Despite 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).
In 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).
Long-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI.
CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.
Abstract Background To thoroughly investigate the diagnostic information obtained by pacemakers, it is important that the stored intracardiac electrograms (EGMs) are analyzed. However, in Medtronic ...pacemakers, only a single intracardiac recording channel is available and thus EGM channel selection is critical. Methods The study population comprised 150 patients who underwent implantation of Medtronic's dual chamber pacemakers with a single intracardiac EGM memory channel. We first set the electrogram channel to “summed,” and the automatic EGM diagnosis during the tachycardia was compared with the manual analysis findings. When the results were not identical for the 2 methods, the atrial EGM (AEGM) and ventricular EGM channels were sequentially selected and the results of each EGM selection were compared to conclude which channel was more valuable for diagnosis of high-rate episodes. The post-ventricular atrial blanking (PVAB) period was adjusted to the shortest interval with a relevant margin to avoid any far-field R wave over-sensing. Results A total of 130 patients were eventually enrolled. High-rate episodes were observed in 115/130 patients (88%). The results of the automated tachycardia diagnosis obtained using the “summed” EGM differed from those obtained manually in 43/115 patients (37%). Changing the intracardiac EGM channel from “summed” to “AEGM” enabled a much better manual diagnosis with intracardiac EGMs because of improved atrial potential sensing, clearer manifestation of atrial electrograms within the PVAB, and more prominent atrial electrograms fused with the ventricular potentials. The ventricular EGM channel was not as useful as the AEGM channel for tachycardia diagnosis. Conclusions In Medtronic pacemakers with single intracardiac EGM channel recording capability, AEGM is the most useful of the 3 EGM channel settings; PVAB should also be set to a much shorter value to achieve a more accurate automatic diagnosis.
The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid.
Between September 1998 and ...April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change.
Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.
The effects of restoration and maintenance of sinus rhythm by a combination of catheter ablation and antiarrhythmic drugs (AADs) on atrial function in patients with chronic atrial fibrillation (AF) ...remain unknown. In 15 patients with chronic AF (>1 year), we attempted to restore and maintain sinus rhythm by ablation targeting complex fractionated atrial electrocardiograms (CFAEs) combined with pulmonary vein isolation with or without AADs. Sinus rhythm was restored in all patients. At 17:7 ± 7:2 months after AF ablation, maintenance of sinus rhythm was achieved in 20% of patients without AADs and in 73.3% of patients with AADs. The left atrial diameter decreased significantly by 9:5 ± 8:1% (P < 0:05) during the 12-month followup. AADs did not have any adverse effects. The aggressive strategy for maintenance of sinus rhythm involving AF ablation and AADs potentially led to recovery of structural changes in the LA in patients with chronic AF.
Recently, drug-eluting stent (DES) has been recommended as the first choice in those patients who need stent implantation in unprotected left main coronary artery (ULMCA) stenosis. However, the ...long-term safety and efficacy of this procedure is still controversial. The objective of this study was to evaluate the safety and efficacy of bare metal stent (BMS) implantation in ULMCA stenting in the DES era. We implanted BMS (mainly 4 mm-diameter) in large-sized ULMCA after December 2004 when DES became available. The results of BMS implantation (
n
= 19) were compared with those of DES implantation (
n
= 39). There was no significant difference between the 2 groups regarding age, gender and coronary risk factors. Emergency procedures were more frequently performed in the BMS group than in the DES group (53% vs. 26%,
p
= 0.08). The initial mortality was 10.5% (
n
= 2) in the BMS group and 2.6% (
n
= 1) in the DES group (
p
= 0.25). There was no stent thrombosis, Q-wave myocardial infarction or emergent bypass surgery in either group during their hospital stay. The restenosis rate was 0% (
n
= 45) in both groups, and the target vessel revascularization rate was 5.9% in the BMS group (1/17) and 2.6% (1/38) in the DES group (
p
= 0.53). Therefore, there were no statistically significant differences in outcomes between the two study groups. These results indicate that BMS implantation in a large-sized ULMCA may be a safe and effective treatment even in the DES era.
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