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Observational Study
. 2023 Feb 13;16(3):332-343.
doi: 10.1016/j.jcin.2022.09.022.

Guideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions

Kim G Smolderen  1 , Gaëlle Romain  2 , Jeremy B Provance  2 , Lindsey E Scierka  2 , Jialin Mao  3 , Phillip P Goodney  4 , Peter K Henke  5 , Art Sedrakyan  3 , Carlos Mena-Hurtado  2
Affiliations
Observational Study

Guideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions

Kim G Smolderen et al. JACC Cardiovasc Interv. .

Abstract

Background: Lack of guideline-directed medical therapy (GDMT) in patients undergoing peripheral vascular interventions (PVIs) may increase mortality and amputation risk.

Objectives: The authors sought to study the association between GDMT and mortality/amputation and to examine GDMT variability among providers and health systems.

Methods: We performed an observational study using patients in the Vascular Quality Initiative registry undergoing PVI between 2017 and 2018. Two-year all-cause mortality and major amputation data were derived from Medicare claims data. Compliance with GDMT was defined as receiving a statin, antiplatelet therapy, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker if hypertensive. Propensity 1:1 matching was applied for GDMT vs no GDMT and survival analyses were performed to compare outcomes between groups.

Results: Of 15,891 patients undergoing PVIs, 48.8% received GDMT and 6,120 patients in each group were matched. Median follow-up was 9.6 (IQR: 4.5-16.2) months for mortality and 8.4 (IQR: 3.5-15.4) for amputation. Mean age was 72.0 ± 9.9 years. Mortality risk was higher among patients who did not receive GDMT versus those on GDMT (31.2% vs 24.5%; HR: 1.37, 95% CI: 1.25-1.50; P < 0.001), as well as, risk of amputation (16.0% vs 13.2%; HR: 1.20; 95% CI: 1.08-1.35; P < 0.001). GDMT rates across sites and providers ranging from 0% to 100%, with lower performance translating into higher risk.

Conclusions: Almost one-half of the patients receiving PVI in this national quality registry were not on GDMT, and this was associated with increased risk of mortality and major amputation. Quality improvement efforts in vascular care should focus on GDMT in patients undergoing PVI.

Keywords: guideline-directed medical therapy; outcomes research; peripheral artery disease; quality of care.

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Conflict of interest statement

Funding Support and Author Disclosures The VISION registry was supported by a Food and Drug Administration grant (U01FD006936). Dr Mao is supported by a K01 award by the National Heart, Lung, and Blood Institute K01HL159315-01. Dr Goodney is supported by research grants from the American Heart Association (SRFN #18SFRN33900147 and a Food and Drug Administration grant (U01FD006936). Dr Smolderen has received unrestricted research grants from Merck & Co., Shockwave Medical, and Janssen Pharmaceutical Companies of Johnson & Johnson, Philips, Abbott, Merck; and served as a consultant for Optum Labs, Happify, Tegum, and Abbott Laboratories. Dr Mena-Hurtado has received grant funding from Shockwave Medical, Philips, Abbott, and served as a consultant for Abbott Laboratories, Cook Medical, Penumbra, and Optum Labs. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.
Distributions of the Propensity Scores for No GDMT vs. GDMT (a) Before and (b) After Propensity Matching. Abbreviations: GDMT, guideline directed medical therapy.
Figure 2.
Figure 2.
Kaplan Meier Curves by Receipt of No GDMT vs. GDMT for (a) All-Cause Mortality and (b) Major Amputation in the Propensity Matched Cohort (n=12,240). Abbreviations: GDMT, guideline directed medical therapy. Cells with counts <11 are denoted by *.
Figure 3.
Figure 3.
Kaplan Meier Curves by Receipt of 0, 1, 2, or 3 elements of GDMT (a) All-Cause Mortality and (b) Major Amputation in the Propensity Matched Cohort (n=12,240). Abbreviations: GDMT, guideline directed medical therapy. Cells with counts <11 are denoted by *.
Figure 4.
Figure 4.
Variability in GDMT Rates by Sites and Providers in the Cohort Before Matching. Abbreviations: GDMT, guideline directed medical therapy.
Central Illustration.
Central Illustration.
Guideline Directed Medical Therapy (GDMT) Prescription Rates and Outcomes in Patients with Peripheral Artery Disease Undergoing Peripheral Vascular Intervention.
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