Sirolimus-eluting Stent Placement Research Articles

Serial intravascular ultrasound assessment of very late stent thrombosis after sirolimus-eluting stent placement

PurposeIn-stent restenosis has been decreasing through the introduction of drug-eluting stents (DES). On the other hand, adverse events such as very late stent thrombosis (VLST) and late catch-up phenomenon can occur especially with sirolimus-eluting stents (SES, first-generation DES) in long-term follow-up. However, the precise mechanisms underlying VLST have not been well investigated in vivo. Methods and resultsFrom 2004 to 2010, 2034 SES were implanted in 1656 patients and caused eight VLST (0.48% per patient) at Fukuoka Tokushukai Medical Center. Of these, serial intravascular ultrasound (IVUS) images (post-stent implantation and at the time of VLST onset) were obtained from three patients with VLST. Comparing them with eight control patients with SES implanted, the vascular reactivity of VLST patients was analyzed. Eight VLST happened 50±15 months after stent implantation and three of the eight patients with VLST had not taken aspirin daily. There were no differences in minimum stent area, maximum external elastic membrane (EEM) area, and stent edge (distal and proximal) EEM area in post-procedural IVUS images. Compared with the control group patients, ΔEEM area (10.6±3.4mm2 vs. 1.7±1.9mm2, p=0.01) and vessel expansion ratio (185.6±40.3% vs. 112.0±12.1%, p=0.01) were significantly greater in the VLST group based on the greater peri-stent plaque expansion (262.1±72.8% vs. 118.7±21.2%, p=0.01). ConclusionOur serial IVUS study showed that the vascular positive remodeling after SES implantation is one of the most probable morphological mechanisms for VLST development.

Late Development Localized Aneurysmal Ectasia of Stented Coronary Segments after Sirolimus-Eluting Stent Placement, a Case Series

This case series reviews 3 patients who presented with aneurysmal ectasia, suggestive of pseudoaneurysms, at the site of coronary Cypher drug-eluting stents (DES) with Sirolimus as the eluting agent. We examine risk factors and possible etiologies of DES and Sirolimus related aneurysmal formation, specifically focusing on inhibited vessel healing, increased vascular wall apoptosis, as well as inflammatory and hypersensitivity reactions. We also examine various treatment options, including stenting the lesion with a Jomed covered stent. The clinical value of this report is to foster awareness of aneurysms and pseudoaneurysms as possible complications at stented coronary arteries. The patients described include a 56 year-old male with a Left Anterior Descending (LAD) aneurysmal formation 2 years after a Cypher stent placement, 54 year-old male with multiple areas of LAD ectasia at both Cypher stent sites 1 year after placement, and a 47 year-old female with LAD ectasia at the Cypher stent site 10 months after the intervention.

Retrograde percutaneous coronary intervention via critically degenerated saphenous vein grafts for chronic total occlusion in native coronary arteries

We report the case of a 78-year-old woman with saphenous vein graft (SVG) disease and chronic total occlusion (CTO) in three native coronary arteries [left anterior descending artery (LAD), left circumflex artery, and the right coronary artery], who was successfully treated by percutaneous coronary intervention (PCI) using the retrograde approach via the critically degenerated SVGs. The patient, a 78-year-old woman, presented with sudden chest pain and dyspnea. She had previously undergone coronary artery bypass surgery using SVGs for the three vessels and percutaneous coronary intervention with sirolimuseluting stent placement in the posterolateral branch 13 and 3 years ago, respectively. Electrocardiography revealed ST-segment elevation in leads V1-4, whereas emergent coronary angiography revealed total occlusion in her native coronary arteries. Primary PCI was scheduled. A channel dilator was advanced very smoothly and safely into the distal site of the CTO lesion in the LAD, which showed complete occlusion in the proximal region, via an SVG that was temporally occluded four days earlier. A reverse controlled antegrade and retrograde tracking technique was used to successfully perform percutaneous recanalization. Subsequently, the other two native CTO lesions protected by critically degenerated SVGs were treated with retrograde intervention via the SVGs. The retrograde approach via critically degenerated SVGs is safe, reliable, and fast. If an SVG bypassing the native CTO lesion is critically degenerated, percutaneous coronary intervention should be performed via the SVG.

