Author + information
- Received December 4, 2019
- Revision received February 6, 2020
- Accepted February 19, 2020
- Published online June 1, 2020.
- David E. Kandzari, MDa,∗ (, )
- Jacques J. Koolen, MD, PhDb,
- Gheorghe Doros, PhDc,
- Hector M. Garcia-Garcia, MD, PhDd,
- Johan Bennett, MD, PhDe,
- Ariel Roguin, MD, PhDf,
- Elie G. Gharib, MDg,
- Donald E. Cutlip, MDh,
- Ron Waksman, MDd,
- for the BIOFLOW V Investigators
- aPiedmont Heart Institute, Atlanta, Georgia
- bCatharina Hospital, Eindhoven, the Netherlands
- cDepartment of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, Massachusetts
- dDivision of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC
- eDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
- fDepartment of Cardiology, Hillel Yaffe Medical Center, Hadera, Israel
- gCharleston Area Medical Center, Charleston, West Virginia
- hBeth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. David E. Kandzari, Piedmont Heart Institute, 95 Collier Road, Suite 2065, Atlanta, Georgia 30309.
Objectives The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).
Background Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.
Methods BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.
Results Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
Conclusions In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)
An emerging evidence base comparing ultrathin-strut versus thin-strut drug-eluting stents (DES) indicates improved outcomes favoring ultrathin-strut DES. Specifically, thinner stent struts permit accelerated endothelialization, reduce inflammation and arterial injury, and decrease neointimal proliferation and thrombogenicity (1), which may translate to reduced thrombotic events and clinical restenosis.
The BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) trial is an international, randomized study comparing clinical outcomes among patients undergoing percutaneous coronary revascularization with an ultrathin-strut (60 μm for stent diameters ≤3.0 mm, 80 μm for stent diameters ≥3.5 mm) bioresorbable-polymer sirolimus-eluting stent (BP SES) (Orsiro, Biotronik, Bülach, Switzerland) or contemporary thin-strut (81 μm) durable-polymer everolimus-eluting stent (DP EES) (Xience, Abbott Vascular, Santa Clara, California) (2). At 1 year, significant differences were observed favoring treatment with BP SES regarding the primary endpoint of target lesion failure (TLF) (6.0% vs. 10.0%; p = 0.04) and target vessel–related myocardial infarction (MI) (5.0% vs. 8.0%; p = 0.02) (3). By 2 years, significant differences in TLF and target vessel MI persisted, with the emergence of significant differences in target lesion revascularization (TLR) and late or very late stent thrombosis (ST) favoring treatment with BP SES (4).
Whether these observed differences between BP SES and DP EES persist over longer surveillance is uncertain. Indeed, prior studies comparing late-term (e.g., 3- to 5-year follow-up) events between ultrathin-strut BP SES and thin-strut, durable-polymer DES have reported inconsistent results (5–7). Specific to the BIOFLOW V trial, a focus of attention is directed to whether benefits observed at 1 year with BP SES versus DP EES are sustained over longer duration and if differences might emerge regarding other clinical endpoints. We therefore report the pre-specified 3-year safety and efficacy outcomes among patients treated with BP SES and DP EES in the BIOFLOW V trial.
Study design and patient population
BIOFLOW V (NCT02389946) is a prospective, randomized, multicenter trial comparing BP SES and DP EES in patients undergoing elective and urgent percutaneous coronary intervention of no more than 3 de novo native coronary artery lesions in a maximum of 2 native target vessels. Description of the study design as well as 1- and 2-year results of the BIOFLOW V trial have been previously reported (2–4). Briefly, patients were randomized 2:1 to BP SES versus DP EES. Hemodynamically stable patients with non–ST-segment elevation MI and acute coronary syndromes were eligible for enrollment. Angiographic inclusion criteria included reference vessel diameter between 2.25 and 4.0 mm with lesion length ≤36 mm by visual estimation. Major angiographic exclusion criteria included chronic total occlusions, bifurcations involving a side branch with diameter >2.0 mm, bypass graft stenoses, and DES in-stent restenosis. Calcified lesions requiring atherectomy were permitted following instances of inadequate angioplasty balloon pre-dilation. Patients with recent (<72 h) ST-segment elevation MI, left ventricular ejection fractions <30%, ST, impaired renal function, and any prior nontarget percutaneous coronary intervention within 30 days or within 9 months involving the target vessel and those unlikely to adhere to dual-antiplatelet therapy were also excluded. The study was approved by the Institutional Review Board or ethics committee at each enrolling site, and eligible patients provided written informed consent prior to the interventional procedure.
