The American journal of cardiology
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Randomized Controlled Trial Multicenter Study
Relation between coronary calcium and major bleeding after percutaneous coronary intervention in acute coronary syndromes (from the Acute Catheterization and Urgent Intervention Triage Strategy and Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trials).
Percutaneous coronary intervention (PCI) of calcified coronary lesions has been associated with increased rates of adverse ischemic events. However, the potential association between the presence and severity of calcific deposits and bleeding complications has yet to be investigated. Data from 6,855 patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) or ST-segment elevation myocardial infarction (STEMI) treated with PCI were pooled from 2 large-scale randomized controlled trials-Acute Catheterization and Urgent Intervention Triage Strategy and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction. ⋯ By multivariable analysis, presence of severe calcium was an independent predictor of non-coronary artery bypass graft major bleeding after PCI (hazard ratio 1.54, 95% confidence interval 1.09 to 2.17, p = 0.01). In conclusion, in patients undergoing PCI for non-ST-segment elevation acute coronary syndrome and ST-segment elevation myocardial infarction, target lesion coronary calcium was an independent predictor of major bleeding events. Further studies are needed to elucidate mechanisms underlying this finding and to optimize treatment of this high-risk population.
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Randomized Controlled Trial Comparative Study
Comparison of endovascular versus epicardial lead placement for resynchronization therapy.
Cardiac resynchronization therapy (CRT) has been shown to improve survival and symptoms in patients with severe left ventricular (LV) dysfunction, congestive heart failure, and prolonged QRS duration. LV lead placement is achieved by placing the lead in the coronary sinus, an endovascular approach, or by a minimally invasive robotic-assisted thoracoscopic epicardial approach. There are no data directly comparing the 2 methods. ⋯ There were no significant differences in the secondary end points between the 2 groups. In conclusion, there were no differences in echocardiographic and clinical outcomes comparing a conventional endovascular approach versus robotic-assisted surgical epicardial LV lead placement for CRT in patients with heart failure. Surgical approaches are still a viable alternative when a transvenous procedure has failed or is not technically feasible.
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Randomized Controlled Trial Multicenter Study Comparative Study
Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial).
A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >83 normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intraaortic balloon pump (IABP, n[211) or a left ventricular assist device (Impella, n[216). ⋯ There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio[0.75 [95% confidence interval 0.61 to 0.92], p[0.007) andMACCE (odds ratio[0.76 [95% confidence interval 0.61 to 0.96], p[0.020) at 90 days postprocedure. In conclusion, hemodynamic support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further supported by multivariate analyses.
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Randomized Controlled Trial Multicenter Study Comparative Study
Impact of atrial fibrillation in patients with ST-elevation myocardial infarction treated with percutaneous coronary intervention (from the HORIZONS-AMI [Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction] trial).
Atrial fibrillation (AF) has been associated with worse outcomes after primary percutaneous coronary intervention (PCI) for acute myocardial infarction. The aim of this study was to evaluate the incidence and impact of new-onset AF after primary PCI in patients with ST-segment elevation myocardial infarctions from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. HORIZONS-AMI was a large-scale, multicenter, international, randomized trial comparing different antithrombotic regimens and stents during primary PCI in patients with ST-segment elevation myocardial infarctions. ⋯ Compared with patients without AF after PCI, patients with new-onset AF had higher 3-year rates of net adverse clinical events (46.5% vs 25.7%, p <0.0001), mortality (11.9% vs 6.3%, p = 0.01), reinfarction (16.4% vs 7.0%, p <0.0001), stroke (5.8% vs 1.5%, p <0.0001), and major bleeding (20.9% vs 8.2%, p <0.0001). By multivariate analysis, new-onset AF after PCI was a powerful independent predictor of net adverse clinical events (hazard ratio 1.74, 95% confidence interval 1.30 to 2.34, p = 0.0002) and major adverse cardiac events (hazard ratio 1.73, 95% confidence interval 1.27 to 2.36) at 3 years. In conclusion, new-onset AF after PCI for ST-segment elevation myocardial infarction was associated with markedly higher rates of adverse events and mortality.
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Randomized Controlled Trial Multicenter Study Comparative Study
Association between intraprocedural thrombotic events and adverse outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (a Harmonizing Outcomes With RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Substudy).
The present study sought to determine the extent to which adverse angiographic events encountered during percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) are associated with adverse clinical outcomes. Patients with STEMI represent a cohort at particularly high risk of intraprocedural thrombotic events (IPTEs). The overall frequency and implications of IPTEs occurring in patients with STEMI have not been systematically quantified in previous studies. ⋯ On multivariate analysis, IPTEs were independently associated with 30-day major adverse cardiovascular events, major bleeding, and death. In conclusion, the development of IPTEs in patients undergoing primary percutaneous coronary intervention for STEMI was associated with subsequent adverse outcomes, including major adverse cardiovascular events, major bleeding, and death. Additional studies of strategies to decrease the occurrence of IPTEs are warranted.