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There is still a scarcity of data on causes of long-term mortality in patients with venous thromboembolism (VTE).The COMMAND VTE Registry is a physician-initiated, retrospective, multicenter cohort study in which consecutive 3027 patients with acute symptomatic VTE among 29 centers in Japan were included between January 2010 and August 2014. We investigated detailed causes and risk factors for long-term mortality.During a median observation period of 1218 days, a total of 764 patients died, and the prevalence of active cancer was higher in patients who died than in patients alive (61 % versus 10 %, P 0.001). The cumulative incidences of cardiac death, pulmonary embolism (PE)-related death, bleeding death, cancer death, and non-cardiovascular non-cancer death were 2.2 %, 2.9 %, 2.0 %, 16.1 %, and 6.7 % at 5 years, respectively. The incidence of cancer death increased gradually, which was the most common cause of long-term death. Among patients without active cancer, the incidence of PE-related death increased rapidly and became a plateau beyond the acute phase, whereas the incidence of non-cardiovascular non-cancer death kept increasing, which became most common in the long term. The separate multivariable analysis among patient with and without active cancer identified independent risk factors of all-cause death including a few patient characteristics among patients with active cancer and several patient characteristics among patients without active cancer.Cancer was the most common cause of long-term mortality, while non-cardiovascular non-cancer death became most common among patients without active cancer.

Background There is a paucity of data on the long-term clinical outcomes according to the severity of pulmonary embolism (PE) at initial diagnosis. Methods The COMMAND VTE Registry is a multicenter registry enrolling 3027 consecutive patients with acute symptomatic venous thromboembolism (VTE). After excluding 1312 patients without PE, the current study population consisted of 1715 patients with PE, who were divided into 3 groups according to the clinical severity; massive PE, sub-massive PE and low-risk PE. Results There were 179 patients (10%) with massive PE, 742 patients (43%) with sub-massive PE, and 794 patients (46%) with low-risk PE. By the landmark analysis at 3 months, the cumulative incidences of recurrent VTE were similar among the 3 groups both within and beyond 3 months (Massive PE: 2.9%, Sub-massive PE: 4.2%, and Low-risk PE: 3.3%, P = 0.61, and 4.3%, 8.8%, and 7.8% at 5 years, P = 0.47, respectively). After adjusting confounders, the risk of massive PE relative to low-risk PE for recurrent VTE beyond 3 months remained insignificant (adjusted HR 0.54, 95% CI: 0.13–1.51, P = 0.27). Patients with massive PE at initial diagnosis more often presented as severe recurrent PE events than those with sub-massive and low-risk PE. Conclusions In the current real-world large registry, the long-term risk of overall recurrent VTE in patients with massive PE at initial diagnosis did not significantly differ from those with sub-massive and low-risk PE beyond 3 months, although patients with massive PE at initial diagnosis more frequently developed recurrent VTE as PE with severe clinical presentation.

The treatment of coronary artery disease has substantially changed over the past two decades. However, it is unknown whether and how much these changes have contributed to the improvement of long-term outcomes after coronary revascularization. We assessed trends in the demographics, practice patterns and long-term outcomes in 24,951 patients who underwent their first percutaneous coronary intervention (PCI) (n = 20,106), or isolated coronary artery bypass grafting (CABG) (n = 4,845) using the data in a series of the CREDO-Kyoto PCI/CABG Registries (Cohort-1 [2000 to 2002]: n = 7,435, Cohort-2 [2005 to 2007]: n = 8,435, and Cohort-3 [2011 to 2013]: n = 9,081). From Cohort-1 to Cohort-3, the patients got progressively older across subsequent cohorts (67.0 ± 10.0, 68.4 ± 9.9, and 69.8 ± 10.2 years, ptrend

