Publications by authors named "Michael Haude"

173 Publications

Reply: Cardiac CT prior to percutaneous coronary sinus-based mitral annuloplasty with the Carillon device.

EuroIntervention 2020 Nov;16(10):863-864

Department of Cardiology, Rheinlandklinikum Neuss, Neuss, Germany.

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http://dx.doi.org/10.4244/EIJ-D-20-00621RDOI Listing
November 2020

Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial.

Cardiovasc Diabetol 2020 10 16;19(1):179. Epub 2020 Oct 16.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland.

Background: Patients with both diabetes mellitus (DM) and chronic kidney disease (CKD) are a subpopulation characterized by ultrahigh ischemic and bleeding risk after percutaneous coronary intervention. There are limited data on the impact of ticagrelor monotherapy among these patients.

Methods: In this post hoc analysis of the GLOBAL-LEADERS trial, the treatment effects of the experimental (one-month dual-antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin alone) were analyzed according to DM/CKD status. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at 2-years. The patient-oriented composite endpoint (POCE) was defined as the composite of all-cause death, any stroke, site-reported MI and any revascularization, whereas net adverse clinical events (NACE) combined POCE with BARC type 3 or 5 bleeding events.

Results: At 2 years, the DM + /CKD + patients had significantly higher incidences of the primary endpoint (9.5% versus 3.1%, adjusted HR 2.16; 95% CI [1.66-2.80], p < 0.001), BARC type 3 or 5 bleeding events, stroke, site-reported myocardial infraction, all revascularization, POCE, and NACE, compared with the DM-/CKD- patients. Among the DM + /CKD + patients, after adjustment, there were no significant differences in the primary endpoints between the experimental and reference regimen; however, the experimental regimen was associated with lower rates of POCE (20.6% versus 25.9%, HR 0.74; 95% CI [0.55-0.99], p = 0.043, p = 0.155) and NACE (22.7% versus 28.3%, HR 0.75; 95% CI [0.56-0.99], p = 0.044, p = 0.310), which was mainly driven by a lower rate of all revascularization, as compared with the reference regimen. The landmark analysis showed that while the experimental and reference regimen had similar rates of all the clinical endpoints during the first year, the experimental regimen was associated with significantly lower rates of POCE (5.8% versus 11.0%, HR 0.49; 95% CI [0.29-0.82], p = 0.007, p = 0.040) and NACE (5.8% versus 11.2%, HR 0.48; 95% CI [0.29-0.82], p = 0.007, p = 0.013) in the second year.

Conclusion: Among patients with both DM and CKD, ticagrelor monotherapy was not associated with lower rates of all-cause death or new Q-wave, or major bleeding complications; however, it was associated with lower rates of POCE and NACE. These findings should be interpreted as hypothesis-generating.

Clinical Trial Registration: ClinicalTrials.gov (NCT01813435).
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http://dx.doi.org/10.1186/s12933-020-01153-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568378PMC
October 2020

Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel.

J Am Coll Cardiol 2020 09;76(12):1468-1483

Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/Drroxmehran.

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.
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http://dx.doi.org/10.1016/j.jacc.2020.06.085DOI Listing
September 2020

Regional variation in patients and outcomes in the GLOBAL LEADERS trial.

Int J Cardiol 2021 Feb 15;324:30-37. Epub 2020 Sep 15.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland; NHLI, Imperial College London, London, UK. Electronic address:

Background: Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy.

Methods: Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years.

Results: Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (P = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction.

Conclusions: Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed.

Clinical Trial Registration: ClinicalTrials.gov (NCT01813435).
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http://dx.doi.org/10.1016/j.ijcard.2020.09.039DOI Listing
February 2021

Sustained Safety and Performance of the Second-Generation Sirolimus-Eluting Absorbable Metal Scaffold: Pooled Outcomes of the BIOSOLVE-II and -III Trials at 3 Years.

Cardiovasc Revasc Med 2020 Sep 13;21(9):1150-1154. Epub 2020 Apr 13.

Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.

