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The concept of lifetime management has not been discussed in the field of percutaneous coronary intervention (PCI), because the durability of drug-eluting stent (DES) is considered to be long enough for most patients. Furthermore, even if in-stent restenosis occurs, the treatment for in-stent restenosis is simple in most cases. On the other hand, the long-term clinical outcomes after DES implantation are worse in severely calcified coronary lesions than in non-calcified lesions. Moreover, the treatment for in-stent calcified restenosis or restenosis due to stent underexpansion is not simple. The concept of lifetime management of severely calcified lesions may be necessary like that of aortic stenosis. Recently, several algorithms have been published in PCI to severely calcified lesions, partly because of the emergence of IVL. These algorithms focus on the selection of cracking and debulking devices for the preparation of stenting. However, the optimal stent expansion does not guarantee the long-term patency, when the target lesion includes calcified nodules. Stent restenosis due to calcified nodules is difficult to manage. In this review article, we propose the algorithm for severely calcified lesions focused on the shape of calcification. We do not need to hesitate stenting when multiple cracks on circumferential calcification are observed by intravascular imaging devices. However, DCB may be an option as final device in some situations, when lifetime management of severely calcified lesions is considered., (© 2023. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

Aims: Calcified nodule (CN) has been known as the advanced stage of coronary calcification. However, clinical outcomes following percutaneous coronary intervention (PCI) to CN remain unknown. This study aimed to compare clinical outcomes, including target lesion revascularization (TLR), between calcified coronary lesions with and without CN., Methods: Two hundred forty-nine lesions undergoing intravascular ultrasound-guided PCI with rotational atherectomy (RA) were enrolled and divided into the CN group (n=100) and the non-CN group (n=149) according to the presence of CN. The cumulative incidence of clinically driven TLR (CD-TLR) and the reasons for CD-TLR were compared between the CN and non-CN groups., Results: The incidence of CD-TLR was significantly higher in the CN group than in the non-CN group. In the landmark analysis at 1 year, the CN group showed a significantly higher incidence of CD-TLR within 1 year. However, the incidence of CD-TLR beyond 1 year was numerically lower in the CN group than in the non-CN group. In the multivariate Cox hazard model, CN was significantly associated with CD-TLR. In the CN group, in-stent CN was the major reason for CD-TLR (52%) and was observed mainly within 1 year (90%)., Conclusions: In the heavily calcified lesions requiring RA, CN was the factor associated with the higher rate of CD-TLR especially within 1 year. The timing of CD-TLR in lesions with CN may indicate that the process of CN protruding through the struts was progressed monthly.

Objectives: This study aimed to investigate the relationship between immediate incomplete stent apposition (ISA) detected by intravascular ultrasound (IVUS) and midterm stent failure., Background: Stent failure is one of serious clinical events related to percutaneous coronary intervention (PCI). The previous studies using optical coherence tomography showed that ISA could be associated with stent thrombosis. However, the association between immediate ISA detected by IVUS and stent failure has not been fully investigated., Methods: We included 396 lesions that underwent elective PCI, and divided those into the appropriate stent apposition (ASA) group (n = 290) and the ISA group (n = 106). The primary endpoint was stent failure, which was defined as a composite of ischemia-driven target lesion revascularization and stent thrombosis. We compared clinical and lesion characteristics between the two groups, and performed a multivariate COX hazard analysis to investigate the association between immediate ISA and stent failure., Results: The median follow-up duration was 1296 days. The Kaplan-Meier curves revealed the higher incidence of stent failure in the ISA group than in the ASA group (p < 0.001). The multivariate stepwise COX hazard analysis showed that immediate ISA (hazard ratio 4.97, 95% confidence interval 1.31-18.82, p = 0.018) was significantly associated with stent failure. When we set the cut-off value of the immediate ISA distance as 0.25 mm, the distance ≥ 0.25 mm had 68.8% sensitivity and 85.0% specificity to predict stent failure., Conclusions: Immediate ISA detected by IVUS was associated with midterm stent failure. We should pay attention to reduce immediate ISA for improving the midterm outcomes., (© 2022 Wiley Periodicals LLC.)

