Kenji Makino

Impact of ultra-long second-generation drug-eluting stent implantation.

This study investigated the safety and prognosis of ultra‐long second DES (UL‐2nd DES) implantation in real‐world practice.

Characteristics and clinical outcomes of repeat endovascular therapy after infrapopliteal balloon angioplasty in patients with critical limb ischemia

We clarified characteristics and clinical outcomes of critical limb ischemia (CLI) patients who underwent repeat endovascular therapy (EVT) for infrapopliteal lesions.

Clinical Outcomes of the Intraluminal Approach for Long Occlusive Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Aim: To investigate the relationship between intravascular ultrasound (IVUS) findings and restenosis after stent implantation for long occlusive femoropopliteal (FP) lesions using the intraluminal approach. Methods: This was a single-center retrospective study of 45 patients (49 lesions) with de novo long occlusive FP lesions treated with bare metal stents implanted using the intraluminal approach under IVUS guidance from April 2007 to December 2014. All patients were followed up at least 12 months. The preprocedural and postprocedural IVUS findings were compared for patients with and without restenosis, which was defined as a peak systolic velocity ratio of > 2.4 on duplex ultrasonography or > 50% diameter stenosis on angiography. Results: Within 12 months, 13 patients (14 lesions) developed restenosis, whereas 32 patients (35 lesions) did not (restenosis rate = 29%). The male:female ratio and the prevalence of diabetes mellitus, hemodialysis, and critical limb ischemia were similar between the two groups. No significant differences were observed in lesion length, chronic total occlusion (CTO) length, and the percentage of involving popliteal lesion between the two groups. A whole intraplaque route was gained in 15 lesions (31%). Multivariate analysis revealed that the within-CTO intramedial route proportion and the distal lumen cross-sectional area (CSA) were independent predictors of restenosis. Receiver operating characteristic analysis showed that the best cutoff values of these parameters were 14.4% and 17.7 mm2, respectively. Conclusions: In patients with long occlusive FP lesions undergoing stent placement using the intraluminal approach, a whole intraplaque route was gained in 31%. Restenosis is more likely if IVUS shows a within-CTO intramedial route proportion of > 14.4% or distal lumen CSA of < 17.7 mm2.

Ability of Fractional Flow Reserve to Predict Restenosis After Superficial Femoral Artery Stenting.

Purpose: To evaluate the clinical efficacy of poststenting fractional flow reserve (FFR) in terms of predicting restenosis in superficial femoral artery (SFA) disease. Methods: This prospective, single-center, nonrandomized study enrolled 48 patients (mean age 76±9 years; 38 men) with 51 SFA lesions from July 2013 to June 2014. Mean FFR (distal mean pressure/proximal mean pressure) and systolic FFR (distal systolic pressure/proximal systolic pressure) were calculated, and the relationship between these FFR values and restenosis at 12 months was investigated using receiver operating characteristic (ROC) curve analysis. Results: Poststenting FFR was significantly lower in the restenosis group (poststenting mean FFR 0.85±0.07 vs 0.93±0.05, p=0.001; poststenting systolic FFR 0.76±0.14 vs 0.87±0.08, p=0.015). The area under the ROC curve for restenosis in poststenting mean FFR was higher, but not statistically significant, than that in poststenting systolic FFR (0.84 vs 0.74, p=0.08). The best poststenting mean FFR cutoff value for predicting restenosis was 0.92 (sensitivity 0.64, specificity 0.91). The 4.5% restenosis rate at 12 months in the high (>0.92) poststenting mean FFR group was significantly lower (35.7%, p=0.008) than in the low (≤0.92) poststenting mean FFR group. Conclusion: Poststenting mean FFR is useful for predicting restenosis in SFA disease.

Wound healing of critical limb ischemia with tissue loss in patients on hemodialysis.

We assessed wound healing in patients on hemodialysis (HD) with critical limb ischemia (CLI). This study enrolled 267 patients (including 120 patients on HD and 147 patients not on HD) who underwent endovascular therapy (EVT) for CLI. The primary endpoint was wound-healing rate at two years. Secondary endpoints were time to wound healing, wound recurrence rate, and limb salvage at two years. The percentage of male and young patients was higher in the HD patients (p < 0.01). A lower patency of the pedal arch after EVT was observed frequently in HD patients (p < 0.01). The wound-healing rate was significantly lower in HD patients (79.5% vs. 92.4%, p < 0.001). Time to wound healing was significantly longer in HD patients (median 132 days vs. 82 days, p = 0.005). Wound recurrence was observed more frequently in HD patients (25.0% vs. 10.2%, p = 0.007). Limb salvage (72.8% vs. 86.4%, p = 0.002) was significantly lower in HD patients. In a cox proportional hazard model, HD was an independent predictor of wound healing (risk ratio (RR), 0.46; 95% confidence interval (CI), 0.33–0.62; p < 0.001) and wound recurrence (RR, 1.58; 95% CI, 1.11–2.22; p = 0.01). HD was independently associated with lower and delayed wound healing, and wound recurrence.

