Key result
Drug-eluting peripheral vascular interventions were associated with lower unadjusted in-hospital all-cause mortality (2.2% vs 2.9%, p<0.001) compared to nondrug interventions, but this difference was no longer significant after propensity matching.
Why the study?
Drug-eluting peripheral vascular interventions offer higher patency rates than nondrug devices, but recent data raised safety concerns regarding their use.
Does drug-eluting peripheral vascular intervention reduce in-hospital mortality and complications compared to nondrug intervention in patients undergoing lower extremity revascularization?
Cohort (n=49,883)
Yes
Does drug-eluting peripheral vascular intervention reduce in-hospital mortality and complications compared to nondrug intervention in patients undergoing lower extremity revascularization?
Absolute Event Rate: 2.2% vs 2.9%
p-value: p=<0.001
In a large real-world US cohort, drug-eluting peripheral vascular interventions were not associated with increased in-hospital mortality compared to nondrug interventions, supporting the short-term safety of these devices.
Supports short-term safety of drug-eluting devices; leaves open long-term efficacy questions for randomized trials.
Introduction Drug-eluting (DRUG) peripheral vascular interventions (PVIs) are associated with higher patency rates than nondrug (NONDRUG) PVIs. Recent data raised safety concerns with using DRUG devices in PVIs. Material and methods The study population was extracted from the 2016 Nationwide Readmissions Database using the International Classification of Diseases, tenth edition, clinical modifications/procedure coding system codes for PVI, DRUG and NONDRUG devices, and in-hospital procedural complications. Study endpoints included in-hospital all-cause mortality, length of index hospitalization, acute kidney injury (AKI), amputation, compartment syndrome, vascular complications, bleeding, and blood transfusion. Propensity matching was used to adjust for baseline characteristics. Results 49,883 discharged patients who underwent lower extremity arterial PVI were identified, 25.3% DRUG and 74.7% NONDRUG PVI. Mean age was 68.3 years and 40.6% were female. Critical limb ischemia was reported in 33.2%, claudication in 7.6%, and acute limb ischemia in 0.1%. In comparison to the NONDRUG group, the DRUG group was associated with lower in-hospital all-cause mortality (2.2 vs. 2.9%, p < 0.001), shorter length of index hospitalization (8.3 vs. 8.6 days, p = 0.001), bleeding (12.0% vs. 13.5%, p < 0.001), and need for blood transfusion (10.1% vs. 11.0%, p = 0.004). There was no significant difference in terms of AKI (17.3% vs. 18.0%, p = 0.10), amputation (15.3% vs. 15.4%, p = 0.63), compartment syndrome (0.5% vs. 0.6%, p = 0.07), or vascular complications (0.8% vs. 0.8%, p = 0.50). After propensity matching, the mortality benefit was no longer present. Conclusions DRUG PVI was associated with lower in-hospital all-cause mortality, bleeding events and shorter length of index hospitalization and comparable vascular-related complications. However, this mortality benefit was no longer present after propensity matching.
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Enezate et al. (2022) conducted a cohort in Peripheral arterial disease (n=49,883). Drug-eluting peripheral vascular interventions vs. Nondrug peripheral vascular interventions was evaluated on In-hospital all-cause mortality (unadjusted) (p=<0.001). Drug-eluting peripheral vascular interventions were associated with lower unadjusted in-hospital all-cause mortality (2.2% vs 2.9%, p<0.001) compared to nondrug interventions, but this difference was no longer significant after propensity matching.
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