Sirolimus-eluting stents for percutaneous coronary intervention in acute myocardial infarction Lesson from a case-controlled comparison of bare metal versus drug-eluting stents in thrombus-laden lesions

BACKGROUND: Given the encouraging results on early restenosis rate with drug-eluting coronary stents, both safety and 6 months outcomes of PCI with sirolimus-eluting stents (SES) in acute myocardial infarction are scarce. METHODS AND RESULTS: Fifty consecutive patients with acute myocardial infarction were subjected to acute PCI with SES and compared to 50 matched control patients who received a bare metal stent (BMS). All patients were followed over 6 months; in addition repeat angiography was obtained in 88.0% of SES and 92.0% of BMS patients. As a result of matching both groups were similar with regard to demographic, clinical, and infarction characteristics, as well as procedural data and adjunctive medication. SES diameter was 3.0 +/- 0.1 versus 3.3 +/- 0.5 mm with BMS, while the length of stented segment was 24 +/- 11 mm with SES versus 16 +/- 8 mm with BMS (p<0.05). No subacute stent thrombosis occurred in either group. At 6 months, all-cause mortality was 2.0% with SES, and 4.0% with BMS (n. s.); reinfarction rate was 2.0% in both groups, but binary restenosis rate (4.0 versus 18.0%; p<0.05) and target vessel revascularization (TVR) were improved with SES (2.0 versus 16.0%; p<0.05) resulting in lower MACE rate of 6.0 versus 22.0% with BMS (p<0.05). CONCLUSION: Placement of SES with PCI for myocardial infarction is feasible and as safe as BMS; 6-month outcome is superior with SES due to the lower rate of both angiographic restenosis and TVR.     

Sirolimus-eluting stents in real-world patients with ST-segment elevation acute myocardial infarction

Recently, the use of sirolimus-eluting stents (SES) has been demonstrated to significantly reduce the rate of adverse events among selected patients with ST-segment elevation acute myocardial infarction (STEMI). We present real-world experience from a single center registry evaluating the safety and efficacy of primary percutaneous coronary intervention (PCI) in unselected patients with STEMI using SES. Clinical outcome at 300-day follow-up in two cohorts of 225 consecutive patients who underwent bare metal stent (BMS) (January 2004-February 2005, n = 123) or SES (March 2005-December 2006, n = 102) implantation was examined. The primary endpoint was a composite of major adverse cardiovascular events (MACE: death, nonfatal reinfarction, and target vessel revascularization [TVR]). The incidence of short-term MACE was similar between the SES group and BMS group (30-day rate of MACE: 4.9% versus 8.9%, P = 0.30). Angiographically documented stent thrombosis within 30 days after primary PCI was not diagnosed in any patient in the SES group and occurred in 1 patient treated with BMS (0 versus 0.8%, P = 1.0). At 300 days, SES implantation significantly reduced the incidence of MACE (7.8% versus 22.8%, hazard ratio [HR] 0.32 [95% confidence interval (CI) 0.15 to 0.71], P = 0.005), mainly due to a marked reduction in the risk of TVR (1.0% versus 17.1%, HR 0.05 [95% CI 0.01 to 0.39], P < 0.001). There was no new onset of documented stent thrombosis between 30 and 300 days in either group. Thus, this real-world registry confirmed the safety and efficacy of SES with remarkably lower rates of TVR and MACE in the setting of primary PCI for unselected patients with STEMI in a real-world scenario.     