Frequency and predictors of bleeding events after 2nd generation drug-eluting stent implantation differ depending on time after implantation

BACKGROUND Antiplatelet therapy is required after drug-eluting stent (DES) implantation, but bleeding events occur unexpectedly. We aimed to assess whether bleeding event predictors after 2nd generation DES (2nd DES) implantation differed by time after implantation. METHODS We studied 1912 consecutive patients who underwent successful 2nd DES implantation (70±10 years, 72% male). Bleeding events were recorded as early (≤1 year) and late (>1 year). Major bleeding events were defined as a composite of type 5, 3, and 2 bleeding in the Bleeding Academic Research Consortium criteria. Predictors were assessed using a Cox proportional hazard model. RESULTS Bleeding event rates were 3.3%, 5.1%, and 6.7% at 1, 2, and 3 years, respectively, with the highest 1-year rate in year 1 (p<0.001). Cause and severity of bleeding events were similar between early and late bleeding events. Prior history of gastrointestinal bleeding, non-steroidal anti-inflammatory drug use, and triple antithrombotic therapy [adjusted risk ratio (RR): 3.68, 3.21, 4.57, respectively; p<0.01] were independent predictors of early bleeding events. Age >80 years and severe renal dysfunction (adjusted RR: 2.27, 2.02, respectively; p<0.01) were independent predictors of late bleeding events. Survival rate was significantly lower in patients with bleeding events compared with patients without bleeding events (82.4% vs 90.1%; p<0.001). CONCLUSION Frequency and predictors of bleeding events after 2nd DES implantation differ by time after implantation. Treatment strategies corresponding to individual patients are required.

Comparison of Long‐Term Clinical Outcomes of Lesions Exhibiting Focal and Segmental Peri‐Stent Contrast Staining

Background Peri‐stent contrast staining (PSS) after metallic drug‐eluting stent deployment is associated with target lesion revascularization and very late stent thrombosis. However, the type of PSS that influences the clinical outcomes is unknown. Therefore, we aimed to reveal which PSS type was influencing clinical outcomes. Methods and Results This study included 5580 de novo lesions of 4405 patients who were implanted with a first‐ or second‐generation drug‐eluting stent and who were evaluated using follow‐up angiography within 12 months after stent implantation. We compared the clinical outcomes of patients divided into focal PSS and segmental PSS groups for 6 years after stent implantation. Total PSS was observed in 97 lesions (2.2%), of which 42 and 55 lesions were focal and segmental PSS, respectively. Baseline characteristics were similar between groups, except for intraoperative chronic total occlusion (segmental PSS=47.3% versus focal PSS=11.9%, P=0.0001). The incidence of segmental PSS tended to be higher in patients with a first‐generation drug‐eluting stent (83.6% versus 16.4%, P=0.05). The cumulative incidence of stent thrombosis in the 6 years of segmental PSS group was significantly higher than that of the focal PSS group (13.9% versus 0%, P=0.04). The cumulative incidence of overall target lesion revascularization for restenosis, excluding target lesion revascularization procedures for stent thrombosis, was significantly higher in the segmental PSS group (38.0% versus 0%, P=0.01). Conclusions The incidence of segmental PSS tended to be higher in patients with a first‐generation drug‐eluting stent and appeared to be significantly associated with target lesion revascularization and stent thrombosis.

Efficacy And Safety of Coadministration of Tolvaptan And Carperitide for Acute Decompensated Heart Failure Patients

For acute decompensated heart failure (ADHF) therapy, combination of carperitide, a human atrial natriuretic peptide, and tolvaptan, a novel vasopressin type 2 receptor antagonists, has not been used. Tolvaptan is a drug newly developed to treat volume overload in ADHF patients. Of 102 consecutive cases treated upon admission for ADHF between April and October 2012, we analyzed 51 patients treated with carperitide plus tolvaptan (tolvaptan+carperitide group) and 51 patients treated with carperitide plus conventional diuretics (carperitide group). On comparison between both groups, total dose of carperitide and loop diuretic doses during 48 h in tolvaptan +carperitide group were lower than those in the carperitide group (both p<0.001). Urine output at 24 h and 48 h after admission in the tolvaptan+carperitide group were significantly higher than those in carperitide group (p=0.02 and p<0.001, respectively). Changes in NT-pro brain-type natriuretic peptide levels in tolvaptan+carperitide group were significantly higher than those in carperitide group (p=0.01). No significant differences were detected in worsening renal function. On conclusion, in ADHF therapy, coadministration of tolvaptan and carperitide was more effective and safe compared with conventional therapy.

Optical frequency-domain imaging findings to predict good stent expansion after rotational atherectomy for severely calcified coronary lesions

We aimed to evaluate the optical frequency-domain imaging (OFDI) findings after rotational atherectomy (RA) that predict good stent expansion for severely calcified coronary lesions. Fifty consecutive calcified lesions were subjected to RA under OFDI guidance. We performed OFDI just after RA and stenting. We measured the morphology of calcium after RA, and assessed how these factors influence stent expansion. The stent expansion index was defined as the minimum stent area divided by the average of the proximal and distal reference lumen areas. Minimum thickness of calcification in the intima after RA showed a significant negative correlation with stent expansion (r = − 0.53, P < 0.001), while calcium arc, length, and maximum thickness of calcification in the intima did not. Dissection after RA occurred in 22 lesions (44%), and the stent expansion index was significantly better in dissected lesions than in lesions without dissection (0.96 ± 0.08 vs. 0.82 ± 0.19, P = 0.002). Multiple regression analysis showed that the minimum thickness of calcification in the intima (standardized coefficient: − 0.451, P < 0.001) and dissection formation (standardized coefficient: 0.316, P = 0.011) were predictors of good stent expansion. Minimum of thickness of calcification in the intima and dissection formation were positively associated with good stent expansion after RA. In the clinical setting, achieving these two endpoints should be the aim of RA to ensure good stent expansion.

TCT-18 Validation of Wound, Ischemia, foot Ischemia (WIFI) classification system in Japanese patients after endovascular treatment for critical limb ischemia (CLI).

The Wound, Ischemia, foot Infection (WIfI) a classification system is a system to predict the amputation risk in patients with critical limb ischemia (CLI). Validation for WIfI classification for Japanese CLI patients is still unknown. This single-center study evaluated the prognostic value of WIfI