Extended follow‐up safety and effectiveness of the Endeavor zotarolimus‐eluting stent in real‐world clinical practice: Two‐year follow‐up from the E‐Five Registry

Objectives: To present data from the cohort of patients in the all‐comers Endeavor zotarolimus‐eluting stent (ZES) registry (E‐Five) who underwent 2‐year follow‐up. Background: The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E‐Five evaluated the ZES in over 8,000 real‐world patients, at 188 sites followed to 1 year. A subset of sites continued follow‐up through 2 years to evaluate late‐term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics. Methods: E‐Five, a prospective, multicenter, nonrandomized global registry, collected 2‐year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow‐up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis. Results: The outcomes in the 2‐year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively. Conclusions: Long‐term efficacy and safety outcomes were maintained between 1 and 2 years for the 2‐year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events. © 2010 Wiley‐Liss, Inc.     

Early and long‐term results of percutaneous coronary intervention for unprotected left main trifurcation disease

Objectives: We aimed to conduct a retrospective cohort study focusing on our 5‐year experience in the percutaneous treatment of unprotected left main (ULM) trifurcation disease. Background: Percutaneous treatment of ULM trifurcation remains a challenging and rare procedure for most interventional cardiologists. Moreover, data on long‐term outcomes are lacking. Methods: We retrieved all patients with ULM trifurcation disease treated percutaneously at our Institution since 2002, and adjudicated baseline, procedural, and outcome data. The primary end point was the long‐term rate of major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, bypass surgery, or target vessel revascularization). Results: A total of 27 patients underwent percutaneous coronary intervention with stent implantation for ULM trifurcation disease, with 14 (52%) cases of true trifurcations, i.e., with concomitant significant stenoses of the distal ULM/ostial left anterior descending plus ostial ramus intermedius and ostial circumflex. Bare‐metal stents were implanted in 8 (29%) patients and drug‐eluting stents (DES) in 26 (96%), with a main branch stent only strategy in 11 (40%), T stenting in 9 (33%), and V stenting in 6 (27%). Procedural and clinical success occurred in 26 (96%), with one postprocedural death. Angiographic follow‐up was obtained in 22 patients (81%), and clinical follow‐up was completed in all subjects after a median of 28 ± 17 months, showing overall MACE in 9 (33%), with cardiac death in 4 (15%), myocardial infarction in 1 (4%), coronary artery bypass grafting (CABG) in 4 (15%), and percutaneous target vessel revascularization in 5 (19%). Definite stent thrombosis was adjudicated in 1 (3%) patient. Treatment of a true trifurcation lesion and recurrence of angina during follow‐up were significantly associated with an increased risk of MACE (P = 0.029 and P = 0.050, respectively). Conclusions: Percutaneous treatment of ULM trifurcation disease is feasible, associated with favorable mid‐term results, and may be considered given its low invasiveness in patients at high surgical risk or with multiple comorbidities. © 2008 Wiley‐Liss, Inc.     

Treatment of unprotected left main disease with drug-eluting stents in patients at high risk for coronary artery bypass grafting.

BACKGROUND: Percutaneous coronary intervention (PCI) for high-grade stenosis of the left main coronary artery with bare-metal stents has been limited by restenosis, and most patients are managed with coronary artery bypass grafting (CABG). Recently, drug-eluting stents (DES) have reduced instent restenosis after PCI, but their role in the treatment of left main disease remains unclear. AIMS: The aim of this study was to determine the outcomes after utilizing DES to treat left main disease. METHODS: Twenty consecutive symptomatic patients with >50% angiographic stenosis of the left main coronary artery with no prior history of CABG ["unprotected left main" (ULM)] underwent PCI with DES. Patients were divided into two groups based on the presence (Group A, n=5) or absence (Group B, n=15) of preprocedural cardiogenic shock. At follow up (median, 14 months), cumulative major adverse cardiac events (MACE-death, myocardial infarction, or target vessel revascularization) were determined. RESULTS: Sixteen (80%) of 20 patients were at high risk for CABG because of comorbidity, advanced age, or cardiogenic shock. Procedural success was 100% (20/20). Three of five patients in Group A (60%) died in hospital and the two surviving patients experienced no MACE at follow up. In Group B (n=15), there was no in-hospital MACE, but one patient died suddenly 8 weeks postprocedure [cumulative MACE of 7% (1/15)]. CONCLUSIONS: Our study demonstrates the feasibility of ULM treatment with DES with acceptable medium-term outcomes. While CABG remains the best form of revascularization for the majority of patients with ULM, DES should be considered in those who are at high risk.     