Background The majority of acute pulmonary embolism (PE) is caused by thrombus developed from leg veins. However, impact of concomitant deep venous thrombosis (DVT) on clinical outcomes has not been fully evaluated in patients with acute PE. Methods The COMMAND VTE Registry is a multicenter registry enrolling consecutive 3027 patients with acute symptomatic venous thromboembolism (VTE) in Japan. The current study population consisted of 655 acute PE patients who underwent lower extremities ultrasound examination at diagnosis for the assessment of concomitant DVT status. Results There were 424 patients with proximal DVT (64.7%), 162 patients with distal DVT (24.7%), and 69 patients with no DVT (10.5%). The cumulative 90-day incidence of all-cause death was higher in proximal DVT patients than in distal DVT and no DVT patients (7.9%, 2.5%, and 1.4%, p = 0.01). Regarding the causes of death, the cumulative 90-day incidence of PE-related death was low, and not significantly different across the 3 groups (1.4%, 0.6%, and 1.7%, p = 0.62). The most frequent cause of death was cancer in proximal and distal DVT patients. There were no significant differences in 90-day rates of recurrent VTE and major bleeding, regardless of the status of concomitant DVT (2.9%, 3.2%, and 2.2%, p = 0.79, and 1.5%, 4.4%, and 4.9%, p = 0.46, respectively). Conclusions Acute PE with proximal DVT at diagnosis was associated with a higher risk for short-term mortality than in patients without DVT, while the risk for short-term mortality was not significantly different between distal DVT patients and patients without DVT.

There is a scarcity of data comparing long-term clinical outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease (3VD) in the new-generation drug-eluting stents era. CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who had undergone first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. We identified 2525 patients with 3VD (PCI: n = 1747 [69%], and CABG: n = 778 [31%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.7 (interquartile range: 4.4 to 6.6) years. The cumulative 5-year incidence of all-cause death was significantly higher in the PCI group than in the CABG group (19.8% vs 13.2%, log-rank p = 0.001). After adjusting confounders, the excess risk of PCI relative to CABG for all-cause death remained significant (HR, 1.45; 95% CI, 1.14 to 1.86; p = 0.003), which was mainly driven by the excess risk for non-cardiovascular death (HR, 1.88; 95% CI, 1.30 to 2.79; p = 0.001), while there was no excess risk for cardiovascular death between PCI and CABG (HR, 1.19; 95% CI, 0.87 to 1.64; p = 0.29). There was significant excess risk of PCI relative to CABG for myocardial infarction (HR, 1.77; 95% CI, 1.19 to 2.69; p = 0.006), whereas there was no excess risk of PCI relative to CABG for stroke (HR, 1.24; 95% CI, 0.83 to 1.88; p = 0.30). In conclusion, in the present study population reflecting real-world clinical practice in Japan, PCI compared with CABG was associated with significantly higher risk for all-cause death, while there was no excess risk for cardiovascular death between PCI and CABG.

There is a paucity of data on the influence of low body weight on clinical outcomes in patients with acute venous thromboembolism (VTE).The COMMAND VTE registry is a multicenter cohort study enrolling 3027 consecutive patients with acute symptomatic VTE. The current study population consisted of 2778 patients with available body weight value, who were divided into 2 groups; 1705 patients with lower body weight (≤60 kg) and 1073 patients with higher body weight (60 kg).Patients with lower body weight were older (70.8 versus 60.9 years, P 0.001), and more often women (75% versus 38%, P 0.001), and more often had active cancer (27% versus 19%, P 0.001) than those with higher body weight. The cumulative 5-year incidence of recurrent VTE was not significantly different between the 2 groups (10.6% versus 10.7%, P = 0.51). The cumulative 5-year incidences of major bleeding and all-cause death were significantly higher in patients with lower body weight than in those with higher body weight (14.6% versus 9.6%, P 0.001, and 35.8% versus 19.8%, P 0.001, respectively). The excess adjusted risk of patients with lower body weight relative to those with higher body weight remained significant for major bleeding and all-cause death (HR 1.57, 95%CI: 1.16-2.12, P = 0.003, and HR 1.50, 95%CI: 1.24-1.81, P 0.001, respectively).In the current Japanese real-world registry, there were a high proportion of patients with low body weight, who had a higher risk for major bleeding and mortality without significant excess risk for recurrent VTE.

