Publications by authors named "Rene van der Schaaf"

Background: In patients with acute coronary syndromes (ACS) and multivessel coronary disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome at 1 year. The authors report clinical outcomes at 2 years of follow-up.

Methods: Patients with ACS and multivessel coronary disease were randomly assigned to immediate complete revascularization or to staged complete revascularization at 29 sites in Europe.

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  • The BIOMAG-I study evaluated the first-in-human resorbable magnesium scaffold (DREAMS 3G) and showed positive outcomes for clinical results and late lumen loss after 12 months.
  • The current substudy looked into vascular healing parameters using optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on aspects like strut visibility and neointimal growth.
  • Results from 56 patients indicated that almost all scaffold struts became invisible by 12 months, with a favorable vascular healing response, including a significant decrease in protruding neointimal tissue.
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  • - The EXPLORE trial was a 10-year study comparing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) to no-CTO PCI in patients who had a ST-segment-elevation myocardial infarction (STEMI).
  • - The trial found that after a median follow-up of 10 years, there was no significant difference in major adverse cardiac events or overall mortality between the two groups, but the CTO PCI group experienced higher cardiovascular mortality.
  • - Although the CTO PCI group had more effective relief from dyspnea (83% vs. 65%), the findings suggest that the benefits of symptom relief should be carefully considered against the increased risk of cardiovascular mortality.
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Background: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear.

Objectives: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD.

Methods: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD.

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  • The study aimed to evaluate how the initial composition of plaque affects late loss in the lumen after DREAMS 3G implantation and to compare plaque changes over 6 and 12 months.
  • 116 patients from the BIOMAG-I trial underwent imaging using optical coherence tomography (OCT) before and after the procedure, revealing that those with more fibrous tissue in their plaque initially had greater differences in lumen area after a year.
  • Results showed a significant reduction in lipid areas and an increase in fibrous tissue at follow-up, indicating favorable healing of coronary walls post-implantation.
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  • The LEGACY study examines whether stopping aspirin right after PCI for NSTE-ACS and using only P2Y-inhibitor therapy is safer and effective compared to continuing dual antiplatelet therapy (DAPT) for 12 months.
  • The research involves 3,090 patients, comparing the incidence of bleeding events between those on aspirin and those who aren’t, while also ensuring no significant increase in serious health issues like heart attacks or strokes.
  • This study is groundbreaking as it specifically investigates the effects of immediately omitting aspirin, making it a crucial step in understanding optimal post-PCI treatment options.
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  • The DREAMS 3G is a new coronary magnesium scaffold designed to match the performance of traditional drug-eluting stents (DES).
  • The BIOMAG-I study is a first-in-human trial that evaluates the safety and effectiveness of this scaffold with a follow-up period of up to 5 years.
  • Results showed that after 12 months, the scaffold demonstrated low rates of complications, confirming its safety and efficacy as a potential alternative to DES.
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  • Coronary artery calcification can hinder the results of procedures like percutaneous coronary intervention (PCI), often leading to stent issues like underexpansion or fractures.
  • The study, called EXIT-CALC, aimed to compare the effectiveness of intravascular lithotripsy (IVL) versus traditional balloon methods in improving stent expansion in severely calcified coronary arteries.
  • Results showed no significant difference in stent expansion between the IVL and conventional groups, and there were no major adverse cardiac events reported during the study period.
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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.

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Background: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged.

Methods: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain.

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  • The study examined the effects of large-bore arterial access through either the transradial (TRA) or transfemoral (TFA) methods on upper and lower-extremity function in patients undergoing complex coronary intervention.
  • Results showed that patients generally maintained their upper and lower-extremity functionality over time, with minimal clinically relevant dysfunction reported (6% for TRA and 9% for TFA).
  • Additionally, some trends indicated higher upper-limb dysfunction rates in female patients after TRA and greater lower-extremity pain linked to complications from femoral access.
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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.

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  • The study focused on how the right ventricle (RV) functions in STEMI patients with concurrent chronic total occlusion (CTO) in the right coronary artery (RCA).
  • It involved analyzing RV performance in three patient groups using various measurements over a 4-month period, revealing that RV function improved in those with RCA-related issues but not in those without RCA involvement.
  • Additionally, while some RV parameters did not predict long-term mortality, right ventricular global longitudinal strain (RV GLS) was found to be a useful indicator for functional status post-treatment.
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  • The study examined the long-term (five-year) clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) compared to the XIENCE everolimus-eluting stent (EES) in patients with coronary artery disease.
  • There was no significant difference in target vessel failure rates between the two devices; however, the Absorb BVS had a notably higher incidence of device thrombosis (4.8% vs. 1.5% for XIENCE).
  • The use of prolonged dual antiplatelet therapy (DAPT) appeared to reduce the risk of scaffold thrombosis over the five-year follow-up period.
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  • This study explored how the time from hospital admission to percutaneous coronary intervention (PCI) affects 1-year mortality rates in non-ST-elevation myocardial infarction (NSTEMI) patients.
  • It involved analyzing data from 848 NSTEMI patients treated at a high-volume PCI center in Amsterdam, assessing different time windows for PCI: under 24 hours, 24-72 hours, 72 hours to 7 days, and over 7 days.
  • The findings indicated that PCI within 24 hours did not significantly improve survival compared to treatment within 72 hours, but delays beyond 7 days significantly increased mortality risk.
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Objectives: The aim of this study was to investigate whether transradial (TR) percutaneous coronary intervention (PCI) is superior to transfemoral (TF) PCI in complex coronary lesions with large-bore guiding catheters with respect to clinically relevant access site-related bleeding or vascular complications.

Background: The femoral artery is currently the most applied access site for PCI of complex coronary lesions, especially when large-bore guiding catheters are required. With downsizing of TR equipment, TR PCI may be increasingly applied in these patients and might be a safer alternative compared with the TF approach.

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Background And Aims: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy.

Methods: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT.

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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.

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  • In a study involving patients with non-ST elevated acute coronary syndrome (NSTE-ACS), researchers compared immediate invasive treatment (<3 hours) to an early treatment approach (12-24 hours) to see which was more effective at reducing heart damage and ensuring safety.
  • The trial involved 249 patients who received a combination of heart medications, and its main goal was to measure the size of heart damage based on CK-MB levels within 48 hours, while also tracking other health outcomes.
  • Results showed no significant difference in heart damage between the two strategies, and due to the lack of expected results, the study was ended early after including 71% of the intended participants.
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  • - The study compares the effectiveness of absorb bioresorbable vascular scaffolds (BVS) and Xience everolimus-eluting stents (EES) in patients with diabetes mellitus (DM) during routine percutaneous coronary interventions (PCI) over a 3-year period.
  • - Among 1,845 participants, rates of target vessel failure (TVF) were similar for both devices in diabetic patients, but Absorb BVS showed significantly higher rates of device thrombosis compared to Xience EES for both diabetic and nondiabetic patients.
  • - Overall, both Absorb BVS and Xience EES yielded poorer outcomes for diabetic patients, with Absorb BVS being linked to increased risk of device thromb
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Introduction: The radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required.

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