Rationale and study design for one-stop assessment of renal artery stenosis and renal microvascular perfusion with contrast-enhanced ultrasound for patients with suspected renovascular hypertension / 中华医学杂志(英文版)

BACKGROUND@#Renal artery stenosis (RAS) is always associated with abnormalities in renal microvascular perfusion (RMP). However, few imaging methods can simultaneously evaluate the degree of luminal stenosis and RMP. Thus, this study will aim to evaluate the feasibility of using contrast-enhanced ultrasound (CEUS) for assessing both RAS and RMP to achieve a one-stop assessment of patients with suspected renovascular hypertension.@*METHODS@#This will be a single-center diagnostic study with a sample size of 440. Patients with chronic kidney disease (CKD) and suspected of having resistant hypertension will be eligible. Patients with Stages 1-3 CKD will undergo CEUS and computed tomography (CT) angiography (CTA). Values obtained by CEUS and CTA for diagnosing low-grade (lumen reduced by <60%) and high-grade (lumen reduced by ≥60%) RAS will be compared. Moreover, all patients will also undergo radionuclide imaging. The diagnostic value for RAS will be assessed by the receiver operating characteristic curve, including the accuracy, sensitivity, specificity, positive predictive values, negative predictive values, and area under the ROC. Pearson correlation analysis will be performed to assess the association between CEUS findings for RMP and glomerular filtration rate measured by a radionuclide imaging method.@*CONCLUSION@#The data gathered from this study will be used to evaluate the feasibility of expanding clinical applications of CEUS for evaluation of patients with suspected renovascular hypertension.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry, ChiCTR1800016252; https://www.chictr.org.cn.

Increased plasma C-reactive protein level predicts rapid progression of non-target atherosclerotic lesions in patients with stable angina after stenting / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Although the role of C-reactive protein (CRP) in predicting rapid progression of atherosclerotic lesions has been intensively studied in unstable coronary artery disease, the data from patients with stable angina (SA) are largely absent. The present study evaluated a middle-size patient cohort who underwent percutaneous coronary intervention (PCI) with stent implantation and follow-up coronary angiography (CAG) and tested the hypothesis that increased plasma level of high-sensitive CRP would indicate rapid progression of de novo non-target coronary artery lesions in Chinese patients with SA.</p><p><b>METHODS</b>The study population comprised of 311 consecutive patients with chronic SA who underwent coronary stent implantation on initial admission and angiographic follow-up ((8.5 ± 1.2) months). Rapid angiographic progression of non-target lesion was angiographically assessed and the patients were classified into two groups according to whether the progression existed or not. The relation of plasma CRP levels to the progression of atherosclerosis was investigated.</p><p><b>RESULTS</b>Baseline demographic, clinical, and angiographic data were similar in patients with and without progression. Rapid angiographic progression of non-target lesions occurred in 136 patients (43.7%) at follow-up: 77 had a ≥ 10% diameter reduction of pre-existing stenosis ≥ 50%, 26 had a ≥ 30% diameter reduction of a pre-existing stenosis < 50%, 64 developed a new lesion ≥ 30% in a previously normal segment, and 4 had progression of a lesion to total occlusion. Progression of non-target lesions was not associated with target lesion restenosis formation. High-sensitive CRP levels were markedly higher in progression patients than in non-progression ones (1.60 (0.80 - 3.46) mg/L vs. 0.96 (0.55 - 1.87) mg/L, P < 0.001). Multivariate regression analysis showed that plasma CRP independently predicted rapid angiographic progression of non-target lesions (P = 0.001). High-sensitive CRP levels above 1.32 mg/L (the cutoff value) were associated with a 3.5-fold increase in the risk of developing rapid atherosclerotic progression (OR = 3.497, 95%CI 2.045 - 5.980).</p><p><b>CONCLUSION</b>The data confirmed and extended previous studies that plasma CRP might independently predict non-target lesion progression in patients with SA after stent implantation.</p>

The in-hospital outcome and predictors of major adverse cardiac events after transradial intervention in patients with coronary artery disease / 中华心血管病杂志

<p><b>OBJECTIVE</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSIONS</b>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.</p>

