Coronary artery bypass grafting vs. drug-eluting stent implantation: the probabilities of reintervention, transition to severe care-need, nursing home, and death in patients with coronary artery disease within the first three years: evaluations based on health claims data in Germany

Introduction

Coronary artery diseases (CAD) belong to the most common diseases of the cardiovascular system and are one of the leading causes of death in aging societies due to the large increase in individuals with older age (1). Due to the high and increasing need for treatment of these diseases, numerous variants of surgical and minimally invasive intervention have been developed to minimize or end the effects of this degenerative disease. Conservative open-heart coronary artery bypass grafting (CABG) and the minimally invasive insertion of a drug-eluting stent (DES) have emerged as the dominant treatment strategies (2,3). The optimal revascularization method is a topic of ongoing debate, as it affects patients, clinicians, healthcare providers and third-party payers (4).

Currently, the incidence of CABG in Western European countries is 62/100,000, while in Germany it is 68/100,000 (5). In 2015, 50,000 CABG procedures were conducted in Germany, while more than 300,000 DES procedures were performed (6). Over time, DES have gradually replaced both CABG and other stents such as bare-metal stents due to their lower revascularization rate (7,8) and lower surgical risks and costs (9). However, the procedures are associated with different short-term and long-term complications, e.g., in terms of mortality, myocardial infarction (MI) and the need for repeated interventions of revascularization (5). Previous studies have shown lower risks of both mortality and repeated revascularization in CABG patients, particularly in the medium and long term (4,10,11). However, so far, there has largely been no study of further complications or consequences of CABG and DES interventions.

From a societal and individual perspective, it is highly relevant to consider the incurred consequences of these interventions on the quality of life of the patients and indirectly the costs for the healthcare systems, as these interventions are always associated with high costs. With increasing life-expectancy coronary artery reinterventions become ever more likely. These reinterventions are a significant survival risk factor for patients and incur high costs for the health system (12). In addition, repeat or late interventions have an impact on quality of life and the ability to live independently without family, outpatient, or institutional care needs (13).

The aim of our analysis was to explore the probability of reintervention among atherosclerotic heart disease (AHD) patients who had received DES or CABG. We differentiated by the number and the type of reintervention (fist/second/third DES or CABG) over a period of maximum three years following the initial first intervention. In addition, we investigated the procedure-specific probabilities for the need for severe long-term care, the move to a nursing home, and death. This study concentrated on transitions following an initial intervention thus deals with the short- and medium-term effects of the respective interventions. The findings yield significant aspects for future research on the underlying mechanisms and causes of procedure-related negative health outcomes. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-251/rc).

Methods

Health claims data

The study used an age-stratified random sample of 250,000 insured persons of the largest German health insurance fund, the Allgemeine Ortskrankenkassen (AOK), aged 50 and older. These registry data are available as panel data in a cohort design on a quarterly basis. In the analysis information about age, sex, quarter, year, living in a private or nursing home, severe care need, and date of death (if deceased) were added to the data on surgeries, interventions and diagnoses. The diagnosis and surgery data, in which any diagnoses and interventions for reimbursement purpose were reported by the treating physicians, are the basis for calculating the payment of physicians and hospitals. Documentation is done using the International Classification of Diseases (ICD-10) system and treatments are classified using the Operations and Procedures (OPS) coding system. Severe care need was defined as receiving benefits from the public German care insurance. Eligibility is based on a standardized medical assessment by specialists who assign care levels from 0 to 3 before 2017 and care grades from 1 to 5 after a reform of the care system in 2017. The three care levels or five care grades assess an individual’s ability to manage their daily life independently, taking into account mental, psychological, and physical impairments. Care levels are determined based on the average amount of time per day that an individual requires assistance with personal care, nutrition, mobility, and household tasks. The assessment of care grades is based on the degree of independence with regard to self-care, coping and dealing with illness and treatment-related demands and stresses, cognitive and communication skills, behavior and psychological aspects, planning day-to-day living and maintaining social contact, and mobility. A higher level of impairment is associated with a higher care level/grade (and also long-term care insurance benefits). Although all care levels and grades represent increasingly severe significant restrictions on independent living and the need for support, we defined severe care need as care level 3 for the years prior to 2017 and as grades from 4 to 5 from 2017. The rationale for the restriction was that individuals with coronary interventions are generally older and therefore were at risk of needing care already before the procedure. In addition, the severe care need places an enormous burden on the affected person, family members, and the health care system. Admission to a nursing home is also officially recorded, as it is accompanied by a claim to benefits from the health insurance system.

