A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial.

BACKGROUND: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. OBJECTIVES: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

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.

Impact of postprocedural minimum lumen area on clinical outcome after femoropopliteal drug-eluting stent implantation.

INTRODUCTION: Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions. METHODS: A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method. RESULTS: The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm2) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm2), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031). CONCLUSION: A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes.

Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: Rationale and Design of the ATLAS-OCT Study.

Even after successful revascularization with primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), subsequent adverse events still occur. Previous studies have suggested potential benefits of intravascular imaging, including optical coherence tomography (OCT). However, the feasibility of OCT-guided primary PCI has not been systematically examined in these patients. The ATLAS-OCT (ST-elevation Acute myocardial infarcTion and cLinicAl outcomeS treated by Optical Coherence Tomography-guided percutaneous coronary intervention) trial was designed to investigate the feasibility of OCT guidance during primary PCI for STEMI in experienced centers with expertise on OCT-guided PCI as a prospective, multicenter registry of consecutive patients with STEMI who underwent a primary PCI. The sites' inclusion criteria are as follows: (1) acute care hospitals providing 24/7 emergency care for STEMI, and (2) institutions where OCT-guided PCI is the first choice for primary PCI in STEMI. All patients with STEMI who underwent primary PCI at participating sites will be consecutively enrolled, irrespective of OCT use during PCI. The primary end point will be the rate of successful OCT imaging during the primary PCI. As an ancillary imaging modality to angiography, OCT provides morphologic information during PCI for the assessment of plaque phenotypes, vessel sizing, and PCI optimization. Major adverse cardiac events, defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization at 1 year, will also be recorded. The ATLAS-OCT study will clarify the feasibility of OCT-guided primary PCI for patients with STEMI and further identify a suitable patient group for OCT-guided primary PCI.

Clinical impact of optical coherence tomography findings after drug-coated balloon treatment for patients with acute coronary syndromes.

BACKGROUND: Drug-coated balloon (DCB) became a potential treatment option for patients with acute coronary syndrome (ACS); however, factors associated with target lesion failure (TLF) remain uncertain. METHODS: This retrospective, multicentre, observational study included consecutive ACS patients who underwent optical coherence tomography (OCT)-guided DCB treatment. Patients were divided into two groups according to the occurrence of TLF, a composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target lesion revascularisation. RESULTS: We enrolled 127 patients in this study. During the median follow-up period of 562 (IQR: 342-1164) days, 24 patients (18.9%) experienced TLF, and 103 patients (81.1%) did not. The cumulative 3-year incidence of TLF was 22.0%. The cumulative 3-year incidence of TLF was the lowest in patients with plaque erosion (PE) (7.5%), followed by those with rupture (PR) (26.1%) and calcified nodule (CN) (43.5%). Multivariable Cox regression analysis revealed that plaque morphology was independently associated with TLF on pre-PCI (percutaneous coronary intervention) OCT, and residual thrombus burden (TB) was positively associated with TLF on post-PCI OCT. Further stratification by post-PCI TB revealed a comparable incidence of TLF in patients with PR (4.2%) to that of PE if the culprit lesion had a smaller post-PCI TB than the cut-off value (8.4%). TLF incidence was high in patients with CN, regardless of TB size on post-PCI OCT. CONCLUSIONS: Plaque morphology was strongly associated with TLF for ACS patients after DCB treatment. Residual TB post-PCI might be a key determinant for TLF, especially in patients with PR.

Predictors of target lesion revascularisation after drug-eluting stent implantation for calcified nodules: an optical coherence tomography study.

