Author + information
- Received September 22, 2015
- Revision received March 30, 2016
- Accepted April 21, 2016
- Published online August 22, 2016.
- Cordula M. Felix, MD,
- Jiang Ming Fam, MD,
- Roberto Diletti, MD, PhD,
- Yuki Ishibashi, MD, PhD,
- Antonios Karanasos, MD, PhD,
- Bert R.C. Everaert, MD, PhD,
- Nicolas M.D.A. van Mieghem, MD, PhD,
- Joost Daemen, MD, PhD,
- Peter P.T. de Jaegere, MD, PhD,
- Felix Zijlstra, MD, PhD,
- Evelyn S. Regar, MD, PhD,
- Yoshinobu Onuma, MD, PhD and
- Robert-Jan M. van Geuns, MD, PhD∗ ()
- ↵∗Reprint requests and correspondence:
Dr. Prof. dr. Robert-Jan M. van Geuns, Thoraxcenter, Room Ba585, Erasmus Medical Center, ′s-Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands.
Objectives This study sought to report on clinical outcomes beyond 1 year of the BVS Expand registry.
Background Multiple studies have proven feasibility and safety of the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California). However, data on medium- to long-term outcomes are limited and available only for simpler lesions.
Methods This is an investigator-initiated, prospective, single-center, single-arm study evaluating performance of the BVS in a lesion subset representative of daily clinical practice, including calcified lesions, total occlusions, long lesions, and small vessels. Inclusion criteria were patients presenting with non–ST-segment elevation myocardial infarction, stable/unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native previously untreated coronary artery. Procedural and medium- to long-term clinical outcomes were assessed. Primary endpoint was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Results From September 2012 to January 2015, 249 patients with 335 lesions were enrolled. Mean number of scaffolds per patient was 1.79 ± 1.15. Invasive imaging was used in 39%. In 38.1% there were American College of Cardiology/American Heart Association classification type B2/C lesions. Mean lesion length was 22.16 ± 13.79 mm. Post-procedural acute lumen gain was 1.39 ± 0.59 mm. Median follow-up period was 622 (interquartile range: 376 to 734) days. Using Kaplan-Meier methods, the MACE rate at 18 months was 6.8%. Rates of cardiac mortality, myocardial infarction, and target lesion revascularization at 18 months were 1.8%, 5.2%, and 4.0%, respectively. Definite scaffold thrombosis rate was 1.9%.
Conclusions In our study, BVS implantation in a complex patient and lesion subset was associated with an acceptable rate of adverse events in the longer term, whereas no cases of early thrombosis were observed.
- Absorb bioresorbable vascular scaffold
- coronary artery disease
- mid- to long-term
- percutaneous coronary intervention
Drug-eluting stents (DES) currently form the mainstay of coronary devices used in percutaneous coronary interventions (PCI) in many parts of the world. Despite advantages in clinical outcomes such as reduction in target lesion revascularization (TLR) rates, shortcomings related to the use of DES still exist such as delayed arterial healing, late scaffold thrombosis, and hypersensitivity reactions to the polymer, with observations of ongoing very late stent failure beyond 1 year (1,2).
In addition, from a physiological point of view, a vessel that is indefinitely caged in a metal stent may not be desirable with both short- and long-term implications and potentially adverse consequences such as impaired endothelial function, the reduced potential for vessel remodeling, interference with the normal arterial healing process, and the risk of occlusion of covered side branches by neointima hyperplasia. Furthermore, interference with noninvasive imaging (cardiac computed tomography or magnetic resonance imaging) during patient follow-up and possible impairment of future treatment options (re-PCI or coronary artery bypass surgery) are drawbacks of metallic stents (3).
To overcome these issues, bioresorbable vascular scaffolds (BVS) were developed. The BVS most studied is the Absorb BVS (Abbott Vascular, Santa Clara, California). The BVS provides transient vessel support and gradually elutes the antiproliferative drug everolimus. After degradation of the polymer (after approximately 3 years) no foreign material remains and the risk for developing very late scaffold thrombosis (ST) is potentially reduced.
