The effect of β-blockers in ST-elevation myocardial infarction (STEMI) patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. Using a large multi-center registry in Japan, we identified 3,692 patients who underwent PCI within 24 h from onset of STEMI and were discharged alive from 2005 to 2007. Three-year cardiovascular outcomes were compared between the 2 groups of patients with (N = 1,614) or without (N = 2,078) β-blocker prescription at discharge. Compared with patients in the no-β group, patients in the β group were younger, more frequently male, more often had hypertension and atrial fibrillation but less often had chronic obstructive pulmonary disease than in the no-β group. Statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers were more frequently prescribed in the β group. Crude incidence of cardiac death and/or recurrent myocardial infarction (cardiac death/MI) tended to be higher in the β group (7.6 vs. 6.2%, log-rank p = 0.1). After adjusting for potential confounders, β-blockers were associated with significantly higher risk for cardiac death/MI (hazard ratio 1.43, 95% CI: 1.06-1.94, p = 0.01). β-Blocker prescription at discharge was not associated with better cardiovascular outcomes in patients who underwent PCI after STEMI. Large-scale randomized controlled trials are needed to evaluate the role of β-blocker therapy in these patients.
BackgroundDespite its recommendation by the current guidelines, the role of long-term oral beta-blocker therapy has never been evaluated by randomized trials in uncomplicated ST-segment elevation myocardial infarction (STEMI) patients without heart failure, left ventricular dysfunction or ventricular arrhythmia who underwent primary percutaneous coronary intervention (PCI).Methods and resultsIn a multi-center, open-label, randomized controlled trial, STEMI patients with successful primary PCI within 24 hours from the onset and with left ventricular ejection fraction (LVEF) ≥40% were randomly assigned in a 1-to-1 fashion either to the carvedilol group or to the no beta-blocker group within 7 days after primary PCI. The primary endpoint is a composite of all-cause death, myocardial infarction, hospitalization for heart failure, and hospitalization for acute coronary syndrome. Between August 2010 and May 2014, 801 patients were randomly assigned to the carvedilol group (N = 399) or the no beta-blocker group (N = 402) at 67 centers in Japan. The carvedilol dose was up-titrated from 3.4±2.1 mg at baseline to 6.3±4.3 mg at 1-year. During median follow-up of 3.9 years with 96.4% follow-up, the cumulative 3-year incidences of both the primary endpoint and any coronary revascularization were not significantly different between the carvedilol and no beta-blocker groups (6.8% and 7.9%, P = 0.20, and 20.3% and 17.7%, P = 0.65, respectively). There also was no significant difference in LVEF at 1-year between the 2 groups (60.9±8.4% and 59.6±8.8%, P = 0.06)ConclusionLong-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI.Trial registrationCAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.
We aimed to investigate the effectiveness of a scoring balloon catheter in expanding a circumferentially calcified lesion compared to a conventional balloon catheter using an in vitro experiment setting and elucidate the underlying mechanisms of this ability using a finite element analysis. True efficacy of the scoring device and the underlying mechanisms for heavily calcified coronary lesions are unclear. We employed a Scoreflex scoring balloon catheter (OrbusNeich, Hong Kong, China). The ability of Scoreflex to dilate a calcified lesion was compared with a conventional balloon catheter using 3 different sized calcium tubes. The thickness of the calcium tubes were 2.0, 2.25, and 2.5 mm. The primary endpoints were the successful induction of cracks in the calcium tubes and the inflation pressures required for inducing cracks. The inflation pressure required for cracking the calcium tubes were consistently lower with Scoreflex (p < 0.05, Student t test). The finite element analysis revealed that the first principal stress applied to the calcified plaque was higher by at least threefold when applying the balloon catheter with scoring elements. A scoring balloon catheter can expand a calcified lesion with lower pressure than that of a conventional balloon. The finite element analysis revealed that the concentration of the stress observed in the outside of the calcified plaque just opposite to the scoring element is the underlying mechanism of the increased ability of Scoreflex to dilate the calcified lesion.
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