Clinical Outcomes of Drug-Eluting Stents vs. Bare-Metal Stents in Acute Myocardial Infarction Patients Under Dialysis　– A Nationwide Cohort Study –

Abstract

Background: Data on the cardiovascular (CV) outcomes of drug-eluting stents (DES) vs. bare-metal stents (BMS) in patients with acute myocardial infarction (AMI) under dialysis are limited.

Methods and Results: We analyzed the data from 42,592 AMI patients in the Taiwan National Health Insurance Research Database between 1 January 2007 and 31 December 2011. A total of 984 AMI patients under dialysis were selected as the study cohort. We evaluated the clinical outcomes by comparing 492 subjects who had DES to 492 matched subjects who had BMS. The primary composite outcomes, which included recurrent MI, coronary revascularization and CV death, were significantly lower in the DES group than in the BMS group (41.7% vs. 47.6%, hazard ratio (HR), 0.77; 95% confidence interval (CI), 0.63–0.92, P=0.005) after mean 1.2 years. The patients who received DES had a lower risk of recurrent MI (HR, 0.63; 95% CI, 0.45–0.90), CV death (HR, 0.74; 95% CI, 0.56–0.98) and all-cause mortality (HR, 0.74; 95% CI, 0.61–0.89) than those who used BMS, but a similar risk of major bleeding (HR, 0.99; 95% CI, 0.69–1.42, P=0.952) and ischemic stroke (HR, 1.15; 95% CI, 0.66–2.01, P=0.631).

Conclusions: Among AMI patients on dialysis undergoing percutaneous coronary interventions, DES implantation significantly reduced the risk of recurrent MI, CV death and all-cause mortality compared with BMS implantation. (Circ J 2016; 80: 363–370)

The incidence of dialysis for patients with chronic kidney disease has increased in recent years. Approximately 110,000 patients started dialysis therapy in the USA in 2008, and 800,000 prevalent patients are expected to receive dialysis in 2020.¹ For patients with endstage renal disease (ESRD) on dialysis, cardiovascular (CV) events are the most common comorbid condition. Dialysis patients are more likely to have multivessel disease with complex, total occlusion, and multiple significant coronary lesions.² Furthermore, once patients on dialysis experience acute myocardial infarction (AMI), the risk of mortality increases by more than 50% at 1 year, and the long-term survival is poor, with a 5-year survival rate of only 10%.³

Percutaneous coronary intervention has been suggested as superior to medical treatment with regard to survival of dialysis patients with coronary artery disease.⁴ However, whether the use of drug-eluting stents (DES) rather than bare-metal stents (BMS) is beneficial for dialysis patients is unclear, with inconsistent results being reported in different trials. Some studies have suggested a decreased risk of major adverse CV events with the use of DES,^5–9 while others have revealed similar clinical outcomes between DES and BMS.^10–17 Furthermore, none of the studies has focused on dialysis patients with AMI as the main study population. There are very limited data on the CV safety and efficacy of DES compared with BMS among AMI patients under dialysis. As a result, we conducted this nationwide cohort study to evaluate the efficacy and safety of DES vs. BMS with respect to CV outcomes of MI, coronary revascularization and CV death in dialysis patients with AMI.

Methods

Data Source

We conducted this nationwide population-based cohort study using the National Health Insurance Research Database (NHIRD) of Taiwan, which consists of standard computerized claims data submitted by medical institutions that seek reimbursement through the NHI program. The NHIRD has been described in previous studies.^18,19 Briefly, the NHI program covers the medical needs of more than 23 million people, representing more than 99% of the population in Taiwan. All clinical diagnoses were recorded according to the International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes. The accuracy of the diagnoses of major diseases in the claims database such as MI, stroke or chronic kidney disease has been validated.^20–22 The information and records of the patients were de-identified prior to analysis to ensure patient anonymity. This study was approved by the Ethics Institutional Review Board of Chang Gung Memorial Hospital (103-6077B).

