Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

BACKGROUND: There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years. AIMS: We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. METHODS: The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES. RESULTS: From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. CONCLUSIONS: The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.

Impact of Periprocedural Myocardial Infarction on 10-Year Mortality After Coronary Stent Implantation in Patients With Diabetes Mellitus.

The long-term prognostic implication of periprocedural myocardial infarction (PMI) after coronary stent implantation in patients with diabetes mellitus (DM) remains unclear. We assessed the incidence and size of PMI and the impact of PMI on 10-year all-cause and cardiac deaths using competing risk analysis in 1,095 patients, including 453 patients with DM. All patients had normal preprocedural creatinine kinase-myocardial band levels and underwent their first elective sirolimus-eluting stent implantation for stable angina pectoris. Comparing patients with and without DM, the incidence of PMI was 4.4% versus 5.9% (p = 0.34) and the size of PMI (median of postprocedural peak creatinine kinase-myocardial band) was 34.6 versus 31.6 IU/L (p = 0.58). The cumulative incidence of 10-year all-cause and cardiac deaths significantly differed between patients with and without PMI only in patients with DM (log-rank p = 0.03 and Gray's test p = 0.014, respectively). In the multivariable analysis using the Fine-Gray model, PMI was a significant prognostic factor for cardiac death only in patients with DM (hazard ratio 3.82, 95% confidence interval 1.57 to 9.30, p = 0.003). In conclusion, the incidence and size of PMI did not significantly differ between patients with and without DM. However, PMI was a significant prognostic factor for 10-year all-cause and cardiac deaths only in patients with DM who underwent elective sirolimus-eluting stent implantation.

Trends in prognosis after hospitalization for acute heart failure in Kurashiki Central hospital 2015-2018: single-center prospective study.

Recently, we have been working on enhancing the effectiveness of treatment for acute heart failure (HF) through team-based care. This study was designed to assess the benefits of this initiative by quantifying the prognostic impact on HF patients receiving treatment at our hospital. We identified 1977 consecutive HF patients (mean age 78.3 ± 11.9 years) being discharged from our hospital between February 2015 and December 2018, divided them by admission year, and tracked changes over time, with 2015 as a reference. The postdischarge clinical outcome measures were defined as a composite of all-cause death or rehospitalization for HF, all-cause death, and rehospitalization for HF. The risk of a composite of all-cause death or rehospitalization for HF was lower in 2017 (adjusted hazard ratio, 0.72; 95% confidence interval: 0.57 to 0.91; p = 0.005) and 2018 (adjusted hazard ratio, 0.78; 95% confidence interval: 0.61 to 0.99; p = 0.045) than in 2015, and that of all-cause death was lower in 2017 (adjusted hazard ratio, 0.72; 95% confidence interval: 0.53 to 0.98; p = 0.04) and 2018 (adjusted hazard ratio, 0.60; 95% confidence interval: 0.43 to 0.85; p = 0.004) than in 2015, but that of rehospitalization for HF was not significantly different through the study period. The mortality rate decreased at the end of the study period, but the rate of rehospitalization for HF did not. The benefits of team-based care were difficult to evaluate by quantification.

Appropriateness of Percutaneous Coronary Intervention Performed by Japanese Expert Operators in Patients With Chronic Total Occlusion.

BACKGROUND: The appropriateness of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions has rarely been investigated.Methods and Results: The Japanese CTO-PCI Expert Registry enrolled consecutive patients undergoing CTO-PCI carried out by highly experienced Japanese CTO specialists who performed more than 50 CTO-PCIs per year and 300 CTO-PCIs in total. This study included patients undergoing CTO-PCI between January 2014 and December 2019. The appropriateness, trends, and differences among the procedures performed by the operators using the 2017 appropriate use criteria were analyzed. Furthermore, we performed a logistic regression analysis to assess whether the appropriateness was associated with in-hospital major adverse cardiovascular and cerebrovascular events (MACCE). Of the 5,062 patients who underwent CTO-PCI, 4,309 (85.1%) patients who did not undergo the non-invasive stress test were classified as having no myocardial ischemia. Of the total cases, 3,150 (62.2%) were rated as "may be appropriate," and 642 (12.7%) as "rarely appropriate" CTO-PCI cases. The sensitivity analyses showed that the number (%) of "may be appropriate" ranged from 4,125 (57.8%) to 4,744 (66.4%) and the number of "rarely appropriate" ranged from 843 (11.8%) to 970 (13.6%) among best and worst scenarios. CONCLUSIONS: In a large Japanese CTO-PCI registry, approximately 13% of CTO-PCI procedures were classified as "rarely appropriate". Substantial efforts would be required to decrease the number of "rarely appropriate" CTO-PCI procedures.