Background/purpose: To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed, as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium-based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption.

Methods/materials: BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease, and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6 months.

Results: Patients were 65.5 ± 10.8 years old, and lesions were 12.1 ± 4.5 mm long and located in vessels with a diameter of 2.7 ± 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.

Conclusion: In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis.

Annotated Table Of Contents: BIOSOLVE-II and -III are prospective, international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.
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http://dx.doi.org/10.1016/j.carrev.2020.04.006DOI Listing
September 2020

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

Catheter Cardiovasc Interv 2020 Sep 3. Epub 2020 Sep 3.

Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.

Objectives: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population.

Background: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance.

Methods: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months.

Results: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy.

Conclusion: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.
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http://dx.doi.org/10.1002/ccd.29260DOI Listing
September 2020

EAPCI Core Curriculum for Percutaneous Cardiovascular Interventions (2020): Committee for Education and Training European Association of Percutaneous Cardiovascular Interventions (EAPCI). A branch of the European Society of Cardiology.

EuroIntervention 2020 Jul 7. Epub 2020 Jul 7.

CHRU Lille, Institut Coeur-Poumon, Department of Cardiology, Lille, France.

The proposed 2020 Core Curriculum for Percutaneous Cardiovascular Interventions aims to provide an updated European consensus that defines the level of experience and knowledge in the field of Percutaneous Cardiovascular Intervention (PCI). It promotes homogenous education and training programmes among countries, and is the cornerstone of the new EAPCI certification, designed to support the recognition of competencies at the European level and the free movement of certified specialists in the European Community. It is based on a thorough review of the ESC guidelines and of the EAPCI Textbook in Percutaneous Interventional Cardiovascular Medicine. The structure of the current Core Curriculum evolved from previous EAPCI Core Curriuclum and from the "2013 core curriculum of the general cardiologist" to follow the current ESC recommendations for Core Curriculums. In most subject areas, there was a wide - if not unanimous - consensus among the task force members on the training required for the interventional cardiologist of the future. The document recommends that acquisition of competence in Interventional Cardiology requires at least 2 years of postgraduate training, in addition to 4 years devoted to cardiology. The first part of the curriculum covers general aspects of training and is followed by a comprehensive description of the specific components in 54 chapters. Each of the chapters includes statements of the objectives, and is further subdivided into the required knowledge, skills, behaviours, and attitudes.
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http://dx.doi.org/10.4244/EIJ-D-18-00448DOI Listing
July 2020

CT-Angiography to predict outcome after indirect mitral annuloplasty in patients with functional mitral regurgitation.

Catheter Cardiovasc Interv 2021 Feb 30;97(3):495-502. Epub 2020 Jun 30.

Department of Cardiology, Rheinlandklinikum Neuss, Neuss, Germany.

Objectives: Coronary sinus (CS) based mitral annuloplasty using the Carillon device is effective in reducing functional mitral valve regurgitation (FMR). However, this positive effect might be dependent on the relation between CS and the mitral annulus.

Background: Computed tomography (CT) assessment prior to mitral valve interventions is an emerging technique to optimize patient selection.

Methods: In a retrospective analysis 30 patients underwent Carillon device implantation and received CT-angiography prior to CS based percutaneous mitral valve repair. Patients were assigned to responders or non-responders according to the 3-month transthoracic echocardiographic follow-up including quantitative mitral valve regurgitation assessment. A prototype software for CS reconstruction was used to assess distance and angle of both CS and mitral annulus planes.

Results: Comparison of the distance and angle of the CS plane and the mitral valve annulus plane showed a significant shorter distance and lower angle in the responder group implicating an impact on procedure success. Our results suggest a CS plane and MV annulus plane with a favorably distance of <7.8 mm and an optimal angle of <14.2° could be considered favorably for mitral annuloplasty using a Carillon device.

Conclusions: Distance and angle of mitral annulus and CS planes determined by three-dimensional reconstructions of CT-angiography might predict a reduction in echocardiographic FMR using Carillon Mitral Contour System.
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http://dx.doi.org/10.1002/ccd.29107DOI Listing
February 2021

Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project.

