Intraluminal vs Subintimal Drug-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Chronic Total Occlusions.

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.

Clinical Outcomes After Percutaneous Coronary Intervention in Patients With Cancer.

BACKGROUND: The aim of this study is to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with cancer.Methods and Results:Cancer screening was recommended before PCI in consecutive 1,303 patients who underwent their first PCI. By using cancer screening, cancer was diagnosed in 29 patients (2.2%). In total, 185 patients had present or a history of cancer. Patients with cancer more often suffered from non-cardiac death than those without (4.4% vs. 1.5%, P=0.006), and patients with cancer requiring ongoing therapy (n=18) more often suffered from major bleeding compared with those with recently (≤12 months) diagnosed cancer who do not have ongoing therapy (n=59) (16.7% vs. 3.4%, P=0.049). During the 1-year follow up, 25 patients (2.0%) were diagnosed as having cancer, in which 48.0% of bleeding events led to a cancer diagnosis. Patients with high bleeding risk according to the Academic Research Consortium for high bleeding risk (ARC-HBR) were associated with a greater 1-year major bleeding risk than those without high bleeding risk in patients with (7.9% vs. 0.0%, P=0.02) and without cancer (7.1% vs. 2.5%, P<0.001), respectively. CONCLUSIONS: Cancer was diagnosed in 2.2% of 1,303 unselected patients before PCI by cancer screening and in 2.0% within 1-year after PCI. Cancer was associated with a greater risk of non-cardiac death, whereas ongoing active cancer was associated with greater risk of major bleeding. ARC-HBR criteria successfully identified high-bleeding risk patients, irrespective of the presence or absence of cancer.

Drug-coated stent implantation vs. bypass surgery for in-stent occlusion after femoropopliteal stenting.

The optimal revascularization for in-stent occlusion (ISO) lesions after femoropopliteal (FP) bare-nitinol stenting has not been established. We, therefore, investigated the comparison between drug-coated stent (DCS) implantation and bypass surgery (BSX) for ISO lesions after FP bare-nitinol stenting. This study was a dual-center, observational study from January 2004 to December 2015. A total of 172 ISO lesions were observed, and after excluding 120 ISO lesions, 52 ISO lesions (50 patients; mean age, 71.0 ± 9.2 years; male, 59.6%) after FP bare-nitinol stenting were enrolled. The included patients with clinical symptoms underwent either DCS implantation (n = 28) or BSX (n = 22). The primary endpoint was recurrent in-stent restenosis (ReISR); secondary endpoints were recurrent target lesion revascularization (ReTLR), recurrent occlusion (reocclusion) and major adverse limb events (MALE), and perioperative complications (POCs), respectively. ReISR or reocclusion was defined as ISR or occlusion after TLR. Stent restenosis was defined as a peak systolic velocity ratio (PSVR) > 2.4 on a duplex scan or ≥ 50% stenosis on angiography. Graft restenosis was defined as a PSV > 300 cm/s and velocity ratio 3.5 or uniformly low PSV < 45 cm/s throughout the entire graft based on graft surveillance. The mean follow-up period was 36.6 ± 25.5 months. At 2 years, the rates of freedom from ReISR, ReTLR, and MALE were not significantly different between the DCS implantation and BSX groups (68.9% vs. 73.7%, p = 0.81; 84.7% vs. 73.7%, p = 0.45; 84.7% vs. 78.6%, p = 0.60, respectively). However, the freedom from reocclusion rate was significantly lower in the DCS implantation group (81.6% vs. 100%, p = 0.04). The occurrence of POCs was not significantly different between the DCS implantation and BSX groups (7.1% vs 4.2%, p = 1.0). Although BSX was the gold-standard therapy for ISO lesions after FP bare-nitinol stenting, DCS implantation might be a good option because the rates of freedom from ReISR, ReTLR, and MALE were similar.