Clinical events were assessed during the hospital stay and 30 days, 6 months, and annually through 3 years after the index procedure, with planned annual follow-up through 5 years. Surveillance angiography in the absence of clinical indications was not performed, per protocol.
All data were submitted to a central data coordinating facility (Baim Institute for Clinical Research, Boston, Massachusetts). An independent clinical events committee (Baim Institute for Clinical Research) adjudicated all primary and secondary clinical endpoints blinded to stent type, and an independent core laboratory (MedStar Cardiovascular Research Network, Angiographic Core Laboratory, Washington, District of Columbia) performed all related angiographic assessments. Biotronik funded the study and participated in site selection and management. The Baim Institute for Clinical Research was responsible for study and site management, monitoring, and data collection.
The 3-year primary endpoint assessment consisted of TLF, defined as the composite of cardiac death, target vessel–related MI, or ischemia-driven TLR. Additional pre-specified endpoints include major adverse cardiac events (all-cause death, MI, or ischemia-driven TLR), target vessel failure (cardiac death, target vessel–related MI, or ischemia-driven target vessel revascularization), the individual components of the composite endpoints, and definite or probable ST according to Academic Research Consortium criteria (8).
Periprocedural MI was defined according to the modified Academic Research Consortium criteria (8) as a creatine kinase–myocardial band or troponin level measured within 48 h of the interventional procedure elevated >3 times above the upper limit of normal. Spontaneous MI was defined as any creatine kinase–myocardial band or troponin elevation above the upper normal limit with associated ischemic symptoms, new electrocardiographic abnormalities suggestive of ischemia, and/or new development of imaging evidence of infarction or regional wall motion abnormalities. Ischemia-driven revascularization was identified as any repeat revascularization of the target lesion or target vessel associated with either: 1) ischemic symptoms and/or abnormal results on functional study and ≥50% coronary stenosis by quantitative angiography; or 2) any revascularization of a ≥70% diameter stenosis. Cardiac death was considered any death due to any proximate cardiac cause, unwitnessed death, or death of unknown etiology.
All analyses were performed in the intention-to-treat population, which consisted of all the patients who underwent randomization, regardless of the treatment received.
Baseline characteristics of study patients are summarized as frequencies and percentages for categorical variables and as mean ± SD for continuous variables. Treatment differences on dichotomous variables were evaluated using the Fisher exact tests. Categorical variables were compared between treatments using the Cochran-Mantel-Haenszel modified Ridit score (9) (i.e., Cochran-Mantel-Haenszel of general association for nominal variables and Cochran-Mantel-Haenszel of row mean score for ordinal variables). Continuous variables were compared between treatments using 2-sample Student’s t-tests. Kaplan-Meier estimates were used to construct survival curves through 3-year follow-up for time-to-event variables that were compared using the log-rank test. Proportional hazards models were performed with treatment arm, subgroup, and a treatment-by-subgroup interaction term included as predictors to assess treatment effect among each subgroup. Hazard ratios and 95% confidence intervals of the primary endpoint through 3 years were reported for each subgroup level. In addition, type III p values of the treatment-by-subgroup interaction term were also presented to evaluate the heterogeneity of treatment effect across subgroups. Additional analyses, including summaries, were conducted using SAS version 9.4 (SAS Institute, Cary, North Carolina), unless otherwise noted. Proportions were calculated using known nonmissing values. A p value of 0.05 was established as the level of statistical significance.
Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), 3-year clinical follow-up was complete for 94.8% (n = 838) and 94.2% (n = 424) of patients treated with BP SES and DP EES, respectively. The median duration of follow-up for the primary endpoint was 1,097 days (interquartile range: 1,031 to 1,140 days). As reported previously, both groups had similar baseline clinical and angiographic characteristics (Table 1). There were no significant differences in target lesion length, vessel diameter, or lesion characteristics with modest but statistically significant differences regarding total stent length, number of stents and prevalence of overlapping stents (Table 1).
