Publications by authors named "Evald Høj Christiansen"

107 Publications

Impact of endothelial shear stress on absorption process of resorbable magnesium scaffold: A BIOSOLVE-II substudy.

Cardiovasc Revasc Med 2021 Apr 9. Epub 2021 Apr 9.

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA. Electronic address:

Background/purpose: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)-based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation.

Methods And Results: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (<1.0 Pa), intermediate (1.0-2.5 Pa), or high (>2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of -1.857 ± 1.902 mm at 1 year compared to -1.277 ± 1.562 mm in the intermediate-ESS segment (P = 0.017) and - 0.709 ± 1.213 mm in the high-ESS segment (P = 0.001).

Conclusion: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss.

Summary For Table Of Contents: The authors analyzed 22 patients from the BIOSOLVE-II trial who underwent optical coherence tomography assessment immediately after receiving a Magmaris second-generation drug-eluting resorbable magnesium scaffold. The analysis found that after Magmaris implantation, the presence of higher endothelial shear stress (ESS) might be associated with slower strut absorption process but less luminal loss. This study is the first demonstrating the impact of ESS assessed by OCT on absorption process and coronary lumen dimension after Magmaris implantation.
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http://dx.doi.org/10.1016/j.carrev.2021.04.003DOI Listing
April 2021

Age-Stratified Outcome in Treatment of Left Main Coronary Artery Stenosis: A NOBLE Trial Substudy.

Cardiology 2021 Apr 13:1-10. Epub 2021 Apr 13.

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.

Background: In the treatment of left main coronary artery (LMCA) disease, patients' age may affect the clinical outcome after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This study stratified the clinical outcome according to the age of patients treated for LMCA stenosis with PCI or CABG in the Nordic-Baltic-British Left Main Revascularization (NOBLE) study.

Methods: Patients with LMCA disease were enrolled in 36 centers in northern Europe and randomized 1:1 to treatment by PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST elevation myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCEs), a composite of all-cause mortality, nonprocedural myocardial infarction, any repeat coronary revascularization, and stroke. Age-stratified analysis was performed for the groups younger and older than 67 years and for patients older than 80 years.

Results: For patients ≥67 years, the 5-year MACCEs were 35.7 versus 22.3% (hazard ratio [HR] 1.72 [95% confidence interval [CI] 1.27-2.33], p = 0.0004) for PCI versus CABG. The difference in MACCEs was driven by more myocardial infarctions (10.8 vs. 3.8% HR 3.01 [95% CI 1.52-5.96], p = 0.0009) and more repeat revascularizations (19.5 vs. 10.0% HR 2.01 [95% CI 1.29-3.12], p = 0.002). In patients younger than 67 years, MACCE was 20.5 versus 15.3% (HR 1.38 [95% CI 0.93-2.06], p = 0.11 for PCI versus CABG. All-cause mortality was similar after PCI and CABG in both age-groups. On multivariate analysis, age was a predictor of MACCE, along with PCI, diabetes, and SYNTAX score.

Conclusions: As the overall NOBLE results show revascularization of LMCA disease, age of 67 years or older was associated with lower 5-year MACCE after CABG compared to PCI. Clinical outcomes were not significantly different in the subgroup younger than 67 years, although no significant interaction was present between age and treatment. Mortality was similar for all subgroups (ClinicalTrials.gov identifier: NCT01496651).
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http://dx.doi.org/10.1159/000515376DOI Listing
April 2021

Performance of quantitative flow ratio in patients with aortic stenosis undergoing transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2021 Feb 3. Epub 2021 Feb 3.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Objectives: This study aims to evaluate the diagnostic performance of quantitative flow ratio (QFR) pre transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis (AS) and coronary artery disease (CAD). Post-TAVI fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) was used as reference.