国产雷帕霉素药物洗脱支架在老年急性心肌梗死患者中的应用与研究

目的评估老年ST段抬高心肌梗死(STEMI)患者应用国产雷帕霉素药物洗脱支架(Firebird)和金属裸支架(BMS)的安全性和有效性。方法入选1年中≥60岁的STEMI患者113例,随机分为Firebird组56例,BMS组57例。本研究一级终点是6个月的靶病变晚期管腔丢失,次要终点包括6个月的支架内血栓形成和主要心脏不良事件。结果6个月随访期中,Firebird组和BMS组的6个月造影随访率分别为62.5%和64.9%。Firebird组死亡、靶血管重建、主要心脏不良事件分别为3.6%、3.6%7、.2%;BMS组则分别为3.5%、28.1%、33.3%,两组各有1例亚急性血栓形成。Firebird组和BMS组的平均晚期管腔丢失分别是(0.19±0.33)mm和(0.73±0.73)mm。结论老年STEMI患者应用Firebird比用BMS可降低6个月的靶血管重建和主要心脏不良事件,且急性、亚急性支架内血栓发生率低。     

药物洗脱支架与金属裸支架在急性ST段抬高心肌梗死急诊介入治疗中应用长期随访结果的比较

目的 探讨与金属裸支架(BMS)相比,Cypher支架(Cordis公司,美国)在急性ST段抬高心肌梗死(STEMI)急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和长期有效性.方法 连续选择2002年12月至2005年3月间STEMI患者407例,均于发病12 h内行急诊PCI治疗,于梗死相关血管靶病变置入Cypher支架或BMS.对所有病例随访1.5～4.0年(平均28.7±11.7个月),比较两类支架院内及出院后严重心脏不良事件(MACE,包括死亡、再发心肌梗死、靶病变重建等)发生的差异.结果 407例患者中置入Cypher支架者131例,置入BMS者276例.Cypher支架组所置入支架的直径明显小于BMS组(3.0 mm与3.2 mm,P=0.00).两组在随访期间心因性死亡(1.5%与6.9%,P=0.02)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率差异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置入Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率 异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置人Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.     

糖尿病急性ST段抬高心肌梗死应用雷帕霉素药物洗脱支架1年随访分析

目的探讨雷帕霉素药物洗脱支架在糖尿病急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择2002年11月至2005年10月间首都医科大学附属北京朝阳医院心脏中心收治的糖尿病急性STEMI患者106例,于发病12h内行急诊PCI治疗,置入雷帕霉素药物洗脱支架。记录术后1个月和12个月随访终点时的心血管事件发生率、支架内血栓发生率及支架内再狭窄发生率。结果105例患者急诊PCI治疗获得成功。106支梗塞相关血管(IRA)的110处罪犯病变处置入雷帕霉素药物洗脱支架134枚,未发生与介入治疗有关的并发症。1个月随访终点时死亡4例(3.77%),发生急性心肌梗死1例,心血管事件总发生率为4.72%;发生支架内血栓1例;血运重建1例。12个月随访终点时除1个月时死亡的4例外未再发生死亡病例,共发生心血管事件11例(10.38%),发生支架内血栓2例(1.89%),52例接受冠状动脉造影复查患者中发生支架内再狭窄6例(11.54%)。结论雷帕霉素药物洗脱支架在STEMI急诊PCI中应用有较高的安全性和有效性,并可以明显降低再狭窄率。     

Clinical results of drug eluting stents compared to bare metal stents for patients with ST elevation acute myocardial infarction

OBJECTIVE: To investigate the clinical outcomes in patients with ST segment elevation acute myocardial infarction (STEMI) treated with drug eluting stents (DES) versus a matched control group of patients with STEMI treated with bare metal stents (BMS). METHODS: This registry included 122 patients with STEMI undergoing primary coronary angioplasty with DES implantation at our institution. The control group consisted of 506 patients implanted with BMS, who were matched for age, infarct location, and diabetic status. The incidences of major adverse cardiac events (MACE) including target vessel/lesion revascularization (TVR/TLR) and stent thrombosis were assessed up to 12 months. RESULTS: Twelve months follow up showed a non-significant trend towards reduced deaths (3.3% versus 7.1%, P=0.1), significantly reduced recurrent MI (0.0% versus 6.1%, P=0.02), TVR (5.7% versus 15.2%, P=0.006) and TLR (2.5% versus 14.0%, P=0.004) events in the DES group as compared to BMS group. The composite incidences of MACE at 12 months follow-up was lower in the DES group (11.5%) as compared to the BMS group (21.3%, P=0.01). CONCLUSION: According to our experiences, the use of DES in STEMI is safe and effective as compared to BMS. DES was effective in reducing the incidence of restenosis outcomes and overall adverse cardiac events up to 12 months.     

