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Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.
RESUMO
Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has asimilar efficacy to currently available agents; however it requires a lower dose,and less polymer, and is therefore conceivably safer.Methods and results: The EXCELLA II study was a prospective, multicentre,single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardialvessels in a ratio of 2:1 to treatment with either the Elixir DESyne NovolimusEluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA)or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA,USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-monthsfollow-up. In-stent percent volume obstruction (%VO) was measured in asub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up.Clinical secondary endpoints included a device orientated composite of cardiacdeath, target vessel myocardial infarction (MI), and clinically indicated target lesionrevascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, thein-stent LLL was 0.11±0.32 mm in the NES arm, as compared to 0.63±0.42 mm inthe ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was4.5±5.1% and 20.9±11.3% for NES and ZES, respectively (p<0.001). There wasno significant difference between stent groups in the device orientated compositeendpoint (NES 2.9% vs. ZES 5.6%, 2.8% [-8.8%, 3.3%], p=0.45) or its individualcomponents of cardiac death, target vessel MI and CI-TLR.Conclusions: This non-inferiority randomised study not only met its primaryendpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.