Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.     

Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry

Objective : This study evaluates the safety and efficacy of the XIENCE V® 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background : In the SPIRIT III trial, the XIENCE V® everolimus‐eluting stent (EES), compared with the TAXUS EXPRESS² paclitaxel‐eluting stent (PES) in 2.5–3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods : The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions ≤28 mm in length and reference vessel diameter 3.75–4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8‐month in‐segment LL compared with the randomized PES arm. Results : In‐segment LL was 0.17 ± 0.38 mm in the 4.0 mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1‐year rates of ischemia‐driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8‐month LL or 1‐year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions : In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. © 2009 Wiley‐Liss, Inc.     

Evaluation of the effects of everolimus‐eluting and paclitaxel‐eluting stents on target lesions with jailed side branches: 2‐year results from the SPIRIT III randomized trial

Objective: To evaluate whether an everolimus‐eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. Background: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS² paclitaxel‐eluting stent (PES) compared to the bare metal EXPRESS²® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. Methods: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS² PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two‐year clinical outcomes were evaluated. Results: A periprocedural increase in Creatine Kinase‐MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). Conclusions: In this post‐hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley‐Liss, Inc.     

Long‐term clinical,angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents

Background: The residual drug carriers on drug‐eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus‐eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long‐term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single‐center registry. Antiplatelet protocol was 6‐month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in‐segment and in‐stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target‐lesion revascularizations due to in‐stent restenosis (ISR). All patients received follow‐up up to 24 ± 0.4 months and no cardiac death, MI, and in‐stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in‐stent lesion restenosis, 5.4% (6/112) in‐segment lesion restenosis, 0.12 ± 0.34 mm in‐stent late lumen loss, and 0.08 ± 0.35 mm in‐segment late lumen loss. Conclusions: In this single‐center experience with complex patients and lesions, the EXCEL^TM stent implantation with 6‐month dual antiplatelet treatment proved to markedly reduce the incidence of 24‐month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials. © 2008 Wiley‐Liss, Inc.     

Impact of a prolonged delivery inflation time for optimal drug‐eluting stent expansion

Purpose: We examined the importance of prolonged inflation time for optimal sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) expansion. Methods: Eighty‐one de novo lesions deployed single SES or PES between April 2007 and March 2008 were divided into four groups; group 1: 21 SES deployed at 20 atm × 60 sec, group 2: 20 SES deployed with 2‐step inflation at 20 atm × 60 sec following 20 atm × 20 sec, group 3: 20 PES deployed same as group 1, group 4: 20 PES deployed same as group 2. The minimal lumen diameter (MLD) and stent expansion ratio (SER; stent cross‐ sectional area at lesion/balloon cross‐sectional area which was calculated according to the compliance chart at the same atmosphere as stent deployment) were compared between group 1 and group 2 in SES, between group 3 and group 4 in PES. Results: The MLD of post 60 sec was significantly higher than that of post 20sec (2.84 ± 0.28 mm in group 1, 2.76 ± 0.33 mm in group 2 vs. 2.54 ± 0.33 mm in group 2; P = 0.003, 0.045, respectively and 2.94 ± 0.28 mm in group 3, 3.00 ± 0.34 mm in group 4 vs. 2.69 ± 0.35 mm in group 4; P = 0.022, 0.007, respectively). The SER of post 60 sec was significantly higher than that of post 20 sec (79.3% ± 8.5% in group 1, 80.8% ± 7.8% in group 2 vs. 71.1% ± 10.2% in group 2; P = 0.014, 0.011, respectively and 81.1% ± 7.9% in group 3, 84.3% ± 9.9% in group 4 vs. 72.6% ± 10.5% in group 4, P = 0.011, 0.001, respectively). Conclusion: The prolonged delivery inflation for 60 sec may result in a more optimal stent expansion. It is therefore considered to be a useful method for deploying drug‐eluting stent. © 2008 Wiley‐Liss, Inc.     

Aneurysm formation after drug‐eluting balloon treatment of drug‐eluting in‐stent restenosis: First case report

A 55‐year‐old male underwent paclitaxel‐eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in‐stent restenosis developed 15 months after implantation of the drug‐eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug‐eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow‐up. © 2012 Wiley Periodicals, Inc.     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

The paclitaxel‐eluting coroflex™ please stent study (PECOPS I): The 3‐year clinical follow‐up

Background : The evaluation of drug‐eluting devices in humans should include longterm follow‐up owing to risk of late target vessel thrombosis with the possible fatal sequel. Methods and Results : Therefore, the three‐year clinical outcome of the paclitaxeleluting Corofiex^® Please stent in patients with de‐novo coronary lesions was evaluated in the single‐arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 ± 0.12 years following stent deployment. In the intention‐to‐treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in‐segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 ± 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (?3.0 ± 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3‐year MACE rate was 22/123 (17.9%). Conclusion : The present study describes the paclitaxel‐eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low. © 2009 Wiley‐Liss, Inc.     

