Ivo M. van Dongen

Bioresorbable Scaffolds versus Metallic Stents in Routine PCI

BACKGROUND Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug‐eluting stents in percutaneous coronary intervention (PCI). We performed an investigator‐initiated, randomized trial to compare an everolimus‐eluting bioresorbable scaffold with an everolimus‐eluting metallic stent in the context of routine clinical practice. METHODS We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target‐vessel failure (a composite of cardiac death, target‐vessel myocardial infarction, or target‐vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end‐point events. RESULTS The median follow‐up was 707 days. Target‐vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2‐year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan–Meier estimates in time‐to‐event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2‐year cumulative event rates, 2.0% and 2.7%, respectively), target‐vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2‐year cumulative event rates, 5.5% and 3.2%), and target‐vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2‐year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2‐year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001). CONCLUSIONS In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target‐vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow‐up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077.)

The impact of the location of a chronic total occlusion in a non-infarct-related artery on long-term mortality in ST-elevation myocardial infarction patients

AIMS Several studies have evaluated the impact of a CTO on short- and long-term mortality in STEMI patients. It has been speculated that the adverse effect on prognosis could differ per coronary location. The purpose of this study was to evaluate whether the long-term prognosis of STEMI patients differs according to the coronary location of the CTO. METHODS AND RESULTS Between 2000 and 2012, a total of 480 STEMI patients with a CTO in a non-infarct-related artery were included. The primary outcome for the present analysis was three-year all-cause mortality, evaluating the impact of the coronary CTO and infarct location. Four hundred and thirteen patients had a single CTO in a non-infarct-related artery, whereas 67 patients had more than one CTO and in this group mortality was higher. In patients with a single CTO, the highest risk of mortality was observed when the culprit lesion was located in the LAD or proximal LCX or when the CTO lesion was located in the proximal LAD. CONCLUSIONS We previously reported that STEMI patients with a CTO have a worse prognosis than STEMI patients without a CTO. We now show that, in these patients, LAD or proximal LCX location for the culprit lesion, or proximal LAD location for the CTO lesion, is associated with the highest risk. As a result, almost all CTO patients are at increased risk for mortality due to the combination of the culprit and CTO artery location.

Long-term impact of chronic total occlusion recanalisation in patients with ST-elevation myocardial infarction

Background During primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO. Methods The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO. Patients were randomised to either CTO-PCI or CTO-No PCI. The primary end point of the current study was occurrence of major adverse cardiac events (MACE): cardiac death, coronary artery bypass grafting and MI. Other end points were 1-year left ventricular function (LVF); LV-ejection fraction and LV end-diastolic volume and angina status. Results The median long-term follow-up was 3.9 (2.1–5.0) years. MACE was not significantly different between both arms (13.5% vs 12.3%, HR 1.03, 95% CI 0.54 to 1.98; P=0.93). Cardiac death was more frequent in the CTO-PCI arm (6.0% vs 1.0%, P=0.02) with no difference in all-cause mortality (12.9% vs 6.2%, HR 2.07, 95% CI 0.84 to 5.14; P=0.11). One-year LVF did not differ between both arms. However, there were more patients with freedom of angina in the CTO-PCI arm at 1 year (94% vs 87%, P=0.03). Conclusions In this randomised trial involving patients with STEMI with a concurrent CTO, CTO-PCI was not associated with a reduction in long-term MACE compared to CTO-No PCI. One-year LVF was comparable between both treatment arms. The finding that there were more patients with freedom of angina after CTO-PCI at 1-year follow-up needs further investigation. Clinical trial registration EXPLORE trial number NTR1108 www.trialregister.nl.

Evaluation of the Impact of a Chronic Total Coronary Occlusion on Ventricular Arrhythmias and Long‐Term Mortality in Patients With Ischemic Cardiomyopathy and an Implantable Cardioverter‐Defibrillator (the eCTOpy‐in‐ICD Study)

Background Previous studies report conflicting results about a higher incidence of ventricular arrhythmias in patients with a chronic total coronary occlusion (CTO). We aimed to investigate this association in a large cohort of implantable cardioverter defibrillator patients with long‐term follow‐up. Methods and Results All consecutive patients from 1992 onwards who underwent implantable cardioverter defibrillator implantation for ischemic cardiomyopathy at the Leiden University Medical Center were evaluated. Coronary angiograms were reviewed for the presence of a CTO. The occurrence of ventricular arrhythmias and survival status at follow‐up were compared between patients with and patients without a CTO. A total of 722 patients constitute the study cohort (age 66±11 years; 84% males; 74% primary prevention, median left ventricular ejection fraction 30% [first–third quartile: 25–37], 44% received a cardiac resynchronization therapy defibrillator). At baseline, 240 patients (33%) had a CTO, and the CTOs were present for at least 44 (2–127) months. The median follow‐up duration was 4 (2–6) years. On long‐term follow‐up, CTO patients had a higher crude appropriate device therapy rate (37% versus 27%, P=0.010) and a lower crude survival rate (51% versus 67%, P<0.001) compared with patients without a CTO. Corrected for baseline characteristics including left ventricular ejection fraction, the presence of a CTO was an independent predictor for appropriate device therapy. Conclusions The presence of a CTO in implantable cardioverter defibrillator patients was associated with more appropriate device therapy and worse prognosis at long‐term follow‐up. Further investigation is warranted regarding a potential beneficial effect of CTO revascularization on the incidence of ventricular arrhythmias.

Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI

AIMS The aim of this report of the AIDA trial is to provide full two-year outcomes for the primary endpoint of target vessel failure (TVF) and an update on device thrombosis. METHODS AND RESULTS AIDA was a single-blind, multicentre, investigator-initiated, non-inferiority, randomised (1:1) clinical trial. At complete two-year follow-up, the primary endpoint of TVF had occurred in 100 patients in the Absorb BVS arm versus 90 patients in the XIENCE EES arm (HR 1.12, 95% CI: 0.94-1.49; psuperiority=0.436). Estimated two-year Kaplan-Meier event rates of TVF were 11.0% and 9.9%, respectively (95% CI: -0.9%-3.0%; pnon-inferiority=0.003). Definite or probable device thrombosis at two years occurred in 30 patients in the Absorb BVS arm and in eight patients in the XIENCE EES arm. Kaplan-Meier estimates of device thrombosis were 3.3% in the Absorb BVS arm and 0.9% in the XIENCE EES arm (HR 5.22, 95% CI: 2.00-13.59; p<0.001). CONCLUSIONS AIDA formally met its criterion for non-inferiority of Absorb BVS versus XIENCE EES in terms of the combined endpoint of TVF. The Absorb BVS, however, was associated with higher rates of scaffold thrombosis and target vessel myocardial infarction at complete two-year follow-up.

Impact of collateralisation to a concomitant chronic total occlusion in patients with ST-elevation myocardial infarction: a subanalysis of the EXPLORE randomised controlled trial

Objective The impact on cardiac function of collaterals towards a concomitant chronic total coronary occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) has not been investigated yet. Therefore, we have evaluated the impact of well-developed collaterals compared with poorly developed collaterals to a concomitant CTO in STEMI. Methods and results In the EXPLORE trial, patients with STEMI and a concomitant CTO were randomised to either CTO percutaneous coronary intervention (PCI) or no-CTO PCI. Collateral grades were scored angiographically using the Rentrop grade classification. Left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume (LVEDV) at 4 months were measured using cardiac magnetic resonance imaging. Well-developed collaterals (Rentrop grades 2–3) to the CTO were present in 162 (54%) patients; these patients had a significantly higher LVEF at 4 months (46.2±11.4% vs 42.1±12.7%, p=0.004) as well as a trend for a lower LVEDV (208.2±55.7 mL vs 222.6±68.5 mL, p=0.054) when compared with patients with poorly developed collaterals to the CTO. There was no significant difference in the total amount of scar in the two groups. Event rates were statistically comparable between patients with well-developed collaterals and poorly developed collaterals to the CTO at long-term follow-up. Conclusions In patients with STEMI and a concomitant CTO, the presence of well-developed collaterals to a concomitant CTO is associated with a better LVEF at 4 months. However, this effect on LVEF did not translate into improvement in clinical outcome. Therefore, the presence of well-developed collaterals is important, but should not solely guide in the clinical decision-making process regarding any additional revascularisation of a concomitant CTO in patients with STEMI. Clinical trial registration NTR1108.

The effect of revascularization of a chronic total coronary occlusion on electrocardiographic variables. A sub-study of the EXPLORE trial

INTRODUCTION Chronic total coronary occlusions (CTOs) have been associated with a higher prevalence of ventricular arrhythmias compared to patients without a CTO. We evaluated the effect of CTO revascularization on electrocardiographic (ECG) variables. METHODS We studied a selection of ST-elevation myocardial infarction patients with a concomitant CTO enrolled in the EXPLORE trial. ECG variables and cardiac function were analysed at baseline and at 4 months follow-up. RESULTS Patients were randomized to percutaneous coronary intervention (PCI) of their CTO (n = 77) or to no-CTO PCI (n = 81). At follow-up, median QT dispersion was significantly lower in the CTO PCI group compared to the no-CTO PCI group (46 ms [33-58] vs. 54 ms [37-68], P = 0.043). No independent association was observed between ECG variables and cardiac function. CONCLUSION Revascularization of a CTO after STEMI significantly shortened QT dispersion at 4 months follow-up. These findings support the hypothesis that CTO revascularization reduces the pro-arrhythmic substrate in CTO patients.

Collateral Quality Decay Several Days After Primary Percutaneous Coronary Intervention: A Unique Observation From the EXPLORE Trial

In patients with ST-segment elevation myocardial infarction (STEMI), presence of a chronic total coronary occlusion (CTO) is associated with a worse prognosis. The presence of well-developed collateral vessels towards a concomitant CTO has been associated with improved outcomes [(1)][1]. In the

TCT-188 The impact of the location on left ventricular function in ST-elevation Myocardial Infarction patients with a chronic total occlusion in a non-infarct related artery treated with percutaneous coronary intervention

The optimal treatment for the CTO found during primary PCI in STEMI patients remains unknown and the best strategy may be based on coronary location of the CTO. In this EXPLORE substudy, we evaluated LVEF and LVEDV measured on 4 months cardiac MRI, compared across the different coronary locations

TCT-140 Explore trial (additional early CTO PCI in STEMI patients with a concurrent CTO) and SYNTAX score. What are lessons learned?

The EXPLORE trial studied the impact on Left Ventricular Function (LVF) of additional early PCI of a concurrent chronic total occlusion in post STEMI patients, compared to no early PCI. No difference was observed between both arms. However, previous observational data consistently showed an