BACKGROUND: Evidence of prognostic factors for stent failure after drug-eluting stent implantation for calcified nodules (CNs) is limited. AIMS: We aimed to clarify the prognostic risk factors associated with stent failure among patients who underwent drug-eluting stent implantation for CN lesions using optical coherence tomography (OCT). METHODS: This retrospective, multicentre, observational study included 108 consecutive patients with CNs who underwent OCT-guided percutaneous coronary intervention (PCI). To evaluate the quality of CNs, we measured their signal intensity and analysed the degree of signal attenuation. All CN lesions were divided into dark or bright CNs according to the half width of signal attenuation, greater or lower than 332, respectively. RESULTS: During the median follow-up period of 523 days, 25 patients (23.1%) experienced target lesion revascularisation (TLR). The 5-year cumulative incidence of TLR was 32.6%. Multivariable Cox regression analysis revealed that younger age, haemodialysis, eruptive CNs, dark CNs assessed by pre-PCI OCT, disrupted fibrous tissue protrusions, and irregular protrusions assessed by post-PCI OCT were independently associated with TLR. The prevalence of in-stent CNs (IS-CNs) observed at follow-up OCT was significantly higher in the TLR group than in the non-TLR group. CONCLUSIONS: Factors such as younger age, haemodialysis, eruptive CNs, dark CNs, disrupted fibrous tissue, or irregular protrusions were independently related to TLR in patients with CNs. The high prevalence of IS-CNs might indicate that the main cause of stent failure implanted in CN lesions could be the recurrence of CN progression in the stented segment.

Success rate and influencing factors of a balloon-push technique: A new technique to remove side branch-jailed struts under three-dimensional optical coherence tomography guidance.

BACKGROUND: Kissing balloon inflation with distal guide wire recross can cause severe stent deformation depending on the stent link location with respect to the carina. The balloon-push technique, by which an inflated balloon is forced into the SB from the proximal main vessel (MV), is a feasible way to remove jailed struts without causing severe stent deformation. AIMS: We investigated the procedural success rate, patterns of jailed strut removal at side branch (SB) orifices, factors related to failure of jailed strut removal, and follow-up angiogram results of the balloon-push technique. METHODS: Between September 2015 and December 2020, 51 bifurcation stenting cases in which the balloon-push technique was used were enrolled. Based on three-dimensional optical coherence tomography images, strut removal with 1 stent crown length was defined as successful. Strut removal patterns were classified into two types: parallel-slide type (stent struts shifted distally into the MV lumen without inversion) and under-carina type (stent struts shifted distally under the carina with strut inversion or strut slide). RESULTS: Procedural success was attained in 39 cases (success rate: 76.5%). Parallel-slide type and under-carina type occurred in 43% and 33% of cases, respectively. Factors related to failure were trifurcation lesions and a smaller pushed balloon-SB artery ratio compared with those in success cases (0.95 ± 0.18 vs. 1.10 ± 0.22, p = 0.032). Follow-up angiography was performed in 37 cases, and 2 cases had binary in-stent restenosis. CONCLUSIONS: Removal of jailed struts with the balloon-push technique was feasible, without severe stent deformation, in bifurcation stentings.

Potential relationship between high wall shear stress and plaque rupture causing acute coronary syndrome.

The relationship between high wall shear stress (WSS) and plaque rupture (PR) in longitudinal and circumferential locations remains uncertain. Overall, 100 acute coronary syndrome patients whose culprit lesions had PR, documented by optical coherence tomography (OCT), were enrolled. Lesion-specific three-dimensional coronary artery models were created using OCT data. WSS was computed with computational fluid dynamics analysis. PR was classified into upstream-PR, minimum lumen area-PR, and downstream-PR according to the PR's longitudinal location, and into central-PR and lateral-PR according to the disrupted fibrous cap circumferential location. In the longitudinal 3-mm segmental analysis, multivariate analysis demonstrated that higher WSS in the upstream segment was independently associated with upstream-PR, and thinner fibrous cap was independently associated with downstream-PR. In the PR cross-sections, the PR region had a significantly higher average WSS than non-PR region. In the cross-sectional analysis, the in-lesion peak WSS was frequently observed in the lateral (66.7%) and central regions (70%) in lateral-PR and central-PR, respectively. Multivariate analysis demonstrated that the presence of in-lesion peak WSS at the lateral region, thinner broken fibrous cap, and larger lumen area were independently associated with lateral-PR, while the presence of in-lesion peak WSS at the central region and thicker broken fibrous cap were independently associated with central-PR. In conclusion, OCT-based WSS simulation revealed that high WSS might be related to the longitudinal and circumferential locations of PR.