Analysis sample and operationalization

Longitudinal health claims data from 2014 to 2019 were used to identify AHD patients at the time of the first procedure. Among them, 9,573 had an initial first DES procedure and 2,008 an initial first CABG reported and billed by their health insurer. AHD was defined by ICD I25.10-I25.19, DES by OPS 8-837.m and open surgical bypass, defined as creation of an aortocoronary bypass, by OPS 5-361, 5-362. Severe care need or admission to a nursing home were defined as new events after an intervention if they were not already reported in the quarter of the respective intervention.

Estimation of probabilities of reinterventions, care need, nursing home and death

We calculated one- and three-year probabilities of reintervention (DES or CABG) and of transition into severe care need, nursing home and death, with the observation period for all patients starting with the initial first coronary intervention documented during the study period (2014–2019). The observation period ended with a follow-up intervention or transition or after the first or the third year.

We considered up to three DES procedures and one CABG procedure per individual. For individuals with a second or third procedure, the observation period started again at the time of the preceding procedure and the probability of another procedure was calculated. Thus, it was possible to reproduce complex and rare treatment courses up to the third DES procedure and the first CABG procedure. In addition, we calculated the probabilities of transition into severe care need, moving into a nursing home, and death after each reintervention (Figure 1). The events (intervention, nursing home admission, onset of need for severe care, and death) were assumed to occur in the middle of the quarter. Probabilities were estimated by logistic regression models.

Figure 1 Estimated probabilities of revascularization after 1st, 2nd and 3rd DES (green) and 1st CABG (purple) and of transition to severe care need (gray), nursing home (red) and death (yellow). DES, drug-eluting stent implantation; CABG, coronary artery bypass grafting.

Statistical analysis

To estimate the probability of reintervention, and of the transition to severe care need, nursing home or death, in a first step, logistic regression models adjusting for age and sex were specified: Yι∧=b0+b1X1i+b2X2i, where Yι∧ denotes the estimated outcome, b0 the estimated intercept and b1 and b2 the estimated slope coefficients for age in five-year age-groups and sex. Then marginal effects were determined to estimate the probabilities and their confidence intervals. In a second step, we then used direct age- and sex standardization by combining the estimated probabilities from the logistic regression models with the German population aged 50 and above in 2014. This procedure allows the sample to be aligned with the population in Germany and proved to be appropriate to making inference with the overall population (14). All calculations were performed in Stata, version 17.

Ethical statement

All analyses of this study are based on anonymized administrative claims data which never identify patients directly. As individuals are anonymous, the results presented here do not in any way affect the persons whose records were used. No ethical approval and patient consent were required. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).

Results

Descriptive overview of the study population

The study population included significantly more individuals with an initial first DES implantation (9,573 individuals) than with an initial first CABG intervention (2,008 individuals). Over time, the proportion of DES increased slightly from 79.4% in 2014 to 84.4% in 2019 (Table 1).

In both study groups (first CABG and first DES, Table 1), there were significantly more men than women, with a higher proportion of men in the CABG patients (74.5%) than in the DES patients (65.5%). The type of intervention changed with age: between the ages of 60 and 79 years, the proportion of CABG patients was higher than that of DES patients, and the reverse was true between the ages of 50 and 54 years and from the age of 80 years upwards. Over time, the proportion of CABG patients decreased, while the proportion of DES patients remained largely stable.

