[Impact of cytochrome P450 2C19 polymorphisms on outcome of cardiovascular events in clopidogrel-treated Chinese patients after percutaneous coronary intervention].

OBJECTIVE: To investigate the impact of cytochrome P450 (CYP) 2C19 681G > A polymorphism on long-term prognosis of clopidogrel-treated Chinese patients after percutaneous coronary intervention (PCI). METHODS: Between January 1, 2009 and August 31,2009, 267 patients with coronary heart disease who received PCI and treated with clopidogrel for 12 months were enrolled. CYP2C19 * 2 was detected by MALDI-TOF MS and patients were grouped into CYP2C19 * 1/ * 1 (n = 130) and CYP2C19 * 2 carriers group (n = 137). Follow-up was 12 months. The primary endpoint was angina recurrence, urgent coronary revascularization, acute myocardial infarction, stent thrombosis, death and the combined end points. RESULTS: Baseline data were similar between two groups (P > 0.05). Urgent coronary revascularization and the combined end points occurred more frequently in CYP2C19 * 2 carriers than in CYP2C19 * 1/* 1 patients (7.3% vs. 1.5% and 8.0% vs. 2.3% respectively, all P < 0.05). But incidence of angina recurrence, acute myocardial infarction, stent thrombosis and death was similar between two groups (all P > 0.05). Hazard risk of 1 year cumulative survival of CYP2C19 * 2 carriers group was significantly higher than CYP2C19 * 1/ * 1 group after PCI ( HR = 3.59, 95% CI: 1.02 - 12.87, P < 0.05). CONCLUSION: CYP2C19 681G > A polymorphism is a determinant of prognosis in coronary heart disease patients receiving chronic clopidogrel treatment after PCI.

[The in-hospital outcome and predictors of major adverse cardiac events after transradial intervention in patients with coronary artery disease].

OBJECTIVE: The purpose of this study is to evaluate the in-hospital clinical outcome of patients with coronary artery disease who underwent transradial intervention (TRI) and analyze the predictors of clinical outcome. METHODS: From May 2004 to May 2009, there were 16 281 patients who underwent transradial intervention, as well as 5388 patients who underwent transfemoral intervention (TFI) at our institution. The clinical characteristics, procedural characteristics, and in-hospital clinical adverse events were compared between TRI and TFI groups. Multivariable logistic regression analysis was performed to determine predictors of in-hospital major adverse cardiac events (composite of death, myocardial infarction, or target lesion revascularization) of TRI. RESULTS: The annulations time was significantly longer for TRI than TFI (P < 0.01), fluoroscopy time, amount of contrast agent and procedural success rate (95.5% for TRI and 96.2% for TFI) were similar between the two groups. However, the rates of vascular complications (0.1% for TRI group and 1.3% for TFI group, P < 0.01), incidence of in-hospital major adverse cardiac events (1.6% vs. 3.8%, P < 0.01) and in-hospital death (0.2% vs. 0.4%, P < 0.01) were all significantly lower in TRI group compared with TFI group. The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI: age ≥ 65 (OR: 1.98, 95%CI: 1.50 - 2.61, P < 0.01), prior myocardial infarction (OR: 2.14, 95%CI: 1.63 - 2.82, P < 0.01), use of drug-eluting stent (DES) (OR: 0.68, 95%CI: 0.47 - 0.98, P = 0.04), dissection during procedure (OR: 4.08, 95%CI: 2.28 - 7.33, P < 0.01), left main lesion (OR: 2.12, 95%CI: 1.09 - 4.13, P = 0.03), number of implanted stents (OR: 1.25, 95%CI: 1.09 - 1.43, P < 0.01), and total stented length (OR: 1.01, 95%CI: 1.00 - 1.02, P = 0.03). CONCLUSIONS: In this large single-centre patient cohort, the transradial intervention is superior to transfemoral intervention in terms of in-hospital safety and efficacy. Age ≥ 65, prior myocardial infarction, use of DES, dissection during procedure, left main lesion, number of implanted stents and total stented length were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI.