Percutaneous coronary intervention (PCI) is a standard strategy for non-ST-segment elevation myocardial infarction (NSTEMI) as well as for ST-segment elevation myocardial infarction (STEMI). The device cost for PCI may be more expensive in NSTEMI, because the culprit lesion morphology may be more complex in NSTEMI. This study aimed to compare the total device cost of PCI between STEMI and NSTEMI. We included 504 patients with acute myocardial infraction (AMI) who underwent PCI, and divided those into a STEMI group (n = 286) and a NSTEMI group (n = 218). We compared the total device cost, the number of used devices, and procedure cost between the 2 groups. The total device cost was significantly higher in the NSTEMI group [¥371,300 (¥320,700-503,350)] than in the STEMI group [¥341,200 (¥314,200-410,475)] (p = 0.001), whereas the procedure cost was significantly higher in the STEMI group [¥343,800 (¥243,800-343,800)] than in the NSTEMI group [¥220,000 (¥216,800-243,800)] (p < 0.001). Drug eluting stent (85.3% vs. 76.1%, p = 0.029) and aspiration catheter (16.8% vs. 2.3%, p < 0.001) were more frequently used in the STEMI group, whereas rotablator (0.7% vs. 8.3%, p < 0.001) were more frequently used in the NSTEMI group. The multivariate logistic regression analysis revealed that NSTEMI was significantly associated with the high device cost (odds ratio 1.899, 95% confidence interval 1.166-3.093, p = 0.01). In conclusion, the total device cost for PCI was significantly higher in the culprit lesions of NSTEMI than in those of STEMI, whereas the procedure cost was significantly higher in the culprit lesions of STEMI than in those of NSTEMI., (© 2021. Japanese Association of Cardiovascular Intervention and Therapeutics.)

Background: Stent edge dissection (SED) is a well-known predictor of worse clinical outcomes. However, impact of SED after current-generation drug-eluting stent (DES) implantation remains unknown since there was no study using only current-generation DES to assess impact of SED. This study aimed to investigate a relationship between SED detected by optical coherence tomography (OCT) and clinical outcomes after current-generation DES implantation., Methods: This study enrolled 175 patients receiving OCT after current-generation DES implantation. The SED group was compared with the non-SED group in terms of the primary study endpoints which was the cumulative incidence of major adverse cardiac event (MACE) composed of cardiac death, target vessel myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (CD-TLR)., Results: Of 175 patients, SED detected by OCT was observed in 32 patients, while 143 patients did not show SED. In the crude population, the SED group showed a significantly higher incidence of CD-TLR, definite stent thrombosis, TV-MI and cardiac death relative to the non-SED group. After adjustment by an inverse probability weighted methods, the SED group showed a significantly higher incidence of MACE compared with the non-SED group (hazard ratio 3.43, 95% confidence interval 1.09-10.81, p = 0.035). Fibrocalcific or lipidic plaques, greater lumen eccentricity, and stent-oversizing were the predictors of SED., Conclusions: SED detected by OCT after the current-generation DES implantation led to unfavorable outcomes. Aggressive post-dilatation around the stent edge might worse clinical outcomes due to SED, although achievement of optimal stent expansion is strongly encouraged to improve clinical outcomes., Competing Interests: Dr. Jinnouchi has received speaking honoraria from Abbott Vascular. Dr. Sakakura has received speaking honoraria from Abbott Vascular, Boston Scientific, Medtronic Cardiovascular, Terumo, OrbusNeich, Japan Lifeline, Kaneka, and NIPRO; he has served as a proctor for Rotablator for Boston Scientific, and he has served as a consultant for Abbott Vascular and Boston Scientific. Prof. Fujita has served as a consultant for Mehergen Group Holdings, Inc. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

A method to manage ST-segment elevated myocardial infarction (STEMI) caused by very late stent thrombosis (VLST) has yet to be established. In this case series, we present several cases of STEMI caused by VLST, which were successfully revascularized using a perfusion balloon. Since the perfusion balloon (Ryusei: Kaneka Medix Corporation, Osaka, Japan) has the unique advantage of maintaining blood flow during balloon inflation, we can keep dilating the target lesion for more than several minutes. Extended inflation might work to prevent acute recoil, and to achieve optimal expansion without an additional stent. Our case series may provide a reasonable option for the treatment of VLST.