Results of the pre-specified primary analysis of the TLF and secondary endpoints are represented in Supplemental Table 1. At 3 years, the significant differences observed at 1 and 2 years favoring BP SES regarding composite endpoints of TLF, target vessel failure, and major adverse cardiac events were maintained (Table 2, Central Illustration). Specifically, TLF was significantly lower among patients treated with BP SES (8.2% vs. 13.6%; p = 0.002) (Kaplan-Meier estimates, Figure 1, Table 2), representing a modest increase in the absolute difference in event rates compared with 1- and 2-year events (5.4% at 3 years vs. 3.2% and 4.0% at 1 and 2 years, respectively). The difference in TLF was driven principally by a significant difference in target vessel–related MI (5.0% vs. 9.2%; p = 0.003) (Kaplan-Meier estimates, Figure 1, Table 2) in addition to significantly lower ischemia-driven TLR among patients treated with BP SES (3.2% vs. 6.7%; p = 0.006) (Kaplan-Meier estimates, Figure 1, Table 2). Between 1 and 3 years, a significant difference in late ischemia-driven TLR was observed between BP SES and DP EES (1.5% vs. 4.7%; p < 0.001) (Figure 2). Specifically, between 1 and 3 years, the absolute difference in ischemia-driven TLR progressively increased between BP SES and DP EES treatment groups (1 year, 2.0% vs. 2.3% [Δ = 0.3%]; 2 years, 2.5% vs. 4.8% [Δ = 2.4%]; 3 years, 3.2% vs. 6.7% [Δ = 3.5%]). Landmark analysis of ischemia-driven TLR is presented in Figure 2. In addition, using a time-varying variable for intervals before and after 1 year, a robust benefit of treatment with BP SES over DP EES after 1 year and a nonsignificant benefit before the 1-year landmark was identified (Supplemental Table 2). In multivariate analysis, treatment with BP SES favored most pre-specified subgroups regarding the 3-year occurrence of TLF with no significant interactions observed other than age (Figure 3).
The incidence of cardiac death or MI was also lower in the BP SES group versus DP EES (7.7% vs. 11.7%; p = 0.017) (Table 2). In a landmark analysis of target vessel–related MI beyond 30 days of index revascularization through 3 years, a significantly higher event rate was observed among DP EES–treated patients (0.95% vs. 2.8%; p = 0.01) (Figure 2). In addition to the landmark analysis of target vessel–related MI, using treatment as a time-varying variable, separate hazard ratios were estimated for the intervals of 0 to 30 days and 30 days to 3 years. The results confirm a consistent benefit of treatment with BP SES over DP EES in both intervals (Supplemental Table 2). Over the entire 3-year period, cumulative rates of both Q-wave (0.1% vs. 1.4%; p = 0.003) and non-Q-wave (4.9% vs. 8.1%; p = 0.022) target vessel–related MI were also higher with DP EES.
Multivariate analyses of 3-year occurrence of TLF, target vessel–related MI, and ischemia-driven TLR were performed. For each endpoint analysis, no clinical, angiographic, or procedural characteristic that differed between groups was identified as a predictor of adverse outcome (Supplemental Table 3).
Approximately one-third of patients in the entire study population were adherent to dual-antiplatelet therapy at 3 years (35.5% in the BP SES group vs. 36.3% in the DP EES group; p = 0.53). The cumulative incidence of definite and definite or probable ST was numerically, but not statistically, lower among patients treated with BP SES (0.5% vs. 1.5%; p = 0.094) (Table 3). However, combined late and very late rates of both definite and definite or probable ST were significantly lower in the BP SES cohort (0.1% vs. 1.2%; p = 0.018 for both comparisons). An emergence of a statistical difference in very late definite or probable ST was also identified at 3 years (0% vs. 0.74%; p = 0.038).
The present analysis extends our understanding to the durability of late-term comparative outcomes between an ultrathin-strut BP SES and thin-strut DP EES, further revealing differences in safety and efficacy endpoints. Specifically, significant differences in TLF and the individual outcomes of target vessel–related MI and ischemia-driven TLR continued to diverge through 3 years, favoring treatment with BP SES over DP EES. In addition, by 3 years, the significant difference in late or very late ST persisted, with the emergence of significantly lower very late ST among patients treated with BP SES. These results affirm stability in safety and efficacy outcomes beyond the first year after index revascularization with ultrathin-strut BP SES, leading to continued and diverging significant differences compared with thin-strut DP EES.