Background: CAD is prevalent in patients with AS, but the hemodynamics of AS confounds evaluation using pressure wire-based assessments. QFR might be less sensitive to the presence of AS thereby allowing for CAD evaluation before aortic valve replacement. Further, QFR does not require the use of pressure wire and therefore has the potential for reducing costs and complications related to insertion of a coronary pressure wire.

Methods: The diagnostic performance of QFR in coronary angiograms from 28 patients undergoing TAVI was evaluated. In all patients, both FFR and iFR were measured pre- and immediately post-TAVI while QFR was measured pre-TAVI.

Results: Using post-TAVI FFR and iFR as reference the diagnostic accuracy of pre-TAVI QFR were 83% (95%CI; 68-97) and 52% (95%CI; 30-74) p = .008, respectively.

Conclusions: Pre-TAVI QFR showed a good diagnostic performance using post-TAVI FFR as reference. QFR could become a wire-free, safe, and quick way of evaluating CAD in patients with severe AS undergoing TAVI.
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http://dx.doi.org/10.1002/ccd.29518DOI Listing
February 2021

Distribution and prognostic value of left ventricular global longitudinal strain in elderly patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve replacement.

BMC Cardiovasc Disord 2020 12 2;20(1):506. Epub 2020 Dec 2.

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.

Aims: The aim of present study was to examine the preoperative prevalence and distribution of impaired left ventricular global longitudinal strain (LVGLS) in elderly patients with symptomatic aortic stenosis (AS) undergoing transcutaneous aortic valve replacement (TAVR) and to determine the predictive value of LVGLS on survival.

Methods: We included 411 patients with symptomatic severe AS treated with TAVR during a 5-year period, where a baseline echocardiography including LVGLS assessment was available.

Results: Mean age was 80.1 ± 7.1 years and aortic valve area (AVA) index 0.4 ± 0.1 cm. 78 patients died during a median follow-up of 762 days. Mean left ventricular ejection fraction (LVEF) was 50 ± 13% and mean LVGLS was - 14.0%. LVEF was preserved in 60% of patients, while impaired LVGLS > - 18% was seen in 75% of the patients. Previous myocardial infarction, LVEF < 50%, LVGLS > - 14%, low gradient AS (< 4.0 m/s), tricuspid regurgitant gradient > 30 mmHg were identified as significant univariate predictors of all-cause mortality. On multivariate analysis LVGLS > - 14% (HR 1.79 [1.02-3.14], p = 0.04) was identified as the only independent variable associated with all-cause mortality. Reduced survival was observed with an impaired LVGLS > - 14% in the total population (p < 0.002) but also in patients with high AS gradient with preserved LVEF. LVGLS provided incremental prognostic value with respect to clinical characteristics, AVA and LVEF (χ 19.9, p = 0.006).

Conclusions: In patients with symptomatic AS undergoing TAVR, impaired LVGLS was highly prevalent despite preserved LVEF. LVGLS > - 14% was an independent predictor of all-cause mortality, and survival was reduced if LVGLS > - 14%.
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http://dx.doi.org/10.1186/s12872-020-01791-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709407PMC
December 2020

One-step anatomic and function testing by cardiac CT versus second-line functional testing in symptomatic patients with coronary artery stenosis: head-to-head comparison of CT-derived fractional flow reserve and myocardial perfusion imaging.

EuroIntervention 2020 Nov 17. Epub 2020 Nov 17.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Aims: CT-QFR is a novel coronary computed tomography angiography (CTA) based method for on-site evaluation of patients with suspected obstructive coronary artery disease (CAD). We compared the diagnostic performance of CT-QFR with myocardial perfusion scintigraphy (MPS) and cardiovascular magnetic resonance (CMR) as second-line tests in patients with suspected obstructive CAD after coronary CTA.