Eur Heart J 2020 Jul;41(27):2579-2588

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.

Aims: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes.

Methods And Results: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001).

Conclusion: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.
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http://dx.doi.org/10.1093/eurheartj/ehaa475DOI Listing
July 2020

Preclinical investigation of neoatherosclerosis in magnesium-based bioresorbable scaffolds versus thick-strut drug-eluting stents.

EuroIntervention 2020 Dec 4;16(11):e922-e929. Epub 2020 Dec 4.

Deutsches Herzzentrum München and Deutsches Zentrum für Herz-Kreislaufforschung e.V., Munich, Germany.

Aims: Neoatherosclerosis is a frequent finding after implantation of permanent metallic stents. Bioresorbable scaffolds (BRS) are considered to reduce the incidence of neoatherosclerosis owing to their dissolution and consequent vascular restoration. The aim of this study was to evaluate the formation of neoatherosclerosis between magnesium-based BRS and thick-strut metallic drug-eluting stents (DES) in a rabbit model of neoatherosclerosis and in proportion to the effect of high-dose statin medication.

Methods And Results: Fully bioresorbable magnesium scaffolds (BRS, n=45) and thick-strut permanent metallic DES of equivalent geometry and design (n=45) were implanted into the iliac arteries of New Zealand White rabbits (n=45) following endothelial balloon injury and exposure to a cholesterol diet. Endothelialisation was assessed in 12 animals after 35 days using scanning electron microscopy (SEM), showing significantly enhanced re-endothelialisation above struts in the BRS (n=13) compared to DES (n=10). Eleven (11) animals were terminated for baseline assessment after 91 days while the remaining 22 animals were randomised to receive high-dose statin treatment (3 mg/kg) or placebo. BRS-treated vessels showed a significant reduction in foam cell infiltration as a sign of early neoatherosclerosis by histology and OCT when compared to thick-strut DES-treated vessels. Statin treatment resulted in significant reduction of foam cell infiltration in BRS and DES by histology.

Conclusions: Our findings suggest reduced neoatherosclerosis formation in magnesium-based BRS relative to thick-strut DES. High-dose statin treatment may be a promising measure to reduce neoatherosclerosis progression, both on its own and in synergy with site-targeted device-based treatment.
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http://dx.doi.org/10.4244/EIJ-D-19-00747DOI Listing
December 2020

CT-Angiographic imaging of the Carillon device topography after unsuccessful treatment of FMR.

EuroIntervention 2020 May 12. Epub 2020 May 12.

Department of Cardiology, Rheinlandklinikum, Neuss, Germany.

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http://dx.doi.org/10.4244/EIJ-D-20-00332DOI Listing
May 2020

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device.

Cardiovasc Revasc Med 2020 06 25;21(6):712-716. Epub 2020 Feb 25.

Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.

Purpose: To report long-term survival and to identify potential determinants of survival among patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device.

Methods: This was a post hoc analysis in which we pooled prospectively collected data from three studies of the Carillon device with available long-term vital status data. Patient eligibility in these trials specified symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction. Echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression.

Results: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon device. Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling. The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up.

Conclusions: Among patients with congestive heart failure and grade 2 to 4 FMR who were symptomatic despite guideline-directed medical therapy, transcatheter mitral valve repair with the Carillon device resulted in a favorable 5-year survival rate. The survival benefit was greatest among patients with improvement in clinical and hemodynamic parameters during the first year of follow-up.
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http://dx.doi.org/10.1016/j.carrev.2020.02.012DOI Listing
June 2020

Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study.

Circ Cardiovasc Interv 2020 03 25;13(3):e008657. Epub 2020 Feb 25.

Deutsches Herzzentrum München, Technische Universität München, Germany (H.R., R.B., M.J.).

Background: The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia.

Methods: Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or ≥0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography.

