Five-year follow-up of the endothelial progenitor cell capturing stent versus the paxlitaxel-eluting stent in de novo coronary lesions with a high risk of coronary restenosis.

OBJECTIVES: To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis. BACKGROUND: Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts. METHODS: In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES. RESULTS: At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group. CONCLUSION: This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure.

Duration of dual antiplatelet therapy and outcomes after coronary stenting with the Genous™ bio-engineered R stent™ in patients from the e-HEALING registry.

OBJECTIVE: We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous™ endothelial progenitor cell capturing R stent™ placement in patients from the e-HEALING registry. BACKGROUND: Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended. METHODS: Patients were analyzed according to continuation or discontinuation of DAPT at a 30-day and 6-month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression. RESULTS: No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65-1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55-1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable. CONCLUSIONS: In a post-hoc analysis of e-HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding.

Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

One-year clinical outcome in an unselected patient population treated with the Genous™ endothelial progenitor cell capturing stent.

OBJECTIVE: We assessed the 1-year clinical outcome in a large cohort of unselected patients treated with an endothelial progenitor cell (EPC) capturing coronary stent. BACKGROUND: The novel EPC capturing stent is coated with CD34+ antibodies that bind circulating EPCs to the stent surface, thereby accelerating endothelialization of the stent struts; it is hypothesized that this may prevent restenosis and stent thrombosis. METHODS: A total of 405 unselected patients were treated percutaneously with the EPC capturing stent. The majority of patients had complex lesions with an estimated high risk of restenosis. RESULTS: The primary endpoint defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 1-year was 13.3%, mainly attributable to TLR which was 10.9%. The occurrence of definite and probable ST was low, 0.5 and 0.7%, respectively. Based on the risk of restenosis, in patients with an estimated high risk of restenosis (n = 249), the composite primary endpoint was 16.1% versus 9.0% in patients with an estimated low risk (n = 155). Moreover, the 1 year clinical outcomes in diabetic patient compared well with the nondiabetic patients. CONCLUSION: In this single-center study, the 1-year clinical follow-up in a "real-world" population treated with the EPC capturing stent showed good results. Currently, large randomized studies are conducted to evaluate the long-term safety and efficacy of this stent.

Two-year follow-up of the Genous™ endothelial progenitor cell capturing stent versus the Taxus Liberté stent in patients with de novo coronary artery lesions with a high-risk of restenosis: a randomized, single-center, pilot study.

BACKGROUND: In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr. METHODS: A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent. RESULTS: Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%). CONCLUSIONS: In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.

Three-year clinical follow-up of an unselected patient population treated with the genous endothelial progenitor cell capturing stent.

BACKGROUND: We assessed the 3-year clinical outcome in our single-center cohort of mainly unselected patients treated with the endothelial progenitor cell capturing stent (ECS). The ECS is coated with CD34+ antibodies specifically targeting the circulating endothelial progenitor cells population to accelerate endothelialization that in turn may prevent the occurrence of in-stent restenosis and stent thrombosis (ST). METHODS: All patients in our study had coronary artery lesions that were treated with an ECS. The majority of patients had complex lesions with an estimated high risk of restenosis. RESULTS: A total of 405 patients were enrolled. The primary end-point of target lesion failure (TLF) was defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). At 3 years, TLF was 18.3% and TLR was 14.2%. Early ST occurred in 2 patients. No cases of late and very late definite ST were reported. CONCLUSIONS: This single-center study demonstrates the safety at 3 years of the ECS in an unselected patient population, including a fair number of patients with complex lesions, reflecting daily practice. Our data compare well with drug-eluting stent and bare metal stent registries enrolling unselected patient populations. Importantly, in our analysis, no cases of late or very late definite ST were reported.

Twelve-month outcomes after coronary stenting with the Genous™ bio-engineered R Stent™ in diabetic patients from the e-HEALING registry.

OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous™ EPC capturing R stent™ during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. RESULTS: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).

Coronary stenting with the Genous™ Bio-Engineered R Stent™ in elderly patients.

BACKGROUND: We evaluated the Genous™ Bio-engineered R stent™ in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST). METHODS AND RESULTS: In the e-HEALING registry, 2,651 patients were <65, 1,403 were 65-74 and 869 were ≥ 75 years old. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related car-diac death or myocardial infarction and target vessel revascularization. Secondary outcomes included target lesion revascularization (TLR) and ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. TVF occurred significantly more often in elderly patients compared with younger patients (7.0% in patients aged < 65, 8.8% in patients aged 65-74 and 11.7% in patients aged ≥ 75 years, P<0.001). There was a trend to higher TLR with increasing age (log-rank P=0.06) and no difference in ST. CONCLUSIONS: The 1-year results of the Genous stent in a population of elderly patients show a significantly higher TVF rate compared with younger patients, mainly driven by a higher mortality. Although there was a trend to higher TLR rates with increasing age, there was no difference in ST. This attests to the safety of this therapy for the elderly, in whom there could be concerns with administering long-term dual antiplatelet therapy.

