Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
Journal website https://www.cardiologyres.org

Original Article

Volume 15, Number 3, June 2024, pages 189-197


Selection Criteria in the Era of Perfect Competition for Drug-Eluting Stents in Association With Operator Volumes: An Operator-Volume Analysis of the Selection DES Study

Figure

Figure 1.
Figure 1. The main results of Table 2. This figure represents the current drug-eluting stent market share in Japan where CoCr-EES was selected by more than 70% of respondents in different operator volumes in > 20% of their percutaneous coronary intervention (PCI) procedures. On the other hand, UPF-SES, BCS, and DTS were less likely to be selected, indicating that more than 70% of respondents select < 5% of these in their procedures. The percentage of selection by low-, intermediate-, and high-volume operators among the DESs used demonstrated no difference, except for DTS. CoCr-EES: Abbott’s Xience™ cobalt chromium everolimus-eluting stent; PtCr-EES: Boston Scientific’s Synergy™ platinum chromium everolimus-eluting stent; ZES: Medtronic’s Resolute Onyx™ zotarolimus-eluting stent; BP-SES: Terumo’s Ultimaster™ sirolimus-eluting stent with bioresorbable polymer; BCS: Biosensors’s BioFreedom™ biolimus-coated stent; UPF-SES: B.antibody-coated Combo® ISAR Neo sirolimus-eluting stent; DTS: OrbusNeich’s dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo® stent.

Tables

Table 1. Backgrounds of the Study Participant
 
TotalLow (< 50 PCIs/yr)Intermediate (50 - 100 PCIs/yr)High (> 100 PCIs/yr)P value
PCI: percutaneous coronary intervention; yr: year.
Operator volume12649 (38.9)47 (37.3)30 (23.8)
Hospital types
  University Hospital21 (16.7)8 (16.3)9 (19.1)4 (13.3)0.011
  Public General-City Hospital31 (24.6)19 (38.8)11 (23.4)1 (3.3)
  Private General-City Hospital65 (51.6)21 (42.9)22 (46.8)22 (73.3)
  Cardiovascular Center9 (7.1)1 (2.0)5 (10.6)3 (10.0)
Age distribution
  Less than 316 (4.8)1 (2.0)1 (2.1)4 (13.3)0.267
  31 - 4044 (34.9)20 (40.8)17 (36.2)7 (23.3)
  41 - 5024 (19.0)10 (20.4)10 (21.3)4 (13.3)
  51 - 6039 (31.0)14 (28.6)13 (27.7)12 (40.0)
  More than 6013 (10.3)4 (8.2)6 (12.8)3 (10.0)
Hospital annual PCI volume
  Less than 212 (1.6)2 (4.1)0 (0)0 (0)< 0.001
  21 - 504 (3.2)3 (6.1)1 (2.1)0 (0)
  51 - 10011 (8.7)9 (18.4)2 (4.3)0 (0)
  101 - 20022 (17.5)14 (28.6)3 (6.4)5 (16.7)
  More than 20087 (69.0)21 (42.9)41 (87.2)25 (83.3)
Hospital annual emergent/urgent PCI volume
  Less than 2111 (8.7)8 (16.3)2 (4.3)1 (3.3)< 0.001
  21 - 5026 (20.6)19 (38.8)4 (8.5)3 (10.0)
  51 - 10048 (38.1)15 (30.6)22 (46.8)11 (36.7)
  101 - 20027 (21.4)6 (12.2)14 (29.8)7 (23.3)
  More than 20014 (11.1)1 (2.0)5 (10.6)8 (26.7)
Operator's PCI experience
  Less than 5 yrs16 (12.7)11 (22.4)2 (4.3)3 (10.0)0.122
  5 - 10 yrs25 (19.8)9 (18.4)13 (27.7)3 (10.0)
  11 - 20 yrs57 (45.2)18 (36.7)23 (48.9)16 (53.3)
  21 - 30 yrs26 (20.6)11 (22.4)8 (17.0)7 (23.1)
  More than 30 yrs2 (1.6)0 (0)1 (2.1)1 (3.3)
Position at the hospital
  President/vice president14 (11.1)4 (8.2)4 (8.5)6 (20.0)0.745
  Director39 (31.0)14 (28.6)17 (36.2)8 (26.7)
  Manager33 (26.2)13 (26.5)12 (25.5)8 (26.7)
  Staff37 (29.4)16 (32.7)13 (27.7)8 (26.7)
  Others3 (2.4)2 (4.1)1 (2.1)0 (0)
Device selection right
  PCI operator103 (81.7)41 (83.7)39 (83.0)23 (76.7)0.789
  Director/manager of the division14 (11.1)6 (12.2)4 (8.5)4 (13.3)
  Device dependent9 (7.1)2 (4.1)4 (8.5)3 (10.0)