In the year after the initial first DES implantation (n=9,573), 1,122 (11.7%) required reintervention (Table 2). Of these, 1,056 individuals had a second DES implanted, and 66 had a first CABG. Further on, 126 transitioned to severe care need, 157 to nursing home, and 411 to death. The absolute numbers of individuals starting from second DES, third DES and first CABG were lower, which is also true of the numbers of transitions. In the first year after the second DES, 142 individuals received a third DES, 11 received a first CABG, 20 experienced severe care need, 25 moved into a nursing home, and 59 died. Among individuals with a third DES, 3 had a first CABG, 2 transitioned to severe care need, 3 to nursing home, and 11 died. Of those with a first CABG (n=2,008), 41 (2.0%) required reintervention. Of these, 34 had a first DES, 5 had a second DES, and 2 had a third DES. Twenty-seven individuals transitioned to severe care need, 49 to a nursing home, and 91 to death.

Within three years after the first intervention (Table 2), the figures increased compared to one year. Overall, 1,552 individuals (16.2%) after an initial first DES (n=9,573) and 85 individuals (4.2%) after an initial first CABG (n=2,008) received reintervention in this period. A total of 1,453 individuals with a first DES had a second DES, 99 had a first CABG, 321 experienced severe care need or transitioned to a nursing home, and 913 died. Among individuals with a second DES, 231 had a third DES, 18 had a first CABG, 46 transitioned to severe care need, 47 to nursing home, and 131 died. For those with a third DED, 3 had a first CABG, 6 transitioned to severe care need, 7 to nursing home, and 24 died. For 66 individuals, a first CABG resulted in a first DES within the first three years, for 13 in a second DES, for 6 in a third DES, for 56 in severe care need, for 67 in transition into a nursing home, and 180 died.

Thus, the results revealed different transition patterns over time depending on the initial intervention. Compared to one year after initial intervention, the figures among individuals with a first, second or third DES increased by a factor of around 1.5 for reinterventions within the first three years, and more than doubled for the other transitions. The figures after a first CABG roughly doubled when comparing reintervention outcomes, severe care need and death after one and three years, but only slightly increased for nursing home transitions (Table 2).

Probabilities of reintervention, severe care need, nursing home and death

In Table 3 and Figure 2 the age- and sex standardized probabilities one year after the entry into the prior state and three years after the entry into the prior state are shown.

Figure 2 Age- and sex standardized probabilities of experiencing a revascularization by duration from starting state (A) within one year, (B) within three years, AOK data 2014–2019. DES, drug-eluting stent implantation; CABG, coronary artery bypass grafting.

The 1-year probability of a second DES intervention in initial first DES patients was 0.42 (95% CI: 0.39; 0.45), i.e., 42% of those who had a first DES received a second DES within the first year. After a second DES, the probability of another DES procedure was 0.30 (0.21; 0.39). The probabilities of a follow-up CABG after DES were comparably low and similar for all DES patients: 0.05 (0; 0.10) after first DES, 0.05 (0; 0.16) after second DES, and 0.04 (0; 0.27) after third DES. The probability of a first DES after a first CABG was between these figures [0.14 (0.01; 0.27)]. Severe care need within the first year occurred in patients after a first DES with a probability of 0.07 (0.01; 0.12), after a second DES of 0.06 (0; 0.17), after a third DES of 0.02 (0; 0.27), and after a first CABG of 0.07 (0; 0.32). The probabilities of moving to a nursing home were slightly higher [first DES: 0.08 (0.02; 0.13), second DES: 0.06 (0; 0.18), third DES: 0.04 (0; 0.28), first CABG: 0.13 (0; 0.26)]. Death-probabilities were particularly high in patients preceding a first CABG [0.25 (0.12; 0.38)] and first DES [0.21 (0.16; 0.27)], and remarkably lower in individuals with a second [0.14 (0.02; 0.25)] and third DES [0.13 (0; 0.36)].

