Gender-Specific Outcomes After Sirolimus-Eluting Stent Implantation Emilia Solinas, Eugenia Nikolsky, Alexandra J. Lansky, Ajay J. Kirtane, Marie-Claude Morice, Jeffrey J. Popma, Joachim Schofer, ...Erick Schampaert, Tereza Pucelikova, Jiro Aoki, Martin Fahy, George D. Dangas, Jeffrey W. Moses, Donald E. Cutlip, Martin B. Leon, Roxana Mehran In this analysis of pooled data from the RAVEL (Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization), SIRIUS (SIRolImUS-coated Bx velocity balloon expandable stent in the treatment of patients with de novo coronary artery lesions), E-SIRIUS (Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries), and C-SIRIUS (Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries) trials, sirolimus-eluting stent (SES) versus bare metal-stent (BMS) implantation was associated with significant reductions in rates of in-segment binary restenosis both in women (6.3% vs. 43.8%) and in men (6.4% vs. 35.6%), as well as reductions in adverse clinical outcomes in both genders. By multivariable analysis, female gender was not an independent predictor of restenosis and clinical outcomes in SES- or BMS-treated patients.
In the setting of ST-segment elevation myocardial infarction (STEMI), patients at high risk of systemic emboli who undergo primary percutaneous coronary intervention (PCI) using stents might require ...triple antithrombotic therapy (a combination of aspirin, thienopyridine, and vitamin K antagonist VKA). The risks and benefits of such therapy in the setting of STEMI have been incompletely characterized. We, therefore, assessed the outcomes of patients who received triple therapy after primary PCI in the large-scale, contemporary Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction HORIZONS-AMI trial. Among the 3,320 patients triaged to primary PCI, 126 (3.8%) were prescribed triple therapy and 3,194 (96.2%) were prescribed dual antiplatelet therapy. The most frequent indications for VKA treatment were a severely reduced left ventricular ejection fraction with a large akinetic area, atrial fibrillation (23.8% each), and mural thrombus (23.0%). The assignment to triple therapy was associated with older age, female gender, rhythm disturbances, Killip class >1 on admission, lower left ventricular ejection fraction, left anterior descending artery territory infarcts, and Final Thrombolysis In Myocardial Infarction flow grade <3. Patients treated with triple versus dual therapy had comparable short- and long-term ischemic outcomes but had significantly increased rates of major bleeding during the index hospitalization (17.1% vs 6.5%, p <0.0001), resulting in premature VKA discontinuation in 14.3% of those patients. In conclusion, in the setting of STEMI treated with primary PCI, the combination of aspirin, thienopyridine, and VKA results in an excess of bleeding complications and premature discontinuation of VKA. The risk of adding oral anticoagulation to patients admitted for STEMI should be carefully considered before choosing drug-eluting or bare metal stents.
The aim of this study was to assess the impact of baseline anemia on the outcomes of patients with ST elevation myocardial infarctions who underwent primary percutaneous coronary intervention in ...relation to contemporary adjunctive antithrombotic therapy and gender. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients were randomized to bivalirudin alone or to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor before primary percutaneous coronary intervention. Outcomes were assessed at 30 days and 1 year according to anemia and gender. Baseline anemia was present in 331 of 3,153 patients (10.5%). Patients with versus without baseline anemia had a more than twofold increase in major bleeding at 30 days (13.5% vs 6.7%, p <0.0001) and at 1 year (14.8% vs 7.2%, p <0.0001), an association that on multivariate analysis was independent of gender. Mortality was significantly higher in men with versus without baseline anemia (4.6% vs 1.8% at 30 days, p = 0.003; 8.9% vs 3.0% at 1 year, p <0.0001) but not in women (5.3% vs 3.6% at 30 days, p = 0.42; 7.5% vs 5.9% at 1 year, p = 0.54). On multivariate analysis, anemia independently predicted 1-year all-cause mortality in men but not in women. Bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor resulted in twofold lower rates of all-cause and cardiac mortality and major bleeding in patients without but not in those with baseline anemia. In conclusion, baseline anemia was associated with increased major bleeding and death in patients with ST elevation myocardial infarctions who underwent primary PCI but was a stronger predictor of early and late mortality in men than in women. Paradoxically, in this post hoc analysis, the reductions in major bleeding and mortality in ST elevation myocardial infarction afforded by bivalirudin occurred primarily in patients without baseline anemia.
Low hematocrit predicts contrast-induced nephropathy after percutaneous coronary interventions.
The relationship between low hematocrit and contrast-induced nephropathy has not been investigated.
Of ...6,773 consecutive patients treated with percutaneous coronary intervention, contrast-induced nephropathy (an increase of ≥25% or ≥0.5mg/dL in preprocedure serum creatinine, at 48 hours postprocedure) occurred in 942 (13.9%) patients.
