Objective

Because the treatment of intermittent claudication (IC) is elective, good short- and long-term outcomes are imperative. The objective of the present study was to examine the outcomes of endovascular management of IC reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines.

Methods

Patients undergoing peripheral vascular intervention for IC from 2004 to 2017 with complete data and >9 month follow-up were included. The primary outcome measures were IC recurrence and repeat procedures performed ≤2 years after the initial treatment.

Results

A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years.

Conclusions

Most patients treated with an endovascular approach to IC did not meet the Society for Vascular Surgery guidelines for long-term freedom from recurrent symptoms of >50% at 2 years. Many lacked preprocedure optimization of medical management. The use of atherectomy and treatment of more than two arteries were associated with poor outcomes after peripheral vascular intervention for IC, because only 32% of these patients were free from recurrent symptoms at 2 years. Even when risk factor modification is optimized before the procedure, vascular specialists should be aware of the association between atherectomy and multivessel interventions with poorer long-term outcomes and counsel patients appropriately before intervention.

Objectives

Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.

Design setting and participants

We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.

Main outcome measures

Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.

Results

Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.

Conclusions

We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

This online structured survey has demonstrated the global impact of the COVID-19 pandemic on vascular services. The majority of centres have documented marked reductions in operating and services provided to vascular patients. In the months during recovery from the resource restrictions imposed during the pandemic peaks, there will be a significant vascular disease burden awaiting surgeons. One of the most affected specialties.