Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high-risk patients: The e-Cobra study.

BACKGROUND: The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. AIMS: To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. METHODS: e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. RESULTS: Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). CONCLUSION: The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Genotypic and phenotypic assessment of platelet function and response to P2Y12 antagonists.

The P2Y12-ADP receptor antagonists are the cornerstone of oral antiplatelet therapy in the secondary prevention of coronary artery disease, especially after acute coronary syndrome or percutaneous coronary intervention. Currently, the therapeutic agents available to block the receptor include clopidogrel and prasugrel; ticagrelor is not available everywhere. Clopidogrel was the gold standard, but recently it has been challenged by prasugrel and ticagrelor. One pitfall of clopidogrel is that in some patients it cannot induce optimal platelet reactivity inhibition in connection with several factors, including some genetic polymorphisms of enzymes participating in its bioabsorption or metabolism. This variability of response can be evaluated by platelet reactivity monitoring. This comprehensive review provides the available data regarding the genotypic and phenotypic interaction with the response to P2Y12-ADP receptor antagonists and discusses the concept of personalized antiplatelet therapy based on a genotypic or phenotypic profile.

Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.

AIMS: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. CONCLUSION: Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.

Prognostic value of procedure-related myocardial infarction according to the universal definition of myocardial infarction in saphenous vein graft interventions.

BACKGROUND: In the recently published universal definition of myocardial infarction (MI), a troponin elevation above 3x above the 99th percentile of normal after percutaneous coronary intervention (PCI) is a procedure-related (type 4a) MI. Although troponin rise is common after saphenous vein graft (SVG) PCI, its prognostic value remains undetermined. We aimed to investigate the prognostic value of the universal definition of PCI-related MI in SVG interventions. METHODS: A cohort of 589 unselected consecutives patients with normal preprocedural troponin Ic undergoing isolated SVG PCI with drug-eluting stent implantation was included. Patients were divided into 2 groups according to the peak troponin value post PCI: those with MI defined as a peak troponin value above 3x the 99th percentile of normal post-PCI (MI group, n = 166) and those without (no MI group, n = 423). The primary end point was the rate of major adverse cardiac events including death, MI, and target vessel revascularization at 1-year follow-up. RESULTS: Baseline characteristics were similar between the 2 groups. In the MI group, patients had more complex angiographic features (type C lesions: 44.7 vs 34.8%; P = .006). The rate of direct stenting and distal protection use were similar in the 2 groups (MI vs no MI: 29.2 vs 28.7%; P = .9 and 32 vs 37.5%; P = .24, respectively). Patients in the MI group had a worse inhospital course but a similar 1-year rate of major adverse cardiac events (22.3 vs 19.1%; P = .39). CONCLUSION: Procedure-related MI after PCI, as defined by the universal definition, is associated with an adverse inhospital course but may not predict long-term outcome in SVG PCI.

Paclitaxel-eluting balloon: from bench to bed.

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in-stent restenosis. Brachytherapy and drug-eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in-stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non-stent based local drug delivery and particularly the use of paclitaxel-eluting balloons could be one of these strategies. We aimed to review the concept, preclinical-, and clinical data available with non-stent based local drug delivery and, in particular, with paclitaxel-eluting balloons.

Prognosis of patients suffering an acute coronary syndrome while already under chronic clopidogrel therapy.

OBJECTIVE: To assess the prognosis of patients presenting with an acute coronary syndrome (ACS) despite chronic clopidogrel therapy (CCT). BACKGROUND: CCT has been shown to be beneficial in decreasing the frequency of major adverse cardiovascular events (MACE) in patients after an ACS or drug-eluting stent (DES) implantation. Some patients, however, still suffer thrombotic events while on CCT. The outcome of this particular subgroup of patients is unknown. METHODS: A cohort of 1,281 patients undergoing percutaneous coronary intervention (PCI) for an ACS was studied. They were divided according to their treatment prior to the ACS. The CCT group was composed of all patients who had been taking clopidogrel for >or=30 days before the onset of the ACS (n = 175) and the no CCT group of all patients not on clopidogrel before the ACS (n = 1,106). Rates of cardiovascular death and myocardial infarction at 6 months' follow-up were compared. RESULTS: Patients in the CCT group were older (66 +/- 11 vs. 63 +/- 13; P< 0.001), and more often diabetic (46.8 vs. 31.9%; P < 0.01). In-hospital outcomes were similar, including the rate of death and myocardial infarction (no CCT vs. CCT group: 4.2 vs. 2.3%; P = 0.2). At 6 months, patients already taking clopidogrel before the ACS had a higher rate of MACE than patients who were not (18.3 vs. 11.8%; P = 0.02). In multivariate analysis, CCT before the ACS was associated with a hazard ratio of 1.7 for MACE. CONCLUSION: This study suggests that patients suffering an ACS while under on CCT have a poor long-term prognosis, which could be linked to clopidogrel low-response.