Five‐year clinical follow‐up after implantation of the endeavor zotarolimus‐eluting stent: ENDEAVOR I,first‐in‐human study

Objective : To evaluate the 5‐year clinical outcomes of patients treated with the Endeavor zotarolimus‐eluting stent (ZES) in the ENDEAVOR I first‐in‐human study. Background : ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. Methods : Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have ≥50% stenosis, be ≤15 mm in length, and located in a vessel with a reference diameter of 3.0–3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. Results : The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non‐Q‐wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. Conclusions : Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Hybrid coronary revascularization for the treatment of left main coronary stenosis: a feasibility study

Objective : To determine the feasibility of a hybrid coronary revascularization (HCR) approach for the treatment of left main (LM) coronary artery stenosis. Background : The recommended therapy for significant LM stenosis is coronary artery bypass grafting (CABG). Percutaneous coronary intervention (PCI) of unprotected LM lesions is reserved for patients at high risk for complications with CABG. HCR in LM disease has not been studied. Methods : Twenty‐two consecutive patients with LM stenosis >70% underwent staged HCR. Following a robotic or thoracoscopic‐assisted minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) coronary bypass, PCI of the LM, and non‐LAD targets was performed after angiographic confirmation of LIMA patency. Intravascular ultrasound confirmed optimal stent deployment. Thirty‐day adverse outcomes and long term follow up was obtained. Results : In the 22 patients with LM lesions, 6 were ostial, 5 mid, and 11 distal. LIMA patency was FitzGibbon A in all cases. LM stenting was successful in all patients with drug‐eluting stents (DES) placed in 21 of 22 cases. Three patients underwent stent implantation in the right coronary artery. There were no 30‐day major adverse cardiac or cerebrovascular events. At a mean of 38.8 ± 22 months postprocedure, 21 patients were alive without reintervention; one death occurred at 454 days. Conclusions : HCR for LM coronary disease is a feasible alternative to CABG and unprotected LM PCI. This approach combines the long‐term durability of a LIMA‐LAD bypass with the less invasive option of PCI in non‐LAD targets with DES. © 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.     

Coexistent in-stent restenosis, late incomplete stent apposition and mural thrombus in a zotarolimus-eluting stent

Drug-eluting stents (DES) have been demonstrated to dramatically reduce the rate of in-stent restenosis (ISR). However, some studies found an increased rate of late incomplete stent apposition (ISA) and late stent thrombosis (ST) in DES compared to traditional bare-metal stents (BMS). Endeavor stent, a new cobalt-alloy DES coated with phosphorylcholine and zotarolimus, has been reported to have a very favorable safety profile with few documented late-acquired ISA and late ST. In the present report, we described an interesting case with coexistent ISR, late ISA and mural thrombus in an Endeavor zotarolimus-eluting stent 8 months after primary percutaneous coronary intervention.     

Comparison of 2‐year outcomes between zotarolimus‐eluting and everolimus‐eluting new‐generation cobalt–chromium alloy stents in real‐world diabetic patients

Background : To date, it remains unknown whether different types of new‐generation drug‐eluting stents have a differential impact on long‐term outcomes in diabetic patients. Methods and Results : In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new‐generation CoCr zotarolimus‐eluting stents (R‐ZES: 136 patients, 196 lesions) or everolimus‐eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2‐year follow‐up period. MACE was defined as all‐cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R‐ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2‐year follow‐up, there was no significant difference in occurrence of MACE (R‐ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all‐cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity‐score matching did not alter the aforementioned associations. Conclusion : After 2 years of follow up similar outcomes (MACE, all‐cause mortality/MI, TLR) were observed in real‐world diabetic patients, including those with complex lesions and patient characteristics, treated with R‐ZES and EES. © 2015 Wiley Periodicals, Inc.     

