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Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

BACKGROUND: The comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention (PCI) has not been defined. METHODS: This post hoc analysis included all patients with acute coronary syndrome treated with PCI and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment). Complex PCI was defined as at least one of the following: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, and total stented length >60 mm. The primary efficacy end point was the composite of all-cause death, myocardial infarction, or stroke; the safety end point was Bleeding Academic Research Consortium types 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization. RESULTS: Among the 3377 patients treated with PCI in the ISAR-REACT 5 trial, 1429 underwent complex PCI (ticagrelor, N=696 and prasugrel, N=733) and 1948 underwent noncomplex PCI (ticagrelor, N=980 and prasugrel, N=968). There was no interaction between PCI complexity, assignment to either ticagrelor or prasugrel, and the primary efficacy or safety end points (P for interaction: ≥0.13). In the complex PCI group, the primary efficacy end point (11.0% versus 9.2%, hazard ratio: 1.19 [0.85-1.66], P=0.303) and the safety end point (5.2% versus 6.1%, hazard ratio: 0.83 [0.53-1.31], P=0.419) were not statistically different in patients receiving either ticagrelor or prasugrel. In the noncomplex PCI group, the primary efficacy end point occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (8.9% versus 5.5%, hazard ratio: 1.66 [1.18-2.34], P=0.004) without significant difference in terms of the safety end point (5.4% versus 4.1%, hazard ratio: 1.41 [0.92-2.17], P=0.110). CONCLUSIONS: In patients with acute coronary syndrome, PCI complexity does not influence the comparative efficacy and safety of ticagrelor and prasugrel. The observed comparable performance of ticagrelor and prasugrel in patients with acute coronary syndrome undergoing complex PCI requires further confirmation. [ABSTRACT FROM AUTHOR]

Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

BACKGROUND: The value of vascular closure devices (VCD) in women undergoing transfemoral catheterization has not been sufficiently investigated. METHODS AND RESULTS: This is a sex-specific analysis of 1395 women enrolled in a large-scale, randomized, multicenter trial, in which patients undergoing transfemoral diagnostic coronary angiography were randomly assigned in a 1:1:1 ratio to arteriotomy closure with an intravascular VCD, extravascular VCD, or manual compression (MC). Primary objective was to assess the safety and efficacy of 2 different VCD compared with MC regarding vascular access-site complications at 30 days. A secondary comparison was between 2 different types of contemporary VCD. Overall, women were at higher risk for vascular access-site complications compared with men (9.0% versus 6.4%; P=0.002). Vascular access-site complications were comparable in women assigned to VCD and MC (8.6% versus 9.8%; P=0.451). There was no interaction of treatment effect and sex (Pinteraction=0.970). Time to hemostasis was significantly shortened with VCD compared with MC (1 [interquartile range, 0.5-2.0] minutes) versus 11 [interquartile range, 10-15] minutes; P<0.001); however, more women with VCD required repeat MC (2.4% versus 0.6%; P=0.018). The use of the intravascular compared with the extravascular VCD was associated with a numerical reduction in vascular access-site complications (6.6% versus 10.7%; P=0.027) and significant reductions in time to hemostasis and VCD failure. CONCLUSIONS: In women undergoing diagnostic coronary angiography via the common femoral artery, VCD and MC provided comparable safety, while time to hemostasis was reduced with VCD. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis. Background DCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy. Methods In this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year. Results Follow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year. Conclusions In patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371 ) [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent. Background It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy. Methods In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel–related myocardial infarction, or target lesion revascularization. Results At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size. Conclusions Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533 ) [ABSTRACT FROM AUTHOR]

