One-year outcomes of patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy catheter: Insights from the J-PCI OUTCOME registry.

OBJECTIVES: We sought to investigate the 1-year outcomes, including all-cause and cardiovascular mortality, major adverse cardiovascular events (MACEs), and major bleeding, of patients undergoing percutaneous coronary intervention (PCI) with or without the revived directional coronary atherectomy (DCA) catheter in a Japanese nationwide registry. BACKGROUND: Clinical data regarding the midterm outcomes of patients undergoing PCI with DCA are scarce in contemporary real-world practice. METHODS: We analyzed the data of 74,764 patients who underwent PCI at 179 hospitals from January 2017 to December 2018. The baseline characteristics and 1-year outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA were assessed. RESULTS: Overall, 431 patients (0.6%) underwent PCI with DCA. Patients in the DCA group were younger and predominantly male, with fewer comorbidities than patients in the non-DCA group. Stentless PCI with DCA following additional drug-coated balloon (DCB) angioplasty was the dominant strategy in the DCA group (43.6%). One-year outcomes, including all-cause mortality (1.2% in the DCA group vs. 2.5% in the non-DCA group, respectively, p = 0.075), cardiovascular death (0.9% vs. 1.0%, p = 0.69), MACEs (1.9% vs. 1.8%, p = 0.96), and nonfatal major bleeding requiring readmission (1.2% vs. 1.4%, p = 0.62), were comparable between the two groups. In the DCA group, 1-year outcomes were comparable, regardless of whether the stent or DCB was used. CONCLUSIONS: One-year clinical outcomes after PCI with DCA in patients with stable coronary artery disease or unstable angina are acceptable, regardless of stent use.

Overview of in-hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy.

OBJECTIVES: We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry. BACKGROUND: Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice. METHODS: We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed. RESULTS: Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group. CONCLUSIONS: In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina.

Impact of directional coronary atherectomy followed by drug-coated balloon strategy to avoid the complex stenting for bifurcation lesions.

Although the simple single stenting rather than complex double stenting is recommended on percutaneous coronary intervention (PCI) for bifurcation lesions, double stenting cannot always be avoided. We investigated the impact of directional coronary atherectomy (DCA), followed by drug-coated balloon (DCB) treatment to reduce the number of stents and avoid complex stenting in PCI for bifurcation lesions and short-term patency. DCA treatment without stents was attempted for 27 bifurcation lesions in 25 patients, of those, 26 bifurcation lesions in 24 patients were successfully treated and 3-month follow-up angiography and optical coherence tomography (OCT) were performed. Sixteen lesions (59.3%) were related to left main trunk distal bifurcations, and 7 (25.9%) were true bifurcation lesions. Among the true bifurcation lesions, 4 lesions (57.1%) needed 1 stent, and the other 3 lesions (42.9%) needed no stents. Among the non-true bifurcation lesions, 1 lesion (5.0%) needed bailout stent and other lesions (95.0%) needed no stents. According to DCA followed by DCB treatment, the angiographic mean diameter stenosis improved from 65.5 ± 15.0% to 7.8 ± 9.8%, and the mean plaque area in intravascular ultrasound improved from 80.4 ± 10.5% to 39.0 ± 11.5%, respectively. Angiographic and OCT late lumen loss values were 0.2 ± 0.6 mm and 1.4 ± 1.9 mm, respectively. No patient had in-hospital major adverse cardiac events (MACE) and 3-month MACE. In conclusion, compared with standard provisional side branch stenting strategy, DCA followed by DCB treatment might reduce the number of stents, avoid complex stenting for major bifurcation lesions and provide good short-term outcomes.

Efficacy of plaque debulking for bifurcated or ostial lesions by directional coronary atherectomy prior to second-generation drug eluting stenting.

OBJECTIVES: We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) prior to second-generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting is used. METHODS: Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-second-generation DES plaque debulking with a novel DCA catheter (ATHEROCUT®, Nipro Co., Osaka, Japan) was conducted. All patients were scheduled to perform a follow up angiography (9-12 month coronary angiography or coronary computed tomography). The primary end point was target vessel failure (TVF) at follow up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. RESULTS: A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all cases without any major procedure-related event and only one case required complex stenting. The TVF rate at 9-12 month follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at the ostium of the main-branch in three cases. No death, coronary artery bypass grafting, or myocardial infarction were reported for any patients within the first year. CONCLUSION: DCA before second-generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions.

