Angiographic outcomes with biodegradable polymer and permanent polymer drug‐eluting stents

Background : In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents (ISAR‐TEST‐4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus‐eluting stent to permanent polymer (PP) sirolimus/everolimus‐eluting stent (Cypher/Xience‐V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR‐TEST‐4 patients with paired angiographic studies. Methods : Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in‐stent late lumen loss, in‐segment binary restenosis, and restenosis morphology at 6–8‐month follow‐up angiogram. Results : Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST‐4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6–8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in‐stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in‐segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion : Angiographic characteristics of restenosis after BP‐based limus‐eluting stents are similar to those of PP‐based limus‐eluting stents. © 2011 Wiley‐Liss, Inc.     

Difference of neointimal growth patterns in bifurcation lesions among four kinds of drug‐eluting stents

Aim: Neointimal proliferation of bifurcation lesions after implantation of drug‐eluting stents (DES) has not been well evaluated. Thus, we compared neointimal proliferation of bifurcation lesions among four DES using optical coherence tomography (OCT). Methods: 8‐month follow‐up OCT was performed in 68 bifurcation lesions treated by 15 sirolimus‐eluting stents (SES) and 17 paclitaxel‐eluting stents (PES) as first‐generation DES, and by 17 zotarolimus‐eluting stents (ZES) and 19 everolimus‐eluting stents (EES) as second‐generation DES. Cross‐sectional images of the bifurcation lesion using OCT were analyzed every 450 µm. All images were divided into three areas: inner wall of the bifurcation (IB), outer wall of the bifurcation (OB), and ostium of the side branch (SB). We compared the incidence of uncovered struts (IUS) among three areas and the averaged neointimal thickness (NIH) between IB and OB in each stent and also compared these OCT parameters among all DES. Results: There were no significant differences of IUS between IB and OB in second‐generation DES, while in first‐generation DES, IUS of IB and OB showed significant differences. The IUS of SES in both areas was significantly higher than in the other DES (all P < 0.001). PES had a significantly higher IUS in SB than the others (all P < 0.001). NIH of OB was significantly higher than that of IB in PES, ZES, and EES, but in SES the NIH was similar in the two areas. Conclusions: OCT revealed different neointimal growth patterns among SES, PES, ZES, and EES in bifurcation lesions. © 2014 Wiley Periodicals, Inc.     

Prospective evaluation of myocardial ischemia related to post‐procedural side‐branch stenosis in bifurcated lesions treated by provisional approach with drug‐eluting stents

Objectives : To prospectively assess the impact of post‐procedural side‐branch (SB) stenosis on inducible myocardial ischemia in patients with bifurcated lesions undergoing percutaneous interventions. Background : Provisional‐stenting with drug‐eluting stents (DES) is the recommended strategy to treat percutaneously bifurcated lesions but is associated to variable degrees of residual SB stenosis. The role of SB residual stenosis on post‐procedural myocardial ischemia is uncertain. Methods : Patients with bifurcations treated by DES according to provisional‐stenting technique were enrolled in the study if they had no other untreated lesion. Patients were divided into two groups according to post‐procedural 3D‐quantitative coronary analysis (3DQCA): group OR (optimal result: stenosis < 50% of SB lumen area at 3DQCA) and group SR, suboptimal result: (stenosis ≥ 50% of SB lumen area at 3DQCA). Treadmill exercise stress test (EST) was performed within 1 week from PCI. The primary study endpoint was myocardial ischemia (≥1 mm ST‐segment depression at EST). Results : Sixty patients were enrolled: 49 (81.7%) comprised group OR and 11 (18.3%) group SR. Post‐PCI myocardial ischemia at EST was inducible in 17 (34.7%) patients of group OR versus 10 (90.9%) patients of group SR (P = 0.0007). During the follow‐up, patients of Group SR (vs. Group OR) had a significantly higher occurrence of inducible myocardial ischemia during late (>8 weeks) stress tests (P < 0.001). Conclusions : In patients with bifurcated lesions treated by a provisional‐stenting technique, residual SB stenosis ≥ 50% at 3DQCA is associated with post‐procedural inducible myocardial ischemia at EST. © 2011 Wiley Periodicals, Inc.     

