ABSORB II randomized controlled trial: A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: Rationale and study design

doi:10.1016/j.ahj.2012.08.010

American Heart Journal

Volume 164, Issue 5, November 2012, Pages 654-663

https://doi.org/10.1016/j.ahj.2012.08.010 Get rights and content

Background

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents.

Methods

The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS–virtual histology at baseline (pre–device and post–device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years.

Conclusions

The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions.

Section snippets

Investigational device

The second-generation Absorb BVS (Abbott Vascular, Santa Clara, CA) is a balloon-expandable device consisting of a polymer backbone of poly-l-lactide (PLLA) coated with a thin layer of a 1:1 mixture of an amorphous matrix of poly-d, l-lactide (PDLLA) polymer and 100 μg/cm² of the antiproliferative drug everolimus. Two platinum markers located at each Absorb BVS edge allow for accurate visualization of the radiolucent Absorb BVS during angiography or other imaging modalities. The PDLLA controls

Control device

The control device to be used in the trial is a CE Marked everolimus eluting coronary stent system from the XIENCE family of stents (manufactured by Advanced Cardiovascular Systems, Inc., a subsidiary of Abbott Vascular, Inc) referred to hereafter as XIENCE stent. The XIENCE stent is a balloon-expandable metallic platform stent manufactured from a flexible cobalt chromium alloy with a multicellular design and coated with a thin nonadhesive, durable, biocompatible acrylic, and fluorinated

Treatment strategy

Quantitative assessment of target vessel diameter by online quantitative coronary angiography (QCA) is required at baseline after nitroglycerin for appropriate Absorb BVS or XIENCE stent size selection. The required range for target vessel diameter is assessed in terms of the online QCA parameters distal Dmax and proximal Dmax, which refer to maximum lumen diameter evaluated before predilatation up to 5 to 10 mm distal and proximal to the boundaries of the lesion length defined by QCA. A 3.5 mm

Dual-antiplatelet therapy

All subjects will receive ≥75 mg of aspirin daily after the index procedure and throughout the length of the clinical investigation. All subjects will be maintained at a minimum of 75 mg of clopidogrel daily or a minimum of 10 mg of prasugrel daily for a minimum of 180 days after the procedure, leading to a dual-antiplatelet therapy for a minimum of 180 days. If a subject develops sensitivity to clopidogrel or prasugrel, they may be switched to ticlopidine according to standard hospital

Trial design and objective

The ABSORB II randomized controlled trial (RCT) is intended to continue to evaluate the safety and efficacy of the Absorb BVS and to directly compare it to the metallic drug-eluting stent XIENCE stent.

XIENCE stent and Absorb BVS share the same basic MULTI-LINK design, and both devices are similar in terms of drug, drug dose density, and elution profile.

The ABSORB II RCT is a prospective, randomized, active-controlled, single-blinded, parallel 2-arm, multicenter clinical trial. A total of

Patient selection

Subjects enrolled into the clinical trial will be male or female derived from the general interventional cardiology population. The clinical trial will randomize up to approximately 501 subjects. Subjects meeting the general inclusion and exclusion criteria (Table II, Table III) will be asked to sign an informed consent form. Nonroutine laboratory assessments specific to the clinical investigation will not be performed before an informed consent form has been signed.

Screening failures will be

Follow-up schedule

Subjects will be observed for a 3-year period post–index procedure with clinical and invasive imaging follow-up (Figure).

Primary end points and rationale

The coprimary end points of the clinical trial are as follows: (1) vasomotion assessed by change in mean lumen diameter between prenitrate and postnitrate at 2 years by QCA (superiority) and (2) MLD at 2 years postnitrate minus MLD postprocedure postnitrate by QCA (noninferiority, reflex to superiority) (Table IV).

Secondary clinical and imaging end points are reported in Table IV.

Sample size calculations and assumptions

The sample size calculation is based on the first coprimary end point (superiority for vasomotion assessed by change

Study management

The ABSORB II trial is funded by Abbott Vascular. The Data Safety Monitoring Board will monitor the safety of subjects and/or efficacy throughout the subject enrollment and on an ongoing basis. The Clinical Events Committee will comprise qualified physicians who are not investigators in the trial. The Clinical Events Committee will be responsible for adjudicating all major adverse cardiac event–related end points. Central laboratory cardiac enzymes values will be used for event adjudication (in

Discussion

The introduction in the last decade of drug-eluting coronary stents marked an important progress in the field of coronary artery disease treatment. The inhibition of neointimal growth by locally delivering antiproliferative drugs translated into a reduction in intrastent restenosis lowering the need for repeated revascularizations.14, 15