Role of plasma C-reactive protein in predicting in-stent restenosis in patients with stable angina after coronary stenting / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The role of plasma high sensitivity C-reactive protein (hs-CRP) in in-stent restenosis (ISR) remains controversial. We investigated plasma hs-CRP level at both admission and follow-up in patients with stable angina (SA) after successful coronary stenting in order to clarify the predictive value of hs-CRP for ISR.</p><p><b>METHODS</b>We summarized 303 consecutive chronic SA patients with coronary drug-eluting stent (DES) implantation. The ISR was analyzed by quantitative coronary analysis (QCA) at a mean follow-up of 8 months, and the patients were divided into two groups according to the detected ISR as ISR group (n = 48) and non-ISR group (n = 255). Plasma hs-CRP was examined at both admission and 8-month follow-up in all patients, standard medication continued throughout the investigation period.</p><p><b>RESULTS</b>QCA presented that 48 patients (15.8%) suffered from ISR at follow-up. The basic clinical characteristics were similar between the two groups, while plasma hs-CRP was higher in ISR group than that in non-ISR group at both admission and follow-up, P < 0.001 respectively. Multivariate regression analysis indicated that plasma hs-CRP level at either admission or follow-up could independently predict ISR occurrence (OR = 5.581, 95%CI 2.532-12.302, P < 0.001 and OR = 6.299, 95%CI 2.722-14.577, P < 0.001, respectively).</p><p><b>CONCLUSIONS</b>Our data indicate that plasma hs-CRP level may independently predict ISR at both admission and follow-up in SA patients with coronary DES implantation, which implies that a chronic, sustained systemic inflammatory response might be involved in ISR pathogenesis.</p>

Clinical characteristics and outcome comparison between young (< or = 45 years) female and male patients with coronary artery disease undergoing percutaneous coronary intervention / 中华心血管病杂志

<p><b>OBJECTIVE</b>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).</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>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.</p>

Long-term clinical outcomes after bioabsorbable polymer- and durable polymer-based sirolimus-eluting stents implantation: two-year follow-up results from a large single-center database / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSIONS</b>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.</p>

Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation: results from a large single-center database / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>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.</p>

Angiographic prevalence of myocardial bridging in a defined very large number of Chinese patients with chest pain / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSIONS</b>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.</p>

Effects of sirolimus-eluting stent on calcified coronary lesions / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>

Clinical and angiographic outcome in coronary artery disease patients with type-II diabetes mellitus undergoing elective bare-metal stenting or drug-eluting stenting / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the clinical and angiographic outcome in patients with type-II diabetes mellitus undergoing drug-eluting stent (DES) or bare-metal stent (BMS).</p><p><b>METHODS</b>A total of 139 consecutive diabetic patients (114 males) with coronary disease who underwent successful elective percutaneous coronary intervention with DES (n = 83 with 151 lesions) or BMS (n = 56 with 70 lesions) on native coronary arteries from April 2004 to August 2005 at our institution were included in this study. All patients were treated according to guidelines and coronary angiography was repeated at 6 months post procedure in all patients. Aspirin (300 mg/d) and clopidogrel (75 mg/d) were administered till 6 months after the procedure.</p><p><b>RESULTS</b>There were 42.5% C type by ACC/AHA and 19.0% total occlusion lesions. The average stent length of each lesion was 26.53 +/- 14.72 mm, and mean reference diameter was 2.80 +/- 0.43 mm. Baseline characteristics were similar between DES and BMS groups except lower mean reference vessel diameter in DES than that of BMS group (2.71 +/- 0.41 mm vs. 2.98 +/- 0.53 mm, P < 0.001). The in stent restenosis rate at 6 months (10.6% vs. 38.6%, P < 0.001) and in-segment late loss (0.24 +/- 0.56 mm vs. 0.91 +/- 0.77 mm, P < 0.001) were significantly lower in DES group than those of BMS group. The target lesion revascularization (TLR) incidence was also significantly lower in DES group compared to BMS group (8.6% vs. 30.0%, P < 0.001). However, 4 late in-stent thrombosis were seen in DES group and none in BMS group of DES (P = 0.148).</p><p><b>CONCLUSION</b>DES implantation in patients with diabetes mellitus is associated with lower in-stent restenosis and TLR rates compared to BMS implantation 6 months after procedure and attention should be paid on late in-stent thrombosis after DES implantation.</p>

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease / 中华医学杂志(英文版)

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

Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent / 中华医学杂志(英文版)