Study Group and Cohort Definition

We identified 42,592 patients with admission for AMI (ICD-9-CM code 410) between 1 January 2007 and 31 December 2011. Only patients undergoing peritoneal dialysis or hemodialysis who underwent a coronary intervention were included in this study. ESRD was confirmed by both specific ICD-9-CM codes and inclusion in the Registry for Catastrophic Illness Patient Database, a subsection of the NHIRD. The index hospitalization was defined as the date when the patient was admitted for AMI. The follow-up period was defined as the index hospitalization to the date of death, loss of follow-up, or until December 31, 2011, whichever occurred first. The patients were classified into a DES or BMS group according to which type of stent they received. Patients who had sirolimus, everolimus, zotarolimus, biolimus or tacrolimus stents were defined as the limus-eluting stent group while those who had paclitaxel stents were in the paclitaxel-eluting stent group.

Patients were excluded if they met any of the following criteria: (1) no stent implantation during the coronary intervention or (2) received more than 1 type of stent (ie, both DES and BMS) (Figure 1).

Figure 1.

Enrollment of the study patients. Patients with AMI who were under dialysis were identified as our study cohort after relevant exclusions. AMI, acute myocardial infarction; BMS, bare metal stent; DES, drug-eluting stent.

Outcomes and Covariate Measurements

Baseline comorbidities were identified by ICD-9-CM diagnostic codes and medications prescribed during the index hospitalization. Primary outcomes were composite events of recurrent MI, coronary revascularization and CV death during the follow-up period. Coronary revascularization was defined as percutaneous coronary revascularization or coronary artery bypass surgery. Recurrent MI was defined as recurrent admissions with the primary diagnosis of MI. CV death was defined according to the criteria of the Standardized Definitions for End Point Events in Cardiovascular Trials published by the Food and Drug Administration,²³ which included death from AMI, sudden cardiac death, death from heart failure or cardiogenic shock, death from stroke, and death form other CV causes such as dysrhythmia, pulmonary embolism, aortic aneurysm rupture or peripheral arterial disease (Table S1). Death and causes of death were identified according to the registry data of the NHIRD. Other secondary outcomes of interest were deaths of any cause, ischemic stroke, hemorrhagic stroke or major bleeding. The definition of major bleeding has been described in a previous study and listed in Table S1.¹¹ The CV outcomes between the different DES groups were also analyzed.

Statistical Analysis

To minimize bias in the estimated effect, the patients who received DES were matched with those who received BMS at a 1:1 ratio using propensity scoring. The propensity score-matching algorithm was based on the nearest-neighbor method and used the caliper radius (set as 0.5 sigma), which signifies a tolerance level for the maximum distance in the propensity score. The covariates used to calculate the propensity score included the patients’ characteristics, baseline comorbidities, operative characteristics, medications during the indexed hospitalization (Table 1), and index year and month. The matching procedure was performed using SAS Version 9.3 (SAS Institute, Cary, NC, USA).

Table 1. Baseline Characteristics of the Study Patients With AMI and Stent Implantation Under Dialysis