Methods And Results: Paired analysis of CT-QFR and MPS or CMR, with an invasive FFR-based classification as reference standard. Symptomatic patients with >50% diameter stenosis on coronary CTA were randomized to MPS or CMR and referred for invasive coronary angiography. The rate of coronary CTA not feasible for CT-QFR analysis was 17%. Paired patient-level data were available for 118 patients in the MPS group and 113 in the CMR group, respectively. Patient-level diagnostic accuracy was better for CT-QFR than for both MPS ((82.2% (95%CI 75.2-89.2) vs. 70.3% (95%CI 62.0-78.7), p=0.029) and CMR ((77.0% (95%CI 69.1-84.9) vs. 65.5% (95%CI 56.6-74.4), p=0.047). Following a positive coronary CTA and with the intention-to diagnose, CT-QFR, CMR and MPS were equally suitable as rule-in and rule-out modalities.

Conclusions: The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.
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http://dx.doi.org/10.4244/EIJ-D-20-00905DOI Listing
November 2020

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

Validation and update of the minimal risk tool in patients suspected of chronic coronary syndrome.

Int J Cardiovasc Imaging 2021 Feb 1;37(2):699-706. Epub 2020 Sep 1.

Department of Cardiology, Hospital Unit West, Gødstrup Hospital, Gl. Landevej 61, 7400, Herning, Denmark.

Risk stratification in patients with suspected coronary artery disease (CAD) is important. Recently, the minimal-risk-tool (MRT) was developed to identify individuals with low CAD risk despite symptoms in order to avoid unnecessary testing. We aimed to validate and update the MRT-model in a contemporary cohort. The Dan-NICAD trial cohort, consisting of 1675 consecutive patients referred for coronary computed tomography angiography (CTA), was used to calculate the MRT-score based on the published fitted variable coefficients from the PROMISE and SCOT-HEART trials. Minimal risk was defined as zero calcium score, no coronary atherosclerosis at coronary CTA, and no cardiovascular events in the follow-up period. We tested an updated MRT-model by pooling the fitted variable coefficients from all three trials. A total of 1544 patients fulfilling the inclusion criteria were followed for 3.1 [2.7-3.4] years. In 710 (46%) patients, the criteria for minimal risk were fulfilled. Despite substantial coefficient variation, the MRTs based on the PROMISE, the SCOT-HEART and the updated MRT variables showed similar moderate to high discriminative performance for minimal risk estimation. Although all three models tended to underestimate minimal risk, the updated MRT had the best performance. Using a 75% minimal risk cut-off, the updated MRT showed a sensitivity of 11.6% (95% CI 9.3-14.2%) and specificity of 99.3% (95% CI 98.6-99.8%). An updated MRT model based on three large studies increased calibration compared to the existing MRT models, whereas discrimination was similar despite substantial coefficient variation. The updated MRT might supplement currently recommended pre-test probability models.
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http://dx.doi.org/10.1007/s10554-020-01982-7DOI Listing
February 2021

Agreement between nonculprit stenosis follow-up iFR and FFR after STEMI (iSTEMI substudy).

BMC Res Notes 2020 Sep 1;13(1):410. Epub 2020 Sep 1.

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.

Objective: To evaluate agreement between instantaneous wave free ratio (iFR) and fractional flow reserve (FFR) for the functional assessment of nonculprit coronary stenoses at staged follow-up after ST-segment elevation myocardial infarction (STEMI).

Results: We measured iFR and FFR at staged follow-up in 112 STEMI patients with 146 nonculprit stenoses. Median interval between STEMI and follow-up was 16 (interquartile range 5-32) days. Agreement between iFR and FFR was 77% < 5 days after STEMI and 86% after ≥ 5 days (p = 0.19). Among cases with disagreement, the proportion of cases with hemodynamically significant iFR and non-significant FFR were different when assessed < 5 days (5 in 8, 63%) versus ≥ 5 days (3 in 15, 20%) after STEMI (p = 0.04). Overall classification agreement between iFR and FFR was comparable to that observed in stable patients. Time interval between STEMI and follow-up evaluation may impact agreement between iFR and FFR.
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http://dx.doi.org/10.1186/s13104-020-05252-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7466494PMC
September 2020

Culprit lesion morphology in patients with ST-segment elevation myocardial infarction assessed by optical coherence tomography.

