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
Tables
Total | Low (< 50 PCIs/yr) | Intermediate (50 - 100 PCIs/yr) | High (> 100 PCIs/yr) | P value | |
---|---|---|---|---|---|
PCI: percutaneous coronary intervention; yr: year. | |||||
Operator volume | 126 | 49 (38.9) | 47 (37.3) | 30 (23.8) | |
Hospital types | |||||
University Hospital | 21 (16.7) | 8 (16.3) | 9 (19.1) | 4 (13.3) | 0.011 |
Public General-City Hospital | 31 (24.6) | 19 (38.8) | 11 (23.4) | 1 (3.3) | |
Private General-City Hospital | 65 (51.6) | 21 (42.9) | 22 (46.8) | 22 (73.3) | |
Cardiovascular Center | 9 (7.1) | 1 (2.0) | 5 (10.6) | 3 (10.0) | |
Age distribution | |||||
Less than 31 | 6 (4.8) | 1 (2.0) | 1 (2.1) | 4 (13.3) | 0.267 |
31 - 40 | 44 (34.9) | 20 (40.8) | 17 (36.2) | 7 (23.3) | |
41 - 50 | 24 (19.0) | 10 (20.4) | 10 (21.3) | 4 (13.3) | |
51 - 60 | 39 (31.0) | 14 (28.6) | 13 (27.7) | 12 (40.0) | |
More than 60 | 13 (10.3) | 4 (8.2) | 6 (12.8) | 3 (10.0) | |
Hospital annual PCI volume | |||||
Less than 21 | 2 (1.6) | 2 (4.1) | 0 (0) | 0 (0) | < 0.001 |
21 - 50 | 4 (3.2) | 3 (6.1) | 1 (2.1) | 0 (0) | |
51 - 100 | 11 (8.7) | 9 (18.4) | 2 (4.3) | 0 (0) | |
101 - 200 | 22 (17.5) | 14 (28.6) | 3 (6.4) | 5 (16.7) | |
More than 200 | 87 (69.0) | 21 (42.9) | 41 (87.2) | 25 (83.3) | |
Hospital annual emergent/urgent PCI volume | |||||
Less than 21 | 11 (8.7) | 8 (16.3) | 2 (4.3) | 1 (3.3) | < 0.001 |
21 - 50 | 26 (20.6) | 19 (38.8) | 4 (8.5) | 3 (10.0) | |
51 - 100 | 48 (38.1) | 15 (30.6) | 22 (46.8) | 11 (36.7) | |
101 - 200 | 27 (21.4) | 6 (12.2) | 14 (29.8) | 7 (23.3) | |
More than 200 | 14 (11.1) | 1 (2.0) | 5 (10.6) | 8 (26.7) | |
Operator's PCI experience | |||||
Less than 5 yrs | 16 (12.7) | 11 (22.4) | 2 (4.3) | 3 (10.0) | 0.122 |
5 - 10 yrs | 25 (19.8) | 9 (18.4) | 13 (27.7) | 3 (10.0) | |
11 - 20 yrs | 57 (45.2) | 18 (36.7) | 23 (48.9) | 16 (53.3) | |
21 - 30 yrs | 26 (20.6) | 11 (22.4) | 8 (17.0) | 7 (23.1) | |
More than 30 yrs | 2 (1.6) | 0 (0) | 1 (2.1) | 1 (3.3) | |
Position at the hospital | |||||
President/vice president | 14 (11.1) | 4 (8.2) | 4 (8.5) | 6 (20.0) | 0.745 |
Director | 39 (31.0) | 14 (28.6) | 17 (36.2) | 8 (26.7) | |
Manager | 33 (26.2) | 13 (26.5) | 12 (25.5) | 8 (26.7) | |
Staff | 37 (29.4) | 16 (32.7) | 13 (27.7) | 8 (26.7) | |
Others | 3 (2.4) | 2 (4.1) | 1 (2.1) | 0 (0) | |
Device selection right | |||||
PCI operator | 103 (81.7) | 41 (83.7) | 39 (83.0) | 23 (76.7) | 0.789 |
Director/manager of the division | 14 (11.1) | 6 (12.2) | 4 (8.5) | 4 (13.3) | |
