What is the clinical evidence from this study?

Study design: Observational. Population: Transcatheter Aortic Valve Replacement (TAVR) (n=27440). Intervention: Peripheral artery disease (PAD) vs. Absence of PAD. Primary outcome: 1-year mortality (transfemoral access) (HR 1.14, p=0.01).

October 1, 2017Open Access

Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes

Key Result

Peripheral artery disease in patients undergoing transfemoral TAVR was associated with higher 1-year mortality compared to those without PAD (16.8% vs 14.4%; HR 1.14; P=0.01).

Study Design

Type

Observational (n=27,440)

Multicenter

Yes

Structured PICO

Does the presence of peripheral artery disease increase the risk of 1-year adverse outcomes in patients undergoing TAVR?

Population

27,440 patients ≥65 years old undergoing transcatheter aortic valve replacement (TAVR) from 2011 to 2015 (19,660 transfemoral, 7,780 nontransfemoral) identified from the STS/TVT Registry linked to Medicare claims data.

Intervention

Presence of peripheral artery disease (PAD)

Comparator

Absence of peripheral artery disease (PAD)

Outcome

1-year adverse outcomes, including mortality, readmission, and bleedinghard clinical

Peripheral artery disease is common in TAVR patients and is associated with increased 1-year mortality, readmission, and bleeding specifically in those undergoing transfemoral access.

Main Result

Effect estimate: HR 1.14

Absolute Event Rate: 16.8% vs 14.4%

p-value: p=0.01

Abstract

Background— Peripheral artery disease (PAD) is associated with increased cardiovascular mortality, and PAD risk factors overlap with those for aortic stenosis. The prevalence and outcomes associated with PAD in a population undergoing transcatheter aortic valve replacement (TAVR) are unknown. Methods and Results— Using the Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry linked to Medicare claims data, we identified patients ≥65 years old undergoing TAVR from 2011 to 2015. We calculated hazard ratios for 1-year adverse outcomes, including mortality, readmission, and bleeding, for patients with PAD compared with those without, adjusting for baseline characteristics and postprocedure medications. Analyses were performed separately by access site (transfemoral and nontransfemoral). Of 19 660 patients undergoing transfemoral TAVR, 4810 (24.5%) had PAD; 3730 (47.9%) of 7780 patients undergoing nontransfemoral TAVR had PAD. In both groups, patients with PAD were significantly more likely to have coronary and carotid artery diseases. At 1-year follow-up, patients with PAD undergoing TAVR via transfemoral access had a higher incidence of death (16.8% versus 14.4%; adjusted hazard ratio, 1.14; P =0.01), readmission (45.5% versus 42.1%; hazard ratio, 1.11; P <0.001), and bleeding (23.1% versus 19.7%; hazard ratio, 1.18; P <0.001) compared with patients without PAD. Patients with PAD undergoing TAVR via nontransfemoral access did not have significantly higher rates of 1-year mortality or readmission compared with patients without PAD. Conclusions— PAD is common among patients undergoing commercial TAVR via transfemoral and nontransfemoral access. Among patients undergoing transfemoral TAVR, PAD is associated with a higher incidence of 1-year adverse outcomes compared with absence of PAD. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01737528.