Renal cortex thickness and changes in renal function after transcatheter aortic valve implantation.

BACKGROUND: The association between renal morphological findings and changes in renal function in patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. AIMS: We aimed to investigate the association between renal morphological findings and changes in renal function in patients undergoing TAVI. METHODS: Among 283 consecutive patients undergoing TAVI between 2018 and 2021, the study sample included 224 patients. Renal morphological measurements were performed by preoperative multidetector computed tomography. Estimated glomerular filtration rate (eGFR) improvement and deterioration were defined as positive or negative changes in an eGFR of ≥10% one month after TAVI. The renal cortex thickness index was defined as the ratio of total renal cortex thickness to body surface area. RESULTS: The incidences of eGFR improvement and deterioration were 33.9% and 24.1%, respectively. The renal cortex thickness index had a significant correlation with changes in eGFR (r=0.34, p<0.01). The index of the area under the curve of renal cortex thickness for eGFR improvement and deterioration were 0.73 and 0.68, respectively. The cut-off values were 5.82 mm/m2 for eGFR improvement (odds ratio [OR]: 0.10; 95% confidence interval: 0.05-0.20; p<0.01) and 4.89 mm/m2 for eGFR deterioration (OR: 9.07; 95% confidence interval: 4.55-18.6; p<0.01). CONCLUSIONS: The renal cortex thickness index was associated with changes in renal function in patients who underwent TAVI. Its measurements might be useful for predicting the renal function change in patients undergoing TAVI.

Outcomes at 1 Year of Non-Left Main Trunk Bifurcation Lesions Treated With a 2-Stent Strategy Using Newer-Generation Everolimus-Eluting Stents.

BACKGROUND: Percutaneous coronary intervention (PCI) for coronary bifurcation lesions using the 2-stent strategy remains a challenging procedure for interventionalists because of the higher incidence of in-stent restenosis (ISR) and adverse events. ISR predictors in patients treated with newer-generation everolimus-eluting stents (EES) and the 2-stent strategy remain unknown. Hence, we aimed to evaluate the 1-year clinical and angiographic outcomes of non-left main trunk (LMT) bifurcation lesions treated with the 2-stent strategy using newer-generation EES.Methods and Results:The study sample consisted of 262 non-LMT bifurcation lesions treated using culotte or T-stenting with EES between 2010 and 2018. One-year post-procedural angiographic and clinical examinations were conducted in 208 (79.4%) and 260 (99.2%) lesions, respectively. The primary outcome measure was the 1-year post-procedural ISR rate, which was found to be 15.9%. Independent predictors of 1-year post-procedural ISR were long side branch lesions (adjusted odds ratio [aOR] 2.31; 95% confidence interval [CI] 1.02-5.23; P=0.04) and 3-link EES implantation (aOR 2.45; 95% CI 1.07-5.61; P=0.03). The 1-year cumulative incidence of target lesion revascularization was 3.5%. CONCLUSIONS: The 1-year clinical outcomes of non-LMT bifurcation lesions treated with the 2-stent strategy using EES were acceptable. Long side branch lesions and lesions treated with 3-link EES were independent predictors of 1-year post-procedural ISR.

Admission systolic blood pressure as a prognostic predictor of acute decompensated heart failure: A report from the KCHF registry.