Vessel Patency and Associated Factors of Drug-Coated Balloon for Femoropopliteal Lesion.

Background Although clinical trials have reported favorable outcomes after drug-coated balloon (DCB) therapy for femoropopliteal lesions, their real-world performance and predictors have not been well evaluated. This study aimed to elucidate 1-year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1-year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow-up of 14.2 months, 811 patients experienced restenosis. The Kaplan-Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1-year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low-dose DCB, and residual stenosis. Conclusions The 1-year clinical outcomes after DCB use for femoropopliteal lesions in real-world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.

Intravascular ultrasound-based decision tree model for the optimal endovascular treatment strategy selection of femoropopliteal artery disease-results from the ONION Study.

BACKGROUND: The role of catheter-based imaging in peripheral interventions for lower extremity artery disease (LEAD) has increased with percutaneous interventions. To clarify the relation between intravascular ultrasound (IVUS) information and procedure selection strategy for endovascular treatment therapy (EVT) of the femoropopliteal artery in the real-world clinical settings wherein new endovascular technologies (NETs), including drug-coated balloon (DCB), drug-eluting stent (DES), and covered stent-graft (CS). Our retrospective multicenter analysis examined symptomatic 970 patients treated by EVT for de novo femoropopliteal lesions with IVUS guidance. The decision tree analysis was performed retrospectively to determine the association of IVUS and angiography parameters with the strategy selection of endovascular procedures. We divided the study population according to the developed tree, and identified the most popular strategy selection in each subgroup. We finally examined whether the restenosis risk would be different among respective subgroups of the tree. RESULTS: During the study periods, plain old balloon angioplasty, DCB, and bare nitinol stent were most frequently selected (25.3%, 23.9%, and 23.8%, respectively). The drug-eluting stent (DES), covered stent (CS), and spot stent strategies were used in 7.3%, 11.5%, and 8.1%. NETs had the lowest restenosis risk in the overall population. The decision tree had a depth of six branches and divided the patients into 11 subgroups by IVUS and angiography parameters. The restenosis rate was similarly low among these 11 subgroups when the most popular NET in each subgroup was selected (P = 0.94). CONCLUSIONS: The use of IVUS data along with angiography data would standardize the selection of endovascular procedures and can improve patency outcomes if NETs are used properly.

Optical Coherence Tomography Fractional Flow Reserve and Cardiovascular Outcomes in Patients With Acute Coronary Syndrome.

BACKGROUND: Optical coherence tomography-derived fractional flow reserve (OCT-FFR) correlates strongly with wire-based FFR; however, its clinical significance remains uncertain. OBJECTIVES: This study sought to investigate the relationship between post-percutaneous coronary intervention (PCI) OCT-FFR and long-term clinical outcomes in acute coronary syndrome (ACS). METHODS: This retrospective, multicenter, observational cohort study included consecutive patients with ACS who underwent OCT-guided emergency PCI. We analyzed post-PCI OCT images and calculated OCT-FFR to identify independent factors associated with target vessel failure (TVF) after PCI. RESULTS: Among 364 enrolled patients, 54 experienced TVF during a median follow-up of 36 (IQR: 26-48) months. Vessel-level OCT-FFR was significantly lower in the TVF group than in the non-TVF group (0.87 vs 0.94; P < 0.001). In the multivariable Cox regression analysis, low vessel-level OCT-FFR (HR per 0.1 increase: 0.38; 95% CI: 0.29-0.49; P < 0.001) and thin-cap fibroatheroma in the nonculprit lesion were independently associated with TVF. The TVF rate of vessels with both low vessel-level OCT-FFR (<0.90) and thin-cap fibroatheroma in the nonculprit lesion was 8.1 times higher than that of all other vessels (69.3% vs 12.4%; HR: 8.13; 95% CI: 4.33-15.25; log-rank P < 0.001). Furthermore, adding vessel-level OCT-FFR to baseline characteristics and post-PCI OCT findings improved discriminatory and reclassification ability in identifying patients with subsequent TVF. CONCLUSIONS: Vessel-level OCT-FFR was an independent factor associated with TVF after PCI in patients with ACS. Adding the OCT-FFR measurement to post-PCI OCT findings may enable better discrimination of patients with subsequent TVF after PCI for ACS. (Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome; UMIN000043858).

