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Improved Quality of Life After 1 Year With an Invasive Versus a Noninvasive Treatment Strategy in Claudicants: One-Year Results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial | Journal Scan
Study Questions:
In patients with peripheral artery disease (PAD), what are the quality of life (QOL) outcomes associated with invasive versus conservative treatment?
Methods:
Unselected patients ages ≤80 years with stable intermittent claudication were randomly assigned (nonblinded) to invasive (n = 79) or noninvasive (n = 79) treatment groups at a single center in Sweden. Only six patients randomized to the noninvasive arm “crossed over” and received invasive therapy. All patients received medical management, including patient education about PAD and the importance of regular exercise, low-dose aspirin therapy, statin therapy, and cilostazol. Patients randomized to the invasive arm received endovascular intervention for all Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Artery Disease (TASC II) class A-C lesions or open repair for TASC II class D lesions. The primary endpoint was QOL assessment at 1 year using the Medical Outcomes Study Short Form-36 (SF-36) and the Vascular Quality of Life Questionnaire (VascQoL). The secondary outcome assessed was walking distance on a graded treadmill.
Results:
Patients randomized to invasive therapy reported greater improvements in SF-36 (p < 0.001) compared to the patients treated in the noninvasive arm. Patients in the invasive arm also reported larger improvements in score for the VascQoL domains focused on activities, symptoms, and emotion compared to patients in the noninvasive arm of the study. Improved walking time was greater in patients randomized to the invasive arm compared to patients randomized to the noninvasive arm (+234 m vs. +50 m, p = 0.003). Ankle-brachial index (0.85 vs. 0.69, p < 0.001) and toe pressure (81 mm Hg vs. 69 mm Hg, p = 0.01) at 1 year were higher in the invasive versus noninvasive groups. Current smoking was present in 22% of the invasive group compared to 27% of the noninvasive group.
Conclusions:
The authors concluded that an invasive strategy applying TASC II principles improves QOL and functional capacity compared to noninvasive therapy in patients with stable intermittent claudication.
Perspective:
This trial highlights the potential benefits of an invasive strategy for patients with stable intermittent claudication when combined with an aggressive medical regimen and recommendations for exercise. It is important to note that the primary outcome of this study was the patient’s self-reported QOL measures, highlighting that invasive therapies are important therapies aimed at reducing symptom burden and improving functional status. Although caution must be made when generalizing the findings from smaller, single-center, nonblinded trials, this study was very well structured with good adherence to TASC II principles, and with a strong noninvasive therapy regimen applied to all patients. Outside the setting of supervised exercise interventions, use of invasive therapy along with standard of care medical therapy for stable intermittent claudication appears to be a reasonable choice.
Keywords: Ankle Brachial Index, Aspirin, Cost of Illness, Emotions, Exercise Therapy, Intermittent Claudication, Peripheral Arterial Disease, Quality of Life, Smoking, Standard of Care, Sweden, Tetrazoles, Walking
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