Background The simplified Pulmonary Embolism Severity Index (sPESI) score is a practical score for identification of patients with low-risk pulmonary embolism (PE), although it has not been applied in patients with active cancer. The current study aimed to evaluate the usefulness of the sPESI score in patients with PE and active cancer. Methods The COMMAND VTE Registry is a multicenter registry enrolling consecutive patients with acute symptomatic VTE. The current study population consisted of 368 patients with PE and active cancer. The 30-day clinical outcomes were compared between patients with sPESI score = 1 and patients with sPESI scores ≥ 2. Results Overall, 37 patients (10%) died during the 30 days after diagnosis. The cumulative 30-day incidences of mortality, and PE-related death, were lower in patients with sPESI score = 1 than in patients with sPESI scores ≥ 2 (6.3% vs 13.1%; log-rank P = .03; and 0.7% vs 3.9%; log-rank P = .046). Among patients with sPESI score = 1, the predominant cause of death was cancer. There were no significant differences in the cumulative 30-day incidence of recurrent VTE and major bleeding between the two groups (3.9% vs 5.6%; log-rank P = .46; and 6.4% vs 4.5%; log-rank P = .45). Conclusions Among patients with PE and active cancer, patients with sPESI score = 1 had a lower 30-day mortality rate compared with patients with sPESI scores ≥ 2, and they showed very low PE-related mortality risk, although the overall mortality rate remained high because of cancer-related mortality. They also showed relatively high risks for recurrence and major bleeding, suggesting the need for careful follow-up. Trial Registry UMIN Clinical Trials Registry; No.: UMIN000021132; URL: http://www.umin.ac.jp/ctr/index.htm

The duration of anticoagulation therapy after venous thromboembolism (VTE) should be based on the balance between risks of recurrent VTE and bleeding. However, there is uncertainty about the impact of these events on subsequent mortality.We evaluated the association of recurrent VTE and major bleeding events with mortality among 3026 patients in the COMMAND VTE Registry. We estimated the risks of the recurrent VTE events and the major bleeding events for subsequent mortality by the time-updated multivariable Cox proportional hazard model.During the median follow-up period of 1218 days, 225 patients developed recurrent VTE events, 274 patients developed major bleeding events, and 763 patients died. The multivariable Cox proportional hazard model revealed that both the recurrent VTE and major bleeding events were strongly associated with subsequent mortality risk (recurrent VTE: HR 3.24, 95%CI 2.57-4.08, P 0.001; major bleeding: HR 3.53, 95%CI 2.88-4.31, P 0.001). Both the recurrent pulmonary embolism (PE) and recurrent deep vein thrombosis (DVT) events were associated with subsequent mortality risk (recurrent PE events: HR 4.42, 95%CI 3.28-5.95, P 0.001; recurrent DVT events: HR 2.42, 95%CI 1.75-3.36, P 0.001).In the real-world patients with VTE, both the recurrent VTE events and the major bleeding events were strongly associated with subsequent mortality risk with the comparable effect size. The recurrent PE and recurrent DVT events were also associated with increased risks for mortality, although the magnitude of the effect on mortality was numerically greater with the recurrent PE events than with the recurrent DVT events.

Objectives The purpose of this study was to assess neoatherosclerosis in a registry of prospectively enrolled patients presenting with stent thrombosis using optical coherence tomography. Background In-stent neoatherosclerosis was recently identified as a novel disease manifestation of atherosclerosis after coronary stent implantation. Methods Angiography and intravascular optical coherence tomography were used to investigate etiologic factors of neoatherosclerosis in patients presenting with stent thrombosis >1 year after implantation (very late stent thrombosis [VLST]). Clinical data were collected according to a standardized protocol. Optical coherence tomographic acquisitions were analyzed in a core laboratory. Cox regression analysis was performed to identify factors associated with the formation of neoatherosclerosis and plaque rupture as a function of time. Results Optical coherence tomography was performed in 134 patients presenting with VLST. A total of 58 lesions in 58 patients with neoatherosclerosis were compared with 76 lesions in 76 patients without neoatherosclerosis. Baseline characteristics were similar between groups. In-stent plaque rupture was the most frequent cause (31%) in all patients presenting with VLST. In patients with neoatherosclerosis, in-stent plaque rupture was identified as the cause of VLST in 40 cases (69%), whereas uncovered stent struts (n = 22 [29%]) was the most frequent cause in patients without neoatherosclerosis. Macrophage infiltration was significantly more frequent in optical coherence tomographic frames with plaque rupture compared with those without (50.2% vs. 22.2%; p Conclusions Neoatherosclerosis was frequently observed in patients with VLST. Implantation of a drug-eluting stent was significantly associated with neoatherosclerosis formation. In-stent plaque rupture was the prevailing pathological mechanism and often occurred in patients with neoatherosclerosis and previous myocardial infarction at index percutaneous coronary intervention. Increased macrophage infiltration heralded plaque vulnerability in our study and might serve as an important indicator.