Results: Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL ≥0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53±0.68 mm) compared with those with LLL ≥0.5 mm (1.48±1.20 mm; <0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47±0.33 mm) compared with patients with LLL ≥0.5 mm (1.68±0.34 mm; =0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63±1.23 mm; calcified: 0.81±1.44 mm; and fibrous: 1.20±1.52 mm; <0.001), while there was no difference with regards to neointimal hyperplasia area (=0.132).

Conclusions: In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008657DOI Listing
March 2020

Impact of clinical and hemodynamic factors on coronary flow reserve and invasive coronary flow capacity in non-obstructed coronary arteries - A patient level pooled analysis of the DEBATE and ILIAS studies.

EuroIntervention 2020 Jan 21. Epub 2020 Jan 21.

Amsterdam UMC, University of Amsterdam, Heart Center, Amsterdam, the Netherlands.

Aims: Coronary Flow Reserve (CFR) is a physiological index for the assessment of myocardial flow impairment due to focal or microcirculatory coronary artery disease (CAD). Coronary flow capacity (CFC) is another flow-based concept in diagnosing ischemic heart disease, based on hyperemic average peak velocity (hAPV) and CFR. We evaluated clinical and hemodynamic factors which potentially influence CFR and CFC in non-obstructed coronary arteries.

Methods And Results: Intracoronary Doppler flow velocity measurements to obtain CFR and CFC were performed after inducing hyperemia in 390 non-obstructed vessels of patients who were scheduled for elective percutaneous coronary intervention (PCI) of another vessel. Akaike's Information Criterion (AIC) revealed age, female gender, history of myocardial infarction, hypercholesterolemia, diastolic blood pressure, oral nitrates and rate pressure product as independent predictors of CFR and CFC. After regression analysis, age and female gender were associated with lower CFR and age was associated with worse CFC in angiographically non-obstructed vessels.

Conclusions: Age and female gender are associated with lower CFR, and age with worse CFC in an angiographically non-obstructed coronary artery. CFC seems to be less sensitive to variations in clinical and hemodynamic parameters than CFR, and therefore is a promising tool in contemporary clinical decision making in the cardiac catheterization laboratory.
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http://dx.doi.org/10.4244/EIJ-D-19-00774DOI Listing
January 2020

Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial.

Clin Res Cardiol 2020 Jul 10;109(7):930-943. Epub 2020 Jan 10.

University Hospital of Wales, Cardiff, UK.

Background: Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF.

Methods: A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m).

Results: At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35-1.98, p = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61-1.11, p = 0.192, p = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71-1.71, p = 0.656, p = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (p = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (p = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF.

Conclusions: IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy.

Clinical Trial Registration: The trial has been registered with ClinicalTrials.gov, number NCT01813435.
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http://dx.doi.org/10.1007/s00392-019-01586-9DOI Listing
July 2020

Evolving paradigms in valvular heart disease: where should guidelines move?

EuroIntervention 2019 Nov;15(10):851-856

William Harvey Research Institute, Queen Mary University of London, and Barts Heart Centre, London, United Kingdom.

The field of valve intervention is rapidly changing. Clinical practice guidelines are based on evidence and practical clinical experience. The randomised trials considered for the guideline recommendations regarding indications for TAVI cover the high-risk and intermediate-risk subgroups of patients. With new evidence for low-risk patients, consideration has to be given to discussing TAVI as the default strategy in the majority of patients. This is a paradigm shift from the established practice. More than ever, the patient will be at the centre of the decision making. The Heart Team is essential for optimal patient pathways, as patient factors, longevity and durability considerations have to inform the discussion. Further developments discussed in this article revolve around evidence on secondary mitral regurgitation and mitral edge-to-edge repair.
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http://dx.doi.org/10.4244/EIJ-D-19-00818DOI Listing
November 2019

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

Int J Cardiol 2020 02 6;300:60-65. Epub 2019 Nov 6.

Lukaskrankenhaus Neuss, Neuss, Germany.

Background: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations.

Methods: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups.

Results: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months.