Genous endothelial progenitor cell capturing stent vs. the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study.

AIMS: The purpose of this study was to evaluate the Genous(TM) endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis. METHODS AND RESULTS: We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter <2.8 mm, or any lesion in a diabetic patient. At 1-year, the rate of the primary end point, target vessel failure (TVF), was 17.3% in the Genous stent group when compared with 10.5% in the Taxus stent group [risk difference (RD) 6.8%, 95% CI -3.1 to 16.7%], a difference predominantly due to a higher incidence of repeat revascularization in patients treated with the Genous stent. In contrast, no stent thrombosis was observed in the Genous stent group compared to 4 stent thromboses in the Taxus stent group (RD -4.2%; 95% CI -10.3 to 0.3%). Repeat angiography between 6 and 12 months in a subgroup of patients showed a significantly higher late loss in the Genous stent compared with the Taxus stent (1.14 +/- 0.64 and 0.55 +/- 0.61 mm). CONCLUSION: In patients with lesions carrying a high risk of restenosis, the Genous stent resulted in a non-significant higher rate of TVF compared with the Taxus stent mainly due to more repeat revascularizations in the Genous stent group. There were four stent thromboses with Taxus stent, none with the Genous stent.

A case report of myocardial infarction with non-obstructive coronary artery disease: Graves' disease-induced coronary artery vasospasm.

BACKGROUND: Coronary artery spasm can occur either in response to drugs or toxins. This response may result in hyper-reactivity of vascular smooth muscles or may occur spontaneously as a result of disorders in the coronary vasomotor tone. Hyperthyroidism is associated with coronary artery spasm. CASE SUMMARY: A 49-year-old female patient with a 2-day history of intermittent chest pain and electrocardiographic evidence of myocardial ischaemia was referred for emergency coronary angiography. This revealed severe right coronary artery (RCA) and left main (LM) coronary artery ostial vasospasm, both subsequently relieved with administration of multiple doses intracoronary nitroglycerine. Intravascular optical coherence tomography showed absence of atherosclerosis and no evidence of thrombus or dissection confirming the diagnosis of coronary artery vasospasm. Laboratory tests of the thyroid function were performed immediately after coronary angiography revealing Graves' disease as the cause of vasospasm. DISCUSSION: Our case represents a rare presentation of Graves' disease-induced RCA and LM coronary artery ostial vasospasm. In patients with coronary artery vasospasm thyroid function study should be mandatory, especially in young female patients.

Design and rationale of the TRI-stent adjudication study (TRIAS) program.

BACKGROUND: In the treatment of coronary artery disease, a "pro-healing" approach for prevention of in-stent restenosis and late stent thrombosis is intuitively favored over the use of cytotoxic or cytostatic drugs released from a drug-eluting stent (DES). Promoting accelerated endothelial coverage of the stent surface, the endothelial progenitor cell (EPC) capturing stent has shown its safety and efficacy in the HEALING observational studies; however, randomized trials evaluating the device are lacking. METHODS: The multicenter, randomized, controlled, 2-armed TRIAS program aims to include a total of 2560 patients. In the TRIAS Low Risk trial, a total of 1300 patients with lesions carrying a low risk of restenosis are randomized between the EPC capturing stent and a bare metal stent, assuming superiority in the incidence of target lesion failure (TLF) at 1 year. In the TRIAS High Risk trial, 1260 patients with lesions carrying a high risk of restenosis are randomized, assuming the noninferiority in TLF at 1 year of the EPC capturing stent as compared to DES. TLF is defined as the composite of cardiac death, myocardial infarction, and clinically driven target lesion revascularization. In addition, the duration of clinical follow-up is extended to 5 years to capture late events. Angiographic follow-up at 13 months is performed as part of the TRIAS Program ancillary study. IMPLICATION: The results of the TRIAS Program will provide information on a relevant patient population with coronary artery lesions, comprising the full spectrum of low risk and high risk of restenosis treated with a novel stent technology in a randomized, controlled manner (TRIAS Low Risk trial: ISRCTN 47701105 and TRIAS High Risk trial: ISRCTN 74297220).

Very Long-Term Follow-Up After Coronary Rotational Atherectomy: A Single-Center Experience.

