Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry
Abstract
1. Introduction
2. Materials and Methods
2.1. Data Sources
2.2. Population
2.3. Procedures
2.4. Definitions and Study Endpoints
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Clinical Outcomes
3.3. Subgroup Analysis: Treatment Strategy and Clinical Outcomes
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| CLTI | critical limb-threatening ischemia |
| DCB | drug-coated balloon |
| DES | drug-eluting stent |
| FPA | femoropopliteal artery |
| IC | intermittent claudication |
| IPTW | inverse probability weighting |
| POBA | plain old balloon angioplasty |
| PTA | percutaneous transluminal angioplasty |
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| Crude Population | IPTW Population | |||||
|---|---|---|---|---|---|---|
| Variables Mean ± SD or n (%) | CLTI (n = 812) | Claudication (n = 1112) | SMD | CLTI (n = 1915) | Claudication (n = 2010) | SMD |
| Sex, male | 618 (76.1) | 953 (85.7) | 0.011 | 1565 (81.7) | 1642 (81.6) | 0.000 |
| Age, years | 70.3 ± 10.7 | 69.0 ± 10.3 | −0.013 | 69.1 ± 11.1 | 70.4 ± 10.9 | 0.011 |
| Body mass index, kg/m2 | 22.6 ± 3.5 | 23.6 ± 3.2 | 0.029 | 23.3 ± 3.7 | 23.1 ± 3.2 | −0.007 |
| Patient risks | ||||||
| Hypertension | 601 (74.0) | 855 (76.8) | 0.003 | 1441 (75.2) | 1464 (72.8) | −0.003 |
| Diabetes mellitus | 581 (71.5) | 672 (60.4) | −0.014 | 1266 (66.1) | 1302 (64.7) | −0.002 |
| Dyslipidemia | 422 (51.9) | 689 (61.9) | 0.013 | 1086 (56.7) | 1095 (54.4) | −0.003 |
| Chronic kidney disease | 288 (35.4) | 210 (18.8) | −0.032 | 507 (26.4) | 538 (26.7) | 0.001 |
| eGFR-MDRD | 60 ± 39 | 69 ± 33 | 0.026 | 64 ± 36 | 65 ± 37 | 0.002 |
| ESRD | 188 (23.1) | 101 (9) | −0.035 | 295 (15.4) | 272 (13.5) | −0.005 |
| COPD | 32 (3.9) | 41 (3.6) | −0.001 | 86 (4.4) | 81 (4.0) | −0.002 |
| Congestive heart failure | 54 (6.6) | 37 (3.3) | −0.015 | 90 (4.6) | 84 (4.1) | −0.002 |
| Coronary artery disease | 370 (45.5) | 606 (54.4) | 0.013 | 973 (50.8) | 975 (48.5) | −0.003 |
| Prior MI | 60 (7.3) | 92 (8.2) | 0.003 | 146 (7.6) | 154 (7.6) | 0.000 |
| Prior PCI | 198 (24.3) | 361 (32.4) | 0.015 | 580 (30.2) | 573 (28.5) | −0.003 |
| Prior CABG | 72 (8.8) | 97 (8.7) | 0.000 | 154 (8.0) | 156 (7.7) | −0.001 |
| Stroke | 166 (20.4) | 177 (15.9) | −0.011 | 346 (18.0) | 336 (16.7) | −0.003 |
| Prior PTA | 287 (35.3) | 351 (31.5) | −0.007 | 646 (33.7) | 650 (32.3) | −0.002 |
| Smoking | 195 (24.0) | 331 (29.7) | 0.011 | 559 (29.1) | 517 (25.7) | −0.007 |