Coron Artery Dis 2020 12;31(8):671-677

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT).

Methods And Results: Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7-29.8] vs 11.3% [IQR 6.9-18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8-7.5) vs 8.1% (IQR 5.7-11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0-1.7) vs 2.2% (IQR 0.9-4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0-1) vs 1 (IQR 1-2) and 0 mm (IQR 0-2.7) vs 4.5 mm (IQR 2.3-7.7), P < 0.001].

Conclusions: One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.
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http://dx.doi.org/10.1097/MCA.0000000000000957DOI Listing
December 2020

Resting distal to aortic pressure ratio and fractional flow reserve discordance affects the diagnostic performance of quantitative flow ratio: Results from an individual patient data meta-analysis.

Catheter Cardiovasc Interv 2021 Apr 1;97(5):825-832. Epub 2020 Jun 1.

Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.

Objective: To evaluate the diagnostic performance of quantitative flow ratio (QFR) related to fractional flow reserve (FFR) and resting distal-to-aortic pressure ratio (resting Pd/Pa) concordance.

Background: QFR is a method for computation of FFR based on standard coronary angiography. It is unclear how QFR is performed in patients with discordance between FFR and resting pressure ratios (distal-to-aortic pressure ratio [Pd/Pa]).

Materials And Methods: The main comparison was the diagnostic performance of QFR with FFR as reference stratified by correspondence between FFR and resting Pd/Pa. Secondary outcome measures included distribution of clinical or procedural characteristics stratified by FFR and resting Pd/Pa correspondence.

Results: Four prospective studies matched the inclusion criteria. Analysis was performed on patient level data reaching a total of 759 patients and 887 vessels with paired FFR, QFR, and resting Pd/Pa. Median FFR was 0.85 (IQR: 0.77-0.90). Diagnostic accuracy of QFR with FFR as reference was higher if FFR corresponded to resting Pd/Pa: accuracy 90% (95% CI: 88-92) versus 72% (95% CI: 64-80), p < .001, and sAUC 0.95 (95% CI: 0.92-0.96) versus 0.73 (95% CI: 0.69-0.77), p < .001. Resting Pd/Pa and FFR discordance were related to age, sex, hypertension, and lesion severity.

Conclusion: Diagnostic performance of QFR with FFR as reference is reduced for lesions with discordant FFR (≤0.80) and resting Pd/Pa (≤0.92) measurements.
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http://dx.doi.org/10.1002/ccd.28976DOI Listing
April 2021

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

Circulation 2020 06 21;141(25):2052-2063. Epub 2020 May 21.

Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.

Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; <0.0001).

Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040241DOI Listing
June 2020

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Coron Artery Dis 2020 09;31(6):485-492

Department of Cardiology, Odense University Hospital, Odense.

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.

Methods: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.

Results: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.

Conclusion: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.
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http://dx.doi.org/10.1097/MCA.0000000000000875DOI Listing
September 2020

Instantaneous wave-free ratio cutoff values for nonculprit stenosis classification in patients with ST-segment elevation myocardial infarction (an iSTEMI substudy).

Coron Artery Dis 2020 08;31(5):411-416

Department of Cardiology, Aarhus University Hospital, Denmark.

Objectives: The instantaneous wave-free ratio cutoff value of <0.90 for hemodynamic significance of coronary stenoses has been validated in stable patients. We examined different cutoff values in the evaluation of nonculprit stenoses in patients with ST-segment elevation myocardial infarction.

Methods: We measured instantaneous wave-free ratio across nonculprit stenoses in the acute setting and at follow-up in 120 patients with ST-segment elevation myocardial infarction and 157 nonculprit stenoses, of which, 113 patients with 147 nonculprit stenoses completed follow-up.