Background Drug-eluting stents with biodegradable polymer coatings have shown promising outcomes in randomised studies. Methods We compared neointimal healing patterns including strut coverage and assessed neointimal maturity using a novel algorithm in coronary lesions treated with sirolimus-eluting stents with biodegradable polymer coating (BP-SES) or everolimus eluting stents with permanent polymer coating (PP-EES) using optical coherence tomography after 6months. Results A total of 39 patients were randomised to BP-SES ( n =19) or PP-EES ( n =20) for the treatment of coronary lesions. Of those, 29 patients (14 BP-SES and 15 PP-EES) underwent optical coherence tomography (OCT) and angiography at 6-month follow-up. Tissue coverage and apposition were assessed in a total of 6162 struts (BP-SES, n =2889; PP-EES, n =3273). Neointimal maturity was assessed in 3672 neointimal regions above struts using grey scale intensity analysis. OCT analysis showed neointimal coverage of 2433 (BP-SES) vs. 2702 (PP-EES) struts (84.2% vs. 82.6%, p =0.70), whereas the remainder was uncovered after 6months. Mean neointimal thickness did not differ significantly between groups (54.3±7.8μm vs. 80±14.6μm, p =0.12). The rate of malapposed struts was comparable between groups (1.3% vs. 2.2%, p =0.27). Grey scale signal intensity analysis showed mature tissue coverage of struts in 46.2% in BP-SES vs. 31.8% in PP-EES ( p =0.31) of neointimal regions. Conclusion The present study showed comparable early vascular healing response characterised by neointimal coverage with mainly immature neointima in both BP-SES and PP-EES.

Gender-related differences in the association between hyperuricaemia and cardiovascular events remain poorly understood. The objective of this study was to assess gender-related differences in the association between hyperuricaemia and cardiovascular events in patients with coronary artery disease (CAD).This study included 13,273 patients with CAD. Hyperuricaemia was defined as a plasma uric acid7.0mgdl(-1) in men and5.7mgdl(-1) in women. The primary outcome was 1-year all-cause mortality. Hyperuricaemia was found in 3745 men (36.5%) and 1562 women (50.3%); odds ratio (OR)=1.76, 95% confidence interval (CI) 1.62-1.91; P0.001. Women with hyperuricaemia were older, had higher proportions of patients with diabetes and arterial hypertension and had reduced renal function and higher C-reactive protein levels compared with men with hyperuricaemia. One-year all-cause mortality was 9.3% (n=143) in women with hyperuricaemia versus 6.9% (n = 252) in men with hyperuricaemia (P=0.002). After adjustment in multivariable Cox proportional hazards model, uric acid predicted 1-year mortality with an adjusted hazard ratio (HR)=1.17, 95% CI (1.03-1.31), P=0.012 in men and HR=1.25, 95% CI (1.06-1.48), P=0.007 in women, for each standard deviation increase in the natural logarithm. Uric acid predicted 1-year mortality with an area under the receiver-operating characteristic curve=0.625, 95% CI (0.594-0.656) in men and 0.676, 95% CI (0.635-0.717) in women (P=0.044, for women versus men).Hyperuricaemia predicts an increased risk of 1-year mortality in both genders with a stronger association in women. Differences in cardiovascular risk profile may explain the stronger association between hyperuricaemia and cardiovascular events in women.

The performance of paclitaxel-coated balloon (PCB) or primary bare nitinol stent (BNS) versus uncoated balloon angioplasty (UCB) for femoropopliteal artery disease and the relative efficacy and safety of PCB versus BNS are still debated.A meta-analysis of trials in which patients were randomly assigned to PCB versus UCB or BNS versus UCB was performed, as well as an indirect comparison of PCB versus BNS, with UCB common comparator. The primary endpoint was target lesion revascularization (TLR); secondary endpoints were restenosis, death and amputation.In total, 1464 patients were assigned to revascularization with PCB versus UCB (n = 441) or BNS versus UCB (n = 1023). Treatment with PCB versus UCB reduced the risk of TLR (odds ratio [95% confidence interval] = 0.29 [0.15-0.56], p0.001) and restenosis (0.31 [0.19-0.51], p0.001) without affecting mortality (1.05 [0.41-2.71], p = 0.92) or amputation (0.68 [0.04-10.31], p = 0.78). BNS versus UCB therapy reduced the risk of TLR (0.46 [0.27-0.80], p = 0.006) and restenosis (0.51 [0.34-0.77], p = 0.02) without affecting mortality (2.08 [0.93-4.66], p = 0.07) or amputation (0.84 [0.30-2.35], p = 0.74). The indirect comparison found no difference with PCB versus BNS in the risk of TLR (0.63 [0.26-1.48] p = 0.29), restenosis (0.60 [0.32-1.15], p = 0.13) death (0.50 [0.05-4.82], p = 0.55) or amputation (0.80 [0.04-15.63], p = 0.66).In atherosclerotic disease of femoropopliteal artery, both PCB and BNS therapy have superior antirestenotic efficacy to UCB, without safety issues. At indirect comparison, PCB and BNS may have comparable antirestenotic efficacy and safety.

