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Article ; Online: 5-Year Clinical Outcomes of Paclitaxel-Coated Balloon Angioplasty vs DES in Acute MI: The REVELATION Trial.

Niehe, Sander R / Vos, Nicola S / Van Der Schaaf, René J / Amoroso, Giovanni / Herrman, Jean-Paul R / Patterson, Mark S / Slagboom, Ton / Vink, Maarten A

JACC. Cardiovascular interventions

2024

Language	English
Publishing date	2024-03-05
Publishing country	United States
Document type	Letter
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2024.01.288
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Zs.A 6669: Show issues

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Article ; Online: Transulnar coronary intervention complicated by compartment syndrome.

Smits, Matthijs W L / van der Schaaf, Rene J / Herrman, Jean-Paul / Kuipers, Remko S

BMJ case reports

2021 Volume 14, Issue 2

Abstract: We describe a case of a compartment syndrome after transulnar coronary intervention. As far as we are aware of, this is the first report of such a complication after a transulnar approach described in the literature. Compartment syndrome is a very rare ... ...

Abstract	We describe a case of a compartment syndrome after transulnar coronary intervention. As far as we are aware of, this is the first report of such a complication after a transulnar approach described in the literature. Compartment syndrome is a very rare but possibly devastating complication of coronary angiography and percutaneous coronary interventions. We retrospectively observed an incidence rate of 0.007% after 13,948 coronary angiographies or 0.013% after 7532 interventions performed through the wrist in our centre in the last 5 years. Rapid recognition and treatment of this rare complication may prevent long-term morbidity and are thus of utmost importance. General measures should be taken to reduce this incidence of this serious complication.
MeSH term(s)	Angina Pectoris/diagnosis ; Angina Pectoris/therapy ; Biomarkers/blood ; Compartment Syndromes/diagnostic imaging ; Compartment Syndromes/etiology ; Compartment Syndromes/surgery ; Diagnosis, Differential ; Drug-Eluting Stents ; Electrocardiography ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention/adverse effects ; Suture Techniques ; Ulnar Artery ; Ultrasonography
Chemical Substances	Biomarkers
Language	English
Publishing date	2021-02-09
Publishing country	England
Document type	Case Reports ; Journal Article
ISSN	1757-790X
ISSN (online)	1757-790X
DOI	10.1136/bcr-2020-237339
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Article ; Online: Pronounced late acquired focal coronary artery dilatation after paclitaxel-coated balloon angioplasty: observations from the randomized REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION (REVELATION) trial.

Vos, Nicola S / Amoroso, Giovanni / Herrman, Jean-Paul R / Patterson, Mark S / van der Schaaf, René J / Slagboom, Ton / Vink, Maarten A

Coronary artery disease

2022 Volume 33, Issue 2, Page(s) 151–152

MeSH term(s)	Aged ; Angioplasty, Balloon, Coronary/methods ; Angioplasty, Balloon, Coronary/statistics & numerical data ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/physiopathology ; Drug-Eluting Stents/standards ; Drug-Eluting Stents/statistics & numerical data ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction/physiopathology ; Myocardial Infarction/therapy ; Paclitaxel/pharmacology ; Paclitaxel/therapeutic use ; Treatment Outcome
Chemical Substances	Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2022-02-03
Publishing country	England
Document type	Journal Article
ZDB-ID	1047268-x
ISSN	1473-5830 ; 0954-6928
ISSN (online)	1473-5830
ISSN	0954-6928
DOI	10.1097/MCA.0000000000001047
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Zs.A 3039: Show issues

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Article ; Online: EAPCI Focus on the Interventional Cardiology Working Group of The Netherlands Society of Cardiology (NVVC).

van der Schaaf, René J

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

2015 Volume 10, Issue 11, Page(s) 2 p following 1259

MeSH term(s)	Accreditation ; Cardiology ; Europe ; Humans ; Netherlands ; Percutaneous Coronary Intervention ; Practice Guidelines as Topic ; Quality Assurance, Health Care ; Quality of Health Care ; Registries ; Societies, Medical
Language	English
Publishing date	2015-03
Publishing country	France
Document type	Interview ; Portraits
ZDB-ID	2457174-X
ISSN	1969-6213 ; 1774-024X
ISSN (online)	1969-6213
ISSN	1774-024X
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Zs.A 6680: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 571: Show issues

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Article ; Online: EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries.