Conclusion: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.
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http://dx.doi.org/10.1016/j.ijcard.2019.11.003DOI Listing
February 2020

Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials.

JACC Cardiovasc Interv 2020 01 16;13(2):157-166. Epub 2019 Oct 16.

Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.

Objectives: The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.

Background: Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.

Methods: BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol.

Results: Patients' mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm and 1.9 ± 0.5 cm, and mean gradient was 6.4 mm Hg at 30 days and 6 months.

Conclusions: Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis.
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http://dx.doi.org/10.1016/j.jcin.2019.07.058DOI Listing
January 2020

Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey.

Circulation 2019 10 12;140(14):1156-1169. Epub 2019 Sep 12.

Université de Paris, France (A.V.).

Background: Valvular heart disease (VHD) is an important cause of mortality and morbidity and has been subject to important changes in management. The VHD II survey was designed by the EURObservational Research Programme of the European Society of Cardiology to analyze actual management of VHD and to compare practice with guidelines.

Methods: Patients with severe native VHD or previous valvular intervention were enrolled prospectively across 28 countries over a 3-month period in 2017. Indications for intervention were considered concordant if the intervention was performed or scheduled in symptomatic patients, corresponding to Class I recommendations specified in the 2012 European Society of Cardiology and in the 2014 American Heart Association/American College of Cardiology VHD guidelines.

Results: A total of 7247 patients (4483 hospitalized, 2764 outpatients) were included in 222 centers. Median age was 71 years (interquartile range, 62-80 years); 1917 patients (26.5%) were ≥80 years; and 3416 were female (47.1%). Severe native VHD was present in 5219 patients (72.0%): aortic stenosis in 2152 (41.2% of native VHD), aortic regurgitation in 279 (5.3%), mitral stenosis in 234 (4.5%), mitral regurgitation in 1114 (21.3%; primary in 746 and secondary in 368), multiple left-sided VHD in 1297 (24.9%), and right-sided VHD in 143 (2.7%). Two thousand twenty-eight patients (28.0%) had undergone previous valvular intervention. Intervention was performed in 37.0% and scheduled in 26.8% of patients with native VHD. The decision for intervention was concordant with Class I recommendations in symptomatic patients with severe single left-sided native VHD in 79.4% (95% CI, 77.1-81.6) for aortic stenosis, 77.6% (95% CI, 69.9-84.0) for aortic regurgitation, 68.5% (95% CI, 60.8-75.4) for mitral stenosis, and 71.0% (95% CI, 66.4-75.3) for primary mitral regurgitation. Valvular interventions were performed in 2150 patients during the survey; of them, 47.8% of patients with single left-sided native VHD were in New York Heart Association class III or IV. Transcatheter procedures were performed in 38.7% of patients with aortic stenosis and 16.7% of those with mitral regurgitation.

Conclusions: Despite good concordance between Class I recommendations and practice in patients with aortic VHD, the suboptimal number in mitral VHD and late referral for valvular interventions suggest the need to improve further guideline implementation.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.041080DOI Listing
October 2019

Impact of ticagrelor monotherapy on two-year clinical outcomes in patients with long stenting: a post hoc analysis of the GLOBAL LEADERS trial.

EuroIntervention 2020 Oct;16(8):634-644

Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Aims: The aim of this study was to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL).

Methods And Results: This is a post hoc analysis of the GLOBAL LEADERS trial, a prospective, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR] 0.67, 95% confidence interval [CI]: 0.49-0.90; pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR 0.99, 95% CI: 0.66-1.49; pinteraction=0.975).

Conclusions: Ticagrelor monotherapy could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.
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http://dx.doi.org/10.4244/EIJ-D-19-00498DOI Listing
October 2020

The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.

Catheter Cardiovasc Interv 2020 05 5;95(6):1076-1084. Epub 2019 Sep 5.

Cardiovascular Research Foundation, New York, New York.

Objectives: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.

Background: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.

Methods: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.

Results: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.

Conclusion: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.
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http://dx.doi.org/10.1002/ccd.28483DOI Listing
May 2020

BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months.

