Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry.
Methods and resultsIn the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013?at the Amsterdam University Medical Centre—Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4?year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy.
ConclusionIn a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.
相似文献Diabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI).
AimsWe intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication.
MethodsThe ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT).
ResultsBetween April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%).
ConclusionAbsorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.
相似文献Background
Recent evidence has raised concerns regarding the safety of the everolimus-eluting bioresorbable vascular scaffold (E-BVS) (Absorb, Abbott Vascular, Santa Clara, CA, USA). Following these data, the use of this device has diminished in the Netherlands; however, daily practice data are limited. Therefore we studied the incidence of safety and efficacy outcomes with this device in daily clinical practice in a single large tertiary centre in the Netherlands.Methods
All E?BVS treated patients were included in this analysis. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel non-fatal myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (TLR). The secondary endpoint was the incidence of definite scaffold thrombosis.Results
Between October 2013 and January 2017, 105 patients were treated with 147 E?BVS. This population contained 42 (40%) patients with diabetes mellitus and 43 (40.9%) undergoing treatment for acute coronary syndrome, and thus represents a high-risk patient cohort. Mean follow-up was 19.8 months. Intravascular imaging guidance during scaffold implantation was used in 64/105 (43.5%) patients. The primary endpoint (TLF) occurred in 3 (2.9%) patients. All-cause mortality and cardiac mortality occurred in 2 (2%) and 0 (0%) patients respectively. TV-MI occurred in 2 patients (1.9%): both were periprocedural and not related to the BVS implantation. TLR occurred in 1 patient (1.0%) during follow-up. No definite scaffold thrombosis occurred during follow-up.Conclusion
This single-centre study examining the real-world experience of E?BVS implantation in a high-risk population shows excellent procedural safety and long-term clinical outcomes.Background
Dual antiplatelet therapy (DAPT) remains the cornerstone therapy in the prevention of ischaemic events following drug-eluting stent (DES) implantation. Mandatory duration of DAPT after DES however, is a matter of debate. We aimed to evaluate safety and efficacy of short-term (up to 6 months) versus long-term (12 months) DAPT after DES implantation.Methods
We searched PubMed, EMBASE, Cochrane databases, and international meetings for randomised clinical trials (RCTs) comparing short with long DAPT. We performed a systematic review and meta-analysis of major trials with primary outcomes: all-cause death, myocardial infarction, definite or probable stent thrombosis, stroke, and major bleeding event.Results
Nine RCTs with a total number of 19,099 patients were pooled in the present meta-analysis. When compared with long DAPT, short DAPT was associated with a significant reduction in major bleeding events (0.62% vs. 1.10%, risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.86, p?<?0.007, I2?=?21%), whereas all-cause death (1.65% vs. 1.84%, RR 0.90, 95% CI 0.73 to 1.11, p?=?0.34, I2?=?0%), myocardial infarction (1.91% vs. 1.68%, RR 1.14, 95% CI 0.92 to 1.40, p?=?0.23, I2?=?0%), definite or probable stent thrombosis (0.62% vs. 0.47%, RR 1.25, 95% CI 0.84 to 1.86, p?=?0.27, I2?=?0%), and stroke (0.60% vs. 0.67%, RR 0.91, 95% CI 0.63 to 1.31, p?=?0.61, I2?=?0%) were similar.Conclusions
Short DAPT following DES implantation results in a significant reduction of major bleeding events with no apparent increase in all-cause death, myocardial infarction, stent thrombosis, or stroke. Future dedicated trials should investigate the optimal strategies for patient-tailored DAPT in various subgroups.Backgrounds
Drug-eluting stents (DES) with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES) versus durable polymer DES.Methods
Systematic database searches of MEDLINE (1950 to June 2013), EMBASE (1966 to June 2013), the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013), and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included.Results
Eight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848–1.111; p = 0.662). However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755–1.802; p = 0.487; RR 0.273; 95% CI 0.115–0.652; p = 0.003; p for interaction = 0.003).Conclusions
In this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up.PROSPERO register number
http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J 相似文献The cardiology and clinical genetics subspecialty of cardiogenetics has experienced a tremendous growth in the past 25 years. This review discusses examples of the progress that has been made as well as new challenges that have arisen within this field, with special focus on the Netherlands. A significant number of Dutch founder mutations, i.e. mutations shared by a number of individuals who have a common origin and all share a unique chromosomal background on which the mutation occurred, have been identified and have provided unique insights into genotype-phenotype correlations in inherited arrhythmia syndromes and inherited cardiomyopathies.
