Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study.

AIMS: Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting. METHODS AND RESULTS: A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5). CONCLUSIONS: The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions.

[Update on interventional cardiology]. / Actualización en cardiología intervencionista.

This article contains a review of the most important studies on interventional cardiology reported in either publications or presentations. In the area of coronary interventions, ST-elevation myocardial infarction continues to take center place: recent studies have confirmed the importance of timely intervention and the safety of drug-eluting stents. The numerous studies that have compared different generations of drug-eluting stents indicate that there has been a steady improvement in safety and efficacy. In addition, the use of stents in the left main coronary artery and in multivessel disease have also been investigated in major studies. Of the different intracoronary diagnostic techniques, optical coherence tomography is highlighted by this review, particularly for its use in the study of drug-eluting stents. There is increasing interest in the percutaneous treatment of structural heart disease, specifically percutaneous aortic valve implantation, especially following the publication of the first randomized trial, which produced encouraging results.

Ventricular arrhythmias among implantable cardioverter-defibrillator recipients for primary prevention: impact of chronic total coronary occlusion (VACTO Primary Study).

BACKGROUND: An implantable cardioverter-defibrillator (ICD) is the therapy of choice for primary prevention in patients with ischemia who are at risk for sudden cardiac death (SCD). One third of patients with significant coronary disease have chronic total coronary occlusion (CTO), which is associated with long-term mortality in patients with previous myocardial infarction. However, the impact of CTO on the occurrence of ventricular arrhythmias and long-term mortality in ICD recipients remains unknown. METHODS AND RESULTS: All consecutive patients with coronary artery disease receiving ICD therapy for the prevention of SCD were included in the study. Among other characteristics, the existence of CTO was assessed. During follow-up, the occurrence of appropriate device delivery because of ventricular arrhythmias as well as mortality were noted. A total of 162 patients (mean age, 62±9 years; 93% men) with an ICD were included and followed for a median of 26 months (interquartile range, 12-42). At least 1 CTO was present in 71 (44%) patients. Appropriate device therapy was detected in 18% of the patients during the follow-up. The presence of CTO was associated with higher ventricular arrhythmia and mortality rates (log-rank test, <0.01). Multivariable analysis revealed that CTO was independently associated with appropriate ICD intervention (hazard ratio, 3.5; P=0.003). CONCLUSIONS: In patients with ischemic heart disease receiving ICDs for primary prevention of SCD, CTO is an independent predictor for the occurrence of ventricular arrhythmias and has an adverse impact on long-term mortality.

[Update in interventional cardiology]. / Actualización en cardiología intervencionista.

This article contains a detailed review of the most important studies on interventional cardiology reported in either publications or presentations. With regard to coronary interventions, ST-elevation myocardial infarction is highlighted because of the ongoing substantial expansion in primary angioplasty programs. Drug-eluting stents, especially new-generation stents, continue to be the focus of numerous studies. Clinical outcomes in diabetic patients with left main coronary artery or multivessel disease are also dealt with by much research. In addition, intracoronary diagnostic techniques, particularly optical coherence tomography, is reviewed. Finally, there is increasing interest in the percutaneous treatment of structural heart disease, particularly percutaneous aortic valve implantation.