The results of the present study are consistent with an evolving body of evidence specific to this BP SES that demonstrate superiority compared with alternative DES. Amid noninferiority design trials and progressively lower event rates that challenge the opportunity to identify differences among DES, recent studies with the Orsiro BP SES have featured improved safety and efficacy outcomes over comparator DES. In the large, randomized BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) trial among patients with acute MI, BP SES were superior to DP EES regarding 1-year TLF, a difference driven primarily by lower TLR (10). Similarly, TLR was significantly lower at 1 year for BP SES compared with a polymer-free DES in the randomized SORT OUT IX (BioFreedom Stent Versus Orsiro Stent) trial (1.3% vs. 3.5%; p < 0.001) (11). As dedicated longitudinal follow-up in clinical trials offers further insight to the effectiveness of DES, the accrual of events may also permit the ability to distinguish outcomes between therapies. By 3 years in the BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial, for example, significantly lower overall and late (1 to 3 years) TLR with BP SES versus zotarolimus-eluting stents was observed in treatment of small-caliber (<2.5 mm) vessels (7). In the BIOFLOW V trial, a similar benefit with BP SES regarding TLR was observed across all vessel sizes and treatment lengths. As with previous studies, the present findings demonstrate a plateau in late (>1 year) TLR with differences from DP EES that continue to diverge over annual follow-up. For BP SES, the pattern of late TLR therefore is distinct from the persistence of late TLR that seems constant with alternative existing DES (12–15). Nevertheless, inconsistency across comparative trials with differential follow-up is evident. For example, no significant differences in major cardiovascular events were observed between patients randomized to treatment with BP SES or DP SES over 5-year follow-up in the BIOSCIENCE (Sirolimus-Eluting Stents With Biodegradable Polymer Versus an Everolimus-Eluting Stents) trial (5). Notwithstanding the challenges of comparison across trials, such variance may be related in part or entirely to differences in patient and lesion complexity, endpoint definitions and event adjudication, sample size, or other unmeasured variables related to trial conduct and/or patient treatment.
Detailed ascertainment of events over longer duration provides perspective not only regarding late efficacy but also on the annualized estimates of MI and ST. Aside from a significant difference in early (periprocedural) MI favoring BP SES over DP EES, statistically significant differences in late (>30 days) spontaneous target vessel–related MI continue to diverge through 3 years. Similarly, no very late ST events occurred in the BP SES cohort, contributing to significantly lower rates of late and very late as well as very late ST compared with DP EES and despite similar rates of dual-antiplatelet therapy adherence. Altogether, these findings are largely consistent with a broader collection of recent comparative studies of ultrathin-strut DES and contemporary thin-strut DES; in meta-analysis of randomized trials comparing ultrathin-strut BP DES with contemporary generation thin-strut DES (10 trials, N = 11,658), revascularization with ultrathin-strut DES was associated with significant reductions in TLF (relative risk: 0.84; 95% confidence interval: 0.72 to 0.99) and MI (relative risk: 0.80; 95% confidence interval: 0.65 to 0.99) and numerically lower ST (relative risk: 0.72; 95% confidence interval: 0.51 to 1.01) (16).
In the BIOFLOW V trial, the significant difference in the 1-year composite TLF endpoint was driven principally by a lower risk for target vessel-related MI associated with BP SES compared with DP EES (3). In particular, a significant difference in procedure-related MI was observed favoring BP SES, although a trend toward lower spontaneous MI events (>30 days from index revascularization through 1 year) was also identified. Now through 3 years, however, both overall and spontaneous target vessel–related MI event rates were significantly lower in the BP SES cohort, including significant differences in both target vessel non-Q-wave and Q-wave MI. Yet beyond 1 year, a significant difference in late TLR favoring BP SES also emerged, such that the superiority of the composite TLF endpoint is now driven by differences in both safety and efficacy outcomes. Whether these continued diverging event rates represent additional benefit of very thin strut stents, observed even in prior bare-metal stent trials (17,18), and/or polymer resolution and absence of stimulus for neointimal hyperplasia and atherosclerotic disease progression that has been observed with permanent polymers (19–21), is speculative. This observation is particularly relevant given that 1-year differences in TLF and MI emerged during a period before complete polymer dissolution (an approximate 24-month period), and ST and TLR leveled after 1 year in comparison with progression with the durable-polymer, thin-strut EES. The lower incidence of MI and ST has similarly been observed with alternative bioresorbable-polymer ultrathin-strut DES yet with variable polymer degradation profiles (16). Altogether, whether the benefit observed with BP SES is isolated to a specific design feature or multifactorial, and whether the improvements in different endpoints may be attributed to selected elements of stent design, remains uncertain.