[Comparison of outcomes after transradial intervention in patients of different age groups].

OBJECTIVE: To compare the in-hospital clinical outcome of patients with coronary artery disease in different age groups [< 65 years (younger), 60 to 79 years (older), and ≥ 80 years (octogenarians)] underwent transradial intervention (TRI) so asto analyze the predictors of adverse events. METHOD: From May 2004 to May 2009, a total of 16 293 patients underwent transradial intervention at our institution. The in-hospital outcome for patients in different age groups after TRI was investigated. Multivariable logistic regression analysis was performed to determinate the predictors of in-hospital major adverse cardiac events (MACE) (composed of death, myocardial infarction or target vessel revascularization). RESULTS: Angiographic success rates were not different (97.5%, 97.4%, 98.1%, P > 0.05) between 3 groups. However, the rates of procedural complications became progressively higher with age group (0.8%, 1.2%, 4.0%, P < 0.01). In-hospital MACE (1.3% vs 2.2% vs 7.5%, P < 0.01) and mortality (0.1% vs 0.3% vs 2.9%, P < 0.01) increased incrementally with age group. Aad it was associated with a significant decrement of DES (92.0%, 89.6%, 57.3%, P < 0.01). The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events: age ≥ 80 (OR 6.26, 95%CI: 3.33 to 11.74; P < 0.01), prior myocardial infarction (OR 2.19, 95%CI: 1.66 to 2.88; P < 0.01), left main lesion (OR 2.02, 95%CI: 1.04 to 3.91; P = 0.04), age of 65 to 79 (OR 1.83, 95%CI: 1.37 to 2.43; P < 0.01), number of implanted stents (OR 1.31, 95%CI: 1.15 to 1.50; P < 0.01), total stented length (OR 1.01, 95%CI: 1.01 to 1.02; P = 0.03), and use of DES (OR 0.59, 95%CI: 0.39 to 0.89; P = 0.01). CONCLUSIONS: The younger and older patients undergoing TRI have a more favorable in-hospital outcome. However the octogenarians has a substantially higher risk of in-hospital MACE.

[Clinical characteristics and outcome comparison between young (< or = 45 years) female and male patients with coronary artery disease undergoing percutaneous coronary intervention].

OBJECTIVE: To compare the clinical characteristics and clinical outcomes in young (< / = 45 years) female and male coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). METHODS: Angiographic and clinical data from 124 premenopausal female patients who underwent elective PCI from April 2004 to February 2008 were compared to age-matched 430 male patients who underwent elective PCI between 2006 and 2007 in our department. All patients were treated according to guidelines and coronary angiography was repeated after 6 months. One year clinical follow-up were performed in all patients. RESULTS: Incidences of dyslipidemia, the history of myocardial infarction and smoking were significantly lower in female patients than in male patients (all P < 0.01). Left main, left anterior descending and bifurcation lesions were more common while type C lesion and right coronary lesion were less common in young female CAD group compared to young male CAD group (P < 0.01-0.05). The average lesion length in female patients was significantly longer than that in male patients [(20.36 +/- 13.37) mm vs. (23.04 +/- 13.86) mm, P < 0.05]. The in-hospital and follow-up incidences of major adverse cardiac events, stent thrombosis and in-stent restenosis were similar between young female and male CAD patients. CONCLUSIONS: CAD risk factors were less and vessel lesions were more likely to be found at left main, left anterior descending and bifurcation in young female CAD patients compared to young male CAD patients. The clinical outcomes were similar between young female and male CAD patients.

Comparison of changes in early inflammatory markers between sirolimus- and paclitaxel-eluting stent implantation.