BACKGROUND: Admission systolic blood pressure has emerged as a predictor of postdischarge outcomes of patients with acute decompensated heart failure; however, its validity in varied clinical conditions of this patient subset is unclear. The aim of this study was to further explore the prognostic value of admission systolic blood pressure in patients with acute decompensated heart failure. METHODS: The Kyoto Congestive Heart Failure (KCHF) registry is a prospective, observational, multicenter cohort study enrolling consecutive patients with acute decompensated heart failure from 19 participating hospitals in Japan. Clinical characteristics at baseline and prognosis were examined by the following value range of admission systolic blood pressure: <100, 100-139, and ≥140 mmHg. The primary outcome measure was defined as all-cause death after discharge. Subgroup analyses were done for prior hospitalization for heart failure, hypertension, left ventricular ejection fraction, and medications at discharge. We excluded patients with acute coronary syndrome or insufficient data. RESULTS: We analyzed 3564 patients discharged alive out of 3804 patients hospitalized for acute decompensated heart failure. In the entire cohort, lower admission systolic blood pressure was associated with poor outcomes (1-year cumulative incidence of all-cause death: <100 mmHg, 26.8%; 100-139 mmHg, 20.2%; and ≥140 mmHg, 15.1%, p<0.001). The magnitude of the effect of lower admission systolic blood pressure for postdischarge all-cause death was greater in patients with prior hospitalization for heart failure, heart failure with reduced left ventricular ejection fraction, and ß-blocker use at discharge than in those without. CONCLUSIONS: Admission systolic blood pressure is useful for postdischarge risk stratification in patients with acute decompensated heart failure. Its magnitude of the effect as a prognostic predictor may differ across clinical conditions of patients.

Impact of high-dose statin on cardiovascular outcomes in real-world patients with ST-elevation acute myocardial infarction.

Little is known about the impact of a high-dose statin on cardiovascular outcomes after ST-elevation acute myocardial infarction (STEMI) in real-world Japanese patients. Between July 2011 and June 2017, 1110 consecutive STEMI patients underwent primary percutaneous coronary intervention at our hospital and were discharged. A high-dose statin was administered in 117 patients (10.5%) and non-high-dose statin was administered in 947 patients (85.3%). The low-density lipoprotein cholesterol level was significantly higher in the high-dose statin group at admission (129.8 ± 44.9 vs. 110.4 ± 32.7, p < 0.0001), but the levels were not significantly different at follow-up (86.7 ± 25.7 vs. 85.0 ± 25.0, p = 0.52). The cumulative 2-year incidence of a composite of cardiac death, myocardial infarction, ischemic stroke, and any unplanned coronary revascularization was significantly lower in the high-dose statin group (6.2% vs. 16.9%, log-rank p = 0.004). Propensity score matched analysis indicated similar results. Among the types of coronary revascularization, a high-dose statin was significantly correlated with a lower rate of de novo lesion revascularization (hazard ratio 0.31; 95% confidence interval 0.08-0.83; p = 0.02). The results of our analyses indicate that administration of a high-dose statin may result in better cardiovascular outcomes after STEMI mainly by reducing the rate of revascularization for de novo lesions regardless of the achieved low-density lipoprotein cholesterol level in real-world patients.

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Effects of Carperitide on Degree of Pulmonary Congestion in Treatment of Acute Heart Failure.

BACKGROUND: Carperitide is used to treat acute heart failure (AHF) in Japan. Whether the degree of pulmonary congestion is associated with the effects of carperitide on AHF is unclear.Methods and Results:We retrospectively investigated the in-hospital outcomes and prognoses of 742 patients hospitalized for AHF between February 2015 and January 2017 and classified them into carperitide and non-carperitide groups, stratified according to the degree of pulmonary congestion. The median follow-up duration after admission was 231 days. In patients with moderate-severe pulmonary congestion, the rate of remaining congestion on chest X-ray at discharge was lower in the carperitide group than in the non-carperitide group (1.5% vs. 9.0%, P=0.004). Also, the carperitide group had significant reduction in a composite of all-cause death or rehospitalization for HF (adjusted hazard ratio, 0.62; 95% CI: 0.41-0.93; P=0.02). In patients with no-mild pulmonary congestion, carperitide was not associated with better clinical outcome. CONCLUSIONS: In the treatment of AHF with moderate-severe pulmonary congestion, carperitide is associated with more effective decongestion in the short term and better prognosis in the long term.

