Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Assessment of Microvasculature After Intervention as a Predictor of Wound Healing in Patients With Tissue Loss.

OBJECTIVES: This study investigated the correlation between vascular flow reserve (VFR) values and wound healing rate in patients with critical limb ischemia. BACKGROUND: Peripheral VFR may be useful for predicting complete wound healing after endovascular therapy (EVT). However, published reports included small numbers of patients from single centers and long-term outcomes remain unknown. METHODS: This was a prospective multicenter study that consecutively enrolled 104 patients (115 limbs) who received EVT for ischemic ulcerations. All lesions were treated with conventional balloon angioplasty. After EVT, VFR was measured using a pressure/temperature guidewire. The study endpoints were correlation between VFR values and wound healing rate at 3 months and 1 year. RESULTS: The median VFR was 2.9. A total of 110 and 104 limbs completed the 3-month and 1-year follow-up, respectively. The 3-month and 1-year wound healing rates were 49% and 76%, respectively. VFR was significantly associated with the 3-month and 1-year wound healing (p < 0.001 for both). The crude hazard ratios of VFR (per 2-fold increase) for the 3-month and 1-year wound healing were 2.6 (1.7 to 3.9) and 2.9 (2.0 to 4.2), respectively. The estimated median time to wound healing was 5.0 (3.2 to 7.2) months, 3.3 (2.8 to 4.9) months, and 2.5 (2.0 to 3.0) months, when the VFR value was 2.4, 2.9, and 3.9, respectively. CONCLUSIONS: Post-procedure VFR is significantly associated with wound healing. VFR, measured in the catheterization laboratory, is useful in clinical risk stratification for patients with critical limb ischemia after EVT. (Predictor of Wound Healing in Patients with Critical Limb Ischemia-Multicenter Prospective Study; UMIN000012746).

OCT assessment of thin-cap fibroatheroma distribution in native coronary arteries.

OBJECTIVES: We evaluated the geographic distribution of thin-cap fibroatheromas (TCFAs) in the coronary arteries using optical coherence tomography (OCT), a high-resolution imaging modality. BACKGROUND: Plaque rupture is the most frequent cause of acute myocardial infarction (AMI). It has been recognized that TCFA is the primary plaque type at the site of plaque rupture. METHODS: We performed 3-vessel OCT examinations in 55 patients: 35 AMI and 20 stable angina pectoris patients. The criteria for TCFA in an OCT image was a lipid-rich plaque with fibrotic cap thickness <65 microm. The distance between each TCFA location and the respective coronary artery ostium was measured with motorized OCT imaging pullback. The total length of all 3 coronary arteries imaged by OCT pullbacks was 82 +/- 21 mm in the left anterior descending coronary artery (LAD), 67 +/- 26 mm in the left circumflex coronary artery (LCx), and 104 +/- 32 mm in the right coronary artery (RCA). RESULTS: OCT detected 94 TCFAs in 165 coronary arteries. The minimum fibrous-cap thickness of TCFAs was 57.4 +/- 5.4 microm in AMI patients, and 55.9 +/- 7.3 microm in stable angina pectoris patients (p = 0.4). Of the total of 94 TCFAs, 28 were detected in the LAD, 18 in the LCx, and 48 in the RCA. Most LAD TCFAs were located between 0 and 30 mm from the LAD ostium (76%). Conversely, LCx and RCA TCFAs were evenly distributed throughout the entire coronary length. The clustering of the TCFAs was similar in culprit segments as compared with nonculprit segments. In AMI patients, most LAD TCFAs were distributed near side branches, mainly positioned opposite the side branch bifurcation. CONCLUSIONS: Three-vessel OCT imaging showed that TCFAs tend to cluster in predictable spots within the proximal segment of the LAD, but develop relatively evenly in the LCx and RCA arteries.