Effect of Target Lesion Revascularization on Restenosis Lesions of the Superficial Femoral Artery without Recurred Symptoms after Endovascular Therapy.

AIM: This study aims to elucidate the effects of early application of target lesion revascularization (TLR) to restenosis lesions of the superficial femoral artery (SFA) without recurrence of symptoms. Despite recent improvements in endovascular therapy (EVT) for the SFA, restenosis remains to be a problem. However, restenosis is not always associated with the recurrence of limb symptoms. Although early application of TLR is not generally approved for restenosis lesions of the SFA without recurred symptoms, it is expected to contribute to long-term patency and other favorable outcomes. Nonetheless, its effectiveness remains to be determined. METHODS: We retrospectively analyzed 616 patients who developed restenosis after undergoing femoro-popliteal EVT for claudication (Rutherford category 1 to 3) due to de novo femoro-popliteal lesions between January 2010 and December 2016 at 11 centers in Japan. Recurred symptoms were defined as symptoms of the same or higher Rutherford categories than those immediately before the initial EVT. RESULTS: Of the patients, 291 (47 %) lacked recurred symptoms; 69 (24 %) underwent TLR for restenosis. After propensity matching, the risk of occlusion was determined to be not significantly different between the TLR and observation groups; the 3-year occlusion-free rate was 68 % and 62 %, respectively (P=0.84). The risk of recurring symptoms, critical limb ischemia, and all-cause death was also found to be comparable between groups. The incidence of target vessel revascularization was significantly higher in the TLR than in the observation group (1.55 [95 % confidence interval: 1.25-1.93] vs. 0.59 [0.41-0.85] per 3 person-years). CONCLUSIONS: In patients with SFA restenosis without recurred symptoms, early application of TLR showed no advantages.

Lumen Loss at 1 Year After Bare Nitinol Stent Implantation in the Superficial Femoral Artery.

PURPOSE: To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model. RESULTS: Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%). CONCLUSION: Mean LL progressed by at least 1.6 mm up to 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.

Ten-year clinical outcomes for patients undergoing lower extremity endovascular interventions.

BACKGROUND: Midterm outcomes after endovascular therapy (EVT) had been well-evaluated; however, 10-year outcomes after EVT are rarely reported. METHODS: A total of 713 patients underwent successful EVT for de novo lesions without acute limb ischemia. We divided patients according to lesion location: aortoiliac lesions only (AI group; n = 260); femoropopliteal lesions with or without aortoiliac lesions (FP group; n = 336); and below-the-knee lesions with or without other lesions (BTK group; n = 117). RESULTS: The clinical follow-up rate was 91% at 10 years. All-cause mortality was significantly higher in the BTK group (75%; P < .001) than in the AI group (54%), whereas no significant difference was observed between the FP (53%; P = .76) and AI groups. Compared with patients in the AI group, those in the FP and BTK groups more often suffered from target lesion revascularization (TLR; AI 15% vs FP 50% [P < .001] or BTK 73% [P < .001]) and non-TLR (AI 37% vs FP 49% [P = .005] or BTK 54% [P < .001]); however, after adjusting for baseline characteristics, differences in the risk of non-TLR were marginal between the FP and AI groups (adjusted hazard ratio, 1.35; 95% confidence interval, 0.99-1.84; P = .051) and BTK and AI groups (adjusted hazard ratio, 1.43; 95% confidence interval, 0.91-2.25; P = .11), respectively. CONCLUSIONS: Within 10 years after EVT, more than one-half of patients with AI or FP lesions and three-fourths of patients with BTK lesions died. Although the risk of TLR after EVT for AI lesions was relatively low, non-TLR continued to occur up to 10 years, irrespective of lesion location.

One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease.

AIM: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX. METHODS: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year. RESULTS: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group. CONCLUSION: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Spot stenting versus full coverage stenting after endovascular therapy for femoropopliteal artery lesions.

