Objectives The aim of this study was to test whether the left ventricular assist device (LVAD) Impella LP2.5 (Abiomed Europe GmbH, Aachen, Germany) provides superior hemodynamic support compared with ...the intra-aortic balloon pump (IABP). Background Cardiogenic shock caused by left ventricular failure is associated with high mortality in patients with acute myocardial infarction (AMI). An LVAD may help to bridge patients to recovery from left ventricular failure. Methods In a prospective, randomized study, 26 patients with cardiogenic shock were studied. The primary end point was the change of the cardiac index (CI) from baseline to 30 min after implantation. Secondary end points included lactic acidosis, hemolysis, and mortality after 30 days. Results In 25 patients the allocated device (n = 13 IABP, n = 12 Impella LP2.5) could be safely placed. One patient died before implantation. The CI after 30 min of support was significantly increased in patients with the Impella LP2.5 compared with patients with IABP (Impella: ΔCI = 0.49 ± 0.46 l/min/m2 ; IABP: ΔCI = 0.11 ± 0.31 l/min/m2 ; p = 0.02). Overall 30-day mortality was 46% in both groups. Conclusions In patients presenting with cardiogenic shock caused by AMI, the use of a percutaneously placed LVAD (Impella LP 2.5) is feasible and safe, and provides superior hemodynamic support compared with standard treatment using an intra-aortic balloon pump. (Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock ISAR-SHOCK; NCT00417378 )
Objectives The aim of this prospective trial was to assess whether platelet reactivity to clopidogrel assessed with multiple electrode platelet aggregometry (MEA) correlates with the risk of early ...drug-eluting stent thrombosis (ST). Background Studies using light transmission aggregometry (LTA) have shown that insufficient suppression of platelet reactivity to adenosine diphosphate (ADP) after clopidogrel treatment is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI). However, LTA is time- and labor-intensive and inconvenient for the routine. A point-of-care assay with similar predictive power would be of great value. Methods Between February 2007 and April 2008, a total of 1,608 consecutive patients with coronary artery disease and planned drug-eluting stent implantation were enrolled. Before PCI, all patients received 600 mg clopidogrel. Blood was obtained directly before PCI. The ADP-induced platelet aggregation was assessed in whole blood with MEA on a Multiplate analyzer (Dynabyte, Munich, Germany). The primary end point was definite ST at 30 days. Results The upper quintile of patients according to MEA measurements (n = 323) was defined as clopidogrel low responders. Compared with normal responders (n = 1,285), low responders had a significantly higher risk of definite ST within 30 days (2.2% vs. 0.2%; odds ratio OR: 9.4; 95% confidence interval CI: 3.1 to 28.4; p < 0.0001). Mortality rates were 1.2% in low versus 0.4% in normal responders (OR: 3.2; 95% CI: 0.9 to 11.1; p = 0.07). The composite of death or ST was higher in low versus normal responders (3.1% vs. 0.6%; OR: 5.1; 95% CI: 2.2 to 11.6; p < 0.001). Conclusions Low response to clopidogrel assessed with MEA is significantly associated with an increased risk of ST. Further studies are warranted to evaluate the ability of MEA to guide antiplatelet therapy in patients undergoing PCI.
Objectives The objective of this study was to investigate the impact of no-reflow phenomenon on 5-year mortality among patients with acute ST-segment elevation myocardial infarction (STEMI) treated ...by primary percutaneous coronary intervention (PCI). This impact was also assessed in relation to infarct size. Background The impact of no-reflow on long-term mortality in patients with STEMI has been insufficiently studied. Methods This study included 1,406 patients with STEMI treated by primary PCI. No-reflow was diagnosed using angiographic criteria. Infarct size was measured with single-photon emission computed tomography imaging 7 to 14 days after the acute event. The primary outcome was 5-year mortality. Results The no-reflow phenomenon was diagnosed in 410 patients (29%). Infarct size was 15.0% (6.0% to 29.0%) of the left ventricle in the no-reflow group versus 8.0% (2.0% to 21.0%) of the left ventricle in the reflow group (p < 0.001). There were 132 deaths during follow-up. Of them, 59 deaths occurred among patients with no-reflow and 73 deaths occurred among patients with reflow (Kaplan-Meier estimates of 5-year mortality 18.2% and 9.5%, respectively; odds ratio: 2.02; 95% confidence interval: 1.44 to 2.82; p < 0.001). The Cox proportional hazards model adjusting for infarct size among other variables identified the no-reflow phenomenon as an independent correlate of 5-year mortality (hazard ratio: 1.66; 95% confidence interval: 1.17 to 2.36; p = 0.004). Conclusions In patients with STEMI treated by primary PCI, no-reflow phenomenon is a strong predictor of 5-year mortality. No-reflow phenomenon after PCI provides prognostic information that is independent of and beyond that provided by infarct size.