We assessed the very long-term follow-up of a large cohort of unselected patients treated with coronary rotational atherectomy (RA). All 143 patients who underwent RA at our institution from 2000 to 2013 and with complete baseline and follow-up information were analyzed in a retrospective manner. Major adverse cardiac events (MACE) were defined as the composite of target vessel revascularization (TVR), acute myocardial infarction, and all-cause mortality. The mean follow-up was 8.2 years. The 10-year cumulative incidence of MACE for all patients was 57.9% (standard error [SE]: 5.0%). When comparing patients who received a drug-eluting stent (DES; n = 68) versus patients who did not (balloon only, bare-metal stent, or none of the aforementioned; n = 75), the RA + DES demonstrated very long-term MACE of 49.2% (SE: 7.5%) versus 62.7% (SE: 6.1%), P = .160 with TVR as the most discriminating factor, 10.7% (SE: 4.0%) versus 29.2% (SE: 6.0%), P = .016. Our results point to RA having reasonable long-term clinical results, especially in combined treatment with DES. To date, our study has the longest follow-up after RA.

Differences in cardiovascular risk factors and clinical outcomes between Western European and Southeast Asian patients treated with the Genous Bio-engineered R stent: an e-HEALING worldwide registry substudy.

OBJECTIVE: Percutaneous coronary interventions (PCIs) are increasingly being performed worldwide to treat patients with coronary artery disease. However, studies on the influence of ethnicity on clinical outcomes after PCI are scarce. In our current analysis, we evaluate the differences in baseline clinical, angiographic and procedural characteristics, and 12-month clinical outcomes in patients undergoing nonurgent PCI in Western Europe and in Asia. METHODS: We analyzed all patients enrolled in the worldwide e-HEALING (electronic Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry living in Western Europe and Asia. All patients were treated with at least one endothelial progenitor cell capturing stent. The main study outcome was target vessel failure at the 12-month follow-up, defined as the composite of cardiac death or myocardial infarction and target vessel revascularization. RESULTS: A total of 3504 patients, 2873 living in Western Europe and 731 living in Asia, were assessed in the current analysis. Almost all of the baseline clinical and angiographic characteristics differed significantly between both populations. Target vessel failure at the 12-month follow-up occurred in 11.4% of the Western Europe patients and in 5.6% of the Asian patients (P<0.01). CONCLUSION: We conclude that differences exist in the baseline, angiographic, and procedural characteristics between Western European and Asian patients undergoing nonurgent PCI. In addition, the 1-year clinical outcomes differ significantly after PCI between Western European and Asian patients. Our results indicate that reports from studies performed worldwide should include both overall and regional subgroup outcomes.

Twelve-month clinical outcomes after coronary stenting with the Genous Bio-engineered R Stent in patients with a bifurcation lesion: from the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) registry.

BACKGROUND: The e-Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth (e-HEALING) registry was designed to capture clinical data on the use of the endothelial progenitor cell capture stent (ECS) in routine clinical practice. In this analysis, we investigated the 12-month clinical outcomes in patients treated with an ECS for a bifurcation lesion. METHODS: The worldwide, prospective, nonrandomized e-HEALING registry aimed to enroll 5000 patients treated for coronary artery disease with one or more ECS between October 2005 and October 2007. Clinical follow-up was obtained at 1, 6, and 12 months. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization at 12 months. RESULTS: A total of 573 patients were treated for at least one bifurcation lesion and were assessed in the current analysis. Baseline characteristics showed a median age of 65 years; 21% were diabetic patients and 36% had unstable angina. A total of 63% of the bifurcation lesions were located in the left artery descending and the mean stent length was 20.7±12.6 mm. At 12 months, TVF was 12.7% and target lesion revascularization was 7.5%. Definite or probable stent thrombosis occurred in 1.7% of the patients. Moreover, one or more stents per lesion [hazard ratio (HR): 2.79, 95% confidence interval (CI): 1.60-4.86, P<0.001], predilatation (HR: 0.39, 95% CI: 0.17-0.87, P=0.023), and lesions located in the right coronary artery (HR: 4.56, 95% CI: 1.07-19.5, P=0.041) were independent predictors of TVF. CONCLUSION: In the e-HEALING registry, coronary bifurcation stenting with the ECS results in favorable clinical outcomes and low incidences of repeat revascularization and stent thrombosis.

The relationship between the number of preprocedural circulating endothelial progenitor cells and angiographic restenosis following coronary artery stent placement.

