Author + information
- Received August 10, 2015
- Revision received September 16, 2015
- Accepted September 25, 2015
- Published online December 1, 2015.
- Runlin Gao, MD∗∗ (, )
- Yuejin Yang, MD, PhD∗,
- Yaling Han, MD, PhD†,
- Yong Huo, MD‡,
- Jiyan Chen, MD§,
- Bo Yu, MD‖,
- Xi Su, MD¶,
- Lang Li, MD#,
- Hai-Chien Kuo, PhD∗∗,
- Shih-Wa Ying, MS∗∗,
- Wai-Fung Cheong, PhD∗∗,
- Yunlong Zhang, MD∗∗,
- Xiaolu Su, MS∗∗,
- Bo Xu, MBBS∗,
- Jeffery J. Popma, MD††,
- Gregg W. Stone, MD‡‡,
- ABSORB China Investigators
- ∗Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- †General Hospital of Shenyang Military Region, Shenyang, China
- ‡Peking University First Hospital, Beijing, China
- §Guangdong General Hospital, Guangzhou, China
- ‖The 2nd Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia of Chinese Ministry of Education, Harbin, China
- ¶Wuhan Asia Heart Hospital, Wuhan, China
- #The 1st Affiliated Hospital of Guangxi Medical University, Nanning, China
- ∗∗Abbott Vascular, Santa Clara, California
- ††Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ‡‡Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Runlin Gao, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Bei Lishi Lu 167, Beijing 100037, China.
Background The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established.
Objectives This study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China.
Methods Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1:1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm.
Results A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES–treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 ± 0.38 mm for BVS versus 0.13 ± 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (pnoninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00).
Conclusions In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population—ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740)
Cardiovascular disease is the leading cause of death in China, accounting for 41% of all deaths (1,2). Exponential increases in percutaneous coronary intervention (PCI) in China have been observed over the last 10 years (2), with approximately 450,000 PCI cases performed in 2013 (3). The everolimus-eluting bioresorbable vascular scaffold (BVS) (Absorb, Abbott Vascular, Santa Clara, California) offers a new PCI option for this growing patient population.
The BVS is constructed from a poly L-lactide backbone coated with a bioresorbable polymeric poly (D,L-lactide) layer containing everolimus, and it was designed to provide comparable radial strength and antirestenotic efficacy to metallic drug-eluting stents (DES) in the first year. The degradation of poly L-lactide in vivo is governed by bulk erosion beginning with a decline in molecular weight, followed by mass loss via hydrolysis upon exposure to water over time (4,5). Complete bioresorption at approximately 3 years may then provide unique long-term benefits not possible with a permanent metallic stent, including restoration of physiological vasomotion and late adaptive remodeling. Real-world registries have shown favorable outcomes of BVS in simple and complex coronary anatomy with proper implantation technique (6,7).
Whether BVS is noninferior to current-generation DES within 1 year and whether BVS has late clinical advantages to metallic DES can only be answered by adequately powered randomized trials. The ABSORB II randomized trial suggested comparable clinical outcomes between BVS and cobalt-chromium everolimus-eluting stents (CoCr-EES) (Xience V, Abbott Vascular) in 501 randomized patients at 1 year (8), although routine angiographic follow-up was not performed in this study. The pivotal, randomized ABSORB China trial sought to establish comparable angiographic efficacy and clinical safety and effectiveness between BVS and CoCr-EES to enable regulatory approval of BVS in China. The present report describes the 1-year principal outcomes from the ABSORB China randomized trial.
Study design and patient population
ABSORB China is a prospective, randomized, active-controlled, open-label, multicenter trial designed to evaluate the safety and efficacy of BVS compared with CoCr-EES. The study was performed in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines of the China Food and Drug Administration. All patients signed written informed consent before randomization.