The risks and benefits of drug-eluting stents in the setting of STEMI

Primary percutaneous coronary intervention (PCI) represents the treatment of choice in patients with ST-segment elevation myocardial infarction (STEMI). In randomized trials excluding STEMI patients, using drug-eluting stents (DES) significantly reduced angiographic restenosis and target vessel revascularization compared with bare metal stents (BMS); however, concerns exist regarding an increased follow-up incidence of stent thrombosis after DES implantation. This complication, which is associated with higher mortality and morbidity rates, may be more frequent among STEMI patients receiving DES versus BMS. Various registries, randomized trials, and two recent meta-analyses on patients undergoing primary PCI have shown that using DES is safe and is associated with significantly reduced rates of restenosis and repeat intervention without an increased risk of myocardial infarction or stent thrombosis at intermediate-term follow-up. However, large trials with hard clinical end points and longer follow-up are needed before routine DES use can be recommended in patients undergoing primary PCI.     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry

Background: Multiple randomized trials and observational studies have shown drug‐eluting stents (DES) to be safe and effective at 3‐year follow‐up in stent thrombosis (ST)‐segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3–4 years after DES implantation are sparse. Methods: We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end‐points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end‐points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression. Results: There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow‐up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log‐rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31–0.76], P = 0.0007) than BMS implantation. Conclusion: In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long‐term follow‐up. (J Interven Cardiol 2012;25:118–125)     

Mechanisms of Late Stent Malapposition After Primary Stenting in ST-Elevation Myocardial Infarction: A Subanalysis of the Selection Trial

Background: One of the major predictors of late stent malapposition (LSM) is primary stenting in acute myocardial infarction. However, mechanisms of LSM are still under debate.
Methods: Patients with ST-elevation myocardial infarction (STEMI) and enrolled in the SELECTION trial (38 patients in the paclitaxel-eluting stent, PES, and 35 in the bare metal stent, BMS, cohort) were retrospectively analyzed to evaluate LSM, by means of intravascular ultrasound (IVUS) data recorded at the index and 7-month follow-up procedures.
Results: Stent malapposition was documented in 21 lesions in 21 patients (28.8%): in 8 of these 21 patients (38.1%) it was LSM. Although statistical significance was not reached, LSM was more frequent after PES than BMS implantation (15.8% vs. 5.7%). LSM was mainly located within the body of the stent (62.5% of the cases). At the LSM segment, a significant increase of vessel area (19.2 ± 3.3 mm² vs. 21.9 ± 5.3 mm², P = 0.04) and a reduction of plaque area (12.6 ± 4.6 mm² vs. 9.1 ± 3.9 mm², P = 0.04) were observed at IVUS between the index and follow-up procedure.
Conclusions: After primary stenting for STEMI, LSM seems to be more frequent after PES rather than BMS implantation. In the STEMI setting, possible mechanisms leading to LSM include positive remodeling and plaque mass decrease.     

雷帕霉素药物洗脱支架治疗急性心肌梗死六个月随访结果

目的探讨雷帕霉素药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗（PCI）中应用的安全性和有效性.方法选择2002年11月至2004年12月间的急性ST段抬高心肌梗死患者168例,于发病12 h内行急诊PCI治疗,于梗死相关血管的靶病变置入Cypher支架.记录1个月和6个月随访终点时的主要心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）发生率、支架内血栓发生率、支架内再狭窄发生率.结果 168例患者急诊PCI治疗均获得成功.168支梗死相关血管的171处罪犯病变共置入175枚Cypher支架,未发生与介入治疗有关的并发症.1个月随访终点时死亡3例（死亡率1.8%）;支架内亚急性血栓1例;主要心脏不良事件发生率2.4%.6个月随访终点时死亡4例（死亡率2.4%）;主要心脏不良事件发生率4.2%;支架内血栓发生率1.2%;支架内再狭窄发生率1.8%.结论药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊PCI中应用与普通支架一样有较强的安全性和有效性,并可以明显降低再狭窄率.     

Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

Background : There are limited data on the long‐term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Objective : We aimed to assess the 4‐year clinical outcome in patients who received a bare‐metal stent (BMS), sirolimus‐eluting stent (SES), or a paclitaxel‐eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000–2005. Methods : In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI‐cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). Results : At 4 years follow‐up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47–0.81; HR = 0.67, 95% CI: 0.55–0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target‐vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37–0.75; HR = 0.71, 95% CI: 0.62–0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. Conclusion : These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow‐up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI. © 2010 Wiley‐Liss, Inc.     

ST段抬高心肌梗死应用国产西罗莫司洗脱支架与金属裸支架的对比研究

目的评估在ST段抬高心肌梗死(STEMI)患者应用国产西罗莫司洗脱支架的安全性和有效性。方法将1年内连续入选STEMI的患者随机分为国产西罗莫司洗脱(火鸟)支架组或金属裸支架(BMS)组。对所有患者连续临床随访6个月,术后6个月常规行冠状动脉造影。试验主要终点是术后6个月靶病变区晚期管腔丢失(LLL),次要终点包括支架内血栓发生率和主要心脏不良事件(MACE)。结果试验前6个月共入选85例患者。国产西罗莫司(火鸟)支架组42例,平均年龄58·1岁。BMS组43例,平均年龄59·8岁。两组6个月血管造影随访率分别为47·6%和44·2%。6个月随访结果显示,国产西罗莫司(火鸟)支架组死亡率、靶血管重建率(TVR)和MACE分别为2·4%,0%和2·4%,BMS组相应为4·7%,31·6%和25·6%(P<0·05)。BMS组有1例发生支架内亚急性血栓。定量冠状动脉造影结果显示,国产西罗莫司(火鸟)支架组支架内平均LLL为0·18mm,BMS组为0·72mm。结论与BMS比较,国产西罗莫司(火鸟)支架能够有效降低STEMI患者6个月死亡率、TVR和MACE发生率,其急性或亚急性支架血栓发生率低。     

Comparison of one-year clinical outcomes with paclitaxel-eluting stents versus bare metal stents in everyday practice

BACKGROUND:

In randomized trials, paclitaxel-eluting stents (PES) have been shown to be superior to bare metal stents (BMS) in reducing restenosis. However, the effectiveness of PES in patients treated during routine practice has not been fully established.

METHODS:

A retrospective comparison of PES with BMS in consecutive patients undergoing percutaneous coronary intervention (PCI) from April 2003 to March 2004 was conducted. Outcomes included the composite of death, myocardial infarction and target lesion revascularization (TLR) at one year, as well as stent thrombosis.

RESULTS:

A total of 512 patients were treated with PES, and 722 patients were treated with BMS. Patients in the PES group were more likely to receive stents that were 20 mm in length or longer (52.2% versus 33.3%, P<0.0001), 2.5 mm in diameter or smaller (29.1% versus 12.5%, P<0.0001) and implanted in bifurcation positions (15.4% versus 11.6%, P=0.02). At one year, the composite outcome of death, myocardial infarction and TLR was 6.1% in the PES group compared with 10.8% in the BMS group (P=0.004). The one-year rate of stent thrombosis was 0.59% in the PES group compared with 0.28% in the BMS group (P=0.4).

CONCLUSIONS:

Despite being used in higher-risk lesions, there was a lower rate of major cardiac events at one year in patients treated with PES, primarily driven by the reduction in TLR. Thus, the experience with PES in contemporary practice applied to a broader population appears to be consistent with the results reported in randomized trials.     