| Laboratory findings | ||||||
| Glucose levels, mg/dL | 152 ± 82 | 145 ± 74 | −0.010 | 148 ± 77 | 150 ± 81 | 0.003 |
| Glycated hemoglobin, % | 7.7 ± 5.7 | 7.5 ± 5.7 | −0.004 | 7.5 ± 4.3 | 7.4 ± 4.6 | −0.002 |
| Creatinine levels, mg/dL | 2.26 ± 2.53 | 1.61 ± 2.05 | −0.028 | 1.93 ± 2.25 | 1.88 ± 2.28 | −0.002 |
| Hemoglobin levels, mg/dL | 11.4 ± 2.2 | 12.6 ± 3.5 | 0.041 | 12.1 ± 2.4 | 11.9 ± 3.1 | −0.006 |
| Total cholesterol levels, mg/dL | 141 ± 40 | 143 ± 39 | 0.006 | 145 ± 41 | 143 ± 39 | −0.006 |
| Triglyceride levels, mg/dL | 121 ± 76 | 139 ± 95 | 0.021 | 144 ± 129 | 130 ± 85 | −0.012 |
| HDL levels, mg/dL | 37 ± 11 | 41 ± 11 | 0.031 | 39 ± 12 | 39 ± 11 | −0.003 |
| LDL levels, mg/dL | 81 ± 32 | 79 ± 33 | −0.005 | 81 ± 32 | 80 ± 33 | −0.004 |
| Crude Population | IPTW Population | |||||
|---|---|---|---|---|---|---|
| Variables Mean ± SD or n (%) | CLTI (n = 812) | Claudication (n = 1112) | SMD | CLTI (n = 1915) | Claudication (n = 2010) | SMD |
| Angiographic and procedural characteristics | ||||||
| Limb side, Right | 395 (48.6) | 543 (48.8) | 0.000 | 956 (49.9) | 983 (48.9) | −0.001 |
| Procedural approach | ||||||
| Ipsilateral | 311 (38.3) | 260 (23.3) | −0.027 | 575 (30.0) | 589 (29.3) | −0.001 |
| Contralateral | 525 (64.6) | 888 (79.8) | 0.018 | 1410 (73.6) | 1475 (73.3) | 0.000 |
| Lesion location | ||||||
| Distal aorta | 108 (13.3) | 162 (14.5) | 0.003 | 271 (14.1) | 323 (16.0) | 0.005 |
| Common iliac artery | 108 (13.3) | 167 (15.0) | 0.005 | 271 (14.1) | 328 (16.3) | 0.006 |
| Common femoral artery | 25 (3.0) | 45 (4.0) | 0.005 | 62 (3.2) | 61 (3.0) | −0.001 |
| Superficial femoral artery | 812 (100.0) | 1112 (100.0) | - | 1915 (100.0) | 2010 (100.0) | - |
| Infra-popliteal artery | 395 (48.6) | 205 (18.4) | −0.052 | 594 (31.0) | 670 (33.3) | 0.004 |
| Anterior tibial artery | 227 (27.9) | 74 (6.6) | −0.051 | 331 (17.2) | 342 (17.0) | −0.001 |
| Posterior tibial artery | 157 (19.3) | 44 (3.9) | −0.045 | 203 (10.6) | 308 (15.3) | 0.013 |
| Peroneal artery | 110 (13.5) | 39 (3.5) | −0.034 | 148 (7.7) | 168 (8.3) | 0.002 |
| Total occlusion lesion | 394 (48.5) | 541 (48.6) | 0.000 | 957 (49.9) | 1000 (49.7) | 0.000 |
| Calcified lesion | 493 (60.7) | 584 (52.5) | −0.011 | 1020 (53.2) | 1124 (55.9) | 0.004 |
| Moderate/Severe calcification | 260 (32.0) | 312 (28.1) | −0.087 | 547 (28.6) | 669 (33.3) | 0.102 |
| TASC-II (A/B) | 329 (40.5) | 497 (44.7) | 0.085 | 776 (40.5) | 824 (41.0) | 0.010 |
| TASC-II (C/D) | 483 (59.5) | 615 (55.3) | −0.085 | 1139 (59.5) | 1186 (59.0) | −0.010 |