BACKGROUND: Systemic inflammation after coronary intervention identifies patients at increased risk of subsequent cardiac events. Cardiac events, especially in-stent restenosis, are less frequent after use of sirolimus-eluting stent (SES) compared with paclitaxel-eluting stent (PES). However, the underlying mechanism for this disparity is not well investigated. We hypothesize that an attenuated inflammatory response after SES implantation may be a contributor. PURPOSE: In the present study, we sought to determine the early inflammatory response after SES implantation in patients with single-vessel disease compared with PES implantation, and evaluate the relationship between inflammatory response and late clinical outcomes in a randomized design. METHODS: Thirty-two patients with stable angina were randomly enrolled into the two groups, SES or PSE group (n = 16 respectively). Peripheral blood samples were taken before PCI, 24 and 72 h after stenting. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA). The clinical and angiographic follow-up was performed at 8 months after stenting. RESULTS: The data showed that there was no significant difference in clinical and angiographic baseline characteristics between the two groups. The plasma CRP and IL-6 levels at 24 h after stenting were significant higher in both groups compared with baseline (p < 0.01 respectively). Likewise, the CRP levels at 72 h after stenting were also significant higher compared with baseline in both groups (p < 0.01 respectively). However, the plasma levels of IL-6 at 24 h and CRP at 72 h after stenting were higher in PES group compared with SES group (p < 0.05). At 8 months follow-up, the rates of major adverse cardiac events, target lesion revascularization, in-stent and in-segment restenosis were similar in both groups. However, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (p < 0.001 respectively). CONCLUSIONS: Our findings suggest that a drug-eluting stent implantation could trigger a systemic inflammatory response as previously demonstrated. However, SES implantation results in a lower inflammatory response compared with PES implantation, which seems to be associated with greater late of in-stent and in-segment loss at 8-month follow-up with PES.

[Analysis of acute myocardial infarction one month after stent implantation].

OBJECTIVE: To study the possible causes of ST-elevated acute myocardial infarction (STEAMI) occurring one month after percutaneous coronary intervention (PCI). METHODS: One hundred and ninety two patients aged from 40 - 79 years who had a successful previous PCI and also received primary PCI due to STEAMI in this hospitalization were included in this study. The AMI-related lesions and previous angiographic findings such as the number of lesions, the degree of the stenosis, the type of stents and the acute results of last PCI, etc. were recorded in detail. If the AMI-related lesion was localized in-stents or at the edge of stents (distance from the edge < or = 5 mm), it was defined as late thrombosis, otherwise it was regarded as an AMI induced by new-lesion. RESULTS: New lesions, as the cause of STEAMI, were found in 144 cases (Group A, 75%), and late thrombosis in 48 patients (Group B, 25%). There was a significant difference in the average time from previous PCI to AMI (30.1 +/- 12.4 vs. 20.3 +/- 11.9 months) between the two groups. Diabetes mellitus (DM) and drug-eluting stents (DES) utilization were associated with markedly higher morbidity of late thrombosis in adjusted logistic regression analysis [hazard ratio (HR) 3.387, 95% CI 1.053 - 10.898 and HR 5.311, 95%CI 1.066 - 26.464]. CONCLUSIONS: STEAMI occurred 1 month after PCI are more likely to be developed from previous insignificant lesions than from late thrombosis in stents. Moreover, DM and DES are associated with a high incidence of late thrombosis, which may indicate that intensive antiplatelet therapy should be considered in diabetic patients receiving PCI.

Immediate and long-term outcomes of drug-eluting stent implantation for unprotected left main coronary artery disease: comparison with bare-metal stent implantation.

BACKGROUND: The efficacy and safety of drug-eluting stent (DES) implantation for unprotected left main coronary artery (LMCA) disease remain to be established in different clinical settings. METHODS: Elective DES implantation for unprotected LMCA stenosis was performed in 220 patients at the Fu Wai Hospital, China, from April 2003 to February 2006. Data derived from the latter group were compared with those derived from 224 patients treated with bare-metal stents (BMSs) before March 2003 in a Chinese registry of unprotected LMCA stenting. RESULTS: Compared with the historical BMS control group, the DES group had more multivessel disease and underwent more bifurcation stenting. The inhospital major adverse cardiac events were significantly higher in the DES than in the BMS recipients (4.1% vs 0.9%, P = .030) because of more complex lesions and procedures in the DES group. During the 15-month mean follow-up period, cumulative cardiac death (0.5% vs 4.9%, P = .004), target-vessel revascularization (5.9% vs 11.6%, P = .034), and major adverse cardiac event (9.5% vs 16.5%, P = .029) rates were significantly lower in the DES than in the BMS group. There was no significant difference in clinical efficacy between sirolimus- and paclitaxel-eluting stents. Angiographic follow-up was performed in 46.4% of DES and 45.7% of BMS recipients, respectively; and the binary restenosis rate was significantly lower in the DES versus the BMS control group (16.7% vs 31.4%, P = .014). CONCLUSIONS: Based on this comparison with a historical control, DES implantation for unprotected LMCA appears safe in selected patients and might be more effective in preventing major adverse cardiac events compared with BMS implantation over a mean follow-up period of 15 months.