Post-discharge clinical and angiographic outcomes of patients presenting within 48 h of STEMI treated with paclitaxel- or sirolimus-eluting stents

Background and purposeThe purpose of the present study was to examine the mid-term clinical and angiographic outcomes of patients with ST-segment elevation myocardial infarction (STEMI) who presented within 48h and received paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES). Methods and resultsThis study was a retrospective, non-randomized, single-center study. The post-discharge clinical outcomes of 357 consecutive patients who presented within 48h of their first STEMI and received PES (n=163) or SES (n=194) between February 2007 and February 2009 were analyzed in May 2011. The incidence of post-discharge events (i.e. cardiac death and non-fatal recurrent MI) after PES placement (0.6%) did not significantly differ from that after SES placement (1.5%). Treatment with PES was not related to the risk of adverse events post-discharge (mean follow-up period for PES placement, 1170±243 days; hazard ratio, 0.346; 95% CI, 0.036–3.371; p=0.361). No definite stent thromboses developed after treatment with PES or SES. The incidence of binary in-stent restenosis (stenosis of more than 50% of the diameter at secondary angiography performed 10–18 months after the initial procedure) after PES placement (17.1%) was significantly higher than that after SES placement (4.8%; p<0.001). PES placement was an independent predictor of binary in-stent restenosis (odds ratio, 3.892; 95% CI, 1.470–10.30; p=0.006). ConclusionsRetrospective examination of the post-discharge clinical course after placement of PES and SES showed favorable midterm clinical outcomes among Japanese STEMI patients treated within 48h of onset. However, SES treatment resulted in superior angiographic outcomes compared to PES.

Comparing outcomes after off-pump coronary artery bypass versus drug-eluting stent in diabetic patients

Off-pump coronary artery bypass surgery and sirolimus-eluting stent placement have been widely used for the treatment of coronary artery disease. The goal of this study was to compare long-term outcomes after off-pump coronary artery bypass surgery or sirolimus-eluting stent placement in diabetic patients with multivessel disease. This observational study enrolled 350 off-pump coronary artery bypass patients and 143 sirolimus-eluting stent patients receiving care at our institution between 2000 and 2007. All patients had diabetes and multivessel disease including proximal left anterior descending or left main coronary artery. The choice of revascularization (percutaneous coronary intervention versus coronary artery bypass surgery) was left to the physician's discretion rather than randomization. Cox proportional-hazard analyses, adjusting baseline risk factors and propensity score, which predicted the probability of receiving off-pump coronary artery bypass, were conducted to evaluate outcomes, including all-cause mortality, cardiac death, target vessel revascularization, and major adverse cardiac and cerebrovascular events. During the follow-up (2.6±1.6 years) period, there was no difference between off-pump coronary artery bypass and sirolimus-eluting stent placement in all-cause mortality or cardiac death. However, the incidences of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events were markedly lower in the patients undergoing off-pump coronary artery bypass than in those receiving sirolimus-eluting stent placement. Off-pump coronary artery bypass is superior to sirolimus-eluting stent placement in terms of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events in diabetic patients with multivessel coronary artery disease.

Sirolimus-Eluting Stents for the Treatment of Infrapopliteal Arteries in Chronic Limb Ischemia: Long-term Clinical and Angiographic Follow-up

To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3-6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) >50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1±20.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p=0.022). Treatment of focal infrapopliteal lesions with SES showed encouraging long-term angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.

Comparison of restenosis rate with sirolimus-eluting stent i n STEMI patients with and without diabetes at 6-month angiographic follow-up

Objective Patients with diabetes mellitus (DM) are at high risk for restenosis after coronary stenting. However, whether drug-eluting stents are eff ective in diabetic patients presenting with ST-segment elevation myocardial infarction (STEMI) is uncertain. We report on a series of patients with or without DM followed up for 6 months after sirolimus-eluting stent implantation.Methods This cohort study enrolled 195 STEMI patients who underwent sirolimus-eluting stent implantation and accepted angiographic followup at 6 months.Results There were no signifi cant diff erences between the two groups in baseline clinical characteristics and risk factors. The two groups were treated with similar stent lengths and diameters. The unadjusted in-stent restenosis was signifi cantly higher in diabetic than in non-diabetic patients at 6 months (7.8 vs 1.7, P < 0.05). Multivariate analysis showed that only diabetes and current smoking were independent predictors of restenosis (odds ratio 12.82 and 7.98, respectively, both P < 0.05).Conclusion The present study demonstrated that diabetes increased restenosis after sirolimus-eluting stent placement in STEMI patients. This fi nding implicates that diabetes remains an important predictor for restenosis in the DES era.