	DES	BMS	P value
No. of patients	492	492	–
Age (years)
Median (interquartile range)	68 [60, 77]	69 [60, 77]	0.440
≥65 years	304 (61.8)	307 (62.4)	0.844
Male	297 (60.4)	299 (60.8)	0.896
Prior MI	50 (10.2)	58 (11.8)	0.415
Prior stroke	113 (23.0)	109 (22.2)	0.760
Known peripheral arterial disease	94 (19.1)	102 (20.7)	0.523
Prior PCI	124 (25.2)	131 (26.6)	0.611
Prior CABG	36 (7.3)	33 (6.7)	0.708
Comorbidities
Hypertension	446 (90.7)	447 (90.9)	0.912
Dyslipidemia	148 (30.1)	150 (30.5)	0.890
Diabetes mellitus	361 (73.4)	361 (73.4)	1.000
Previously known CAD	207 (42.1)	219 (44.5)	0.440
Heart failure	131 (26.6)	149 (30.3)	0.203
Peptic ulcer disease history	123 (25.0)	119 (24.2)	0.767
Atrial fibrillation	34 (6.9)	39 (7.9)	0.543
Gout	78 (15.9)	92 (18.7)	0.238
COPD	48 (9.8)	49 (10.0)	0.915
Malignancy	37 (7.5)	30 (6.1)	0.376
Dialysis type			0.066
Peritoneal	38 (7.7)	24 (4.9)
Hemodialysis	454 (92.3)	468 (95.1)
Dialysis duration (years)			0.252
0–2	285 (57.9)	286 (58.1)
2–4	68 (13.8)	83 (16.9)
4–6	58 (11.8)	54 (11.0)
≥6	81 (16.5)	69 (14.0)
No. of diseased vessels			0.692
1	298 (60.6)	294 (59.8)
2	165 (33.5)	174 (35.4)
3	29 (5.9)	24 (4.9)
No. of stents implanted per patient			0.459
1	314 (63.8)	294 (59.8)
2	122 (24.8)	142 (28.9)
3	43 (8.7)	40 (8.1)
≥4	13 (2.6)	16 (3.3)
Intubation	138 (28.0)	138 (28.0)	1.000
Aspiration catheter used	20 (4.1)	29 (5.9)	0.187
IABP use	64 (13.0)	70 (14.2)	0.577
Stay in intensive care unit (days)	4 (3, 9)	4 (2, 10)	0.916
Hospital stay (days)	12 (7, 24)	11 (6, 22)	0.561
Medication at discharge
Aspirin	453 (92.1)	460 (93.5)	0.388
Clopidogrel	487 (99.0)	488 (99.2)	0.738
β-blocker	367 (74.6)	362 (73.6)	0.716
ACEI/ARB	325 (66.1)	315 (64.0)	0.504
Statin	257 (52.2)	258 (52.4)	0.949
PPI	141 (28.7)	149 (30.3)	0.576
DPP4 inhibitor	25 (5.1)	32 (6.5)	0.339
Sulfonylurea	148 (30.1)	125 (25.4)	0.102
TZD	13 (2.6)	8 (1.6)	0.270
Insulin	319 (64.8)	317 (64.4)	0.894

ACEI, angiotensin-converting enzyme inhibitor; AMI, acute myocardial infarction; ARB, angiotensin receptor blocker; BMS, bare-metal stent; CABG, coronary artery bypass graft; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; DES, drug-eluting stent; DPP-4, dipeptidyl peptidase-4; IABP, intra-aortic balloon pump; PCI, percutaneous coronary intervention; PPI, proton-pump inhibitor; TZD, thiazolidinedione.

Clinical characteristics between the study groups (DES and BMS groups) were compared by chi-square test for categorical variables and the independent sample t-test for continuous variables where appropriate. The time to the first occurrence of a predefined primary or secondary outcome after the index hospitalization between the study groups was compared by Cox proportional hazard analysis with adjustment of the propensity score. The cumulative incidence of the predefined primary outcome for each study group was compared using the log-rank test (Figure S1). All data analyses were conducted using SPSS software version 22 (IBM SPSS Inc, Chicago, IL, USA).

Results

Study Patients

From January 2007 to December 2011, a total of 984 AMI patients under dialysis who also underwent percutaneous coronary interventions were identified. Of these 984 patients, 492 (50%) underwent DES implantation and 492 matched patients (50%) had BMS implantation. Among those who received a DES, 53 (10.8%) received sirolimus-eluting stents, 96 (19.5%) had everolimus-eluting stents, 170 (34.6%) had zotarolimus-eluting stents, 33 (6.7%) had biolimus-eluting stents and 140 (28.4%) had paclitaxel-eluting stents. The mean age of the overall cohort was 68.1 years (SD=11.3 years). The mean follow-up period was 1.20 years (SD=1.21 years), and the maximum follow-up period was 4.96 years. The 2 study groups were well balanced with respect to baseline characteristics, comorbidities, and medications at discharge. In total, 7.7% of the DES group and 4.9% of the BMS group received peritoneal dialysis, and 92.3% of the DES group and 95.1% of the BMS group received hemodialysis. There were no significant differences in the type and duration of dialysis between the groups. In total, 73.4% of the DES group and 73.4% of the BMS group had diabetes mellitus. There were no significant differences in the use of antidiabetic agents, including insulin, sulfonylurea, dipeptidyl peptidase-4 inhibitor or thiazolidinedione, between the DES and BMS groups. Overall, 99.0% of the DES group and 99.2% of the BMS group used clopidogrel, and 28.7% of the DES group and 30.3% of the BMS group used proton-pump inhibitors. The number of vessels that received an intervention, the number of implanted stents per patient, intra-aortic balloon pumping and intensive care unit stay were also similar between the groups (Table 1).