Eligible patients were age ≥18 years with evidence of myocardial ischemia and suitability for elective (nonemergent) PCI, with a maximum of 2 de novo coronary artery lesions with reference vessel diameter 2.5 to 3.75 mm and length ≤24 mm as assessed by online quantitative coronary angiography (QCA) or visual estimation. In the case of multiple target lesions, each needed to be in a different epicardial vessel and each must meet eligibility criteria. In addition, 1 nontarget lesion in a nontarget vessel was allowed to be treated during the index procedure. Treatment of the nontarget lesion was required before randomization, and had to be successful and uncomplicated for randomization to proceed. Patients with recent myocardial infarction (MI) without biomarker return to normal, unstable cardiac arrhythmias and left ventricular ejection fraction <30% were excluded. Patients were also excluded for prior PCI in the target vessel within the past 12 months or in a nontarget vessel within the previous 30 days, or if future staged PCI either in a target vessel or nontarget vessel was planned. Left main stenoses, bifurcation lesions with a side branch ≥2.0 mm diameter or ≥50% diameter stenosis (DS) or requiring guidewire protection, ostial lesions, lesions with moderate or heavy calcification, myocardial bridges, and thrombus were also not eligible. Additional inclusion and exclusion criteria are detailed in the Online Appendix.
Randomization and enrollment
A total of 480 eligible patients who provided written informed consent were randomized in a 1:1 ratio to receive BVS or CoCr-EES at 24 sites in China. Randomization was stratified by diabetes status and the planned number of treated lesions, which included 3 options: single-target lesion, dual-target lesion, and 1 target lesion and 1 nontarget lesion. Randomization was performed via an interactive voice response system or an interactive web response system. Patients were considered enrolled in the trial at the time of randomization.
Treatment strategy, medications, and follow-up
Pre-dilation was required, with post-dilation per investigator discretion. Each target lesion had to be covered by a single study stent, although use of a second device as randomized was allowed for edge dissection or other procedural issues. A loading dose of aspirin (≥300 mg) and either clopidogrel (≥300 mg) or ticagrelor (180 mg) 6 to 24 h before the index procedure was required. The P2Y12 inhibitor loading dose could be omitted if the patient was on chronic clopidogrel or ticagrelor therapy (≥3 days), unless an acute coronary syndrome was present. Following PCI, aspirin 100 mg daily for at least 5 years was prescribed, with clopidogrel (75 mg daily) or ticagrelor (90 mg twice a day) for a minimum of 12 months. Prasugrel was not available for use during this study.
Clinical follow-up was planned at 30 days, 6 months, 9 months, and at 1, 2, 3, 4, and 5 years post-procedure. Routine follow-up angiography was planned in all patients at 1 year (±28 days).
Endpoints and definitions
The trial was designed to examine whether BVS was noninferior to CoCr-EES for the primary endpoint of angiographic in-segment late loss (LL), defined as the change in minimal lumen diameter (MLD) from post-procedure to 1 year. In-segment was defined as the stent/scaffold length plus proximal and distal 5-mm margins. If a patient had a TLR >30 days post-procedure, but before his or her scheduled angiographic follow-up, the event angiogram was used for the primary endpoint analysis. Details of angiographic and clinical secondary endpoints are provided in the Online Appendix. Acute device success was defined as successful delivery and deployment of the assigned device and withdrawal of the catheter with <30% residual stenosis by angiography, whether or not bailout was required. Acute procedural success was defined as device success without occurrence of in-hospital cardiac death, target vessel [TV]-MI, or TLR; in the case of dual target lesions, both lesions must be successfully treated. Most clinical endpoint definitions, including stent/scaffold thrombosis, were on the basis of the Academic Research Consortium definitions (9). Periprocedural non–Q-wave MI, however, was defined as a rise in post-PCI creatine kinase (CK)-MB to >5× the upper reference limit (URL) (10), similar to the definition used in the ABSORB III U.S. pivotal trial, which ran concurrently with ABSORB China. The device-oriented composite endpoint was target lesion failure (the composite of cardiac death, TV-MI, or ischemia-driven target lesion revascularization [ID-TLR]). The patient-oriented composite endpoint (PoCE) was the composite of all-cause death, all MI or all revascularization. Detailed definitions of acute device and procedural success, clinical composite endpoints, and angiographic endpoints are provided in the Online Appendix.