Comparison of clinical outcomes of coronary artery stent implantation in patients with end‐stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer‐EES,platinum chromium‐EES,and cobalt chrome‐EES

Backgrounds

New‐generation bioresorbable polymer‐everolimus eluting stents (BP‐EES) are available. This study aimed to compare the clinical outcomes for BP‐EES compared to more established stent designs, namely the platinum chromium‐EES (PtCr‐EES) and cobalt chrome‐EES(CoCr‐EES) in patients with the end‐stage chronic kidney disease (CKD) including hemodialysis (HD).

Methods

One‐hundred‐forty‐one consecutive stents (BP‐EES [n = 44], PtCr‐EES [n = 45], and CoCr‐EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow‐up coronary angiography at 12 months after implantation. End‐stage CKD was defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or the need for HD. The following outcome variables were compared among the three stent groups after implantation and the 12‐month follow‐up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter‐stenosis (%DS) were measured using quantitative coronary angiography.

Results

The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12‐month follow‐up, a tendency towards higher TLR was observed for the BP‐EES group (22.7%) compared with the PtCr‐EES (8.8%) and CoCr‐EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP‐EES (0.51 ± 0.64 mm) group than either the PtCr‐EES (0.20 ± 0.61 mm) and CoCr‐EES (0.25 ± 0.70 mm) groups (P = 0.03).

Conclusions

BP‐EES might increase the risk of in‐stent restenosis in patients with end‐stage of CKD or the need for HD.     

Sustained clinical safety and efficacy of a biodegradable‐polymer coated sirolimus‐eluting stent in “real‐world” practice: Three‐year outcomes of the CREATE (multi‐center registry of EXCEL biodegradable polymer drug eluting stents) study

Background: The CREATE is a post‐marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus‐eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice. Objectives: To evaluate the three‐year clinical safety and efficacy outcomes in patients enrolled in the CREATE study. Methods: A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months. Results: Clinical follow‐up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053). Conclusions: This study demonstrates sustained three‐year clinical safety and efficacy of biodegradable polymer‐based sirolimus‐eluting stents when used with six months of dual antiplatelet therapy in a “real‐world” setting. © 2011 Wiley Periodicals, Inc.     

Late target lesion revascularization after implantation of sirolimus‐eluting stent

Objectives : We evaluated the incidence, clinical presentation, and angiographic in‐stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus‐eluting stent (SES) implantation. Background : Late TLR is an unusual finding beyond 6–9 months after bare‐metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. Methods : The study population consisted of 804 patients with 1,020 native lesions that were patent at 6‐month follow‐up angiogram after SES implantation. Results : Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 ± 2.6 months (range; 18–30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 ± 0.5 mm immediately after SES implantation, 2.4 ± 0.4 mm at 6‐month follow‐up and 0.7 ± 0.6 mm at 24‐month follow‐up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019–1.061). Conclusions : Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6‐month follow‐up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two‐thirds of late TLR lesions had a focal angiographic ISR pattern. © 2007 Wiley‐Liss, Inc.     

Efficacy and safety of a double‐coated paclitaxel‐eluting coronary stent: The EUCATAX trial

Objectives : The aim of this study was the comparison of a new double‐coated paclitaxel‐eluting coronary stent with bare‐metal stent (BMS) in patients undergoing percutaneous coronary intervention. Background : Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. Methods : Multicenter randomized trial comparing a paclitaxel‐eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. Results : At 1 year of follow‐up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P = 0.02), and MACE rate was 10% in PES and 19% in BMS arm (P = 0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. Conclusions : The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow‐up should be necessary to assess true advantages of this technology compared with the previous one. © 2010 Wiley‐Liss, Inc.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 Wiley‐Liss, Inc.     