Oomens, Thomas / Vos, Nicola S / van der Schaaf, René J / Amoroso, Giovanni / Ewing, Mark M / Patterson, Mark S / Herrman, Jean-Paul R / Slagboom, Ton / Vink, Maarten A

International journal of cardiology

2023 Volume 386, Page(s) 24–29

Abstract: Background: Coronary artery calcification is a strong predictor for procedural failure and is independently associated with adverse events after percutaneous coronary intervention (PCI). An important contributor to the impaired outcome is the inability ... ...

Abstract	Background: Coronary artery calcification is a strong predictor for procedural failure and is independently associated with adverse events after percutaneous coronary intervention (PCI). An important contributor to the impaired outcome is the inability to achieve optimal results due to stent underexpansion or stent deformation/fracture. Intravascular lithotripsy (IVL) has emerged as an alternative technique to change the integrity of calcified plaques. Aims: Our aim was to investigate if pre-treatment with IVL in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (OCT), when compared to predilatation with conventional and/or specialty balloon strategy. Methods: EXIT-CALC was a prospective, single-centre, randomised controlled study. Patients with an indication for PCI and severe calcification of the target lesion were allocated to predilatation with conventional angioplasty balloons or pre-treatment with IVL, followed by drug-eluting stenting and mandatory postdilatation. Primary endpoint was stent expansion assessed by OCT. Secondary endpoints were the occurrence of peri-procedural events and major adverse cardiac events (MACE) in hospital and during follow-up. Results: A total of 40 patients were included. The minimal stent expansion in the IVL-group (n = 19) was 83.9 ± 10.3% and 82.2 ± 11.5% in the conventional group (n = 21) (p = 0.630). Minimal stent area was 6.6 ± 1.5 mm Conclusions: In severely calcified coronary lesions we found no significant difference in stent expansion measured by OCT when comparing IVL, as plaque modification, with conventional and/or specialty angioplasty balloons.
MeSH term(s)	Humans ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/surgery ; Coronary Vessels/pathology ; Percutaneous Coronary Intervention/adverse effects ; Prospective Studies ; Treatment Outcome ; Vascular Calcification/diagnostic imaging ; Vascular Calcification/surgery ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/surgery ; Stents ; Lithotripsy/adverse effects ; Lithotripsy/methods
Language	English
Publishing date	2023-05-12
Publishing country	Netherlands
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2023.05.012
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Zs.A 1673: Show issues

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Article ; Online: Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study.

Haude, Michael / Wlodarczak, Adrian / van der Schaaf, René J / Torzewski, Jan / Ferdinande, Bert / Escaned, Javier / Iglesias, Juan F / Bennett, Johan / Toth, Gabor / Joner, Michael / Toelg, Ralph / Wiemer, Marcus / Olivecrona, Göran / Vermeersch, Paul / Garcia-Garcia, Hector M / Waksman, Ron

EClinicalMedicine

2023 Volume 59, Page(s) 101940

Abstract: Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting ... ...

Abstract	Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. Methods: This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). Findings: Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm Interpretation: These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents. Funding: This study was funded by BIOTRONIK AG.
Language	English
Publishing date	2023-04-17
Publishing country	England
Document type	Journal Article
ISSN	2589-5370
ISSN (online)	2589-5370
DOI	10.1016/j.eclinm.2023.101940
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Article ; Online: A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study.

Haude, Michael / Wlodarczak, Adrian / van der Schaaf, René J / Torzewski, Jan / Ferdinande, Bert / Escaned, Javier / Iglesias, Juan F / Bennett, Johan / Toth, Gabor G / Joner, Michael / Toelg, Ralph / Wiemer, Marcus / Olivecrano, Göran / Vermeersch, Paul / Garcia-Garcia, Hector M / Waksman, Ron

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

2023 Volume 19, Issue 5, Page(s) e414–e422

Abstract: Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES).: Aims: The ... ...

Abstract	Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES). Aims: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold. Methods: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years. Results: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent. Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES. Clinicaltrials: gov: NCT04157153.
MeSH term(s)	Humans ; Absorbable Implants ; Coronary Angiography/methods ; Coronary Artery Disease/surgery ; Drug-Eluting Stents ; Magnesium/therapeutic use ; Percutaneous Coronary Intervention ; Prospective Studies ; Treatment Outcome
Chemical Substances	Magnesium (I38ZP9992A)
Language	English
Publishing date	2023-08-07
Publishing country	France
Document type	Clinical Trial ; Journal Article
ZDB-ID	2457174-X
ISSN	1969-6213 ; 1774-024X
ISSN (online)	1969-6213
ISSN	1774-024X
DOI	10.4244/EIJ-D-23-00326
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Zs.A 6680: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 571: Show issues

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Article ; Online: Very long-term outcome of the PRISON-IV trial: 5-year clinical follow-up of ultra-thin struts in CTO-PCI.