Device dependent | 9 (7.1) | 2 (4.1) | 4 (8.5) | 3 (10.0) |
Total | Low (< 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-EES | 126 | 49 | 47 | 30 | |
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-EES | 126 | 49 | 47 | 30 | |
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) | |
ZES | 126 | 49 | 47 | 30 | |
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-SES | 126 | 49 | 47 | 30 | |
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-SES | 126 | 49 | 47 | 30 | |
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) | |
BCS | 126 | 49 | 47 | 30 | |
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) | |
DTS | 126 | 49 | 47 | 30 | |
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) |
Classifications | Variables that affect DES selection criteria | Low-volume operator | Intermediate-volume operator | High-volume operator | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
OR | 95% CI | P value | OR | 95% CI | P value | OR | 95% CI | P value | |||||
Lower | Upper | Lower | Upper | Lower | Upper | ||||||||
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 criteria | Evidence focus | 0.365 | 0.109 | 1.223 | 0.102 | 1.933 | 0.711 | 5.256 | 0.197 | 1.156 | 0.311 | 4.297 | 0.828 |
Product performance/ease of use | 2.631 | 0.866 | 7.988 | 0.088 | 0.549 | 0.211 | 1.428 | 0.219 | 0.812 | 0.228 | 2.889 | 0.748 | |
User experience | 0.941 | 0.398 | 2.223 | 0.889 | 1.931 | 0.811 | 4.596 | 0.137 | 0.412 | 0.141 | 1.201 | 0.104 | |
Patient/lesion background | 1.158 | 0.414 | 3.241 | 0.779 | 0.644 | 0.269 | 1.543 | 0.323 | 1.946 | 0.638 | 5.939 | 0.242 | |
Personal relationship with company/sales representative | 0.402 | 0.175 | 0.922 | 0.031 | 1.161 | 0.61 | 2.206 | 0.65 | 2.218 | 0.863 | 5.7 | 0.098 | |
DES brand | 1.032 | 0.418 | 2.547 | 0.945 | 0.884 | 0.435 | 1.796 | 0.733 | 1.183 | 0.399 | 3.507 | 0.762 | |
Size availability | 0.619 | 0.237 | 1.614 | 0.326 | 1.162 | 0.513 | 2.632 | 0.719 | 2.157 | 0.624 | 7.46 | 0.225 | |
Order from superiors/peers | 1.187 | 0.665 | 2.119 | 0.562 | 0.94 | 0.576 | 1.533 | 0.803 | 1.013 | 0.507 | 2.023 | 0.972 | |
DES types | CoCr-EES | 0.732 | 0.488 | 1.1 | 0.133 | 1.074 | 0.759 | 1.52 | 0.685 | 1.25 | 0.772 | 2.024 | 0.363 |
PtCr-EES | 1.123 | 0.781 | 1.614 | 0.532 | 0.733 | 0.543 | 0.991 | 0.044 | 1.098 | 0.745 | 1.62 | 0.637 | |
ZES | 0.689 | 0.48 | 0.989 | 0.043 | 0.966 | 0.705 | 1.325 | 0.831 | 1.768 | 1.131 | 2.766 | 0.012 | |