Methods: The prevalence of nonculprit stenosis hemodynamic significance was 52% in the acute setting and 41% at follow-up. With follow-up, instantaneous wave-free ratio as reference, acute instantaneous wave-free ratio >0.90 had a negative predictive value of 89%. Acute instantaneous wave-free ratio <0.90 had a positive predictive value of 68%. Acute instantaneous wave-free ratio >0.93 had a negative predictive value of 100%. Acute instantaneous wave-free ratio <0.86 and <0.83 had positive predictive values of 71 and 77%. Using acute instantaneous wave-free ratio <0.90 as cutoff for hemodynamic significance yielded the highest degree of classification agreement between acute and follow-up instantaneous wave-free ratio.

Conclusions: In patients with ST-segment elevation myocardial infarction, acute instantaneous wave-free ratio with the cutoff values <0.90 for hemodynamic significance appears optimal in the evaluation of nonculprit stenoses and has a high negative predictive value and a moderate positive predictive value.
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http://dx.doi.org/10.1097/MCA.0000000000000879DOI Listing
August 2020

Intravascular ultrasound to guide left main stem intervention: a NOBLE trial substudy.

EuroIntervention 2020 Jun;16(3):201-209

Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom.

Aims: We aimed to investigate the association between the use and findings of IVUS with clinical outcomes in the PCI arm of a randomised trial of LMS PCI.

Methods And Results: The NOBLE trial randomised patients with LMS disease to treatment by PCI or CABG. Of 603 patients treated by PCI, 435 (72%) underwent post-PCI IVUS assessment, 224 of which were analysed in a core laboratory. At five years, the composite of MACCE was 18.9% if post-PCI IVUS was performed versus 25.0% if it was not performed (p=0.45, after adjustment). Overall repeat revascularisation was not reduced (10.6% vs 16.5%, p=0.11); however, LMS TLR was (5.1% vs 11.6%, p=0.01) if IVUS was used. For comparison of stent expansion, LMS MSA was split into tertiles. We found no significant difference in MACCE, death, myocardial infarction or stent thrombosis between tertiles. There was a significant difference between the lower and upper tertiles for repeat revascularisation (17.6% vs 5.2%, p=0.02) and LMS TLR (12.2% vs 0%, p=0.002).

Conclusions: Post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE; however, there is an association with reduced LMS TLR. The use of intracoronary imaging to prevent stent underexpansion in LMS PCI is likely to improve outcomes.
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http://dx.doi.org/10.4244/EIJ-D-19-01003DOI Listing
June 2020

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Open Heart 2020 19;7(1):e000947. Epub 2020 Jan 19.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.

Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.

Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.

Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.

Trial Registration Number: NCT01496638.
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http://dx.doi.org/10.1136/openhrt-2018-000947DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999681PMC
June 2020

Determining the Predominant Lesion in Patients With Severe Aortic Stenosis and Coronary Stenoses: A Multicenter Study Using Intracoronary Pressure and Flow.

Circ Cardiovasc Interv 2019 12 22;12(12):e008263. Epub 2019 Nov 22.

National Heart and Lung Institute, Hammersmith Hospital, Imperial College London, United Kingdom (Y.A., J.P.H., C.C., C.R., R.A.-L., R.P., T.W., D.F., J.M., P.S., S.S.).

Background: Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation.

Methods: Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2).

Results: Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s versus post-TAVI 3.04±1.6 mm Hg·cm·s [=0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [=0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74.

Conclusions: TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider using this value to guide treatment of concomitant coronary artery disease.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924937PMC
December 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

Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2): Study design for a controlled study of diagnostic accuracy.

Am Heart J 2019 09 1;215:114-128. Epub 2019 May 1.