Short- and long-term outcomes of single bare metal stent versus drug eluting stent in nondiabetic patients with a simple de novo lesion in the middle and large vessel.

OBJECTIVE: This study was aimed to investigate the short- and long-term outcomes of percutaneous coronary intervention (PCI) between single bare metal stent (BMS) and single drug eluting stent (DES) in nondiabetic patients with a simple de novo lesion in the middle and large vessel. METHODS: Two hundred and thirty-five consecutive patients with a simple de novo lesion in the middle and large vessel were treated with BMS or DES in our hospital from Apr. 2004 to Dec. 2004. The inclusion criteria: a simple de novo lesion in the middle and large vessel, stent diameter > or = 3.0 mm, stent length < or = 18 mm, the exclusion criteria: diabetes mellitus, left main trunk disease and left ventricular ejection fraction < or = 30%. Of them, there were 150 patients in BMS group and 85 patients in DES group, and the rates of lost to follow up were 6.7% and 1.2% respectively. RESULTS: BMS group had lower hypercholesteremia rate (22.0% vs 38.8%) and higher proportion of TIMI grade 0 (12% vs 1.2%) than DES group (all P < 0.05), but both groups had similar stent length (16.16 +/- 2.81 mm vs 16.06 +/- 2.46 mm) and stent diameter (3.85 +/- 3.07 mm vs 3.19 +/- 0.24 mm) after procedure, in-segment restenosis rate (0% vs 1.2%) and target lesion revascularization (TLR, 2.0% vs 2.4%) at 6-month follow-up (all P > 0.05). No difference was found in TLR (1.3% vs 1.2%, P = 1.00) and recurrent myocardial infarction (Re-MI) (0% vs 1.2%, P = 0.36), cardiac death (0.7% vs 1.2%, P = 1.00) between 1- and 3-year. So were TLR (6.0% vs 5.9%, P = 0.97), Re-MI (0% vs 2.4%, P = 0.06), cardiac death (2.0% vs 3.5%, P = 0.48) and major adverse cardiac events (MACE, 8.7% vs 10.6%, P = 0.63), cardiac death-free cumulative survival (98.7% vs 97.7%, P = 0.56), TLR-free cumulative survival (94.0% vs 94.1%, P = 0.98) and Re-MI-free cumulative survival (100% vs 97.7%, P = 0.06) at 3-year follow-up. CONCLUSION: The single BMS has similar efficacy and safety to single DES in nondiabetic patients with a simple de novo lesion in the middle and large vessel at short- and long-term follow-up.

Randomized comparison of early inflammatory response after sirolimus-eluting stent vs bare metal stent implantation in native coronary lesions.

