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Background: The mechanism and characteristics of early and late drug-eluting stent in-stent restenosis (DES-ISR) have not been fully clarified. Whether there are different outcomes among those patients being irrespective of their repeated treatments remain a knowledge gap., Methods: A total of 250 patients who underwent initial stent implantation in our hospital, and then were readmitted to receive treatment for the reason of recurrent significant DES-ISR in 2016 were involved. The patients were categorized as early ISR (<12 months; E-ISR; n = 32) and late ISR (≥12 months; L-ISR; n = 218). Associations between patient characteristics and clinical performance, as well as clinical outcomes after a repeated percutaneous coronary intervention (PCI) were evaluated. Primary composite endpoint of major adverse cardiac events (MACEs) included cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR)., Results: Most baseline characteristics are similar in both groups, except for the period of ISR, initial pre-procedure thrombolysis in myocardial infarction, and some serum biochemical indicators. The incidence of MACE (37.5% vs. 5.5%; P < 0.001) and TLR (37.5% vs. 5.0%; P < 0.001) is higher in the E-ISR group. After multivariate analysis, E-ISR (odds ratio [OR], 13.267; [95% CI 4.984-35.311]; P < 0.001) and left ventricular systolic dysfunction (odds ratio [OR], 6.317; [95% CI 1.145-34.843]; P = 0.034) are the independent predictors for MACE among DES-ISR patients in the mid-term follow-up of 12 months., Conclusions: Early ISR and left ventricular systolic dysfunction are associated with MACE during the mid-term follow-up period for DES-ISR patients. The results may benefit the risk stratification and secondary prevention for DES-ISR patients in clinical practice.

Background: To improve outcomes in patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remain an unmet clinical need. The study aimed to evaluate the efficacy and safety of G2-DESs and BP-DESs in patients with and without DM in a single center in China., Methods: A total of 7666 consecutive patients who exclusively had G2-DES or BP-DES implantation throughout 2013 in our center were studied. The primary efficacy endpoint was any target lesion revascularization (TLR), whereas the primary safety endpoint was a composite of death or myocardial infarction (MI) at 2-year follow-up., Results: G2-DESs had a similar occurrence of death, non-fatal MI, TLR, stroke, and stent thrombosis compared with BP-DESs in patients with DM (all P > 0.05). The incidence of TVR and TLR was lower for G2-DESs than for BP-DESs in patients without DM (3.2% vs. 5.1%, P = 0.002; 2.2% vs. 4.5%, P < 0.001, respectively). Kaplan-Meier analysis also showed better TVR- and TLR-free survival rates for G2-DESs than for BP-DESs in patients without DM. Multivariate analysis showed that a BP-DES was an independent risk factor for TLR (hazard ratio 1.963, 95% confidence interval 1.390-2.772, P < 0.001) in patients without DM, which was not predictive of other components of major adverse cardiac events (P > 0.05)., Conclusions: G2-DESs have better efficacy, represented by a reduced risk of TLR, and similar safety compared with BP-DESs in patients without DM. G2-DESs have similar efficacy and safety compared with BP-DESs in patients with DM at 2-year follow-up.

Background: It remains undetermined whether second-generation drug-eluting stents (G2-DESs) outperform first-generation DESs (G1-DESs) in patients with acute coronary syndrome (ACS). We aimed to compare the efficacy and safety of G1-DES and G2-DES in ACS patients in a high-volume cardiovascular center., Methods: In 2013, 10,724 consecutive patients underwent percutaneous coronary intervention in our institution. We included 4037 patients with ACS who underwent exclusively G1-DES or G2-DES implantation (n = 364 and n = 3673, respectively). We used propensity score matching to minimize the imbalance between the G1-DES and G2-DES groups and followed patients for 2 years. The efficacy endpoints were major adverse cardiac events (MACEs) and its components including target vessel-related myocardial infarction (TV-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), and cardiac death. The safety endpoint was stent thrombosis. Continuous variables were compared by Mann-Whitney U-test, and categorical variables were compared using Pearson's Chi-square or Fisher's exact test. Kaplan-Meier curves were constructed to compare the event-free survival rates, and multivariate Cox proportional hazards regression analysis was used to assess whether stent type was an independent risk factor for the efficacy and safety endpoints., Results: At the 2-year follow-up, the results for MACE and it components, as well as stent thrombosis, were similar for G1-DES and G2-DES (MACE, 5.2% vs. 4.3%, χ 2 = 0.514, P = 0.474; TV-MI, 0.8% vs. 0.4%, P = 0.407; TVR, 4.9% vs. 3.7%, χ 2 = 0.939, P = 0.333; TLR, 3.8% vs. 2.5%, χ 2 = 1.610, P = 0.205; cardiac death, 0.3% vs. 0.5%, P = 0.670; and stent thrombosis, 0.5% vs. 0.4%, P > 0.999). Kaplan-Meier analysis indicated similar event-free survival rates between G1-DES and G2-DES after propensity score matching (all: log-rank P > 0.05). Multivariate analysis demonstrated that stent type was not an independent risk factor for the efficacy and safety endpoints (MACE, hazard ratio [HR] = 0.805, 95% confidence interval [CI]: 0.455-1.424, P = 0.456; TV-MI, HR = 0.500, 95% CI: 0.101-2.475, P = 0.395; TVR, HR = 0.732, 95% CI: 0.403-1.330, P = 0.306; TLR, HR = 0.629, 95% CI: 0.313-1.264, P = 0.193; cardiac death, HR = 1.991, 95% CI: 0.223-17.814, P = 0.538; and stent thrombosis, HR = 0.746, 95% CI: 0.125-4.467, P = 0.749)., Conclusion: G1-DES and G2-DES have similar efficacy and safety profiles in ACS patients at the 2-year follow-up., Competing Interests: There are no conflicts of interest