Department of Cardiology, Hospital Unit West, Gl. Landevej 61, Herning, Denmark. Electronic address:

Background: Coronary computed tomography angiography (CTA) is the preferred primary diagnostic modality when examining patients with low to intermediate pre-test probability of coronary artery disease (CAD). Only 20-30% of these have potentially obstructive CAD. Because of the relatively poor positive predictive value of coronary CTA, unnecessary invasive coronary angiographies (ICAs) are conducted with the costs and risks associated with the procedure. Hence, an optimized diagnostic CAD algorithm may reduce the numbers of ICAs not followed by revascularization. The Dan-NICAD 2 study has 3 equivalent main aims: (1) To examine the diagnostic precision of a sound-based diagnostic algorithm, The CADScor®System (Acarix A/S, Denmark), in patients with a low to intermediate pre-test risk of CAD referred to a primary examination by coronary CTA. We hypothesize that the CADScor®System provides better stratification prior to coronary CTA than clinical risk stratification scores alone. (2) To compare the diagnostic accuracy of 3T cardiac magnetic resonance imaging (3T CMRI), rubidium positron emission tomography (Rb-PET), and CT-derived fractional flow reserve (FFR) in patients where obstructive CAD cannot be ruled out by coronary CTA using ICA fractional flow reserve (FFR) as reference standard. (3) To compare the diagnostic performance of quantitative flow ratio (QFR) and ICA-FFR in patients with low to intermediate pre-test probability of CAD using Rb-PET as reference standard.

Methods: Dan-NICAD 2 is a prospective, multicenter, cross-sectional study including approximately 2,000 patients with low to intermediate pre-test probability of CAD and without previous history of CAD. Patients are referred to coronary CTA because of symptoms suggestive of CAD, as evaluated by a cardiologist. Patient interviews, sound recordings, and blood samples are obtained in connection with the coronary CTA. If coronary CTA does not rule out obstructive CAD, patients will be examined by 3T CMRI Rb-PET, FFR, ICA, and FFR. Reference standard is ICA-FFR. Obstructive CAD is defined as an FFR ≤0.80 or as high-grade stenosis (>90% diameter stenosis) by visual assessment. Diagnostic performance will be evaluated as sensitivity, specificity, predictive values, likelihood ratios, calibration, and discrimination. Enrolment started January 2018 and is expected to be completed by June 2020. Patients are followed for 10 years after inclusion.

Discussion: The results of the Dan-NICAD 2 study are expected to contribute to the improvement of diagnostic strategies for patients suspected of CAD in 3 different steps: risk stratification prior to coronary CTA, diagnostic strategy after coronary CTA, and invasive wireless QFR analysis as an alternative to ICA-FFR.
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http://dx.doi.org/10.1016/j.ahj.2019.03.016DOI Listing
September 2019

Pre-test probability prediction in patients with a low to intermediate probability of coronary artery disease: a prospective study with a fractional flow reserve endpoint.

Eur Heart J Cardiovasc Imaging 2019 Nov;20(11):1208-1218

Department of Cardiology, Hospital Unit West, Herning, Denmark.

Aims: European and North American guidelines currently recommend pre-test probability (PTP) stratification based on simple probability models in patients with suspected coronary artery disease (CAD). However, no unequivocal recommendation has yet been established. We aimed to compare the ability of risk factors and different PTP stratification models to predict haemodynamically obstructive CAD with fractional flow reserve (FFR) as reference in low to intermediate probability patients.

Methods And Results: We prospectively included 1675 patients with low to intermediate risk who had been referred to coronary computed tomography angiography (CTA). Patients with coronary stenosis were subsequently investigated by invasive coronary angiography (ICA) with FFR measurement if indicated. Discrimination and calibration were assessed for four models: the updated Diamond-Forrester (UDF), the CAD Consortium Basic, the Clinical, and the Clinical + Coronary artery calcium score (CACS). At coronary CTA, 24% of patients were diagnosed with a suspected stenosis and 10% had haemodynamically obstructive CAD at the ICA. Calibration for all CAD Consortium models increased compared with the UDF score. However, all models overestimated the probability of haemodynamically obstructive CAD. Discrimination increased by area under the receiver operating curve from 67% to 86% for UDF vs. CAD Consortium Clinical + CACS. The proportion of low-probability patients (pre-test score < 15%) was for the UDF, CAD Consortium Basic, Clinical, and Clinical + CACS: 14%, 58%, 51%, and 66%, respectively. The corresponding negative predictive values were 97%, 94%, 95%, and 98%, respectively.