Intravascular imaging observations 5 years after BVS implantation in a simple patient and lesion subset have demonstrated late luminal enlargement due to plaque reduction, a persistent restoration of vasomotion and a fully completed bioresorption process (4,5), and a low major adverse cardiac event (MACE) rate (3.4%) (6). This is consistent in randomized controlled trials (ABSORB II and ABSORB Japan), which showed comparable clinical event rates in BVS compared with best in class with metallic DES (Xience V, Abbott Vascular, Santa Clara, California) (7,8). However, as these studies included a selected group of patients, extrapolation to a more complex population is limited. Yet, the registry-level clinical data on the outcomes after BVS implantation in more complex patient and lesion subsets have not been well documented that such data are available from registries with a relatively short follow-up of 6 to 12 months, which have shown variable early clinical outcomes (8–10). Thus, the medium- to long-term outcomes beyond 1 year after BVS implantation in such complex real-world lesions remain elusive.
In the current study, we report on extended follow-up beyond 1 year of the BVS Expand Registry. This is a single-center registry initiated in September 2012 that investigates the clinical outcomes after BVS implantation in a more complex real-world population.
This is an investigator-initiated, prospective, single-center, single-arm study performed in an experienced, tertiary PCI center. Patients presenting with non–ST-segment elevation myocardial infarction (NSTEMI), stable or unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native previously untreated coronary artery with intention to treat with a BVS were included. Angiographic inclusion criteria included lesions with a proximal and distal maximal lumen diameter within the upper limit of 3.8 mm and the lower limit of 2.0 mm by online quantitative coronary angiography (QCA). Complex lesions such as bifurcation, calcified (as assessed by angiography), long, and thrombotic lesions were not excluded. Exclusion criteria were patients with a history of coronary bypass grafting, presentation with cardiogenic shock, bifurcation lesions requiring kissing balloon post-dilation, ST-segment elevation myocardial infarction (STEMI) patients, allergy or contraindications to antiplatelet therapy, fertile female patients not taking adequate contraceptives or currently breastfeeding, and patients with expected survival of <1 year. As per hospital policy, patients with a previously implanted metal DES in the intended target vessel were also excluded. Also, although old age was not an exclusion criterion, BVS were in general reserved for younger patients, and left to operator’s interpretation of biological age.
PCI was performed according to current clinical practice standards. The radial or femoral routes were the principal routes of vascular access and 6- or 7-F catheters were used depending on the discretion of the operator. Pre- and post-dilation were recommended with a balloon shorter than the planned study device length and with a noncompliant balloon without overexpanding the scaffold beyond its limits of expansion (0.5 mm > nominal diameter), respectively. Intravascular imaging with the use of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was used for pre-procedural sizing and optimization of stent deployment on the discretion of the operator. All patients were treated with unfractionated heparin (at a dose of 70 to 100 UI/kg). Patients with stable angina were preloaded with 300 mg of aspirin and 600 mg of clopidogrel. Patients presenting with acute coronary syndrome were preloaded with 300 mg of aspirin and 60 mg of prasugrel or 180 mg of ticagrelor.
QCA was performed by 3 independent investigators. Coronary angiograms were analyzed with the CAAS 5.10 QCA software (Pie Medical BV, Maastricht, the Netherlands). The QCA measurements provided reference vessel diameter (RVD), percentage diameter stenosis, minimal lumen diameter (MLD), and maximal lumen diameter. Acute gain was defined as post-procedural MLD minus pre-procedural MLD (in an occluded vessel MLD value was zero by default). For the purpose of this study we defined underexpansion as a ratio of post-procedural MLD to the nominal device diameter of <0.7. The ratio of pre-procedural RVD to the nominal device diameter was used to assess pre-procedural sizing.
Clinical demographic data of all patients were obtained from municipal civil registries. Follow-up information specific for hospitalization and cardiovascular events was obtained through questionnaires. If needed, medical records or discharge letters from other hospitals were requested. Events were adjudicated by an independent clinical events committee. All information concerning baseline characteristics and follow-up was gathered in a clinical data management system.