Objective: To investigate the actual dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) treatment in China., Background: Currently, less is known about actual DAPT duration after drug-eluting stent (DES) treatment in China. Here, we performed a study in the largest cardiovascular center in China to investigate DAPT duration and identify associated factors after DES implantation., Methods: A total of 9,919 consecutive patients with DES implantation from January 2013 to December 2013 were enrolled. DAPT cessation was observed, and factors associated with different DAPT durations were analyzed., Results: The median follow-up time was 882 days. The proportion of patients with DAPT coverage at 1-year of follow-up was 97.3%, and it decreased to 30.1% for 2 years. The distribution of DAPT duration was not significantly different among patients with acute myocardial infarction (AMI) versus non-AMI (P = 0.41) and with new-generation DES versus first-generation DES (P = 0.54). The multivariable analysis indicated some independent predictors prolonging DAPT duration, including target vessel revascularization (OR 2.50, 95% CI 2.04-3.06, P < 0.001), stent numbers (OR 1.10, 95% CI 1.05-1.15, P < 0.001), and previous coronary artery bypass grafting (OR 0.76, 95% CI 0.61-0.96, P = 0.02). Other clinical factors, such as the increased risk of bleeding and high ischemic risk, were not associated with DAPT duration., Conclusions: The 1-year DAPT after DES was applied to 97.3% of Chinese patients in the studied clinical center. However, the DAPT duration after 1 year was not adjusted according to the patients' bleeding situation and ischemic risks., (© 2018 Wiley Periodicals, Inc.)

Background: Lots of trials demonstrate that second-generation drug-eluting stents (G2-DES), with their improved properties, offer significantly superior efficacy and safety profiles compared to first generation DES (G1-DES) for patients with coronary artery disease (CAD) receiving percutaneous coronary intervention (PCI). This study aimed to verify the advantage of G2-DES over G1-DES in Chinese patients with stable CAD (SCAD)., Methods: For this retrospective observational analysis, 2709 SCAD patients with either G1-DES (n = 863) or G2-DES (n = 1846) were enrolled consecutively throughout 2013. Propensity score matching (PSM) was applied to control differing baseline factors. Two-year outcomes, including major adverse coronary events as well as individual events, including target vessel-related myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, and cardiogenic death were evaluated., Results: The incidence of revascularization between G1- and G2-DES showed a trend of significant difference with a threshold P - value (8.6% vs. 6.7%, χ2 = 2.995, P = 0.084). G2-DES significantly improved TLR-free survival compared to G1-DES (96.6% vs. 97.9%, P = 0.049) and revascularization-free survival curve showed a trend of improvement of G2-DES (92.0% vs. 93.8%, P = 0.082). These differences diminished after PSM. Multivariate Cox proportional hazard regression analysis showed a trend for G1-associated increase in revascularization (hazard ratio: 1.28, 95% confidence interval: 0.95-1.72, P = 0.099) while no significance was found after PSM. Other endpoints showed no significant differences after multivariate adjustment regardless of PSM., Conclusions: G1-DES showed the same safety as G2-DES in this large Chinese cohort of real-world patients. However, G2-DES improved TLR-free survival of SCAD patients 2 years after PCI. The advantage was influenced by baseline clinical factors. G1-DES was associated with a trend of increase in revascularization risk and was not an independent predictor of worse medium-term prognosis compared with G2-DES.

The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.

Background: Whether final kissing balloon (FKB) dilatation after one-stent implantation at left-main (LM) bifurcation site remains unclear. Therefore, this large sample and long-term follow-up study comparatively assessed the impact of FKB in patients with unprotected LM disease treated with one-stent strategy., Methods: Total 1528 consecutive patients underwent LM percutaneous coronary intervention in one center from January 2004 to December 2010 were enrolled; among them, 790 patients treated with one drug-eluting stent crossover LM to left anterior descending (LAD) with FKB (n = 230) or no FKB (n = 560) were comparatively analyzed. Primary outcome was the rate of major adverse cardiovascular events, defined as a composite of death, myocardial infarction (MI) and target vessel revascularization (TVR)., Results: Overall, The prevalence of true bifurcation lesions, which included Medina classification (1,1,1), (1,0,1), or (0,1,1), was similar between-groups (non-FKB: 37.0% vs. FKB: 39.6%, P = 0.49). At mean 4 years follow-up, rates of major adverse cardiovascular events (non-FKB: 10.0% vs. FKB: 7.8%, P = 0.33), death, MI and TVR were not significantly different between-groups. In multivariate propensity-matched regression analysis, FKB was not an independent predictor of adverse outcomes., Conclusions: For patients treated with one-stent crossover LM to LAD, clinical outcomes appear similar between FKB and non-FKB strategy.

Background: Studies have suggested that use of prolonged dual antiplatelet therapy (DAPT) following new generation drug-eluting stent implantation may increase costs and potential bleeding events. This study aimed to investigate the association of DAPT status with clinical safety in patients undergoing everolimus-eluting stent (EES) implantation in the SEEDS study (A Registry to Evaluate Safety and Effectiveness of Everolimus Drug-eluting Stent for Coronary Revascularization) at 2-year follow-up., Methods: The SEEDS study is a prospective, multicenter study, where patients (n = 1900) with small vessel, long lesion, or multi-vessel diseases underwent EES implantation. Detailed DAPT status was collected at baseline, 6-month, 1- and 2-year. DAPT interruption was defined as any interruption of aspirin and/or clopidogrel more than 14 days. The net adverse clinical events (NACE, a composite endpoint of all-cause death, all myocardial infarction (MI), stroke, definite/probable stent thrombosis (ST), and major bleeding (Bleeding Academic Research Consortium II-V)) were investigated according to the DAPT status at 2-year follow-up., Results: DAPT was used in 97.8% of patients at 6 months, 69.5% at 12 months and 35.4% at 2 years. It was observed that the incidence of NACE was low (8.1%) at 2 years follow-up, especially its components of all-cause death (0.9%), stroke (1.1%), and definite/probable ST (0.7%). DAPT was not an independent predictor of composite endpoint of all-cause death/MI/stroke (hazard ratio [HR]: 0.693, 95% confidence interval [CI]: 0.096-4.980, P = 0.715) and NACE (HR: 1.041, 95% CI: 0.145-7.454, P = 0.968). Of 73 patients who had DAPT interruption, no patient had ST at 12-month, and only 1 patient experienced ST between 1- and 2-year (1.4%). There was a high frequency of major bleeding events (53/65, 82.5%) occurred in patients receiving DAPT treatment., Conclusions: Prolonged DAPT use was not associated with improved clinical safety. The study emphasized that duration of DAPT needs to be shortened in Chinese patients following EES implantation (ClinicalTrials.gov identifier: NCT 01157455).