Prevalence and Clinical Significance of Layered Plaque in Patients With Stable Angina Pectoris　- Evaluation With Histopathology and Optical Coherence Tomography.

BACKGROUND: Healed plaques are identified as a layered pattern with optical coherence tomography (OCT) imaging, but the exact relationship between healed plaques and the development of significant coronary stenosis in stable angina pectoris (SAP) is not fully understood.Methods and Results:A retrospective clinincal study investigated the OCT characteristics of culprit lesions of SAP patients (n=205), and a prospective study examined the histopathological characteristics of layered plaque in directional coronary atherectomy (DCA) samples (42 samples from 18 SAP patients). In the retrospective study, layered plaque was observed in 36.6% of the SAP culprit lesions. Compared with patients with non-layered plaque, male sex and smoking were more frequent, and HbA1c level was significantly higher in the patients with layered plaque (81.3% vs. 65.9%, P<0.05; 62.7% vs. 41.8%, P<0.05; 6.6±1.3% vs. 6.2±1.0%, P<0.05, respectively). Furthermore, layered plaque was accompanied by higher plaque vulnerability and smaller minimal lumen area. In the histopathological study, the layered plaques had a significantly higher rate of intramural thrombus and macrophages infiltration than non-layered plaques (75.0% vs. 14.3%, P<0.05; 75.0% vs. 38.1%, P<0.05, respectively). CONCLUSIONS: Healed plaque containing intramural thrombus is identified as layered plaque by OCT, and was frequently observed, even in SAP patients. Intramural thrombus might play an important role in the development of coronary plaque with a high degree of stenosis in SAP patients.

In-Stent Restenosis with "Inflammatory" Neointima Following Everolimus-Eluting Stent Implantation.

A 53-year-old male presented with acute myocardial infarction and was subsequently implanted with a 4.0 × 28 mm everolimus-eluting platinum chromium stent in his proximal left anterior descending artery. Eight months after the implantation, he developed exertional angina and underwent coronary angiography, which revealed significant in-stent restenosis (ISR). Percutaneous coronary intervention was performed 1 month later, and the pre-procedural optical coherence tomography (OCT) revealed a diffusely bordered and rapidly attenuated signal-poor region with invisible stent struts at ISR site, potentially indicating a "lipid-laden" neointima. The ISR lesion was excised using a novel directional coronary atherectomy catheter. The histological analysis of the retrieved restenotic tissues revealed substantial inflammation characterized by abundant foamy macrophages and T-cell infiltration. This "inflammatory" neointimal tissue with numerous macrophages (without a necrotic core) detected on OCT was not expected owing to the absence of a known feature of macrophages on OCT (i.e., high backscattering with remarkable attenuation). The current histological confirmation of in vivo OCT findings of restenotic neointima indicated that a "lipid-laden" neointima on OCT may not necessarily reflect necrotic core accumulation, and this could be attributed to substantial inflammation with abundant macrophages.

The first clinical experience with a novel directional coronary atherectomy catheter: Preliminary Japanese multicenter experience.

AIMS: Despite development of drug eluting stents (DES), percutaneous coronary intervention (PCI) for bifurcation lesions using DES alone remains challenging. The aim of this study was to report on the initial clinical experience with a novel directional coronary atherectomy (DCA) catheter. METHODS AND RESULTS: Patients with de novo bifurcation lesions were entered into a prospective registry and a novel DCA catheter was used. Device, procedural success and in-hospital outcomes were evaluated. A total of 14 patients with bifurcation lesions were enrolled. DCA was performed successfully in all cases without any major procedure-related events (device success rate: 100%, procedural success rate: 100%). Four patients (29%) were treated without stent implantation and simple stenting was achieved in the other 10 patients. No in-hospital major adverse cardiac event was observed. CONCLUSIONS: PCI with a novel DCA catheter for bifurcation lesions may be safe and effective. The clinical significance of these findings needs to be determined in future studies. This study was performed to evaluate the safety and efficacy of a novel directional coronary atherectomy catheter for bifurcation lesions. Both the device and procedural success rates were 100%. Complex stenting could be avoided in all cases. No inhospital major adverse cardiac event was observed. The novel directional coronary atherectomy catheter may be safe and effective for bifurcation lesions, even in this drug eluting stent era. © 2016 Wiley Periodicals, Inc.

