Search

BACKGROUND whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. METHODS We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. RESULTS After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P=0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P=0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). CONCLUSIONS In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.) [ABSTRACT FROM AUTHOR]

Clinical outcomes in patients with acute coronary syndromes randomized in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial who underwent percutaneous coronary intervention (PCI) of saphenous vein grafts (SVGs) were examined. The ACUITY trial assessed the safety and efficacy of bivalirudin alone versus bivalirudin plus a glycoprotein (GP) IIb/IIIa inhibitor versus heparin plus a GP IIb/IIIa inhibitor in 13,819 patients with moderate- and high-risk acute coronary syndromes, 7,789 of whom underwent PCI. A total of 329 patients (4.2%) underwent PCI of SVGs in ACUITY. The primary end points at 30 days were composite ischemia or major adverse cardiac events (death, myocardial infarction, or unplanned target vessel revascularization), major bleeding (unrelated to coronary artery bypass grafting), and net adverse clinical events (composite ischemia or major bleeding). The rates of ischemic, bleeding, and net clinical end points were similar with bivalirudin monotherapy, bivalirudin plus a GP IIb/IIIa inhibitor, and heparin plus a GP IIb/IIIa inhibitor. Net adverse clinical outcome rates at 30 days were 22%, 26%, and 22% (p = 0.67), respectively, for the 3 groups. Major adverse cardiac event rates at 1 year were 37%, 37%, and 43% (p = 0.95), respectively. Minor bleeding unrelated to coronary artery bypass grafting at 30 days was significantly lower with bivalirudin alone compared with heparin plus a GP IIb/IIIa inhibitor (26% vs 38%, p = 0.05). In conclusion, bivalirudin is an effective anticoagulant in PCI of SVGs in acute coronary syndromes, with similar rates of major adverse cardiac events and net adverse cardiac events and lower minor bleeding complications in comparison with heparin plus a GP IIb/IIIa inhibitor or bivalirudin plus a GP IIb/IIIa inhibitor. [ABSTRACT FROM AUTHOR]

Sirolimus-eluting stents (SESs) reduce restenosis compared with bare metal stents. Safety issues with drug-eluting stents are particularly important given concerns of possible increased thrombogenicity. Compared with heparin plus glycoprotein IIb/IIIa inhibitors, the direct thrombin inhibitor bivalirudin has been shown to reduce the risk of hemorrhagic complications in patients receiving bare metal stents, with similar efficacy in preventing ischemic complications. The safety and efficacy of percutaneous coronary intervention (PCI) with SESs and bivalirudin anticoagulation have not been prospectively studied. This prospective study performed at 9 United States hospitals evaluated 1,182 patients referred for PCI with SESs in whom the procedural anticoagulant was bivalirudin. Clopidogrel was administered before PCI in 79% of patients, and only 5.3% received procedural glycoprotein IIb/IIIa inhibitors. At 30 days, major adverse cardiac events occurred in 7.1% of patients, including 0.3% mortality, 4.4% myocardial infarction (defined as creatine kinase-MB >3x normal), 1.7% target vessel revascularization, and 0.6% stent thrombosis. Major bleeding occurred in only 0.8% of patients. Thus, use of bivalirudin as the procedural anticoagulant to support SES implantation in a "real world" population of patients undergoing PCI results in low rates of major adverse cardiac events, stent thrombosis, and major bleeding. [ABSTRACT FROM AUTHOR]

Presents several articles on stent implantation. "Relation of Final Lumen Dimensions in Saphenous Vein Grafts After Stent Implantation to Outcome," by I. Iakovou, G. Dangas, G. S. Mintz, and colleagues; "Randomized Study to Evaluate Sirolimus-Eluting Stents Implanted at Coronary Bifurcation Lesions," by A. Colombo, J. W. Moses, M. C. Morice, and colleagues; "Impact of Strut Thickness on Late Luminal Loss After Coronary Artery Stent Placement," by S. Z. Rittersma, R. J. de Winter, K. T. Koch, and colleagues.