Aims: To compare stent strut coverage using optical coherence tomography (OCT) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent (SES) (BuMA) and a PLA-polymer SES (EXCEL)., Methods and Results: This prospective, single-centre, non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions, treated with either the BuMA or the EXCEL stent. The study primary endpoint was OCT-evaluated stent strut coverage at three months. Secondary endpoints were neointimal thickness of stent struts, and incomplete stent apposition evaluated with OCT. A total of 80 patients were randomly assigned to receive the BuMA (n=40) or the EXCEL (n=40) stent. In OCT follow-up (achieved in 86.3% of cases: BuMA, n=33; EXCEL, n=36), the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group (strut level: 94.2% vs. 90.0%, p<0.01; p(non-inferiority)<0.0001; p(superiority) <0.0001), while the proportion of malapposed struts (strut level: 1.28% vs. 1.80%, p=0.51) and the mean neointimal thickness (strut level: 0.07±0.03 mm vs. 0.06±0.02 mm, p=0.31) were similar. Rates of myocardial infarction (periprocedural non-Q-wave, 7.5% vs. 7.5%, p=1.00) and target lesion failure (7.5% vs. 7.5%, p=1.00) were similar between groups, with no cardiac death or stent thrombosis., Conclusions: In the BuMA-OCT randomised trial, the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up.

Aims: The SYNTAX score has been proposed as a valuable tool to characterise coronary anatomy prospectively based on its complexity. This study evaluated the prognostic value on adverse outcomes of the residual SYNTAX score (rSS) in patients with complex lesions treated with an everolimus-eluting stent (EES)., Methods and Results: One thousand eight hundred and fifty-one patients with small vessel (reference diameter <2.75 mm), long lesion (length >25 mm), or multivessel (>2 target vessels) disease who underwent percutaneous coronary intervention (PCI) with EES in the prospective SEEDS (A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization) trial were categorised into low (<6), mid (>6-<12) and high (>12) baseline SYNTAX score (bSS) groups, and into low (=0), mid (>0-<5) and high (>5) rSS groups. Mean bSS and rSS were 10.87±7.26 and 2.18±3.97, respectively; 64% of patients had complete revascularisation (rSS=0). At 12 months the primary outcome of ischaemia-driven target vessel failure (TVF, composite of cardiac death, target vessel myocardial infarction and ischaemia-driven target vessel revascularisation) was significantly higher in the high bSS and rSS groups than in the respective lower groups (p<0.01 for both). In multivariable analysis, rSS was an independent predictor of TVF (hazard ratio: 1.403, 95% confidence interval: 1.081 to 1.820, p=0.01)., Conclusions: Twelve-month TVF was significantly higher in the highest rSS group; rSS with a cut-off of 5 might therefore allow the risk stratification of patients with complex lesions treated with a second-generation drug-eluting stent (Clinical-Trials.gov identifier: NCT 01157455).

Background: Drug-eluting stents (DES) are currently the most popular treatment modality for restenosis in bare metal stents and DES. This study compares risks of adverse cardiovascular events between DES-treated in-stent restenosis (ISR) and de novo lesions, an area that has not been systematically studied thus far., Methods and Results: One thousand three hundred consecutive ISR patients were compared with 27,211 patients with de novo lesions who underwent DES treatment during the same period at the Fu Wai Hospital in Beijing. Angiographic success rate was similar between the ISR and de novo groups (98.0% vs. 98.2%; P = 0.61). Using logistic regression to derive the propensity score model, 1,266 matched patient pairs were compared. In this adjusted model, the rate of target lesion revascularization (TLR) was significantly higher in the ISR group (19.19% vs. 2.37%; P < 0.01) during an average 17-month follow-up, while rates of cardiac death and myocardial infarction (MI) were similar (0.71% vs. 0.79%; P = 0.93 and 3.48% vs. 1.26%; P = 0.13, respectively) between groups. In multivariate regression analysis, ISR was predictive of TLR, but not of cardiac death and MI., Conclusion: Compared with those with de novo lesions, patients with ISR had a higher revascularization rate after DES treatment but no significant difference in rates of cardiac death and MI., (© 2013, Wiley Periodicals, Inc.)

Background: A limited number of studies on the impact of complete revascularization (CR) vs. incomplete revascularization (IR) on long-term outcomes in patients with multivessel coronary disease (MVD) in current percutaneous coronary intervention (PCI) practice have yielded inconsistent results., Methods: Between April 2004 and November 2010, 7,376 consecutive patients with MVD underwent PCI at the Fuwai Hospital in Beijing, China. Patients who underwent prior CABG and those who had an acute myocardial infarction (MI) within 24 hr before revascularization or presented with cardiogenic shock were excluded. Angiographic CR was defined as successful angioplasty of all diseased lesions in the major epicardial coronary vessels and their first degree side branches (diameter ≥2.5 mm), and proximal CR was defined as successful angioplasty of all diseased proximal arteries., Results: Among 7,065 patients with MVD undergoing PCI treatment, angiographic CR was performed in 1,188 patients (16.8%), and proximal CR in 2,053 patients (29.1%). The study found that either angiographic or proximal IR were associated with significantly higher estimated 3-year rate of cardiac death (2.55% vs. 1.13%, log-rank P = 0.016; and 2.70% vs. 1.43%, log-rank P = 0.024, respectively). After adjustment for differences in baseline characteristics between IR and CR patients, angiographic IR was associated with a significantly higher rate of cardiac death (adjusted hazards ratio [HR]: 2.56, 95% confidence interval [CI]: 1.03-6.41) while proximal IR was associated with a numerically higher rate of cardiac death (adjusted HR: 1.72, 95% CI: 0.93-3.17). For the subgroup of ≥2-vessel IR with total occlusion, either angiographic or proximal IR patients had significantly higher rate of cardiac death (adjusted HR: 4.25, 95% CI: 1.50-12.09; and adjusted HR: 3.02, 95% CI: 1.40-6.52, respectively)., Conclusion: Compared with IR, patients with CR had better clinical outcomes, supporting CR as first choice for patients with MVD., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: Currently available evidence suggests that outcomes are less favorable when left main (LM) bifurcation lesions are treated with 2-stent techniques compared with a single-stent technique. We aimed to evaluate the long-term outcomes of the 2-stent techniques for treating unprotected LM bifurcation lesions in Chinese patients., Methods: We enrolled 301 consecutive patients treated with drug-eluting stents (DES) implantation using 2-stent techniques for unprotected LM bifurcation lesions (MEDINA 1, 1, 1, 70.5%). The 2-stent techniques included crush technique, V stenting, T stenting, and Culottes stenting. After stenting, both vessels were redilated at a high pressure before final kissing balloon (FKB). Clinical and angiographic data were analyzed. The primary endpoints were major adverse cardiac events (MACE), which included death, myocardial infarction, and target lesion revascularization., Results: Immediate procedural success was obtained in all cases with a FKB success rate of 95.3%. Follow-up data were available for all patients. The overall incidence of angiographic in-stent restenosis (ISR) rate was 20.3% and most ISRs were of the focal type. During long-term follow-up (mean duration, (54 ± 22) months), the cumulative incidence of MACE was 11.0%, with 8 (2.7%) deaths, 7 (2.3%) myocardial infarctions, and 18 (6.0%) repeated lesion revascularization. MACEs in high SYNTAX score terciles were significantly higher compared with those in low and intermediate SYNTAX score terciles (P = 0.001)., Conclusions: Although percutaneous coronary intervention (PCI) with 2-stent technique for unprotected LM bifurcation lesions was accompanied with a slightly high incidence of ISR, the long-term clinical follow-up is acceptable. Technical modifications and stent innovations may further improve both the angiographic and clinical outcomes for patients with LM bifurcation disease treated by PCI.