Rates of contrast-induced nephropathy steadily increased as baseline hematocrit quintile decreased (from 10.3% in the highest quintile to 23.3% in the lowest quintile) (χ2 for trend, P < 0.0001). Stratification by baseline estimated glomerular filtration rate (eGFR) and baseline hematocrit showed that the rates of contrast-induced nephropathy were the highest (28.8%) in patients who had the lowest level for both baseline eGFR and hematocrit. Patients with the lowest eGFR but relatively high baseline hematocrit values had remarkably lower rates of contrast-induced nephropathy (15.8%, 12.3%, 17.1%, and 15.4% in 2nd, 3rd, 4th, and 5th quintiles of baseline hematocrit, respectively) (P < 0.0001). The rates of contrast-induced nephropathy increased with increment in change in hematocrit. Patients in the lowest quintile of baseline hematocrit with absolute hematocrit drop >5.9% had almost doubled rates of contrast-induced nephropathy compared with patients with hematocrit change <3.4% (38.1% vs. 18.8%, respectively) (P < 0.0001). By multivariate analysis, lower baseline hematocrit was an independent predictor of contrast-induced nephropathy; each 3% decrease in baseline hematocrit resulted in a significant increase in the odds of contrast-induced nephropathy in patients with and without chronic kidney disease (11% and 23%, respectively). When introduced into the multivariate model instead of baseline hematocrit, change in hematocrit also showed a significant association with contrast-induced nephropathy.
Lower hematocrit is an important risk factor for contrast-induced nephropathy. Whether correcting the hematocrit prepercutaneous coronary intervention might decrease the rates of contrast-induced nephropathy should be addressed in a prospectively designed trial.
Objectives The goal of this study was to examine the safety and results of interventional procedures performed during the broadcast of live case demonstrations. Background Professional meetings using ...live case demonstrations to present cutting-edge technology are considered a valuable educational resource. There is an ongoing discussion on whether patients who are treated during live case demonstrations are exposed to a higher risk. Methods Between 1998 and 2010, 101 patients were treated during live transmissions from a single center in 15 invasive-cardiology conferences. Technical success was defined as the ability to effectively perform the planned procedure without any major complication. The primary endpoint of the study was the composite occurrence of death, myocardial infarction, or stroke. Results The interventional procedures included coronary (n = 66), carotid (n = 15), peripheral (n = 1), valvular (n = 2), congenital heart disease (n = 12), and complex electrophysiological mapping and ablation interventions (n = 7). In 4 cases, the intended procedure was not done. The procedure was technically successful in 95%. In 5 cases, the procedure was unsuccessful because of the inability to cross a chronic total occlusion. There were no deaths during the hospital stay, and the composite primary endpoint occurred in 2 patients: a minor stroke following an atrial fibrillation ablation and a rise in serum troponin levels after percutaneous coronary intervention. These results were no different from those of 66 matched controls who underwent procedures performed by the same operators but not as live case demonstrations (relative risk: 0.32; 95% confidence interval: 0.02 to 3.62, p = 0.62). Conclusions In this consecutive series of interventional cardiology procedures that were performed by expert operators during live demonstration courses, the procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data. These results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.
Background Rapid reperfusion has been shown to decrease mortality and improve left ventricular (LV) function. Previous studies have reported that LV thrombus (LVT) is a major complication of ...ST-segment elevation acute anterior wall myocardial infarction (AMI). There are little data on LVT in the current primary percutaneous coronary intervention (PPCI) era. We sought to demonstrate the incidence of LVT after AMI in patients treated with PPCI compared with those treated with thrombolysis or with conservative management. Methods In a 6-year period, 642 patients with anterior wall AMI and echocardiography were treated with PPCI (n = 297), thrombolysis (n = 128), or conservative treatment (n = 217). Left ventricular thrombus was defined as an echodense mass adjacent to an abnormally contracting myocardial segment. Results The rate of LVT among anterior wall AMI was 6.2%. Predictors for LVT were reduced ejection fraction (adjusted relative risk 0.71, 95% CI 0.52-0.96) and severe mitral regurgitation (adjusted relative risk 2.48, 95% CI 1.0-6.44). There was no statistical difference in LVT rate according to treatment: 21 (7.1%) of 297 patients in the PPCI group, 10 (7.8%) of 128 patients in the thrombolytic group, and 9 (4.1%) of 217 patients in the conservative group ( P = .28). Those in the thrombolytic group were characterized by shorter duration from symptom onset and were generally also treated with heparin/low–molecular weight heparin. Conclusions This is the largest report to evaluate the incidence of LVT formation after AMI. In the current era of rapid reperfusion by PPCI, the rate of thrombus formation is similar to that reported in the past and not different than for patients currently treated conservatively or with thrombolysis.