Background--The immune system orchestrates the repair of infarcted myocardium. Imaging of the cellular inflammatory response by 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/magnetic resonance imaging in the heart has been demonstrated in preclinical and clinical studies. However, the clinical relevance of post-MI 18F-FDG uptake in the heart has not been elucidated. The objective of this study was to explore the value of 18F-FDG positron emission tomography/ magnetic resonance imaging in patients after acute myocardial infarction as a biosignal for left ventricular functional outcome. Methods and Results--We prospectively enrolled 49 patients with ST-segment-elevation myocardial infarction and performed 18F-FDG positron emission tomography/magnetic resonance imaging 5 days after percutaneous coronary intervention and follow-up cardiac magnetic resonance imaging after 6 to 9 months. In a subset of patients, 99mTcsestamibi single-photon emission computed tomography was performed with tracer injection before revascularization. Cellular innate immune response was analyzed at multiple time points. Segmental comparison of 18F-FDG-uptake and late gadolinium enhancement showed substantial overlap (κ=0.66), whereas quantitative analysis demonstrated that 18F-FDG extent exceeded late gadolinium enhancement extent (33.2±16.2% left ventricular myocardium versus 20.4±10.6% left ventricular myocardium, P<0.0001) and corresponded to the area at risk (r=0.87, P<0.0001). The peripheral blood count of CD14high/CD16+ monocytes correlated with the infarction size and 18F-FDG signal extent (r=0.53, P<0.002 and r=0.42, P<0.02, respectively). 18F-FDG uptake in the infarcted myocardium was highest in areas with transmural scar, and the standardized uptake valuemean was associated with left ventricular functional outcome independent of infarct size (Δ ejection fraction: P<0.04, Δ end-diastolic volume: P<0.02, Δ end-systolic volume: P<0.005). Conclusions--In this study, the intensity of 18F-FDG uptake in the myocardium after acute myocardial infarction correlated inversely with functional outcome at 6 months. Thus, 18F-FDG uptake in infarcted myocardium may represent a novel biosignal of myocardial injury. [ABSTRACT FROM AUTHOR]

Because of the risk of associated complications, femoral pseudoaneurysm (PSA) formation implies further treatment. Ultrasound-guided thrombin injection (UGTI) is becoming the accepted gold standard, but manual compression (MC) represents an established treatment option including PSAs not feasible for UGTI. This study aims to assess our experience in PSA treatment using MC or UGTI according to a potential algorithm based on morphological properties in a large patient cohort.Between January 2007 and January 2011, a total of 432 PSAs were diagnosed in 29091 consecutive patients (1.49%) undergoing femoral artery catheterization. When compressible, small PSAs (<20 mm), PSAs without clearly definable neck, PSAs directly adjacent to vessels, and PSAs with concomitant arteriovenous fistula were referred to MC (n=145, 34%). All other PSAs were treated by UGTI (n=287, 66%). Follow-up duplex scans were performed within 12 to 14 hours after manual compression therapy and within 4 to 6 hours after UGTI or by the next morning and were available for 428 patients (99.1%). The overall success rate of our institutional therapeutic approach was 97.2%, which was achieved by 178 MC- and 357 UGTI-procedures, respectively. Procedural complications occurred in 5 cases (1.4%) after UGTI and in 3 cases (1.7%) after MC, respectively. The treatment algorithm was not successful in 12 patients, whereas 2 PSAs (0.5%) were successfully excluded by implantation of a covered stent-graft, and 10 patients necessitated surgical intervention (2.3%), which was associated with a high complication rate (30%).The presented treatment algorithm facilitates effective and safe PSA elimination. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. Background: In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. Methods: A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. Results: The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p < 0.001). G2-DES were associated with a similar risk of stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p < 0.001), but not with G2-DES compared with BMS (OR: 1.01; 95% CI: 0.32 to 3.25; p = 0.98). Conclusions: In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS. [Copyright &y& Elsevier]

Background: Factors underlying the increased risk of bleeding after percutaneous coronary intervention (PCI) in women compared with men remain incompletely understood. Methods: The study included 3,351 women and 3,351 men matched for age, body mass index, and type of antithrombotic therapy. Bleeding within the 30 days after PCI was defined using the Bleeding Academic Research Consortium criteria. The main outcome was 1-year mortality. Results: Bleeding occurred in 518 women and 354 men (15.5% vs 10.6%, odds ratio [OR] 1.55, 95% CI 1.34-1.79, P < .001). Severe (Bleeding Academic Research Consortium class ≥2) bleeds (9.4% vs 6.5%, P < .001) and access site bleeds (10.1% vs 5.4%, P < .001) were more common in women. After adjustment, female sex remained an independent correlate of any bleeding (adjusted OR 1.61 [1.35-1.92], P < .001) and access site (adjusted OR 2.00 [1.59-2.50], P < .001) but not of nonaccess site (adjusted OR 1.18 [0.91-1.54], P = .205) bleeding. There were 248 deaths: 32 deaths among men with bleeding versus 107 deaths among men with no bleeding (9.1% vs 3.6%, OR 2.68 [1.78-4.05], P < .001) and 40 deaths among women with bleeding vs 69 deaths among women with no bleeding (7.8% vs 2.5%, OR 3.35 [2.24-5.01], P < .001). No difference in mortality was observed among women and men who bled (P = .487). Bleeding was independently associated 1-year mortality (adjusted hazard ratio 2.18 [1.68-2.84], P < .001) with no bleeding-by-sex interaction (P = .439). Conclusions: Despite matching for age, body mass index, and type of antithrombotic therapy, bleeding risk after PCI remained significantly higher in women than in men. Bleeding was associated with increased risk of 1-year mortality with no bleeding-by-sex interaction. [Copyright &y& Elsevier]