BACKGROUND: The clinical significance of early inflammatory response after coronary stent implantation has been controversial. Sirolimus-eluting stent (SES) has been shown to be better outcomes compared with bare metal stent (BMS). We prospectively investigated the early inflammatory response after SES or BMS implantation in patients with single-vessel lesion, and evaluated the relationship between inflammation and late clinical outcomes in a randomized design. METHODS: Forty-eight patients with single-vessel disease were randomized into SES or BMS implantation group (n=24 respectively). Blood samples were taken before stenting, 1 h, 24 h and 8 months afterward. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by ELISA. The clinical and angiographic follow-up were performed at 8 months after stenting. RESULTS: There was no difference in baseline characteristics, plasma CRP and IL-6 concentrations between the 2 groups. However, plasma IL-6 concentrations at 1 h after stenting were higher in both groups than in baseline (p<0.01). In addition, the plasma CRP and IL-6 concentrations at 24 h after stenting were significantly higher in both groups compared with baseline (p<0.01 respectively). Likewise, plasma CRP and IL-6 concentrations were significantly higher in BMS group compared with SES group at 24 h after stenting (p<0.05 respectively). At the follow-up (mean 8 months after stenting), the rate of in-stent restenosis (ISR) and target lesion revascularization (TLR) were higher in BMS group than in SES group (p<0.05 respectively) although the plasma CRP and IL-6 concentrations are similar between the groups. CONCLUSIONS: Single coronary stenting could trigger an early inflammatory response. However, patients undergoing SES implantation has less augmentation of early inflammatory markers after stenting compared to patients treated with BMS, which was positively related the incidence of ISR and TLR at follow-up. This may reflect the potential impact of SES implantation on the early inflammatory response and late clinical outcomes.

Drug-eluting stents for the treatment of ostial coronary lesions: comparison of sirolimus-eluting stent with paclitaxel-eluting stent.

BACKGROUND: Treatment of ostial coronary lesions represents a challenge for interventional cardiologists. The efficacy of drug-eluting stents (DES) has been demonstrated as improving the outcomes of patients in a few studies. It is not known, however, which DES, sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES), is superior for the treatment of ostial lesions. METHODS: In this retrospective study, 95 consecutive patients with de-novo ostial lesions underwent coronary SES (n=47, lesions=48) or PES implantation (n=45, lesions=47), and quantitative coronary analysis was performed at the time of stent implantation and subsequently at 8 months post stenting. Ostial lesion was defined as > or =50% diameter stenosis rising within 3 mm of either left anterior descending coronary artery or left circumflex artery or right coronary artery measured by quantitative coronary analysis. Major adverse cardiac events including death, thrombosis, nonfatal myocardial infarction, and target lesion revascularization were compared between the two groups. RESULTS: Baseline clinical and angiographic characteristics were well balanced between the two groups. At 8 months clinical and angiographic follow-up, overall major adverse cardiac events and target lesion revascularization rates were similar in both groups (6.4 vs. 11.2%, P=0.184; 4.3 vs. 8.9%, P=0.170, respectively). The in-stent and in-segment restenosis were, however, significantly higher in PES group compared with SES group (15.5 vs. 0%, P=0.001; 22.2 vs. 4.3%, P=0.003). Similarly, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (0.65+ or -0.67 vs. 0.16+ or -0.18 mm; 0.68+ or -0.65 vs. 0.15+ or -0.12 mm; P<0.001, respectively). CONCLUSION: In this small sample-size, nonrandomized, and nonprospective study, the data indicated that implantation of DES appears safe and effective for the treatment of patients with de-novo ostial coronary lesions, but SES implantation 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.

Sirolimus-eluting cobalt-chromium stents: two-year clinical results from first-in-man study on the Firebird 2 stent.

BACKGROUND: Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2 stents in the treatment of patients with CAD. METHODS: This first-in-man study using the Firebird 2 stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird 2, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver, Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups. RESULTS: All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P<0.0001). A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P<0.0001). Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group (P>0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively (all P<0.0001). The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P<0.0001). No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting: this patient presented with unstable angina pectoris and was treated by balloon angioplasty. CONCLUSIONS: Compared with the bare cobalt alloy stent, the Firebird 2 sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.

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.

Effects of sirolimus-eluting stent on calcified coronary lesions.

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. METHODS: 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; in-stent 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.

Angiographic prevalence of myocardial bridging in a defined very large number of Chinese patients with chest pain.