Objective: To investigate the outcomes of overlapping drug-eluting stenting (DES) in small and diffuse lesions., Background: Clinical outcomes of overlapping heterogeneous versus homogeneous DES of diffuse lesions (requiring ≥ 30 mm of length) in small coronary arteries (requiring ≤ 2.75 mm of diameter) are unknown., Methods: From January 2005 to December 2009, there were 99 patients with diffuse lesions in small coronary arteries receiving overlapping heterogeneous DES, and 558 patients receiving overlapping homogeneous DES at our institution. The clinical end-point of the study included in-hospital and 12-month major adverse cardiac events (death, nonfatal myocardial infarction, and target vessel revascularization (TVR)., Results: There were no statistically significant differences between overlapping heterogeneous and homogeneous DES groups in-hospital (2.0% vs. 1.4%, respectively; P = 0.66) and 12-month (9.1% vs. 9.3%, respectively; P = 0.94) major adverse cardiac events. After adjustment, no significant differences for major adverse cardiac events were noted, but the rate of nonfatal myocardial infarction was lower in overlapping homogeneous DES group (odds ratio: 4.20, P = 0.03)., Conclusion: In this analysis, there were no significant differences in major adverse cardiac events between the 2 types of overlapping DES for diffuse lesions in small coronary arteries, except for higher nonfatal myocardial infarction in overlapping heterogeneous DES., (© 2013, Wiley Periodicals, Inc.)

Objective: To assess the clinical outcomes of rotational atherectomy followed by drug-eluting stenting via the transradial approach for the treatment of heavily calcified coronary lesions., Methods: From January 2009 to October 2012, 114 consecutive patients with heavily calcified coronary lesions underwent rotational atherectomy and drug-eluting stents via transradial approach in our hospital were enrolled in this retrospective study. Characteristics of heavily calcified coronary lesions, the success rates of rotational atherectomy and stenting, rates of complication during perioperative treatments, and adverse cardiovascular events during hospitalization and follow up were analyzed., Results: All 114 patients were successfully treated with rotational atherectomy and drug-eluting stent placement, and totally 120 target lesions of type B or C were treated including 8 left main lesions, 93 left anterior descending and 2 circumflex, 17 right coronary lesions. No-reflow was observed in 7 patients during the procedure, there was one case of entrapped rotablator burr which was successfully retrieved together with guiding catheter without serious complication. During the 6 months (median) follow-up, angina was reported in 11 patients and revascularization was performed in 8 patients due to stent restenosis and intensified medical therapy was applied in 3 patients. There was no acute myocardial infarction and death during follow-up., Conclusion: Rotational atherectomy followed by drug-eluting stenting via transradial approach is feasible, effective and safe and the short-term outcome is satisfactory for patients with heavily calcified coronary lesions.

Aims: The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V., Methods and Results: A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups., Conclusions: In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).

Background: Previous 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., Methods: The 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., Results: Fifty 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., Conclusions: Treatment 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.

Background: Though drug-eluting stent (DES) almost solved a problem of restenosis, safety issues related to stent thrombosis are still the major concern of DES. We hypothesized that hybrid stent implantation may decrease the use of DES, probably improving the long-term safety but not affecting efficacy adversely when treating multilesion coronary artery disease in the DES era., Methods: From April 2004 to October 2006, 848 patients with multilesion disease underwent hybrid stent implantation. During the same period 5647 patients with multilesion coronary heart disease were treated by exclusive DES implantation in Fu Wai Hospital. According to propensity score matching, we chose 823 pairs of patients with multileison coronary artery disease for inclusion into our study. We obtained the 24-month clinical outcome including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We used Cox's proportional-hazard models to assess relative risks of all the outcome measures after propensity match., Results: At 24 months, patients in the hybrid stent implantation group showed a significantly higher risk of TLR (8.39% vs. 3.28%, HR 2.38, 95%CI: 1.50 - 3.70), TVR (11.07% vs. 6.32%, HR 1.61, 95%CI: 1.15 - 2.27) and MACE (13.75% vs. 8.75%, HR 1.37, 95%CI: 1.02 - 1.85). No significant difference was apparent in terms of mortality (1.22% vs. 1.70%, HR 0.55, 95%CI: 0.24 - 1.25), MI (1.95% vs. 2.31%, HR 0.73, 95%CI: 0.37 - 1.42), or thrombosis (definite + probable) (0.73% vs. 1.58%, HR 0.40, 95%CI: 0.15 - 1.05)., Conclusions: In patients with multilesion coronary artery disease, the exclusive DES implantation was associated with significantly lower risks of TLR, TVR and MACE, and the hybrid stent implantation did not result in any significant improvements regarding safety issues. Prospective studies are needed to confirm our results.

