Effects of Long-Term Carvedilol Therapy in Patients With ST-Segment Elevation Myocardial Infarction and Mildly Reduced Left Ventricular Ejection Fraction.

The benefits of long-term oral ß-blocker therapy in patients with ST-segment elevation myocardial infarction (STEMI) with mildly reduced left ventricular ejection fraction (LVEF; ≥40%) are still unknown. We sought to evaluate the efficacy of ß-blocker therapy in patients with STEMI with mildly reduced LVEF. In the CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-Scale Randomized Controlled Trial), patients with STEMI with successful percutaneous coronary intervention with an LVEF of ≥40% were randomly assigned to carvedilol or no ß-blocker therapy. Among 794 patients, 280 patients had an LVEF of <55% at baseline (mildly reduced LVEF stratum), whereas 514 patients had an LVEF of ≥55% at baseline (normal LVEF stratum). The primary end point was a composite of all-cause death, myocardial infarction, hospitalization for acute coronary syndrome, and hospitalization for heart failure, and the secondary end point was a cardiac composite outcome: a composite of cardiac death, myocardial infarction, and hospitalization for heart failure. The median follow-up period was 3.7 years. The lower risk of carvedilol therapy relative to no ß-blocker therapy was not significant for the primary end point in either the mildly reduced or normal LVEF strata. However, it was significant for the cardiac composite end point in the mildly reduced LVEF stratum (0.82/100 person-years vs 2.59/100 person-years, hazard ratio 0.32 [0.10 to 0.99], p = 0.047) but not in the normal LVEF stratum (1.48/100 person-years vs 1.06/100 person-years, hazard ratio 1.39 [0.62 to 3.13], p = 0.43, p for interaction = 0.04). In conclusion, long-term carvedilol therapy in patients with STEMI with primary percutaneous coronary intervention might be beneficial for preventing cardiac-related events in those with a mildly reduced LVEF.

Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

BACKGROUND: 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). METHODS AND RESULTS: 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). CONCLUSION: Long-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI. TRIAL REGISTRATION: CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.

A novel guidewire-integrated embolic protection filter device with a handy-folding system: In vitro and in vivo performance assessment.

OBJECTIVES: We developed a novel guidewire-integrated filter device with a handy-folding system (IFD: Inoue filter device). In vitro and in vivo studies were conducted to evaluate the feasibilityof the IFD. BACKGROUND: Although distal atheromatous and thrombotic embolizations remain unresolved critical issues during catheter interventions, distal protection devices are infrequently used partly because of reduced lower maneuverability. METHODS: In the in vitro experiment, we created an experimental circulation model composed of silicone latex tubes, a reservoir, and a roller pump. After the filter device was deployed in the tube, polystyrene fluorescent microspheres were injected and the capture rate was calculated. Ten trials were performed using the IFD and Spider FX. In the in vivo study, five independent operators deployed, and they retrieved the IFD in swine common iliac and internal carotid arteries. The procedural success rate as well as the delivery and retrieval time was evaluated. RESULTS: In the in vitro study, the mean capture rate was 94% and 35% in the IFD and Spider groups, respectively. In the in vivo study, all procedures were successful, with no complications. The mean delivery time was 281 ± 87 s and 194 ± 67 s and the mean retrieval time was 24 ± 9 and 13 ±1 s in the left internal carotid and the left common iliac arteries, respectively. CONCLUSION: Although further studies and improvements are required, the study results indicate that the IFD is feasible.

A novel method to deliver the Filtrap coronary embolic protection filter using a manual thrombectomy catheter: in vitro and in vivo comparison with the conventional method.

BACKGROUND: Although several types of distal embolic protection devices have been developed, they are usually difficult to use because of their stiff and bulky characteristics. We present a novel method to deliver the coronary embolic protection filter via a manual thrombectomy catheter. METHODS: We modified the Filtrap embolic protection filter (Nipro Corporation) to pass through the aspiration thrombectomy catheter. Three interventional cardiologists performed the Filtrap delivery with in vivo and in vitro coronary arteries using two different methods. The in vitro experiments were performed using a Circuit Cardiac Catheterization Simulator (Just Medical Corporation) with and without coronary artery stenosis. The in vivo experiment was performed using a normal pig coronary artery. The times required for Filtrap delivery in the two different methods were compared. The target lesions were the main and side branch of the left anterior descending, left circumflex, and right coronary arteries. RESULTS: The average Filtrap delivery time when using the thrombectomy catheter was significantly shorter compared to the time using the conventional method (in vitro experiment without coronary stenosis, 39 ± 14 seconds vs 30 ± 6 seconds and P=.019; in vitro experiment with multiple coronary stenosis, 69 ± 55 seconds vs 32 ± 11 seconds and P=.012; in vivo experiment, 169 ± 166 seconds vs 51 ± 12 seconds; P=.019). CONCLUSION: The study results indicate that delivery of the coronary embolic protection filter via a manual thrombectomy catheter may simplify the procedure and decrease the procedure time.