However, metallic stent placement is not devoid of important long-term limitations. The metallic implant results in a permanent caging of the vessel, preventing

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Cited by (118)

Diagnostic Accuracy of Coronary CT Angiography for the Evaluation of Bioresorbable Vascular Scaffolds
2018, JACC: Cardiovascular Imaging
The purpose of this study was to assess the diagnostic accuracy of coronary computed tomography angiography (CTA) for bioresorbable vascular scaffold (BVS) evaluation.
Coronary CTA has emerged as a noninvasive method to evaluate patients with suspected or established coronary artery disease. The diagnostic accuracy of coronary CTA to evaluate angiographic outcomes after BVS implantation has not been well established.
In the ABSORB II (A Bioresorbable Everolimus-Eluting Scaffold Versus a Metallic Everolimus-Eluting Stent II) study, patients were randomized either to receive treatment with the BVS or everolimus-eluting metallic stent. At the 3-year follow-up, 238 patients (258 lesions) treated with BVS underwent coronary angiography with intravascular ultrasound (IVUS) evaluation and coronary CTA. The diagnostic accuracy of coronary CTA was assessed by the area under the receiver-operating characteristic curve with coronary angiography and IVUS as references.
The mean difference in coronary CTA-derived minimal luminal diameter was −0.14 mm (limits of agreement −0.88 to 0.60) with quantitative coronary angiography as reference, whereas the mean difference in minimal lumen area was 0.73 mm² (limits of agreement −1.85 to 3.30) with IVUS as reference. The per-scaffold diagnostic accuracy of coronary CTA for detecting stenosis based on coronary angiography diameter stenosis of ≥50% revealed an area under the receiver-operating characteristic curve of 0.88 (95% confidence interval [CI]: 0.82 to 0.92) with a sensitivity of 80% (95% CI: 28% to 99%) and a specificity of 100% (95% CI: 98% to 100%), whereas diagnostic accuracy based on IVUS minimal lumen area ≤2.5 mm² showed an area under the receiver-operating characteristic curve of 0.83 (95% CI: 0.77 to 0.88) with a sensitivity of 71% (95% CI: 44% to 90%) and a specificity of 82% (95% CI: 75% to 87%). The diagnostic accuracy of coronary CTA was similar to coronary angiography in its ability to identify patients with a significant lesion based on the IVUS criteria (p = 0.75).
Coronary CTA has good diagnostic accuracy to detect in-scaffold luminal obstruction and to assess luminal dimensions after BVS implantation. Coronary angiography and coronary CTA yielded similar diagnostic accuracy to identify the presence and severity of obstructive disease. Coronary CTA might become the method of choice for the evaluation of patients treated with BVS.
Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study
2018, Atherosclerosis
Citation Excerpt :
The design of the study was previously described [12]. In brief, it was a single-arm study including 101 patients with non-complex, not calcified lesions treated with second iteration of BVS [12]. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed at baseline and 5-year follow-up. (
Whether coronary calcification is correlated with plaque/media shrinkage (PS) remains unclear. The aim of this study was to assess the relationship between the calcification process and PS, combining serial optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in vessels treated with bioresorbable vascular scaffolds (BVS).
In 15 patients (16 vessels), OCT and IVUS images were matched using anatomic landmarks at post-procedure and five years. PS was defined as relative decrease in plaque/media area >5%. The association between the calcification process and PS was investigated. Mixed effect models were used to assess correlations and changes over time.
Seventy-two OCT and IVUS paired cross sections in- and out-scaffolded segments were matched at baseline and follow-up (432 images). In total, 35 out of the 72 cross sections showed PS, and 37 cross sections showed no PS (non-PS) at 5-year follow-up. Delta (Δ) plaque/media area showed negative correlation with Δ OCT calcium area (r = −0.29, p = 0.004), Δ OCT calcium arc (r = −0.42, p < 0.001), Δ OCT calcium length (r = −0.5, p < 0.001), and Δ IVUS calcium arc (r = −0.31, p = 0.024), respectively. On echogenicity analysis, Δ plaque/media area was positively associated with Δ hypoechogenic area (r = 0.47, p = 0.002). An increase in calcium area was negatively correlated to Δ hypoechogenicity (r = −0.29, p < 0.016). The increase in calcium area was positively correlated with Δ lumen area (r = 0.24, p = 0.044).
In segments treated with BVS, the calcification process was associated with PS, decrease in the hypoechogenic tissue and late luminal enlargement. Combining IVUS and OCT provides a unique method to assess the correlation between the calcification process and plaque/media shrinkage.
Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation: Analysis From the ABSORB Trials
2017, Journal of the American College of Cardiology
Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes.
This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters).
TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and post-dilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics.