Background: Stent thrombosis (ST) remains a severe complication following stent implantation. We previously reported the risk factors for ST after 2nd-generation drug-eluting stent (DES) in the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation DES Implantation) registry., Methods and results: In this subanalysis, we aimed to reveal the difference in ST between right coronary (RCA) and left (LCA) coronary arteries. A total of 307 patients with ST were divided into the RCA-ST group (n=93) and the LCA-ST group (n=214). Multivariate analysis revealed younger age (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.93-0.99, P=0.01), ostial lesion at the time of index percutaneous coronary intervention (OR 4.37, 95% CI 1.43-13.33, P=0.01), bifurcation lesion at the time of index PCI (OR 0.05, 95% CI 0.02-0.12, P<0.01), chronic total occlusion (CTO) lesion at the time of index PCI indication (OR 4.19, 95% CI 1.05-16.71, P=0.04), and use of prasugrel at the time of ST (OR 7.30, 95% CI 1.44-36.97, P=0.02) were significantly associated with RCA-ST., Conclusions: Younger age, ostial or CTO lesion, and use of prasugrel at the time of ST were prominent factors in RCA-ST, whereas bifurcation lesion was associated with LCA-ST. We should pay attention to the differences between RCA-ST and LCA-ST to prevent ST.

Background: Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04)., Conclusions: Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

Slow flow is a serious complication in primary percutaneous coronary intervention (PCI) and is associated with poor clinical outcomes. Intravascular ultrasound (IVUS)-guided PCI may improve clinical outcomes after drug-eluting stent implantation. The purpose of this study was to seek the factors of slow flow following stent implantation, including factors related to IVUS-guided primary PCI. The study population consisted of 339 ST-elevation myocardial infarction patients, who underwent stent deployment with IVUS. During PCI, 56 patients (16.5%) had transient or permanent slow flow. Multivariate logistic regression analysis showed age (OR 1.04, 95% CI 1.01-1.07, P = 0.01), low attenuation plaque on IVUS (OR 3.38, 95% CI 1.70-6.72, P = 0.001), initial Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 (vs. TIMI 0: OR 0.44, 95% CI 0.20-0.99, P = 0.046), and the ratio of stent diameter to vessel diameter (per 0.1 increase: OR 2.63, 95% CI 1.84-3.77, P < 0.001) were significantly associated with slow flow. A ratio of stent diameter to vessel diameter of 0.71 had an 80.4% sensitivity and 56.9% specificity to predict slow flow. There was no significant difference in ischemic-driven target vessel revascularization between the modest stent expansion (ratio of stent diameter to vessel diameter <0.71) and aggressive stent expansion (ratio of stent diameter to vessel diameter ≥0.71) strategies. Unlike other variables, the ratio of stent diameter to vessel diameter was the only modifiable factor. The modest stent expansion strategy should be considered to prevent slow flow following stent implantation in IVUS-guided primary PCI.

