Μεγάλες κλινικές µελέτες του 2016 Στην...

E. N. Σηµαντηράκης MD, Phd, FESC

Aναπληρωτής Καθηγητής Καρδιολογίας

Πανεπιστηµιακό Γενικό Νοσοκοµείο Ηρακλείου

Μεγάλες κλινικές µελέτες του 2016

Στην ηλεκτροφυσιολογία

Disclosures

❑None

• ATRIAL FIBRILLATION catheter ablation oral anticogulation devices

• CARDIAC PACING antibradycardic CP CRT

• SUDDEN CARDIAC DEATH

ATRIAL FIBRILLATION

Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation

❑N ENGL J MED 374;23 June 9, 2016

N ENGL J MED 374;23 June 9, 2016Karl-Heinz Kuck et al,

Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation

cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy

no significant difference between the two methods with regard to overall safety

Karl-Heinz Kuck et al, N ENGL J MED 374;23 June 9, 2016

Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure

and an Implanted Device

Results From the AATAC Multicenter Randomized Trial

LuigiDiBiase et al. Circulation.2016;133:1637-164

This multicenter randomized study shows that catheter abla- tion of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospital- ization and mortality in patients with HF and persistent AF.

Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-

AF): a randomised, open-label, phase 3b trial

Andreas Goette,et al Lancet 2016

Multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin–warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation

Between March 25, 2014, and Oct 28, 2015, 2199 patients were enrolled and randomly assigned to receive edoxaban (n=1095) or enoxaparin–warfarin (n=1104)

Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-

AF): a randomised, open-label, phase 3b trial

The primary safety endpoint occurred in 16 (1%) of 1067 patients given edoxaban versus 11 (1%) of 1082 patients given enoxaparin–warfarin (OR 1·48, 95% CI 0·64–3·55).

Rates of major and CRNM bleeding and thromboembolism were low in the two treatment group

Andreas Goette,et al Lancet 2016

Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-

AF): a randomised, open-label, phase 3b trial

The primary efficacy endpoint occurred in five (<1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin–warfarin group (odds ratio [OR] 0·46, 95% CI 0·12–1·43)

The results were independent of the TEE-guided strategy and anticoagulation status.

Andreas Goette,et al Lancet 2016

Lucas V.A. Boersma et al European Heart Journal (2016)37,2465–2474

Left atrial appendage closure with the WATCHMAN device has a high success rate with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities.

The ABC (age, biomarkers, clinical history) strokerisk score: a biomarker-based risk score for

predicting stroke in atrial fibrillation

European Heart Journal (2016) 37, 1582–1590

The ABC-stroke score performed better than the presently used clinically based risk score and may provide improved decision support in AF

The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study

Lancet2016;387:2302–11

The ABC-bleeding score performed better than HAS-BLED and ORBIT scores and should be useful as decision support on anticoagulation treatment in patients with atrial fibrillation

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery

A.M. Gillinov et alNEJM 2016

•Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control

• The primary end point was the total number of days of hospitalization within 60 days after randomization, as assessed by the Wilcoxon rank-sum test

Postoperative atrial fibrillation occurred in 695 of the 2109 patients (33.0%) who were enrolled preoperatively; of these patients, 523 underwent randomization

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery

A.M. Gillinov et alNEJM 2016

A total of 89.9% of the patients in the rate-control group and 93.5% of those in the rhythm-control group had a stable, sustained heart rhythm without atrial fibrillation at hospital discharge (P = 0.14)

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery

In patients with postoperative atrial fibrillation who are in hemodynamically stable condition, one strategy does not appear to have a net clinical advantage over the other

A.M. Gillinov et alNEJM 2016

The total numbers of hospital days in the rate-control group and the rhythm-control group were similar (median, 5.1 days and 5.0 days, respectively; P = 0.76).

There were no significant between-group differences in the rates of death (P = 0.64) or overall serious adverse events

CARDIAC PACING

A Leadless Intracardiac Transcatheter Pacing System

Micra transcatheter pacing system, was successfully implanted in 99.2% of patients. The device met prespecified criteria for pacing capture threshold in 98.3% of the patients who were followed for 6 months. Although there were 28 major complications in 25 patients, the prespecified safety criteria were also met, and 96.0% of patients had no major complications at 6 months

Dwight Reynolds N ENGL J MED 374;6 February 11, 2016

Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker

Nanostim leadless cardiac pacemaker met prespecified pacing and sensing requirements in 90% of the patients in whom an implantation was attempted and in 93.4% of the patients in whom the implantation was successful. At 6 months, serious adverse events were observed in 6.7% of the patients.

Vivek Y. Reddy N ENGL J MED 373;12 September 17, 2015

Safety and Performance: Leadless and conventional Devises

SUDDEN CARDIAC DEATH

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

NEJM August 28, 2016Lars Køber for the DANISH investigatoors

prophylactic ICD implantation in patients with symptomatic systolic heart failure that was not caused by coronary artery disease was not found to reduce long-term mortality

Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure

Rate of Death from Any Cause (Primary Outcome) in Prespecified Subgroups

August 28,2016 NEJMLars Køber for the DANISH investigatoors

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs

John L. Sap NEJM 375;2July 14, 2016

Multicenter, randomized, controlled trial involving patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite the use of antiarrhythmic drugs.

Patients were randomly assigned to receive either catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group).

The primary outcome was a composite of death, three or more documented episodes of ventricular tachycardia within 24 hours (ventricular tachycardia storm), or appropriate ICD shock.

Of the 259 patients who were enrolled, 132 were assigned to the ablation group and 127 to the escalated-therapy group.

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs

John L. Sap NEJM 375;2July 14, 2016

In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy.

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs

John L. Sap NEJM 375;2July 14, 2016

Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs

John L. Sap NEJM 375;2July 14, 2016