Cardiological and genetic screening of family members of young victims of sudden cardiac death combined with genetic testing in the deceased individual have turned out to be rewarding. However, the interpretation of the results of genetic testing in this setting and in the setting of living patients with a (suspected) phenotype is now considered more challenging than previously anticipated, because the introduction of high-throughput sequencing technologies has resulted in the identification of a significant number of variants of unknown significance. Interpretation of genetic and clinical findings by experienced multidisciplinary teams are key to ensure a high quality of care to the patient and the family.
相似文献Invasive coronary physiology has been applied since the early days of percutaneous transluminal coronary angioplasty, and has become a rapidly emerging field of research. Many physiology indices have been developed, tested in clinical studies, and are now applied in daily clinical practice. Recent clinical practice guidelines further support the use of advanced invasive physiology methods to optimise the diagnosis and treatment of patients with acute and chronic coronary syndromes. This article provides a succinct review of the history of invasive coronary physiology, the basic concepts of currently available physiological parameters, and will particularly highlight the Dutch contribution to this field of invasive coronary physiology.
相似文献Aims
Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent.Methods and results
Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1–3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11–1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88–4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99–8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11–1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20–2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91–1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57–1.46, p = 0.71] were not significantly different between BVS and Xience.Conclusion
This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.In recognition of the increasing health burden of cardiovascular disease, the Dutch CardioVascular Alliance (DCVA) was founded with the ambition to lower the cardiovascular disease burden by 25% in 2030. To achieve this, the DCVA is a platform for all stakeholders in the cardiovascular field to align policies, agendas and research. An important goal of the DCVA is to guide and encourage young researchers at an early stage of their careers in order to help them overcome challenges and reach their full potential. Young@Heart is part of the DCVA that supports the young cardiovascular research community. This article illustrates the challenges and opportunities encountered by young cardiovascular researchers in the Netherlands and highlights Young@Heart’s vision to benefit from these opportunities and optimise collaborations to contribute to lowering the cardiovascular disease burden together as soon as possible.
相似文献Introduction
Optical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria.Methods
Twenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring.Results
Twenty-six indications were rated ‘Appropriate’, eighteen indications ‘May be appropriate’, and five ‘Rarely appropriate’. Use of OCT was unanimously considered ‘Appropriate’ in stent thrombosis, and ‘Appropriate’ for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered ‘Rarely Appropriate’ on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery.Conclusions
The use of OCT in stent thrombosis is unanimously considered ‘Appropriate’ by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings.Ischaemia with no obstructive coronary arteries (INOCA) is a common ischaemic heart disease with a female preponderance, mostly due to underlying coronary vascular dysfunction comprising coronary microvascular dysfunction and/or epicardial coronary vasospasm. Since standard ischaemia detection tests and coronary angiograms are not suitable to diagnose coronary vascular dysfunction, INOCA is often overlooked in current cardiology practice. Future research, including large outcome trials, is much awaited. Yet, adequate diagnosis is possible and treatment options are available and vital to reduce symptoms and most probably improve cardiovascular prognosis. This review intends to give a brief overview of the clinical presentation, underlying pathophysiology, and the diagnostic and treatment options in patients with suspected INOCA.
