Author + information
- Received September 5, 2017
- Revision received September 19, 2017
- Accepted September 26, 2017
- Published online February 5, 2018.
- Yaling Han, MD, PhDa,∗ (, )
- Bo Xu, MBBSb,
- Guosheng Fu, MDc,
- Xiaozeng Wang, MDa,
- Kai Xu, MDa,
- Chongying Jin, MDc,
- Ling Tao, MDd,
- Lang Li, MDe,
- Yuqing Hou, MDf,
- Xi Su, MDg,
- Quan Fang, MDh,
- Lianglong Chen, MDi,
- Huiliang Liu, MDj,
- Bin Wang, MDk,
- Zuyi Yuan, MDl,
- Chuanyu Gao, MDm,
- Shenghua Zhou, MDn,
- Zhongwei Sun, MScb,
- Yanyan Zhao, BSb,
- Changdong Guan, MScb,
- Gregg W. Stone, MDo,p,
- on behalf of the NeoVas Randomized Controlled Trial Investigators
- aDepartment of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China
- bCatheter Lab, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- cDepartment of Cardiology, Sir Run Run Shaw Hospital, Hangzhou, China
- dDepartment of Cardiology, Xijing Hospital, The Fourth Military Medical University, Xi’an, China
- eDepartment of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China
- fDepartment of Cardiology, Nanfang Hospital, Guangzhou, China
- gDepartment of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
- hDepartment of Cardiology, Peking Union Medical College Hospital, Beijing, China
- iDepartment of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China
- jDepartment of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing, China
- kDepartment of Cardiology, Aero Space Center Hospital, Beijing, China
- lDepartment of Cardiology, The First Affiliated Hospital of Xi’an Jiongtong University, Xi’an, China
- mDepartment of Cardiology, Henan Provincial People’s Hospital, Zhengzhou, China
- nDepartment of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China
- oCenter for Interventional Vascular Therapy, Division of Cardiology, Presbyterian Hospital and Columbia University, New York, New York
- pCardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Yaling Han, Department of Cardiology, General Hospital of Shenyang Military Region, 83, Wenhua Road, Shenhe District, Shenyang 110016, China.
Objectives The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.
Background BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating.
Methods Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients.
Results The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07).
Conclusions The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485)
Although drug-eluting stents (DES) have reduced restenosis compared with bare-metal stents in patients undergoing percutaneous coronary intervention (PCI), they still have limitations, including polymer hypersensitivity reactions, delayed arterial healing, strut facture, and neoatherosclerosis, all of which contribute to an ongoing risk of stent thrombosis and target lesion failure (TLF) (1). In addition, the presence of a metal frame in the vessel impairs vasomotion and compensatory vascular remodeling, interferes with noninvasive imaging, and may limit options for coronary artery bypass surgery (2–4). By eliminating the permanent metallic cage, bioresorbable scaffolds (BRS) allow the vessel to recover cyclic pulsatility and the capability to respond and remodel to shear and wall stress, physiological cyclic strain, and pharmacological agents (5,6). The most widely used BRS is the everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, California) (4). Preclinical and imaging-based clinical findings with Absorb have demonstrated favorable healing characteristics, restoration of vasomotor function, and an increase in lumen caliber due to positive vessel remodeling once bioresorption is complete in ∼3 years (3). However, Absorb has been associated with an increased rate of adverse events within the first 3 years compared with cobalt-chromium everolimus-eluting stents (CoCr-EES) (7–10), a finding that may be related to the relatively thick struts of Absorb and suboptimal implantation technique. Other BRS with different designs are now under investigation, although none have reported randomized trial results (11).
NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS. A first-in-human study with this device in 31 patients demonstrated an acceptable in-scaffold late loss (LL) and a high percentage of scaffold strut coverage at 6 months without thrombosis (12). In the present study, we evaluated the angiographic efficacy and clinical safety and effectiveness of the NeoVas BRS in a randomized trial designed to enable its approval by the China Food and Drug Administration.
Study design and participants
Patients were eligible for the prospective, single-blind, multicenter NeoVas randomized controlled trial who were 18 to 75 years of age with chronic, stable ischemic heart disease or stabilized acute coronary syndromes, and a single de novo native coronary lesion with a visually estimated stenosis of ≥70% in a vessel with Thrombolysis In Myocardial Infarction flow grade ≥1, reference vessel diameter (RVD) ≥2.5 mm and ≤3.75 mm, and lesion length ≤20 mm. Exclusion criteria included myocardial infarction (MI) within 1 month, elevated baseline creatine kinase-MB, left ventricular ejection fraction ≤40%, and lesions that were chronic total occlusions, in-stent restenosis, ostial, bifurcations with a side branch RVD ≥2.0 mm, in the left main coronary artery, or contained thrombus. Full inclusion and exclusion criteria are provided in the Online Appendix.