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

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a "real world" setting: six-month follow-up results / 中华医学杂志(英文版)

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

Comparison of short- and mid-term outcomes between CYPHER and TAXUS stents in patients with complex lesions of the coronary arteries / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Drug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with complex lesion.</p><p><b>METHODS</b>This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were in CYPHER group, and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.</p><p><b>RESULTS</b>Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group (P < 0.05).</p><p><b>CONCLUSIONS</b>CYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.</p>

A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Stents are widely used in China but the clinical impression is somehow that restenosis is less common because of the lower prevalence of coronary artery disease (CAD) and associated risk factors in Chinese populations. However, no large-sample published studies are available on angiographic stent restenosis including those of bare-metal stent (BMS) or drug-eluting stent (DES) in Chinese Han ethnic population.</p><p><b>METHODS</b>A total of 1633 consecutive patients with CAD who had undergone coronary stenting, quantitative coronary angiography (QCA) were retrospectively studied. At the time of stent implantation and at 7 months post-stenting 675 patients had a follow-up angiography. Statistical analysis was made with the chi-square test for categorical variables, unpaired t test for continuous variables, univariate or multivariate regression for baseline and angiographic characteristics and the Kaplan-Meier method for rate of target lesion revascularization (TLR).</p><p><b>RESULTS</b>Stent restenosis was defined as > or = 50% diameter stenosis in the dilated segment. A total of 675 patients with 1074 lesions were subjected to angiographic follow-up for 7 months on average. Of these lesions, 448 were implanted with BMS whereas 626 lesions with DES. At 7 months, bare-metal in-stent restenosis occurred in 148 lesions (33.0%), and bare metal in-segment restenosis in 155 lesions (34.6%) in contrast to drug-eluting in-stent restenosis in 48 lesions (7.7%) and drug-eluting in-segment restenosis in 73 lesions (11.7%) (P < 0.001 compared with BMS respectively). Late loss in both in-stent and in segment was higher in BMS than in DES groups [(1.00 +/- 0.69) vs (0.28 +/- 0.52); (0.78 +/- 0.71) vs (0.21 +/- 0.52), P < 0.001 respectively]. Angulated lesion, lesion length, pre-procedural minimal luminal diameter (MLD), and BMS were independent predictors for TLR, (P < 0.01 respectively), whereas current smoker, ostial lesion, and stent overlapping, post-procedure in-stent MLD, lesion length, and stent types were independent predictors for in-segment restenosis (P < 0.01 respectively). Standard coronary risk factors such as hypertension, hyperlipidemia, diabetes, and history of CAD were not associated with a higher rate of restenosis caused by BMS or DES implantation in our Chinese Han ethnic population.</p><p><b>CONCLUSIONS</b>Coronary stenting including BMS or DES implantation in Chinese Han ethnic patients is associated with a restenosis rate comparable to that demonstrated in previous studies from the western countries, and predictors of stent restenosis are somehow different from those in the western population.</p>

Compare drug-eluting stent to bare-metal stent in prognosis on treating diffuse coronary lesions / 中华心血管病杂志

<p><b>OBJECTIVE</b>Compare drug-eluting stent (DES) to bare-metal stent (BMS) in prognosis on treating diffuse coronary lesions and analysis risk factor of treating complex and diffuse lesions in PCI.</p><p><b>METHODS</b>205 consecutive patients with complex and diffuse coronary lesions enrolled our hospital, who were treated with more than 25 mm long DES or BMS. We exclude unsuccessful operation and location. All patients received medical treatment by guideline, and aspirin 300 mg and clopidogrel 75 mg once daily were continued at 6 months after the procedure. The patients were followed up after 6 months.</p><p><b>RESULTS</b>The study population were consisted of 205 patients that there were 181 man, and 24 women, who got 382 stents for 227 target lesions in coronary. There were 93.8% C and 6.2% B2 ACC/AHA type lesion. There were 86.8% patients with binary or above vessel treated. The average reference vessel diameter was 2.88 +/- 0.43 mm. The average stent length of per lesion was 40.09 +/- 12.94 mm. There were 54.2% lesions treated with overlapping stent. There were not different between DES and BMS in patients baseline characteristics, but RVD of group DES less than of group BMS (2.80 +/- 0.37 mm, 3.10 +/- 0.48 mm, P = 0.005) in lesion baseline characteristics. After 6 months, restenosis rate in group DES was less than in group BMS (15.4%, 48.4%, P < 0.001). There were obvious superiority TVR of DES than of BMS (11.6%, 38.5%, P < 0.001). The rate of local restenosis in group of DES was higher than that in group of BMS (33.3%, 18.2%, P = 0.029). We analyzed the risk factors for diffuse lesion by a logistic regression model, the significant univariate clinical and angiographic predictors of restenosis were treating with overlapping stent (OR = 2.82, P = 0.017) and drug-eluting stent (OR = 5.71, P < 0.001).</p><p><b>CONCLUSIONS</b>We find that implantation of DES in patients with diffuse lesions in coronary is relatively more safe and associated with more good clinical outcomes, than of BMS.</p>