Real World,Long‐Term Outcomes Comparison Between Paclitaxel‐Eluting and Sirolimus‐Eluting Stent Platforms

We compare real‐world, extended target vessel revascularization (TVR)‐free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) following an index drug‐eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES‐supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in‐hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan‐Meier and Cox's proportional hazard survival methods were performed. TVR‐free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan‐Meier survival curves did not significantly differ (adjusted hazard ratio ?1.39 [95% CI 0.99–1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3–97.6] vs. 95.7% for PES [95% CI 94.1–96.9]) and two (95.0%[95% CI 93.0–96.4] for SES vs. 93.7% for PES [95% CI 91.6–95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7–97.3) and 95.3% for PES (95% CI 93.7–96.5). SES and PES drug‐eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI. (J Interven Cardiol 2010;23:167‐175)     

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.     

Seven‐year safety and efficacy of the unrestricted use of drug‐eluting stents in saphenous vein bypass grafts

Objectives : The aim was to investigate the 7‐year clinical outcomes of patients treated with either drug‐eluting stents (DES) or bare‐metal stents (BMS) for saphenous vein graft disease (SVG). Background : Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long‐term safety and efficacy results for DES in SVG have been published. Methods : Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus‐ or paclitaxel‐eluting stents) or with BMS. Yearly follow‐up was performed. Results : At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P‐value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39–1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67–1.3). Conclusions : In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years‐ and the use of DES resulted in a clinically relevant lower rate of TVR. © 2011 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.     

A completely fractured zotarolimus‐eluting stent in an aortocoronary saphenous vein bypass graft

Drug‐eluting stents (DES) have significantly improved the rate of target vessel revascularization in comparison with bare metal stents. DES fracture was not reported in multicenter randomized clinical trials, but several case reports of DES fracture have been published, mostly with sirolimus‐eluting stents. DES fracture is associated with stent restenosis and thrombosis. We report a zotarolimus‐eluting stent fracture in an aortocoronary saphenous vein graft (SVG) bypass. The patient presented with chest pain and a non‐ST‐elevation myocardial infarction. He underwent cardiac catheterization that showed a complete fracture of a zotarolimus‐eluting stent in the ostium of a sequential SVG to the diagonal and obtuse coronary arteries. His management included coronary angioplasty and retrieval of the proximal fractured segment. We discuss the potential causes for this stent fracture and suggest caution when using a DES in an ostial location of a SVG bypass, especially in a highly mobile vessel. © 2012 Wiley Periodicals, Inc.     

The fine balance of quality and quantity: the time has come to define quality of PCI!

Drug‐eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus‐eluting stents (SES) showed better outcomes than paclitaxel‐eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor‐eluting stents in the treatment of bifurcation lesions according to the provisional T‐stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus‐eluting stents (ZES) were implanted in 53 patients and everolimus‐eluting stents (EvES) in 62 patients. Primary end‐point of the study was the 12‐month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of >50% restenosis on the main vessel or TIMI flow <3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non‐ST‐segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed. © 2010 Wiley‐Liss, Inc.     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

Randomized evaluation of two drug‐eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1‐Year results of the PAINT trial

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.     

Percutaneous intervention on the saphenous vein bypass grafts—Long‐term outcomes

Background/Objective : In this era of drug eluting stents (DES), the long‐term outcome of percutaneous intervention (PCI) on saphenous venous grafts (SVG) is unknown. The objective of the study was to compare the long‐term outcomes of DES versus bare metal stent (BMS) in this population and to determine the predictors of outcomes. Methods : We reviewed the medical records of all patients who had PCI performed during January 2003 to February 2005 to obtain data cardiac risk factors, medications at discharge, angiographic details and outcomes. Results : One hundred and nine patient had PCI to SVG; of these, 37 patients received DES and the remaining had BMS. Over a mean follow‐up of 33 months, the PCI using DES was associated with 30% restenosis, 35% target vessel revascularization (TVR) and major adverse cardiac event (MACE) rate of 46% versus 35% restenosis, 38% TVR and 50% MACE rate with BMS. There was no significant difference in long‐term outcome with DES as compared to BMS. Conclusion : There was no difference in the long‐term outcomes of PCI on SVG irrespective of the type of stent used. © 2008 Wiley‐Liss, Inc.     