The institutional review board and ethics committee at each center approved the protocol. All patients provided written informed consent for participation.
Randomization, study device, and procedure
Following mandatory pre-dilatation, patients were randomly assigned to treatment with either NeoVas BRS or CoCr-EES in a 1:1 ratio in fixed blocks of 4, stratified by center and diabetes using a web-based allocation system. As previously reported (12), the NeoVas PLLA-based BRS elutes sirolimus (15.3 μg/mm) from a poly (D, l-lactide) (PDLLA) coating. In vitro studies have demonstrated 70% to 75% sirolimus elution from the polymer coating within 1 month, and 100% by 2 months. In vivo porcine studies have demonstrated that the PLLA polymer is completely resorbed in approximately 36 months. The total strut thickness of the NeoVas scaffold is 170 μm, with 160 μm and 10 μm corresponding to the backbone and polymer thickness, respectively. It is manufactured in expanded diameters ranging from 2.5 to 3.5 mm, and with scaffold lengths from 12 to 24 mm.
A loading dose of aspirin (300 mg) and either clopidogrel (300 to 600 mg) or ticagrelor (180 mg) was administered at least 24 h before the index procedure unless the patient was on chronic P2Y12 inhibitor therapy for >3 days. All lesions had to be covered by a single study stent or BRS; use of a second device was allowed as randomized for edge dissection or otherwise as required. Post-dilation was strongly recommended. Following PCI, aspirin 100 mg daily indefinitely 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 in China during this study. Patients were masked to treatment allocation for 1 year after the index procedure.
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. Optical coherence tomography (OCT) and fractional flow reserve (FFR) were both performed in a pre-specified subgroup of 160 patients at baseline, post-procedure, and at 1-year and 3-year follow-up at 2 sites, the General Hospital of Shenyang Military Region (Shenyang, China), and Sir Run Run Shaw Hospital (Hangzhou, China). OCT and FFR methodology are provided in the Online Appendix.
The trial was designed to examine whether NeoVas was noninferior to CoCr-EES for the primary endpoint of angiographic in-segment 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. In addition, in ABSORB II (ABSORB II Randomized Controlled Trial), the rate of recurrent or worsening angina during 1-year follow-up was significantly lower with the Absorb BRS than with Xience (Abbott Vascular) (8). We therefore established the major secondary endpoint as the rate of angina at 1 year, powered for superiority with NeoVas compared with CoCr-EES. Other secondary endpoints included acute success, lesion success, and procedure success; TLF (the composite of cardiac death, target vessel MI, or ischemia-driven [ID] target lesion revascularization [TLR]); the patient-oriented composite endpoint (PoCE) (composite of all death, all MI, or any revascularization); the individual components of TLF and PoCE; and definite or probable device thrombosis according to the ARC criteria (13). Definitions of the secondary endpoints are provided in the Online Appendix.
Clinical endpoint events were adjudicated by an independent clinical events committee, blinded to device assignment. Quantitative coronary angiography (QCA) data were analyzed at an independent angiographic core laboratory. A data safety and monitoring board reviewed the cumulative safety data from the trial at pre-specified intervals, each time recommending the trial continue. Onsite monitoring was performed by independent study monitors on 100% of data. Recurrent angina was collected as patient-reported outcomes in diary cards filled out by patients and questionnaires collected by investigators, and were verified by patient physician discussion. The study organization, investigators, and enrollments per site appear in the Online Appendix. The study was sponsored by Lepu Medical Technology and is registered at ClinicalTrials.gov, NCT02305485.
The trial was powered to test noninferiority for the primary endpoint and superiority for the major secondary endpoint. For the primary endpoint, the mean in-segment LL was assumed to be 0.16 mm for CoCr-EES and 0.19 mm for NeoVas group, with a common SD of ±0.47 mm. With a noninferiority margin of 0.195 mm, allowing for a 30% attrition rate of angiographic follow-up, enrolling 560 patients would yield 93% power to demonstrate noninferiority with a 1-sided alpha of 0.025. For the major secondary endpoint, assuming a 1-year angina rate of 26% in the CoCr-EES group and 16% in the NeoVas group, considering an anticipated loss to follow-up of 5%, 560 patients would yield at least 80% power to detect superiority with a 2-sided alpha of 0.05.
