T. Raymond Foley

Mid-term outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of femoropopliteal disease

To assess the intraprocedural and mid‐term outcomes of orbital atherectomy (OA) combined with drug‐coated balloon (DCB) angioplasty for the treatment of calcified femoropopliteal disease.

Antithrombotic therapy in peripheral artery disease.

Antiplatelet agents are recommended for the reduction of major adverse cardiovascular events among all patients with symptomatic peripheral artery disease. However, the optimal antiplatelet regimen and duration of therapy in peripheral artery disease (PAD) remains unclear, largely due to limited and conflicting data in this patient population. This article reviews current data on antithrombotic therapy in PAD and discusses the implications of this data for current practice and future research.

High‐Intensity Statin Therapy Is Associated With Improved Survival in Patients With Peripheral Artery Disease

Background The relative benefit of higher statin dosing in patients with peripheral artery disease has not been reported previously. We compared the effectiveness of low‐ or moderate‐intensity (LMI) versus high‐intensity (HI) statin dose on clinical outcomes in patients with peripheral artery disease. Methods and Results We reviewed patients with symptomatic peripheral artery disease who underwent peripheral angiography and/or endovascular intervention from 2006 to 2013 who were not taking other lipid‐lowering medications. HI statin use was defined as atorvastatin 40–80 mg or rosuvastatin 20–40 mg. Baseline demographics, procedural data, and outcomes were retrospectively analyzed. Among 909 patients, 629 (69%) were prescribed statins, and 124 (13.6%) were treated with HI statin therapy. Mean low‐density lipoprotein level was similar in patients on LMI versus HI (80±30 versus 87±44 mg/dL, P=0.14). Demographics including age (68±12 versus 67±10 years, P=0.25), smoking history (76% versus 80%, P=0.42), diabetes mellitus (54% versus 48%, P=0.17), and hypertension (88% versus 89%, P=0.78) were similar between groups (LMI versus HI). There was a higher prevalence of coronary artery disease (56% versus 75%, P=0.0001) among patients on HI statin (versus LMI). After propensity weighting, HI statin therapy was associated with improved survival (hazard ratio for mortality: 0.52; 95% confidence interval, 0.33–0.81; P=0.004) and decreased major adverse cardiovascular events (hazard ratio: 0.58; 95% confidence interval 0.37–0.92, P=0.02). Conclusions In patients with peripheral artery disease who were referred for peripheral angiography or endovascular intervention, HI statin therapy was associated with improved survival and fewer major adverse cardiovascular events compared with LMI statin therapy.

Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis:

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

Midterm Outcomes after Infrapopliteal Interventions in Patients with Critical Limb Ischemia Based on the TASC II Classification of Below-the-Knee Arteries

Purpose: To analyze the relationship between the new TransAtlantic Inter-Society Consensus (TASC II) infrapopliteal classification and limb outcomes among patients with critical limb ischemia (CLI). Methods: A single-center retrospective study was performed on 166 consecutive CLI patients (mean age 71 years; 113 men) undergoing endovascular treatment of 244 infrapopliteal lesions from 2006 to 2013. Patient, procedural, angiographic, and limb outcomes were compared for the new TASC A/B vs C/D classification for infrapopliteal lesions. Binary restenosis was determined by a peak systolic velocity ratio >2.0 by duplex ultrasound on follow-up at 1, 3, 6, and 12 months. Results: Seventy-two (43.4%) patients had TASC A/B lesions, while 94 (56.6%) had TASC C/D patterns of infrapopliteal disease. Baseline demographics and tissue loss (93% vs 94%, p=0.59) were similar between the groups. TASC A/B lesions were shorter (53±35 vs 170±83 mm, p<0.001), less severely stenosed (77%±24% vs 93%±14%, p<0.001), had a larger target vessel diameter (2.9±0.5 vs 2.6±0.5 mm, p<0.001), and were less frequently chronic total occlusions (24% vs 64%, p<0.001) compared with the TASC C/D group. Three-year freedom from both amputation (85% vs 67%, p=0.02) and major adverse limb events (79% vs 61%, p=0.02) were significantly higher in the TASC A/B group. Technical success rates (95% vs 80%, p<0.001) and 1-year primary patency (58% vs 51%, p=0.04) were higher in the A/B group. Overall 3-year survival was similar between the groups (96% A/B vs 88% C/D, p=0.2). Conclusion: TASC C/D infrapopliteal lesions are associated with higher amputation and major adverse limb events rates and lower primary patency compared with TASC A/B infrapopliteal lesions. Further studies are needed to assess the association between TASC C/D infrapopliteal lesions and clinical outcomes in patients with CLI.

