Publications by authors named "Margo Klomp"

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.

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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).

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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.

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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.

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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.

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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.

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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.

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Article Synopsis
  • - The study aimed to assess whether endothelial progenitor cell capturing stents (ECS) are at least as effective as drug-eluting stents (DES) in preventing target lesion failure (TLF) within one year after use in patients at high risk of restenosis.
  • - Researchers planned to enroll 1,300 patients but had to stop the trial early when they observed a significantly higher rate of TLF (17.4%) in patients with ECS compared to those with DES (7.0%).
  • - The findings indicate that ECS may not be as effective as DES for preventing restenosis in high-risk patients, suggesting further long-term studies are needed to evaluate the full potential and benefits of ECS.
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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Article Synopsis
  • The text discusses a study aimed at treating coronary artery disease using a new type of stent designed to promote healing and reduce complications like restenosis and thrombosis, as opposed to traditional drug-releasing stents.
  • The TRIAS program is a large, multicenter clinical trial involving 2560 patients, comparing the efficacy of an endothelial progenitor cell (EPC) capturing stent against a bare metal stent and a drug-eluting stent (DES) across different risk groups for restenosis.
  • The trial results are expected to offer valuable insights into the safety and effectiveness of this new stent technology over a 5-year follow-up period, potentially improving treatment options for patients with varying levels of coronary artery disease risk.
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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.

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