Objectives The aim of this trial was to compare the safety and efficacy of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for treatment of unprotected left main coronary artery ...(uLMCA) disease. Background Both PES and SES have reduced the risk of restenosis, particularly in high-risk patient and lesion subsets. However, their comparative performance in uLMCA lesions is not known. Methods In this randomized study, 607 patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA were enrolled: 302 were assigned to receive a PES (Taxus, Boston Scientific, Natick, Massachusetts) and 305 assigned to receive a SES (Cypher, Cordis, Johnson & Johnson, New Brunswick, New Jersey). The primary end point was the combined incidence of death, myocardial infarction, and target lesion revascularization (TLR) at 1 year. The secondary end point was angiographic restenosis on the basis of the LMCA area analysis at follow-up angiography. Results At 1 year the cumulative incidence of death, myocardial infarction, or TLR was 13.6% in the PES and 15.8% in the SES group (relative risk RR: 0.85, 95% confidence interval CI: 0.56 to 1.29, p = 0.44). One patient in the PES group (0.3%) and 2 patients in the SES group (0.7%) experienced definite stent thrombosis (p = 0.57). Mortality at 2 years was 10.7% in the PES and 8.7% in the SES group (RR: 1.14, 95% CI: 0.66 to 1.95, p = 0.64). Angiographic restenosis was 16.0% with PES and 19.4% with SES (RR: 0.82, 95% CI: 0.57 to 1.19, p = 0.30). Conclusions Implantation of either PES or SES in uLMCA lesions is safe and effective; both of these drug-eluting stents provide comparable clinical and angiographic outcomes. (Drug-Eluting-Stents for Unprotected Left Main Stem Disease ISAR-LEFT-MAIN; NCT00133237 )
A Meta-Analysis of 16 Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease Albert Schömig, Alban Dibra, Stephan Windecker, Julinda ...Mehilli, José Suárez de Lezo, Christoph Kaiser, Seung-Jung Park, Jean-Jacque Goy, Jae-Hwan Lee, Emilio Di Lorenzo, Jinjin Wu, Peter Jüni, Matthias E. Pfisterer, Bernhard Meier, Adnan Kastrati We performed a meta-analysis of 16 randomized trials of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) with a total number of 8,695 patients. Mean follow-up period ranged from 9 to 37 months. Compared with PES, SES significantly reduced the risk of reintervention (hazard ratio HR of 0.74; 95% confidence interval CI 0.63 to 0.87), and stent thrombosis (HR of 0.66; 95% CI 0.46 to 0.94), without significantly impacting on the risk of death (HR of 0.92; 95% CI 0.74 to 1.13), or myocardial infarction (HR of 0.84; 95% CI 0.69 to 1.03). Thus, SES are superior to PES in terms of a significant reduction of the risk of reintervention and stent thrombosis.
Prognostic Value of Coronary Computed Tomographic Angiography for Prediction of Cardiac Events in Patients With Suspected Coronary Artery Disease Martin Hadamitzky, Barbara Freißmuth, Tanja Meyer, ...Franziska Hein, Adnan Kastrati, Stefan Martinoff, Albert Schömig, Jörg Hausleiter Although coronary computed tomography angiography (CCTA) is an attractive tool to rule out coronary artery stenoses, only limited data are available concerning its prognostic value. In a large series of consecutive patients undergoing CCTA, who were followed up for a period of 18 months, event rates were significantly higher among patients with obstructive coronary artery disease as compared with patients without stenoses on computed tomography. The odds ratios were as high as 20 for severe cardiac events among patients with obstructive disease, and the annual event rate among patients without obstructive disease was significantly lower (0.1%) than predicted by the Framingham score. The Editors' Page in this issue of iJACC welcomes CCTA into the prognosis club of imaging strategies.
A Meta-Analysis of 17 Randomized Trials of a Percutaneous Coronary Intervention-Based Strategy in Patients With Stable Coronary Artery Disease Albert Schömig, Julinda Mehilli, Antoinette de Waha, ...Melchior Seyfarth, Jürgen Pache, Adnan Kastrati We identified 17 randomized trials comparing a percutaneous coronary intervention (PCI)-based invasive treatment strategy with medical treatment in 7,513 patients with symptoms or signs of myocardial ischemia and no acute coronary syndrome. Of these patients, 3,675 were assigned to the PCI group and 3,838 to the medical treatment group. Allocation to the PCI group was associated with 20% reduction in the odds ratio (OR) of all-cause death (OR: 0.80; 95% confidence interval: 0.64 to 0.99). These findings suggest that a PCI-based invasive strategy may improve long-term survival compared with a medical treatment-only strategy in patients with stable coronary artery disease.