Prognostic value of the Syntax score in patients undergoing coronary artery bypass grafting for three-vessel coronary artery disease.

BACKGROUND: The Syntax score prognostic value has recently been highlighted in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary artery disease (CAD), however its prognostic value in patients undergoing coronary artery bypass grafting (CABG) for multivessel CAD is still unknown. The aim of this study was to evaluate the prognostic value of the Syntax score in patients undergoing CABG for 3-vessel CAD. METHODS: A cohort of 320 consecutive patients with multivessel (3-vessel) CAD who were subjected for CABG were included in this study and divided into tertiles according to the Syntax score (<24.5, 24.5-34, and >34). During the 1-year follow-up, cardiovascular events including death, myocardial infarction (MI), and stroke were systematically indexed. The primary end point was the composite criteria death/MI/stroke. RESULTS: The Syntax score ranged from 11-74 with a mean of 31.2 +/- 12.6 and a median of 28.5 [22-38]. Baseline clinical characteristics were similar among the tertiles. No statistical difference was found for the composite criteria death/MI/stroke: 9.4% versus 7.5% versus 10.4% in the groups with a Syntax score <24.5, 24.5-34, and >34, respectively (P = 0.754). CONCLUSION: Unlike for PCI, the Syntax score has a poor prognostic value for severe cardiovascular events in patients undergoing CABG for 3-vessel CAD. Other risk scores should be used to predict the outcome of this population.

Impact of bivalirudin on in-hospital bleeding and six-month outcomes in octogenarians undergoing percutaneous coronary intervention.

OBJECTIVES: This study aimed to analyze the impact of replacing heparin with bivalirudin in octogenarians undergoing percutaneous coronary intervention (PCI) on postprocedure hemorrhage and 6-month mortality. BACKGROUND: Randomized trials comparing the antithrombin agent bivalirudin with heparin as the intraprocedural anticoagulant identify a reduction in periprocedural bleeding after PCI. Further, the occurrence of such bleeding seems to predict an increased risk of death or myocardial infarction both in-hospital and at long-term follow-up. Importantly, elderly people who are at the greatest risk of post-PCI bleeding complications are underrepresented in these randomized trials. METHODS: From 2000 to 2007, 2,766 consecutive patients from our center who were > or = 80 years of age underwent PCI with stent implantation and were included in this analysis. Bivalirudin was used in 1,207 (43.6%) patients and heparin in 1,559 (56.4%). We compared the rates of post-PCI bleeding complications and 6-month mortality. RESULTS: The overall in-hospital bleeding and 6-month mortality rates were 4.6% and 11.8%, respectively. By multivariate logistic regression and after adjustment by propensity score analysis, bivalirudin was associated with a significant decrease in in-hospital bleedings (HR = 0.41, 95% CI = 0.23-0.73, P = 0.003). By multivariate Cox analysis, bivalirudin was also associated with a significant decrease (HR = 0.6, 95% CI = 0.4-0.9, P = 0.01) and in-hospital bleedings with a significant increase in the 6-month mortality (HR = 2.5, 95% CI = 1.6-3.9, P < 0.001). CONCLUSION: This study suggests an important subset for use of bivalirudin in lieu of heparin that will benefit the very elderly.

Clinical manifestation and prognosis of early versus late stent thrombosis of drug-eluting stents.

BACKGROUND: Stent thrombosis (ST) is a serious complication of drug-eluting stents (DES), leading to catastrophic events. ST can occur early or late following the percutaneous coronary intervention (PCI) with different possible consequences. METHODS: The records of 91 consecutive patients who presented with a definite ST (as defined by the Academic Research Consortium) from 2003 to 2007 were reviewed. Clinical presentation and outcome were compared based on the time of the event. Fifty-one patients presented with an early ST versus 40 with a late ST. The primary end-point was a composite of death-recurrent myocardial infarction (MI)-recurrent ST at 1 year. RESULTS: Baseline characteristics were similar. Patients with early ST had more initial stent implantation for an acute MI indication and presented more with cardiogenic shock when compared to patients with late ST: 43.1% versus 17.5% (P = 0.007) and 39.2% versus 20% (P = 0.042), respectively. There was no difference in the ST treatment except for more intraaortic balloon pump (IABP) use in the early ST group (28% vs. 10%, P = 0.034). Angiographic success rates were similar. The incidence of the composite primary end-point was 52.9% in the early ST group versus 30% in the late ST group (P = 0.034). CONCLUSION: Early definite ST is associated with more dramatic presentation and worse long-term prognosis when compared with definite late ST. This could be explained at least in part by the occurrence of two successive MIs within 30 days in almost 45% of the patients with early ST, leading to a higher rate of cardiogenic shock.