Of 1,369 consecutive patients who underwent stent-assisted coronary angioplasty and who were treated with glycoprotein IIb/IIIa inhibitors during these procedures, 17.5% were >or=75 years of age. Compared with patients <75 years old, those >or=75 years of age had similar procedural and in-hospital outcomes but significantly higher rates of hemorrhagic stroke (0.08% vs 1.2%, p <0.001). [ABSTRACT FROM AUTHOR]

The impact of the degree of anticoagulation in patients who underwent stent implantation without glycoprotein IIb/IIIa inhibitors was examined in 1,020 patients. High levels of procedural anticoagulation with heparin were found to increase hemorrhagic complications without improving clinical or angiographic outcomes. [ABSTRACT FROM AUTHOR]

In 1986, the first metallic stent was implanted inside a human coronary artery in order to reduce the incidence of abrupt vessel occlusion and restenosis after percutaneous coronary balloon angioplasty. Little was known at that time regarding the adequate anticoagulation regimen needed and the initial enthusiasm was soon marred by a high rate of thrombotic stent closure that usually occurred 2 days to 4 weeks after stent implantation. Antithrombotic drugs such as heparin, aspirin (acetylsalicylic acid), low molecular weight heparins, dextran, dipyridamole and warfarin (coumadin) were incorporated in a series of trials which reduced the risk of stent thrombosis, but increased substantially the rate of bleeding complications and the length of hospitalisation. The greatest breakthrough came with the improvement in stent deployment techniques using intravascular ultrasound-guided, high-pressure balloon inflation inside the stent, and the understanding of the central role of platelet activation in stent thrombosis. These 2 factors have led to ‘optimal stent deployment’ with high-pressure ballooning after stent deployment and the simultaneous use of more potent antiplatelet agents in conjunction with aspirin. Newly developed selective inhibitors of the platelet glycoprotein IIb/IIIa receptor and new stent designs have also recently been integrated into clinical practice and are currently being evaluated in clinical trials. [ABSTRACT FROM AUTHOR]

Background- The relationship between white blood cell count (WBCc) and mortality in patients with ST-segment-elevation acute myocardial infarction treated with percutaneous coronary intervention is poorly understood. Furthermore, whether there is a relationship between WBCc and risk of noncardiac mortality and bleeding after percutaneous coronary intervention is unknown. Methods and Results- The baseline WBCc was available in 3193 of 3345 patients (95.5%) who underwent percutaneous coronary intervention in the Harmonizing Outcome With Revascularization and Stent in Acute Myocardial Infarction (HORIZONS-AMI) trial. In a propensity-adjusted multivariable analysis, WBCc was an independent predictor of 1-year cardiac mortality (hazard ratio, 1.15; 95% confidence interval, 1.09 to 1.22), noncardiac mortality (hazard ratio, 1.19; 95% confidence interval, 1.10 to 1.29), and major bleeding (hazard ratio, 1.08; 95% confidence interval, 1.04 to 1.12). After adjustment for baseline creatinine phosphokinase levels and left ventricular ejection fraction, WBCc remained an independent predictor of 1-year all-cause mortality and cardiac mortality. In patients matched for baseline creatinine phosphokinase levels at hospital admission, the median peak creatinine phosphokinase level was significantly higher in patients with high WBCc (>11 000 per 1 mm(3)) compared with low WBCc (1851 U/L [range, 880-3307 U/L] versus 1241 U/L [range, 540 to 2,78], respectively; P<0.0001). In this subgroup of patients, WBCc was an independent correlate of peak creatinine phosphokinase level, and remained an independent predictor of 1-year mortality. Conclusions- In patients with ST-segment-elevation acute myocardial infarction undergoing percutaneous coronary intervention, elevated baseline WBCc is an independent predictor of infarct size, as assessed by peak creatinine phosphokinase level, and of 1-year cardiac mortality, noncardiac mortality, and major bleeding. Clinical Trial Registration- URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00433966. [ABSTRACT FROM AUTHOR]