A 79-year-old male who had a history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) received coronary angiography (CAG), because of angina pectoris. CAG showed in-stent restenosis of the paclitaxel-eluting stent (PES). Since the devices could not pass the lesion, we performed rotational atherectomy. Although we could not identify the calcified lesion by the optical frequency domain imaging (OFDI) findings because of strong attenuation, the intravascular ultrasound (IVUS) image showed the superficial calcification. On the other hand, strong attenuation in OFDI suggested the presence of foamy macrophage, which was essential for the diagnosis of neoatherosclerosis. We could obtain a favorable result by deploying another drug-eluting stent. While an earlier report showed the calcified neoatherosclerosis following bare-metal stent implantation, we clearly showed the calcified neoatherosclerosis following PES implantation., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The optimal strategy for diffuse right coronary artery (RCA) stenosis remains unclear., Objective: The objective of this study was to compare the mid-term outcomes of "complete full-metal jacket (c-FMJ) stenting strategy" with "incomplete full-metal jacket (i-FMJ) stenting strategy" for the diffuse long RCA lesion using drug-eluting stents (DES)., Methods: Between July 2007 and October 2015, 121 patients underwent percutaneous coronary intervention (PCI) for diffuse RCA lesions using DES. Fifty-three patients underwent c-FMJ PCI, whereas 68 patients underwent i-FMJ. Thirty patients received angiographical follow-up in the c-FMJ group, while 34 patients received angiographical follow-up in the i-FMJ group. The primary endpoint was major adverse cardiac events (MACE): cardiac death, stent thrombosis (ST), target lesion revascularization (TLR), and target vessel revascularization (TVR)., Results: The incidence of MACE was significantly lower in the c-FMJ group (13.3%) as compared to the i-FMJ group (41.2%) (p=0.013). There was no cardiac death in either group. The incidence of ST was comparable between the i-FMJ group (2.9%) and c-FMJ group (3.3%) (p=1.00), while TLR was significantly less in the c-FMJ group (6.7%) compared to the i-FMJ group (32.4%) (p=0.011)., Conclusions: The mid-term MACE was significantly less in the c-FMJ group than in the i-FMJ group, indicating that c-FMJ stenting was a favorable strategy for the diffuse long RCA lesion., (Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

While rotational atherectomy (RA) is used for complex lesions in percutaneous coronary intervention, there are several contraindications such as unprotected left main stenosis or left ventricular dysfunction. We previously reported that the incidence of in-hospital complications was significantly greater in off-label as compared to on-label use RA. However, the mid-term clinical outcomes between off-label and on-label RA have not been investigated. The purpose of this study was to compare the mid-term clinical outcomes between off-label (n = 156) and on-label RA (n = 94). The primary endpoint was the incidence of major adverse cardiovascular events (MACE) defined as the composite of ischemia-driven target vessel revascularization (TVR), non-fatal MI, and all-cause death. We also identified 154 patients who underwent RA and follow-up angiography within 1 year, and compared quantitative coronary analysis between the off-label group (n = 96) and on-label group (n = 58). There was no significant difference in late luminal loss between the groups (0.03 ± 0.53 mm in the off-label and -0.05 ± 0.44 mm in the on-label groups, P = 0.57). However, the incidence of MACE was less in the on-label group (3.2 %) as compared to the off-label group (9.0 %) without reaching statistical significance (P = 0.08). In conclusion, mid-term clinical outcomes tended to be worse in the off-label group than in the on-label group. We may have to follow-up the patient who underwent off-label RA more carefully than the patient who underwent on-label RA.