Drug eluting stenting in bifurcation coronary lesions long-term results applying a systematic treatment strategy

Objectives : To explore the long‐term results following implantation of drug‐eluting stents (DES) in bifurcation lesions according to contemporary “real world” practice. Background : Limited information is available on the long‐term outcomes of patients with bifurcation lesions who are treated using DES. A systematic approach for bifurcation lesion management was applied, using either a “provisional” single stent technique or a dedicated two stents strategy according to the side‐branch diameter and severity of its ostial stenosis. Methods : Four hundred one consecutive patients underwent bifurcation percutaneous coronary intervention (PCI) using DES and were included in our prospective registry. All adverse events were recorded up to 2 years and distinguished according to the planned PCI strategy (e.g., one versus two stents technique). Results : A planned two stents strategy was used in 141 patients (35% of patients). In 260 patients (65%), the planned treatment involved stenting of the main branch only with “provisional” stenting of the side‐branch according to procedural course. Thus, 24 patients (9.2%) needed additional stenting at the side‐branch to complete the PCI. Cumulative major adverse cardiac event rate at 1 and 2 years was similar for both groups (11.4% vs. 14.8% at 1 year and 19.4% vs. 25.7% at 2 years for the single vs. two stents groups, accordingly, P = NS for both). Likewise, there was no difference in mortality, cardiac mortality, myocardial infarction, need for target lesions or target vessel revascularization, or definite stent thrombosis rate between the two groups at 6, 12, and 2 years follow‐up. The rate of angiographically confirmed (i.e., definite) stent thrombosis did not differ between the two groups during follow‐up. Conclusions : Our study revealed favorable long‐term clinical results following DES implantation using a systematic, rather simplified approach towards bifurcation stenting and using either a single or double stenting technique. © 2011 Wiley Periodicals, Inc.     

Treatment of coronary bifurcation lesions with drug-eluting stents: insights from the first phase of the prospective multicenter german drug-eluting stent registry

Background: Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug‐eluting stents (DES). We sought to investigate 1‐year outcome of the treatment of bifurcation lesions using DES in a large “real‐world” cohort. Methods and Results: Among 5,126 patients enrolled in phase I of the multicenter German Drug‐Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus‐eluting stents (SES) versus paclitaxel‐eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1‐year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum‐defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively). Conclusion: In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1‐year outcomes after DES implantation. The outcomes for SES and PES were similar. (J Interven Cardiol 2012;25:344–352)     

Comparison of 2‐year clinical outcomes with sirolimus and paclitaxel‐eluting stents for patients with diabetes: Results of the Registro Regionale AngiopLastiche Emilia‐Romagna Registry

Background: Long‐term outcomes of percutaneous coronary interventions (PCI) with sirolimus‐eluting stents (SES) compared to paclitaxel‐eluting‐stents (PES) in unselected diabetics in routine practice is still debated. Objective: This study compared the 2‐year incidence of MACE (all‐cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real‐world setting of patients with diabetes. Design: Observational, multicenter, nonrandomized study. Setting: Prospective web‐based registry (REAL Registry; study period, 2002–2005) comprising all 13 hospitals performing PCI. Patients: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin‐requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. Measurements: Unadjusted and propensity score‐adjusted 2‐year clinical outcome. Results: After propensity score adjustment, 2‐year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72–1.42, P = 0.96). Adjusted 2‐year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real‐world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long‐term safety of different types of DES in patients with diabetes. © 2009 Wiley‐Liss, Inc.     

