The Use and Impact of Cilostazol on Patients Undergoing Peripheral Vascular Interventions

Abstract

Cilostazol is used for the treatment of intermittent claudication. The impact of cilostazol on the outcomes of peripheral vascular interventions (PVIs) remains controversial. This study assesses the use and impact of cilostazol on patients undergoing PVI for peripheral arterial disease (PAD). The Vascular Quality Initiative (VQI) database files for PVI were reviewed. Patients who underwent PVI for PAD were included and divided based on the use of cilostazol preoperatively. After propensity matching for patient demographics and comorbidities, the short-term and long-term outcomes of the two groups were compared. A total of 183,661 patients underwent PVI procedures, and 6.5% (n = 12,014) of them were on cilostazol preoperatively. PVI was performed for claudication in 62% (n = 6174) on cilostazol. Patients that received cilostazol were more likely to be White (77% vs 75%; P < .001) and smokers (84% vs 77%; P < .001). They were more likely to undergo balloon angioplasty (39% vs 31%; P < .001) and less likely to have diabetes mellitus (50% vs 56%; P < .001), congestive heart failure (14% vs 22%; P < .001), and prior amputation (10% vs 19%; P < .001) compared with patients who did not receive cilostazol. After 3:1 propensity matching, there were 37,304 patients included in the analysis. Patients receiving cilostazol had significantly higher incidence of dissection (3.3% vs 2.6%; P = .007) with but were more likely to be discharged home (95% vs 94%; P < .001). Patients on cilostazol had lower rates of long-term mortality (10% vs 12%; P = .003). There were no significant differences in rates of major amputation, reintervention, major adverse limb events, or patency rates after PVI (Table). Amputation-free survival rates were significantly higher for patients on cilostazol, after 4 years of follow-up (90% vs 88%; P = .03) (Fig). Cilostazol is underutilized in the VQI database and seems to be associated with improved amputation-free survival. Cilostazol therapy should be considered in all patients with PAD who can tolerate it prior to PVI.TableCharacteristics and outcomes of patients treated with PVI with and without cilostazol after propensity matchingCharacteristicsNo cilostazol, n = 27,978Cilostazol, n = 9326P-valueaSMDDemographics Age, years68 ± 1068 ± 100.015 Female sex10,108 (36)3446 (37)0.017 Race0.059White21,857 (78)7054 (76)African American4231 (15)1581 (17)Other1890 (6.8)691 (7.4) Hispanic1611 (5.8)675 (7.2) Body mass index, kg/m228.2 ± 6.128.1 ± 6 Living status0.016Nursing home/homeless492 (1.8)184 (2.0) Function0.043Independent21,987 (79)7165 (77)Assisted5248 (19)1885 (20)Non-ambulatory743 (2.7)276 (3.0)Comorbidities Hypertension25,127 (90)8433 (90)0.03 Diabetes14,279 (51)4856 (52)0.021 Smoking23,136 (83)7623 (82)0.025 Chronic obstructive pulmonary disease7489 (27)2595 (28)0.024 Congestive heart failure3764 (13)1321 (14)0.021 Cardiovascular disease4000 (14)1132 (12) Coronary artery disease9792 (35)3396 (36)0.03 Coronary artery bypass graft5464 (20)1979 (21)<.001 Percutaneous coronary intervention7195 (26)2475 (27).11 Renal status0.034Chronic kidney disease21,203 (76)6937 (74)End-stage renal disease1210 (4.3)411 (4.4) Prior lower-extremity revascularization15,927 (57)5408 (58)0.021 Prior amputation2926 (10)1054 (11).022 Prior coronary artery stenting/carotid endarterectomy2465 (8.8)852 (9.1).3 Prior aneurysm894 (3.2)190 (2.0)<.001Medications Angiotensin-converting enzyme inhibitor15,563 (56)5481 (59)<.001 Aspirin20,786 (74)7387 (79)<.001 Statin21,593 (77)7837 (84)<.001 P2Y12 inhibitors13,409 (48)4964 (53)<.001 Anticoagulation5163 (18)1441 (15)<.001Procedural characteristics Indication0.008Claudication17,384 (62)5833 (63)Chronic limb-threatening ischemia10,594 (38)3493 (37) Urgency0.055Elective25,485 (91)8344 (89)Urgent/emergent2493 (8.9)982 (11) Fluoroscopy time, minutes14 (8-22)15 (9-24)<.001OutcomesNo cilostazol, n = 16,619bCilostazol, n = 5435b Periprocedural outcomesTechnical success15,461 (95)5105 (95).9Thrombosis99 (0.6)28 (0.5).5Dissection428 (2.6)177 (3.3).007Hematoma349 (2.1)121 (2.2).6 Surgical length of stay, days2.2 ± 15.41.6 ± 7.1.052 Systemic complicationsCardiac169 (1.0)48 (0.9).4Myocardial infarction54 (0.3)13 (0.2).3Pulmonary48 (0.3)16 (0.3)>.9Renal85 (0.5)23 (0.4).4Infection13 (<0.1)3 (<0.1).8 30-day mortality122 (0.7)28 (0.5).088 Discharge status<.001Home15,537 (94)5165 (95)Rehab unit447 (2.7)104 (1.9)Others609 (3.7)157 (2.9)Long-term outcomes Follow-up time, days393 ± 183396 ± 174.2 Reintervention1971 (16)641 (15).3 Secondary patency8675 (90)3042 (91).4 Major amputation571 (4.5)166 (3.8).059 Major adverse limb events2415 (19)780 (18).13 Mortality1928 (12)550 (10).003SMD, Standardized mean differences for variables used in propensity-matching.Data are expressed as median (interquartile range), number (%), or mean ± standard deviation.Boldface P values indicates statistically significant difference for P < .05 and SMD >0.1.aWilcoxon rank sum test; Pearson χ- test.bSample numbers changed due to loss to follow-up. 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