In-Hospital Bleeding and Utility of a Maintenance Dose of Prasugrel 2.5 mg in High Bleeding Risk Patients With Acute Coronary Syndrome.

BACKGROUND: Data on bleeding events in Japanese patients with acute coronary syndrome (ACS) are insufficient. In addition, the efficacy and safety of a maintenance dose of prasugrel 2.5 mg/day in high bleeding risk patients are unknown.Methods and Results:We prospectively enrolled 1,167 consecutive patients with suspected ACS and undergoing percutaneous coronary intervention. The maintenance dose of prasugrel 2.5 mg/day was prescribed for patients with a low body weight (≤50 kg), elderly (≥75 years), or renal insufficiency (eGFR ≤30 mL/min/1.73 m2). In-hospital events were assessed in 992 ACS patients treated with drug-eluting stents. Excluding 29 in-hospital deaths, out-of-hospital events were assessed in 963 ACS patients. The primary safety outcome measure was major bleeding (Bleeding Academic Research Consortium types 3 and 5). The incidence of in-hospital major bleeding was 3.4%. Multivariate analysis showed that being elderly, low body weight, renal insufficiency, stroke history, femoral approach, and mechanical support usage were independent predictors of in-hospital major bleeding. The cumulative 1-year incidence of out-of-hospital major bleeding was not significantly different between the prasugrel 2.5 mg/day (n=284) and 3.75 mg/day (n=487) groups (1.6% vs. 0.7%, log-rank P=0.24). That of out-of-hospital definite or probable stent thrombosis was 0% in both groups. CONCLUSIONS: The maintenance dose of adjusted prasugrel 2.5 mg/day seems to be one option in ACS patients at high bleeding risk.

Relationship between n-3 Polyunsaturated Fatty Acids and Extent of Vessel Disease in Patients with ST Elevation Myocardial Infarction.

A relationship between serum polyunsaturated fatty acids (PUFAs) and cardiovascular disease has been reported; however, the existence of a relationship between serum PUFAs and extent of vessel disease (VD) in patients with ST elevation myocardial infarction (STEMI) remains unclear.Between July 2011 and June 2015, 866 consecutive STEMI patients underwent emergent percutaneous coronary intervention, 507 of whom were enrolled and classified into three groups according to the initial angiograms: 1VD, 294 patients; 2VD, 110 patients; and 3VD/left main trunk disease (LMTD), 103 patients. Serum levels of PUFAs, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid, and other laboratory data during hospitalization were evaluated.The serum EPA level in the 3VD/LMTD group was significantly lower than that in the 1VD group (55.5 ± 22.1 versus 66.2 ± 28.7, P = 0.002) and was slightly lower than that in the 2VD group (55.5 ± 22.1 versus 65.2 ± 28.9, P = 0.0167). Multivariate adjustment analysis revealed that age ≥ 70 years (odds ratio, 1.72; 95% confidence interval, 1.03-2.89; P = 0.038) and a low serum EPA level (odds ratio, 0.98; 95% confidence interval, 0.99-1.00; P = 0.023) were independent risk factors for 3VD/LMTD, while a low serum DHA level was not.A low serum EPA level may be more strongly related than a low serum DHA level to the extent of VD in STEMI patients. Age ≥ 70 years and a low serum EPA level may be independent risk factors for 3VD/LMTD.

Long-term (8-10†years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation.

OBJECTIVE: Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8-10 years) clinical and angiographic outcomes after BP-BES implantation. METHODS: Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years). RESULTS: The median follow-up duration was 9.4 years (IQR 8.2-10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort. CONCLUSIONS: The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.