| Lesion length ≥ 150 mm | 461 (56.8) | 532 (48.1) | −0.176 | 1076 (56.3) | 1112 (55.6) | −0.014 |
| Distal runoff vessels | 2.39 (0.85) | 2.86 (0.45) | 0.069 | 2.59 (0.80) | 2.64 (0.70) | 0.007 |
| lesion stenosis, % | 89.7 ± 13.1 | 91.1 ± 11.6 | 0.011 | 90.6 ± 12.4 | 90.7 ± 12.3 | 0.001 |
| Lesion diameter, mm (max) | 6.08 ± 0.9 | 6.24 ± 0.8 | 0.019 | 6.14 ± 0.87 | 6.18 ± 0.79 | 0.004 |
| Total lesion length, mm | 175 ± 105 | 163 ± 110 | −0.011 | 173 ± 104 | 173 ± 106 | 0.000 |
| Sub-intimal approach | 158 (19.4) | 160 (14.3) | −0.012 | 322 (16.8) | 306 (15.2) | −0.004 |
| Atherectomy | 86 (10.5) | 130 (11.6) | 0.003 | 224 (11.6) | 288 (14.3) | 0.007 |
| DAART | 71 (8.7) | 120 (10.7) | 0.007 | 194 (10.1) | 249 (12.3) | 0.007 |
| Lesion treatment | ||||||
| POBA only | 231 (28.4) | 215 (19.3) | −0.019 | 448 (23.3) | 451 (22.4) | −0.002 |
| BMS only | 262 (32.2) | 382 (34.3) | 0.004 | 618 (32.2) | 615 (30.5) | −0.003 |
| DCB only | 203 (25.0) | 304 (27.3) | 0.005 | 508 (26.5) | 611 (30.3) | 0.007 |
| DCB + BMS | 31 (3.8) | 71 (6.3) | 0.011 | 115 (6.0) | 99 (4.9) | −0.005 |
| DES only | 61 (7.5) | 115 (10.3) | 0.009 | 179 (9.3) | 172 (8.5) | −0.003 |
| Type of DCB | ||||||
| IN.PACT Admiral | 161 (73.9) | 261 (74.6) | 0.089 | 440 (68.8) | 472 (73.8) | 0.108 |
| Lutonix | 41 (18.8) | 38 (10.9) | −0.081 | 108 (16.9) | 97 (15.2) | −0.045 |
| Ranger | 12 (5.5) | 42 (12.0) | 0.139 | 92 (14.4) | 71 (11.1) | −0.103 |
| Crude Population | IPTW Population | |||||
|---|---|---|---|---|---|---|
| Variables Mean ± SD or n (%) | CLTI (n = 812) | Claudication (n = 1112) | p-Value | CLTI (n = 1915) | Claudication (n = 2010) | p-Value |
| Procedural outcomes | ||||||
| Residual stenosis, >30% | 17 (2.0) | 23 (2.0) | 0.969 | 27 (1.4) | 33 (1.6) | 0.554 |
| Technical success | 785 (96.6) | 1075 (96.6) | 0.998 | 1869 (97.5) | 1958 (97.4) | 0.710 |
| Ankle brachial index (ABI) | ||||||
| ABI before PTA | 0.59 ± 0.26 | 0.62 ± 0.18 | 0.019 | 0.59 ± 0.23 | 0.60 ± 0.18 | 0.155 |
| ABI after PTA | 0.87 ± 0.20 | 0.89 ± 0.17 | 0.028 | 0.87 ± 0.20 | 0.90 ± 0.16 | 0.001 |
| Procedural complications | ||||||
| Any complications | 51 (6.2) | 31 (2.7) | <0.001 | 101 (5.2) | 62 (3.0) | 0.001 |
| Bleeding | 33 (4.0) | 20 (1.7) | 0.003 | 60 (3.1) | 41 (2.0) | 0.030 |
| Vascular rupture | 15 (1.8) | 8 (0.7) | 0.025 | 33 (1.7) | 15 (0.7) | 0.005 |
| Distal embolization | 6 (0.7) | 3 (0.2) | 0.180 | 13 (0.6) | 5 (0.2) | 0.046 |
| Discharge medications | ||||||