The primary angiographic endpoint of in-segment LL was analyzed in the per-treatment evaluable (PTE) population, consisting of patients who received only the study device (BVS or CoCr-EES as treated), and who had no pre-specified protocol deviations. All clinical and angiographic endpoints, including a secondary analysis of the in-segment LL, were reported in the intention-to-treat (ITT) population, consisting of all randomized patients. For the ITT analysis, patients remained in their assigned group, regardless of device implant cross-overs.
Clinical endpoint events were adjudicated by an independent clinical events committee, blinded to device assignment. QCA data were assessed by an independent angiographic core laboratory. A data safety and monitoring board reviewed the cumulative safety data from the trial at pre-specified intervals. On-site monitoring was performed on 100% of data. The study organization, investigators, and enrollment per site appears in the Online Appendix. The study was sponsored by Abbott Vascular and is registered on ClinicalTrials.gov (NCT01923740).
A noninferiority margin of 0.15 mm was chosen, a more conservative delta than that used to evaluate the CoCr-EES compared with a paclitaxel-eluting DES in the SPIRIT III (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients with De Novo native Coronary Artery Lesions Trial) (11). Assuming no difference in the mean in-segment LL, an SD of 0.47 mm for both devices, and an anticipated 70% angiographic follow-up rate, randomizing 480 patients would provide 80% power to demonstrate noninferiority of BVS to CoCr-EES with a 1-sided alpha of 2.5%.
The primary endpoint hypothesis testing was pre-specified to be performed on a per-subject basis, in which the LL of 2 target lesions would be averaged. All follow-up angiographic endpoints were also evaluated in both PTE and ITT populations, with generalized estimating equations used to adjust for within-patient correlations.
The 1-year clinical follow-up was performed at 365 ± 28 days. All events occurring before 393 days were included in the 1-year categorical rates, even if they occurred after routine 1-year angiographic follow-up. Continuous variables are presented as mean ± SD and were compared by Student t tests. Binary variables are presented as counts and percentages, and were compared by Pearson's chi-square test when Cochran's rule was met; otherwise, the Fisher exact test was used. The noninferiority test was on the basis of the asymptotic Z test. The 95% confidence interval of the difference between 2 treatment arms was calculated by normal approximation for continuous variables and by the Newcombe score method for binary variables. Time to first event curves were plotted using Kaplan-Meier estimates and were compared with the log-rank test. All statistical analyses were carried out using SAS version 9.2 (SAS Institute, Cary, North Carolina).
Patients and procedural results
Between July 31, 2013, and March 13, 2014, 480 patients were randomized at 24 sites in China (241 to BVS and 239 to CoCr-EES). Subject disposition is shown in Figure 1. Five patients withdrew consent before use of any study device. Four crossovers occurred, 2 in each group. One crossover from BVS to CoCr-EES occurred after the BVS failed to cross the target lesion, and the other was due to absence of the appropriate BVS device size at the time of randomization. The 2 crossovers from CoCr-EES to BVS were due to site error. Of the 480 patients in the ITT population, 20 did not meet PTE criteria: 5 were subject withdrawals before any study device attempts during the index procedure (3 BVS and 2 CoCr-EES); 13 were subjects with at least 1 pre-specified protocol deviation (9 BVS and 4 CoCr-EES); 1 was the BVS subject who had no study device implanted at the target lesion (treated with CoCr-EES due to BVS product unavailability at the site); and 1 was a BVS subject treated with both a BVS and CoCr-EES at the target lesion (the latter for bail-out after a BVS edge dissection). The PTE population thus consisted of 460 patients (228 BVS and 232 CoCr-EES).
Patient demographics, risk factors, and lesion characteristics at baseline were well-balanced between the BVS and CoCr-EES arms (Table 1). Most BVS and CoCr-EES patients (94.5% and 93.7%, respectively) had a single target lesion treated, and 8.4% and 6.8%, respectively, had a single nontarget lesion treated (Table 2). Device diameters and length were also similar between groups. Use of intravascular imaging was infrequent. Device post-dilation was performed in a slightly greater proportion of BVS cases. Acute device and procedural success rates were similar with BVS and CoCr-EES, as was discharge medication use (Table 2).