Background: Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown., Methods: In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed., Results: At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P = 1.000) and myocardial infarction (2.8% vs. 1.2%, P = 0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs. 10.7%, P = 0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P = 0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P = 0.475). Multivariate analysis showed that DES restenosis (OR = 1.907, 95%CI 1.108 - 3.285, P = 0.020) and smoking (OR = 2.069; 95%CI 1.188 - 3.605; P = 0.010) were independent predictors of MACE., Conclusions: Although SES implantation appears to be safe and effective, it was associated with higher TLR recurrence for DES than BMS restenosis.

Objective: To investigate the neointimal coverage at the very early phase after drug-eluting stent (DES) implantation using optical coherence tomography (OCT)., Methods: OCT examination was performed immediately after stent deployment and about one week post stenting in 12 patients with coronary artery disease to detect neointimal coverage and stent thrombus. Sirolimus eluting stent implantation was also performed in 5 healthy Chinese minipigs, OCT and histopathology examination were made one week later in these minipigs., Results: (1) Twenty-nine DES were implanted in 12 patients. There was no major cardiovascular event post stenting. The mean time of follow-up was (7.7 ± 2.6) d, the mean percentage of stent coverage was (21.8 ± 17.7)%, and neointimal hyperplasia thickness was (42.9 ± 32.2) µm and the percentage of malapposition struts was (1.5 ± 3.0)%, respectively. Mural stent thrombus was found in 2 of the 12 patients (the percentage is 16.7%). (2) In the minipigs model, OCT evidenced that (43.2 ± 11.5)% struts were covered by neointima with a mean neointimal hyperplasia thickness of (24.0 ± 8.5) µm at one week. Histopathology examination illustrated that the neointima was mainly consisted of proteoglycan, inflammation cells, fibrin and organized thrombus at the very early phase after DES implantation, while endothelial cells were barely found on the neointima., Conclusions: Neointimal coverage is found as early as one week after DES implantation by OCT. The covered struts rate is very low and the main components of neointima are proteoglycan, inflammation cells, fibrin and organized thrombus. Re-endothelialization is rather poor at the very early phase post DES implantation.

Very late stent thrombosis is a life-threatening complication of implantation of drug-eluting stent (DES). The mechanisms are still unidentified. Stent malapposition is supposed to be one debated reason. Here we report a case of 33 months after DES implanted. Observed by optical coherence tomography, we detected a lipid-rich plaque with defective fibrous cap within the neointima and many local aneurysmal dilatations between stent struts, which mimic “malapposition” on the angiogram. These indicated that vulnerable plaque hidden in the neointima at the stent segment might be a potential mechanism of very late stent thrombosis after DES implantation.

Background: Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove., Methods: A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses < 30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up., Results: Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13 ± 0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization., Conclusions: The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.

Background: Delayed vessel healing after drug-eluting stent implantation is thought to be the underlying mechanisms of late stent thrombosis (LST)., Methods and Results: In the animal model of stenting, 45 minipigs were divided into 3 groups (n=15 each): bare metal stent (BMS), sirolimus-eluting stent (SES), and SES plus atorvastatin treatment (SES+ator). Neointimal coverage and endothelium coverage were evaluated separately by optical coherence tomography (OCT), pathology, and scanning electron microscopy (SEM) at days 7, 14 and 28. OCT showed that SES significantly delayed neointimal coverage compared with BMS and the percentage of uncovered struts in the SES+ator group was significantly decreased on days 7 (42.7±1.3% vs. 56.8±5.7%, P<0.01) and 14 (24.8±4.3% vs. 45.3±2.8%, P<0.01) compared with the SES group. However, re-endothelialization was even more seriously delayed than neointima formation after SES deployment (P<0.05). Pathology and SEM revealed improved re-endothelialization of the neointima with atorvastatin therapy in terms of more struts covered by endothelium, less platelet adhesion, and higher endothelial nitric oxide synthase expression of the endothelial cells in the SES+ator group. Flow cytometry illustrated that the SES+ator group had more mobilized endothelial progenitor cells (EPCs) compared with the SES group at day 7 (0.21±0.02% vs. 0.11±0.03%, P=0.022)., Conclusions: Atorvastatin pretreatment can accelerate both neointimal coverage and re-endothelialization after SES implantation, which may be mediated by the mobilization of EPC and enhancement of the endothelial function of the neointima.

Background: Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available., Methods: From April 2004 to October 2006, 3979 consecutive patients who underwent successful SES (FIREBIRD 2274; CYPHER 1705) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. Follow-up data, including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), TVR, and major adverse cardiac events (MACE, the composite of death, MI, and TVR) were obtained at 24 months. Cox's proportional-hazards models were used to assess relative risks of all the outcome measures between the two groups before and after propensity match., Results: Unadjusted clinical outcomes demonstrated higher TVR (hazard ratio (HR) 1.78, 95%CI 1.26 - 2.50) and MACE (HR 1.40, 95%CI 1.08 - 1.82) for patients treated with FIREBIRD SES. After propensity match, the results showed a non-significant trend towards superiority of the CYPHER stent in all the analyzed parameters, however, no significant differences were found for all events at 24 months between FIREBIRD and CYPHER groups, and all thrombosis rates by Academic Research Consortium (ARC) definition were comparable between the two groups., Conclusions: In this large, real-world population, the use of domestic FIREBIRD SES in China was associated with nearly the same safety and efficacy versus the imported CYPHER SES. FIREBIRD SES can be taken as an alternative for CYPHER SES in daily practice.

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.