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Predictors and outcomes of ischemia-driven target lesion revascularization in deferred lesion based on fractional flow reserve: a multi-center retrospective cohort study.

Background: Fractional flow reserve (FFR) has become the gold standard for diagnosing ischemia in angiographically intermediate epicardial coronary artery stenosis. This study investigated the clinical outcomes and predictors of revascularization deferral based on FFR. Methods: In this retrospective cohort study, we assessed 474 lesions (440 patients) where revascularization was deferred based on the FFR value. Minimum lumen diameter and %-diameter stenosis were measured. Calcification was graded as none, mild, moderate, or heavy. The synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) score I was also determined. The primary outcome was ischemia-driven target lesion revascularization (TLR) in deferred lesions within 3 years. Patients were also assigned into two groups based on FFR value. Results: The average age of the patients was 69.7±10.4 years. The average FFR value was 0.86±0.05. Stable angina pectoris was noted in 298 (67.7%) cases, and in-stent restenosis (ISR) was present in 28 (5.9%). The average SYNTAX score was 7.2±4.2. The 3-year ischemia-driven TLR was 18 lesions (3.8%). Cox proportional hazard model revealed that the SYNTAX score and ISR were independent predictors for TLR in deferred lesions [hazard ratio (HR) =1.10, 95% confidential interval (CI): 1.01-1.19, P=0.03; HR =6.33; 95% CI: 2.25-17.8, P<0.01, respectively]. The deferral group, with a low FFR value, tended to have higher TLR rates than other groups. Conclusions: Lesions with lower FFR values were associated with a higher incidence of ischemia-driven TLR than those with higher FFR values. SYNTAX score and ISR were predictors for ischemia-driven TLR at 3 years in the deferred lesions.

Clinical Impact of Intravascular Ultrasound-Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions.

BACKGROUND: Treatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined. OBJECTIVES: This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease. METHODS: As a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed. RESULTS: A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044). CONCLUSIONS: The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.

Real-world clinical outcomes of percutaneous transluminal septal myocardial ablation for patients with drug-refractory hypertrophic obstructive cardiomyopathy: results from a retrospective multicenter registry of non-high-volume centers.

Percutaneous transluminal septal myocardial ablation (PTSMA) is a well-established interventional therapy for drug-refractory hypertrophic obstructive cardiomyopathy (HOCM) as an alternative to surgical myectomy. Although guidelines recommend that PTSMA should be performed in institutions with extensive experience, it is not centralized to such high-volume centers in real-world clinical practice. Thus, this study aimed to assess the feasibility of PTSMA in non-high-volume centers. We retrospectively examined patients with HOCM who underwent PTSMA between August 2012 and May 2020 at four institutions that experienced fewer than 20 cases of PTSMA procedures. The primary clinical endpoint was a composite of safety (all-cause death, electrical defibrillation for ventricular tachycardia or fibrillation, cardiac tamponade, permanent pacemaker implantation, and repeated interventions) and efficacy endpoints (repeated interventions [PTSMA or surgical myectomy]). Fifty-eight consecutive patients were enrolled. During the 30-day follow-up, no major clinical adverse events were noted except three patients (5.2%) requiring permanent pacemaker implantation for complete atrioventricular block. The percentage of patients with New York Heart Association functional class 1 or 2 significantly increased from 8.6 to 100% (p < 0.001). In the Cox proportional hazard model, left ventricular outflow tract pressure gradient at rest ≥ 30 mmHg (hazard ratio [HR] 6.56; 95% confidence interval [CI] 1.44-29.90; p = 0.015) and mitral regurgitation grade ≥ 3 (HR 10.75; 95% CI 1.81-63.79; p = 0.009) at the 30-day follow-up were associated with a composite of major clinical adverse events. The current study demonstrated that 58 patients who underwent PTSMA in non-high-volume centers had favorable 30-day clinical outcomes, with a primary composite endpoint rate of 5.2%. A prospective study with a larger sample size and longer follow-up is warranted to verify the safety and efficacy of PTSMA in non-high-volume centers.