Objectives: We sought to determine the impact of aggressive stent expansion on creatine kinase-MB isoenzyme (CK-MB) release and clinical restenosis.Background: Elevation of CK-MB after percutaneous coronary interventions has been associated with late mortality.Methods: We identified 989 consecutive patients who underwent intravascular ultrasound-guided stenting of 1,015 coronary lesions. Patients were divided into three groups according to stent expansion, defined as the ratio of final lumen over the reference lumen cross-sectional areas: Group 1 (ratio <70%, n = 117 patients with 126 lesions); Group 2 (ratio 70% to 100%, n = 551 patients with 562 lesions); Group 3 (ratio >100%, n = 321 patients with 327 lesions).Results: The peak CK-MB values increased significantly with increasing stent expansion: CK-MB = 3 to 5x normal occurred 16%, 18%, and 25% in Groups 1, 2, and 3, respectively, p = 0.02; CK-MB >5 times normal occurred 9%, 13%, and 16% respectively, p = 0.02. Conversely, at one year follow-up there was a stepwise decrease in target lesion revascularization (11% vs. 19% and 17%, respectively, p = 0.04) and major adverse cardiac events with increasing stent expansion. In addition, there was a trend toward lower mortality in Group 3 (9% vs. 4.4% vs. 4.0%, p = 0.07).Conclusions: Intravascular ultrasound-guided stent overexpansion (final lumen greater than reference lumen cross-sectional area) is accompanied by a higher periprocedural CK-MB release but a lower target lesion revascularization and a trend toward lower mortality at one year. Increased periprocedural CK-MB release appears as a trade-off for optimal stent implantation and lower clinical restenosis. [ABSTRACT FROM AUTHOR]

Treatment of diffuse in-stent restenosis in saphenous vein grafts with excimer laser coronary angioplasty plus adjunct balloon angioplasty achieves an adequate acute result. However, this population has high long-term mortality and frequent need for repeat revascularization. [ABSTRACT FROM AUTHOR]

Evaluates the interaction of baseline remodeling characteristics and clinical restenosis in native coronary lesions treated with stent implantation. Baseline clinical characteristics and lesion location; Angiographic and intravascular ultrasound analysis; Clinical events at follow-up.

"Optimal" percutaneous transluminal coronary angioplasty (PTCA) may have a late restenosis rate similar to stenting. We sought to assess short- and long-term results of a provisional stenting/optimal PTCA approach compared with elective stenting in a prospective, randomized study. A total of 97 patients with discrete, de novo lesions in native coronary arteries > or =3 mm in diameter were randomized 2:1 in PTCA with prolonged perfusion balloon inflation (n = 66) versus elective stenting (n = 31). Recoil after PTCA was assessed by routine delayed angiograms (5 and 20 minutes). Cross over to stent was allowed for an inadequate result; there was no on-line quantitative angiography. An independent core angiographic laboratory assessed all results and evaluated the adequacy of the subjective interpretation. Within the PTCA arm, there were 24 (36%) crossovers to stenting (5 of 24 [21%] due to recoil), whereas 2 stents could not be delivered to the lesion and crossed over to PTCA. As assessed by quantitative angiography, baseline reference vessel diameters were similar between the PTCA and stent groups. The immediate lumen diameter achieved with PTCA was smaller than that achieved with stenting (2.18+/-0.49 vs. 2.44+/-0.38 mm, respectively, p = 0.01). There were no differences in angiographic results between elective and crossover stenting and there were no in-hospital complications in any patient. Target lesion revascularization at 8 months was 19% (n = 6) in the elective stent arm versus 21% (n = 14) in the PTCA arm, p = NS; respective rates in PTCA alone and crossed over-to-stent subsets were 23% (n = 10) versus 17% (n = 4), p = NS. Angiographic restenosis was 47% after elective stenting versus 38% after PTCA (intention to treat), p = NS. By received treatment, it was 41% (11 of 27) in the group treated with the PTCA versus 33% (5 of 15) in the crossover-to-stent arm (p = NS). Thus, provisional stenting can be safely performed in the treatment of discrete, native de novo lesions. Early recoil after PTCA cannot be reliably assessed without quantitative angiography. [ABSTRACT FROM AUTHOR]

In this initial study, we found that autoantibodies against actin and myosin were present during and after an acute coronary syndrome. Moreover, they correlated with persistent troponin-I elevation at follow-up, and with late myocardial infarction. [ABSTRACT FROM AUTHOR]