Background: The introduction of drug-eluting stents (DES) dramatically changed the practice of percutaneous coronary intervention (PCI) in the 2000s. Little is known about trends in in-hospital outcome after PCI in the DES era., Hypothesis: The in-hospital outcomes after PCI might be continuously improved over time., Methods: We analyzed in-hospital outcomes of 21,667 patients who underwent PCI at Fu Wai Hospital in the past 5 years. The patients were divided into 5 groups according to the time of their intervention: group 1 (June 2004 to May 2005), group 2 (June 2005 to May 2006), group 3 (June 2006 to May 2007), group 4 (June 2007 to May 2008), and group 5 (June 2008 to May 2009)., Results: Procedural success rates for the 5 groups were 93.6%, 95%, 94.4%, 94.2%, and 94.3%, respectively (P = 0.39). Significant reduction in in-hospital major adverse cardiac events (3.1%, 3.4%, 2.8%, 1.6%, and 1.0%, P < 0.001) and need for target-vessel revascularization (2.0%, 2.2%, 1.5%, 0.4%, and 0.2%, P < 0.001) was noted over time, which was associated with a significant increase in use of DES (from 56.6% to 97.0%, P < 0.001). On multivariate analysis, use of DES, dissection during procedure, left main lesion, prior myocardial infarction, and age > or = 65 years were independent predictors of major adverse cardiovascular events., Conclusions: There were substantial reductions in in-hospital major adverse cardiac events and target-vessel revascularization over the past 5 years. This reduction was associated with the concurrent increased use of DES.

Background: Late stent thrombosis (LST) is still concerned by interventional cardiologists in daily clinical practice. This study aimed to compare the incidence of LST after implantation of different drug-eluting stents (DES) in coronary heart disease (CHD) patients in the real world., Methods: From December 2001 to February 2009, a total of 11 875 consecutive CHD patients undergone DES implantation were enrolled in this single-center registry study. Patients with acute ST-segment elevation myocardial infarction, mixed DES implantation, restenosis lesions, and patients who could not take dual antiplatelet medication and those who were contraindicated for coronary interventional treatment were excluded. All patients were treated with completed dual antiplatelet medications for at least 9 months after DES deployment. The follow-up was completed by outpatient visits, letter correspondence, phone calls and coronary angiography. Definite LST was diagnosed according to the Academic Research Consortium (ARC) definition., Results: Cypher or Cypher Select stents were implanted in 4104 cases, Taxus or Taxus Liberty stents in 2271 cases and Firebird stents (Chinese rapamycin-eluting stents) in 5500 cases. One-year follow-up was completed in 9693 patients, including 3346 cases with Cypher or Cypher Select stents, 1529 cases with Taxus or Taxus Liberty stents and 4818 cases with Firebird stents. Two- and three-year follow-up results were obtained in 7133 and 4353 patients, respectively, including 2410 and 1760 cases with Cypher or Cypher Select stents, 1285 and 900 cases with Taxus or Taxus Liberty stents as well as 3438 and 1693 cases with Firebird stents. One-year follow-up results showed that the incidence of LST was 1.08% in patients with Cypher or Cypher Select stents, 1.24% in those with Taxus or Taxus Liberty stents and 0.71% in those with Firebird stents; there was no significant difference between those with Cypher or Cypher Select and Firebird stents, but there was significant difference between those with Taxus or Taxus Liberty and Firebird stents (P = 0.044). The incidence of LST at the 2- and 3-year follow-up was 1.33% and 1.70% in those with Cypher or Cypher Select stents, 1.40% and 1.70% in those with Taxus or Taxus Liberty stents, and 0.83% and 0.95% in those with Firebird stents, respectively. There were no significant differences among the three groups., Conclusions: This study indicates that first-generation DES are acceptable to treat complex coronary lesions, and there is no significant difference of LST for three different DES.

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 population 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 (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, 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 (HR 0.38, 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.

Background: Calcified coronary lesions have commonly been considered as a challenge for interventional cardiologists, and few previous studies of sirolimus-eluting stent (SES) for calcified lesion have been limited by small sample size. Therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified lesions in a large Chinese cohort of real world practice., Methods: A total of 956 consecutive patients who successfully received SES placement were enrolled in this study, and were divided into the two groups according to whether the mild-moderate calcified lesion treated with SES exists or not: noncalcified group (n = 637) and calcified group (n = 319). Lesions treated with SES were subjected to quantitative coronary angiography immediately and 8 months after stenting., Results: Baseline characteristics including clinical, demographic or angiographic data were well balanced between the noncalcified and calcified groups. In the angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were similar in both the groups (in-stent restenosis: 3.8 vs. 4.0%, P>0.05; in-segment restenosis: 8.5 vs. 9.7%, P>0.05). The target lesion revascularization was not different between the two groups (5.2 vs. 6.8%; P>0.05). In addition, the in-stent late loss and overall thrombosis rate were also similar in both the groups (0.17+/-0.41 vs. 0.18+/-0.35 mm and 1.8 vs. 1.8%, P>0.05, respectively)., Conclusion: Although stenting of the calcified lesion was hard, successful treatment with SES for mild-moderate calcified lesions was conferred to similar favorable results compared with noncalcified lesions in patients with coronary artery disease.

Objective: The aim of this study was to assess the long-term clinical outcome of patients with diabetes mellitus and chronic total occlusion (CTO) underwent drug-eluting stents (DES) implantation., Methods: Data of 143 consecutive eligible patients from January, 2006 to May, 2007 were retrospectively analyzed. The endpoint of the study was the major adverse cardiac events (MACE), including death, myocardial infarction, target lesion revascularization. The patients were divided into two groups, event group and non-event group, according to the result of follow-up., Results: Long-term follow-up was finished in 139 (97.2%) patients. Mean follow-up duration was (19.8 + or - 5.1) months. MACE rate was 10.5% during follow-up: 3 deaths, 1 myocardial infarction and 11 repeated target lesion revascularization with PCI. Compared with the non-event group, the percentage of residual lesion [(17.7 + or - 1.8)% vs. (15.4 + or - 5.0)%, P = 0.001] was significantly higher in the event group, however, the final minimal luminal diameter [(2.14 + or - 0.22)% vs. (2.89 + or - 0.37)%, P = 0.004] was lower. Cox regression analysis showed that final luminal diameter (OR: 0.097, 95%CI: 0.013 - 0.694, P = 0.020) was the only dependent predictor at follow-up., Conclusion: Final minimal luminal diameter is an independent predictor of MACE during follow-up for patients with diabetes and CTO underwent DES implantation.