CV Outcomes

The primary composite outcomes of recurrent MI, coronary revascularization and CV death were significantly lower in the DES group (205 patients, 41.7%) than in the BMS group (234 patients, 47.6%) (hazard ratio (HR), 0.77; 95% confidence interval (CI), 0.63–0.92; P=0.005) after a mean follow-up period of 1.20 years (Table 2, Figure 2A). The patients who received DES had a lower risk of recurrent MI and CV death, with HRs of 0.63 (95% CI, 0.45–0.90) and 0.74 (95% CI, 0.56–0.98), respectively, compared with those who received BMS (Figures 2B,C). There was a reduced risk of coronary revascularization in the DES group at 1 year of follow-up (16.7 vs. 22.6%, P=0.002), but not at all-course follow-up (24.8 vs. 26.2%, P=0.057) (Figure 2D).

Table 2. Primary Outcomes of the Study Patients With AMI and Stent Implantation Under Dialysis After Various Follow-up Periods

Outcome	No. of events (%)		DES vs. BMS HR (95% CI)*	P value
	DES (n=492)	BMS (n=492)
30-day follow-up
Primary composite endpoint†	61 (12.4)	74 (15.0)	0.80 (0.57–1.12)	0.198
MI	13 (2.6)	16 (3.3)	0.80 (0.38–1.66)	0.547
CV death	40 (8.1)	57 (11.6)	0.68 (0.45–1.01)	0.059
Revascularization	11 (2.2)	8 (1.6)	1.33 (0.54–3.32)	0.534
1-year follow-up
Primary composite endpoint†	159 (32.3)	209 (42.5)	0.69 (0.56–0.85)	0.001
MI	38 (7.7)	66 (13.4)	0.52 (0.35–0.78)	0.001
CV death	73 (14.8)	96 (19.5)	0.72 (0.53–0.98)	0.037
Revascularization	82 (16.7)	111 (22.6)	0.64 (0.48–0.85)	0.002
All-course follow-up
Primary composite endpoint†	205 (41.7)	234 (47.6)	0.77 (0.63–0.92)	0.005
MI	57 (11.6)	77 (15.7)	0.63 (0.45–0.90)	0.010
CV death	87 (17.7)	110 (22.4)	0.74 (0.56–0.98)	0.033
Revascularization	122 (24.8)	129 (26.2)	0.79 (0.61–1.01)	0.057

*Adjusted by propensity score; ^†any 1 of MI, CV death, and coronary revascularization. CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction. Other abbreviations as in Table 1.

Figure 2.

Cumulative probability of event rates in each study group for (A) primary composite endpoint, (B) myocardial infarction, (C) cardiovascular death, and (D) coronary revascularization. The primary endpoint was a composite of myocardial infarction, cardiovascular death, and coronary revascularization, which was significantly lower in the DES group than in the BMS group after a mean of 1.20 years of follow-up. BMS, bare metal stent; DES, drug-eluting stent.

In terms of secondary outcomes, the patients who received DES had a lower risk of all-cause mortality (HR, 0.74; 95% CI, 0.61–0.89, P=0.001), but similar risks of major bleeding (HR, 0.99; 95% CI, 0.69–1.42, P=0.952) and ischemic stroke (HR, 1.15; 95% CI, 0.66–2.01, P=0.631) compared with those who received BMS (Table 3).

Table 3. Secondary Outcomes of the Study Patients With AMI and Stent Implantation Under Dialysis

	No. of events (%)		DES vs. BMS HR (95% CI)*	P value
	DES (n=492)	BMS (n=492)
Other CV outcomes
Death from any cause	197 (40.0)	241 (49.0)	0.74 (0.61–0.89)	0.001
Any CVA†	34 (6.9)	23 (4.7)	1.33 (0.78–2.25)	0.295
Ischemic stroke	28 (5.7)	22 (4.5)	1.15 (0.66–2.01)	0.631
Unspecified stroke	3 (0.6)	3 (0.6)	0.71 (0.14–3.64)	0.683
Safety outcomes
Major bleeding	62 (12.6)	56 (11.4)	0.99 (0.69–1.42)	0.952
Hemorrhagic stroke	8 (1.6)	0 (0.0)	NA	NA

*Adjusted by propensity score. ^†A discrepancy may exist between the sum of the subgroups and the total as a result of a single patient having had 2 or more strokes. CVA, cerebral vascular accident; NA, not applicable. Other abbreviations as in Tables 1,2.

