results from a large single-center database

Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polymer） and the EXCEL stent （coated with bioabsorbable polymer） are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term （6-month） angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.
Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types （EXCEL or FIREBIRD） used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target vessel revascularization） and stent thrombosis during a 2-year follow-up period were compared between the two groups.
Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group （HR 0.84, 95%CI0.50-1.43）, whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% （HR 0.74, 95%CI0.30-0.85）, 1.8% vs 1.3% （HR 1.41,95%CI 0.45-4.43） and 2.5% vs 4.0% （HR 0.62, 95%CI0.28-0.37）, respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group （P=0.5610）, whereas the rate of very late stent thrombosis was 0.5% vs 1.3% （P=0.2550）.
Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.     

A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease: 8-month angiographic and 2-year clinical follow-up results

Background  Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease. 

Methods  A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤40 mm, reference vessel diameter 2.25–4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

Results  Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25±0.33) mm vs. (0.57±0.55) mm, diff (95% CI) –0.23 (–0.32, –0.14), P <0.0001; in-segment (0.25±0.33) mm vs. (0.42±0.55) mm, diff (95% CI) –0.13 (–0.23, –0.02), P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).

Conclusions  TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

     

Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study

Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents （BMS）-Multi-link （ML） Vision / ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease （CAD） after implanting the Multi-link Vision or MiniVision stent were investigated in this study. Methods An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS- ML Vision / ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization （TLR） at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events （MACE） and serious adverse events （SAE） in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study, The average reference diameter of the lesions was （3.0±0.5） mm, and the mean length was （15.7±5.0） mm. Results The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization （TVR） were 6.8%, 3.5% and 1.4% respectively. Conclusion The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.     

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

Background Advanced age independently predicts early and late mortality and major adverse cardiac events （MACE） after percutaneous coronary intervention （PCI）. Randomized clinical trials indicate that siroUmus-eluting stent （SES） implantation reduces target lesion revascularization （TLR）, but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease （CAD） in real-world practice. Methods A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age： a young group （〈65 years old, 244 patients with 369 lesions） and elderly group （≥65 years old, 89 patients with 113 lesions）. Clinical follow-up and quantitative coronary angiography （QCA） were performed seven months after PCh Results Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group （21.3% vs 9.8%, P=-0.006）. Primary success rate was similar in both groups （96.5% in young group vs 95.7% in elderly group, P〉0.05）. During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups （4.7% vs 1.8%; 9.7% vs 8.8%, P〉0.05 respectively）. Both sub-acute and late thrombosis rates were similar in the two groups （0.3% vs 0.9% and 1.2% vs 0.9%, P〉0.05 respectively. TLFI was not significantly different between the two groups （6.5% vs 3.5%;P=-0.246）. The rates of bleeding, stroke, angina rehospitalization during the, follow-up period were also similar in both groups （P〉0.05 respectively）. Conclusion Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.     

国产药物洗脱支架在急性冠脉综合征中的应用

目的：探讨国产药物洗脱支架（Firebird支架）在急性冠脉综合征急诊介入治疗中应用的安全性和有效性.方法：2004年10月～2005年7月间治疗急性冠脉综合征患者86例,所有患者均于发病12h内行急诊经皮冠状动脉介入治疗（PCI）.治疗时随机置入Firebird支架或Cypher支架.Firebird支架组46例,Cypher支架组40例.结果：86例患者急诊PCI治疗均获得成功.Firebird组46支罪犯血管置入53枚Firebird支架,Cypher组40支罪犯血管置入49枚Cypher支架.其中1例置入Cypher支架者术后出现脑出血而死亡.Firebird支架组和Cypher支架组比较,PCI术后TIMI3级率和并发症发生率无显著性差异.对85例患者进行了3～6个月的随访,两组患者均未发生任何心血管事件,术后6个月Firebird支架组有20例（43%）行冠状动脉造影检查,无一例发生支架内再狭窄;Gypher支架组有19例（49%）行冠状动脉造影检查,1例发生支架内再狭窄,两组再狭窄率无显著性差异.结论：Firebird支架在急性冠脉综合征急诊介入治疗中应用有较好的安全性和有效性.     

Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies

Background  The difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus^TM) vs. SES-BDP (Excel^TM) from our database.

Methods  A total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints.

Results  At follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11±0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47±0.56) mm, P <0.001, 3.2%, P=0.006, 4.9%, P=0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P=0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group.

Conclusion  The Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.

     

Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

Background  Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry. 

Methods  The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.

Results  Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21±0.40) mm in-segment and (0.23±0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.

Conclusions  The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

     

国产药物洗脱支架在冠心病弥漫性长病变中的临床应用

目的研究国产雷帕霉素药物洗脱支架(Firebird)在冠心病弥漫性长病变中的疗效及安全性。方法 2008年1月1日至2008年12月22日单纯置入Firebird支架的冠心病弥漫性长病变患者72例。随访患者住院期间和出院后主要不良心脏事件(包括心肌梗死、心源性猝死及靶血管再次血运重建术)、心绞痛发作情况等。结果 72例患者术后随访10~24(16.54±6.68)个月,57例心绞痛症状消失(79.17%,57/72),14例心绞痛复发(19.44%,14/72),1例猝死(1.39%,1/72)。再狭窄2例(2.78%,2/72),随访期间发生猝死1例,无急性心肌梗死发生病例。结论国产Firebird药物涂层支架应用于冠心病弥漫性长病变患者中介入治疗是安全有效的。     

Smoking control hindered by realities in China

Background Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents （SES） for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.Mothods A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group （n=-264） and calcification group （n=-189）. Lesions treated with SES were subjected to quantitative coronary angiography （QCA） immediately and 8 months following stenting. Results Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; instent restenosis： 3.8% vs 4.2%; P=0.081; in-segment restenosis： 8.7% vs 10.6%, P=0.503. The target lesion revascularization （TLR） was also not significantly different between the two groups; 4.9% vs 6.9%, P=0.378. In addition, the in-stent late loss was similar in both groups; （0.16±0.40） mm vs （0.17±0.33） mm, P〉0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P〉0.05. Conclusion Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.