Background: Treatment options for patients with coronary artery disease at high risk for bleeding complications are limited. The aim of the current preclinical study was to evaluate neointimal coverage, endothelial recovery, inflammation and thrombogenicity in a novel thin-strut (71μm thickness) Cobalt Chromium (CoCr) stent modified with a nano-thin Polyzene®-F (PzF) surface coating., Methods and Results: Twenty-eight single PzF nano-coated stents and 20 bare metal control stents (BMS) were implanted in the coronary arteries of 24 pigs, with scheduled 5- (n=5), 28- (n=13), and 90-day (n=6) follow-up in addition to overlapping configuration (n=6 each), examined at 28-days. Histomorphometric analysis showed significantly lower neointimal thickness in PzF nano-coated stents than BMS controls at both 28- and 90-days (p=0.023 and 0.005) and reduced inflammation (p=0.06 and 0.13). Endothelial coverage over luminal surfaces at all time points was similar between nano-coated stents and BMS controls. We conducted supplementary in-vitro experiments using human monocytes and an ex-vivo swine carotid-jugular arterio-venous shunt model to better understand the healing properties afforded by the PzF nano-coating. Overall, the PzF-nano-coating showed reduced monocyte adhesion and thrombus formation compared to the un-coated controls., Conclusions: Stents modified with a nano-thin PzF-coating implanted in healthy swine indicate favorable vascular healing properties shown by reduced neointimal hyperplasia and inflammation, along with resistance to thrombus formation in an ex-vivo shunt model over unmodified stents., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Rotational atherectomy to an angulated calcified lesion is always challenging. The risk of catastrophic complications such as a burr becoming stuck or vessel perforation is greater when the calcified lesion is angulated. We describe the case of an 83-year-old female suffering from unstable angina. Diagnostic coronary angiography revealed an angulated calcified lesion in the proximal segment of the right coronary artery. We performed rotational atherectomy to the lesion, but intentionally did not advance the rotational atherectomy burr beyond the top of the angulation. We controlled the rotational atherectomy burr and stopped it just before the top of the angulation to avoid complications. Following rotational atherectomy, balloon dilatation with a non-compliant balloon was performed, and drug-eluting stents were successfully deployed. In this manuscript, we provide a review of the literature on this topic, and discuss how rotational atherectomy to an angulated calcified lesion should be performed.

Objectives: This study sought to evaluate whether the permanent fluoropolymer-coated Xience Xpedition everolimus-eluting stent (Xience-EES) exhibits lower acute thrombogenicity compared with contemporary drug-eluting stents (DES) with biodegradable polymer coatings in an acute swine shunt model., Background: Previous pre-clinical and clinical experience suggests that several factors may influence the predisposition for acute thrombus formation of polymer-coated DES, including stent design and the polymer coating technology. It remains unclear whether relevant differences exist with respect to acute thrombogenicity, particularly between current commercial stent designs using permanent polymers and those using biodegradable polymers., Methods: An ex vivo carotid to jugular arteriovenous porcine shunt model involving a test circuit of 3 in-line stents, was used to test acute thrombogenicity, where Xience-EES (n = 24) was compared with 4 CE-marked DES with biodegradable polymer coatings (BioMatrix Flex, Synergy, Nobori, and Orsiro [n = 6 each]). After 1 h of circulation, platelet aggregation in whole mount stents was evaluated by confocal microscopy with immunofluorescent staining against dual platelet markers (CD61/CD42b) along with scanning electron microscopy., Results: Xience-EES showed the least percentage of thrombus-occupied area as compared with the biodegradable polymer-coated DES, with a significant difference compared with BioMatrix Flex and Synergy (mean differences: [BioMatrix Flex: 15.54, 95% confidence interval [CI]: 11.34 to 19.75, p < 0.001; Synergy: 8.64, 95% CI: 4.43 to 12.84, p < 0.001; Nobori: 4.22, 95% CI: -0.06 to 8.49, p = 0.055; Orsiro: 2.95, 95% CI: -1.26 to 7.15, p = 0.286). The number of cell nuclei on strut surfaces was also the least in Xience-EES, with a significant difference relative to BioMatrix Flex, Nobori, and Orsiro (mean ratios: BioMatrix Flex: 4.73, 95% CI: 2.46 to 9.08, p < 0.001; Synergy: 1.44, 95% CI: 0.75 to 2.76, p = 0.51; Nobori: 5.97, 95% CI: 3.11 to 11.44, p < 0.001; Orsiro: 5.16, 95% CI: 2.69 to 9.91, p < 0.001)., Conclusions: Xience-EES's overall design confers acute thromboresistance relative to contemporary DES with biodegradable coatings, with less platelet aggregation versus BioMatrix Flex and Synergy, and less inflammatory cell attachment versus BioMatrix Flex, Nobori, and Orsiro, in an ex vivo swine shunt model, which lends support to reported clinical findings of lower early stent thrombosis., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Clinical outcomes of implantation of the newer-generation drug-eluting stent (DES) following rotational atherectomy for heavily calcified lesions remain unclear in the real-world setting., Methods and results: We enrolled 252 consecutive patients (273 lesions) treated with newer-generation DES following rotational atherectomy. The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization, and definite stent thrombosis. Complete clinical follow-up information at 2-year was obtained for all patients. The mean age was 73.2±9.0 years and 155 patients (61.5%) were male. Cumulative 2-year incidence of MACE (cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis) was 20.3% (7.0%, 2.1%, 18.1% and 2.1%, respectively). Predictors of MACE were presenting with acute coronary syndrome (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.29-11.2, P=0.02), hemodialysis (HR: 1.93, 95% CI: 1.04-3.56, P=0.04) and previous coronary artery bypass graft (HR: 2.26, 95% CI: 1.02-5.00, P=0.045)., Conclusions: PCI for calcified lesions requiring rotational atherectomy is still challenging even in the era of newer-generation DES.