Thrombotic risk in hyperlipidemic women and its response to lipid therapy is unknown. We prospectively studied 28 men and 29 women with high low-density lipoprotein (LDL) cholesterol during 6 months of therapy with pravastatin. Women had significantly higher high-density lipoprotein (HDL) cholesterol (54.2 +/- 1.7 vs 39.5 +/- 2.2 mg/dl, p <0.01), lower prevalence of coronary artery disease (41% vs 67%, p = 0.04), and otherwise similar baseline characteristics compared with men. Both genders achieved a 33% reduction in LDL at 6 weeks (188 +/- 6 to 133 +/- 5 mg/dl) and maintained similar LDL levels throughout the study. Systemic hemostatic markers and thrombus formation under dynamic flow conditions were evaluated at baseline, and at 3 and 6 months of follow-up. Prothrombin fragment F1.2, a marker of thrombin generation, was higher in women versus men at baseline (2.4 +/- 0.2 vs 1.4 +/- 0.3 nmol/L, p = 0.02). The levels decreased in women to 2.0 +/- 0.3 nmol/L at 3 months and to 1.6 +/- 0.2 nmol/L at 6 months (p <0.045, analysis of variance), whereas it remained unchanged in men. Plasminogen activator inhibitor-I significantly decreased at 3 and 6 months of follow-up: by 12.6% and 18.7%, respectively, in women, and by 18.8% and 23.5%, respectively, in men. Similarly, tissue plasminogen activator decreased significantly by 7.4% in women and 11.8% in men at 6 months compared with baseline. Fibrinogen showed an increase in both genders at follow-up. Thrombus formation was similar at baseline between the 2 genders, and decreased at 3 and 6 months compared with baseline by 12.5% and 29.5% in women, and by 18.6% and 19.4% in men (p <0.04 at 6 months vs baseline in both men and women). Other markers, including C-reactive protein, fibrinopeptide A, D-dimer, and factor VIIa, did not differ between genders and did not change with therapy. Thus, despite higher HDL, and lower incidence of coronary disease, women with high LDL had a comparable thrombotic and/or fibrinolytic profile to men and even evidence of increased thrombin generation at baseline. Blood thrombogenicity was reduced with pravastatin in both genders; in addition, thrombin generation was gradually reduced in women to a level similar to that of men by 6 months of follow-up. [ABSTRACT FROM AUTHOR]

This study reports the association of elevated serum lipoprotein(a) levels with angiographically extensive coronary disease and the presence of totally occluded coronary arteries, as well as the association of elevated lipoprotein(a) with unstable angina. These results support the role of lipoprotein(a) in the human atherothrombotic process. [ABSTRACT FROM AUTHOR]

BACKGROUND Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). M E T H O D S In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [Cl], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% Cl, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% Cl, -0.97 to 0.84; hazard ratio, 0.99; 95% Cl, 0.78 to 1.25; P<0.001 for noninferiority). C O N C L U S IO N S Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.) [ABSTRACT FROM AUTHOR]

Background: Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes.Methods: HORIZONS-AMI was a prospective, open-label, randomised trial undertaken at 123 institutions in 11 countries. Patients aged 18 years or older were eligible for enrolment if they had ST-segment elevation myocardial infarction (STEMI), presented within 12 h after onset of symptoms, and were undergoing primary percutaneous coronary intervention. By use of a computerised interactive voice response system, we randomly allocated patients 1:1 to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI; pharmacological randomisation; stratified by previous and expected drug use and study site) and, if eligible, randomly allocated 3:1 to receive a paclitaxel-eluting stent or a bare metal stent (stent randomisation; stratified by pharmacological group assignment, diabetes mellitus status, lesion length, and study site). We produced Kaplan-Meier estimates of major adverse cardiovascular events at 3 years by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00433966.Findings: Compared with 1802 patients allocated to receive heparin plus a GPI, 1800 patients allocated to bivalirudin monotherapy had lower rates of all-cause mortality (5·9%vs 7·7%, difference -1·9% [-3·5 to -0·2], HR 0·75 [0·58-0·97]; p=0·03), cardiac mortality (2·9%vs 5·1%, -2·2% [-3·5 to -0·9], 0·56 [0·40-0·80]; p=0·001), reinfarction (6·2%vs 8·2%, -1·9% [-3·7 to -0·2], 0·76 [0·59-0·99]; p=0·04), and major bleeding not related to bypass graft surgery (6·9%vs 10·5%, -3·6% [-5·5 to -1·7], 0·64 [0·51-0·80]; p=0·0001) at 3 years, with no significant differences in ischaemia-driven target vessel revascularisation, stent thrombosis, or composite adverse events. Compared with 749 patients who received a bare-metal stent, 2257 patients who received a paclitaxel-eluting stent had lower rates of ischaemia-driven target lesion revascularisation (9·4%vs 15·1%, -5·7% [-8·6 to -2·7], 0·60 [0·48-0·76]; p<0·0001) after 3 years, with no significant differences in the rates of death, reinfarction, stroke or stent thrombosis. Stent thrombosis was high (≥4·5%) in both groups.Interpretation: The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention.Funding: Boston Scientific and The Medicines Company. [ABSTRACT FROM AUTHOR]