Little is known about the impact of bleeding site on mortality after percutaneous coronary intervention. The aim of this study was to assess the impact of access and non-access site bleeding within 30 days after percutaneous coronary intervention on mortality.This study represents a pooled patient-level analysis of 14 180 patients recruited in 7 randomized trials. Access and non-access site bleeding were assessed using the Bleeding Academic Research Consortium criteria. The primary outcome was 1-year mortality. Follow-up was complete in 97.5% of the patients. There were 414 deaths within the first year after percutaneous coronary intervention: 44 deaths among patients with access site bleeding, 60 deaths among patients with non-access site bleeding, and 310 deaths among patients without bleeding (Kaplan-Meier estimates of mortality, 4.5%, 10.0%, and 2.5%, respectively; adjusted hazard ratio, 1.72 [95% confidence interval, 1.19-2.47] for access site bleeding versus no bleeding; hazard ratio, 2.78 [2.00-3.86] for non-access site versus no bleeding). The inclusion of non-access site bleeding (the absolute and relative integrated discrimination improvement, 0.005 and 8.9%; P=0.031) but not of access site bleeding (the absolute and relative integrated discrimination improvement, 0.0015 and 2.7%; P=0.084) was associated with an improvement of the discriminatory power of multivariable model for mortality prediction.Both access and non-access site bleeding events occurring within 30 days of a percutaneous coronary intervention are independently associated with an increased risk of 1-year mortality. Non-access site bleeding is a stronger correlate of mortality than access site bleeding, and it improves the discriminatory power of models for mortality prediction. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to compare cardiac magnetic resonance (CMR) and single-photon emission computed tomography (SPECT) for assessment of area at risk, scar size, and salvage area after coronary reperfusion in acute myocardial infarction. Background: Myocardial salvage is an important surrogate endpoint assessing the success of coronary reperfusion in acute myocardial infarction. SPECT, the established modality for assessment of myocardial salvage, requires radiopharmaceutical injection before revascularization and 2 examinations. The combination of T2 and late enhancement imaging in CMR can assess myocardial salvage in 1 examination, but up to now, data comparing both modalities are very limited. Methods: We analyzed 207 patients who were treated by primary revascularization in acute myocardial infarction and who underwent both SPECT and CMR for assessment of myocardial salvage. In CMR, T2-weighted turbo spin echo sequences for area at risk and contrast-enhanced inversion recovery gradient echo sequences were performed. Results: Image quality was insufficient in 27 patients (13%). In the remaining 180 patients, mean area at risk was 29.4 ± 18.7% of the left ventricle (LV), and infarct size was 14.7 ± 16.9% LV, resulting in a mean salvage area of 14.9 ± 15.1% LV in SPECT, whereas in CMR, mean area at risk was 28.0 ± 14.5% LV, and infarct size was 16.0 ± 13.5% LV, resulting in a mean salvage area of 11.9 ± 12.3%. Results of both modalities correlated well for area at risk (r = 0.80), scar size (r = 0.87), and salvage area (r = 0.66, all p < 0.0001). Conclusions: Assessment of the salvage area by CMR using T2 and late enhancement imaging correlates well with the established modality of SPECT. CMR therefore may be an alternative to paired SPECT imaging for myocardial salvage assessment, but the contraindications of the modality and limitations in the established T2 imaging sequences currently cause a considerable rate of data loss. [Copyright &y& Elsevier]

Abstract: Background: It is the general perception, that ST-elevation myocardial infarction is associated with transmural ischemia while Non-ST elevation myocardial infarction is found in non-transmural subendocardial ischemia. This association, however, derives primarily from post mortem studies. Methods: A total of 220 patients with acute myocardial infarction (MI) who had PCI on admission and contrast-enhanced cardiac magnetic resonance imaging (CMR) within one week were included into the study. Size and transmural extent of MI was quantified by CMR and correlated with the ECG on admission. Results: Based on the ECG findings, 57% were classified as STEMI and 43% as NSTEMI. CMR infarct size was significantly larger in STEMI than NSTEMI (23.2 vs. 14.2 LV%, p<0.001). As assessed by CMR, STEMI patients were transmural in 63% as compared to 27% of patients with NSTEMI (p<0.001). In a multivariable logistic regression model, total infarct size was significantly associated with presence of STEMI (OR: 1.045, 95% CI [1.014-1.077], p=0.004) whereas the number of transmural segments did not significantly add further information for a STEMI/NSTEMI classification (p=0.054, change of c-index from 0.69 to 0.70). Conclusions: The electrocardiographic STEMI/NSTEMI classification does rather characterize the total size of MI than the transmural extent as assessed by CMR. [Copyright &y& Elsevier]

The article presents a study which examined the use of functional erythropoietin receptor in the treatment of patients with acute ST-elevation myocardial infarction (STEMI). The method used in patient selection, magnetic resonance imaging (MRI) and angiographic evaluation is described. It was found that erythropoietin has no beneficial effect on the left ventricle ejection fraction (LVEF) or infarct size.