DES Subgroup Outcomes

There were no significant differences in the primary composite outcomes of recurrent MI, coronary revascularization or CV death at 1 year follow-up between the limus-eluting stent group and paclitaxel-eluting stent group (P=0.087, 0.113, 0.192, and 0.196, respectively) (Table 4, Figure 3).

Table 4. DES Subgroup Analysis for Primary Outcomes of the Study Patients With AMI and Stent Implantation Under Dialysis at 1-Year Follow-up

Outcome	No. of events (%)		Limus vs. Paclitaxel HR (95% CI)*	P value
	Limus-eluting stent (n=352)	Paclitaxel-eluting stent (n=140)
Primary composite endpoint†	116 (33.0)	43 (30.7)	1.36 (0.96–1.94)	0.087
MI	30 (8.5)	8 (5.7)	1.89 (0.86–4.15)	0.113
CV death	55 (15.6)	18 (12.9)	1.42 (0.83–2.43)	0.196
Revascularization	59 (16.8)	23 (16.4)	1.38 (0.85–2.25)	0.192

*Adjusted by propensity score; ^†any 1 of MI, CV death, and coronary revascularization. Abbreviations as in Tables 1,2.

Figure 3.

Cumulative probability of event rates in DES subgroup for (A) primary composite endpoint (B) myocardial infarction, (C) cardiovascular death, and (D) coronary revascularization. There were no significant differences in the primary composite outcomes, recurrent myocardial infarction, coronary revascularization or cardiovascular death at 1 year follow-up between the 2 different types of drug-eluting stent.

Discussion

In this nationwide population-based cohort study, we found that in AMI patients on dialysis, those who received DES had a decreased risk of major CV events, including recurrent MI and CV death, than those who received BMS. Secondary outcome analysis demonstrated that there were no significant differences in the risk of major bleeding or ischemic stroke between the DES and BMS groups. To the best of our knowledge, very few studies have evaluated the efficacy of DES compared with BMS in AMI patients under dialysis. There were significant decreases in MI and CV death associated with DES compared with BMS, resulting in a number needed to treat of 24.3 for MI and 21.2 for CV death. These results provide important information on the benefits and potential risks of DES vs. BMS in treating AMI patients on dialysis. In this study, we included patients at a considerably high risk of CV events because they had AMI and were receiving dialysis. The primary composite CV event rate was more than 40% during a mean follow-up period of 1.20 years. Even though the rate of adverse events was high, we found that a significant reduction in recurrent MI, CV death and all-cause mortality were associated with the use of DES in AMI patients under dialysis.

These finding are consistent with previous studies, including a smaller population of hemodialysis patients in whom the use of DES was associated with a lower rate of major adverse cardiac events compared with the use of BMS.^7–9 Our results are also consistent with a meta-analysis that confirmed the effectiveness of DES in reducing adverse outcomes among ESRD patients.⁶ Similarly, a large-scale study including 505 Japanese hemodialysis patients as the main population reported a significantly lower rate of major adverse cardiac events in patients who received DES compared with those who received BMS. Although they failed to show beneficial effects on mortality, this was believed to be related to the small number of enrolled patients.⁵ Compared with previous reports, the present study enrolled a greater number of patients and specifically included those with recent AMI, indicating a statistically significant reduction in adverse clinical events with the use of DES in this high-risk group of patients.

Despite the widespread use of DES among hemodialysis patients, controversy remains regarding the efficacy of DES in this population. Several studies have reported no significant differences in mortality, MI or target lesion revascularization rates between patients who received DES and BMS and were under hemodialysis.^10,12,13 However, those studies are limited by small sample sizes. Tsai et al¹¹ published a study using data from the linked American College of Cardiology National Cardiovascular Data Registry to examine the efficacy of DES in older patients with chronic kidney disease. Although the use of DES was not associated with a decrease in MI or revascularization, there was a numerical lower mortality rate in the DES group compared with the BMS group (53.2% vs. 55.9%, P=0.066) among the dialysis patients. The reason for the different results between that study and ours remains unclear. However, unlike our study, which specifically included AMI patients, only 32% of the patients in Tsai et al’s study underwent coronary interventions for MI, and their patients were older (mean age, 74 years). Different severities in the patient populations may also have had an effect on the results and offset potential differences between the study groups.