Left main intervention in myocardial infarction

We report an 84‐year‐old patient who suddenly developed nausea, vomiting, hypotension, and needed intubation, assisted ventilation and pharmacological vasopressor support. Admission EKG showed anterior and lateral leads ST segment depression and 2 mm ST segment elevation in avR lead. Angiogram showed unprotected left‐main coronary‐artery (LM) sub‐occlusive disease and totally occluded ostial right‐coronary‐artery (RCA), distally filled through the left‐coronary system. Unprotected LM disease was immediately treated with bare metal stent. The stent jailed the left‐circunflex coronary‐artery (LCx) ostium but did not compromise the arterial flow. Lately, the patient was discharged in a very good health condition. Ten months angiographic follow‐up showed an extremely compromised LCx ostium treated successfully with drug eluted stent (DES) and mid left anterior descendent (LAD) severe lesion, treated with DES. © 2009 Wiley‐Liss, Inc.     

Comparison of single‐ versus two‐stent techniques in treatment of unprotected left main coronary bifurcation disease

Background : This study sought to compare 3‐year outcomes of single‐ versus two‐stent techniques in patients with distal unprotected left main coronary artery (LMCA) disease treated with drug‐eluting stents (DES). Methods and Results : A total of 392 patients with distal unprotected LMCA disease who underwent DES implantation with single‐ (n = 234) or two‐ (n = 158) stent techniques were evaluated. The primary end point was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). The two‐stent group was more likely to have extensive coronary artery stenosis. After adjustment with weighted Cox model using the inverse probability of treatment weighting, the 3‐year risk of death was similar in the single‐ and two‐stent groups (hazard ratio [HR], 0.77, 95% confidence interval [CI], 0.28–2.13, P = 0.62). However, the 3‐year risks of MI (HR, 0.38, 95% CI, 0.19–0.78, P = 0.008), TLR (HR, 0.16, 95% CI, 0.05–0.57, P = 0.005), and MACE (HR, 0.89, 95% CI, 0.22–0.67, P = 0.0007) were significantly lower in the single‐stent group. Conclusion : Compared with the two‐stent technique, the single‐stent technique showed more favorable long‐term clinical outcomes in patients with distal unprotected LMCA disease who received DES. © 2011 Wiley‐Liss, Inc.     

Long‐term complication after LM bifurcation treatment

Two months after left anterior descending (LAD) artery and left circumflex (LCx) artery bare metal stent implantation, a proliferative subocclusive in‐stent restenosis in LCx coronary with severe LM coronary (LM) involvement developed. The present clinical case describes a simplified strategy for unprotected LM percutaneous coronary intervention using two bioabsorbable biolimus‐eluting stents without involvement of the LAD coronary using an “L” technique. © 2010 Wiley‐Liss, Inc.     

Prediction of Clinical Outcomes in Patients with Unprotected Left Main Trifurcation Lesions Treated by Drug‐Eluting Stents: Importance of 2‐Stent Technique and SYNTAX Score

Background: There were insufficient data on the prognosis of stenting for patients with trifurcated unprotected left main lesions (UPLMS). Methods: From the SPEED (stents for percutaneous treatment of coronary artery disease) registry of all percutaneous coronary interventions (PCI) for all types of UPLMS, data of 44 patients with trifurcated UPLMS were selected and analyzed. Results: Patients were divided into one‐stent (N = 23) or 2‐stent (N = 21) groups. Clinical follow‐up was available for 100%, and angiographic follow‐up at 8 month was available for 91.3%. There were no differences in myocardial infarction, cardiac death, and stent thrombosis between groups. However, the target lesion revascularization (TLR) and target vessel revascularization (TVR) in the 1‐stent group was lower when compared to the 2‐stent group (13.0% vs. 23.8%, P = 0.004; 13.0% vs. 28.6%, P = 0.003, respectively). Cumulative survival free from major adverse cardiovascular events (MACE) in the 1‐stent group was higher than the 2‐stent group (65.2% vs. 57.1%, P = 0.033). Analysis of the receiver operator curve (ROC) of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score showed the area under the curve was 0.414 (standard error = 0.089, 95% CI 0.240–0.589, P = 0.348). Conclusions: In patients with trifurcated UPLMS, higher TLR/TVR and lower cumulative survival from MACE were seen in the 2‐stent group when compared to the 1‐stent group. The SYNTAX scoring system had no predictive value of outcomes for patients with stenting of trifurcated UPLMS. (J Interven Cardiol 2010;23:352–357)     