Within the first three years after the last procedure, the probabilities have clearly changed and mostly decreased. Compared to the first year, the probabilities of a follow-up DES (depending on the initial procedure ranging from 0.10 to 0.28), severe care need (0.03 to 0.06), transition into a nursing home (0.03 to 0.06) and death (0.11 to 0.19) have each decreased on a comparable level of 20% to 35%. Following a third DES, it became clear that there were exceptions to these patterns. The probability of severe care need [0.03 (0; 0.17)] was even slightly higher than in the first year, the probability of death was only slightly smaller [0.12 (0; 0.27)], and the probability of moving to a nursing home remained constant [0.03 (0; 0.19)]. Another exception was the 50% reduction in the probability of admission to a nursing home after a first CABG [0.06 (0; 0.15)]. Finally, the probability of receiving a follow-up first CABG decreased significantly more compared to both the first year and the other changes over time [first DES: 0.01 (0; 0.06); second DES: 0.02 (0; 0.10); third DES: 0.00 (0; 0.18)]. Therefore, the time perspective showed that the probabilities of a follow-up revascularization developed almost proportionally across the initial procedures of CABG and DES. The probabilities of adverse health outcomes, such as severe care need, moving into a nursing home, and death, decreased slightly more over time in CABG patients than in DES patients. However, CABG patients were still more likely to experience severe care need, move into a nursing home, or die, while a follow-up revascularization was much less likely in this group.

Discussion

This study investigated the complex pathways of reinterventions in patients with AHD who had received initial DES or CABG treatment. We also investigated the extent to which these (re)interventions were associated with the three health outcomes of needing severe care, moving into a nursing home and death. We found that patients are particularly vulnerable to reintervention and negative health outcomes in the first year after each intervention, and this is true for both DES and CABG reinterventions.

When comparing the advantages and disadvantages of DES revascularization versus CABG intervention, it must be carefully considered that the first DES intervention leads to a high probability of reinterventions, especially in the first year and particularly with regard to the need for a follow-up DES. In contrast, the probabilities of negative health outcomes were highest in CABG patients, both within the first and the third year after the first intervention.

It is striking that the first DES intervention in particular was associated with the highest probability of negative health outcomes, whereas the probabilities for severe care need, moving to a nursing home and death are lower after the second and third DES.

Our analysis led to five important conclusions. First, the probability of reintervention was significantly higher for repeated DES procedures than for CABG procedures. In patients with a first DES intervention, e.g., the probability of a further DES intervention was three times higher than in patients with a first CABG implantation. The found advantage of CABG over DES in terms of lower probabilities of reintervention is consistent with previous studies, also in its size (15). Our results further showed that the probability of DES reinterventions remains high until the third DES reintervention, while the probability of CABG interventions remains comparable with each DES revascularization. Interestingly, it can again be determined that a high proportion of reinterventions take place shortly after a previous intervention, i.e., within the first year (11).

Second, in the short term, the transition to severe care need was slightly less likely after a first DES intervention than after a CABG intervention. As the probability of severe care need decreased as the number of DES procedures increased, the difference between DES and CABG widened. The lowest probability of transition occurred after the third DES intervention. The advantage of DES revascularization in terms of severe care need was thus small but persisted over time.

Third, the probability of moving to a nursing home was generally slightly higher compared to developing severe care need. In the short-term DES revascularization appeared to be an advantage: the probability of transfer to a nursing home was more than 1.5-fold higher after CABG procedures than after the first DES revascularization, more than two times higher than after the second DES revascularization and more than four times higher than after the third DES revascularization. In the medium term within the first three years, however, this advantage weakened, and only remained lower for patients after a second or third DES.

Fourth, with regard to transition to severe care need and to a nursing home, it seems important to consider time dependencies. CABG and DES have been reported to increase the individual quality of life shortly after revascularization (13). However, particularly the consequences of the serious CABG procedure affect physical limitations, pain and quality of life in the short term (16), resulting in procedure-specific and time-dependent outcomes. Our results illustrate that for CABG all transition probabilities were higher within the first year than within the first three years.

Finally, mortality probabilities had the highest figures when comparing the three negative health outcomes. They were lowest in both the short and medium term after a second or third DES revascularisation, but highest after a CABG and the first DES procedure. Therefore, transition probabilities to death do not differ per se between CABG and DES, but are particularly dependent on the number of previous interventions. Earlier studies did not analyse this dependency, which might explain why we were not able to repeat their findings on procedure-specific mortality differences in favour of CABG, which, however, were reported to be quite heterogeneous (17).