| Aspirin | 612 (75.3) | 901 (81.0) | 0.003 | 1517 (79.2) | 1549 (77.0) | 0.103 |
| P2Y12 inhibitors | 616 (75.8) | 964 (86.6) | <0.001 | 1539 (80.3) | 1718 (85.4) | <0.001 |
| Cilostazol | 212 (26.1) | 365 (32.8) | 0.001 | 477 (24.9) | 612 (30.4) | <0.001 |
| Beraprost | 95 (11.6) | 62 (5.5) | <0.001 | 170 (8.8) | 124 (6.1) | 0.001 |
| Triflusal | 2 (0.2) | 16 (1.4) | 0.007 | 8 (0.4) | 27 (1.3) | 0.002 |
| Sarpogrelate | 3 (0.3) | 3 (0.2) | 0.702 | 6 (0.3) | 4 (0.1) | 0.539 |
| Anticoagulants | 81 (9.9) | 97 (8.7) | 0.349 | 209 (10.9) | 159 (7.9) | 0.001 |
| Warfarin | 65 (8.0) | 73 (6.5) | 0.227 | 155 (8.0) | 115 (5.7) | 0.003 |
| NOAC | 16 (1.9) | 24 (2.1) | 0.776 | 54 (2.8) | 44 (2.1) | 0.206 |
| RAS inhibitors | 332 (40.8) | 569 (51.1) | <0.001 | 832 (43.4) | 898 (44.6) | 0.438 |
| ACE inhibitors | 71 (8.7) | 121 (10.8) | 0.122 | 190 (9.9) | 195 (9.7) | 0.817 |
| ARBs | 267 (32.8) | 456 (41) | <0.001 | 657 (34.3) | 713 (35.4) | 0.444 |
| β-blockers | 276 (33.9) | 393 (35.3) | 0.539 | 682 (35.6) | 723 (35.9) | 0.816 |
| Calcium channel blockers | 275 (33.8) | 404 (36.3) | 0.264 | 663 (34.6) | 730 (36.3) | 0.272 |
| Diuretics | 157 (19.3) | 182 (16.3) | 0.091 | 358 (18.6) | 349 (17.3) | 0.278 |
| Statins | 536 (66.0) | 869 (78.1) | <0.001 | 1399 (73.0) | 1414 (70.3) | 0.060 |
| Outcomes Mean ± SD or n (%) | CLTI | Claudication | p-Value | HR [95% CI] | p-Value |
|---|---|---|---|---|---|
| Crude population | (n = 812) | (n = 1112) | |||
| Primary endpoint | 174 (21.4) | 149 (13.3) | <0.001 | 1.762 [1.385–2.242] | <0.001 |
| Any amputation | 71 (8.7) | 7 (0.6) | <0.001 | 15.12 [6.919–33.06] | <0.001 |
| Clinically driven TER | 96 (11.8) | 116 (10.4) | 0.336 | 1.151 [0.864–1.533] | 0.339 |
| Secondary endpoint | 471 (58.0) | 496 (44.6) | <0.001 | 1.715 [1.428–2.059] | <0.001 |
| Death | 107 (13.1) | 40 (3.5) | <0.001 | 4.067 [2.794–5.920] | <0.001 |
| Cardiac death | 47 (5.7) | 16 (1.4) | <0.001 | 4.208 [2.368–7.477] | <0.001 |
| Non-cardiac death | 60 (7.3) | 24 (2.1) | <0.001 | 3.617 [2.232–5.859] | <0.001 |
| Major amputation | 20 (2.4) | 2 (0.1) | <0.001 | 14.01 [3.266–60.13] | <0.001 |
| Repeated PTA | 107 (13.1) | 127 (11.4) | 0.244 | 1.177 [0.894–1.549] | 0.259 |
| Non-TER | 12 (1.4) | 11 (0.9) | 0.330 | 1.501 [0.659–3.419] | 0.397 |
| MALEs | 161 (19.8) | 132 (11.8) | <0.001 | 1.836 [1.429–2.358] | <0.001 |
| Symptom aggravation | 453 (55.7) | 477 (42.8) | <0.001 | 1.679 [1.399–2.016] | <0.001 |