Successful coronary stent implantation using directional coronary atherectomy without side branch occlusion.

Percutaneous coronary intervention with a drug-eluting stent was successfully performed without a side branch (SB) occlusion. In this case, a directional coronary atherectomy catheter played an important role in modifying the plaque at the proximal left anterior descending artery and in crossing a wire to the jeopardized SB.

Mechanism of Drug-Eluting Stent Thrombosis Diagnosed by Histopathological Evaluation of Directional Coronary Atherectomy Specimen.

An 89-year-old man with a history of percutaneous coronary intervention using a sirolimus-eluting stent presented with recurrent in-stent occlusion. Pathological assessment of the neointima resected via directional coronary atherectomy revealed a double-layered thrombus. Clopidogrel resistance and limited antithrombotic regimen owing to high bleeding risk likely resulted in the in-stent thrombotic occlusion.

Acute Coronary Syndrome Due to Intraplaque Hemorrhage in a Post-gastrectomy Patient with a Latent Severe Glycemic Disorder.

Glycemic disorders involving large glucose fluctuations and recurrent hypoglycemia may lead to adverse cardiovascular events, including acute coronary syndrome (ACS). Flash glucose monitoring (FGM) has reportedly been useful for detecting latent glycemic disorders. However, only a few studies have so far reported latent glycemic disorders in coronary artery disease. Thus, we herein present a unique case of ACS due to intraplaque hemorrhage in a post-gastrectomy patient who had no apparent coronary risk, except for a latent severe glycemic disorder detected via FGM. This masked etiology should be considered in ACS patients who have no apparent cardiovascular risks in order to improve their cardiovascular outcomes.

Stentless percutaneous coronary intervention with directional coronary atherectomy and drug-coated balloon angioplasty in worsening angina patients with metal allergies.

Metal allergy is a concern in percutaneous coronary intervention (PCI) with stent implantation because of its potential association with poor cardiovascular outcomes, such as stent thrombosis and recurrent in-stent restenosis requiring revascularization. Although stentless PCI with drug-coated balloon (DCB) angioplasty is theoretically useful for patients with metal allergies, DCB angioplasty alone for huge plaques in large vessels may yield inadequate luminal enlargement and coronary deep dissection, leading to insufficient results. Directional coronary atherectomy (DCA) is effective to reduce plaque volume. However, the efficacy of DCA followed by DCB (DCA/DCB) angioplasty in patients with metal allergies has never been described. We present two cases wherein stentless PCI with DCA/DCB angioplasty was an alternative revascularization strategy for patients with metal allergy and concomitant worsening angina pectoris involving proximal left anterior descending artery stenoses. Preoperative evaluation using coronary computed tomography angiography in Case 1 and intravascular ultrasound in Case 2 was useful to determine the possible use of the DCA/DCB procedure for huge plaques in large vessels. Learning objective: Revascularization for patients with metal allergy with worsening angina pectoris due to stenoses of the proximal main arteries is often challenging because of the necessity to avoid stent implantation. As stentless percutaneous coronary intervention (PCI) is theoretically useful in such settings, PCI with directional coronary atherectomy (DCA)/drug-coated balloon angioplasty can be one of the treatable strategies. Preoperative evaluation of plaque morphology for the suitability of DCA procedure is important.

Surgical glue-induced left main trunk stenosis removed by directional coronary atherectomy.

A 55-year-old man underwent aortic repair for acute aortic dissection. The pseudolumen of the Valsalva sinus was reapproximated with BioGlue by placing a sponge inside of it to prevent the BioGlue from entering. Postoperative contrast-enhanced computed tomography showed stenosis of the left main trunk. Directional coronary atherectomy was performed; complete release of the stenosis was achieved. Various fragments retrieved from the left main trunk were pathologically consistent with BioGlue. When we reapproximated the dissected aortic wall, inserting a sponge into the aorta did not prevent the surgical glue from entering. Directional coronary atherectomy was a good therapeutic option to treat glue-induced coronary artery stenosis.