CHAD is Dead: Pragmatic Utility of the CHA2DS2-VASc Score in Non-Valvular Atrial Fibrillation?

T he CHADS2 score and its second iteration, CHA2DS2VASc, are ubiquitous in clinical decisions pertaining to assessment of a patient’s thromboembolic risk from nonvalvular atrial fibrillation (AF). Clinicians rely on these scores when deciding whether to prescribe long-term oral anticoagulation (OAC) for AF patients, weighing the bleeding risks of OAC against the actuarial risk of an embolic stroke. However, societal guidelines have incrementally expanded indications for anticoagulant use through the addition of novel risk factors and lowering the threshold for initiation of OAC. In fact, O’Brien et al. recently demonstrated that 91% of patients with non-valvular AF now have a guideline-based indication for anticoagulation. Despite the overwhelming eligibility patients for OAC, a recent retrospective study of patients with non-valvular AF who suffered an acute ischemic stroke demonstrated that only 16% of eligible stroke patients were receiving therapeutic anticoagulation. Given this background, we argue that:

Midterm Outcomes After Endovascular Intervention for Occluded vs Stenosed External Iliac Arteries

Purpose: To evaluate the association between a chronic total occlusion (CTO) and long-term outcomes among patients undergoing endovascular intervention to the external iliac artery (EIA). Methods: A 2-center retrospective study was conducted of 331 patients (mean age 64.7±12.7 years; 221 men) who underwent endovascular intervention for 481 EIA atherosclerotic lesions between 2006 and 2016. A quarter of the lesions (115, 23.9%) were CTOs. The majority of patients (184, 60.9%) were treated for claudication; 172 (38%) lesions were TransAtlantic Inter-Society Consensus type C or D. Target lesion revascularization (TLR) and major adverse limb event (MALE) rates were compared between lesions with or without an EIA CTO. A Cox proportional hazard model was subsequently developed to determine baseline variables associated with long-term outcomes after successful endovascular intervention of stented EIAs; outcomes are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The mean lesion length was longer (84 vs 50 mm, p<0.001) among patients treated for CTOs. While overall the target lesion failure rates were very low (2.8%), vessel perforation (2.7% vs 0.3%, p=0.02) and distal embolization (2.7% vs 0.9%, p=0.02) were more common in the CTO group. Among 377 successfully crossed and stented lesions (93 CTOs), the overall 1-year primary patency was 78% and secondary patency was 92%. One-year and 5-year TLR rates were 8.2% and 15.4%, respectively. CTO intervention was associated with higher 5-year TLR rates in the unadjusted analysis (HR 1.72, 95% CI 1.00 to 2.56, p=0.050), but the association did not remain significant after multivariable adjustment. Conclusion: Intervention to EIA CTOs is associated with increased intraprocedural complexity but with similar midterm outcomes, including high patency and low rates of TLR to 5 years.

Long-term outcomes after re-entry device use for recanalization of common iliac artery chronic total occlusions

To examine the impact of re‐entry device (RED) use on 1‐ and 5‐year outcomes after endovascular treatment of common iliac artery (CIA) chronic total Occlusions (CTOs).