Interestingly, in a meta-analysis of real-world, observational studies, the use of DES was associated with a reduction in mortality and MI compared with BMS.²⁴ Nonetheless, the superiority of DES with regard to death and MI was not found in the meta-analysis of randomized controlled trials (RCTs).²⁴ Possible explanations for these contrasting results include the greater number of patients included in the observational registries compared with the RCTs, providing much greater power to detect differences, and that observational analyses are subject to selection bias and residual confounding. In the current study of a real-world cohort of AMI patients under dialysis as the main population, the results also demonstrated a significant reduction in all-cause death and MI with the use of DES compared with BMS.

Notably, the risk of coronary revascularization for the DES group was significantly lower compared with the BMS group at 1 year, but not at all-course follow-up. Previous studies have reported late complications such as very late stent thrombosis and late catch-up phenomenon in patients after DES implantation.^25–29 Hemodialysis has also been reported to be an independent predictor of late catch-up phenomenon,³⁰ and it occurs with both paclitaxel- and sirolimus-eluting stents.³¹ Consistent with those studies, our results confirmed late catch-up phenomenon in the AMI patients under dialysis who received DES compared with those who received BMS.

Finally, there were no significant differences in the primary composite outcomes of recurrent MI, coronary revascularization or CV death at 1 year of follow-up between those who received limus- or paclitaxel-eluting stents. To date, very few studies have reported on differences in performance with different types of DES in dialysis patients. Most previous studies suggest no differences in major adverse CV events, MI or mortality between hemodialysis patients with limus- or paclitaxel-eluting stents.^32–35 However, some studies have reported similar rates of target lesion revascularization,³³ whereas others have reported decreased target vessel revascularization³² or target lesion revascularization^34,35 among patients with paclitaxel-eluting stents compared with limus-eluting stents. The exact reasons for these discrepancies remain unclear; however, different study designs, study periods, duration of limus-eluting stent implantation, and duration of dual antiplatelet therapy among the studies are possible explanations.³³ In this study, we enrolled a relatively larger population, and our findings provide important efficacy information with regard to different types of DES in AMI patients on dialysis. Further studies are warranted to elucidate this issue.

Study Limitations

First, the common confounders of patient information, such as pre-infarction angina, family history of CV disease, smoking, body mass index, lipid profile, residual renal function or dialyzer membrane type, were not included in the NHIRD. Nonetheless, we were able to include a wide range of variables related to outcomes to balance our 2 study groups. Second, previous studies have shown that stress hyperglycemia is associated with a longer hospital stay, a higher admission rate to an intensive care unit, and that it is a marker for an increased risk of mortality. However, as these data are not included in the NHIRD, we could not evaluate the glucose level at admission. Although the stay in an intensive care unit and hospital stay were similar between the 2 groups, we could not exclude the possible confounding effect of stress hyperglycemia in the current study. Third, although we analyzed repeat revascularizations, we were unable to discern the target vessel, target lesion revascularization, and different coronary revascularization. Fourth, the claims database does not include clinical information regarding stent thrombosis, angiographic characteristics and lesion classification, which may have allowed for a more detailed analysis. Finally, selection bias affecting physician decision-making of stent type may affect our findings, although we did adjust for multiple baseline differences.

Conclusions

Among AMI patients on dialysis undergoing percutaneous coronary interventions, DES implantation significantly reduced the risk of recurrent MI, CV death and all-cause mortality, but not the risk of major bleeding or ischemic stroke compared with BMS implantation. Our results suggest that DES appear to be safe and even better than BMS in AMI patients on dialysis. Our findings may help clinicians when choosing the optimal revascularization strategy for this high-risk group of people.

Acknowledgments

We thank Hsing-Fen Lin for statistical assistance.

Disclosures

The authors report no financial relationships or conflicts of interest regarding the content herein.

Supplementary Files

Supplementary File 1

Table S1. ICD-9-CM codes used for diagnosis in the current study

Figure S1. Cumulative incidence of (A) recurrent myocardial infarction and (B) cardiovascular death at 1-year of follow-up for each DES subtype.

Please find supplementary file(s);

http://dx.doi.org/10.1253/circj.CJ-15-0778

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