相似文献Aim
The aim of this study was to achieve useful insights into pre-hospital management and procedural performance for ST-elevation myocardial infarction (STEMI) in the Netherlands by extrapolating patient characteristics, and procedural and clinical outcomes of the Dutch patient cohort from the APPOSITION-III trial.Methods
This is a retrospective analysis from the APPOSITION-III trial with respect to the geographical borders of STEMI management. The APPOSITION-III trial was a European registry for the use of the STENTYS self-expandable stent in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). 965 Patients were enrolled mainly in the Netherlands (n = 420, 43.5?% of the overall study population), Germany (n = 165) and France (n = 131). The data from the Dutch cohort were compared with both the overall study population, and the French and German cohorts, respectively, as well as the European Society of Cardiology (ESC) STEMI guidelines.Results
In this trial there was a wide inter-country variation on symptom-to-balloon time, 165 minutes (120–318) in the Netherlands, 270 minutes (180–650) in Germany and 360 minutes (120–480) in France, respectively. In general, a preload of dual antiplatelet therapy (DAPT) combined with heparin was more often performed in the Dutch and French cohort than in the German cohort. DAPT at discharge was high across the whole APPOSITION-III population. No important differences were seen between the different groups according to the endpoints major adverse cardiac event and stent thrombosis.Conclusion
In the Dutch cohort of an European multicentre STEMI study (APPOSITION-III trial), the performance in terms of symptom-to-balloon time, and pre-, peri- and post-procedural medical treatment is in line with the recommendations of ESC STEMI guidelines.In the past 20 years the Netherlands-based RACE trials have investigated important concepts in clinical atrial fibrillation (AF). Their scope ranged from rhythm versus rate control to early or delayed cardioversion and also included early comprehensive management of AF in two trials, one focusing on early ‘upstream therapy’ and risk factor management and the other on integrated chronic nurse-led care. Studies were mostly triggered by simple clinical observations including futility of electrical cardioversion in persistent AF; many patients with permanent AF tolerating day-after-day ‘uncontrolled’ resting heart rates of up till 110 beats/min; patients being threatened more by vascular risks than AF itself; and insufficient guideline-based treatments for AF. Also the observation that recent-onset atrial fibrillation generally converts spontaneously, obviating cardioversion, triggered one of the studies. The RACE trials shifted a number of paradigms and by that could change the AF guidelines. The initial ‘shock-and-forget’ attitude made place for increased attention for anticoagulation, and in turn, broader vascular risks were recognised. In a nutshell, the adage eventually became: ‘look beyond the ECG, treat the patient’.
相似文献Background
The introduction of drug-eluting stents (DES) has dramatically reduced restenosis rates compared with bare metal stents, but in-stent thrombosis remains a safety concern, necessitating prolonged dual anti-platelet therapy. The drug 6-Mercaptopurine (6-MP) has been shown to have beneficial effects in a cell-specific fashion on smooth muscle cells (SMC), endothelial cells and macrophages. We generated and analyzed a novel bioresorbable polymer coated DES, releasing 6-MP into the vessel wall, to reduce restenosis by inhibiting SMC proliferation and decreasing inflammation, without negatively affecting endothelialization of the stent surface.Methods
Stents spray-coated with a bioresorbable polymer containing 0, 30 or 300 μg 6-MP were implanted in the iliac arteries of 17 male New Zealand White rabbits. Animals were euthanized for stent harvest 1 week after implantation for evaluation of cellular stent coverage and after 4 weeks for morphometric analyses of the lesions.Results
Four weeks after implantation, the high dose of 6-MP attenuated restenosis with 16% compared to controls. Reduced neointima formation could at least partly be explained by an almost 2-fold induction of the cell cycle inhibiting kinase p27Kip1. Additionally, inflammation score, the quantification of RAM11-positive cells in the vessel wall, was significantly reduced in the high dose group with 23% compared to the control group. Evaluation with scanning electron microscopy showed 6-MP did not inhibit strut coverage 1 week after implantation.Conclusion
We demonstrate that novel stents coated with a bioresorbable polymer coating eluting 6-MP inhibit restenosis and attenuate inflammation, while stimulating endothelial coverage. The 6-MP-eluting stents demonstrate that inhibition of restenosis without leaving uncovered metal is feasible, bringing stents without risk of late thrombosis one step closer to the patient. 相似文献Since the publication of the SIMPLE and NORDIC trials, defibrillation testing (DFT) is rarely performed during routine implantation of transvenous implantable cardioverter-defibrillators (ICD). However, the results of these trials cannot be extrapolated to the later introduced subcutaneous ICD (S-ICD) and a class I recommendation to perform DFT during the implantation of these devices remains in the current guidelines. Due to the high conversion success rate of DFT on one hand, and the risk of complications on the other, a significant number of physicians omit DFT in S‑ICD recipients. Several retrospective analyses have assessed the safety of the omission of DFT and report contradicting results and recommendations. It is known that implant position, as well as device factors and patient characteristics, influence defibrillation success. A better comprehension of these factors and their relationship could lead to more reliable and safer alternatives to DFT. An ongoing randomised clinical trial, which is expected to end in 2023, is the first study to implement a method that assesses implant position to identify patients who are likely to fail their DFT.
相似文献