Retrospective comparison of clinical and angiographic outcomes after primary stenting using sirolimus-eluting and bare-metal stents in nonrandomized consecutive 568 patients with first ST-segment elevated myocardial infarctions

The long-term safety and efficacy of primary stenting using drug-eluting stents (DES) in patients with ST-segment elevation myocardial infarction (STEMI) are not fully understood in Japan. Therefore, we retrospectively examined the midterm clinical and angiographic outcomes in STEMI patients after primary stenting using sirolimus-eluting stents (SES) in a clinical setting through a historical comparison with those of bare-metal stents (BMS). The study design was a retrospective, nonrandomized, and single-center study. The clinical outcomes for 568 consecutive patients who presented within 12 h of their first STEMI and who were treated with BMS (n = 198; 184 STEMIs from June 2003 to August 2004 and 14 STEMIs from September 2004 to May 2007) or SES (n = 370; from August 2004 to May 2007) at our medical center in Japan were retrospectively investigated in February 2010. The incidence of post-discharge events (comprising cardiac death and nonfatal recurrent MI) after SES placement (3.9%) was not significantly different from that after BMS placement (6.7%). SES was not related to the risk of post-discharge events (mean follow-up for SES, 1327 ± 415 days; BMS, 1818 ± 681 days) (hazard ratio of 0.369 at 95% CI, 0.119-1.147, p = 0.085). The incidence of definite stent thromboses after SES placement (0.54%) was not significantly higher than that after BMS placement (0%). The incidence of binary in-stent restenosis (% diameter stenosis of more than 50% at secondary angiography) after SES placement (8.3%) was significantly lower than that after BMS placement (25.7%; p < 0.001). From the present historical comparison of SES and BMS, we conclude that primary stenting using SES in a clinical setting has favorable clinical and angiographic outcomes in Japanese STEMI patients.

Elevated high sensitive C-reactive protein and apelin levels after percutaneous coronary intervention and drug-eluting stent implantation

Percutaneous coronary intervention (PCI) triggers an acute inflammatory response, while sirolimus is known to have anti-inflammatory properties; the inflammatory system response to PCI after sirolimus-eluting stent placement remains unclear. The purpose of this study is to determine the changes in high sensitive C-reactive protein (hs-CRP) and apelin after PCI procedure and drug-eluting stent implantation in patients with and without reduced left ventricular systolic function. Forty-eight consecutive patients undergoing PCI at the Beijing Anzhen Hospital between July and September 2006 were recruited. Sirolimus-eluting stents were employed in all patients. Blood samples were drawn immediately before and 24 h after the procedure. Plasma hs-CRP and apelin levels were determined by enzyme immunoassay. Paired t-test revealed a significant increase in both hs-CRP and apelin post-procedure (P=0.006 and P<0.0001, respectively). Patients with reduced left ventricular ejection fraction (LVEF) had significantly lower baseline apelin levels compared to those with normal ventricular function [(46.8+/-10.8) vs. (72.0+/-8.4) pg/ml, P<0.001]. However, apelin increased to a level similar to the level of those with normal left ventricular systolic function 24 h after the PCI procedure [(86.7+/-11.6) vs. (85.1+/-6.1) pg/ml, P=0.72]. hs-CRP and apelin levels increased after PCI and sirolimus-eluting stent implantation. Patients with impaired left ventricular systolic function had significantly lower baseline apelin levels, which increased significantly after PCI.

Primary Use of Sirolimus-Eluting Stents in the Infrapopliteal Arteries

To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia. A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification. Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year. Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.