Whether the benefits that glycoprotein IIb/IIIa inhibitors confer in patients who undergo bare metal stent implantation extend to drug-eluting stents is unknown. We performed a prespecified subgroup analysis of the TAXUS IV study population to examine the effect of procedural glycoprotein IIb/IIIa inhibition during paclitaxel-eluting stent implantation on periprocedural creatine kinase-MB (CK-MB) levels. Glycoprotein (GP) IIb/IIIa inhibitors were administered to 57.7% of patients who had been randomized to receive the TAXUS stent and to 56.7% of those who had been randomized to receive the control stent. Among patients who received the TAXUS stent, the rate of CK-MB increases of >3 times the normal level was 2.6-fold higher in those who received a GP IIb/IIIa inhibitor than in those who did not (11.4% vs 4.4%, p = 0.0015). Composite rates of major adverse cardiac events and target vessel failure were also higher at 1 month in the GP IIb/IIIa group. By multivariate analysis, use of GP IIb/IIIa inhibitors during stenting with the TAXUS stent was an independent predictor of CK-MB increases >3 times the normal level. Further studies are warranted. [ABSTRACT FROM AUTHOR]

The present study evaluated in-hospital and 1-year outcomes after multivessel stenting in patients aged > or =80 (75 patients, 241 lesions) and <80 years (894 patients, 2,678 lesions). Despite a high technical success rate of multivessel stenting, octogenarians had higher in-hospital cardiac and noncardiac complication rates and a higher mortality rate at 1-year clinical follow-up compared with their younger counterparts. [ABSTRACT FROM AUTHOR]

We report the long-term outcome of 225 patients who failed gamma-brachytherapy for in-stent restenosis. Total adverse events, target vessel revascularization, and myocardial infarction were higher after repeat percutaneous coronary intervention versus coronary artery bypass grafting. Therefore, coronary artery bypass grafting may be the preferable first-line therapy in these patients until other therapies (i.e., drug-eluting stents) are available. Shorter time from brachytherapy to radiation failure and late thrombosis after brachytherapy were independent predictors of adverse events. [ABSTRACT FROM AUTHOR]

Objectives: We analyzed the effects of vascular brachytherapy (VBT) on ostial in-stent restenosis (ISR).Background: In-stent restenosis has a high recurrence rate after percutaneous reintervention. The recurrence rate of ostial ISR lesions and the impact of VBT remain unknown.Methods: We evaluated 133 patients with native coronary ostial ISR from a pooled database of 990 patients enrolled in randomized VBT trials. Independent quantitative angiography was performed at baseline and follow-up in 45 gamma, 27 beta, and 61 placebo patients.Results: Binary restenosis was significantly higher in placebo than radiated patients (75.4% vs. 17.8% in gamma vs. 22.2% in beta, p < 0.0001). The treatment effect of both gamma (odds ratio [OR] 0.06; 95% confidence interval [CI] 0.02 to 0.17) and beta VBT (OR 0.10; 95% CI 0.03 to 0.31) was maintained after controlling for differences in baseline lesion length. Proximal and distal radiation edge restenosis rates were similar among the groups. Vascular brachytherapy of true aorto-ostial lesions (n = 34) was similarly beneficial: restenosis rates of placebo versus gamma or beta patients of 83.3% versus 6.7% versus 28.6%, p = 0.0002.Conclusions: Conventional treatment of ostial ISR is associated with a recurrence rate of over 75%. Vascular brachytherapy with either gamma or beta sources results in significant and similar reductions in restenosis compared with placebo. Similar benefits after VBT prevail in true aorto-ostial lesions. [ABSTRACT FROM AUTHOR]