All principal statistical analyses were performed in the modified intention-to-treat population, consisting of all randomized patients who had PCI attempted. For noninferiority testing of the primary endpoint, analysis was also performed in the as treated per-treatment-evaluation population, consisting of patients who received only study devices. Continuous variables are presented as mean ± SD, and categorical variables are presented as counts and percentages. Normally distributed continuous variables were compared by the Student t test, and non-normally distributed data were compared by the Wilcoxon signed rank test. Categorical variables were compared using the chi-square test or Fisher exact test. Generalized estimating equations were used for lesion-level and strut-level analyses to account for clustering. The 2-sided 95% confidence intervals (CIs) of the difference in LL between groups were estimated using generalized estimating equation model analysis. Cumulative event rates for clinical outcomes between the 2 treatment arms are calculated on the basis of Kaplan-Meier estimates. Survival curves for time-to-event variables were compared by the log-rank test. Cox proportional hazards regression was used to determine hazard ratios and 95% CIs. Unless otherwise specified, all statistical tests were performed at a 2-sided significance level of 0.05 using SAS software, version 9.4 (SAS Institute, Cary, North Carolina).
Patients and procedural results
Between December 1st, 2014 and December 23rd, 2015, 567 patients were randomized at 32 sites in China (Figure 1). Among them, 7 patients withdrew consent after randomization, but before treatment. Of the 560 patients in the modified intention-to-treat population (278 NeoVas and 282 CoCr-EES), 3 patients crossed over to the other randomized group (2 NeoVas-assigned patients received CoCr-EES because of failure of scaffold delivery to the lesion, and 1 CoCr-EES–assigned patient received NeoVas because the proper length CoCr-EES was not available). Six NeoVas-assigned patients did not receive study devices because the scaffold could not be delivered to or cross the lesion and were treated with nonstudy metallic DES. There were no significant differences in the baseline demographics or lesion characteristics between the NeoVas and CoCr-EES groups (Table 1). Baseline lesion QCA measures were balanced between groups, as were device diameters and lengths (Table 2). A lower device success rate was observed with NeoVas compared with CoCr-EES (96.2% vs. 99.6%; p = 0.002), but lesion and procedure success rates were similar with both devices (Table 2). Post-procedural in-device MLD and acute gain were lower with NeoVas compared with CoCr-EES, and the percent diameter stenosis (%DS) was greater, although in-segment measures were similar with both devices (Table 3). The degree of acute recoil was not different between devices. Vessel curvature was maintained to a greater degree with NeoVas compared with CoCr-EES. Medication use before, during, and post-procedure was balanced between the 2 groups (Online Table S1).
One-year angiographic follow-up data were available in 249 of 278 (89.6%) NeoVas patients and 244 of 282 (86.5%) CoCr-EES patients. The primary endpoint of 1-year in-segment LL was 0.14 ± 0.36 mm with NeoVas versus 0.11 ± 0.34 mm with CoCr-EES. The 1-sided 97.5% upper confidence limit of the observed 0.03 mm difference was 0.09 mm, which was below the noninferiority margin of 0.195 mm (pnoninferiority <0.0001, psuperiority = 0.36). In the as-treated per-treatment-evaluation population, 1-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm, respectively (difference 0.04 mm; upper 1-sided 97.5% confidence interval 0.10 mm; pnoninferiority <0.0001, psuperiority = 0.35) (Online Table S2). Other QCA results are reported in Table 3, and in-stent and in-segment LL cumulative frequency distribution curves are shown in Figure 2. At 1 year, NeoVas had a smaller MLD and larger %DS compared with CoCr-EES within the device, but similar in-segment measures. Angiographic binary restenosis rates at 1 year were low and comparable for both devices, both in-device and in-segment. By the Mehran classification (14), of the 9 cases of NeoVas restenosis, 3 were focal, occurring either within the body of the scaffold (Class IC, n = 2) or at the proximal scaffold edge (Class IB, n = 1), 3 were diffuse in-scaffold (Class II), 1 was proliferative (Class III), and 2 were occlusive (Class IV). Vessel curvature at follow-up was maintained to a greater degree with NeoVas than with CoCr-EES.
One-year clinical follow-up was completed in all patients. TLF occurred in 12 (4.3%) NeoVas-assigned patients and 10 (3.5%) CoCr-EES–assigned patients (p = 0.64). Other evaluated safety and efficacy measures were also similar between NeoVas and CoCr-EES (Table 4, Figure 3). Rates of periprocedural MI using different definitions were not significantly different between the 2 groups (Online Table S3). Stent thrombosis within 1 year developed in 1 NeoVas-treated patient and in no CoCr-EES patients. There were no significant differences in the rates of recurrent angina within 1 year between the NeoVas and CoCr-EES groups (27.9% vs. 32.1%; hazard ratio 0.84; 95% CI: 0.62 to 1.14; p = 0.26) (Figure 4).