Objectives: The study interrogated an autopsy registry to investigate the histopathologic features of early stent thrombosis (ST) in patients presenting with acute coronary syndrome (ACS)., Background: The occurrence of early ST following percutaneous coronary intervention (PCI) for ACS remains a clinical problem despite advances in stent technology in both bare-metal and drug-eluting stents., Methods: Sixty-seven stented coronary lesions from 59 patients who presented with ACS and died within 30 days were included. Stented segments were cross sectioned at 3 to 4 mm intervals and evaluated by light microscopy, and morphometric analysis was performed., Results: Early ST (<30 days of PCI) was identified in 34 (58%) of the 59 patients. Early ST was dependent on the underlying plaque morphology and underlying thrombus burden: presence of necrotic core prolapse was more frequent in thrombosed lesions compared with patent lesions (70% vs. 43%, p = 0.045) and maximal underlying thrombus thickness was significantly greater in thrombosed versus patent lesions. All 3 patients with false lumen stenting had ST. Detailed analysis revealed that the percent of necrotic core prolapse, medial tear, or incomplete apposition was significantly greater in the early ST compared with patent group (28% vs.11%, p < 0.001; 27% vs. 15% p = 0.004; and 34% vs. 18% p = 0.008, respectively). Multivariate analysis revealed that maximal depth of strut penetration, % strut with medial tear, and % struts with incomplete apposition were the primary indicators of early ST., Conclusions: The current autopsy study highlights the impact of thrombus burden and suboptimal stent implantation in unstable lesions as a trigger of early ST, suggesting that improvement in implantation technique and refinement of stent design may improve clinical outcomes of ACS patients., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Since drug-eluting stents (DESs) appeared in Japan, coronary artery bypass grafting (CABG) has been indicated for more severe lesions. To understand the implications of this trend, we compared SYNTAX scores in two groups of patients treated with CABG before and after DESs approval., Methods: Consecutive CABG patients during January 2001-July 2003 (pre-DES era patients, n = 160) and January 2008-July 2010 (DES era patients, n = 103) were included. The SYNTAX scores of both groups were compared and a cardiologist retrospectively re-evaluated coronary angiograms to determine whether CABG or percutaneous coronary intervention (PCI) would be recommended under current standards., Results: SYNTAX scores were significantly higher in DES era group compared with pre-DES era group (33.3 ± 10.6 vs. 28.1 ± 10.6, p < 0.01). Percutaneous coronary intervention would be the preferred treatment option in 66 (41 %) of pre-DES patients, whose SYNTAX scores were significantly lower than those of patients who were considered good candidates for CABG (21.9 ± 9.3 vs. 32.5 ± 9.1, p < 0.01)., Conclusions: Although CABG is now being performed in intermediate-to-highly complex cases, DES era outcomes, including operative mortality and early graft failure, have not worsened in comparison to the pre-DES era.

Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months., Methods and Results: A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months., Conclusions: Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥ 36 months. Resorption is considered complete at 36 months., (© 2014 American Heart Association, Inc.)