Impact of bivalirudin use on outcomes in nonagenarians undergoing percutaneous coronary intervention.

BACKGROUND: With an aging population, nonagenarians constitute an increasing percentage of patients with coronary artery disease. The aim of this study was to determine the predictors and outcome of nonagenarians undergoing percutaneous coronary intervention (PCI) for symptomatic coronary artery disease. METHODS: From 2002 to 2007, a cohort of 171 consecutive nonagenarians underwent PCI and stent implantation in our center. Patients given bivalirudin (n = 79) during the procedure were compared to those given heparin (n = 92). In-hospital and 6-month rates of major adverse cardiovascular events (MACE) including death, myocardial infarction (MI), and target lesion revascularization were indexed. In-hospital bleedings were also indexed. RESULTS: The mean age was 92.5 +/- 2.5 years. The population was 52% female. Nearly 30% of patients had diabetes mellitus and >25% had renal failure. The mean left ventricular ejection fraction was 45%+/- 14%. The clinical presentation was an acute MI in 59% of the cases. The in-hospital rates of death and bleedings were 4.1% and 17.5%, respectively. Clinical presentations as MI or cardiogenic shock were associated with high rates of in-hospital death: 19.3% and 30%, respectively. Bivalirudin use was associated with a 41.5% decrease in in-hospital bleedings. The 6-month incidence of MACE was 13.6% and was driven by death. Predictors of 6-month outcomes were clinical presentations as MI or cardiogenic shock, renal failure, and total stent length. CONCLUSION: Nonagenarians represent a particular population with a high percentage of females and a high incidence of comorbidities. In this study, we highlighted that nonagenarians have logically a worse prognosis than is reported in younger patients, with especially high rates of in-hospital bleedings. Bivalirudin use was associated with an important decrease in in-hospital bleedings; thus, it should be systematically considered in such patients to improve early outcome.

Impact of optimal medical therapy and revascularization on outcome of patients with chronic kidney disease and on dialysis who presented with acute coronary syndrome.

Coronary artery disease is the main cause of death in patients with chronic kidney disease (CKD). The poor prognosis associated with acute coronary syndrome (ACS) in these patients has been related to therapeutic nihilism. This study included 2,357 patients with ACS who had percutaneous coronary intervention. According to their creatinine clearance and medical history, they were divided into 3 groups: dialysis (n = 73); CKD (n= 293); and control (n= 1,991). Rates of cardiovascular events were recorded during a 1-year follow-up period. Patients in all groups received similar contemporary therapy for ACS, including percutaneous coronary intervention and optimal medial therapy. On admission, patients with CKD and patients on dialysis more often presented with cardiogenic shock (p = 0.05 and 0.02, respectively). A graded increase in the rate of major adverse cardiovascular events at 1 year was observed with decreasing renal function (control 13%, CKD 22.9%, dialysis 45.2%, p <0.001 for all comparisons). In multivariate analysis, patients with CKD and on dialysis were significantly associated with 1-year major adverse cardiac events with adjusted hazard ratios of, respectively, 1.5 (95% confidence interval 1.1 to 2.1; p = 0.009) and 2.7 (95% confidence interval 1.7 to 4.1; p <0.001). In conclusion, despite optimal contemporary medical therapy and revascularization, the prognosis of patients with CKD and, in particular, of patients undergoing dialysis, remains poor.

Bivalirudin with provisional glycoprotein IIb/IIIa inhibitors in patients undergoing primary angioplasty in the setting of cardiogenic shock.

In patients undergoing percutaneous coronary intervention (PCI), clinical trials have demonstrated that the use of bivalirudin with provisional glycoprotein IIb/IIIa inhibitors is not inferior to heparin with systematic glycoprotein IIb/IIIa inhibitors on major adverse cardiac events and is associated with lower rates of bleeding in various clinical settings. Patients with cardiogenic shock (CS), however, have been excluded from all pivotal trials. A retrospective analysis of 86 consecutive patients undergoing PCI for acute myocardial infarction complicated by CS in our center from April 2003 to September 2007 was performed. In-hospital death, major adverse cardiac events, and bleeding rates were compared in 37 patients who received bivalirudin with or without glycoprotein IIb/IIIa inhibitors and 49 patients who were treated with heparin and glycoprotein IIb/IIIa inhibitors as anticoagulation management. Baseline demographic, clinical, and biological characteristics were similar in the 2 groups. The in-hospital death rate was significantly lower in the bivalirudin group (5.4 vs 32.7%, p = 0.002). There were no differences in the rate of major hematoma between the bivalirudin group and the heparin group (3 vs 2.6%, p = 0.46). In conclusion, bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitors appears to be a safe and effective anticoagualtion strategy in patients undergoing primary PCI for acute myocardial infarction complicated by CS.

Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry).

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.

Bleeding risk and outcomes of Bivalirudin versus Glycoprotein IIb/IIIa inhibitors with targeted low-dose unfractionated Heparin in patients having percutaneous coronary intervention for either stable or unstable angina pectoris.

For patients undergoing elective percutaneous coronary intervention (PCI), procedural anticoagulation with bivalirudin was previously shown to significantly reduce bleeding complications at the cost of a modest increase in ischemic events compared with unfractionated heparin (UFH) and glycoprotein IIb/IIIa inhibitors (GPIs). However, the excess bleeding in patients treated with UFH and GPIs may have been caused by excessively high UFH doses and increased activated clotting times. This study sought to determine the bleeding risk of targeted low-dose UFH with GPIs compared with bivalirudin in patients undergoing elective PCI. Of 1,205 patients undergoing elective PCI, 602 underwent PCI with adjunctive UFH and GPIs with the UFH dose targeted to an activated clotting time of approximately 250 seconds, and 603 patients matched for baseline characteristics underwent PCI with bivalirudin. Outcomes were analyzed for major bleeding (hematocrit decrease >15%, gastrointestinal bleed, or major hematoma) and 6-month major adverse cardiac events (death, myocardial infarction, and target-lesion revascularization). The maximum activated clotting time achieved was 261.7 +/- 61.6 seconds in the UFH/GPI group and 355.4 +/- 66.6 in the bivalirudin group (p <0.001). In-hospital major bleeding rates were similar between groups (1.8% UFH/GPI vs 1.7% bivalirudin; p = 0.83), as were transfusion requirements (1.2% UFH/GPI vs 0.5% bivalirudin; p = 0.61). The 6-month major adverse cardiac event rate was also similar between groups (9.5% UFH/GPI vs 9.0% bivalirudin; p = 0.81). In conclusion, there were no significant differences in major bleeding and 6-month major adverse cardiac events for patients undergoing elective PCI treated with targeted low-dose UFH and GPIs compared with those treated with bivalirudin.

Prognostic value of echocardiographic right/left ventricular end-diastolic diameter ratio in patients with acute pulmonary embolism: results from a monocenter registry of 1,416 patients.

BACKGROUND: In the literature, echocardiographic assessment of the prognosis of acute pulmonary embolism is based on analysis of right ventricle free-wall motion or on a composite index combining right ventricular dilatation, paradoxical septal wall motion, and pulmonary hypertension. The aim of this study was to determine the prognostic value of a single quantitative echocardiographic criterion, the right/left ventricular end-diastolic diameter (RV/LV) ratio. METHODS: Registry data on 1,416 consecutive patients hospitalized for acute pulmonary embolism were used to study retrospectively a population of 950 patients who underwent echocardiographic assessment on hospital admission and for whom the RV/LV ratio was available. RESULTS: The hospital mortality rate for the series was 3.3%. Sensitivity and specificity of RV/LV ratio >or= 0.9 for predicting hospital mortality were 72% and 58%, respectively. Multivariate analysis showed the independent predictive factors for hospital mortality to be the following: systolic BP < 90 mm Hg (odds ratio [OR], 10.73; p < 0.0001), history of left heart failure (OR, 8.99; p < 0.0001), and RV/LV ratio >or= 0.9 (OR, 2.66; p = 0.01). CONCLUSIONS: In our retrospective series, an echocardiographic RV/LV ratio >or= 0.9 was shown to be an independent predictive factor for hospital mortality. This criterion may be of value in selecting cases of submassive pulmonary embolism with a poor prognosis that are liable to benefit from thrombolytic treatment.

Vascular brachytherapy for patients with drug-eluting stent restenosis.

BACKGROUND: The rate of drug-eluting stent (DES) in-stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. METHODS: Ninety-nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1-year follow-up. RESULTS: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in-hospital course were documented in all patients post VBT. At 12 months' follow-up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. CONCLUSIONS: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.

