A Randomized Comparison of Novel Biodegradable Polymer- and Durable Polymer–Coated Cobalt-Chromium Sirolimus-Eluting Stents

ObjectivesThe aim of this study was to investigate the hypothesis that a novel biodegradable polymer–coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.BackgroundNo randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.MethodsIn this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.ResultsAt 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: −1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).ConclusionsIn this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381)     

Paraoxonase-1 activity affects the clopidogrel response in CYP2C19 loss-of-function carriers

Background

The impact of paraoxonase-1 (PON1) activity on the response to clopidogrel may differ in patients treated with drug-eluting stents (DES) in association with CYP2C19 loss-of-function (LOF) polymorphisms.

Methods

This study included 112 Japanese patients receiving clopidogrel (75 mg/day) and aspirin (100 mg/day) who underwent optical coherence tomography (OCT) examination 9 months after DES implantation. The CYP2C19 genotype was analyzed and LOF carriers (*1/*2, *1/*3, *2/*2, *3/*3, *2/*3) were identified. At the 9-month follow-up, platelet reactivity was determined by measuring the P2Y12 reactivity unit (PRU) using a VerifyNow P2Y12 assay, PON1 activity was evaluated and intra-stent thrombus was evaluated by OCT.

Results

Of the 112 Japanese patients, 75 were LOF carriers (67.0%). The patients were divided into tertiles according to the PON1 activity (tertile 1; < 230 U/L, tertile 2; 230–283 U/L, tertile 3; > 283 U/L). In the VerifyNowP2Y12 analysis, tertile 1 had a higher PRU than tertiles 2 and 3 in LOF carriers, and there was no difference among tertiles in non-carriers. The highest incidence of intra-stent thrombus was observed in tertile 1 followed by tertiles 2 and 3 in LOF carriers, whereas there was no such difference in non-carriers. Multivariate analysis revealed that LOF carriers and PON1 activity tertile 1 were independent predictors of intra-stent thrombus in all patients. In LOF carriers, tertile 1 was the only independent predictor for intra-stent thrombus.

Conclusion

Low PON1 activity is associated with a low response to clopidogrel and a high frequency of intra-stent thrombus only in LOF carriers.     

Three-year Follow-up of Patients With Bifurcation Lesions Treated With Sirolimus- or Everolimus-eluting Stents: SEAside and CORpal Cooperative Study

Introduction and objectives

To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents.

Methods

A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization).

Results

At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02).

Conclusions

Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years’ follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted.     

雷帕霉素洗脱支架在ST段抬高性急性心肌梗死患者PCI中的应用

目的 探讨雷帕霉素洗脱支架(SES)在急性ST段抬高性心肌梗死(STEMI)患者经皮冠状动脉介入治疗(PCI)中的近、远期疗效及安全性.方法 226例确诊为STEMI患者分为金属裸支架(BMS)组(n=98)和SES组(n=128),分别植入BMS和SES,对比观察术后30 d内及30 d～1年两组主要心脏事件(MACE)[心脏性死亡、非致死性心肌梗死、靶血管再次血运重建率(TVR)]的发生率.结果 术后30 d内两组MACE发生率差异无统计学意义(P＞0.05).与BMS组相比,术后30 d～1年SES组MACE发生率显著降低(分别为5.7%和14.9%,P＜0.01),主要与TVR显著降低有关(分别为3.3%和11.7%,P＜0.01);两组间再次非致死性心肌梗死(分别为0.8%和1.1%)及心脏性死亡(分别为1.6%和2.1%)的发生率差异无统计学意义(均P＞0.05).结论 STEMI患者采用SES治疗1年内疗效明显优于BMS,两者安全性相似;长期疗效及安全性还需要进一步临床研究证实.     

Comparison of long-term clinical outcomes after the second-generation cobalt–chromium sirolimus-eluting stents implantation in diabetic versus non-diabetic patients: a subgroup analysis from the prospective FOCUS registry

Background: Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt–chromium sirolimus-eluting stents (CoCr-SES) was less known. Methods: A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching. Results: The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p?=?0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p?=?0.938) and target lesion revascularization (1.2% versus 1.1%; p?=?0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p?=?0.012) demonstrated a significant increase in the DM group. Conclusions: This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.

• Key messages

• The overall rate of adverse clinical events in both diabetic and non-diabetic patients was <10%, indicating a satisfying long-term safety and efficacy performance of CoCr-SES, even in high–risk diabetic patients.

• DM significantly increased the risk of MACE (HR 1.3; 95% CI: 1.0–1.6) in patients undergoing CoCr-SES implantation.