Predictors of Worsening Renal Function in Patients With Acute Decompensated Heart Failure Treated by Low-Dose Carperitide.

BACKGROUND: Predictors of worsening renal function (WRF: increase in serum creatinine ≥ 0.3 mg/dl from the value on admission) in patients with acute decompensated heart failure (ADHF) treated by low-dose carperitide (0.01-0.05 µg/kg/min) are unclear. METHODS AND RESULTS: We retrospectively investigated predictors of WRF within the first 24 h of low-dose carperitide therapy in 205 patients (mean age, 75.6 ± 12.1 years) hospitalized for ADHF and treated with low-dose carperitide between January 2006 and April 2014. WRF occurred in 14 patients (7%). A multivariate adjustment analysis showed that independent predictors of WRF within 24 h were hypotension (systolic blood pressure <90 mmHg) within 12 h (odds ratio, 8.7; 95% confidence interval, 2.38-35.88; P=0.0012) and serum creatinine on admission (odds ratio, 3.64; 95% confidence interval, 1.84-7.67; P=0.0003). In patients with estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m(2), the rate of WRF occurrence was higher in those complicated by hypotension than in those without hypotension (22.6% [7/31 patients] vs. 4.4% [5/113 patients], P=0.0041). In contrast, in patients with eGFR ≥ 60 ml/min/1.73 m(2), hypotension did not influence the occurrence of WRF (0% [0/9 patients] vs. 3.9% [2/51 patients], P=NS). CONCLUSIONS: Hypotension within 12 h and renal dysfunction on admission are independent predictors of WRF within 24 h in patients with ADHF treated by low-dose carperitide. Hypotension may not cause WRF in patients with eGFR ≥ 60 ml/min/1.73 m(2).

Stent Fracture After Sirolimus-Eluting Stent Implantation: 8-Year Clinical Outcomes.

BACKGROUND: Stent fracture (SF) after sirolimus-eluting stent implantation is reported to be associated with target lesion revascularization (TLR) and stent thrombosis. We aimed to assess the clinical impact of SF at 8 years. METHODS AND RESULTS: Between 2002 and 2005, 972 patients (1795 lesions) underwent sirolimus-eluting stent implantation and follow-up angiography within 1 year after index procedure. SF, defined as the complete separation of stent segments or stent struts at follow-up angiography, was observed in 105 lesions (5.8%). The study sample comprised 954 patients (1630 lesions), excluding 147 lesions undergoing TLR and 18 patients (18 lesions) who died or in whom stent thrombosis developed within 1 year after sirolimus-eluting stent implantation. The median follow-up duration was 9.1 years (the first and third quarters, 8.7 and 9.4 years). The primary end point was defined as any TLR. The 8-year cumulative rates of adverse events were estimated by Kaplan-Meier methods with P values from log-rank tests. Between patients with and without SF, there were no significant differences in the cumulative rates of all-cause death (23.5% versus 27.6%, P=0.35) and cardiac death (4.7% versus 9.1%, P=0.14), whereas patients with SF had significantly higher cumulative rates in myocardial infarction (10.1% versus 3.3%, P=0.001), very late stent thrombosis (6.8% versus 0.7%, P<0.001), any TLR (38.1% versus 10.8%, P<0.001), and clinically driven TLR (26.2% versus 6.6%, P<0.001). CONCLUSIONS: SF after sirolimus-eluting stent implantation was consistently associated with higher rates of adverse cardiac events during the 8-year follow-up.

Association between tissue characteristics assessed with optical coherence tomography and mid-term results after percutaneous coronary intervention for in-stent restenosis lesions: a comparison between balloon angioplasty, paclitaxel-coated balloon dilatation, and drug-eluting stent implantation.