Meta-analysis of incidence, clinical characteristics and implications of stent fracture

A meta-analysis of published studies was conducted to evaluate the incidence, predictors, and clinical outcomes of stent fractures. Eight studies with 108 stent fractures in 5,321 patients were analyzed using the Bayesian method. Study end points included in-stent restenosis (ISR) and target lesion revascularization (TLR). The mean incidence of stent fracture per patient was 4.0% (95% confidence interval 0.4% to 16.3%). All cases, except 1, were reported with sirolimus-eluting stents. The incidence of stent fracture was 30.4% in the left anterior descending coronary artery, 10.9% in the left circumflex coronary artery, 56.4% in the right coronary artery, < 0.01% in the left main coronary artery, and 1.7% in saphenous vein grafts. The probability of stent fracture was significantly higher in the right coronary artery than in the left anterior descending and left circumflex lesions (p < 0.01). Left main stents were less likely to fracture compared to those in all other vessels (p < 0.01). The probability of stent fracture was significantly increased in overlapping stents (7.5% vs 2.1%, p = 0.01) and long stents (46 vs 32.5 mm, p < 0.01). Lesions with stent fractures had higher rates of ISR (38% vs 8.2%, p < 0.01) and TLR (17% vs 5.6%, p < 0.01). Conversely, the probability of stent fractures was higher in patients with ISR (12.8% vs 2.1%, p < 0.01) and TLR (8.8% vs 2.7%, p < 0.01). In conclusion, although not always associated with clinical sequelae, the probability of ISR and TLR is increased with stent fracture. Conversely, the probability of stent fractures is increased in lesions with ISR or TLR, thus raising the need for surveillance and management guidelines for at-risk patients.     

The EXTREME registry: Titanium‐nitride‐oxide coated stents in small coronary arteries

Objectives : We sought to explore the immediate results of Titan2^® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background : The safety of Titan2^® stent has been confirmed in several studies in real‐life unselected populations. Methods : We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2^® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results : The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2^® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions : Titan2^® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up. © 2010 Wiley‐Liss, Inc.     

Percutaneous unprotected left main angioplasty with drug-eluting stents in a nonagenarian: feasible and safe despite recurrent restenosis

The management of severe coronary artery disease in the very elderly is challenging and the most appropriate revascularization strategy highly debated. To date, coronary artery bypass surgery has been the treatment of choice for significant stenosis of unprotected left main (ULM) coronary. Whether this holds true also in very old patients is unknown. The Authors hereby report the case of a 91-year-old diabetic man who underwent coronary angiography in June 2005 for subacute unstable angina. Angiography disclosed a critical stenoses in the distal unprotected left main, left anterior descending, and distal left circumflex, which were treated with a paclitaxel-eluting stent and a bare-metal stent (BMS), respectively. Four months later, recurrent angina lead to a second angiography which showed critical restenosis in the left anterior descending and significant ostial stenosis in the left circumflex. Another paclitaxel-eluting stent was implanted in the left anterior descending, followed by kissing balloon in the left main, achieving a good angiographic result. Six months later angina recurred again: at angiography diffuse restenosis in the left main, left anterior descending and left circumflex was documented. A crushing technique was thus employed to deliver 2 sirolimus-eluting stents, achieving a satisfactory final result. Since then, and to date for more than 17 months since the last procedure, this nonagenarian has remained free from anginal chest. This case highlights the potentials and drawbacks of percutaneous coronary intervention for unprotected left main disease, suggesting nonetheless, that this revascularization strategy can be safely repeated even in elderly patients.     

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.     