Conclusion: CAD Consortium models improve PTP stratification compared with the UDF score, mainly due to superior calibration in low to intermediate probability patients. Adding the coronary calcium score to the models substantially increases discrimination.

Clinical Trials. Gov Identifier: NCT02264717.
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http://dx.doi.org/10.1093/ehjci/jez058DOI Listing
November 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

Are drug-eluting stents safer than bare-metal stents?

Lancet 2019 06 2;393(10190):2472-2474. Epub 2019 May 2.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

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http://dx.doi.org/10.1016/S0140-6736(19)31000-1DOI Listing
June 2019

Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial.

Am Heart J 2019 07 14;213:1-7. Epub 2019 Mar 14.

Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark.

Background: In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9-coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.

Results: A total of 3,150 patients have been randomized and enrolled in the study.

Conclusions: The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent.
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http://dx.doi.org/10.1016/j.ahj.2019.02.017DOI Listing
July 2019

Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions.

Int J Cardiovasc Imaging 2019 Jul 4;35(7):1199-1210. Epub 2019 May 4.

Department of Cardiology, Aarhus University Hospital Skejby, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.

We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.
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http://dx.doi.org/10.1007/s10554-019-01537-5DOI Listing
July 2019

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study.

Open Heart 2019;6(1):e000941. Epub 2019 Feb 28.

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.

Objectives: We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).

Background: The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.

Methods And Results: FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm and 5.7±1.4 mm at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm and 5.6±1.4 mm in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm at baseline to 7.2±1.4 mm at 6 months (p=0.12), and from 7.4±1.5 mm to 7.3±1.4 mm at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.

Conclusions: The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.
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http://dx.doi.org/10.1136/openhrt-2018-000941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6443130PMC
February 2021

Diagnostic performance of quantitative flow ratio in prospectively enrolled patients: An individual patient-data meta-analysis.

Catheter Cardiovasc Interv 2019 Nov 9;94(5):693-701. Epub 2019 Apr 9.

Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.

Objectives: We aimed to provide robust performance estimates for quantitative flow ratio (QFR) in assessment of intermediary coronary lesions.

Background: Angiography-based functional lesion assessment by QFR may appear as a cost saving and safe approach to expand the use of physiology-guided percutaneous coronary interventions. QFR was proven feasible and showed good diagnostic performance in mid-sized off-line and on-line studies with fractional flow reserve (FFR) as reference standard.

Methods: We performed a collaborative individual patient-data meta-analysis of all available prospective studies with paired assessment of QFR and FFR using the CE-marked QFR application. The main outcome was agreement of QFR and FFR using a two-step analysis strategy with a multilevel mixed model accounting for study and center level variation.

Results: Of 16 studies identified, four studies had prospective enrollment and provided patient level data reaching a total of 819 patients and 969 vessels with paired FFR and QFR: FAVOR Pilot (n = 73); WIFI II (n = 170); FAVOR II China (n = 304) and FAVOR II Europe-Japan (n = 272). We found an overall agreement (mean difference 0.009 ± 0.068, I = 39.6) of QFR with FFR. The diagnostic performance was sensitivity 84% (95%CI: 77-90, I = 70.1), specificity 88% (95%CI: 84-91, I = 60.1); positive predictive value 80% (95%CI: 76-85, I = 33.4), and negative predictive value 95% (95%CI: 93-96, I = 75.9).

Conclusions: Diagnostic performance of QFR was good with FFR as reference in this meta-analysis of high quality studies. QFR could provide an easy, safe, and cost-effective solution for functional evaluation of coronary artery stenosis.
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http://dx.doi.org/10.1002/ccd.28283DOI Listing
November 2019

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).

