A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial.

Based on the latest knowledge and technological advancements, it is still debatable whether a modern revascularisation approach in the setting of acute myocardial infarction (AMI), including complete revascularisation (in patients with significant non-culprit lesions) with newer-generation highly biocompatible drug-eluting stents, requires prolonged dual antiplatelet therapy (DAPT). TARGET-FIRST (ClinicalTrials.gov: NCT04753749) is a prospective, open-label, multicentre, randomised controlled study comparing short (one month) DAPT versus standard (12 months) DAPT in a population of patients with non-ST/ST-segment elevation myocardial infarction, completely revascularised at index or staged procedure (within 7 days), using Firehawk, an abluminal in-groove biodegradable polymer rapamycin-eluting stent. The study will be conducted at approximately 50 sites in Europe. After a mandatory 30-40 days of DAPT with aspirin and P2Y12 inhibitors (preferably potent P2Y12 inhibitors), patients are randomised (1:1) to 1) immediate discontinuation of DAPT followed by P2Y12 inhibitor monotherapy (experimental arm), or 2) continued DAPT with the same regimen (control arm), up until 12 months. With a final sample size of 2,246 patients, the study is powered to evaluate the primary endpoint (non-inferiority of short antiplatelet therapy in completely revascularised patients) for net adverse clinical and cerebral events. If the primary endpoint is met, the study is powered to assess the main secondary endpoint (superiority of short DAPT in terms of major or clinically relevant non-major bleeding). TARGET-FIRST is the first randomised clinical trial to investigate the optimisation of antiplatelet therapy in patients with AMI after achieving complete revascularisation with an abluminal in-groove biodegradable polymer rapamycin-eluting stent implantation.

High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study.

BACKGROUND: Cardiovascular diseases leading to pacemaker implantations are suspected of being associated with a high rate of undiagnosed sleep apnea syndrome (SAS). We sought to determine the prevalence and consequences of SAS in pacemaker patients according to pacing indications: heart failure, symptomatic diurnal bradycardia, and atrioventricular block. METHODS AND RESULTS: Ninety-eight consecutive patients (mean age, 64+/-8 years) not known to have sleep apnea were included; 29 patients were paced for dilated cardiomyopathy (29%), 33 for high-degree atrioventricular block (34%), and 36 for sinus node disease (37%). All underwent Epworth Sleepiness Scale assessment and polysomnography with the pacemaker programmed to right ventricular DDI pacing mode (lower pacing rate, 50 pulses per minute). SAS was defined as an apnea-hypopnea index > or = 10/h. Mean Epworth Sleepiness Scale was in the normal range (7+/-4), although 13 patients (25%) had an abnormal score > 11/h. Fifty-seven patients (59%) had SAS; of these, 21 (21.4%) had a severe SAS (apnea-hypopnea index > 30/h). In patients with heart failure, 50% presented with SAS (mean apnea-hypopnea index, 11+/-7) compared with 68% of patients with atrioventricular block (mean apnea-hypopnea index, 24+/-29) and 58% with sinus node disease (mean apnea-hypopnea index, 19+/-23). CONCLUSIONS: In paced patients, there is an excessively high prevalence of undiagnosed SAS (59%). Whether treating SAS would have changed the need for pacing is unknown. Treatment effects should be further evaluated particularly because these patients are less symptomatic than typical SAS patients. In any case, SAS should be systematically searched for in paced patients owing to potential detrimental effects on their cardiovascular evolution.

Automatic recognition of abnormal respiratory events during sleep by a pacemaker transthoracic impedance sensor.

INTRODUCTION: A number of pacemakers use transthoracic impedance to derive minute ventilation as a sensor for rate adaptation. Transthoracic impedance is also able to track fluctuations in tidal volume occurring in sleep apnea/hypopnea syndromes (SAS). We evaluated the feasibility of a transthoracic impedance-derived pacemaker algorithm for monitoring sleep respiratory disturbances. METHODS AND RESULTS: Forty-two patients who presented with a conventional indication for DDD pacing or cardiac resynchronization underwent conventional polysomnography 1 month after implantation of a Talent trade mark 3 pacemaker (ELA Medical). The respiratory disturbance index (RDI) stored in the pacemaker memory was compared to the apnea/hypopnea index (AHI) derived from polysomnography. The ability of the pacemaker to identify severe SAS patients (AHI > or = 30) was assessed. A minimal systematic error was observed from a Bland and Altman plot (bias = 0.9 events/hour). The ability of the pacemaker RDI to identify severe SAS patients was determined by analysis of the receiver operator characteristic. A cutoff RDI value of 30.6/hour of recording was found to yield 75% sensitivity, 94% specificity, 75% positive predictive value, and 94% negative predictive value. CONCLUSION: The RDI monitoring function appears to be of value in screening pacemaker patients for SAS. Its performance is comparable to existing simple screening techniques. The ability to permanently monitor respiration, in combination with other diagnostic capabilities (such as Holter functions), presents a unique opportunity to monitor the association between arrhythmias and disturbances of breathing during sleep.

Atrial pacing for prevention of atrial fibrillation: assessment of simultaneously implemented algorithms.

AIMS: Several preliminary studies indicated that right atrial pacing could prevent atrial tachyarrhythmias (ATA). We sought to compare the safety and the efficacy of atrial-based pacing supplemented by dedicated combined algorithms with conventional atrial pacing in the prevention of ATA. METHODS: Fifty-five patients with a history of recurrent paroxysmal ATA implanted with a dual-chamber pacemaker were studied during two randomized cross-over pacing periods (conventional DDD and DDD with ATA prevention algorithms) of 6 months duration. The primary endpoint was the burden of ATA episodes recorded by the device mode switch algorithm. RESULTS: The cross-over analysis did not demonstrate any significant difference between the two pacing modes: 254+/-533 h of ATA during the control period versus 238+/-518 h during the ATA prevention period. Analysis of a subgroup of patients found that those with the lower percentage of ventricular pacing benefited from ATA prevention algorithms (120+/-182 h versus 225+/-350 h during the control period; P < 0.04). CONCLUSION: When compared with DDD pacing at 70 bpm, ATA prevention algorithms have not demonstrated significant efficacy. However, a subgroup of patients with preserved native AV conduction (low percentage of ventricular pacing) responded to ATA prevention algorithms.