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XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

ABSTRACT: Background:Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. Aim:To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). Methods:XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. Conclusions:A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. Trial registration:ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.

SUBMITTER: Testa L

PROVIDER: S-EPMC6487315 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

Testa Luca L Pero Gaetano G Bollati Mario M Casenghi Matteo M Popolo Rubbio Antonio A Cuman Magdalena M Moreno Raul R Serra Antoni A Gomez Joan Antoni JA Bedogni Francesco F

International journal of cardiology. Heart & vasculature 20190428

<h4>Background</h4>Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure.<h4>Aim</h4>To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD).<h4>Me ...[more]

PMID: 31061876

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Project description:BackgroundThird generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES.MethodsA total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected.ResultsMost of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints.ConclusionsThe study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy.Clinical trial registrationClinicalTrials.gov, identifier (NCT03745053).

Project description:BackgroundThe use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.Methods/designThe Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study.DiscussionThe Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.Trial registrationClinical Trials.gov: NCT01539603.

Project description:Currently, endovascular treatment is indicated to treat femoropopliteal lesions ?15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (?14 cm).A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ?14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Project description:BackgroundA lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery. The largest modifiable risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy, a combination of P2Y12 inhibitors and aspirin.ObjectiveThis study aimed to determine the acceptability of a protocol and an intervention using the My Interventional Drug-Eluting Stent Educational App (MyIDEA) and to evaluate medication adherence using the proportion of days covered (PDC) and platelet activation tests in a multisite randomized controlled trial.MethodsPotential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached. All patients older than 50 years and who spoke English were recruited. Participants were recruited, baseline demographics were collected, and the Hospital Anxiety and Depression Scale (HADS), Rapid Estimate of Adult Literacy in Medicine-Short Form, Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire were administered. Block randomization was used to randomize participants to either usual care or MyIDEA supplementation. MyIDEA is a personalized educational intervention based on the Kolb experiential learning theory using patient narratives for education. During the visits, participants' blood was collected to measure platelet suppression from medication. During the second and third encounters, the Morisky medication adherence score and cardiology outcomes were measured. The study was conducted at the University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals. Platelet suppression was measured through aspirin reactive units and P2Y12 reactive units. Medication adherence was measured using the PDC. The analysis team was blinded to the participants' group membership. The primary outcome was a feasibility analysis of recruitment and retention.ResultsThe mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic. The majority of patients' reading levels were seventh grade or above, and they were not very familiar with other electronic devices for information and communication. The number of control subjects was 21, and the number of participants in the interventional arm was 24. The interventional group was able to use MyIDEA in both the hospital and outpatient setting. However, there was no significant difference in platelet suppression or medication adherence between groups. There were also differences between the groups in terms of depression and anxiety, initially, as measured by HADS. No documented adverse event associated with the intervention was found.ConclusionsElderly patients are willing to use tablet devices to be educated about health conditions. Additional studies are required to measure the effectiveness and determine the most suitable timing and location for patient education.Trial registrationClinicalTrials.gov NCT04439864; https://clinicaltrials.gov/ct2/show/NCT04439864.

Dataset Information

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

Publications

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial.

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