Chlamydia pneumoniae is Prevalent in Symptomatic Coronary Atherosclerotic Plaque Samples Obtained From Directional Coronary Atherectomy, but its Quantity is Not Associated With Plaque Instability: An Immunohistochemical and Molecular Study.

Aim: To clarify whether there is any association between the extent of Chlamydia pneumoniae (C. pneumoniae) infection and plaque instability or post-directional coronary atherectomy (DCA) restenosis, we determined the frequency of C. pneumoniae infection and its localization in symptomatic coronary atherosclerotic plaques using specimens obtained from DCA. Methods and results: Immunohistochemistry (IHC) and real-time polymerase chain reaction (RT-PCR) revealed the existence of C. pneumoniae in all 50 specimens of coronary atherosclerotic plaques obtained by DCA. C. pneumoniae-positive cell ratio determined with IHC or copy numbers of C. pneumoniae DNA detected by RT-PCR did not differ significantly between patients with stable angina pectoris and those with acute coronary syndrome (IHC: 16.4 ± 7.6% vs 18.0 ± 7.1%, P = .42; RT-PCR: no. of cases with high copy numbers 12/25 vs 10/25, P = .78), or between patients with subsequent post-DCA restenosis and those without (IHC: 17.1 ± 8.0% vs 18.0 ± 7.4%, P = .74; RT-PCR: 5/12 vs 10/21, P = 1.00). Conclusions: C. pneumoniae was highly prevalent in coronary atherosclerotic plaques of patients who underwent DCA. However, the extent of C. pneumoniae infection in coronary atherosclerotic plaques was not associated with plaque instability or post-DCA restenosis.

Histopathological findings of late-phase restenosis after directional coronary atherectomy with drug-coated balloon angioplasty: a case report.

Background: Drug-coated balloon angioplasty after directional coronary atherectomy (DCA) allows for a stentless strategy providing good short-term outcomes; however, late-phase restenosis and its mechanism remain unclear. Moreover, histopathological evaluation for late-phase restenosis post-drug-coated balloon angioplasty after DCA has never been reported. Case summary: We report the first case of late-phase restenosis post-drug-coated balloon angioplasty after DCA, wherein tissue analysis using intravascular coronary imaging and histopathology suggested neovascularization in newly developed neointimal proliferation. A 52-year-old man with a history of dyslipidaemia presented with exertional angina pectoris. He underwent percutaneous coronary intervention (PCI) with drug-coated balloon angioplasty after DCA for the proximal left anterior descending artery. Although coronary angiography after nine months revealed no restenosis, he experienced recurrent chest discomfort after 25 months. Coronary angiography confirmed late-phase restenosis, and intravascular ultrasound showed progressively developed neointima above the underlying residual plaque. Optical coherence tomography suggested developing neovascularization within the neointima. Stentless PCI with drug-coated balloon angioplasty after DCA was re-performed, and collected restenotic sample. The histopathological evaluation confirmed less-cellular neointimal proliferation with rich neovascularization and concomitant diffuse vascular endothelial growth factor (VEGF) expression. Discussion: Late-phase restenosis post-drug-coated balloon angioplasty after DCA comprised less-cellular neointima, suggesting inhibition of cell proliferation by drug-coated balloon efficacy. However, diffuse VEGF expression and concomitant rich neovascularization with haemorrhage and inflammation might indicate neointimal proliferation. Further large-scale investigations of the restenotic mechanism should be performed to avoid long-term target vascular failure after drug-coated balloon angioplasty post-DCA.

Novel strategy for ostial left anterior descending artery acute myocardial infarction: Combined treatment with directional coronary atherectomy followed by drug-coated balloon angioplasty.

A 69-year-old female diagnosed with ostial left anterior descending artery acute myocardial infarction underwent percutaneous coronary intervention using combined directional coronary atherectomy followed by drug-coated balloon angioplasty. This report highlights a novel management strategy with no permanent scaffold left in the coronary artery.