AIMS: Morphological assessment of neointimal tissue using optical coherence tomography (OCT) is important for clarifying the pathophysiology of in-stent restenosis (ISR) lesions. The aim of this study was to determine the impact of OCT findings on recurrence of ISR after various types of percutaneous coronary intervention (PCI) including plain old balloon angioplasty (POBA), paclitaxel-coated balloon (PCB) dilatation, and drug-eluting stent (DES) implantation. METHODS AND RESULTS: Between June 2008 and August 2013, we performed PCI for 428 ISR lesions in 379 patients using POBA (78 lesions, POBA group), PCB dilatation (202 lesions, PCB group), and DES implantation (148 lesions, DES group). Morphological assessment of neointimal tissue at the minimum lumen area site to determine restenotic tissue structure (homogeneous, heterogeneous, or layered type) using OCT was performed. We examined the association between tissue structure and midterm results including ISR and target lesion revascularization (TLR) rates. The patients were 308 men and 71 women with a mean age of 68.9 ± 9.4 years. The mean follow-up period was 211 ± 40 days. ISR and TLR rates of lesions with a homogeneous structure were significantly higher in the POBA group than in the PCB group (ISR: 54.8 vs. 19.1%, P < 0.001; TLR: 38.7 vs. 10.6%, P < 0.001) and DES group (ISR: 54.8 vs. 19.6%, P = 0.002; TLR: 38.7 vs. 10.7%, P = 0.005), whereas there were no differences in ISR and TLR rates between the three groups in lesions with a heterogeneous structure. CONCLUSION: Morphological assessment of ISR tissue using OCT might suggest favourable types of PCI for ISR lesions.

Everolimus-eluting stent implantation versus repeat paclitaxel-coated balloon angioplasty for recurrent in-stent restenosis lesion caused by paclitaxel-coated balloon failure.

AIMS: Although paclitaxel-coated balloon (PCB) angioplasty has been reported to be effective for in-stent restenosis (ISR) lesions, the optimal treatment for recurrent ISR lesions caused by PCB failure remains unclear. This study compared clinical and angiographic outcomes after everolimus-eluting stent (EES) implantation and repeat PCB angioplasty for PCB failure. METHODS AND RESULTS: From November 2008 to October 2011, we performed PCB angioplasty for 599 ISR lesions, of which 93 recurrent ISR lesions underwent EES implantation (53 lesions, 52 patients) or repeat PCB angioplasty (40 lesions, 37 patients). The choice of treatment strategy was decided at the operatorÕs discretion. Angiographic outcomes were evaluated by follow-up angiography at six to eight months after procedure. The baseline characteristics were similar between the two groups. At follow-up angiography (93.5% of all lesions), minimum lumen diameter was significantly larger and the binary restenosis rate was significantly lower after EES implantation than after repeat PCB angioplasty (2.08±0.79 mm vs. 1.45±0.68 mm, p<0.001; 20.0% vs. 54.1%, p=0.001; respectively), whereas late lumen loss was not different between the two groups (0.49±0.62 mm vs. 0.59±0.74 mm, p=0.47). At two years, the incidences of both target lesion revascularisation (TLR) and clinically driven TLR were significantly lower after EES implantation than after repeat PCB angioplasty (17.9% vs. 57.5%, p=0.001; 5.9% vs. 18.1%, p=0.01; respectively). CONCLUSIONS: EES implantation was more effective for PCB failure in preventing subsequent TLR than repeat PCB angioplasty because of better angiographic results.

Clinical and angiographic outcomes after drug-eluting stent implantation with triple-kissing-balloon technique for left main trifurcation lesion: comparison of single-stent and multi-stent procedures.