Although statistical significance was demonstrated across both composite and individual endpoints, the BIOFLOW V study was not designed as a superiority trial, and statistical power is limited for comparison of selected endpoints. As previously suggested, whether the benefit observed with this specific BP SES is isolated to a specific design feature or multifactorial remains uncertain and emphasizes that a class effect among bioresorbable polymer DES also cannot be assumed. Therefore, the results of the present study suggest a new focus for DES development relative to not only an ultrathin-strut stent design but to further elucidate the contribution of bioresorbable polymers.
Through 3 years follow-up in the randomized BIOFLOW V trial, significant differences in TLF and the individual outcomes of target vessel–related MI, ischemia-driven TLR, and late or very late ST persisted, favoring treatment with an ultrathin-strut BP SES over a contemporary-generation thin-strut DP EES. In landmark analyses, differences in late target vessel MI and TLR continued to diverge in favor of treatment with BP SES. Finally, no very late ST events occurred among patients treated with BP SES. Altogether, these findings affirm the durability of late-term comparative outcomes with this specific BP SES, revealing continued differences in both safety and efficacy endpoints. The results not only advance a standard of comparison for new DES but also direct attention to strut thickness and polymer composition as key features for iterative DES development.
WHAT IS KNOWN? Emerging evidence from randomized trials demonstrates the superiority of an ultrathin-strut BP SES compared with contemporary DES in selected patient populations and lesion subgroups.
WHAT IS NEW? Through 3-year follow-up in the randomized BIOFLOW V trial, significant differences in both TLF, target vessel–related MI, TLR, and late or very late ST persisted, favoring treatment with an ultrathin-strut BP SES over a contemporary generation thin-strut DP EES. In landmark analyses, differences in late target vessel MI and TLR continued to diverge in favor of treatment with BP SES. No very late ST events occurred among patients treated with BP SES.
WHAT IS NEXT? Extended late-term ascertainment of clinical events will further clarify the safety and effectiveness of ultrathin-strut BP SES. Further study may elucidate the relative contribution of stent design elements, for example, bioresorbable polymers and ultrathin struts.
This research was funded by Biotronik. Dr. Kandzari has received institutional research and grant support from Biotronik, Boston Scientific, Medinol, Medtronic, Orbus Neich, and Teleflex; and has received personal consulting honoraria from Biotronik, Cardiovascular Systems, and Medtronic. Dr. Koolen has received lecture and consulting fees from Medtronic; and is a proctor for Biotronik. Dr. Doros is a consultant for Pfizer, Sarepta, Novartis, Softworld, and Lipocine. Dr. Cutlip has performed contracted research (to the institution) for Medtronic and Boston Scientific. Dr. Waksman has received consulting fees from Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic, and Philips Volcano; is an advisory board member for Abbott Vascular, Amgen, Boston Scientific, Medtronic, and Philips Volcano; has received grant support from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, and Edwards Lifesciences; and is a member of the Speakers Bureau for AstraZeneca. Drs. Garcia and Bennett have received research grants from Abbott Vascular and Biotronik; and have received speaking fees from Abbott Vascular, Biotronik, Boston Scientific, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Abbreviations and Acronyms
- BP SES
- bioresorbable-polymer sirolimus-eluting stent(s)
- drug-eluting stent(s)
- DP EES
- durable-polymer everolimus-eluting stent
- myocardial infarction
- stent thrombosis
- target lesion failure
- target lesion revascularization
- Received December 4, 2019.
- Revision received February 6, 2020.
- Accepted February 19, 2020.
- 2020 The Authors
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