Objectives In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent ...(Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years. Background Long-term polymer residue is implicated in adverse events associated with delayed vessel healing after drug-eluting stent therapy. The second-generation ZES utilizes an enhanced biocompatibility polymer system whereas a new-generation Dual-DES employs a polymer-free drug-release system. Methods A total of 1,007 patients undergoing coronary stenting of de novo lesions in native vessels were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). Clinical follow-up was performed to 2 years. Angiographic follow-up was scheduled at 6 to 8 months and 2 years. Results There were no significant differences between groups regarding death/myocardial infarction (SES: 10.2% vs. Dual-DES: 7.8% vs. ZES: 9.2%; p = 0.61) or definite stent thrombosis (SES: 0.9% vs. Dual-DES: 0.9% vs. ZES: 0.6%; p = 0.87). Two-year target lesion revascularization (TLR) was 10.7%, 7.7%, and 14.3% lesions in the SES, Dual-DES, and ZES groups, respectively (p = 0.009). Incident TLR between 1 and 2 years in the Dual-DES group (0.9%) was significantly lower than in the Cypher SES group (3.6%) (p = 0.009), but comparable to the Endeavor ZES group (0.7%) (p = 0.72). These findings mirrored those observed for binary restenosis. Conclusions At 2 years, there was no signal of a differential safety profile between the 3 stent platforms. Furthermore, the antirestenotic efficacy of both Dual-DES and ZES remained durable between 1 and 2 years, with Dual-DES maintaining an advantage over the entire 2-year period. (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents ISAR-TEST-2; NCT00332397 )
This study assessed the effect of body mass index (BMI) on platelet aggregation after administration of a high loading dose of clopidogrel 600 mg. Blood samples of 402 patients before percutaneous ...coronary intervention were collected ≥2 hours after administration of clopidogrel 600 mg. Platelet aggregation was measured in response to adenosine diphosphate (ADP; 5 and 20 μM). Patients were categorized as normal weight (BMI <25 kg/m2 ) or overweight (BMI ≥25 kg/m2 ). ADP-induced platelet aggregation was significantly higher in overweight patients than in normal-weight patients (46.0 ± 21.8% vs 38.2 ± 19.3% for ADP 5 μM, p = 0.0007; 55.1 ± 22.7% vs 45.2 ± 21.7% for ADP 20 μM, p <0.0001). Multivariate analyses demonstrated high BMI as the only independent predictor for increased ADP-induced platelet aggregation (p ≤0.005). In conclusion, administration of a single high loading dose of clopidogrel 600 mg does not inhibit platelet aggregation in overweight patients to the same extent as in normal-weight patients.
The association between uric acid and cardiovascular disease is incompletely understood. In particular, the prognostic value of uric acid in patients with acute coronary syndromes who undergo ...percutaneous coronary intervention has not been studied. This study included 5,124 patients with acute coronary syndromes who underwent percutaneous coronary intervention: 1,629 with acute ST-segment elevation myocardial infarction, 1,332 with acute non–ST-segment elevation myocardial infarction, and 2,163 with unstable angina. The primary end point was 1-year mortality. Patients were divided into quartiles according to uric acid level as follows: quartile 1, 1.3 to <5.3 mg/dl; quartile 2, 5.3 to <6.3 mg/dl; quartile 3, 6.3 to <7.5 mg/dl; and quartile 4, 7.5 to 18.4 mg/dl. There were 450 deaths during follow-up: 80 deaths in quartile 1, 77deaths in quartile 2, 72 deaths in quartile 3, and 221 deaths in quartile 4 of uric acid (Kaplan-Meier estimates of 1-year mortality 6.4%, 6.2%, 5.6%, and 17.4%, respectively; unadjusted hazard ratio 3.05, 95% confidence interval 2.54 to 3.67, p <0.001 for fourth vs first quartile of uric acid). After adjustment for traditional cardiovascular risk factors, renal function, and inflammatory status, the association between uric acid and mortality remained significant, with a 12% increase in the adjusted risk for 1-year mortality for every 1 mg/dl increase in the uric acid level. Uric acid improved the discriminatory power of the predictive model regarding 1-year mortality (absolute integrated discrimination improvement 0.008, p = 0.005). In conclusion, elevated levels of uric acid are an independent predictor of 1-year mortality across the whole spectrum of patients with acute coronary syndromes treated with percutaneous coronary intervention.
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