Impact of ultra-thin struts on restenosis after chronic total occlusion recanalization: Insights from the randomized PRISON IV trial

The PRISON-IV trial showed inferior outcome in patients with chronic total occlusions (CTOs) treated with the ultrathin-struts (60\u2009\u3bcm for stent diameter 643\u2009mm, 81\u3bcm >3\u2009mm) hybrid-sirolimus eluting stents (SES) compared with everolimus eluting stents (EES, 81\u2009\u3bcm). The aim of this study is to investigate if the use of smaller stents ( 643\u2009mm) was responsible for the inferior outcome reported in the trial

Impact of percutaneous coronary intervention timing on 5-year outcome in patients with non-ST-segment elevation acute coronary syndromes. The ‘wait a day’ approach might be safer

Background The OPTIMA trial was a randomised multicentre trial exploring the influence of the timing of percutaneous coronary intervention (PCI) on patient outcomes in an intermediate to high risk non-ST-elevation acute coronary syndrome (NSTE-ACS) population. In order to decide the best treatment strategy for patients presenting with NSTEACS, long-term outcomes are essential. Methods Five-year follow-up data from 133 of the 142 patients could be retrieved (94 %). The primary endpoint was a composite of death and spontaneous myocardial infarction (MI). Spontaneous MI was defined as MI occurring more than 30 days after randomisation. Secondary endpoints were the individual outcomes of death, spontaneous MI or re-PCI. Results No significant difference with respect to the primary endpoint was observed (17.8 vs. 10.1 %; HR 1.55, 95 % CI: 0.73–4.22, p = 0.21). There was no significant difference in mortality rate. However, spontaneous MI was significantly more common in the group receiving immediate PCI (11.0 vs. 1.4 %; HR 4.46, 95 % CI: 1.21–16.50, p = 0.02). We did not find a significant difference between the groups with respect to re-PCI rate. Conclusion There was no difference in the composite of death and spontaneous MI. The trial suggests an increased long-term risk of spontaneous MI for patients treated with immediate PCI

Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

<p>Abstract</p> <p>Background</p> <p>In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.</p> <p>Methods/Design</p> <p>The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.</p> <p>Discussion</p> <p>The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.</p> <p>Trial registration</p> <p>trialregister.nl NTR1108.</p

Paroxysmal atrial fibrillation and atrial flutter: current concepts and new strategies

Ondanks het feit dat al meer dan een eeuw geneesmiddelen worden voorgeschreven ter behandeling en preventie van boezemfibrilleren en boezemflutter, zoals het aloude digitalis en kinidine, beschikken wij pas sinds kort over een groeiende reeks van nieuwe en veelbelovende antiaritmica. Met het onderzoek en gebruik van deze stoffen zijn onze inzichten en therapeutische mogelijkheden belangrijk toegenomen. In dit proefschrift worden de recente inzichten en nieuwe strategieën voor de optimale benadering van paroxismaal boezemfibrilleren en boezemflutter beschreven. Deze zijn gebaseerd op de huidige klinische praktijk en de recente literatuur (Hoofdstukken 1-5). Zie: Samenvatting en conclusies

Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial.

BACKGROUND: This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial. METHODS AND RESULTS: This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%). CONCLUSIONS: Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years

Microtransesophageal Echocardiographic Guidance during Percutaneous Interatrial Septal Closure without General Anaesthesia

Objective. To study the safety and efficacy of microtransesophageal echocardiography (micro-TEE) and TEE during percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure. Background. TEE has proven to be safe during ASD and PFO closure under general anaesthesia. Micro-TEE makes it possible to perform these procedures under local anaesthesia. We are the first to describe the safety and efficacy of micro-TEE for percutaneous closure. Methods. All consecutive patients who underwent ASD and PFO closure between 2013 and 2018 were included. The periprocedural complications were registered. Residual shunts were diagnosed using transthoracic contrast echocardiography (TTCE). All data were compared between the use of TEE or micro-TEE within the ASD and PFO groups separately. Results. In total, 82 patients underwent ASD closure, 46 patients (49.1 ± 15.0 years) with TEE and 36 patients (47.8 ± 12.1 years) using micro-TEE guidance. Median device diameter was, respectively, 26 mm (range 10–40 mm) and 27 mm (range 10–35 mm). PFO closure was performed in 120 patients, 55 patients (48.6 ± 9.2 years, median device diameter 25 mm, range 23–35 mm) with TEE and 65 patients (mean age 51.0 ± 11.8 years, median device diameter 27 mm, range 23–35 mm) using micro-TEE. There were no major periprocedural complications, especially no device embolizations within all groups. Six months after closure, there was no significant difference in left-to-right shunt after ASD closure and no significant difference in right-to-left shunt after PFO closure using TEE or micro-TEE. Conclusion. Micro-TEE guidance without general anaesthesia during percutaneous ASD and PFO closure is as safe as TEE, without a significant difference in the residual shunt rate after closure

Lack of long-term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel-eluting stents or bare-metal stents: post-hoc analysis of the PASSION-trial

Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents. We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA. Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups. In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPC

One-year results of coronary revascularization in diabetic patients with multivessel coronary artery disease.Sirolimus stent vs. coronary artery bypass surgery and bare metal stent: insights from ARTS-II and ARTS-I.

peer reviewedBackground: ARTS-II was designed to evaluate the sirolimus-eluting stent (SES) versus ARTS-I. The objective of this analysis is to assess the safety and efficacy of the SES in diabetic patients with multivessel disease (MVD) versus both arms of ARTS-I.Methods and results: The ARTS studies included 367 diabetic patients (ARTS-II: 159; ARTS-I-CABG: 96; ARTS-I-PCI: 112). Baseline characteristics showed a more diseased patient population in the ARTS-II study: 50.3% with 3VD vs. 35.4% (ARTS-I-CABG) and 30.8% (ARTS-I-PCI) (p=0.003). Treated or anastomosed lesions were 3.2+/-1.2 (ARTS-II), 2.8+/-0.8 (ARTS-I-CABG) and 2.5+/-1.1 (ARTS-I-PCI). At 30 days there was a significant difference in MACCE between ARTS-II (4.4%) and ARTS-I-PCI (12.5%) (p=0.02). At 1-year, the death rate was 2.5% (ARTS-II) vs. 3.1% (ARTS-I-CABG) and 6.3% (ARTS-I-PCI) without significant differences. Myocardial infarction rate was 0.6% (ARTS-II) vs. 2.1% (ARTS-I-CABG; p=0.56) and 6.3% (ARTS-I-PCI; p=0.01). The need for repeat revascularization was 12.6% (ARTS-II) vs. 4.2% (ARTS-I-CABG; p=0.027) and 22.3% (ARTS-I-PCI; p= 0.046). MACCE-free survival was 84.3% (ARTS-II) vs. 85.4% (ARTS-I-CABG; p=0.86) and 63.4% (ARTS-I-PCI; p<0.001). Also at 1 year, the overall MACCE rate in patients with diabetes was significantly higher than in nondiabetic patients, 15.7% vs. 8.5%, respectively [RR 1.85, 95%CI (1.16,2.97), p=0.015), due to a higher incidence of death and need for repeat revascularization, 2.5% vs. 0.4 and 12.5% vs. 5.6% in diabetes vs. nondiabetes groups, respectively.Conclusion: Despite more extensive and treated disease, the overall MACCE-free survival in diabetic patients at 1 year in ARTS-II is similar to ARTS-I-CABG