Background: In response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population., Methods: All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent (BMS) in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors., Results: Overall, there were 1465 patients (20.2%) who had undergone an implantation of only BMS, and 5769 patients (79.8%) of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis (definite and probable) of the two groups (1.06% vs 1.21%, P = 0.8580). Although rates of mortality and myocardial infarction (MI) during the 2-year follow-up period had not differed significantly, rates of death/MI (3.0% vs 4.5%, P = 0.0263), target-lesion revascularization (TLR, 3.2% vs 8.5, P = 0.0001), target-vessel revascularization (TVR, 5.8% vs 9.5%, P < 0.0001) and any revascularization (10.0% vs 13.3%, P = 0.0066) were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group., Conclusions: During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.

Background: Drug-eluting stents (DES) are superior to bare metal stents (BMS) for treating ostial left anterior descending artery (LAD) lesions, but DES is not suitable for all patients in real life practice., Hypothesis: We hypothesize that cutting balloon angioplasty (CBA) followed by BMS (CBA + BMS) for treating ostial LAD lesions is an alternative strategy., Methods: In our study, 101 consecutive patients (51 with DES and 50 with CBA + BMS) with ostial LAD stenting were included for retrospective investigation between November 2003 and May 2005. The target vessel diameter was > or =3.0 mm., Results: We compared the DES group with the CBA + BMS group, the rates of restenosis (10.3% versus 17.9%, p = 0.386), target lesion revascularization (TLR) (5.88% versus 10%, p = 0.487) and major adverse cardiac events (MACE) (7.84% versus 12%, p = 0.525) were similar at 6-8 months angiographic follow-up, but there were higher bleeding events in the DES group (p = 0.033). During a 2-year clinical follow-up, no myocardial infarction occurred in the 2 groups, the rates of TLR (7.84% versus 10%, p = 0.741) and MACE (9.8% versus 12%, p = 0.723) were also similar. The MACE-free survival rate was 90.2% versus 88 % (p = 0.723)., Conclusions: The CBA + BMS combination has a good long-term clinical effect in the treatment of ostial LAD lesions; it might be an alternative strategy for patients with contraindication for DES implantation, or patients who cannot endure long-term dual antiplatelet medication, or in elderly patients.

Background: ST-elevated acute myocardial infarction (STEAMI) happening in the first month post percutaneous coronary intervention (PCI) is almost related to acute thrombosis or subacute thrombosis in-stents. This study aimed to investigate the possible causes of myocardial infarction one month later., Methods: Patients who had a history of successful PCI, and received coronary angiography or re-PCI due to STEAMI 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 acute results of last PCI were recorded. If the AMI-related lesion was localized in-stents or at the edge of stents (distance apart from the edge < or = 5 mm), it was defined to be late thrombosis; otherwise as a new-lesion induced AMI., Results: One hundred and ninety-two patients aged 40 - 79 years were included in this study. New lesions, as the cause of STEAMI, were found in 144 patients (Group A, 75%), and late thrombosis in 48 patients (Group B, 25%). Almost all newly built thromboses were found at the sites of previous insignificant lesions (diameter stenosis < 50%). 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 stent (DES) utilization were associated with markedly higher morbidity of late thrombosis in adjusted Logistic regression (hazard ratio (HR) 3.4, 95% confidence interval (CI) 1.1 - 10.9 and 5.3, 95% CI 1.1 - 26.5)., Conclusions: STEAMIs happening 1 month after PCI are more likely to develop from previous insignificant lesion rupture than from late thrombosis in-stents. Moreover, DM and DES are associated with the high incidence of late thrombosis, which may indicate that intensive antiplatelet therapy should be considered in patients with diabetes.

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% CI 0.50-1.43), whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% (HR 0.74, 95% CI 0.30-0.85), 1.8% vs 1.3% (HR 1.41, 95% CI 0.45-4.43) and 2.5% vs 4.0% (HR 0.62, 95% CI 0.28-0.37), 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.

Background: Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention (PCI). Available information on the efficacy and safety of DES and bare metal stent (BMS) in diabetic patients remains scarce., Methods: From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data: death, myocardial infarction (MI), thrombus, target lesion revascularization (TLR), and target vessel revascularization (TVR) at 30 days and 12 and 24 months, as defined by the Academic Research Consortium (ARC). We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox's proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months., Results: At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group (0.08% vs 0.81%, P = 0.016). Patients treated with DES showed a significant lower risk of TLR (3.88% vs 10.89%; hazard ratio (HR) 0.159 (95% CI: 0.151-0.444), P < 0.001), TVR (5.48% vs 11.69%; HR 0.383 (95% CI: 0.232-0.633), P < 0.001), and any revascularization (12.47% vs 18.55%; HR 0.555 (95% CI: 0.370-0.831), P = 0.0004) at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI., Conclusions: In contemporary society's large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There is no significant difference in all-cause mortality, MI, and thrombosis between DES and BMS in the patients with diabetes at 24-month follow-up.

Objective: To compare the long-term effect of three different drug-eluting stents (DES) for in-stent restenotic lesions., Methods: From April 2004 to June 2006, 390 consecutive patients undergoing DES implantation including 187 Cypher (group C), 89 Taxus (group T) and 114 Firebird (group F) with resulting in-stent restenotic lesions were studied. A mean of 2 year clinical and 7-month angiographic follow-up was carried out., Results: Baseline characteristics indicated that there were more unstable angina cases in T group and less left main disease and more triple vessel disease cases in F group. A mean of 2-year follow-up results showed no difference of major adverse cardiac events (MACE) rate among the three groups (23.0% vs 22.5% vs 13.2%, P = 0.081) and no difference of cardiac death, non-fatal myocardial infarction (MI) and target vessel revascularization rate (1.1% vs 4.5% vs 1.8%, P = 0.210, 5.9% vs 2.2% vs 2.6%, P = 0.226 and 2.9% vs 2.2% vs 0.9%, P = 0.509). There was no difference of total stent thrombosis or its components among the three groups (total: 4.8% vs 3.4% vs 2.6%, P = 0.605, early: 0.5% vs 0 vs 0.9%, P = 0.560, late: 1.6% vs 1.1% vs 0.9%, P = 0.849 and very late: 2.9% vs 2.2% vs 0.9%, P = 0.509) according to Academic Research Consortium (ARC) standard definitions (definite + probable). 7-month angiographic follow-up indicated that there was a lower trend of both in-stent and in-segment restenosis rate in C and F groups (17.9% vs 29.4% vs 13.6%, P = 0.214 and 21.8% vs 35.3% vs 15.9%, P = 0.132)and in-stent and in-segment late loss was significantly smaller in C and F groups [(0.31 +/- 0.12) mm vs (0.75 +/- 0.24) mm vs (0.31 +/- 0.13) mm, P = 0.000 and (0.33 +/- 0.18) mm vs (0.61 +/- 0.23) mm vs (0.31 +/- 0.14) mm, P = 0.001]., Results: from this 2-year follow-up, single-center study showed comparable effectiveness and safety of Cypher, Taxus and Firebird DES for in-stent restenotic lesions, but Cypher and Firebird had better effect in reducing restenosis.