EuroIntervention 2019 Dec 6;15(11):e1006-e1013. Epub 2019 Dec 6.

Okinawa Tokushukai Shonan Kamakura General Hospital, Kanagawa, Japan.

Aims: The BIOFLOW-IV clinical trial was designed for regulatory submission in Japan. It assessed the safety and efficacy of a new third-generation sirolimus-eluting stent system with bioresorbable polymer (Orsiro, BP-SES) compared with an everolimus-eluting stent system with permanent polymer (XIENCE Prime/Xpedition, PP-EES).

Methods And Results: This prospective, international, multicentre, 2:1 randomised, non-inferiority trial enrolled 575 patients (385 BP-SES and 190 PP-EES) with 659 stenotic de novo lesions. Of these, 137 patients (23.8%) were Japanese. Follow-up until five years is ongoing. We herein report outcomes at 12 months. Baseline parameters were well balanced. Device success was 98.9% for BP-SES versus 99.6% for PP-EES, p=0.670. Non-inferiority related to 12-month target vessel failure was met (pnon-inferiority <0.001). Further, there was no significant difference in clinical outcomes between the groups. The target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, the target lesion failure rate was 4.2% versus 5.4%, and the definite or probable stent thrombosis rate was 0.8% versus 0%.

Conclusions: The randomised BIOFLOW-IV trial provides further evidence on the safety and efficacy of the Orsiro BP-SES and its non-inferiority to the current benchmark, an everolimus-eluting permanent polymer stent. ClinicalTrials.gov: NCT01939249.
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http://dx.doi.org/10.4244/EIJ-D-18-01214DOI Listing
December 2019

Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk.

Eur Heart J 2019 08;40(31):2632-2653

Cardiovascular European Research Center, Massy, France.

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
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http://dx.doi.org/10.1093/eurheartj/ehz372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6736433PMC
August 2019

Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention.

Circulation 2019 07 22;140(3):240-261. Epub 2019 May 22.

Cardiovascular European Research Center, Massy, France (P.U., U.W., M.-C.M.).

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6636810PMC
July 2019

First Report of Edge Vascular Response at 12 Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study.

Cardiovasc Revasc Med 2019 05 18;20(5):392-398. Epub 2019 Feb 18.

Interventional Cardiology Department, MedStar Washington Hospital Center, Washington, DC, USA.

Introduction And Objective: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities.

Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS.

Results: The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm (p = 0.012) and 2.49 ± 1.53 mm (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm (p = 0.023) and 0.17 ± 0.16 mm (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm (p = 0.045) in a distal frame.

Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS.

Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.
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http://dx.doi.org/10.1016/j.carrev.2019.02.019DOI Listing
May 2019

Safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: three-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial.

EuroIntervention 2020 Feb 7;15(15):e1375-e1382. Epub 2020 Feb 7.

Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.

Aims: We aimed to evaluate the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at three-year follow-up to assess vessel response two years beyond scaffold resorption.

Methods And Results: BIOSOLVE-II is an international, multicentre first-in-man study, including 123 patients with de novo lesions. Predilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for six months. At three years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. The target lesion failure rate was 6.8% (n=8: two cardiac deaths, one target vessel myocardial infarction and five target lesion revascularisations). No probable or definite scaffold thrombosis was observed. Imaging follow-up was voluntary and serial angiographic assessment at 6, 12, and 36 months was available in 25 patients. In these, a slight increase in in-segment and in-scaffold late lumen loss and diameter stenosis was observed between 12 and 36 months (by 0.11±0.28 mm and 0.13±0.30 mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis).

Conclusions: Two years beyond the resorption period of a sirolimus-eluting bioresorbable metal scaffold built from a proprietary magnesium alloy, complication rates remained low. In the patients with serial angiographic assessment, late lumen loss and diameter stenosis did not increase substantially beyond the resorption period.
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http://dx.doi.org/10.4244/EIJ-D-18-01000DOI Listing
February 2020