A comparison of angiographic and clinical outcomes after sirolimus-eluting versus paclitaxel-eluting stents for the treatment of in-stent restenosis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>In-stent restenosis (ISR) remains a challenge for interventional cardiologists. Some data suggest that drug-eluting stents (DES) represent a promising new option for the treatment of patients with ISR. Currently, 2 DES platforms are available [sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)], but the superiority of either approach for treating ISR has not been convincingly demonstrated. The aim of the present study was to retrospectively compare angiographic and clinical outcomes after treatment of ISR with SES or PES in a series of consecutive patients with ISR.</p><p><b>METHODS</b>A total of 745 consecutive patients were treated with bare metal stents from April 12, 2004 to December 31, 2004 in our center. Of these, clinically driven target lesion revascularization (TLR) was performed in 54 ISR from 54 patients at 7 months. Of the 54 patients with ISR, 36 received SES and 18 received PES. Follow-up included angiography and assessment of clinical outcome, both performed 7 months after DES implantation.</p><p><b>RESULTS</b>There were no significant differences in baseline clinical data (including medication usage and lesion characteristics) between the two groups. Except for overlapping of multiple stents, procedural parameters were also similar in both groups. Seven-month angiographic follow-up showed that the binary restenosis rate was higher in patients treated with PES than that in patients treated with SES (in-stent binary restenosis: 27.8% vs 5.6%, P < 0.023; In-segment binary restenosis: 44.4% vs 13.9%, P < 0.014). Major adverse cardiac events (MACE) occurring during hospitalization or during the follow-up period including thrombosis and TLR was similar in both groups (22.2% vs 8.3%, P > 0.05).</p><p><b>CONCLUSIONS</b>Results from this small sample size, retrospective, single-center study showed that SES might be superior to PES in treating ISR because of lower 7-month restenosis rates (both in-stent and in-segment binary restenosis) with no increased incidence of MACE.</p>

Clinical and angiographic outcome in patients undergoing elective bare- metal stenting or drug-eluting stenting for total occlusion lesion / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the clinical and angiographic outcome in patients with total occlusion lesion treated with drug-eluting stent (DES) or bare-metal stent (BMS).</p><p><b>METHODS</b>A total of 155 (138 males) consecutive patients with total occlusion lesion underwent successful revascularization with DES (n = 74) or BMS (n = 81) in our hospital were included in this study. All patients received aspirin 300 mg and clopidogrel 75 mg once daily for at least 3 months after the procedure. Clinical and angiographic follow-up were completed in all patients at 6 months post stenting.</p><p><b>RESULTS</b>Demographic data between the two groups were similar except there was more diabetic patients in DES group (33.8% vs. 18.5%, P < 0.05). A total of 232 stents for 159 target lesions (77 treated with DES, 82 treated with BMS) were implanted. There were 85.4% C ACC/AHA type lesions and 17.0% lesions were treated with overlapping stents. Six months post stenting, the incidence of restenosis (15.6% vs. 41.5%, P < 0.001), the cumulative rate of major adverse cardiac events (MACE) (1.4% vs. 11.1%, P = 0.032) and TLR (5.8% vs. 19.9%, P = 0.001) were significantly lower in DES group than that of BMS group. The incidence of local restenosis in DES group is higher in DES group than that in BMS group (58.3%, 17.6%, P < 0.001). Two DES treated patients developed late in-stent thrombosis.</p><p><b>CONCLUSION</b>For patients with total occlusion lesion, the clinical and angiographic outcome 6 months post DES stenting is clearly superior to that of BMS stenting.</p>