BP-SES | 0.755 | 0.513 | 1.112 | 0.155 | 1.092 | 0.782 | 1.525 | 0.605 | 1.218 | 0.783 | 1.895 | 0.381 | |
UPF-SES | 1.337 | 0.797 | 2.242 | 0.271 | 1.102 | 0.722 | 1.682 | 0.654 | 0.437 | 0.205 | 0.931 | 0.032 | |
BCS | 0.562 | 0.264 | 1.194 | 0.134 | 0.901 | 0.523 | 1.553 | 0.708 | 1.48 | 0.747 | 2.931 | 0.261 | |
DTS | 0.361 | 0.175 | 0.744 | 0.006 | 1.604 | 1.026 | 2.507 | 0.038 | 1.363 | 0.782 | 2.374 | 0.274 | |
Expectations from DES company | Provision of data | 0.691 | 0.259 | 1.849 | 0.462 | 1.518 | 0.545 | 4.225 | 0.425 | 0.827 | 0.247 | 2.768 | 0.758 |
Research and development | 2.777 | 0.75 | 10.282 | 0.126 | 0.491 | 0.176 | 1.37 | 0.174 | 0.74 | 0.153 | 3.579 | 0.708 | |
Provision of product information | 1.276 | 0.395 | 4.128 | 0.684 | 0.633 | 0.197 | 2.038 | 0.444 | 1.26 | 0.276 | 5.757 | 0.766 | |
After sales services | 0.703 | 0.267 | 1.848 | 0.474 | 1.559 | 0.672 | 3.613 | 0.301 | 1.031 | 0.304 | 3.499 | 0.961 | |
More activity support | 1.824 | 0.751 | 4.432 | 0.184 | 0.736 | 0.355 | 1.525 | 0.409 | 1.126 | 0.407 | 3.117 | 0.819 | |
Lesion affecting DES selection | Chronic total occlusion | 1.355 | 0.589 | 3.118 | 0.475 | 0.848 | 0.409 | 1.757 | 0.658 | 0.886 | 0.342 | 2.295 | 0.803 |
Calcification | 1.133 | 0.485 | 2.65 | 0.773 | 1.64 | 0.766 | 3.507 | 0.203 | 0.478 | 0.17 | 1.347 | 0.162 | |
Left-main bifurcation | 1.819 | 0.737 | 4.489 | 0.195 | 0.936 | 0.395 | 2.221 | 0.881 | 0.386 | 0.111 | 1.342 | 0.134 | |
Bending | 0.339 | 0.123 | 0.938 | 0.037 | 1.815 | 0.736 | 4.474 | 0.195 | 1.796 | 0.552 | 5.839 | 0.33 | |
Small vessel | 0.853 | 0.345 | 2.111 | 0.731 | 0.721 | 0.321 | 1.621 | 0.429 | 2.816 | 0.8 | 9.912 | 0.107 | |
Restenosis | 0.797 | 0.382 | 1.662 | 0.545 | 0.897 | 0.468 | 1.722 | 0.745 | 1.912 | 0.737 | 4.963 | 0.183 | |
Patient background influencing DES selection | Patient age | 1.786 | 0.789 | 4.044 | 0.164 | 0.854 | 0.429 | 1.696 | 0.651 | 0.63 | 0.263 | 1.51 | 0.3 |
Diabetes | 1.004 | 0.355 | 2.84 | 0.994 | 0.843 | 0.357 | 1.991 | 0.697 | 1.658 | 0.488 | 5.636 | 0.418 | |
Dialysis | 1.326 | 0.476 | 3.692 | 0.589 | 1.053 | 0.449 | 2.472 | 0.906 | 0.432 | 0.127 | 1.474 | 0.18 | |
High bleeding risk | 1.805 | 0.668 | 4.874 | 0.244 | 1.161 | 0.487 | 2.765 | 0.736 | 0.564 | 0.17 | 1.878 | 0.351 | |
Schedule for surgery | 1.096 | 0.494 | 2.433 | 0.822 | 0.725 | 0.343 | 1.533 | 0.4 | 1.443 | 0.485 | 4.298 | 0.51 | |
Acute coronary syndrome | 0.637 | 0.306 | 1.329 | 0.23 | 0.891 | 0.472 | 1.685 | 0.723 | 1.739 | 0.732 | 4.134 | 0.21 |