Women have a higher risk of adverse outcomes after percutaneous coronary intervention (PCI) than men. However, in acute coronary syndrome (ACS), long-term outcomes after contemporary PCI with ...drug-eluting stent (DES) have not been fully investigated. We aimed to test the impact of gender on outcomes in patients with ACS after PCI with DES. We analyzed all patients with ACS from the prospective NOBORI-2 trial who underwent PCI with a Nobori DES from 2008 through 2009 in 125 centers worldwide. End points of the study were target lesion failure, cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization, and major adverse cardiac events (composite of cardiac death, MI, and target vessel revascularization) at 1 year and yearly up to 5 years. There were 1,640 patients with ACS, 1,268 men (77%) and 372 women (23%). Compared to men, women were 5 years older and more frequently had co-morbidities such as diabetes mellitus and hypertension. There were no gender differences for cardiac death (1.3% vs 2.7%), MI (2.1% vs 3.2%), or target lesion revascularization (2.6% vs 3.8%) at 1 year after the procedure for men and women, respectively. The trend was the same at 2 years (cardiac death 2.0% vs 2.3%, MI 2.5% vs 3.5%, target lesion revascularization 3.2% vs 4.6%). Target lesion failure rates were 4.5% and 5.9% at 1 year and 5.7% and 7.3% at 2 years in men and women, respectively (p = NS). Multivariate analysis, which included age, hypertension, diabetes mellitus, and number of diseased vessels, showed that gender was not a predictor for outcome. There were no differences in bleeding or stent thrombosis rates. Relief from anginal symptoms was similar. The same rate of adherence to dual antiplatelet therapy was observed and reached 73% at 1 year and 31% at 2 years after the ACS event and PCI. In conclusion, although women had worse baseline characteristics, no differences in outcomes were observed between men and women treated for ACS with contemporary DES.
Background Thrombocytopenia (TP) is a common abnormality in patients presenting with acute coronary syndrome. Whether baseline TP has any influence on the outcome of patients treated with primary ...angioplasty for acute myocardial infarction is unknown. Methods We sought to detect the impact of baseline TP on the early and late outcomes of patients with ST-elevation myocardial infarction in the HORIZONS-AMI trial that included a protocol of immediate angiography and primary percutaneous coronary intervention. Results Baseline TP was found in 4.2% of patients and was associated with a higher incidence of cardiovascular mortality, major bleeding, and major cardiovascular events at short- and long-term follow-up. The 30-day rates of death, major bleeding, major cardiac events, and major cardiac events plus major bleeding were 6.2%, 11.9%, 9.6%, and 18.5% in the TP group, respectively, compared with 2.1%, 7%, 5.2%, and 10.8% in those without TP ( P < .05 for all). Similarly, event rates at 2 years were 11.3%, 12.7%, 24.7%, and 30.8% compared with 5.1%, 7.9%, 18.5%, and 23.3% ( P < .05). By multivariate analysis, baseline TP was an independent predictor of 30-day net adverse clinical events but not of any 2-year events. Conclusions We found that baseline TP in patients with ST-elevation myocardial infarction undergoing routine angiography and primary percutaneous coronary intervention is strongly associated with early adverse events and is a maker of late events, related to both ischemia and bleeding.
Objectives We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary ...percutaneous coronary intervention. Background Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown. Methods We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179). Results At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17). Conclusions In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.
The present substudy from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial assessed the outcomes and their relation to different ...antithrombotic regimens in patients with previous coronary artery bypass grafting (CABG) treated with primary percutaneous coronary intervention. Of 3,599 patients with information regarding a history of CABG, 105 (2.9%) had previously undergone CABG. Of these 105 patients, 46 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor and 59 to bivalirudin. The patients with versus without previous CABG were less frequently triaged to primary percutaneous coronary intervention (83.8% vs 93.2%, p = 0.0002) and had a longer door-to-balloon time (median 1.9 vs 1.6 hours, p = 0.047), lower rates of final Thrombolysis In Myocardial Infarction flow grade 2 to 3 in the intervened vessel (92.6% vs 97.8%, p = 0.007), and less frequent rates of complete or partial ST-segment resolution (66.3% vs 77.6%, p = 0.019). At 3 years, previous CABG was associated with a significantly greater incidence of major adverse cardiovascular events (36.4% vs 21.4%, p <0.001) owing to greater rates of mortality (11.2% vs 6.7%, p = 0.08), reinfarction (11.6% vs 7.1%, p = 0.09), stroke (5.1% vs 1.8%, p = 0.013), and ischemic target vessel revascularization (23.6% vs 12.9%, p = 0.005). The outcomes did not differ significantly as a function of the antithrombotic regimen. On multivariate analysis, previous CABG was an independent predictor of 3-year ischemic stroke (hazard ratio 3.57, 95% confidence interval 1.09 to 11.66). Intervention on the saphenous vein graft versus the native vessel predicted 3-year major adverse cardiovascular events (hazard ratio 2.69, 95% confidence interval 1.17 to 6.19). In the HORIZONS-AMI trial, previous CABG was associated with a delay to mechanical reperfusion and lower rates of percutaneous coronary intervention and patency of the infarct related vessel along with worse clinical outcomes.
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