The primary endpoint was MACE, defined as the composite endpoint of cardiac death, myocardial infarction (MI) and TLR. Deaths were considered cardiac unless a noncardiac cause was definitely identified. TLR was described as any repeated revascularization of the target lesion. Target vessel revascularization was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. Non–target vessel revascularization was described as any revascularization in a vessel other than the target lesion. ST and MI were classified according to the Academic Research Consortium (11). Clinical device success (lesion basis) was defined as successful delivery and deployment of all intended scaffolds at the target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of <30% as evaluated by QCA. When bailout device was used, the success or failure of the bailout device delivery and deployment is not one of the criteria for device success. Clinical procedure success (patient basis) was described as achievement of final in-scaffold residual stenosis of <30% by QCA with successful delivery and deployment of all intended scaffolds at the target lesion and successful withdrawal of the delivery system for all target lesions without major periprocedural complications or in-hospital MACE (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success.
The intention-to-treat group includes all the patients regardless of whether or not the scaffold was successfully implanted. The per-treatment group consists of all patients in whom the BVS was successfully implanted. Only events in the per-treatment population were analyzed.
The off-registry population consisted of patients that were excluded in this study, mainly STEMI patients.
Categorical variables are reported as counts and percentages, continuous variables as mean ± SD. Student’s t test and the chi-square test (or Fisher exact test) were used for comparison of means and percentages. The cumulative incidence of adverse events was estimated according to the Kaplan-Meier method. Patients lost to follow-up were considered at risk until the date of last contact, at which point they were censored. All statistical tests were 2-sided and a p value <0.05 was considered statistically significant. To investigate possible predictors for clinical outcomes MACE and ST, univariate analysis using a Cox regression model was used investigating variables that are frequently present. Statistical analyses were performed using SPSS, version 21 (SPSS Inc., Chicago, Illinois).
From September 2012 up to January 2015, 3,373 patients were treated with PCI in our center. The majority of patients were considered not suitable for BVS either to their biological age related to comorbidities, indication for stent >3.5 mm or smaller than <2.5 mm, previous coronary bypass grafting, previous PCI with metal DES in the target vessel, or STEMI as indication for PCI shortly after the commercial introduction of BVS in Europe. These patients were in general older (64.5 ± 11.6 years of age) and presented with more risk factors compared to the BVS population (previous coronary bypass grafting 9.5%, previous PCI 31.3%, previous MI 25.6%) and presented more frequently with multivessel disease (57.8%). Finally, 485 patients were treated with 1 or more BVS in the registry period. Most excluded patients (n = 169) presented with STEMI and entered a separate registry starting later, 5 had a previous coronary bypass grafting, 1 needed kissing balloon post-dilation for bifurcation, 2 had a previous implanted metal DES in the target vessel as formal exclusion criteria for this analysis, and 58 did not return their informed consent because they declined to participate, emigrated abroad, or participated in another trial investigating BVS.
A total of 249 signed the informed consent for follow-up and were eligible on the basis of protocol inclusion and exclusion criteria. In 5 patients delivery failure occurred (intention-to-treat group). The per-treatment group thus consisted of 244 patients. The flow chart of the registry is given in Figure 1.
Baseline characteristics of all BVS treated patients are presented in Table 1. Mean age was 61.3 ± 10.2 years, 73.5% were male, 18.5% were diabetic, and 59.1% presented with an acute coronary syndrome (NSTEMI or unstable angina; STEMI patients were excluded). Multivessel disease was present in 45.6%. The off-registry patients were younger, with fewer comorbidities, and presented more frequently with STEMI.
Lesion characteristics are presented in Table 2. The left anterior descending coronary artery was most commonly treated (50.0% of lesions). Moderate or severe calcification (as assessed by angiography) was present in 42.2% and a chronic total occlusion in 4.2% of the lesions. Bifurcation lesions (involving lesions within 3 mm of the bifurcation and with side branches ≥2 mm by visual estimation in diameter, treated with implantation of at least 1 BVS) were present in 21.3% with significant side branch involvement (true bifurcations: Medina 1,1,1; 1,0,1; and 0,1,1 lesions) in 32% of these. Overall, 38.1% of lesions were American College of Cardiology/American Heart Association type B2 or C. Mean lesion length was 22.16 ± 13.79 mm. Pre-procedural QCA showed a RVD of 2.42 ± 0.74 mm, a MLD of 0.91 ± 0.45 mm, and a percentage diameter stenosis of 59.12 ± 20.72%.