To summarize, our results illustrate that from 2014 to 2019, patients suffering from CAD and treated via the dominating revascularization procedures CABG and/or DES had a considerable probability of needing a reintervention, severe care need, moving to a nursing home and death. CABG procedures had an inherent lower probability of follow-up revascularization with an increased probability of other health consequences compared to DES. Thus, the treatment success of CAD by CABG is offset by a higher probability of other adverse outcomes. In contrast, DES was more often associated with another intervention. Moreover, our results show that DES procedures were more frequent than CABG procedures. This is consistent with other studies and reflects the lower surgical risks of DES due to their minimally invasive procedure (2). Follow-up interventions after DES and CABG were largely DES procedures; the probability of a follow-up CABG after initial DES was much lower, which might reflect longer recovery times after CABG as well as high risks of repeated CABG (18). Additionally, the fact that the observed probabilities (especially with regard to the health outcomes) tended to be most comparable between first DES and (first) CABG could indicate (health) selection mechanisms into the two procedures (19). While CABG has been reported to be associated with lower rates of repeated revascularization and mortality (4,10,11) the guideline for coronary artery revascularization recommends CABG over percutaneous coronary intervention (PCI)—which includes DES—for patients with high-complexity or multivessel CAD (19). In contrast, PCI may be favored in poor candidates for surgical interventions such as CABG and in patients after previous CABG (19). Thus, treatment strategies are based on preconditions that may determine health outcomes. Additionally, further characteristics that could not be integrated into our analyses also determine post-intervention health outcomes, e.g., the number and proportion of revascularized vessels (partial vs. complete revascularization), unstable angina symptoms, body mass index, age, hypertension, physical health and mental health (20-22).

Limitations

Our results must be interpreted considering some limitations.

Firstly, the follow-up covered only three years and was shorter than in other studies (e.g., nine years in the study of Habib et al. 2015 (4), and four years in the study of Weintraub et al. 2012 (10)]. Thus, only short- and medium-term consequences and transitions after CABG and DES were observed. However, our and earlier results indicate that the first months after the procedure are most important for further health interventions (13), so that the focus on the period shortly after the initial intervention provides important implications. These could include, for example, the planning for the need for medical and nursing aftercare depending on the procedure or expected health trajectories following an intervention. Nonetheless, subsequent studies should extent the follow-up period, as studies indicate a delayed need for reintervention after CABG (20,23).

Secondly, it is crucial to consider data limitations. The health claims data only include diagnoses that are relevant for reimbursement purposes, as well as official information on severe care need and transition to a nursing home. It is important to note that recognition of severe care need in Germany is based on an official medical assessment in Germany (24), which means that transition to (severe) care need might be underestimated. Additional and in-depth information could be provided by indicators of quality of life and limitations. Furthermore, the results were adjusted for age and sex only. Information on the context (e.g., medication, success of the procedure, rehabilitation) and on the pre-surgery period (e.g., earlier interventions, severity of the CAD, additional diseases, such as diabetes, or coronary artery complexity) was not integrated. The selection into the two types of revascularization could also be influenced by the SYNTAX score (25), which should be considered in future studies. The OPS coding system only provides information about interventions and not about the underlying or accompanying disease, such as coronary anatomy details, the percentage and type of a possible ejection fraction, kidney disease, and STEMI/NSTEMI. Due to this limitation, the details of the underlying disease could not be considered. Consequently, our study was unable to analyse complex dependencies and group differences, which may vary across the intervention types and shape transitions (20). Subsequent studies on the underlying causes of postoperative differences after CABG and DES should consider these characteristics. Furthermore, it should be noted that the data do not allow for precise differentiation of the treated area. Therefore, when interpreting the results, it must be considered that “repeated revascularizations” may not necessarily refer to the same area. This may be particularly relevant in cases of staged interventions. Our study can therefore be understood as descriptive basic research. Future studies with more comprehensive data should include additional health and outcome factors, such as coronary characteristics or diabetes, that may impact both the selection of initial revascularization and post-intervention outcomes (19,26-29). A detailed description of the treatment area could also provide additional information on the course of treatment and health outcomes.