1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration.

OBJECTIVES: This study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice. BACKGROUND: Although clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated. METHODS: This multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9 cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration. RESULTS: The 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration. CONCLUSIONS: This study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted.

Association of Age with Mortality Rate after Femoropopliteal Endovascular Therapy for Intermittent Claudication.

AIM: This study aimed to reveal the mortality risk by age in patients undergoing femoropopliteal endovascular therapy for intermittent claudication, in comparison to the national age-specific standard value. METHODS: We analyzed 2056 patients undergoing endovascular therapy for moderate to severe intermittent claudication between 2010 and 2018, performed at five cardiovascular centers in Japan. The 3-year mortality risk by age was compared with the data from year- and sex-matched Japanese citizens, which were obtained from Japan's national life table data. Clinical characteristics associated with age in the study patients were also explored. RESULTS: The mean age was 73±9 years. The 3-year mortality risk was increased with age in the patient population, from 6.4% for patients aged ＜65 years to 21.2% for those aged ≥ 85 years. On the contrary, its risk ratio relative to the matched citizens of the same age was decreased with age; the relative risk ratio was 3.08 for patients aged ＜65 years (P=0.001) and 0.60 for those aged ≥ 85 years (P=0.016). Current smoking, body mass index ≥ 25 kg/m2, hyperlipidemia, diabetes mellitus, and dialysis dependence were inversely associated with age (all P＜0.05). CONCLUSION: Mortality risk increased with age, but the risk ratio relative to the matched citizens decreased with age. Younger patients had a higher mortality risk relative to the matched citizens, whereas patients aged ≥ 85 years had a lower mortality risk relative to the matched citizens. Younger patients were more likely to accumulate cardiovascular risk factors.

One-year results for Japanese patients in RANGER II SFA.

The RANGER II SFA objective was to evaluate the safety and effectiveness of the Ranger Drug-Coated Balloon (DCB) for treating superficial femoral artery and/or proximal popliteal artery lesions; the purpose of this cohort analysis is to assess the results among Japanese study participants. Patients eligible for RANGER II SFA had symptomatic lower limb ischemia (Rutherford classification 2-4) and were randomly assigned (3:1) to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). At 12 months, assessments included freedom from major adverse events (i.e., target lesion revascularization, major amputations, or death within 1 month of the index procedure) and core laboratory-assessed primary patency. Japanese patients (n = 102) comprised 27.1% of the overall study sample. Mean lesion lengths were 79.5 ± 44.0 mm and 84.0 ± 56.8 mm among Japanese patients treated with Ranger DCB (n = 77) or PTA (n = 25), respectively. All major adverse events were clinically driven TLRs (6.6% [5/76] for Ranger DCB and 16.0% [4/25] for PTA; p = 0.2194). Kaplan-Meier estimates of primary patency were 89.3% and 72.0%, respectively, at 12 months (log-rank p = 0.2134). Japanese patients treated with Ranger DCB maintained a high patency rate through 12 months and a low re-intervention rate.Trial registration clinicaltrials.gov identifier: NCT03064126.