Optimal pre-dilation (balloon to core laboratory-derived reference vessel diameter ratio ≥1:1), vessel size selection (reference vessel diameter ≥2.25 mm and ≤3.75 mm), and post-dilation (with a noncompliant balloon at ≥18 atm and larger than the nominal scaffold diameter, but not by >0.5 mm larger) in all BVS-treated lesions were performed in 59.2%, 81.6%, and 12.4% of patients, respectively. BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR]: 0.67; p = 0.01) and through 3 years (HR: 0.72; p = 0.01), and of freedom from ScT through 1 year (HR: 0.36; p = 0.004). Aggressive pre-dilation was an independent predictor of freedom from ScT between 1 and 3 years (HR: 0.44; p = 0.03), and optimal post-dilation was an independent predictor of freedom from TLF between 1 and 3 years (HR: 0.55; p = 0.05).
In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281; ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906; A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population—ABSORB CHINA Randomized Controlled Trial [RCT] [ABSORB CHINA]; NCT01923740; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)
First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis
2017, Cardiovascular Revascularization Medicine
The aim of this study is to evaluate the role of drug-coated balloons (DCB) for the management of bioresorbable vascular scaffold (BVS) restenosis.
In a series of 25 BVS restenosis discovered during systematic angiographic follow up of 246 consecutive BVS implantations at our institution, DCB was used as a primary therapeutic tool in 9 patients and 3 different types of DCB were used. Follow-up coronary angiography at 12 months after DCB treatment was performed to all the patients. Among the 9 patients treated with DCB, angiographic follow up revealed failure in two patients that experienced type III restenosis (both of them treated with the same type of DCB). Both patients were treated with drug eluting stent implantation.
In this case series of consecutive patients with BVS restenosis, the use of certain types of DCB is safe and effective in order to maintain vessel patency at mid-term follow up. Despite the small sample size and the study limitations, DCB can provide therefore an alternative treatment option in this setting, avoiding the implantation of further metallic stents in a patient where a different strategy was initially planned.
Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents
2017, Journal of the American College of Cardiology
Citation Excerpt :
The ABSORB II trial was a prospective, single-blind, multicenter clinical trial that randomized patients to percutaneous coronary intervention (PCI) with placement of either Absorb bioresorbable scaffolds or Xience metallic stents in a 2:1 fashion. The trial design, the study devices, and the inclusion and exclusion criteria have been described in detail previously (12,13). As mandated by the protocol, all patients underwent documentary grayscale IVUS and backscattered radiofrequency (virtual histology [VH]) assessment before and after device implantation, as well as at 3-year follow-up.
Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion.
This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling.
In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements.
The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling.
Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)
Follow-up of coronary artery patency after implantation of bioresorbable coronary scaffolds: The emerging role of magnetic coronary artery imaging
2017, Cardiovascular Revascularization Medicine
Bioresorbable vascular scaffolds (BVSs) represent the newest tool in the treatment of coronary artery disease (CAD). Conversely to the previous metal stents and thanks to the polylactate-based backbone, BVSs could be visualized by magnetic resonance imaging (MRI) without artifacts. These properties allow a potential non-invasive assessment of coronary artery patency after percutaneous coronary intervention (PCI), avoiding cardiac catheterization included iodine contrast and radiation exposure, and potentially more sophisticated imaging tool as the optical coherence tomography (OCT). We reviewed the available medical literature on the coronary MRI evaluation of BVS after PCI, also discussing its potential diagnostic role in the long-term follow-up of these patients.

Background

Methods

Conclusions

Section snippets

Investigational device

Control device

Treatment strategy

Dual-antiplatelet therapy

Trial design and objective

Patient selection

Follow-up schedule

Primary end points and rationale

Sample size calculations and assumptions

Study management

Discussion

J Am Coll Cardiol

J Am Coll Cardiol

Health policy

Journal of the American College of Cardiology

Lancet

J Am Coll Cardiol

J Am Coll Cardiol

Atherosclerosis

Biochem Biophys Res Commun

Am Heart J

Biochem Biophys Res Commun

Prog Biophys Mol Biol

Biochem Pharmacol

Atherosclerosis

Lancet

Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial

Circulation

Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with denovo coronary artery disease: the ABSORB trial

EuroIntervention

Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials

Catheter Cardiovasc Interv

Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes

Circulation

A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds

Eur Heart J

Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization?

Circulation

Eur Heart J

A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity

Medical care

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study

Circulation

Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up

Circulation

From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade?

Eur Heart J

Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization

Circulation