BACKGROUND: Muscle fibers overlying the intramyocardial segment of an epicardial coronary artery are termed myocardial bridging (MB). Variable prevalence of MB has been described at autopsy and angiographic series with small and large sample size studies. In addition, no similar study was reported in Chinese population. The aim of this study was to investigate the angiographic prevalence of MB in consecutive 37,106 Chinese patients with chest pain from our center. METHODS: We conducted an observational study to evaluate the consecutive cases with MB among patients undergone selective coronary angiography, and analyzed the angiograhic prevalence and clinical features of MB in this study of very large sample size. RESULTS: Among 37 105 patients with chest pain we found 1002 cases with 1011 MBs in a retrospective manner, and the overall prevalence was 2.70%. Although more than 99% (991/1002) of patients had single bridge, 8 cases were found to have more than two MBs (seven with two, and one with three). Altogether 54.39% of cases (545/1002) had MB without atherosclerotic lesions, and 96.24% (973/1011) of bridging located in the left anterior descending coronary artery (LAD), mainly in the middle of LAD (792/1011, 78.33%). According to Nobel classification, of the single bridge (n=991), <50% of obstruction was predominant (471/991, 47.52%). Totally 50%-69% accounted for 34.81% (345/991), >70% of obstruction was 17.65% (175/991). CONCLUSIONS: These data showed that the prevalence of angiographically detectable MB in Chinese patients with chest pain was similar to those of the previous studies, with 2.7% prevalence in this very large sample size.

[Comparison of different drug-eluting stents in the treatment of coronary artery disease: a single center four-year clinical follow-up].

OBJECTIVES: To investigate the outcomes of sirolimus-eluting stent (Cypher, Cordis/Johnson & Johnson, Warren, NJ, USA) and paclitaxel-eluting stent (Taxus, Boston Scientific, Natick, MA, USA) in the treatment of coronary heart disease after a four-year clinical follow-up. METHODS: 237 consecutive patients were enrolled in this study and treated with Cypher (136 patients) or Taxus (101 patients) from January to October 2003. The rates of stenosis, stent thrombosis according to ARC definition and major adverse cardiac events (MACE a composite of cardiac death, myocardial infarction and target vessel revascularization) were analysed. RESULTS: There was no significant difference on secondary restenosis, target lesion revascularization (TLR) and MACE between Cypher and Taxus groups at six-month angiographic follow-up, but late luminal loss was higher in Taxus group [(0.15 +/- 0.43) mm vs (0.42 +/- 0.34) mm, P = 0.022]. At four-year follow-up, TVR-free survival rate was 88.97% in Cypher group versus 82.28% in Taxus group (P = 0.158). MACE-free survival rate was 83.8% in Cypher group and 79.2% in Taxus group (P = 0.056). The incidence of stent thrombosis was no difference between the two groups (1.47% vs 1.98%). There was also no difference among early (0 vs 0.99%), late (0.73% vs 0.99%) and very late stent thrombosis (0.73% vs 0) between the 2 groups. CONCLUSIONS: There were no difference between Cypher and Taxus in the treatment of coronary artery disease; Both Cypher and Taxus have good clinical outcomes except that Taxus had higher late loss.

[Effects of sirolimus-eluting stent and the paclitaxel-eluting stent: a three-year follow-up study].