OCT and FFR substudy results
The OCT and FFR substudies were performed in 159 and 158 patients, respectively. By OCT there was less post-procedure strut malapposition with NeoVas compared with CoCr-EES (Online Table S4). The rates of both persistent and acquired malapposition were also lower with NeoVas at 1 year, and NeoVas had a higher proportion of covered struts. As a result, the healing score was lower (improved) with NeoVas compared with CoCr-EES. The minimal lumen area was smaller with NeoVas compared with CoCr-EES at 1 year (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001), although FFR was not significantly different between the 2 groups either post-procedure or at 1 year (Online Table S5).
The present study, the first randomized trial of a BRS other than Absorb, powered for follow-up angiographic measures, has demonstrated in patients with simple and moderately complex coronary artery disease that: 1) the NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of angiographic in-segment late loss at 1 year; 2) there was no significant difference in the major secondary endpoint of recurrent angina between the 2 devices; and 3) the 1-year rates of clinical events, including TLF, cardiac death, target vessel–MI, ID-TLR, and device thrombosis were generally low and comparable between NeoVas and CoCr-EES.
The previous first-in-man study showed that the sirolimus-eluting PLLA-based NeoVas scaffold effectively inhibited neointimal hyperplasia at 6 months (angiographic in-scaffold LL 0.26 ± 0.32 mm) (12). We thus compared NeoVas to a leading metallic DES, the XIENCE CoCr-EES in the present randomized trial designed to support regulatory approval in China. In-segment LL was the primary endpoint, comparable to the ABSORB China trial (10). The mean 1-year in-segment LL for NeoVas in the present trial (0.14 mm) was also similar to that noted with Absorb BVS in the ABSORB China study (0.19 mm), and was noninferior to the in-segment LL with CoCr-EES (0.11 mm), thus meeting the primary endpoint of the present study. Event-free survival through 1-year follow-up was also not significantly different with NeoVas compared with CoCr-EES, and only 1 scaffold thrombosis occurred in NeoVas-treated patients.
The clinical and angiographic results with NeoVas were favorable, despite the thick struts of this first-generation device. Several reasons may underlie these findings: 1) strict entry criteria precluded treatment of high-risk patients and complex lesions in which adverse events may have been increased; 2) optimal technique, including accurate vessel sizing with avoidance of very small vessels (QCA RVD <2.25 mm), and mandatory post-dilation were used more commonly than in previous studies; and 3) OCT guidance was used in 28.2% of patients, higher than in prior randomized trials. On the basis of recent data suggesting that suboptimal implantation technique may be associated with an increased risk of adverse events (15), a BVS-specific implantation protocol has been proposed, emphasizing the importance of proper lesion preparation, accurate vessel sizing, and high-pressure post-dilation (16). In our trial, optimal pre-dilatation (defined as pre-dilatation performed in all lesions with a balloon to QCA RVD ratio ≥1:1) was performed in only 39.9% of cases, which may explain the relatively lower NeoVas device success rate in our study. We therefore strongly recommend optimal pre-dilatation to enhance deliverability of the relatively high profile, first-generation NeoVas BRS. Conversely, only 7.2% of NeoVas-treated patients had lesions with RVD <2.25 mm, compared with 18.8% of patients in the ABSORB III trial, the factor most strongly associated with an increased rate of scaffold thrombosis within 1 year (17). In addition, post-dilation was performed in 83.5% of patients assigned to NeoVas, and was optimal (defined as post-dilatation with a noncompliant balloon ≥18 atm with nominal diameter larger than the nominal scaffold diameter, but not >0.5 mm larger) in 37.1% of patients, a relatively high rate that has also been associated with low rates of scaffold thrombosis and TLR (18).
The OCT substudy performed herein is the largest such analysis from any randomized BRS trial to date. Of note, incomplete strut apposition (ISA) was lower with NeoVas compared with CoCr-EES, both post-procedure and at 1-year follow-up. Proper vessel sizing and high-pressure post-dilatation may have contributed to the low rate of ISA in the NeoVas group, facilitating late strut coverage (which was superior to that with CoCr-EES) and improving event-free survival. Although the relationship between ISA and adverse events with BRS remains uncertain (19), in a recent study, strut malapposition was the most frequent OCT finding in 43 patients with early and late Absorb scaffold thrombosis (20). The OCT-derived healing score was also better with NeoVas compared with CoCr-EES, consistent with the trend toward improved healing observed with Absorb BVS compared with CoCr-EES in patients with acute MI in the randomized TROFI-II (ABSORB STEMI: the TROFI II Study) (21). However, the clinical implications of superior healing with NeoVas as assessed by this score have not yet been demonstrated, and long-term follow-up is needed to determine whether less early and late ISA and greater strut coverage during follow-up translate into greater event-free survival, especially during and after the period of active bioresorption.