Long-Term Clinical Follow-up after Sirolimus-Eluting Stent versus Bare Metal Stent Implantation in Patients with Acute Coronary Syndrome

Background and Objective: Drug-eluting stents have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) compared with bare metal stents (BMSs); however, the long-term efficacy of sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) has not been well established. We have investigated the long-term clinical outcome of SES in patients with ACS.
Methods: Consecutive 245 patients with ACS treated by primary stenting within 24 hours after onset were enrolled. There were 128 patients treated with SES and 117 patients were treated with BMS. We evaluated the incidence of major cardiac events (MACE; total death, nonfatal myocardial infarction, TVR) at 3 years, comparing with 8-month clinical outcome.
Results: Eight-month clinical follow-up shows a significantly lower incidence of TVR in the SES group, 3.1% in the SES group versus 9.4% in the BMS group (P = 0.04). At 3-year clinical follow-up, there was no significant difference in the rate of TVR between the two groups, 8.4% versus 12.4% (P = 0.37). Cumulative incidence of total MACE was 9.2% in the SES group compared with 15.9% in the BMS group (P = 0.18). Only one case of stent thrombosis was observed in the SES (late thrombosis), while two cases of stent thrombosis occurred in the BMS group (late and very late thrombosis; P = 0.55).
Conclusion: SES implantation in patients with ACS is associated with favorable long-term clinical outcome with no excess of late stent thrombosis. Further long-term clinical follow-up will be warranted to confirm the safety and efficacy of SES.     

A randomized comparison of paclitaxel-eluting stents versus bare-metal stents for treatment of unprotected left main coronary artery stenosis.

OBJECTIVES: To optimize percutaneous coronary intervention (PCI) strategy for unprotected left main (LM) disease, we performed a randomized study: intravascular ultrasound (IVUS)-guided bare-metal stent (BMS) or paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions. BACKGROUND: Recent studies have shown promising results in terms of safety and feasibility for patients with LM disease who underwent PCI with stent implantation. However, comparison of BMS and PES for LM lesions has not yet been evaluated. METHODS: One hundred three patients were randomly assigned to receive BMS (n = 50) or PES (n = 53) implantation. All interventions were IVUS guided, and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for 6-month follow-up. RESULTS: Baseline clinical characteristics were comparable in both cohorts. Stent implantation was successful in all lesions. Follow-up analysis showed binary restenosis in 11 (22%) BMS and in 3 (6%) PES patients (p = 0.021). By IVUS, percentage of neointimal volume obstruction at 6 months was reduced from 25.20 +/- 22.02% with BMS to 16.60 +/- 17.25% with PES (p = 0.02). At 6 months, the major adverse cardiac event-free survival rate was 70% in BMS and 87% in PES patients (p = 0.036). CONCLUSIONS: This study demonstrates that PCI of LM with IVUS guidance and CB pre-treatment is safe and effective. No serious procedure-related complications were observed, and clinical outcomes appeared to be good. Finally, the findings demonstrate that implantation of PES may be superior to BMS in the large-diameter LM vessel at 6 months, warranting the performance of a large-scale randomized trial.     

Drug-eluting stent-supported percutaneous coronary intervention for chronic total coronary occlusion.

OBJECTIVES: This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). BACKGROUND: There are few data about the efficacy of DES-supported PCI for CTO. METHODS: All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. RESULTS: Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). CONCLUSIONS: DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.     

Patency of paclitaxel-eluting versus bare metal stents long term after implantation in acute ST-segment elevation myocardial infarction