 

Table 2. The Use of Drug-Eluting Stent Rate in Relation to the Operator Volume
 
TotalLow (< 50 PCIs/yr)Intermediate (50 - 100 PCIs/yr)High (> 100 PCIs/yr)P value
The vertical column indicates the proportion of brand DES that the operator uses in practice. Low = less than 5%; Medium = 5-20%; High = more than 20%. DES: drug-eluting stent; CoCr-EES: Abbott’s Xience™ cobalt chromium everolimus-eluting stent; PtCr-EES: Boston Scientific’s Synergy™ platinum chromium everolimus-eluting stent; ZES: Medtronic’s Resolute Onyx™ zotarolimus-eluting stent; BP-SES: Terumo’s Ultimaster™ sirolimus-eluting stent with bioresorbable polymer; BCS: Biosensors’s BioFreedom™ biolimus-coated stent; UPF-SES: B.Braun’s Coroflex® ISAR Neo sirolimus-eluting stent; DTS: OrbusNeich’s dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo® stent; yr: year.
CoCr-EES126494730
  Low (< 5% use)11 (8.7)5 (10.2)3 (6.4)3 (10.0)0.941
  Medium (5-20% use)26 (20.6)11 (22.4)9 (19.1)6 (20.0)
  High (> 20% use)89 (70.6)33 (67.3)35 (74.5)21 (70.0)
PtCr-EES126494730
  Low (< 5% use)31 (24.6)11 (22.4)15 (31.9)5 (16.7)0.563
  Medium (5-20% use)46 (36.5)17 (34.7)17 (36.2)12 (40.0)
  High (> 20% use)49 (38.9)21 (42.9)15 (31.9)13 (43.3)
ZES126494730
  Low (< 5% use)45 (35.7)22 (44.9)16 (34.0)7 (23.3)0.192
  Medium (5-20% use)51 (40.5)17 (34.7)22 (46.8)12 (40.0)
  High (> 20% use)30 (23.8)10 (20.4)9 (19.1)11 (36.7)
BP-SES126494730
  Low (< 5% use)39 (31.0)17 (34.7)13 (27.7)9 (30.0)0.954
  Medium (5-20% use)47 (37.3)17 (34.7)18 (38.3)12 (40.0)
  High (> 20% use)40 (31.7)15 (30.6)16 (34.0)9 (30.0)
UPF-SES126494730
  Low (< 5% use)99 (78.6)41 (83.7)34 (72.3)24 (80.0)0.623
  Medium (5-20% use)20 (15.9)5 (10.2)10 (21.3)5 (16.7)
  High (> 20% use)7 (5.6)3 (6.1)3 (6.4)1 (3.3)
BCS126494730
  Low (< 5% use)110 (87.3)46 (93.9)40 (85.1)24 (80.0)0.349
  Medium (5-20% use)12 (9.5)3 (6.1)5 (10.6)4 (13.3)
  High (> 20% use)4 (3.2)0 (0)2 (4.3)2 (6.7)
DTS126494730
  Low (< 5% use)105 (83.3)47 (95.9)37 (78.7)21 (70.0)0.009
  Medium (5-20% use)16 (12.7)2 (4.1)6 (12.8)8 (26.7)
  High (> 20% use)5 (4.0)0 (0)4 (8.5)1 (3.3)

 