| Clinical patency | 354 (43.5) | 628 (56.4) | <0.001 | 1.678 [1.398–2.014] | <0.001 |
| IPTW population | (n = 1915) | (n = 2010) | |||
| Primary endpoint | 337 (17.5) | 281 (13.9) | 0.002 | 1.314 [1.105–1.561] | 0.002 |
| Any amputation | 120 (6.2) | 17 (0.8) | <0.001 | 7.837 [4.697–13.076] | <0.001 |
| Clinically driven TER | 197 (10.2) | 211 (10.4) | 0.829 | 0.977 [0.796–1.200] | 0.834 |
| Secondary endpoint | 994 (51.9) | 907 (45.1) | <0.001 | 1.312 [1.157–1.488] | <0.001 |
| Death | 184 (9.6) | 85 (4.2) | <0.001 | 2.407 [1.846–3.138] | <0.001 |
| Cardiac death | 75 (3.9) | 33 (1.6) | <0.001 | 2.441 [1.613–3.695] | <0.001 |
| Non-cardiac death | 109 (5.6) | 51 (2.5) | <0.001 | 2.318 [1.652–3.252] | <0.001 |
| Major amputation | 34 (1.7) | 8 (0.3) | <0.001 | 4.523 [2.088–9.796] | <0.001 |
| Repeated PTA | 221 (11.5) | 229 (11.3) | 0.885 | 1.014 [0.833–1.234] | 0.920 |
| Non-TER | 26 (1.3) | 18 (0.8) | 0.169 | 1.523 [0.832–2.787] | 0.176 |
| MALEs | 318 (16.6) | 243 (12.0) | <0.001 | 1.447 [1.209–1.733] | <0.001 |
| Symptom aggravation | 956 (49.9) | 877 (43.6) | <0.001 | 1.287 [1.135–1.460] | <0.001 |
| Clinical patency | 944 (49.2) | 1120 (55.7) | <0.001 | 1.294 [1.141–1.467] | <0.001 |
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Park, S.; Sinurat, M.R.M.P.; Rha, S.-W.; Choi, B.G.; Choi, S.Y.; Choi, C.U.; Ko, Y.-G.; Choi, D.; Lee, J.-H.; Yoon, C.-H.; et al. Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry. J. Clin. Med. 2025, 14, 8919. https://doi.org/10.3390/jcm14248919
Park S, Sinurat MRMP, Rha S-W, Choi BG, Choi SY, Choi CU, Ko Y-G, Choi D, Lee J-H, Yoon C-H, et al. Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry. Journal of Clinical Medicine. 2025; 14(24):8919. https://doi.org/10.3390/jcm14248919
Chicago/Turabian StylePark, Soohyung, Markz R. M. P. Sinurat, Seung-Woon Rha, Byoung Geol Choi, Se Yeon Choi, Cheol Ung Choi, Young-Guk Ko, Donghoon Choi, Jae-Hwan Lee, Chang-Hwan Yoon, and et al. 2025. "Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry" Journal of Clinical Medicine 14, no. 24: 8919. https://doi.org/10.3390/jcm14248919
APA StylePark, S., Sinurat, M. R. M. P., Rha, S.-W., Choi, B. G., Choi, S. Y., Choi, C. U., Ko, Y.-G., Choi, D., Lee, J.-H., Yoon, C.-H., Chae, I.-H., Yu, C. W., Lee, S. W., Choi, S. H., Min, P.-K., Park, C. G., & on behalf of the K-VIS (Korean Vascular Intervention Society) Investigators. (2025). Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry. Journal of Clinical Medicine, 14(24), 8919. https://doi.org/10.3390/jcm14248919