Table 3 shows the procedural characteristics. Pre-dilation was performed in 89.9% (pre-dilation balloon to artery ratio of 1.05 ± 0.23). Post-dilation was performed in 53.3% with a balloon to scaffold ratio of 1.08 ± 0.11. Advanced lesion preparation using rotational artherectomy and scoring balloon was done in 3.1% and 2.7%. Pre-procedural evaluation and device optimization using invasive imaging with IVUS and OCT was done in 14.4% and 24.6% of the procedures, respectively. A total of 445 BVS were implanted with a mean number of 1.34 ± 0.69 scaffolds per lesion and a mean number of 1.79 ± 1.15 scaffolds per patient. For the bifurcation lesions, the provisional side branch treatment was standard in this study. Side branch wiring before main vessel stenting was employed in 37.5%. Side branch dilation after main vessel stent was performed for 31% and bailout stenting only in 1 BVS. Side branch fenestration was performed in 25%. Side branch dilation was followed by mini-kissing post-dilation of just sequential ballooning with proximal optimalization.
Post-procedural QCA characteristics were: RVD 2.77 ± 0.46 mm, MLD 2.30 ± 0.42 mm, and percentage diameter stenosis 16.90 ± 9.04. Acute lumen gain was 1.39 ± 0.59 mm.
Clinical device success was 97.3% and clinical procedural success was 96.8%. In 5 patients delivery failure of the BVS occurred because the scaffold could not pass the lesion, for example due to severe calcification or tortuosity. After multiple attempts, metal DES were placed in these cases.
Survival data was available in 100% with a median follow-up period of 622 days (interquartile range: 376 to 734 days). Two patients withdrew their informed consent within a few weeks after the index procedure.
One-year clinical outcomes are reported in Table 4. Event rates are described as Kaplan-Meier estimates. Figures 2A to 2C give an impression of the event rates during late follow-up. At 18 months, there were 4 fatalities (all cardiac death) with a Kaplan-Meier estimate of 1.8%. In the per-treatment group, MACE rate at 18 months was 6.8%, mainly driven by the rate of MI (5.2%). There were 2 cases of periprocedural MI. TLR at 18 months was performed in 4.0% and target vessel revascularization in 4.0%. Rate of non–target vessel revascularization was 5.4%. Rate of overall ST at 18 months was 2.7%, with a definite ST rate of 1.9%.
Details of ST cases are summarized in Table 5. Narratives of each case are presented in the electronic supplement.
In Figure 3 we present MACE, its components, and definite/probable ST rates in various subgroups. There was no increased rate of both MACE and definite/probable ST in patients presenting with acute coronary syndrome (NSTEMI and unstable angina) compared to the overall population.
Univariate analysis was performed to identify predictors for the occurrence of MACE and definite/probable ST (Tables 6 and 7). Due to lack of power, none of the factors was significant. However, regarding MACE, the following characteristics tended to be associated with ≥2 times increased risk of MACE: male (hazard ratio [HR]: 4.079; p = 0.18), more than 2 scaffolds/lesion (HR: 2.41; p = 0.19), underexpansion (HR: 2.25; p = 0.16), and >65 years of age (HR: 2.11; p = 0.20) (Table 6). Regarding ST, the following characteristics tended to be associated with ≥3 times increased risk of ST: >65 years of age (HR: 4.49; p = 0.19), long lesions (HR: 3.55; p = 0.27 for lesions of 20 mm; HR: 3.42; p = 0.22 for lesions of 32 mm), calcified lesion (HR: 3.55; p = 0.27), and RVD ≤ 2.5 mm (HR: 3.26; p = 0.31).
Concerning intravascular imaging at baseline, patients who did not undergo baseline imaging had a TLR rate of 4.0%, compared to 2.3% in patients who did undergo baseline imaging (log-rank p = 0.29). Intravascular imaging was performed more often in patients who had a complex lesion (American Heart Association classification type B2/C lesion): 44.5% versus 31.1% (p = 0.03).
To examine the relationship between underexpansion, sizing and MACE, a scatterplot of the pre-procedural sizing and post-procedural expansion divided by nominal diameter was created on the basis of QCA (Figure 4). When a cutoff value of MLD post-procedure/nominal device diameter of <0.70 is applied, the scaffold was underexpanded in 26% of the lesions. Patients, in whom underexpansion occurred, tended to have an increased rate of MACE: 8.0% versus 3.8% (p = 0.15, log-rank test).