Baseline lesion length, reference vessel diameter, MLD, and %DS were balanced between groups (Table 3). The post-procedure in-segment MLD, acute gain, and %DS were similar with both devices. However, within the device the post-procedural MLD and acute gain were lower with BVS compared with CoCr-EES, and the %DS was slightly greater.
1-Year angiographic outcomes
The 1-year angiographic follow-up data was available in 86.3% (208 of 241) of BVS and 83.3% (199 of 239) of CoCr-EES patients per ITT, and in 87.7% (200 of 228) BVS and 84.1% (195 of 232) CoCr-EES patients per PTE. The primary endpoint of 1-year in-segment LL in the PTE population based on per-subject analysis was 0.19 ± 0.38 mm with BVS versus 0.13 ± 0.38 mm with CoCr-EES. The 1-sided 97.5% upper confidence limit of the observed 0.06-mm difference is 0.14 mm, which is below the noninferiority margin of 0.15 mm (pnoninferiority = 0.01). In the per-subject analysis in the ITT population, BVS was also noninferior to CoCr-EES for 1-year in-segment LL (Table 4). When analyzed on a per-lesion analysis, BVS was also noninferior to CoCr-EES in both the PTE and ITT populations (Table 4).
The 1-year angiographic results by ITT are reported in Table 3, and late loss cumulative frequency distribution curves are shown in the Central Illustration. At 1-year, BVS had a slightly smaller MLD and larger %DS compared with CoCr-EES within the device, but similar in-segment measures. Angiographic binary restenosis (ABR) rates at 1 year were low and comparable with both devices, whether measured in-device or -segment.
1-Year clinical outcomes
The 1-year clinical follow-up was completed in 98.8% (238 of 241) of BVS patients and in 99.2% (237 of 239) of CoCr-EES patients. At 1 year, 99.6% BVS and 96.2% CoCr-EES patients were taking aspirin (p = 0.02), and 98.3% BVS and 95.8% CoCr-EES patients were taking a P2Y12 inhibitor (p = 0.10).
As shown in Table 5 and Figure 2, the 1-year rates of all evaluated composite safety and efficacy measures were not significantly different between BVS and CoCr-EES. Similarly, the component measures of these endpoints were similar with both devices, other than lower 1-year all-cause mortality with BVS (0% vs. 2.1%; p = 0.03). The periprocedural MI rates were low and similar between BVS and CoCr-EES by the protocol definition (CK-MB >5× URL; 1.3% vs. 0.4%, respectively; p = 0.62), or if a more sensitive definition (CK-MB >3× URL; 1.8% vs. 0.9% respectively; p = 0.69) or less sensitive definition (CK-MB >10× URL; 0.4% vs. 0.0%, respectively; p = 1.0) was used.
There were no definite scaffold or stent thromboses during the 1-year follow-up period. One BVS patient developed an MI within the distribution of the target vessel 15 days post-procedure that was initially treated medically. Angiography performed 6 days later demonstrated 20.7% and 21.6% in-device and -segment diameter stenoses, respectively, at the target lesion site, without thrombus evident. Nonetheless, this event was adjudicated as a probable scaffold thrombosis. There were no other thrombosis events. Thus, the 1-year rate of definite/probable scaffold/stent thrombosis was 0.4% with BVS and 0% with CoCr-EES (p = 1.00).
Side branch analysis
Although bifurcations with a side branch ≥2 mm diameter or ≥50% DS or requiring guidewire protection were excluded from enrollment, 126 BVS and 122 CoCr-EES target lesions in the study were classified as bifurcation lesions by the core laboratory using a more sensitive 1.5-mm side branch diameter cut-off. Core laboratory analysis was completed in 124 and 116 of these lesions, respectively, of which 31 (25.0%) and 22 (19.0%) were true bifurcation lesions (Medina 1:1:1, 1:0:1, or 0:1:1). Side branch TIMI (Thrombolysis In Myocardial Infarction)-3 flow was present in 96.0% of BVS and 97.4% of CoCr-EES bifurcation lesions pre-procedure (p = 0.72), and in 95.2% of BVS vs. 95.7% of CoCr-EES bifurcation lesions post-procedure (p = 0.84). Only 6 (4.8%) and 5 (4.3%) side branches had TIMI flow decrease by ≥1 grade after BVS and CoCr-EES, respectively (p = 0.82).