OBJECTIVE: Although spot stenting (SS) for femoropopliteal (FP) lesions has been preferred compared with full coverage stenting (FCS), which stenting strategy results in better outcomes has remained unclear in the real-world clinical setting. Therefore, we compared the clinical outcomes of SS and FCS for FP lesions using a propensity-matched analysis. METHODS: The present multicenter, retrospective study examined data from a clinical database of 1554 consecutive patients who had undergone FP endovascular therapy for symptomatic peripheral artery disease from January 2010 to December 2016. Of these patients, 1151 had undergone FP stenting. The outcome measures were primary patency and primary assisted patency obtained using propensity score matching. Interaction analysis was also performed to explore the effects of the baseline characteristics on the association between SS and primary patency. RESULTS: After propensity score matching, SS for FP lesions demonstrated a significantly lower primary patency rate compared with FCS at 3 years (29% vs 53%; P = .011). Additionally, primary assisted patency at 3 years was significantly lower in the group with SS than in the FCS group (53% vs 72%; P = .014). Interaction analysis showed that chronic total occlusion lesions, lesion location A (proximal superficial femoral artery portion), and lesion length ≥138 mm were associated with the noninferiority of SS compared with FCS for primary patency. CONCLUSIONS: The propensity-matched analysis demonstrated that primary patency and primary assisted patency at 3 years were significantly lower with SS compared with FCS for FP lesions in real-world clinical settings. The interaction analysis suggested that SS might be suited to more complex FP lesions (ie, chronic total occlusion lesions, proximal superficial femoral artery lesion, lesion length ≥138 mm).

Impact of Frailty on Clinical Outcomes in Patients With Critical Limb Ischemia.

BACKGROUND: The predictive ability of patient frailty on clinical outcomes after revascularization in patients with critical limb ischemia remains largely unknown. METHODS AND RESULTS: We enrolled 643 patients with critical limb ischemia treated with endovascular therapy (N=486) or bypass surgery (N=157) in January 2010 to January 2016, and prospectively assessed them using a 9-level clinical frailty scale (CFS). Patients were divided into 3 groups according to CFS levels: low (CFS level, 1-3; N=234), intermediate (CFS level, 4-6; N=196), and high (CFS level, 7-9; N=213) groups. Clinical follow-up rate was 95.8% at 2 years. In the low, intermediate, and high CFS groups, 2-year overall survival rates were 80.5%, 63.1%, and 49.3% (P<0.001) and amputation-free survival rates were 77.9%, 60.5%, and 46.2% (P<0.001), respectively. In multivariable analysis, higher frailty was independently associated with all-cause death (intermediate CFS group: adjusted hazard ratio, 1.64; 95% confidence interval, 1.12-2.42; P=0.01; high CFS group: adjusted hazard ratio, 2.22; 95% confidence interval, 1.52-3.23; P<0.001) and a composite of all-cause death and major amputation (intermediate CFS group: adjusted hazard ratio, 1.72; 95% confidence interval, 1.19-2.48; P=0.004; high CFS group: adjusted hazard ratio, 2.34; 95% confidence interval, 1.64-3.35; P<0.001). Frailty was also independently associated with overall survival and amputation-free survival in patients aged ≤75 and >75 years, those who underwent endovascular therapy or bypass surgery, and those with or without chronic renal failure, without significant interactions. CONCLUSIONS: Frailty was independently associated with 2-year overall survival and amputation-free survival in patients with critical limb ischemia treated with revascularization, irrespective of age, revascularization mode, and chronic renal failure status.

Exacerbated Peri-Stent Contrast Staining on Serial Angiography and Optical Coherence Tomography After Platinum-Chromium Everolimus-Eluting Stent Implantation for Infrapopliteal Artery Lesions.