To the best of our knowledge this is the first registry reporting on the extended follow-up beyond 1 year, with a median follow-up duration of 622 days. The main findings of our study are that: 1) 12-month MACE incidence for the per-treatment group was 5.1%, mainly driven by rate of MI (approximately 70% due to target vessel MI), with a further flattening of Kaplan-Meier after 1 year (6.8% at 18 months); 2) the rate of definite/probable ST at 1 year was 1.7%, which is higher compared to second generation metal DES (12); 3) patients with acute coronary syndrome did not have increased risk of MACE and ST; and 4) underexpansion of the BVS was a rather frequent finding and there was a trend for an increased rate of MACE.
The BVS Expand registry describes the procedural and medium to long-term clinical outcomes of BVS in patients with native, de novo coronary artery disease. Other studies investigating clinical outcomes of BVS were often characterized by small sample size and inclusion of patients with noncomplex lesions. In this single-center study we report event rates in a more complex lesions including long lesions (mean lesion length 22.10 ± 13.90 mm), calcified and bifurcated lesions, with a relatively high proportion of American College of Cardiology/American Heart Association type B2 or C lesions (38.1%). Furthermore and different from other registries (10), all events were adjudicated by an independent clinical events committee and all angiograms were analyzed using QCA, creating a complete QCA database. Finally, in the present registry there were limited angiographic exclusion criteria that allowed a study population that is more reflective of a real-world population.
Taking into account the complexity of the treated lesions, the 1-year MACE rate of 5.1% observed in the current registry is low and in line with previous trials using BVS in relatively simple lesions: 5% in the ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial (7), 5.0% in the ASSURE BVS (Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds) registry (9), 4.3% in the BVS Extend (The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled) trial (13). Recently, several European registries reported on the 6-month clinical outcomes after implantation of BVS in all-comer settings (Table 8). In our registry, 6-month MACE rate was 4.7%, which is comparable to the other registries.
Recently, some concerns were raised regarding a potentially increased rate of ST after implantation of the Absorb BVS (10,14,15). Scaffold thrombosis in the case of metallic DES is an entity with complex multifactorial pathomechanisms, something that probably applies to the case of BVS (16). The importance of patient selection, lesion preparation, pre- and post-dilation, and the consideration of invasive imaging for optimal device deployment have to be emphasized (17,18), whereas dual antiplatelet therapy continuation for at least 1 year is recommended. Pilot imaging observations in real-world patients with BVS thrombosis suggest suboptimal implantation with underexpansion, malapposition, and incomplete lesion coverage, often in combination with dual antiplatelet therapy discontinuation, to be the major substrate both for acute and late events (19). Although it is not clear why this complication is observed in high incidence with BVS, a potential explanation could be the increased thickness of the BVS struts, which can cause convective flow patterns, potentially triggering platelet deposition and subsequent thrombosis, especially in settings with suboptimal flow conditions (20). For this reason, BVS with thinner struts are currently being developed and animal studies are ongoing.
Rate of definite ST in the AMC (Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold [BVS] in real-world practice: the AMC Single Centre Real World PCI Registry) registry was 3.0% at 6 months (14). However, in the latter trial, STEMI patients were also included. The annual rate of definite/probable ST in the GHOST-EU (Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry) trial was 3.4% and 70% of the ST cases occurred in the first 30 days. In our study, there were 3 cases of definite ST (1.3%) within 1 year (Table 5, Online Appendix). In most of these cases, suboptimal implantation in complex lesions was the main finding, with also inadequate dual antiplatelet therapy duration in 1 case. Notably and in contrast to the other registries, no cases of acute or subacute ST occurred. The lower rate of ST in the BVS Expand registry could presumably be due to the good procedural performance: usage of invasive imaging in almost 40% and pre-dilation in 89%. Unlike the previously mentioned registries, STEMI patients were excluded in our study. The enrolled patients were all appropriately preloaded with P2Y12 inhibitors, which could attribute to the absence of acute and subacute ST, whereas this is not always the case in STEMI patients.
In this study, the presence of with NSTEMI/unstable angina was not associated with an additional risk of MACE or ST. Theoretically, the lesions in patients with acute coronary syndrome are generally lipid rich with or without thrombus, which hinder neither the deployment nor the expansion of the BVS.