OBJECTIVE: In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. However, their role in humans is less well understood. In the present study, the authors aimed to evaluate the relationship between the number of preprocedural EPCs defined as CD34+/KDR+/CD133+ cells and angiographic late loss as a measure of the growth of in-stent intimal hyperplasia. DESIGN SETTING PATIENTS AND INTERVENTIONS: The 59 study patients were treated in the authors' clinic with a Genous EPC capturing stent, a bare metal stent (BMS) or a drug-eluting stent, and angiographic follow-up occurred between 6 and 13 months. RESULTS: The authors found no relationship between preprocedural EPCs and angiographic late loss, irrespective of stent type. Though statistically not significant, patients with a high number of preprocedural CD34 cells and treated with a Genous stent or BMS showed a numerically higher late loss (in Genous patients: 1.03±0.76 mm vs 0.71±0.50 mm, p=0.15; in BMS patients: 1.06±0.73 mm vs 0.35±0.62 mm, p=0.08). CONCLUSIONS: Considering these and other varied observations, further studies aimed at identifying the biological mechanism and the individual roles of EPCs and/or CD34 cells in endothelial repair after coronary vessel stenting are needed.

1-year outcome of TRIAS HR (TRI-stent adjudication study-high risk of restenosis) a multicenter, randomized trial comparing genous endothelial progenitor cell capturing stents with drug-eluting stents.

OBJECTIVES: This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year. BACKGROUND: A "pro-healing" approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions. METHODS: We undertook an international, clinical trial in 26 centers planning to randomize 1,300 patients with stable coronary artery disease and with a high risk of restenosis between treatment, with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was higher and treatment of new patients with an ECS would be unreasonable. RESULTS: At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority). CONCLUSIONS: Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression.

Clinical results after coronary stenting with the Genous™ Bio-engineered R stent™: 12-month outcomes of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

AIMS: e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous™ EPC capturing R stent™. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis. METHODS AND RESULTS: We planned a 5,000 patient registry with ≥1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received ≥1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively. CONCLUSIONS: Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

One-year clinical outcome after provisional T-stenting for bifurcation lesions with the endothelial progenitor cell capturing stent compared with the bare-metal stent.

OBJECTIVE: Currently no data exists regarding the outcomes after the novel endothelial progenitor cell capturing stent (EPCcS) placement in bifurcation lesions using a provisional T-stenting. This study evaluates the 1-year clinical outcome in patients treated with the EPCcS for a bifurcation lesion using a provisional T-stenting technique and compared these to a historical control group treated with an identical bare-metal stent (BMS). METHODS: In single-center study, 178 consecutive patients with a de novo bifurcation lesion treated with an EPCcS and 465 consecutive patients treated with an equivalent BMS were included. Multivariate and propensity-score analyses were performed to adjust for differences in clinical and angiographic characteristics between the EPCcS group and the BMS group. RESULTS: At 1-year, the cumulative rate of the primary end point (cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)) was 12.4% in the EPCcS group and 17.2% in the BMS group (hazard ratio [HR] 0.70; 95% confidence interval CI, 0.44-1.12; P=0.13). The 1-year cumulative rate of TLR was lower among patients treated with EPCcS compared with the control stent as a result of fewer coronary artery bypass grafting, 10.7% vs. 12% respectively (HR 0.88; 95% CI, 0.53-1.49; P=0.64). The cumulative rate of definite ST was 0.6% in the EPCcS as compared with 0.4% in the BMS group. CONCLUSIONS: Although, the EPC stent shows favorable outcomes in the treatment of bifurcation lesions, the reduction in the cumulative rate of cardiac death, MI, or TLR as compared with the BMS was statistically non-significant.

Genous endothelial progenitor cell-capturing stent system: a novel stent technology.

Drug-eluting stents have been demonstrated to significantly reduce clinical and angiographic restenosis in patients with coronary artery disease compared with bare-metal stents. Intuitively, however, a prohealing approach for the prevention of in-stent restenosis by promoting accelerated re-endothelialization is favored over the aggressive pharmacologic cytotoxic and cytostatic approach of the drug-eluting stents. The endothelial progenitor cell-capturing stent attracts circulating CD43(+) progenitor cells that bind to the stent surface and differentiate into a functional endothelial layer. It is theorized that the accelerated establishment of the endothelial layer covering the stent struts will reduce the risk of neointimal hyperplasia and smooth muscle cell proliferation. The safety and efficacy have been demonstrated in the nonrandomized Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth (HEALING) studies, and the device received a CE mark in 2005. This article reviews the realization of the endothelial progenitor cell-capturing stent, its relevance compared with other stent types, current evidence on clinical performance, and future perspectives. At present, the larger randomized Tri-stent Adjudication Study (TRIAS) that is ongoing will directly compare the clinical usefulness of this new endothelial progenitor cell-capturing stent with bare-metal stents and drug-eluting stents.