Unlike coronary arteries, little is known about peri-stent contrast staining (PSS) formation after drug-eluting stent (DES) implantation for infrapopliteal arteries. Herein, we report exacerbated PSS assessed by serial angiography and optical coherence tomography (OCT) after platinum-chromium everolimus-eluting stent (PtCr-EES) implantation for infrapopliteal artery lesions. A 68-year-old women with recurrent left critical limb ischemia was admitted to our hospital. Standard endovascular techniques were performed for the popliteal artery (POP) and tibioperoneal trunk (TPT), but residual stenosis occurred. Therefore, a 4.0 × 38-mm PtCr-EES was placed from the distal POP to TPT using OCT guidance. Ten months later, the patient was referred to our hospital due to recurrent left leg rest pain. Angiography showed severe stenosis from the distal POP to the proximal site of the stent, and diffuse in-stent restenosis (ISR). At the ISR site, stent fracture and compression were observed and vessel evaginations were newly detected on OCT. At that time, good angiographic results were obtained by conventional balloon angioplasty alone. At 6 months follow-up, recurrence of ISR was suspected on duplex ultrasonography. Angiography showed no significant ISR, but PSS had markedly exacerbated from focal type to segmental type. OCT showed exacerbated vessel evagination and in-stent thrombus. The incidence and clinical impact of PSS after DES implantation in infrapopliteal artery lesions remain unclear; therefore, careful follow-up may be needed in such cases.

Pathology of Neointimal Calcification in Very Late Restenosis After Bare Metal Stent Implantation for Superficial Femoral Artery.

A 60-year-old man, who had claudication in his right limb due to total occlusion of the right superficial femoral artery, received bare metal stents. Although the bare metal stents in the superficial femoral artery did not show restenosis 5 years after stent implantation, angiography revealed significant in-stent restenosis when he developed right critical limb ischemia at 8 years post implantation. Ballooning for in-stent lesions did not result in full expansion. His right limb was amputated above the knee due to progressive limb ischemia. In the pathological findings in the superficial femoral artery, marked calcification was observed in the entire circumference of the luminal surface of the neointima. However, lipid core formation was not identified in the neointima. Although several cracks following balloon angioplasty were observed at the superficial calcified layers, injury to neointimal tissue such as compression was not observed. The neointima exhibited heavy calcification in the very late phase of in-stent restenosis after bare metal stent implantation in superficial femoral artery. Therefore, balloon angioplasty in the very late phase of in-stent restenosis potentially results in underexpansion.

Perioperative and Long-term Outcomes of Endovascular Treatment for Subclavian Artery Disease From a Large Multicenter Registry.

PURPOSE: To investigate the perioperative and long-term outcomes of endovascular therapy (EVT) for subclavian artery disease in a large-scale multicenter study. METHODS: The study analyzed the outcomes from a multicenter retrospective registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry: SCALLOP) of 718 consecutive patients with upper extremity artery disease who underwent EVT between January 2003 and December 2012 at 37 Japanese cardiovascular centers. Of the 718 patients enrolled in the registry, 162 patients were excluded, leaving 553 patients (mean 70±7 years, range 41-91; 405 men) who underwent primary EVT for de novo subclavian artery disease (560 arms). RESULTS: Procedure success was achieved in 96.8% (100% for stenoses, 91% for total occlusions). The perioperative complication rate was 9.2%. Stroke was found in 1.8%, with ipsilateral posterior infarction accounting for 0.9%. The 30-day mortality was 0.7%. The mean follow-up was 39±24 months. Primary patency estimates were 90.6%±1.3%, 83.4%±1.8%, and 80.5%±2.2% at 1, 3, and 5 years, respectively. There was no significant difference in primary patency between stenotic and occlusive lesions. Secondary patency estimates were 99.2%±0.4%, 98.2%±0.6%, and 97.7%±0.8% at 1, 3, and 5 years, respectively. The respective overall survival rates were 94.6%±1.0%, 86.8%±1.7%, and 79.0%±2.4%. There were 86 deaths during follow-up, of which half were due to cardiovascular causes. On multivariate analysis, critical hand ischemia (hazard ratio [HR] 4.6, 95% CI 2.06 to 10.2, p<0.001), cerebrovascular disease (HR 1.9, 95% CI 1.14 to 3.06, p=0.01), current smoking (HR 1.8, 95% 1.14 to 2.79, p=0.01), and lesion length (in 1-cm increments; HR 1.02, 95% CI 1.00 to 1.04, p=0.03) were negative independent predictors of primary patency, while IVUS use (HR 0.6, 95% CI 0.30 to 0.96, p=0.04) was a positive predictor of primary patency. CONCLUSION: Primary angioplasty/stenting for subclavian artery disease afforded acceptable outcomes in terms of perioperative complications and long-term patency.