Resuscitated sudden cardiac death due to diminutive coronary artery syndrome

Diminutive coronary artery syndrome (DCAS) refers to myocardial ischemia occurring as a consequence of coronary artery hypoplasia. DCAS was first described in 1964 in a report of 2 previously healthy men, aged 18 and 25, who suffered acute myocardial infarctions (MI) and were found on rudimentary coronary angiography to have hypoplastic right coronary arteries. Subsequent case reports have described an association between DCAS and sudden cardiac death (SCD), with postulated mechanisms of ischemiainduced or scar-mediated reentrant ventricular arrhythmia. The incidence of DCAS is unclear and, to date, antemortem clinical criteria for this disorder have not been proposed, which may lead to substantial under-diagnosis. Herein, we describe clinical and pathophysiologic features of a patient experiencing SCD owing to MI and found to have diminutive coronary arteries on angiography.

Commentary: Intravascular Ultrasound for Femoropopliteal Stenting: Can It Predict Outcomes With Current-Generation Stents?

Endovascular therapy in the femoropopliteal segment remains limited by significant rates of restenosis. Refinement of nitinol stent technology in the past decade has led to improvements in patency following femoropopliteal interventions, but rates of in-stent restenosis (ISR) remain in the range of 19% to 36% in real-world practice. More recently, the application of drug-eluting stenting (DES) in the periphery has yielded promising results. Studies with a paclitaxel-eluting stent showed a 60% reduction in restenosis rates at 1 year compared with a bare nitinol stent in moderate length (<14 cm) lesions. Despite these technological advances, ISR following femoropopliteal stenting remains a vexing problem, and as many as 20% of patients undergoing percutaneous femoropopliteal interventions will require target level revascularization due to ISR at 1 year. A variety of factors have been evaluated as potential determinants of restenosis after stent implantation. In the coronary arteries, stent underexpansion and reference vessel size have been identified as important causes of ISR. Intravascular ultrasound (IVUS), by providing cross-sectional imaging, is a method of assessing both plaque morphology and the adequacy of stent deployment in real time, and its use has been associated with reduced rates of stent thrombosis, myocardial infarction, and major adverse cardiovascular events in patients undergoing percutaneous coronary interventions. To date, there exist little data on the use of IVUS in peripheral endovascular stenting. Early studies showed that nearly half of stents used in iliac vessels were underdeployed despite a satisfactory angiographic appearance. Furthermore, the use of postprocedural IVUS in aortoiliac stenting has been associated with lower restenosis rates when compared to angiographic assessment alone. Prior studies of bare nitinol stents in the superficial femoral artery have suggested that IVUS findings of stent expansion may not influence rates of restenosis, whereas another study suggested that IVUS use was associated with lower subsequent rates of target lesion revascularization. In this issue of the JEVT, Mori et al describe the use of postprocedural IVUS in determining predictors of restenosis following DES placement in femoropopliteal lesions. The authors report the findings of a single center study involving 64 patients with de novo femoropopliteal lesions and symptomatic (Rutherford class 2 to 6) lower extremity ischemia treated with DES in the setting of background exercise and medical therapy. At 12 months, 28% of patients had evidence of restenosis by either ultrasound or quantitative angiography. Several important findings emerge from this study. First, smaller reference vessel diameter (RVD) was associated with a greater risk of restenosis in the femoropopliteal segment. This has been suggested by prior studies using angiographic assessment of vessel size, but Mori et al provide the first intravascular sonographic confirmation of this finding. Second, cross-sectional area (CSA) following stent deployment was also inversely related to patency at 1 year. The impact of RVD and CSA on restenosis may be related to the greater relative effect of neointimal hyperplasia in smaller vessels. However, stent axial symmetry index, the ratio of minimum to maximum stent CSA, was significantly lower in patients who developed restenosis. As the authors suggest, this finding may be related to stent overexpansion and associated endothelial injury predisposing to smooth muscle proliferation. It is therefore possible that chronic 582853 JETXXX10.1177/1526602815582853Journal of Endovascular TherapyFoley and Armstrong research-article2015