We evaluated the short- and long-term clinical outcomes of 326 consecutive patients with chronic renal failure, not on dialysis, who had creatine kinase (CK)-myocardial band (MB) fraction elevation after successful percutaneous coronary intervention in a native coronary artery. Based on peak CK-MB levels measured after intervention, patients were divided into 3 groups: no elevation (group 1, n = 184), 1 to 3 x upper normal levels (group 2, n = 72), and >3 x upper normal levels (group 3, n = 70). Baseline clinical and angiographic characteristics were similar among the 3 groups. Angiographic success was similar among the 3 groups, although there was a significantly higher use of intra-aortic balloon pump in patients who had postprocedural CK-MB >3 x normal values and a higher rate of in-hospital complications, i.e., repeat catheterization, repeat target lesion intervention, pulmonary edema, renal function deterioration, emergency dialysis, and major bleeding complications. At 1-year follow-up, mortality rates were significantly higher in these patients (35.4% vs 22.0% for patients with CK-MB 1 to 3 x normal values and 16.7% for patients without CK-MB elevation, p = 0.007). Multivariate analysis showed that CK-MB >3 x normal (odds ratio 3.04; 95% confidence interval 1.41 to 6.57, p = 0.005) and intra-aortic balloon pump (odds ratio 1.49; confidence interval 1.15 to 1.93, p = 0.002) were independent predictors of late mortality. Therefore, patients with chronic renal failure who had CK-MB elevation >3 x the upper normal limit after a successful percutaneous coronary intervention had a higher incidence of in-hospital complications and a significantly higher mortality rate at 1-year follow-up than patients without CK-MB elevation or with <3 x normal CK-MB elevation. [ABSTRACT FROM AUTHOR]

We compared the combination of aspirin plus clopidrogrel (A+C) with aspirin and ticlopidine (A+T) for prevention of subacute stent thrombosis in 827 patients. At 30-day follow-up, there were trends toward increased subacute thrombosis with A+C compared with A+T (1.3% vs 0.2%, p = 0.10). These results suggest that A+C may have marginally higher subacute stent thrombosis than A+T. [ABSTRACT FROM AUTHOR]

Compared with men, women may have a worse prognosis after native coronary revascularization. However, the influence of gender on clinical outcomes after saphenous vein graft (SVG) stenting is unknown. The purpose of this study was to compare early and 1-year clinical outcomes between men and women after stent implantation in SVG. A total of 1,199 consecutive patients with 1,858 SVG lesions were studied. Procedural success, in-hospital events, and late clinical outcomes were compared between men (n = 951) and women (n = 248). Overall procedural success was similar between men and women (97% vs 96%, p = NS). However, in-hospital (3.2% vs 1.6%, p = 0.07) and 30-day cumulative (4.4% vs 1.9%, p = 0.02) mortality rates were higher in women than in men. In addition, women had a higher incidence of vascular complications (12% vs 7.3%, p = 0.006) and postprocedural acute renal failure (8.1% vs 4%, p = 0.02). At 1-year follow-up, mortality was 13% in women and 11% in men (p = NS) and target lesion revascularization was 18% versus 23%, respectively (p = NS). By multivariate regression analysis, independent correlates of in-hospital mortality were female gender (odds ratio [OR] 3.6, confidence interval [CI] 1.0 to 12.5, p = 0.05) and left ventricular ejection fraction (OR 0.9, CI 0.9 to 1.0, p = 0.01). Female gender was found to predict 30-day mortality (OR 2.5, CI 1.1 to 5.5, p = 0.02). The sole predictor of 1-year mortality was diabetes mellitus (OR 1.6, CI 1.1 to 2.3, p = 0.01). This study shows that women compared with men treated with stent implantation in SVG lesions have (1) a trend toward higher in-hospital mortality, (2) higher risk of 30-day mortality, (3) increased incidence of vascular complications and postprocedure acute renal failure, and (4) similar 1-year clinical outcome. [ABSTRACT FROM AUTHOR]