Thirdly, the detailed analysis was accompanied by a small number of cases for some of the medical diagnoses used to classify AHD, as well as for some of the transitions. Both the small number of cases and the disproportionate coding as I25.19 (unspecified AHD) prevented a differentiated consideration according to coronary anatomy, for example with regard to the subgroups within the ICD code I25.1. The study population included—among other conditions—individuals with single-vessel, two-vessel, and triple-vessel disease. These conditions differ in terms of the recommended revascularization strategy (19). In order to analyse and quantify differences depending on the type of intervention more reliably and adjusting/stratifying for additional covariates, an even larger database is needed. To analyse further outcomes after revascularization, such as major cardiac events (30,31), and to analyse post-procedure pathways, subsequent studies might consider additional data sources and apply survival analyses.

Finally, an analysis of other health outcomes was not conducted due to data limitations and the scope of this analysis. Previous findings indicate differences in short-, medium-, and long-term health outcomes after DES and CABG in terms of MI, major adverse cardiac or cerebrovascular events (MACCE), and stroke (25,29,32,33). Furthermore, periprocedural adverse events, such as bleeding complications, differ across intervention types (29). It should also be noted that, due to the focus of this study, only the probability of death after an intervention could be determined, not the underlying factors. Previous evidence suggests that, for example, total ventilation hours, left ventricular ejection fraction, and MI affect survival affect survival after CABG and DES, and differ between intervention types (34,35). It is recommended that these aspects be included in future studies in order to facilitate a more comprehensive comparison of outcomes between DES and CABG.

Strengths

Our study is—to the best of our knowledge—one of the very few with a focus on revascularization, mortality, severe care need and transition to a nursing home as a consequence of CABG and DES procedures. Both the data used and the analytic strategy allow to derive important new findings, and are the main strengths of our study.

Health claims data were used because of their function as well as because they do not have a problem of underreporting and are representative of the population. Therefore, they have important advantages over observational data and randomized controlled trials (36), and do not require subsequent propensity score matching (4,10). The method of direct standardization additionally ensured alignment between the sample and the population in Germany. Moreover, the data allowed to consider AHDs and thus followed a broader definition of heart diseases than earlier studies, which mainly focused left main CAD (15,17,37). Furthermore, the outcomes with respect to mortality, reintervention, severe care need and transition to a nursing home were also based on objective criteria and officially, routinely recorded information. Thus, only a small bias can be assumed.

Due to the longitudinal design, it is possible to examine complex transitions over a multiyear period. Compared to other studies, or analyses were based on a fixed observation and follow-up period, which allowed to analyse the different transitions in a comparative perspective. There have been high numbers of DES patients and a sufficient number of CABG patients, enabling to analyse several transitions. A particular strength lies in the differentiation of the reinterventions by type and number.

Conclusions

This is the first study to evaluate postoperative health outcomes and the need for reintervention in patients with AHD following DES or CABG. We found high rates of reintervention within the first three years, particularly after DES (up to 42% within the first year). However, the probability of reintervention was dependent on the initial revascularization method, the follow-up method, and the time frame. An initial DES was often followed by another DES. The probability of death was notable (11–25%), particularly after CABG or the first intervention of either type. The probability of transitioning to a nursing home (3–13%) and severe care need (2–7%) was generally lower, with a spike in nursing home transition within the first year after CABG (13%). Therefore, there are various outcomes following CABG and DES revascularization. These findings must be considered when evaluating intervention methods and should be followed by specific postoperative monitoring and treatment.

Acknowledgments

We are grateful to the Scientific Research Institute of the AOK, WIdO, for providing the data.

Funding: This work was supported by the Federal Ministry of Education and Research, Germany (Grant No. 03ZZ0923A).

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-251/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-251/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-251/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-251/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All analyses of this study are based on anonymized administrative claims data which never identify patients directly. As individuals are anonymous, the results presented here do not in any way affect the persons whose records were used. No ethical approval or patient consent were required. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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