OBJECTIVES: This study evaluated clinical and angiographic outcomes after drug-eluting stent (DES) implantation with triple-kissing-balloon technique (triple-KBT) for left main (LM) trifurcation lesions and compared them between single-stent and multi-stent procedures. BACKGROUND: The triple-KBT is a challenging strategy to treat LM trifurcation lesions with both single-stent and multi-stent procedures, and its outcomes after DES implantation were unknown. METHODS: We evaluated 72 patients who underwent triple-KBT after DES implantation for LM trifurcation lesions from April 2005 to October 2012, and compared the clinical and angiographic outcomes between 45 patients in the single-stent group and 27 patients in the multi-stent group. Patients with 2 or 3 stents implanted were included in the multi-stent group. RESULTS: Procedural success was obtained in 93.1% of all patients, with no in-hospital death, myocardial infarction, and target lesion revascularization (TLR). The median follow-up duration was 838 days. The incidence of all-cause death at 3 years was 8.6%, and there was no significant difference between the single-stent and multi-stent groups (8.0% vs. 9.7%; P=.82). There were no patients with myocardial infarction or stent thrombosis. The incidence of TLR at 3 years was 14.5%, and it was significantly higher in the multi-stent group (31.3%) than in the single-stent group (4.6%; P=.01). No incidence of TLR was observed beyond 1 year in both groups. CONCLUSION: DES implantation with triple-KBT was a safe and feasible technique for LM trifurcation lesion. The favorable clinical outcomes could be achieved by single-stent procedure compared with multi-stent procedure.

Low systolic blood pressure on admission predicts mortality in patients with acute decompensated heart failure due to moderate to severe aortic stenosis.

BACKGROUND: We investigated the relationship between admission systolic blood pressure (SBP) and all-cause mortality in patients hospitalized for acute decompensated heart failure (ADHF) because of aortic stenosis (AS). METHODS AND RESULTS: We retrospectively reviewed the data for 71 consecutive patients (mean age 85±7 years) who had been hospitalized for ADHF because of AS between January 2006 and August 2012. The primary endpoint of the study was the 1-year all-cause mortality. Clinical outcomes of patients who survived and those who died during a 1-year period were compared. Low admission SBP was defined as <120 mmHg. During the 1-year period, 26 (37%) of the 71 patients died, including 16 (57%) of 28 patients with low SBP and 10 (23%) of 43 patients with normal or high SBP (log-rank P=0.0065). In both the patients who survived and those who died, there were significant differences in admission SBP (152±43 vs. 116±32 mmHg, P<0.001), estimated glomerular filtration rate on admission (43.2±20.3 vs. 28.2±22.2 ml·min(-1)·1.73 m(-2), P=0.005), and left ventricular ejection fraction <50% (33% [15/45] vs. 65% [17/26], P=0.013). Low admission SBP independently predicted 1-year all-cause mortality (adjusted hazard ratio: 2.41, 95% confidence interval: 1.04-5.57, P=0.033). CONCLUSIONS: Low admission SBP is associated with significantly higher 1-year all-cause mortality in patients hospitalized for ADHF because of AS.

Comparison of long-term outcome after percutaneous coronary intervention for stent thrombosis between early, late, and very late stent thrombosis.

BACKGROUND: Differences in long-term outcome between early stent thrombosis (EST), late stent thrombosis (LST), and very late stent thrombosis (VLST) are unknown. METHODS AND RESULTS: A total of 152 patients who had undergone percutaneous coronary intervention for stent thrombosis between January 2001 and October 2011 were enrolled, and the clinical outcome compared between EST (55 patients), LST (34 patients), and VLST (63 patients) after drug-eluting stent (DES) and bare-metal stent (BMS) implantation. Major adverse cardiac events (MACE), including cardiac death, recurrent stent thrombosis, non-fatal myocardial infarction, and target lesion revascularization (TLR), were evaluated at 5 years. The in-hospital mortality was similar between EST, LST, and VLST (P=0.37). The incidence of MACE was significantly lower in VLST (21.9%) than in EST (66.9%, P<0.001) and LST (66.6%, P<0.001), mainly because of a lower TLR rate after VLST (11.1%) than after EST (50.8%, P<0.001) and LST (52.2%, P<0.001). The 5-year mortality rate was also significantly lower in VLST (14.7%) than in EST (29.3%, P=0.049) and LST (41.6%, P=0.025). The incidence of MACE was similar between DES and BMS (46.2% vs. 50.0%, P=0.82), and this finding was observed in EST (P=0.83), LST (P=0.77), and VLST (P=0.57). CONCLUSIONS: Compared with EST and LST, long-term outcome was markedly better in VLST, mainly because of a lower TLR rate, whether after DES or BMS implantation.