雷帕霉素洗脱支架与紫杉醇涂层支架治疗冠状动脉复杂病变

目的评价雷帕霉素洗脱支架(CypherTM)与紫杉醇涂层支架(Taxus ExpressTM)治疗冠状动脉复杂病变(B2／C型病变)的近期和远期疗效。方法入选本研究267例,男性占68％,糖尿病占38．5％。雷帕霉素洗脱支架组169例,共植入雷帕霉素洗脱支架172条;紫杉醇涂层支架组98例,植入紫杉醇涂层支架165条。观察6个月的主要心血管事件。结果两组的临床特征相似。支架植入成功率100％,95％的病人完成6个月的随访。主要心血管事件发生率:雷帕霉素洗脱支架组5．9％(10／169),紫杉醇涂层支架组9．2％(9／98),两组差异无统计学意义(X2=1．001,P=0．317)。结论雷帕霉素洗脱支架治疗冠状动脉复杂病变疗效和安全性与紫杉醇涂层支架相似。     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Novel paclitaxel‐eluting,biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry

Objectives: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc‐Chopin²) based on 9‐months angiographic and 12‐months clinical follow‐up results. Background: First‐generation drug‐eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long‐term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. Methods: We conducted a prospective, multicenter first‐in‐man registry of a novel, locally developed, bioabsorbable‐coated, paclitaxel‐eluting coronary stent in 116 patients with single‐lesion de novo coronary disease. Results: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia‐driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core‐lab assessed binary in‐stent restenosis (≥50% DS) was noted in 11.9% patients and mean late loss was 0.46 ± 0.47 mm. Conclusions: This first‐in‐man experience obtained in a multicenter registry of real‐world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience. © 2008 Wiley‐Liss, Inc.     

Comparison of sirolimus‐eluting stent and paclitaxel‐eluting stent for long‐term cardiac adverse events in diabetic patients: The Korean multicenter angioplasty team (KOMATE) registry

Background: There is some controversy on long‐term cardiac outcomes between sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in diabetes mellitus (DM). We compared cardiac adverse events after SES and PES implantation in patients with DM over a period of 3 year. Methods: A total of 634 patients with DM treated with SES (n = 428) or PES (n = 206) were consecutively enrolled in the KOMATE registry from 2003 to 2004. We assessed major adverse cardiac events (MACEs, cardiovascular death, nonfatal myocardial infarction, ischemia driven target vessel revascularization) and stent thrombosis (ST) according to the definitions set by the Academic Research Consortium. Results: Propensity score (PS) analysis was performed to adjust different baseline characteristics. The mean follow‐up duration was 38 ± 8 month (at least 36 month and up to 53 month). The 3‐year MACE rate did not show a significant difference between the two groups [52 (12.1%) in SES vs. 29 (14.1%) in PES, P = 0.496]. The definite and probable ST at 3 year were similar in both SES and PES [12 (2.8%) in SES vs. 7 (3.4%) in PES, P = 0.681]. There were no differences in hazard ratio for MACE and ST between two stents [MACE, crude: 0.844 (0.536–1.330) and adjusted for PS: 0.858 (0.530–1.389); ST, crude: 0.820 (0.323–2.083) and adjusted for PS: 0.960 (0.357–2.587)]. Conclusions: The present study demonstrated that long‐tem cardiac outcomes including ST were not significantly different between SES and PES in patients with DM. © 2008 Wiley‐Liss, Inc.     

Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating

Background: Permanent polymers used in current drug‐eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. Objectives: We sought to evaluate a novel, potentially innately anti‐inflammatory, bioabsorbable salicylate‐based polymer as a DES coating, in a clinically relevant animal model. Methods: Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer‐only coated metal stents (SA/AA); biostable polymeric sirolimus‐eluting stents (Cypher?); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 μg/mm of stent length (similar to Cypher?) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. Results: Both SA/AA + S and Cypher? stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer‐only groups (6 ± 4% and 5 ± 4% vs. 15 ± 7% and 16 ± 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher? than for BMS (0.14 ± 0.06 and 0.13 ± 0.04 mm vs. 0.23 ± 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher? when compared with BMS (22 ± 7% and 23 ± 6% vs. 33 ± 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher? groups (P = 0.072). Conclusions: This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate‐based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices. © 2008 Wiley‐Liss, Inc.     

Angiographic and intravascular ultrasound follow up of paclitaxel‐ and sirolimus‐eluting stent after poststent high‐pressure balloon dilation: From the poststent optimal stent expansion trial

Objectives : The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug‐eluting stent (DES) and compare paclitaxel‐eluting stent (PES) to sirolimus‐eluting stent (SES). Background : Although poststent high‐pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. Methods : Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9‐month follow‐up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in‐stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. Results : At 9‐month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm²) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm² and 0.21 ± 0.37, P < 0.001 in PES and SES]. Conclusions : OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high‐pressure balloon dilatation. © 2010 Wiley‐Liss, Inc.