In the ABSORB China randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of angiographic in-segment LL at 1 year (Table 4). Other angiographic in-segment measures were also similar between the 2 devices post-procedure and at follow-up. In-device acute gain was lower and 1-year in-device LL was greater with BVS compared with CoCr-EES, although these differences were small, and in-segment measures were similar between the 2 devices, as were the 1-year rates of in-device and in-segment ABR. BVS and CoCr-EES also demonstrated comparable rates of acute device and procedural success, with similar 1-year rates of the PoCE, the device-oriented composite endpoint, MI, TLR, and scaffold/stent thrombosis. All-cause mortality was significantly lower at 1 year with BVS compared with CoCr-EES, which although likely due to chance, is again reassuring for the safety of BVS.
In accordance with China regulatory guidance, ABSORB China was designed with in-segment LL as the primary endpoint, a well-accepted surrogate of the clinical endpoint of ID-TLR (12–14). Indeed, ABSORB China is the first randomized ABSORB trial powered to test this as a primary endpoint. In-segment LL is a robust measure of clinical effectiveness as it accounts for restenosis both within the stent as well as the peristent margins where issues may arise due to mismatch of the device and balloon, drug diffusion effects, and others (14). The mean 1-year in-segment LL for CoCr-EES in this trial (0.13 mm) is similar to that reported for CoCr-EES in the SPIRIT III trial at 8 months (0.14 mm) (11), and more recently for the platinum chromium everolimus-eluting stent at 9 months (0.20 mm) from the contemporary EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) randomized trial (15). The mean 1-year in-segment LL for BVS in the present trial (0.19 mm) is less than the 0.30 mm mean in-segment LL with BVS at 9 months in EVERBIO II trial, which enrolled an all-comers population (15).
Despite the similar 1-year in-segment angiographic measures with BVS and CoCr-EES in the present study, the mean in-device LL was greater with BVS than with CoCr-EES (0.23 mm vs. 0.10 mm, respectively). Conversely, no significant difference in the mean in-device LL was noted between BVS and metallic DES at 9 months in the EVERBIO II trial (0.28 mm vs. 0.25 mm, respectively) (15). This discordance may be due to differences in patient and lesion characteristics, different procedural techniques, and possibly, timing of angiographic follow-up between the 2 studies. Nonetheless, given their absolute magnitude, the differences in 1-year in-device (and in-segment) LL in the present study between BVS and CoCr-EES are not likely to be clinically meaningful. Pocock et al. (14) demonstrated that when the absolute 1-year in-segment LL is <0.3 mm and the in-stent LL is <0.4 mm, TLR rates are very low, with further reductions in LL unlikely to reduce clinical restenosis. As also predicted by Pocock et al. (14), the low 1-year in-device and -segment LL in the BVS arm from the present study (0.23 and 0.18 mm, respectively) were associated with low rates of in-device and -segment ABR (2.9% and 3.9%, respectively) and 1-year ID-TLR (2.5%), comparable to the rates of in-device and -segment ABR (0.8% and 2.8%, respectively) and ID-TLR (2.1%) observed with CoCr-EES.
The first-generation BVS has thicker struts and a larger crossing profile than contemporary metallic DES. Nevertheless, issues with deliverability and tracking of BVS were not observed in the present study, with high rates of acute device and procedural success achieved in the present and prior ABSORB studies, comparable to CoCr-EES in noncomplex lesions (8,16). Aggressive pre-dilation was recommended, and post-dilation was performed at a higher rate with BVS than CoCr-EES, which may have helped achieve high rates of acute procedural success with only a 2.0% bailout rate. Nonetheless, improvements in implantation technique (e.g., routine post-dilation or more frequent use of intravascular imaging guidance, which was rarely used in the present study) and device iterations (thinner struts with reduced recoil) may further improve deliverability and angiographic and clinical outcomes, especially in complex lesions.