Resumen Introduccion y objetivos La eficacia angiografica y clinica de los stents liberadores de rapamicina sin polimero frente a los liberadores de paclitaxel con polimero sigue siendo motivo de debate. En nuestro estudio se compararon las medidas de eficacia angiograficas y clinicas de los stents liberadores de rapamicina sin polimero frente a los liberadores de paclitaxel con polimero. Metodos Se combinaron los datos de pacientes procedentes del estudio clinico aleatorizado ISAR-TEST (prueba de equivalencia entre dos stents farmacoactivos respecto al implante de stent intracoronario y reestenosis angiografica) y el estudio clinico LIPSIA Yukon (comparacion aleatorizada de stents farmacoactivos liberadores de rapamicina sin polimero frente a liberadores de paclitaxel con polimero en pacientes con diabetes mellitus). El criterio de valoracion angiografico (primario) fue la perdida luminal tardia en el stent entre los 6 y los 9 meses. Los criterios de valoracion clinicos (secundarios) fueron: infarto de miocardio o muerte, muerte cardiaca o infarto de miocardio, revascularizacion de la lesion tratada e infarto de miocardio. Resultados El estudio incluyo a un total de 686 pacientes ( stents liberadores de rapamicina sin polimero [n = 345] frente a stents liberadores de paclitaxel con polimero [n = 341]) y 751 lesiones ( stents liberadores de rapamicina sin polimero [n = 383] frente a stents liberadores de paclitaxel con polimero [n = 368]). La angiografia de control (606 lesiones [80,6%]) mostro una perdida luminal tardia en el stent comparable entre los dos tipos de stents estudiados (0,53 ± 0,59 mm en los stents sin polimero frente a 0,46 ± 0,57 mm en stents con polimero; p = 0,15). La mediana de seguimiento fue de 34,8 meses. Los stents liberadores de rapamicina sin polimero y los liberadores de paclitaxel con polimero se asociaron con similares riesgos de muerte o infarto de miocardio (riesgo relativo =1,17; intervalo de confianza del 95%, 0,49-2,80; p = 0,71); muerte cardiaca o infarto de miocardio (riesgo relativo = 1,17; intervalo de confianza del 95%, 0,72-1,89; p = 0,50); revascularizacion de la lesion que hay que tratar (riesgo relativo = 0,98; intervalo de confianza del 95%, 0,65-1,47; p = 0,93) e infarto de miocardio (riesgo relativo = 1,79; intervalo de confianza del 95%, 0,85 3,76; p = 0,12). Conclusiones En este analisis combinado, los valores de eficacia angiografica y clinica fueron similares para los stents liberadores de rapamicina sin polimero y los liberadores de paclitaxel con polimero.

Evidence on the usefulness of fibrinogen for the risk stratification of patients with coronary artery disease remains inconclusive. The aims of this study were to investigate the association of fibrinogen with cardiovascular events and to assess whether this biomarker provides additional prognostic information on top of that provided by traditional cardiovascular risk factors. This study included 13,195 patients with angiography-proved coronary artery disease and fibrinogen measurements available. Receiver-operating characteristic curve analysis showed that the best fibrinogen cutoff for mortality prediction was 402.0 mg/dl. On the basis of this cutoff, patients were divided into 2 groups: the group with fibrinogen >402.0 mg/dl (n = 5,198) and the group with fibrinogen ≤402.0 mg/dl (n = 7,997). The primary outcome was 1-year mortality. All-cause deaths occurred in 393 patients with fibrinogen >402.0 mg/dl and in 246 patients with fibrinogen ≤402.0 mg/dl (Kaplan-Meier estimates of mortality 7.7% and 3.1%, log-rank test p