Background: Clinical trials have demonstrated that the second-generation cobalt-chromium everolimus-eluting stent (CoCr-EES) is superior to the first-generation paclitaxel-eluting stent (PES) and is noninferior or superior to the sirolimus-eluting stent (SES) in terms of safety and efficacy. It remains unclear whether vascular responses to CoCr-EES are different from those to SES and PES because the pathology of CoCr-EES has not been described in humans., Methods and Results: A total of 204 lesions (SES=73; PES=85; CoCr-EES=46) from 149 autopsy cases with duration of implantation >30 days and ≤3 years were pathologically analyzed, and comparison of vascular responses was corrected for duration of implantation. The observed frequency of late and very late stent thrombosis was less in CoCr-EES (4%) versus SES (21%; P=0.029) and PES (26%; P=0.008). Neointimal thickness was comparable among the groups, whereas the percentage of uncovered struts was strikingly lower in CoCr-EES (median=2.6%) versus SES (18.0%; P<0.0005) and PES (18.7%; P<0.0005). CoCr-EES showed a lower inflammation score (with no hypersensitivity) and less fibrin deposition versus SES and PES. The observed frequency of neoatherosclerosis, however, did not differ significantly among the groups (CoCr-EES=29%; SES=35%; PES=19%). CoCr-EES had the least frequency of stent fracture (CoCr-EES=13%; SES=40%; PES=19%; P=0.007 for CoCr-EES versus SES), whereas fracture-related restenosis or thrombosis was comparable among the groups (CoCr-EES=6.5%; SES=5.5%; PES=1.2%)., Conclusions: CoCr-EES demonstrated greater strut coverage with less inflammation, less fibrin deposition, and less late and very late stent thrombosis compared with SES and PES in human autopsy analysis. Nevertheless, the observed frequencies of neoatherosclerosis and fracture-related adverse pathological events were comparable in these devices, indicating that careful long-term follow-up remains important even after CoCr-EES placement.

Drug-eluting stents (DES) have proven to be effective for reducing the rate of restenosis, whereas stent thrombosis (ST) after DES implantation has raised safety concerns. Everolimus-eluting stents (EES) are a new generation of DES that have demonstrated safety and efficacy compared with first-generation DES. However, the use of EES in patients presenting with acute coronary syndrome (ACS) has not been adequately investigated. We compared the clinical outcomes between the ACS and non-ACS groups treated with EES. A total of 335 consecutive patients who received EES implantation between January 2010 and January 2011 were investigated (ACS; n = 172, non-ACS; n = 163). Clinical outcome data were obtained for 94.3% of the patients. Follow-up angiography was performed in 58.5% of all patients. The median follow-up period was 8 months in both groups. Clinical outcomes were not statistically different between the groups. The rate of target lesion revascularization (TLR) was 2.5% in the ACS group and 3.8% in the non-ACS group (P = 0.37). MACE occurred in 8.2% of the ACS group and 10.2% of the non-ACS group (P = 0.54). A definite ST was identified in one patient in each group (P = 0.75). The unadjusted cumulative event rates estimated by the Kaplan-Meier method and the log-rank test showed no significant difference between the groups for TLR, target vessel revascularization (TVR), all-cause death, or MACE. In conclusion, EES was safe and efficacious for patients presenting with ACS, as well as for those with non-ACS during a mid-term follow-up period.