We used the serial intravascular ultrasound (IVUS) data from the Serial Ultrasound REstenosis trial to explain why positive remodeling lesions have a higher rate of clinical restenosis after non-stent interventions. Serial IVUS was performed before intervention and immediately and 1 and 6 months after percutaneous transluminal coronary angioplasty (n = 35) or directional coronary atherectomy (n = 26). External elastic membrane, lumen, and plaque + media (external elastic membrane minus lumen) areas were measured at the reference and stenosis. Stenoses were divided into 3 groups: positive remodeling (lesion greater than proximal reference external elastic membrane), intermediate remodeling (lesion external elastic membrane smaller than proximal reference but larger than distal reference), and negative remodeling (lesion equal to or less than distal reference external elastic membrane). The early (postintervention to 1 month) and late (1- to 6-month) changes in lesion external elastic membrane and plaque + media areas were compared. An early increase in plaque + media area was associated with an equal or greater increase in external elastic membrane area in positive (r = 0.78, p < 0.0001), intermediate (r = 0.69, p < 0.0001), and negative (r = 0.59, p = 0.0003) remodeling lesions. A late (1- to 6-month) decrease in external elastic membrane area correlated inversely with the early increase in plaque + media area in positive (r = 0.77, p = 0.0002) and intermediate (r = 0.45, p = 0.0003), but not in negative (r = 0.02, p = 0.9) remodeling lesions. In positive remodeling lesions, the early increase in plaque + media area was associated with both an exaggerated early increase and late decrease in external elastic membrane area. Positive remodeling lesions have an exaggerated early increase in external elastic membrane area and, especially, an exaggerated late decrease in external elastic membrane area after percutaneous transluminal coronary angioplasty and directional coronary atherectomy. This may explain that the increased clinical restenosis after positive remodeling lesions is treated with non-stent interventions. [ABSTRACT FROM AUTHOR]

Postoperative atrial fibrillation (AF) is a frequent adverse event after coronary artery bypass grafting (CABG) and may negatively affect the early clinical outcome. We sought to investigate the risk factors, prevalence, and prognostic implications of postoperative AF in patients submitted to CABG without cardiopulmonary bypass (off-pump). The study population comprised 969 patients, 645 men (67%) and 324 women (33%) who had off-pump CABG at the Washington Hospital Center from January 1987 to May 1999. Preoperative AF patients were excluded (n = 15). Two hundred six patients (age 69 +/- 10 years, 137 men [66%]) developed AF, whereas 763 patients (age 61 +/- 12 years, 508 men [67%]) did not. Predictors of AF included age >75 years (odds ratio [OR] 3.0, 95% confidence interval [CI] 1.9 to 4.5; p <0.001), history of stroke (OR 2.1, CI 1.2 to 3.7; p = 0. 007), postoperative pleural effusion requiring thoracentesis (OR 3.2, CI 1.0 to 9.4; p = 0.03), and postoperative pulmonary edema (OR 5.1, CI 1.2 to 21; p = 0.02). Minimally invasive direct CABG was associated with a lower incidence of AF (OR 0.4, CI 0.3 to 0.7; p <0. 001). AF was associated with a prolonged postoperative hospital stay (9 +/- 6 days AF vs 6 +/- 5 days no AF, p <0.001). In-hospital mortality was significantly higher in AF patients (3% AF vs 1% no AF, p = 0.009). Patients with persistent AF had a higher postoperative in-hospital stroke rate than patients without persistent AF (9% vs 0. 6%, p <0.001). AF after beating heart surgery is associated with a higher in-hospital morbidity, mortality, and prolonged hospital stay. A minimally invasive surgical approach (minimally invasive direct CABG) is associated with a lower risk of AF. [ABSTRACT FROM AUTHOR]