Statins have multiple effects in patients with coronary artery disease. No studies have investigated whether chronic statin pretreatment before percutaneous coronary intervention (PCI) has an impact on long-term mortality in patients with stable angina.The study included 8041 patients with stable angina. At the time of PCI, 5939 patients (73.8%) were receiving statins for ≥ 1 month before procedure and 2102 patients (26.2%) were not receiving statins. The primary outcome analysis was 1-year mortality.There were 192 deaths during the follow-up: 119 deaths among patients receiving statins and 73 deaths among patients not receiving statins (Kaplan-Meier estimates of 1-year mortality 2.06% and 3.59%; unadjusted hazards ratio [HR]=0.56, 95% confidence interval [CI] 0.42-0.75; P0.001). Landmark analysis showed that almost all mortality benefit occurred in the first 30-days after PCI: 10 deaths among patients receiving statins and 22 deaths among patients not receiving statins (Kaplan-Meier estimates of 30-day death, 0.17% and 1.06%, respectively; HR=0.16, 95% CI 0.08-0.34, P0.001). No significant difference in mortality according to statin pretreatment between 30 days and 1 year was observed (109 deaths among patients receiving statins vs 51 deaths among patients not receiving statins; Kaplan-Meier estimates 1.89% and 2.53%; HR=0.75, 95% CI 0.53-1.05, P=0.095). After adjustment in the Cox proportional hazards model, statin pretreatment was associated with a 35% reduction in the adjusted risk for 1-year mortality (adjusted HR=0.65, 95% CI 0.44-0.98, P=0.039).Pretreatment with statins before PCI was associated with a significant reduction of 1-year mortality in patients with stable angina.

Recently, stent implantation for left main coronary artery (LMCA) lesions has become a common clinical practice; however, the effects of bifurcation lesion and stenting strategies on long-term clinical outcomes remain to be investigated. We assessed 1809 consecutive patients undergoing stent

Whether the final kissing balloon technique (FKBT) is mandatory after crossover stenting of the left main coronary artery (LMCA) in patients with or without true bifurcation remains unclear. The Assessing Optimal Percutaneous Coronary Intervention for LMCA (AOI-LMCA) registry is a retrospective

The aim of this study was to evaluate the impact of neointimal tissue characteristics assessed by OCT using gray-scale intensity (GSI) on treatment for in-stent restenosis (ISR) with drug-coated balloon (DCB). Neointimal tissue characterization using OCT-based GSI analysis was performed for a total

Aims: The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis. Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent. Methods: We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year. Results: The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%. Conclusions: The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up.

To validate optical coherence tomography (OCT) data for assessment of vascular healing in a preclinical animal model and to translate these findings to the assessment of vascular healing after drug eluting stent (DES) implantation in human autopsy cases and clinical practice. The validation of OCT

The high incidence of caval penetration after inferior vena cava (IVC) filter implantation has been reported. However little is known regarding clinical outcomes related to caval penetration of IVC filters. We evaluated a total of 87 IVC filters that implanted between July 2008 and June 2014 in

Risk of bleeding among diabetic patients treated with drug-eluting stents (DES) has not been fully elucidated. We assessed the influence of diabetes on both short-term (within 30 days) and long-term (beyond 30 days) bleeding risk after coronary DES implantation. Accounting for the differences in

Inhospital stent thrombosis (ST) and cerebrovascular accidents (CVA) are rare but serious adverse events after percutaneous coronary intervention (PCI). The association of ST or CVA with long-term outcome after PCI remains poorly investigated.The study included 18,334 consecutive patients who underwent PCI. Patients were divided into 3 groups: the group with ST, the group with CVA, and the group without these events. The primary outcome was all-cause mortality at 3-year follow-up.Inhospital ST or CVA occurred in 59 patients (0.32%) and in 90 patients (0. 49%), respectively. There were 2,149 deaths (11.7%) during the follow-up: 26 deaths among patients with ST, 32 deaths among patients with CVA, and 2,091 deaths among patients without ST or CVA (Kaplan-Meier estimates of 3-year mortality 45.3%, 38.0%, and 12.9%, odds ratio 6.1, 95% CI 3.6-10.2, P.001 for ST group vs the group without ST or CVA and odds ratio 4.2 [2.7-6.6], P.001 for CVA group vs the group without ST or CVA). There was no significant difference in the 3-year mortality between CVA and ST groups (P = .29). The Cox proportional hazards model showed that ST (adjusted hazard ratio 4.97, 95% CI 2.58-9.56, P.001) and CVA (adjusted hazard ratio 2.25 [1.25-4.04], P = .006) were independently associated with the increased risk of 3-year mortality.Inhospital ST and CVA after PCI are associated with the increased risk of 3-year mortality. Both events seem to have a similar impact on long-term survival.