Reducing risk of stroke in patients with acute coronary syndrome: is screening for asymptomatic carotid disease useful?

Stroke is a rare but severe event after acute coronary syndrome. Relations between both arterial territories are still discussed but prevalence of asymptomatic carotid stenosis potentially implicated in the mechanism of stroke is under-investigated. This study aimed to determine the prevalence of asymptomatic carotid stenosis in that population and review the value of screening in a view to potential surgical correction or other preventive therapies. Systematic carotid Doppler ultrasound screening was implemented on 152 consecutive patients admitted to the intensive care unit due to acute coronary syndrome. Fifty-two percent of patients had at least one carotid artery stenosis determined using the NASCET method. Forty-three percent had at least one carotid stenosis <30%, 6% had mild (30-60%) stenosis, and 2.6% had high-grade (>60%) stenosis. Existence of carotid stenosis was associated with age, diabetes mellitus, hypertension, and with the extent of the coronary atherosclerosis (left main artery stenosis). In multivariate analysis, age and diabetes were independently associated with existence of a carotid stenosis. When ultrasound screening was restricted to patients identified by multivariate analysis, the prevalence of carotid stenosis potentially requiring surgical treatment rose to 4.6%. The frequency of asymptomatic carotid atherosclerosis was high in this population but lesions were mild. While the small number of high-grade lesions indicates that systematic screening is not to be recommended, screening of patients aged >65 years or with diabetes, or both, with a view to surgery may be envisaged, since the role of mild stenosis in the occurrence of stroke remains debatable.

Comparison of the beneficial effect of beta-blockers on mortality in patients with ischaemic or non-ischaemic systolic heart failure: a meta-analysis of randomised controlled trials.

UNLABELLED: Mechanisms by which beta-blockers bring benefit may differ according to the aetiology of heart failure (HF). It is uncertain whether the magnitude of the benefit of beta-blockers is the same in ischaemic or non-ischaemic HF. METHODS: We performed a systematic review of all randomised, placebo-controlled, parallel-design trials of beta-blockers in HF that collected data on mortality during follow-up. RESULTS: Among 26 randomised trials comparing beta-blockers with placebo in HF, 4 studies with 7250 patients provided information on the number of patients who died during follow-up in subgroups of ischaemic and non-ischaemic aetiology of HF. Two studies were performed with bisoprolol, one with carvedilol and one with metoprolol. HF was associated with ischaemic aetiology in 4746/7250 patients (65%) and non-ischaemic aetiology in 2504/7250 patients (35%). Mortality occurred in 301 patients. The risk ratio (RR) for beta-blockers versus placebo was 0.62 (95% confidence interval [CI] 0.52-0.75, p<0.00001) in ischaemic HF, compared with a RR of 0.62 (95% CI 0.45-0.84, p=0.002) in the presence of non-ischaemic HF. CONCLUSION: The magnitude of the prognostic benefit conferred by beta-blockers for overall mortality in non-ischaemic HF appears to be very similar to that in ischaemic HF.

Revascularization algorithm in acute STEMI should take into account age.

BACKGROUND: In the elderly patients, the optimal reperfusion strategy of acute ST-segment elevation myocardial infarction (STEMI) remains a topic of debate. Moreover, there is a lack of data regarding the effect of time to treatment (TT) on prognosis of STEMI in elderly patients. PURPOSE: The goal of our work was to analyze, in real life, the link between TT and 1-year mortality in patients with STEMI (> or =75 years) who were treated with thrombolysis (THL) or primary percutaneous coronary intervention (PCI). METHODS AND MATERIALS: Data were extracted from our university hospital prospective registry. Between 1995 and 2005, all patients who met the criteria (> or =75 years old, has had an acute STEMI <12 h, has been admitted directly into our cardiologic care unit, and has had a revascularization procedure) were included in the analysis. Using logistic regression, we studied the relation between TT and 1-year mortality for each strategy of reperfusion in patients with STEMI who were > or =75 years old. RESULTS: One hundred fifty-nine consecutive patients with STEMI <12 h were analyzed; 35 were treated with THL and 124 were treated with primary PCI. Mean age (+/-S.D.) was 80+/-4 years, and 56% of patients were men. In logistic regression analysis, TT was not associated to death after THL (P=.81), while it was positively correlated after PCI (P=.03). All-cause 1-year mortality was markedly higher in the THL group than in the PCI group (51.4% vs. 15.3%; P<.001). CONCLUSION: Our work suggests that the extrapolation of algorithm of revascularization used in younger patients is not appropriate for elderly patients. Specific algorithm of revascularization and recommendations are needed in elderly patients.