Treatment of mild–moderate calcified coronary lesions with sirolimus-eluting stent: real world data from a single center

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

Sirolimus-eluting stent placement for refractory renal artery in-stent restenosis: sustained patency and clinical benefit at 24 months

Renal artery stenosis may cause or exacerbate hypertension and renal failure. Percutaneous transluminal renal artery stent placement, increasingly the first-line therapy for ostial atherosclerotic renal artery stenosis, can be complicated by in-stent restenosis weeks to months after the procedure. There is currently no consensus for the treatment of in-stent restenosis. Sirolimus-eluting stents have been shown to be effective to treat in-stent restenosis in the coronary circulation. We report a case of sustained 24-month patency after repair of recurrent renal artery in-stent restenosis with use of a sirolimus-eluting stent.

Improved cardiac function after sirolimus-eluting stent placement in diabetic patients by pioglitazone: Combination therapy with statin

Peroxisome proliferator-activated receptor-gamma (PPAR-gamma) agonists are used as anti-diabetic drugs, and their pleiotrophic action has been reported to improve endothelial function leading to cardioprotective effects. In this study we evaluated the long-term effect of pioglitazone on cardiac function in diabetic patients after percutaneous coronary intervention (PCI) by drug-eluting stent (DES). We investigated 54 diabetic patients who received PCI using a sirolimus-eluting stent. We excluded cases of acute myocardial infarction. They were divided into two groups: Group C received only conventional therapy (n=26) and Group P received additionally pioglitazone 15 mg/day (n=28). The left ventricular ejection fraction (LVEF) was measured by left ventriculography and analyzed before and 8 months after PCI. In Group C, LVEF did not change significantly: 55.6% vs. 56.7%, before and after PCI respectively (p=0.58). However, pioglitazone significantly improved LVEF: 54.4% vs. 60.0% (p=0.014). Multiple linear regression analysis showed that DeltaLVEF was significantly related to pioglitazone therapy (p=0.037). In particular, the combination of pioglitazone and statin improved LVEF (DeltaLVEF 9.6% with vs. 2.2% without statin). Pioglitazone improved cardiac function after PCI using SES in diabetic patients, especially in combination with a statin.

A case of a newly developed yellow neointima at stent implanted site 1 year after sirolimus-eluting stent placement

Coronary angioscopy is a useful tool for understanding plaque characteristics through the plaque color and surface thrombus formation. We experienced an interesting case of a newly developed yellow neointima 400 days after a sirolimus-eluting stent implantation. A 72-year-old woman suffering from angina pectoris was admitted to our hospital. Coronary angiography revealed severe stenosis at the proximal left descending artery and she was implanted with a sirolimus-eluting stent. Coronary angioscopic observation immediately after stent implantation revealed the presence of yellow plaque only at the most severe stenosis lesion in the stent placement site. We performed a coronary angiography 400 days after the sirolimus-eluting stent implantation and did not find an in-stent restenosis. An intravascular ultrasound indicated minimum neointimal formation. By coronary angioscopy, we could clearly observe that the neointima had covered the surface of the stent struts; the stent struts were barely visible under the neointima. Surprisingly, neointima formed in response to the sirolimus-eluting stent was entirely yellow. Precise mechanisms of producing yellow neointima was unknown, we may observe a pathologic neointima induced by sirolimus-eluting stent.

Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions

AimsWe investigated whether routine T-stenting reduces restenosis of the side branch as compared with provisional T-stenting in patients with de novo coronary bifurcation lesions.Methods and resultsOur randomized study assigned 101 patients with a coronary bifurcation lesion to routine T-stenting with sirolimus-eluting stents (SES) in both branches and 101 patients to provisional T-stenting with SES placement in the main branch followed by kissing-balloon angioplasty and provisional SES placement in the side branch only for inadequate results. Primary endpoint was per cent diameter stenosis of the side branch at 9 month angiographic follow-up. Angiographic follow-up in 192 (95%) patients revealed a per cent stenosis of the side branch of 23.0 ± 20.2% after provisional T-stenting (19% with side-branch stent) and of 27.7 ± 24.8% (P = 0.15) after routine T-stenting (98.2% with side-branch stent). The corresponding binary restenosis rates were 9.4 and 12.5% (P = 0.32), prompting re-intervention in 5.0 and 7.9% (P = 0.39), respectively. In the main branch, binary restenosis rates were 7.3% after provisional and 3.1% after routine T-stenting (P = 0.17). The overall 1 year incidence of target lesion re-intervention was 10.9% after provisional and 8.9% after routine T-stenting (P = 0.64).ConclusionsRoutine T-stenting with SES did not improve the angiographic outcome of percutaneous coronary intervention of coronary bifurcation lesions as compared with stenting of the main branch followed by kissing-balloon angioplasty and provisional side-branch stenting.