Background: Systemic inflammation after percutaneous coronary intervention (PCI) identifies patients at increased risk of subsequent major adverse cardiac event. During PCI, the technique of stent implantation including direct stenting (DS) and complementary stenting (CS) is guided using both clinical and angiographic features. DS was practiced with increased frequency during PCI in an attempt to reduce both restenosis and major adverse cardiac event in the drug-eluting stent (DES) era. Impact of DS on the early inflammatory response has, however, not been investigated. We hypothesized that a direct DES implantation may attenuate the early inflammatory response compared with CS., Purpose: In this study, therefore, we prospectively select the sirolimus-eluting stent (SES) as a model of DESs, and sought to determine the early systemic inflammatory response in patients with single-vessel disease after PCI using either DS or CS techniques., Methods: Thirty-nine patients who had single-vessel disease implanted with SES were randomly enrolled into the two groups: DS group (n=20) or CS group (n=19). The blood samples were taken before PCI, 24 and 72 h after stenting. The plasma concentrations of C-reactive protein and interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay., Results: No significant difference in baseline clinical, angiographic, and inflammatory parameters between the two groups is observed. The plasma IL-6 levels at 24 h after stent implantation were significantly higher than that at baseline in both groups (P<0.05, respectively). Plasma IL-6 level was, however, higher in CS group than in DS group (P<0.01) and was returned to baseline levels in both groups at 72 h after stenting. Meanwhile, the plasma levels of C-reactive protein were also significant higher in CS group compared with DS group at both 24 and 72 h after stenting (P<0.05, respectively)., Conclusion: Taken together, our findings demonstrated that a direct SES implantation significantly attenuated the early systemic inflammatory response in patients with single-vessel disease compared with CS technique.

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.

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.

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.

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.

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.

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.

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.

Background: Recently, several randomized and controlled trials have demonstrated great advantages of a drug-eluting stent (DES) with respect to significant reduction in restenosis and recurrence of symptoms, and improvement in clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects of the 1-DES plus the kissing balloon technique with the 2-DES for bifurcation angioplasty in a Chinese population., Methods: From April 2004 to June 2006, 566 consecutive Chinese patients underwent DES implantation for true bifurcation lesions, including 346 1-DES with the kissing balloon technique (300 male, 57.7 +/- 11.5 y old) and 220 2-DES (183 male, 58.1 +/- 10.7 y old) were analyzed. Clinical and angiographic follow-up was performed after 7 mo., Results: The major adverse cardiac event (MACE) rates were higher in the 2-DES group than in the 1-DES group (5.5% versus 2.0%; p = 0.032), which was mainly contributed to by acute myocardial infarction (AMI) (4.5% versus 1.4%; p = 0.032), rather than death and target lesion revascularization (TLR) (0% versus 0.5%; p = 0.389, 1.4% versus 2.7%; p = 0.352). Stent thrombosis rates were higher in the 2-DES group than in the 1-DES group (0.6% versus 2.7%; p = 0.042), except for 1 late-stent thrombosis in the 2-DES group, and all of them were subacute stent thrombosis (2 in the 1-DES group and 5 in the 2-DES group). The 7 mo angiographic follow-up rate was 36.4%. In the main branch there was no difference in restenosis rate in the 1-DES group compared with the 2-DES group (9.8% versus 11.9%; p = 0.652), but in the side branch the restenosis rate was higher in the 1-DES group (33.6% versus 15.5%; p = 0.004). However, there was no difference in in-segment late loss between the 2 groups, either in the main or side branch., Conclusion: Compared with the 2-DES strategy, if a final kissing balloon could be achieved, the 1-DES strategy may be more efficient and safe., (Copyright (c) 2008 Wiley Periodicals, Inc.)

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.

Background: With the advent of drug-eluting stents (DES) and much lower rates of target vessel revascularization (TVR), whether adjunctive balloon postdilatation can further optimize outcome is still unknown. The present study was to compare the outcomes of postdilatation with un-postdilatation following deployment of DES., Methods: From April 2004 to September 2006, 6479 consecutive Chinese patients who underwent DES implantation, including 1769 with postdilatation (1454 male, (57.9+/-10.8) years old) and 4710 without postdilatation (3819 male, (57.9+/-10.6) years old) were analyzed. Clinical and angiographic follow-up was performed at 7 months., Results: Compared with the un-postdilatation group, the postdilatation group had more complex lesions and larger relevant vessel diameter (RVD). In the postdilatation group, in-stent residual restenosis was significantly improved right after the procedure ((16.80+/-5.88)% vs (19.60+/-6.07)%; P=0.000). There was no statistical difference in the major adverse cardiac events (MACE) rate between the groups (2.9% vs 3.3%; P=0.420), and there were also no statistical differences in death, acute myocardial infarction (AMI) and target lesion revascularization (TLR) rates in the two groups (0.1% vs 0.4%, P=0.127; 1.7% vs 1.3%, P=0.229; and 1.5% vs 2.0%, P=0.206, respectively). The in-stent thrombosis rate was almost the same in both groups (0.5% vs 0.5%; P=1.000). Seven months angiographic follow-up results showed that both in-stent and in-segment restenosis rates were lower in the postdilatation group (8.8% vs 15.6%, P=0.000; and 10.5% vs 17.3%, P=0.000), and so were in-stent and in-segment late loss ((0.32+/-0.12) mm vs (0.49+/-0.13) mm, P=0.000; and (0.24+/-0.08) mm vs (0.36+/-0.09) mm, P=0.001)., Conclusion: Postdilatation after DES deployment was safe and could reduce the restenosis rate, especially for more complex lesions.

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.

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.