Drug-eluting stents effectively inhibit neointimal hyperplasia within the first year, thereby reducing the need for repeat revascularization. However, a delayed pattern of restenosis might be more prominent in drug-eluting stents compared to bare metal stents (BMSs). The extent of restenosis of paclitaxel-eluting stents (PESs) long term after implantation in acute ST-segment elevation myocardial infarction is currently unknown. The present study was designed to evaluate very late luminal loss (VLLL) of PESs used in ST-segment elevation myocardial infarction compared to BMSs. A total of 116 patients (61 with PESs and 55 with BMSs) initially included in the Paclitaxel Eluting Stent Versus Conventional Stent in ST-segment Elevation Myocardial Infarction (PASSION) trial and who were free from previous lesion failure underwent angiographic follow-up. Off-line quantitative coronary analysis of the angiogram immediately after stent implantation and at follow-up was performed. The primary end point was VLLL within the stent. The presence of binary restenosis was defined as diameter stenosis >50% as a secondary end point. The mean interval between stent implantation and follow-up was 4.1 ± 0.5 years in both stent groups. In-stent VLLL was 0.12 mm (interquartile range -0.03 to 0.42) in the PES group versus 0.30 mm (interquartile range 0.08 to 0.69) in the BMS group (p = 0.011). In-segment binary restenosis was found in 4 patients (6.6%) with a PES and 6 patients (10.9%) with a BMS (p = 0.40). In conclusion, angiographic follow-up 4 years after implantation in ST-segment elevation myocardial infarction showed that in patients prospectively randomized to PESs or BMSs, VLLL was low in both stent groups. PESs were associated with lower VLLL than BMSs, and the observed rate of binary restenosis was not significantly different between the 2 stent groups.     

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.     

国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死临床疗效的比较

目的探讨国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死（AMI）临床疗效的差异。方法173例连续行直接PCI的AMI患者随机分为西罗莫司洗脱支架组（87例）和裸支架组（86例）,分析住院期间和支架置入后6个月的支架内血栓、主要心血管事件（包括再次心肌梗死、缺血性靶血管重建和死亡）发生率及6个月再狭窄率。结果两组患者在术后血管通畅、肌酸激酶峰值、心功能和住院期间心脏事件方面差异均无统计学意义（P〉0．05）。两组各有2例支架内血栓（2．4％比2．3％,P〉0．05）。6个月时,国产西罗莫司洗脱支架组的支架内再狭窄率（4．5％比40．0％,P〈0．01）、节段内再狭窄率（6．8％比44．9％,P〈0．01）和主要不良心脏事件发生率（8．0％比24．4％,P〈0．01）显著低于裸支架组。国产西罗莫司洗脱支架组主要心脏事件的减少主要是因为缺血性靶血管重建减少所致（3．4％比11．6％,P〈0．05）。结论与裸支架相比,国产西罗莫司洗脱支架治疗AMI患者并未增加6个月内支架内血栓的发生,而显著降低6个月的再狭窄率和主要心脏事件发生率。     

Impact of increased transmitral gradients after undersized annuloplasty for chronic ischemic mitral regurgitation

Introduction

It is unknown whether drug-eluting stents (DES), in comparison with bare-metal stents (BMS), improve clinical outcomes of ST-elevation myocardial infarction (STEMI) patients with renal insufficiency. We aimed to compare the clinical outcomes of BMS versus DES, as well as sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES), in STEMI patients with renal insufficiency.

Methods

From the Korea Acute Myocardial Infarction Registry, 874 STEMI patients with renal insufficiency (glomerular filtration rate < 60 ml/min) comprising 116 patients with BMS and 758 patients with DES (430 SES and 328 PES) implantation were selected. Major adverse cardiac events (MACE) within 1 year, defined as composite of all-cause mortality, nonfatal myocardial infarction and target lesion revascularization were compared. In addition to multivariate adjusted analysis, propensity analysis for stent choice was performed.

Results

With a median follow-up of 342 days, 116 MACE occurred. MACE was more frequent in the BMS group than in the DES group before (HR [95% CI] = 2.3 [1.3-3.8]) and after propensity score matching (HR [95% CI] = 2.0 [1.0-3.8]). The difference of MACE was mainly driven by a higher rate of target lesion revascularization rate in the BMS group. In comparison between SES and PES, there was no significant difference between the 2 groups in propensity score-matched populations (HR [95% CI] = 0.7 [0.4-1.1]).

Conclusions

In STEMI patients with renal insufficiency, DES implantation exhibits a favorable 1 year clinical outcomes than BMS implantation, however, no difference was found between SES and PES.