Stentless treatment strategy for left circumflex artery ostial stenosis: Directional coronary atherectomy followed by drug-eluting balloon.

A 60-year-old man with history of exertional angina pectoris was referred for treatment of an ostial left circumflex (LCX) coronary artery stenosis. The branch angle between left anterior descending artery (LAD) and LCX was shallow, therefore stent implantation seemed at risk of "carina shift" of plaque to the LAD ostium as well as higher in-stent restenosis. Therefore, directional coronary atherectomy (DCA, Atherocut™, L-size, NIPRO, Osaka, Japan) was performed at the ostium of the LCX lesion. After evaluating plaque accumulation using intravascular ultrasound (IVUS), DCA was circumferentially performed 16 times, from 2 atm to 3 atm, using an 8 fr guide system. Although angiogram and IVUS showed excellent results, adjunctive balloon dilatation with 3.5 mm paclitaxel-coated balloon was performed to prevent restenosis. At 8 months, the patient reported being angina-free, and subsequent follow-up angiogram showed no restenosis of LCX. Paclitaxel-coated balloon following DCA for LCX ostial stenosis seems to be safe and effective for both acute and chronic results, suggesting a potential stentless therapeutic option. .

Formation of Calcified Nodule as a Cause of Early In-Stent Restenosis in Patients Undergoing Dialysis.

Background Dialysis is an independent risk factor for in-stent restenosis (ISR) after stent implantation in coronary arteries. However, the characteristics of ISR in patients undergoing dialysis remain unclear, as there are no histological studies evaluating the causes of this condition. The aim of the present study was to investigate the causes of ISR between patients who are undergoing dialysis and those who are not by evaluating tissues obtained from ISR lesions using directional coronary atherectomy. Methods and Results A total of 29 ISR lesions from 29 patients included in a multicenter directional coronary atherectomy registry of 128 patients were selected for analysis and divided into a dialysis group (n=8) and a nondialysis group (n=21). Histopathological evaluation demonstrated that an in-stent calcified nodule was a major histological characteristic of ISR lesions in the dialysis group and the prevalence of an in-stent calcified nodule was significantly higher in the dialysis group compared with the nondialysis group (75% versus 5%, respectively; P<0.01). On the other hand, the prevalence of an in-stent lipid-rich plaque was significantly lower in the dialysis group compared with the nondialysis group (0% versus 43%, respectively; P=0.03). In all cases with an in-stent calcified nodule, the underlying calcification before stent implantation was moderate to severe. When tissue characteristics were stratified according to duration post-stent implantation, an in-stent calcified nodule in the dialysis group was mainly observed within 1 year after stent implantation. Conclusions In-stent calcified nodules are a common cause of ISR in patients undergoing dialysis and are observed within 1 year after stent implantation, suggesting different causes of ISR between patients undergoing dialysis and those who are not.

Short-term outcome of percutaneous coronary intervention with directional coronary atherectomy followed by drug-coated balloon: a preliminary report.

Directional coronary atherectomy (DCA) is a unique technique used in percutaneous coronary intervention (PCI) which involves the removal of plaque from the coronary artery. Treatment with a drug-coated balloon (DCB) appears to be effective, especially when a predilatation of the lesion is performed appropriately. We hypothesize that the combination therapy of DCA with DCB is an effective strategy in PCI. PCI with DCA followed by DCB was performed for 23 patients from December 2014 to April 2017. All DCA procedures were performed under the guidance of intravascular ultrasound (IVUS) findings and all procedures were successfully performed without incurring major complications such as a coronary perforation. Plaque area (PA) was reduced from 77.3 ± 10.4% at baseline to 50.9 ± 9.2% after DCA and luminal cross-sectional area (CSA) after PCI was enlarged from 3.6 ± 1.8 to 9.3 ± 3.3 mm2. Follow-up coronary angiography (CAG) performed at 6-10 months showed no cases having incurred restenosis. Plaque area at follow-up CAG was 52.0 ± 8.5% and luminal CSA was 9.5 ± 2.1 mm2. There were no cases undergoing target vessel revascularization (TVR) and target lesion revascularization (TLR) during the follow-up periods. PCI with DCA followed by DCB might be an effective strategy for de novo lesions.