Five‐year long‐term clinical follow‐up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT FIRST trial

Background : Drug‐eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long‐term follow‐up data are scarce and only available for sirolimus‐ and paclitaxel‐eluting stents. Aim : To assess the feasibility and performance of the XIENCE V everolimus‐eluting stent (EES) versus an identical bare metal stent after a 5‐year follow‐up period. Methods : SPIRIT FIRST was a First in Man, multicentre, prospective, single‐blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent. Results : At 5‐year clinical follow‐up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1‐ and 5‐year follow‐up. The 5‐year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2‐ and 5‐year follow‐up. No additional clinically driven TVR events were observed between 3‐ and 5‐year follow‐up. The 5‐year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years. Conclusion : The favorable 5‐year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow‐up. © 2010 Wiley‐Liss, Inc.     

Long‐term outcome of provisional side‐branch T‐stenting for the treatment of unprotected distal left main coronary artery disease

Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side‐branch (SB) only when required (provisional T‐stenting), has become the default approach to most bifurcation lesions. This prospective registry sought to investigate the long‐term safety and efficacy of provisional SB T‐stenting for the treatment of unprotected distal LM disease in patients undergoing PCI. From January 2006 to May 2009, 107 consecutive patients affected by unprotected distal LM disease underwent PCI at our center with the intent to use a provisional SB‐stenting technique. We evaluated the rate of major adverse cardiac events (MACE) at long‐term follow‐up (up to 12–41 months). Procedural success was obtained in 98% of patients. A final kissing balloon inflation was performed in 95% and intravascular ultrasound in 83% of patients. Additional stenting on the SB after provisional stenting on MB was required in 29% of lesions. Long‐term follow‐up (3.5 years; 25–75th percentile and 1.1–4.5 years) was completed in 97% of patients. The cumulative incidence of MACE was 32.7%: all‐cause death was 15.8%, nonfatal myocardial infarction 8.4%, and target vessel revascularization 21.5%. At multivariable analysis, age (hazard ratio, 2.08; 95% confidence interval: 2.01–3.32, P = 0.03), European System for Cardiac Operative Risk Evaluation (HR 1.20, 95% CI: 1.04–1.33, P = 0.02), and diabetes mellitus (HR 3.48, 95% CI: 1.12–6.87, P = 0.01) were identified as independent predictors of MACE. In patients with unprotected distal LM disease undergoing PCI, a provisional strategy of stenting the MB only is associated with good long‐term clinical outcomes. © 2011 Wiley‐Liss, Inc.     

雷帕霉素药物洗脱支架在冠心病复杂病变中应用的近远期疗效

目的　评价雷帕霉素药物洗脱支架 (Cypher)应用的临床近、远期疗效。方法　对 2 0 0 2年 4月至 2 0 0 3年 12月期间 4 0 0例冠心病患者 4 15处病变置入 4 5 0个Cypher支架的临床近、远期疗效进行统计学分析。在 4 15处病变中弥漫性病变 12 6处 (30 4 % )、分叉病变 98处 (2 3 6 % )、慢性完全闭塞性病变 5 5处 (13 3% )、支架内再狭窄病变 4 5处 (10 8% )、开口部病变 2 3处 (5 5 % )。结果支架置入成功率为 99 5 % ,术中和住院期间无死亡 ,2例发生急性心肌梗死 ,住院期间主要心脏不良事件发生率为 0 5 % (2 / 4 0 0 ) ,35 7例患者随访超过 6个月 ,1例死于癌症 ,2例发生急性心肌梗死 ,9例进行了靶血管重建 ,主要心脏不良事件发生率为 2 5 %。 6～ 8个月的冠状动脉造影再狭窄率为8 8% (支架内为 3 8% ) ,靶病变重建率为 1 9%。结论　有选择地应用Cypher支架是安全和有效的 ,在适当放宽病变的适应证后 ,其支架内再狭窄率仍明显低于普通金属支架。     

Vascular brachytherapy for patients with drug-eluting stent restenosis

Background: The rate of drug‐eluting stent (DES) in‐stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Methods: Ninety‐nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1‐year follow‐up. Results: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in‐hospital course were documented in all patients post VBT. At 12 months' follow‐up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. Conclusions: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.