Objectives: Our aim was to determine whether serial contrast-enhanced cardiac magnetic resonance (CE-CMR) is useful for the characterization of tissue signal changes within the coronary vessel wall in patients after acute myocardial infarction (AMI). Background: Inflammation plays a key role in the development of AMI. CE-CMR of the vessel wall has been found useful for the characterization of inflammatory tissue signal changes in patients with carotid artery stenosis, giant cell arteritis, or Takayasu''s arteritis; however, it has never been serially performed in the coronary artery wall in patients with acute and chronic myocardial infarction using a gadolinium-based contrast medium and compared with systemic markers of inflammation. Methods: CE-CMR using a T1-weighted 3-dimensional gradient echo inversion recovery sequence of the coronary artery wall and 0.2 mmol/kg of gadolinium-diethylenetriaminepentaacetic acid was performed in 10 patients with AMI 6 days and 3 months after coronary intervention and in 9 subjects without coronary artery disease on invasive coronary angiography. Contrast-to-noise ratio (CNR) within the coronary artery wall was quantified in comparison with blood signal. Results: Patients with AMI demonstrated a significantly increased coronary vessel wall enhancement 6 days after infarction compared with normal subjects (CNR 7.8 ± 4.4 vs. 5.3 ± 3.2, p < 0.001). Three months after infarction, CNR decreased to 6.5 ± 4.7 (p < 0.03). This decrease paralleled declines in C-reactive protein. Angiographically normal segments showed no contrast changes, but CNR significantly decreased in stenotic segments, from 10.9 ± 3.8 to 6.8 ± 5.0 (p < 0.002), resulting in a reduction of enhanced segments from 70% to 25% (p < 0.01). Conclusions: Serial CE-CMR identified changes in spatial extent and intensity of coronary contrast enhancement in patients after AMI. This technique may be useful for the characterization of transient coronary tissue signal changes, which may represent edema or inflammation during the post-infarction phase. In addition, CE-CMR may offer the potential for visualization of inflammatory activity in atherosclerosis associated with acute coronary syndromes. [Copyright &y& Elsevier]

Supplemental Digital Content is available in the text. Background: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. Methods and Results: Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14–0.46]; P <0.001) and recurrent ISR (0.19 [0.10–0.35]; P <0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. Conclusions: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated. [ABSTRACT FROM AUTHOR]

Background 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. Methods 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. Results 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. Conclusion 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. [ABSTRACT FROM AUTHOR]

Background: An increasing number of patients undergoing coronary stenting need lifelong anticoagulation and therefore require a triple therapy typically consisting of aspirin, clopidogrel, and a vitamin K antagonist. Triple therapy confers an elevated bleeding risk as compared with dual therapy; however, omission of either antiplatelet or anticoagulation therapy might increase the risk of stent thrombosis or thrombembolic events. Although guidelines recommend a duration of dual antiplatelet therapy of 6 to 12months after drug-eluting stent (DES) implantation, the optimal duration of dual antiplatelet therapy in patients receiving oral anticoagulation is not known. Hypothesis: We postulate that 6-week clopidogrel therapy after DES implantation as compared with 6-month therapy is associated with improved clinical outcomes in patients undergoing DES implantation receiving concomitant aspirin and vitamin K antagonists. Study design: The ISAR-TRIPLE is a randomized, open-label trial that examines the restriction of clopidogrel therapy from 6 months to 6 weeks after DES implantation in the setting of concomitant aspirin and oral anticoagulant. Patients are randomized in a 1:1 fashion to either 6-week or 6-month clopidogrel therapy. The primary end point is a composite of death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding. The secondary end point comprises ischemic and bleeding complications. According to sample size calculations, a total of 600 patients are required to be enrolled. Clinical follow-up is scheduled at 6 weeks and at 6 and 9 months after randomization. Summary: There is clinical equipoise regarding the optimal duration of triple therapy after DES implantation in patients who need vitamin K antagonist therapy. The ISAR-TRIPLE trial aims to test the hypothesis that a 6-week triple therapy compared with a 6-month triple therapy improves net clinical outcomes. [Copyright &y& Elsevier]