     

雷帕霉素洗脱支架对吻术与单支架术对冠状动脉分叉病变疗效的影响

目的比较雷帕霉素洗脱支架对吻技术与单支架技术对真性分叉病变的近、远期疗效的影响。方法 200名分叉病变患者,随机分为对吻支架术和单支架术两组。随访1年,观察两组节段内再狭窄率、死亡率、非致死性心肌梗死率、靶病变再次血运重建率和支架内血栓形成率。结果术后1年,单支架组与对吻支架组相比,再狭窄率、死亡率、心肌梗死发生率、靶病变再次血运重建率、支架内血栓发生率及严重心血管不良事件发生率差异均无统计学意义（P〉0.05）;分支预扩张后,出现夹层的患者分析提示单支架与对吻支架组节段内再狭窄率、靶病变再次血运重建率及严重心血管不良事件发生率差异有统计学意义（P〈0.05）,而支架内血栓率、死亡率及心肌梗死率差异无统计学意义（P〉0.05）。结论对于直径较大的分叉病变患者,对吻支架技术的近、远期疗效与单支架术相近。预扩张后分支出现夹层应采用对吻支架术,没有夹层则应采用单支架植入。     

西罗莫司洗脱支架与其他冠脉支架治疗冠心病的临床安全性比较

目的 对西罗莫司洗脱支架(SES)和其他冠脉支架治疗冠心病的临床安全性进行比较.方法 通过文献检索国内外大型数据库如pubmed、OVID medline、sciencedirect、CNKI、万方数据库等,检索近5年发表的关于SES与裸金属支架及其他药物洗脱支架术后主要心脏不良事件(MACE)、靶血管重建率和靶病变重建率等终点的对比性研究.结果 SES与裸金属支架相比,术后MACE明显下降,靶血管重建率和靶病变重建率也显著下降.SES与其他药物洗脱支架相比,临床安全性与紫杉醇洗脱支架(PES)相当,在某些患者(如合并糖尿病或冠脉分叉病变)可能优于佐他莫司洗脱支架(ZES).对于合并肾功能不全的患者,SES同样优于BES,安全性与PES相当.C反应蛋白对于SES术后发生MACE可能具有预测价值.结论 SES与裸金属支架相比,安全性明显提高,与PES相当.     

Evaluation of neointimal coverage of overlapping sirolimus- eluting stents by optical coherence tomography

Background Although overlapping sirolimus-eluting stents are often used in long lesions during percutaneous coronary intervention, it was not clear how intimal hyperplasia at the overlapping segments compares with that of single-layer sirolimus-eluting stents.
Methods Optical coherence tomography （OCT） examinations were performed on 22 patients in whom overlapping sirolimus-eluting stents （SESs） were implanted. OCT images were analyzed off-line after the procedure. Still frames were selected and classified, and the length of overlap, lumen loss, and average neointimal thickness on the strut were measured. The stent strut was classified into well-apposed to vessel wall with apparent neointimat coverage （type A）, well-apposed to vessel wall without neointimal coverage （type B）, malapposed to the vessel wall without neointimal coveraae （tvDe C）, and strut located at a major side branch （type D）.
Results Tlqere was no statistically significant difference between strut coverage types within overlapping and non-overlapping segments, but a greater percentage of type C struts were observed within the overlapping segments （5.2% vs 1.4%, P 〉0.05）. Neither neointimal thickness （（175.0±59.9） μm vs （168.3±90.2）μm, P=0.715） nor lumen loss （（1.61±0.55） mm^2 vs （1.48±0.37） mm^2, P=0.397） was statistically different between the two segments. One patient was diagnosed with suspected in-stent thrombosis at 6 months. Although no specific characteristics of thrombosis were seen on the OCT images, a greater number of malapposed struts without neointima coverage were observed.
Conclusions About 90% struts were completely covered by neointimal proliferation at 12 months follow-up, and the thicknesses of neointima on overlapping and non-overlapping segments were similar. Most of type C struts at the overlapping segments were found on the inside layer stents. Delayed antiplatelet therapy was beneficial for the patients with incompletely covered struts.     

Thrombosis and drug-eluting stents: an objective appraisal

Stent thrombosis (ST) after percutaneous coronary intervention has been the focus of intense interest because of its attendant morbidity and mortality. There is controversy about several facets of the problem. These include the frequency of ST with drug-eluting stents (DES) versus bare-metal stents (BMS), the timing of the event, clinical consequences, risk factors, adjunctive therapy, and new preventive approaches. Information has accrued rapidly from several sources, including randomized controlled clinical trials of DES versus BMS in carefully selected subsets of patients and registry experiences in larger patient groups, which provide a more universal real-world picture. The results from these different data sets are not completely concordant. However, several general conclusions can be made: 1) ST is an infrequent but very severe complication of both BMS and DES; 2) at the present time, during 4 years of follow-up from randomized controlled trials that compared DES and BMS, there is no apparent difference in overall ST frequency, although the time course for occurrence appears to differ, with a relative numeric excess of ST late after DES implant; 3) despite this relative imbalance, no differences in the end points of death or death and infarction between DES and BMS are observed; 4) longer-term follow-up of these patients as well as larger angiographic and clinical subsets of patients who receive this technology outside of randomized trials are required to fully study this issue; and 5) advances in stent platforms for drug elution as well as adjunctive pharmacologic therapy are being evaluated to enhance long-term safety.