OBJECTIVE: To compare the long-term effects of the China-made sirolimus-eluting stent (Firebird) and the imported paclitaxel-eluting stent (Taxus). METHODS: From April 2004 to April 2005, 314 consecutive patients underwent implantation of Firebird (n=88, F Group), aged (57.9 +/- 10.5), or Taxus (n=226, T group), aged (57.2 +/- 10.2). Then the patients were followed up in ward or out-patients department 1, 3, and 6 months after implantation and 1, 2, and 3 years after implantation by phone. Seven months after implantation coronary angiographic follow-up was performed. RESULTS: The baseline type B2 + C lesion rate of T Group was 85.5%, significantly higher than that of F Group (75.5%; P = 0.026). The percent diameter stenosis of T Group was 70.1% +/- 15.2%, significantly higher than that of F Group (64.4% +/- 14.5%; P = 0.026). The balloon pre-dilation rate of T Group was 88.2%, significantly higher than that of F Group (70.9%, P = 0.000). The stent length ofT Group was (21.5 +/- 7.84) mm, significantly longer than that of F Group [(18.6 +/- 4.51) mm, P = 0.035]. The major adverse cardiac event (MACE) rate of T Group was 21.7%, significantly higher than that of F Group (8.0%, P = 0.05), the target vessel revascularization rate of T Group was 16.4%, ignificantly higher than that of F Group (6.8%, = 0.028), However, there were not significant differences in the rates of cardiac death and fatal myocardial infarction between these two groups (0% vs 1.8%, P = 0.580 and 1.1% vs. 3.5%, P = 0.45 respectively). There was no significant differences in the total, early, late, and very late stent thrombosis between these 2 groups (1.1% vs. 3.5%., P = 0.453, 1.1% vs. 0.9%, P = 0.580, and: 0% vs. 1.3%, P = 0.562, and 0% vs. 1.3%; P = 0.562). Angiography indicated that the in-stent and in-segment restenosis rates of T Group were both significantly lower than those of F Group (0% vs21.0.%; P 0.002, and 0% vs 24.0.% ; P =0.001 ). The in-stent and in-segment late loss levels of T Group were significantly smaller than those of F Group [(0.11 +/- 0.07) mm vs. (0.53 +/- 0.38)mm; P = 0.000, and (0.05 +/- 0.03) mm vs. (0.38 +/- 0.19) mm; P = 0.000]. CONCLUSION: Firebird stent is more effective and safer than Taxus stent, especially is superior in the restenosis-reducing effect.

[Outcome of patients implanted with bioabsorbable polymer sirolimus-eluting stent (Excel) and the durable polymer sirolimus-eluting stent (Cypher)].

OBJECTIVE: To compare the outcome of patients with coronary artery disease implanted with bioabsorbable polymer sirolimus-eluting stent (Excel) and the durable polymer sirolimus-eluting stent (Cypher). METHODS: One year clinical and 7 months angiographic follow-up data were analyzed in 591 consecutive patients implanted with Excel (E group: n = 350, 58.1 +/- 10.9 years old) or Cypher (C group: n = 241, 56.4 +/- 10.7 years old) during May 2006 to November 2006 in our center. RESULTS: There were more patients with old myocardial infarction and triple vessel diseases while there were less left main stem disease in E group compared to those of C group at baseline. Reference vessel diameter [(2.76 +/- 0.45) mm vs. (2.87 +/- 0.38) mm, P = 0.043], stent diameter [(3.11 +/- 0.48) mm vs. (3.25 +/- 0.34) mm, P = 0.045] and minimal stent diameter [(2.67 +/- 0.43) mm vs. (2.78 +/- 0.35) mm, P = 0.046] and rate of post-dilation (15.9% vs. 46.7%, P < 0.001) were all significantly smaller in E group compared to those in C group. Procedure was successful in all patients. One year clinical follow-up results showed similar results on major adverse cardiac events (MACE) rate (8.3% vs. 7.1%, P = 0.641), rate of cardiac death (0.9% vs.0.0%, P = 0.274), non-fatal myocardial infarction (2.0% vs. 1.2%, P = 0.747) and target vessel revascularization (5.4% vs. 5.8%, P = 0.857) between E and C groups. Total (0.9% vs. 0.4%, P = 0.649), early (0.6% vs. 0.0%, P = 0.516) and late (0.3% vs. 0.4%, P = 1.000) stent thrombosis rates according to Academic Research Consortium (ARC) standard definitions (definite + probable) were also similar between the E and C groups. Seven months angiographic follow-up results indicated that there were no differences of in-stent and in-segment restenosis rate between E and C groups (4.7% vs. 3.2%, P = 0.725; 5.6% vs. 3.2%, P = 0.505) but in-stent and in-segment late loss were significantly smaller in E group than those in C group [(0.18 +/- 0.07) mm vs. (0.21 +/- 0.08) mm, P < 0.001; (0.21 +/- 0.09) mm vs. (0.23 +/- 0.11) mm, P = 0.003]. CONCLUSION: One year clinical and 7 months angiographic outcome were comparable in patients implanted with Excel and Cypher sirolimus-eluting stents.