No significant differences in FFR were present between the devices either post-procedure or at 1-year follow-up. The immediate post-PCI FFR has been associated with long-term outcomes after metallic DES (22), and a decrease in FFR over time is consistent with either restenosis or lesion progression outside the treated segment. Although findings from the present FFR substudy are consistent with the similar rates of angiographic late loss, recurrent angina, and TLF observed with NeoVas and CoCr-EES during 1-year follow-up, further studies are required to elucidate the clinical implications of serial progression in FFR after PCI. Of note, the lack of difference in the rates of angina during 1-year follow-up between BRS and metallic DES in our trial is consistent with the results from the ABSORB III trial (23), in contrast to what was observed in the earlier ABSORB II trial in which Absorb BVS had less recurrent angina than CoCr-EES (8).
First, our study was not powered to detect differences in clinical results between the 2 groups, especially very low rates of device thrombosis. In this regard, although the primary noninferiority endpoint for in-segment LL was met, the post-implant and 1-year follow-up in-device MLDs were smaller and %DS were greater with NeoVas compared with CoCr-EES. Although this finding may in part be due to differences in QCA edge detection between polymeric scaffolds and metallic stents (24), and binary restenosis rates were not different between the devices, the OCT-derived minimal luminal diameter at 1 year was smaller in the NeoVas group. Larger trials are warranted to determine the true relative risk between NeoVas and metallic DES in late clinical events. Second, our study was too small for subgroup analysis, and we excluded most high-risk patients and complex lesions from enrollment. Further study is required to determine the performance of NeoVas in such patients and lesions. Third, follow-up to date is only complete through 1 year; longer-term follow-up is required to assess the very late safety of NeoVas as it naturally “dismantles” during the bulk erosion process (25). Moreover, the clinical benefits of BRS compared with metallic DES would be expected to emerge only after complete scaffold bioresorption, which in the case of NeoVas occurs at approximately 3 years. Fourth, the operators in the study had little experience with scaffolds before this trial, and optimal implantation technique was not used in all patients. Outcomes may improve over time with increasing operator experience. Finally, the NeoVas scaffold is a first-generation device with thicker and wider struts and other mechanical limitations compared with contemporary metallic DES; iterative enhancements in its design may further improve vascular responses and clinical outcomes.
In the present multicenter randomized trial, the NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year in patients with simple and moderately complex coronary artery disease undergoing PCI, and resulted in comparable 1-year clinical outcomes, including recurrent angina.
WHAT IS KNOWN? By eliminating the permanent metallic cage, BRS allow the vessel to recover cyclic pulsatility and the capability to respond and remodel to shear and wall stress, physiological cyclic strain, and pharmacological agents. The most widely used BRS is the everolimus-eluting Absorb BVS. Other BRS with different designs are now under investigation, but none have reported randomized trial results.
WHAT IS NEW? In this multicenter randomized trial, we demonstrated that NeoVas, a new sirolimus-eluting PLLA-based BRS, was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment late loss, and resulted in comparable 1-year clinical outcomes, including recurrent angina.
WHAT IS NEXT? The NeoVas BRS is a promising device, however, longer-term follow-up of the study and larger trials are needed to determine the true relative risk between NeoVas and metallic DES in late clinical outcomes.
The NeoVas randomized controlled trial was sponsored by Lepu Medical, Beijing, China. Dr. Stone is the global chairman of the Absorb clinical trial program (uncompensated); and a consultant for Reva Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Han, Xu, and Fu contributed equally to this work.
- Abbreviations and Acronyms
- diameter stenosis
- bioresorbable scaffold(s)
- confidence interval
- cobalt-chromium everolimus-eluting stent(s)
- drug-eluting stent(s)
- fractional flow reserve
- incomplete strut apposition
- late loss
- minimal lumen diameter
- myocardial infarction
- optical coherence tomography
- percutaneous coronary intervention
- poly-l-lactic acid
- patient-oriented composite endpoint
- quantitative coronary angiography
- reference vessel diameter
- target lesion failure
- target lesion revascularization
- Received September 5, 2017.
- Revision received September 19, 2017.
- Accepted September 26, 2017.
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