Table 3. Internal and External Factors that Affect the Different Operator Volume
 
ClassificationsVariables that affect DES selection criteriaLow-volume operatorIntermediate-volume operatorHigh-volume operator
OR95% CIP valueOR95% CIP valueOR95% CIP value
LowerUpperLowerUpperLowerUpper
CoCr-EES: Abbott’s Xience™ cobalt chromium everolimus-eluting stent; PtCr-EES: Boston Scientific’s Synergy™ platinum chromium everolimus-eluting stent; ZES: Medtronic’s Resolute Onyx™ zotarolimus-eluting stent; BP-SES: Terumo’s Ultimaster™ sirolimus-eluting stent with bioresorbable polymer; BCS: Biosensors’s BioFreedom™ biolimus-coated stent; UPF-SES: B.Braun’s Coroflex® ISAR Neo sirolimus-eluting stent; DTS: OrbusNeich’s dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo® stent.
Overall devise selection criteriaEvidence focus0.3650.1091.2230.1021.9330.7115.2560.1971.1560.3114.2970.828
Product performance/ease of use2.6310.8667.9880.0880.5490.2111.4280.2190.8120.2282.8890.748
User experience0.9410.3982.2230.8891.9310.8114.5960.1370.4120.1411.2010.104
Patient/lesion background1.1580.4143.2410.7790.6440.2691.5430.3231.9460.6385.9390.242
Personal relationship with company/sales representative0.4020.1750.9220.0311.1610.612.2060.652.2180.8635.70.098
DES brand1.0320.4182.5470.9450.8840.4351.7960.7331.1830.3993.5070.762
Size availability0.6190.2371.6140.3261.1620.5132.6320.7192.1570.6247.460.225
Order from superiors/peers1.1870.6652.1190.5620.940.5761.5330.8031.0130.5072.0230.972
DES typesCoCr-EES0.7320.4881.10.1331.0740.7591.520.6851.250.7722.0240.363
PtCr-EES1.1230.7811.6140.5320.7330.5430.9910.0441.0980.7451.620.637
ZES0.6890.480.9890.0430.9660.7051.3250.8311.7681.1312.7660.012
BP-SES0.7550.5131.1120.1551.0920.7821.5250.6051.2180.7831.8950.381
UPF-SES1.3370.7972.2420.2711.1020.7221.6820.6540.4370.2050.9310.032
BCS0.5620.2641.1940.1340.9010.5231.5530.7081.480.7472.9310.261
DTS0.3610.1750.7440.0061.6041.0262.5070.0381.3630.7822.3740.274
Expectations from DES companyProvision of data0.6910.2591.8490.4621.5180.5454.2250.4250.8270.2472.7680.758
Research and development2.7770.7510.2820.1260.4910.1761.370.1740.740.1533.5790.708
Provision of product information1.2760.3954.1280.6840.6330.1972.0380.4441.260.2765.7570.766
After sales services0.7030.2671.8480.4741.5590.6723.6130.3011.0310.3043.4990.961
More activity support1.8240.7514.4320.1840.7360.3551.5250.4091.1260.4073.1170.819
Lesion affecting DES selectionChronic total occlusion1.3550.5893.1180.4750.8480.4091.7570.6580.8860.3422.2950.803
Calcification1.1330.4852.650.7731.640.7663.5070.2030.4780.171.3470.162
Left-main bifurcation1.8190.7374.4890.1950.9360.3952.2210.8810.3860.1111.3420.134
Bending0.3390.1230.9380.0371.8150.7364.4740.1951.7960.5525.8390.33
Small vessel0.8530.3452.1110.7310.7210.3211.6210.4292.8160.89.9120.107
Restenosis0.7970.3821.6620.5450.8970.4681.7220.7451.9120.7374.9630.183
Patient background influencing DES selectionPatient age1.7860.7894.0440.1640.8540.4291.6960.6510.630.2631.510.3
Diabetes1.0040.3552.840.9940.8430.3571.9910.6971.6580.4885.6360.418
Dialysis1.3260.4763.6920.5891.0530.4492.4720.9060.4320.1271.4740.18
High bleeding risk1.8050.6684.8740.2441.1610.4872.7650.7360.5640.171.8780.351
Schedule for surgery1.0960.4942.4330.8220.7250.3431.5330.41.4430.4854.2980.51
Acute coronary syndrome0.6370.3061.3290.230.8910.4721.6850.7231.7390.7324.1340.21