Our analysis shows that underexpansion of BVS occurs frequently and had a nonsignificant association with an increased risk of MACE and probable/definite ST. Compared to other BVS registries rate of post-dilation in our study is somewhat low (53.3%) and this could partly explain the frequent occurrence of underexpansion. This low post-dilation rate was an extension of the ABSORB-EXTEND (The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled) and ABSORB II studies, where post-dilation was discouraged as a reflex to a single case where strut fractures were observed due to severe undersizing and post-dilation with an oversized balloon beyond the expansion limits of the scaffold. This is a different situation compared to underexpansion due to atherosclerotic disease where struts are still apposed but the initial lesions are difficult to dilate. It is now clear that for underexpansion high-pressure post-dilation does not result in strut fractures as long as noncompliant post-dilation balloons are used within the maximum expansion limit of the implanted device.
Nevertheless, the arbitrary definition of underexpansion we used for this manuscript was partly on the basis of QCA measurements, which are known to underestimate vessel dimensions when compared to invasive imaging methods such as IVUS and OCT, which is considered the standard at the moment (21,22). The difference for IVUS might be even larger compared to OCT, with an underestimation of approximately of QCA of 0.2 mm versus OCT and 0.3 mm versus IVUS. Use of intravascular imaging might improve pre-procedural vessel sizing, whereas a more liberal use of post-dilation has to be underlined, with the aim of minimizing BVS underexpansion and, eventually, improving the clinical outcome.
This is a single-center, single-arm registry with no direct comparison with metallic DES. The total number of patients in this study was limited. Thus, these findings warrant further confirmation in a large-scale trial. Ongoing and upcoming trials such as the ABSORB III, ABSORB IV, and the Compare Absorb (ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis) will provide data derived from larger patient cohorts and in direct comparison to metallic DES.
Furthermore, deciding which patient or lesion was suitable for BVS implantation could have led to selection bias. Almost 80% of the patients returned their study informed consent and thus follow-up was only investigated in these patients. The event rate is unknown in the remaining patients.
In our study, BVS implantation in a more complex patient and lesion subset was associated with an acceptable rate of adverse events at the longer term, comparable to rates reported with contemporary second-generation metallic DES, whereas no cases of early thrombosis were observed. This study supports a more extensive use of BVS and launch of randomized trials aiming to demonstrate superiority in the longer term, when optimal implantation strategies are used.
WHAT IS KNOWN? Multiple studies, mainly registries, have proven feasibility and safety of the Absorb BVS. However, data on medium- to long-term outcomes are limited and available only for simpler lesions.
WHAT IS NEW? At a median follow-up duration of 622 days, MACE rate in a regular cath lab population was reasonable with a warning signal for scaffold thrombosis potentially linked to underexpansion.
WHAT IS NEXT? Large randomized controlled trials comparing BVS with metal DES in a more real-world patient population with strict and dedicated BVS implantation strategies are coming up to establish the value of BVS in this setting.
The authors want to thank Isabella Kardys, Martijn Akkerhuis, and Johannes Schaar for their contribution in the event adjudication. They also want to thank Nienke van Ditzhuijzen and Saskia Wemelsfelder for their contribution to data management.
For an expanded Discussion section, please see the online version of this article.
This study was supported by an unrestricted grant from Abbott Vascular. Dr. Karanasos has received research support from St. Jude Medical. Dr. van Mieghem has served as on the Speakers Bureau for and has received speakers fees from Abbott Vascular. Dr. Daemen has received institutional research support from Boston Scientific, St. Jude Medical, Medtronic, and Recor Medical. Dr. Onuma has served as a member of the advisory board for and has received speakers fees from Abbott Vascular. Dr. van Geuns has received speakers fees from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- bioresorbable vascular scaffold(s)
- drug-eluting stent(s)
- intravascular ultrasound
- major adverse cardiac event
- myocardial infarction
- minimal lumen diameter
- non-ST-segment elevation myocardial infarction
- optical coherence tomography
- quantitative coronary angiography
- reference vessel diameter
- ST-segment elevation myocardial infarction
- scaffold thrombosis
- target lesion revascularization
- Received September 22, 2015.
- Revision received March 30, 2016.
- Accepted April 21, 2016.
- American College of Cardiology Foundation
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