In the present study, the 1-year rates of device- and patient-oriented composite outcomes were comparable between BVS and CoCr-EES. Similar results were reported from the ABSORB II European multicenter randomized trial (8). Acknowledging the known caveats of statistical power and cross-study examinations, ABSORB China and ABSORB II showed similar performance of BVS in Chinese and European patients. In both trials (480 and 501 randomized patients, respectively), BVS and CoCr-EES had comparable rates of PoCE, target lesion failure, cardiac death, TV-MI, all MI, and ID-TLR. Moreover, despite the wider struts of BVS compared with CoCr-EES, similar rates of periprocedural myonecrosis were noted with both devices in both trials, regardless of whether a threshold of 3, 5, or 10× CK-MB was used. By core laboratory analysis, reductions in side branch TIMI flow were not more common after BVS than the thinner strutted CoCr-EES. Further study is required to determine whether this observation holds in more complex bifurcations or with larger side branches than were enrolled in these studies.
Stent and scaffold thrombosis rates were very low in our trial. Only 1 patient experienced a probable scaffold thrombosis, and no definite thromboses occurred. The cumulative 1-year scaffold thrombosis rate for BVS was slightly lower in our study than that in ABSORB II (0.4% vs. 0.9%) (8). These results should be interpreted cautiously given the low incidence of device thrombosis and the modest sample size of both studies.
ABSORB China was an open-label trial (in contrast to other DES studies), and some degree of bias cannot be excluded. However, the effect of potential bias on outcomes was minimized by use of an independent clinical events committee to adjudicate events on the basis of original source documents and an independent angiographic core laboratory using established algorithms and criteria. Intravascular imaging was utilized in only 2 patients in our study, and additional studies are required to determine if routine use of either intravascular ultrasound or optical coherence tomography would improve BVS outcomes. The lesions enrolled were relatively noncomplex, and follow-up duration to date is short (only 1 year). BVS is still undergoing active bioresorption at 1 year, a process which is not complete until ∼3 years. Ongoing follow-up is required to assess the long-term effect of BVS on clinical outcomes. Angiographic follow-up was performed in temporal proximity to the 1-year clinical follow-up, and an effect of the oculostenotic reflex cannot be excluded (17). Finally, the present study was not powered to detect changes in clinical outcomes between the groups, and the significantly lower rate of all-cause mortality with BVS compared with CoCr-EES may represent type I error. Larger investigations, such as the ongoing ABSORB IV trial (NCT01751906), are required to determine whether there are meaningful early or late clinical differences between these 2 devices.
In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment late loss at 1 year.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: In patients undergoing PCI, the safety and angiographic efficacy of the BVS was similar at 1 year to the CoCr-EES metallic DES.
TRANSLATIONAL OUTLOOK: Additional studies are required to assess longer-term clinical outcomes following deployment of BVS in patients with complex coronary lesions compared with more conventional stent devices.
For supplemental methods, including inclusion and exclusion criteria, study endpoints, definitions, study organization, investigators, and enrollment per site, please see the online version of this article.
The ABSORB China RCT was sponsored by Abbott Vascular. Dr. Gao has received a research grant from Abbott Vascular. Dr. Han has received institutional research grant support from Lepu Medical. Drs. Kuo, Ying, Cheong, Zhang, and Su are employees of Abbott Vascular. Dr. Stone is a consultant to Reva Corp. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- angiographic binary restenosis
- bioresorbable vascular scaffold(s)
- cobalt-chromium everolimus-eluting stent(s)
- diameter stenosis
- late loss
- myocardial infarction
- minimum lumen diameter
- patient-oriented composite endpoint
- Received August 10, 2015.
- Revision received September 16, 2015.
- Accepted September 25, 2015.
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