JACC Cardiovasc Interv 2019 04;12(7):624-633

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).

Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.

Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.

Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).

Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).
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http://dx.doi.org/10.1016/j.jcin.2018.12.036DOI Listing
April 2019

Quantitative flow ratio for immediate assessment of nonculprit lesions in patients with ST-segment elevation myocardial infarction-An iSTEMI substudy.

Catheter Cardiovasc Interv 2019 Nov 25;94(5):686-692. Epub 2019 Mar 25.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Objectives: We evaluated the diagnostic performance of quantitative flow ratio (QFR) assessment of nonculprit lesions (NCLs) based on acute setting angiograms obtained in patients with ST-segment elevation myocardial infarction (STEMI) with QFR, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) in the staged setting as reference.

Background: QFR is an angiography-based approach for the functional evaluation of coronary artery lesions.

Methods: This was a post-hoc analysis of the iSTEMI study. NCLs were assessed with iFR in the acute setting and with iFR and FFR at staged (median 13 days) follow-up. Acute and staged QFR values were computed in a core laboratory based on the coronary angiography recordings. Diagnostic cut-off values were ≤0.80 for QFR and FFR, and ≤0.89 for iFR.

Results: Staged iFR and FFR data were available for 146 NCLs in 112 patients in the iSTEMI study. Among these, QFR analysis was feasible in 103 (71%) lesions assessed in the acute setting with a mean QFR value of 0.82 (IQR: 0.73-0.91). Staged QFR, FFR, and iFR were 0.80 (IQR: 0.70-0.90), 0.81 (IQR: 0.71-0.88), and 0.91 (IQR: 0.87-0.96), respectively. Classification agreement of acute and staged QFR was 93% (95%Cl: 87-99). The classification agreement of acute QFR was 84% (95%CI: 76-90) using staged FFR as reference and 74% (95%CI: 65-83) using staged iFR as reference.

Conclusions: Acute QFR showed a very good diagnostic performance with staged QFR as reference, a good diagnostic performance with staged FFR as reference, and a moderate diagnostic performance with staged iFR as reference.
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http://dx.doi.org/10.1002/ccd.28208DOI Listing
November 2019

One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting.

Interact Cardiovasc Thorac Surg 2019 Mar 21. Epub 2019 Mar 21.

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.

Objectives: To evaluate the cost-effectiveness and safety of simultaneous hybrid coronary revascularization (sHCR) compared to conventional coronary artery bypass grafting (CABG) in elective patients with multivessel coronary artery disease.

Methods: Cost-utility analysis of a prospective cohort follow-up study comparing per protocol 50 sHCR patients to 50 contemporaneous matched patients undergoing CABG. Resource utilization data and health-related quality of life were collected prospectively, and the cumulative 1-year costs were assessed from the Danish health sector perspective. Effectiveness was measured by quality-adjusted life years using EuroQol-5D. Probabilistic sensitivity analyses using bootstrapping were conducted. Secondary safety measures including early clinical outcomes and freedom from major adverse cardiac or cerebrovascular events at 1 year were assessed.

Results: The clinical trial was discontinued prematurely due to safety reasons after inclusion of 50 patients (24 sHCR; 26 CABG), as the chest tube output and the risk of postoperative pleural effusions requiring thoracocentesis were significantly increased following sHCR compared with CABG. Based on 48 patients available for 1-year follow-up, both treatment strategies were similarly effective (quality-adjusted life year difference between the groups -0.019), with a net cost difference in favour of conventional CABG estimated to be €2173 per patient. Exclusion of 1 outlier patient with chronic renal failure and deep sternal wound infection in the sHCR group resulted in an equalization of the total 1-year costs.

Conclusions: At 1 year, sHCR was less cost-effective than conventional CABG and associated with higher chest tube output and a higher risk of postoperative pleural effusions requiring thoracocentesis.

Clinical Trial Registration: NCT01496664.
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http://dx.doi.org/10.1093/icvts/ivz083DOI Listing
March 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