First nine‐month complete invasive assessment (angiography,IVUS, and OCT) of the novel NEVO™ sirolimus‐eluting stent with biodegradable polymer

At present, percutaneous coronary intervention with drug‐eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long‐term safety of first‐generation DES have prompted the development of novel DES systems such as the NEVO? (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus‐eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res‐Elution I study. © 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.     

Multicenter international registry of unprotected left main coronary artery percutaneous coronary intervention with drug‐eluting stents in patients with myocardial infarction

Background: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high‐risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in MI patients has not been extensively studied. Methods: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST‐elevation MI [STEMI] and 39 non‐ST‐elevation MI [NSTEMI]) from 2002 to 2006. Results: The mean age was 70 ± 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 ± 8. Angiographic success was achieved in all patients. Overall in‐hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 ± 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07–17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90–0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62–30.21), P = 0.009) were significantly associated with increased mortality. Conclusions: Patients with MI and ULMCA disease represent a very high‐risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long‐term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients. © 2008 Wiley‐Liss, Inc.     

Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy

The aim of this study was to investigate clinical outcomes of patients treated with a provisional stenting (PS) versus a double stenting (DS) strategy for coronary bifurcation lesions with bioresorbable scaffolds (BRS). There are limited data available with regards to outcomes following BRS implantation for bifurcation lesions. A total of 132 bifurcation lesions treated with BRS between 2012 and 2014 were analyzed. Of the total of 132 bifurcation lesions, 10 lesions were treated without crossover stenting. 99 lesions (81%) were treated with a PS strategy and 23 lesions (19%) with a DS strategy. The DS group consisted of patients with a greater number of true bifurcation lesions (PS 52.0% vs. DS 91.3%: P < 0.001). In the PS group, seven lesions (7.1%) were crossed‐over to T‐stenting. In the DS group, 13 lesions (57%) were treated with BRS to the side branch (SB). A hybrid stenting technique [BRS to the main branch, and metallic drug‐eluting stent (DES) to the SB] was utilized in 10 (43%) lesions. Target lesion revascularization (TLR) rates were 5.5% for PS and 11.2% for DS (P = 0.49) at 1‐year follow‐up. Definite scaffold thrombosis did not occur at the site of any bifurcation lesion. These findings suggest that BRS implantation for bifurcation lesions is technically feasible. The rates of TLR tended to be higher in the DS group compared to when a PS strategy was employed. Larger studies are eagerly awaited to determine longer‐term follow‐up of this treatment strategy. © 2015 Wiley Periodicals, Inc.     

Risk Factors and Clinical Impacts of Peri‐Stent Contrast Staining After Second‐Generation Drug‐Eluting Stent Implantation

Background

Peri‐stent contrast staining (PSS) after sirolimus‐eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second‐generation DES implantation remain unclear.

Methods and Results

This study comprised 2,090 patients with 2,883 lesions treated with second‐generation DES from April 2009 to February 2013. Angiographic findings and clinical outcomes were compared between PSS and non‐PSS groups. Follow‐up angiography was available for 2,411 lesions. PSS was observed in 23 lesions: 4 in biolimus‐eluting stents, 4 in zotarolimus‐eluting stents (ZES), and 15 in everolimus‐eluting stents (EES). Right coronary artery lesions, chronic total occlusion (CTO), and lesions with severe angulation (>90°) were more frequent in the PSS group compared with the non‐PSS group. Lesions were longer and the cumulative TLR incidence at 3 years was higher in the PSS group than those in the non‐PSS group (27.9 mm vs. 19.4 mm, P < 0.0001; 27.4% vs. 8.6%, P = 0.0002). There was no significant difference in stent thrombosis between the two groups. Multivariable analysis identified CTO [odds ratio (OR) 3.75, 95%CI 1.52–8.88, P = 0.005] as an independent predictor of PSS.

Conclusions

PSS after second‐generation DES implantation was associated with an increased risk of subsequent TLR. CTO was the independent predictor of PSS. (J Interven Cardiol 2016;29:179–187)