Successful endovascular treatment for high take off aorto-iliac occlusive disease.

A 73-year-old man with a history of intermittent claudication for the previous six years visited our hospital. His ankle-brachial index (ABI) was very low on both sides, and computed tomography (CT) indicated bilateral aorto-iliac occlusive disease (AIOD). As he refused to undergo open surgery, endovascular treatment (EVT) was administered. After the first and second EVT sessions, the intermittent claudication improved completely. In addition, the ABI normalized (right: 1.01, left: 0.99), and CT demonstrated full expansion of the stents. His post-EVT course was uneventful for 18 months. The use of EVT to treat AIOD is technically feasible and may serve as a potential treatment option for patients with an inoperable condition.

Impact of runoff grade after endovascular therapy for femoropopliteal lesions.

BACKGROUND: We conceived a new method, runoff grade, to evaluate runoff after endovascular therapy (EVT). We evaluated the validity of using runoff score based on angiographic findings. METHODS: The subjects were 859 consecutive patients (males, 69%; mean age, 73.0 ± 9.0 years) who underwent EVT for de novo femoropopliteal lesions at Kokura Memorial Hospital. We evaluated the postprocedural tibial runoff, named it runoff grade, classified it into 0 through 2, and retrospectively assessed the relationship with the outcome of EVT. Primary, secondary, and assisted primary patency rates and freedom from major adverse limb events (MALE) were compared between runoff grades. RESULTS: The mean follow-up period was 31 ± 25 months. The lesion length was 91.5 ± 83.0 mm. The rate of stent use was 52.0%. The primary patency rates at 1, 2, and 3 years were 68.1%, 59.1%, and 53.9%; the secondary patency rates were 90.9%, 88.1%, and 85.9%; the assisted primary patency rates were 79.4%, 72.6%, and 68.5%; and freedom from MALE was 72.5%, 64.8%, and 61.0%, respectively. The primary patency rates at 1, 2, and 3 years were significantly lower in the runoff grade 0 group than in the other groups (55.5% vs 66.7% and 75.6%; 35.8% vs 57.6% and 69.2%; 35.8% vs 53.3% and 60.9% for grade 0, 1, 2, respectively; log-rank, P < .0001). Secondary patency rate (78.5% vs 91.8% and 91.8%; 76.3% vs 88.6% and 89.9%; 72.8% vs 86.3% and 88.2%, respectively; P = .015), assisted primary patency rate (67.0% vs 78.5% and 85.1%; 56.9% vs 71.6% and 79.3%; 47.6% vs 68.0% and 74.8%; respectively, P = .0002), and freedom from MALE (60.8% vs 71.2% and 79.4%; 44.3% vs 64.0% and 72.6%; 36.6% vs 60.7% and 68.5%, respectively; P < .0001) were also similar. After adjustment for age, gender, diabetes, hemodialysis, critical limb ischemia, TransAtlantic Inter-Society Consenus II classification, and stent use, runoff grade was an independent predictor of primary patency. CONCLUSIONS: Vessels with runoff grade 0 had significantly worse cumulative outcomes. Our results suggested that runoff grade seemed to play an important role to keep the primary patency.