Rotational atherectomy (RA) can facilitate smooth stent delivery and stent expansion through lesion modification for a calcified coronary lesion. Several studies reported that sirolimus-eluting stent (SES) implantation following RA showed a lower rate of revascularization compared with bare-metal stents (BMS). However, there are limited data that compared the clinical outcomes between SES and paclitaxel-eluting stents (PES) after RA. We compared the long-term clinical outcomes of SES and PES following RA. Two hundred and thirty-three consecutive patients (SES n = 179, PES n = 54) who were treated with SES or PES following RA between 10 th September 2004 and 13 th April 2010 were investigated. Follow-up data for clinical outcomes were obtained in 91.4% of all subjects. The median follow-up period was 630 days (interquartile range, 300 to 1170 days) in the SES group, and 625 days (interquartile range, 285 to 900 days) in the PES group. Clinical outcomes including target lesion revascularization (TLR) (SES 4.9% versus PES 9.8%, P = 0.31), target vessel revascularization (TVR) (SES 6.8% versus PES 11.8%, P = 0.25), and major adverse cardiac events (MACE) (SES 14.8% versus PES 13.7%, P = 0.8) were not statistically different between the groups. The unadjusted cumulative event rates estimated by the Kaplan-Meier method and the log-rank test showed no significant differences between the two groups for time to event for TLR, cardiovascular death, all-cause death, or MACE. In conclusion, there was no significant difference in the long-term clinical outcomes between SES and PES following RA.

Background and Objective: Drug-eluting stents have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) compared with bare metal stents (BMSs); however, the long-term efficacy of sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) has not been well established. We have investigated the long-term clinical outcome of SES in patients with ACS., Methods: Consecutive 245 patients with ACS treated by primary stenting within 24 hours after onset were enrolled. There were 128 patients treated with SES and 117 patients were treated with BMS. We evaluated the incidence of major cardiac events (MACE; total death, nonfatal myocardial infarction, TVR) at 3 years, comparing with 8-month clinical outcome., Results: Eight-month clinical follow-up shows a significantly lower incidence of TVR in the SES group, 3.1% in the SES group versus 9.4% in the BMS group (P = 0.04). At 3-year clinical follow-up, there was no significant difference in the rate of TVR between the two groups, 8.4% versus 12.4% (P = 0.37). Cumulative incidence of total MACE was 9.2% in the SES group compared with 15.9% in the BMS group (P = 0.18). Only one case of stent thrombosis was observed in the SES (late thrombosis), while two cases of stent thrombosis occurred in the BMS group (late and very late thrombosis; P = 0.55)., Conclusion: SES implantation in patients with ACS is associated with favorable long-term clinical outcome with no excess of late stent thrombosis. Further long-term clinical follow-up will be warranted to confirm the safety and efficacy of SES.

Background: Recent guidelines for ST-elevation myocardial infarction (STEMI) recommended the door-to-balloon time (DTBT) <90 minutes. However, some patients could have poor clinical outcomes in spite of DTBT <90 minutes, which suggest the importance of therapeutic targets except DTBT. The purpose of this study was to find factors associated with poor clinical outcomes in STEMI patients with DTBT <90 minutes. Methods: This retrospective study included 383 STEMI patients with DTBT <90 minutes. The primary endpoint was the major adverse cardiac events (MACE) defined as the composite of all-cause death, acute myocardial infarction, and acute heart failure requiring hospitalization. Result: The median follow-up duration was 281 days, and the cumulative incidence of MACE was 16.2%. In the multivariate Cox hazard model, low body mass index (< 20 kg/m2) (vs. >20 kg/m2: HR 2.80, 95% CI 1.39–5.64, p = 0.004), history of previous myocardial infarction (HR 2.39, 95% CI 1.06–5.37, p = 0.04), and Killip class 3 or 4 (vs. Killip class 1 or 2: HR 2.39, 95% CI 1.30–4.40, p = 0.005) were significantly associated with MACE. In another multivariate Cox hazard model, flow worsening during percutaneous coronary intervention (PCI) (HR 3.24, 95% CI 1.79–5.86, p<0.001) and use of mechanical support (HR 3.15, 95% CI 1.71–5.79, p<0.001) were significantly associated with MACE, whereas radial approach (HR 0.54, 95% CI 0.32–0.92, p = 0.02) was inversely associated with MACE. Conclusion: Low body mass index, Killip class 3/4, history of previous myocardial infarction, use of mechanical support, and flow worsening were significantly associated with MACE, whereas radial-access was inversely associated with MACE. It is important to avoid flow worsening during primary PCI even when appropriate DTBT was achieved. [ABSTRACT FROM AUTHOR]