Long‐term clinical outcomes of real‐world experience using sirolimus‐eluting stents in saphenous vein graft disease

To evaluate the long-term clinical outcomes of patients undergoing percutaneous coronary intervention for saphenous vein graft (SVG) disease. Specifically, we compared clinical endpoints of patients who received sirolimus-eluting stents (SES) versus bare-metal stents (BMS) for SVG disease. A recent small randomized-controlled trial (RCT) reported increased mortality with the use of SES in SVG disease. We retrospectively identified patients who underwent SES placement for a SVG lesion(s) at our institutions over a 4-year period. The procedural and medical records were reviewed to identify predetermined clinical outcomes. 318 patients who underwent SES placement for a SVG lesion were identified. 7 patients were lost to follow-up. 141/311 patients (45%) received SES, while 170/311 (55%) received BMS. At a mean follow-up of 34 months, there was a reduction in target lesion revascularization (TLR) (7% vs. 14%, P = 0.07) without an increased risk of mortality (6% vs. 12%, P = 0.06) in patients who received SES compared to patients who received BMS. When compared to the recent RCT's SES patients at long-term follow-up, our SES patients had significantly less mortality; rates of myocardial infarction, TLR, target vessel revascularization, and major adverse cardiac events; and were more likely to be taking dual antiplatelet and statin medications. Our results support that SES used in SVG lesions result in a reduction in TLR without an increased risk of mortality, and therefore may be an equally safe and feasible technique for revascularization with excellent long-term clinical outcomes. These patients may benefit from prolonged dual antiplatelet and statin medication regimens.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Long-Term Clinical Outcome after Sirolimus-Stent Implantation for in Sirolimus-Eluting Stent Restenosis

Restenosis after sirolimus-eluting stents (SES) remains a clinical problem. We report our experience with the use a second SES in the fi rst SES to treat in-SES restenosis. Twenty-seven patients with in-SES restenosis were included in the registry. In-SES restenosis was focal in 34%, diffuse in 59% and proliferative in 7%. The procedure was successful in all patients without any acute in-hospital complications. During a mean follow-up of 14 ± 7 months MACE occurred in 8 patients (30%), (1 death, 1 myocardial infarction, 4 target lesion revascularisation, 1 target vessel revascularisation and 1 patient underwent CABG). Nineteen patients (70%) had an event-free outcome. In conclusion SES placement to treat in-SES is safe and feasible and could be considered as a therapeutic option. However the incidence of MACE remains high on a long-term period. The use of stents has significantly improved the outcome of percutaneous coronary interventions (PCI) (1,2). However, despite major advances in angioplasty and stenting, in-stent restenosis remains a major limitation. Recently, drug-eluting stents and especially sirolimus-eluting stents (SES) have emerged as a very promising approach in preventing restenosis, and several different compounds have been shown to have a major impact on both the angiographic and the clinical outcome (6–9). However, even after drug eluting stents implantation in-stent restenosis (ISR) remains and represents a clinical challenge. Several approaches have been proposed to deal with ISR like plain old balloon angioplasty (POBA), rotational atherectomy, brachytherapy (1–3). Few reports are actually available about the use of SES in SES for ISR treatment. We report our experience about the use SES for treating an ISR after SES implantation.

Prognostic Value of the Modified American College of Cardiology/American Heart Association Lesion Morphology Classification for Clinical Outcome After Sirolimus-Eluting Stent Placement (Results of the Prospective Multicenter German Cypher Registry)

The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.

Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials

Background:The impact of incomplete stent apposition (ISA) after drug-eluting stent implantation determined by intravascular ultrasound (IVUS) on late clinical events is not well defined.Objective:To evaluate the clinical impact of ISA...