Reinterventions In Patients With Claudication And CLTI
Alaa Mohamedali1, Gathe Kiwan1, Tanner Kim2, Navid Gholitabar2, Mara DeTrani2, Yawei Zhang3, Haoran Zhuo3, Britt Tonnessen2, Alan Dardik2, Cassius I. Ochoa Chaar2.
1Yale School of Medicine, New Haven, CT, USA, 2Division of Vascular Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, USA, 3Division of Surgical Outcomes and Epidemiology, Department of Surgery, Yale School of Medicine, New Haven, CT, USA.
Objectives:
Patients with peripheral artery disease (PAD) present with claudication or chronic limb threatening ischemia (CLTI). CLTI patients have increased comorbidities compared to claudicants and therefore are at an elevated risk of major amputation and mortality after lower extremity revascularization (LER). However, reinterventions for claudication and CLTI have not been compared. Our hypothesis is that patients with CLTI undergo more reinterventions to sustain patency and limb salvage.
Methods:
A single-center retrospective chart review of consecutive patients undergoing lower extremity revascularization (LER) for PAD in 2013-2015 was performed. Patients were stratified based on indication for revascularization into claudication or CLTI. Patient characteristics, outcomes, and reinterventions were compared between the two groups.
Results:
There were 840 patients undergoing LER and 44% (N=367) had CLTI. Patients treated for CLTI were more likely to be smokers (p<.001), to have diabetes (p<.001), chronic renal insufficiency (p<.001), ESRD (p<.001), and cardiac disease (p<.001). CLTI patients were less likely to be on optimal medical management as reflected by decreased rate of ASAs (p<.001), ADP receptor/P2Y12 inhibitors (p<.001), and statins (p<.001) compared to patients with claudication. Not surprisingly, patients with CLTI had significantly higher major amputation (3.92% vs .22%, P<.001) and morbidity (25.89% vs 8.03%, P<.001) at 30 days. At 3 years, major amputation (15.26% vs 1.27%, P<.001) and mortality (37.88% vs 18.03%, P<.001) were significantly higher after LER for CLTI. However, the ipsilateral reintervention rate as well as the mean number of ipsilateral reinterventions were no different between the two groups. Moreover, patients with CLTI were as likely to undergo intervention on the contralateral lower extremity since there was no difference in the overall reintervention rate or mean number of reinterventions between the two groups.
Conclusions: Despite more advanced disease burden and worse outcomes after LER, patients with CLTI in this study undergo similar frequency of reinterventions compared to patients with claudication. Ipsilateral reintervention in both groups is common and occurred in approximately 40% of patients, with the average patient receiving two additional procedures in a period of three years. Thresholds for reintervention in CLTI and claudication should be defined to ensure clinical benefit.
| Claudication | CLTI | p-value | |
| N=473 | N=367 | ||
| Demographics | |||
| Age | 68.19 ± 10.03 | 69.46 ± 12.42 | 0.109 |
| Male | 298 (63.00%) | 220 (59.95%) | 0.366 |
| Smoking | <.001 | ||
| Former | 260 (55.44 %) | 167 (45.63%) | |
| Current | 159 (33.90%) | 93 (25.41%) | |
| Nonsmoker | 50 (10.66%) | 106 (28.96%) | |
| Race | <.001 | ||
| White | 387 (83.59%) | 245 (68.25%) | |
| African American | 42 (9.07%) | 73 (20.33%) | |
| Other | 34 (7.34%) | 41 (11.42%) | |
| BMI | 28.44 ± 5.86 | 28.75 ± 6.70 | 0.481 |
| Comorbidities | |||
| Diabetes | 212 (44.82%) | 243 (66.21%) | <.001 |
| Chronic renal insufficiency | 43 (9.13%) | 88 (24.11%) | <.001 |
| ESRD | 6 (1.27%) | 46 (12.53%) | <.001 |
| Hypertension | 440 (93.22%) | 321 (87.47%) | 0.004 |
| Hyperlipidemia | 377(80.04%) | 220 (59.95%) | <.001 |
| Coronary artery disease | 285 (60.25%) | 167 (45.63%) | <.001 |
| Congestive heart failure | 47 (9.94%) | 73 (19.89%) | <.001 |
| Stroke | 48 (10.17%) | 44 (11.99%) | 0.403 |
| Hypercoagulable | 3 (0.63%) | 2 (0.55%) | 1.000 |
| History of cancer | 71 (15.01%) | 58 (15.80%) | 0.752 |
| Prior endovascular intervention | 147 (31.14%) | 53 (14.44%) | <.001 |
| Prior open surgery | 63 (13.32%) | 48 (13.08%) | 0.919 |
| Serum creatinine | 1.01 ± 0.68 | 1.65 ± 1.87 | 0.944 |
| Medications | |||
| Aspirin | 393 (83.26%) | 232 (63.56%) | <.001 |
| P2Y12 inhibitor | 209 (44.19%) | 110 (29.97%) | <.001 |
| Anticoagulation | 59 (12.47%) | 69 (18.80%) | 0.011 |
| Statins | 367 (77.59%) | 238 (65.03%) | <.001 |
| 30-day outcomes | |||
| Hematoma | 6 (1.31%) | 8 (2.25%) | 0.308 |
| Pseudoaneurysm | 10 (2.18%) | 4 (1.12%) | 0.288 |
| Bleeding | 9 (1.97%) | 31 (8.73%) | <.001 |
| Wound infection | 4 (0.88%) | 26 (7.30%) | <.001 |
| Pneumonia | 2 (0.44%) | 5 (1.40%) | 0.250 |
| Urinary tract infection | 4 (0.87%) | 4 (1.13%) | 0.734 |
| Thrombosis | 3 (0.66%) | 4 (1.12%) | 0.705 |
| Deep venous thrombosis | 2 (0.44%) | 8 (2.25%) | 0.025 |
| Stroke | 0 (0.00%) | 1 (0.28%) | 0.437 |
| Acute renal failure | 1 (0.22%) | 19 (5.34%) | <.001 |
| Acute/new HD | 1 (0.22%) | 5 (1.40%) | 0.092 |
| Return to OR | 22 (4.81%) | 50 (14.08%) | <.001 |
| Major Amputation | 1 (0.22%) | 14 (3.92%) | <.001 |
| Any morbidity | 38 (8.03%) | 95 (25.89%) | <.001 |
| Mortality | 1 (0.22%) | 5 (1.40%) | 0.092 |
| Long-term outcomes | |||
| Reintervention Rate (any leg) | 282 (59.62%) | 196 (53.41%) | 0.071 |
| Mean number of reinterventions (any leg) | 2.55 ± 2.07 | 2.48 ± 2.10 | 0.752 |
| Ipsilateral reintervention rate | 186 (39.32%) | 154 (41.96%) | 0.440 |
| Mean number of ipsilateral reinterventions | 2.15 ± 1.93 | 1.99 ± 1.68 | 0.419 |
| Major amputation | 6 (1.27%) | 56 (15.26%) | <.001 |
| Mortality | 84 (18.03 %) | 136 (37.88%) | <.001 |
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