[Effects of treating ostial left anterior descending artery stenosis by drug eluting stents via precisely positioning or crossing over into left main stem].

OBJECTIVE: To compare the effect of treating ostial left anterior descending artery (LAD) stenosis using drug-eluting stents (DES) by precisely positioning versus crossing over into left main (LM) technique. METHODS: From April 2004 to May 2006, DES implantations in 224 consecutive patients with ostial LAD lesions were performed by precisely positioning in 161 patients (P group) and crossing over into LM in 63 patients (C group). Clinical and angiographic follow-up was performed at 7 months post DES implantations. RESULTS: Relevant vessel diameter (RVD) was significantly larger (3.44 +/- 0.52 mm vs. 3.17 +/- 0.40 mm, P = 0.039) and LM/LAD diameter ratio was significantly lower (1.16 +/- 0.07 vs. 1.28 +/- 0.05, P = 0.000) in C group compared that in P group. Stent (3.53 +/- 0.31 mm vs. 3.16 +/- 0.29 mm, P = 0.035) and postdilatation balloon (3.59 +/- 0.65 mm vs. 3.24 +/- 0.32 mm, P = 0.035) diameter were significantly larger and postdilatation (94.1% vs. 29.5%, P = 0.000) and kissing balloon (47.1% vs. 15.2%, P = 0.000) rates were significantly higher in P group than that in C group. Both groups achieved 100% procedure success rate. Major adverse cardiac events (MACE) rate (4.3% vs. 1.6%, P = 0.447), death (0 vs. 0, P = 1.000), AMI (1, 2% vs. 1.6%, P = 1.000) and target vessel revascularization (TVR) rate (3.1% vs. 0%, P = 0.325) were similar between the 2 groups. One patient in P group developed subacute in-stent thrombosis. Follow-up angiography at 7 months showed that in-stent (0 vs.7.7%, P = 0.316) and in-segment restenosis rate (3.8%vs. 10.8%, P = 0.431) tended to be lower while in-stent (0.12 +/- 0.08 mm vs. 0.59 +/- 0.37 mm, P = 0.000) and in-segment (0.17 +/- 0.09 mm vs. 0.64 +/- 0.49 mm, P = 0.000) late loss were significantly lower in C group compared with P group. CONCLUSION: Compared with precisely positioning technique, crossing over into LM technique was more feasible and tended to reduce restenosis rate for ostial LAD lesions treated with DES.

[Efficacy comparison between drug-eluting stents versus cutting balloon angioplasty followed by bare metal stents for the treatment of ostial lesions of the left anterior descending coronary artery].

OBJECTIVE: To compare the short and long-term clinical and angiographic outcomes of drug-eluting stents (DES) versus cutting balloon angioplasty followed by bare metal stents (CBA + BMS) for the treatment of ostial lesions of the left anterior descending coronary artery (LAD). METHODS: A total of 51 consecutive patients with LAD ostial lesions were treated by DES and all patients had completed 2-year clinical follow-up, 50 consecutive patients with LAD ostial lesions treated by CBA + BMS and followed up for 2 years prior to the DES era (May 2000 to November 2003) served as control group. RESULTS: In DES group, one patient experienced acute myocardial infarction (AMI) during hospitalization, the in-hospital major adverse cardiac event (MACE) was 1.96% (1/51), angiography follow-up data at 6-8 months were available in 29 patients and the in-DES restenosis was 10.3% (3/29), at 2-year clinical follow-up, 1 patient died, 4 patients received target lesion revascularization. Total MACE rate was 9.8% (5/51). In CBA + BMS group, there was no in-hospital death and AMI. Angiographic follow-up at 6-8 months was completed in 28 cases and in-stent restenosis rate was 17.9% (5/28). During 2-year follow-up, there was no death and AMI and 6 patients underwent target lesion revascularization. MACE rate was 12% (6/50) in this group. CONCLUSION: This study showed that both clinical and angiographic outcomes were comparable between DES and CBA + BMS treated patients with LAD ostial lesions during the 2-year follow up period.