We hypothesized that biodegradable polymer siroimus-eluting stents (BP-SES) might enhance vascular healing as compared to permanent polymer everolimus-eluting stents (PP-EES). Accordingly we compared the healing patterns of BP-SES (Osiro(r)) with PP-EES (Xience(r)) using optical coherence tomography

The aim of this study was to evaluate benefits and risks of extending dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in the drug-eluting stent era.We searched electronic databases (Medline, EMBASE, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, chapters in books, and proceedings of advisory panels for the US Food and Drug Administration, for randomized controlled trials investigating the clinical impact of extending DAPT duration in patients undergoing PCI. The primary endpoint was all-cause death. The secondary endpoints were myocardial infarction (MI), stent thrombosis (ST), cerebrovascular accidents (CVAs), and thrombolysis in myocardial infarction (TIMI) major bleeding. We included four trials that randomized 8231 patients (50.2%, extended DAPT duration vs. 49.8%, control duration). A total of 8158 patients (99.1%) were available for final analyses. The median DAPT duration was 16.8 vs. 6.2 months for the extended DAPT and control groups, respectively. At follow-up (median 16.8 months) extending DAPT duration did not reduce all-cause death [odds ratio (95% confidence interval) = 1.15 (0.85-1.54), P = 0.36], MI [0.95 (0.66-1.36), P = 0.77], ST [0.88 (0.43-1.81), P = 0.73], or CVAs [1.51 (0.92-2.47), P = 0.10]. Conversely, extended DAPT duration clearly increased the risk of TIMI major bleeding [2.64 (1.31-5.30), P = 0.006].The extension of DAPT duration after percutaneous coronary interventions may increase the risk of bleeding without reducing ischaemic events. These results need corroboration from large ongoing trials.

Background: In the ISAR-REACT 4 clinical trial in 1721 randomized patients undergoing percutaneous coronary angioplasty for non-ST elevation myocardial infarction, treatment with abciximab and heparin demonstrated an increased risk of bleeding in comparison to bivalirudin. However the results were not analyzed with respect to the age of the patients and it was not clear if this excess bleeding risk occurred in any particular sub-group. Methods: In this study, the patients from the ISAR REACT study were organized into four quartile groups according to age, and the outcomes analyzed with respect to treatment with abciximab and heparin or bivalirudin. The primary endpoint was the composite of death, large myocardial infarction, urgent target vessel revascularization or major bleeding within 30 days. The secondary endpoints were death, myocardial infarction or target vessel revascularization (efficacy endpoint) and major bleeding (safety endpoint) at 30 days. Results: A total of 1721 patients entered the study. The primary endpoint occurred in 11.8% vs. 11.6% in Q1, 10.2% vs. 9.8% in Q2, 10.7% vs. 10.3% in Q3 and 11.0% vs. 12.4% in Q4 in patients treated with abciximab and heparin or bivalirudin respectively. There was no overall interaction between age and occurrence of the primary endpoint (PINTERACTION 0.81). There were no differences within the age quartile groups and no interaction between age and clinical outcome for the secondary efficacy endpoint (PINTERACTION 0.84) or for the primary safety endpoint (PINTERACTION 0.59) Conclusions: In patients undergoing treatment for non-ST elevation myocardial infarction and stratified by age, there were no differences in clinical outcome, safety or efficacy between those receiving abciximab and those receiving bivalirudin. This finding was consistent across a variety of key risk sub-groups.

Everolimus-eluting stents (EES) are among the most commonly used second-generation drug-eluting stents in clinical practice and have clearly-proven superiority over paclitaxel-eluting stents. Nevertheless, the relative merits of EES against the previous gold-standard sirolimus-eluting stent (SES)