Wilgenhof, Adriaan / Zivelonghi, Carlo / Teeuwen, Koen / van der Schaaf, René J / Henriques, José P S / Vermeersch, Paul H M J / Bosschaert, Mike A R / Agostoni, Pierfrancesco / Suttorp, Maarten J

Cardiovascular revascularization medicine : including molecular interventions

2022

Language	English
Publishing date	2022-08-12
Publishing country	United States
Document type	Letter
ZDB-ID	2212113-4
ISSN	1878-0938 ; 1553-8389
ISSN (online)	1878-0938
ISSN	1553-8389
DOI	10.1016/j.carrev.2022.08.013
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Zs.A 5562: Show issues

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Article ; Online: Two-Year Clinical Outcomes of the REVELATION Study: Sustained Safety and Feasibility of Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction.

Niehe, Sander R / Vos, Nicola S / Van Der Schaaf, René J / Amoroso, Giovanni / Herrman, Jean-Paul R / Patterson, Mark S / Slagboom, Ton / Vink, Maarten A

The Journal of invasive cardiology

2021 Volume 34, Issue 1, Page(s) E39–E42

Abstract: Objectives: The randomized REVELATION (REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION) trial showed that in the setting of ST-segment elevation myocardial infarction (STEMI), a ... ...

Abstract	Objectives: The randomized REVELATION (REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION) trial showed that in the setting of ST-segment elevation myocardial infarction (STEMI), a drug-coated balloon (DCB) strategy was non-inferior to a drug-eluting stent (DES) strategy in terms of fractional flow reserve assessed at 9 months. The aim of the present study is to evaluate the long-term clinical outcome of this treatment strategy. Methods: Between October 2014 and November 2017, a total of 120 patients with a non-severely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after predilation were randomized to treatment with DCB or DES. Primary clinical endpoint was the occurrence of major adverse cardiac events, defined as death, recurrent myocardial infarction, or target-lesion revascularization, the occurrence of definite ST, and non-coronary artery bypass grafting (CABG) major bleeding. Results: Complete clinical follow-up at 2 years was available for 109 patients (91%). A major adverse cardiac event occurred in 3 patients (5.4%) in the DCB group and 1 patient (1.9%) in the DES group (hazard ratio, 2.86; 95% confidence interval, 0.30-27.53; P=.34). Between 9 months and 2 years, only 1 additional event occurred (target-lesion revascularization in a patient randomized to DCB). Conclusion: In this randomized study of DCB vs DES in selected patients presenting with STEMI, 2-year clinical outcome was excellent and comparable between the DCB and DES groups.
MeSH term(s)	Angioplasty, Balloon, Coronary ; Coated Materials, Biocompatible ; Drug-Eluting Stents/adverse effects ; Feasibility Studies ; Fractional Flow Reserve, Myocardial ; Humans ; Myocardial Infarction/diagnosis ; Myocardial Infarction/surgery ; Paclitaxel ; Treatment Outcome
Chemical Substances	Coated Materials, Biocompatible ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2021-11-18
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1154372-3
ISSN	1557-2501 ; 1042-3931
ISSN (online)	1557-2501
ISSN	1042-3931
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Zs.A 3701: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 272: Show issues
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Article ; Online: Temporal changes in coronary plaque as assessed by an artificial intelligence-based optical coherence tomography: from the first-in-human trial on DREAMS 3G scaffold.

European heart journal. Cardiovascular Imaging

2023 Volume 25, Issue 4, Page(s) 491–497

Abstract: Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up.: Methods and results: A total of 116 ...

Abstract	Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up. Methods and results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001. Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue.
MeSH term(s)	Humans ; Absorbable Implants ; Artificial Intelligence ; Coronary Angiography ; Coronary Artery Disease ; Coronary Vessels ; Drug-Eluting Stents ; Lipids ; Percutaneous Coronary Intervention ; Plaque, Atherosclerotic ; Tomography, Optical Coherence/methods ; Treatment Outcome
Chemical Substances	Lipids
Language	English
Publishing date	2023-11-08
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	2638345-7
ISSN	2047-2412 ; 2047-2404
ISSN (online)	2047-2412
ISSN	2047-2404
DOI	10.1093/ehjci/jead299
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