Is there a role for thoracic aortic calcium to fine-tune cardiovascular risk prediction?

Screening asymptomatic subjects to streamline measures for the prevention of cardiovascular events remains a major challenge. The established primary prevention risk-scoring methods use equations derived from large prospective cohort studies, but further fine-tuning of cardiovascular risk assessment remains important as 25 % of individuals with low estimated risk may experience cardiac events. Independent studies provided evidence that extended risk assessment using coronary artery calcium quantification may improve risk stratification as it can lead to reclassification of persons at increased risk. Particularly in intermediate-risk subjects, coronary artery calcium scoring can help to correctly identify individuals at highest risk. Data on the extent of calcification of the ascending and descending thoracic aorta might be useful for additional cardiovascular risk stratification. Future analyses and studies will be required to answer the question of whether the implementation of such data may allow further fine-tuning of cardiovascular risk prediction in specific subpopulations—for instance in women or men with an increased risk of stroke and/or symptomatic peripheral vascular diseas

Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year. Methods and results: The multicentre COMFORTABLE AMI trial (NCT00962416) randomly assigned 1,161 patients to treatment with biolimus-eluting stents with biodegrable polymer and bare metal stents of otherwise identical design at 11 international sites. The primary endpoint is a composite of cardiac death, target-vessel MI and target lesion revascularisation at one year. Assuming a relative risk reduction of 40% in event rates of the primary endpoint in favour of biolimus-eluting stents with biodegradable polymer, 1,064 patients will provide 80% power to demonstrate superiority. Clinical follow-up will be continued through five years. Conclusions: The COMFORTABLE AMI trial will determine whether biolimus-eluting stents with biodegradable polymer are superior to bare metal stents of otherwise identical design. This is the first randomised controlled trial (RCT) investigating DES with a biodegradable polymer surface coating for drug release in the treatment of patients with STEM

Intravascular Ultrasound for the Evaluation of Therapies Targeting Coronary Atherosclerosis

Many cardiovascular events are clinical manifestations of underlying atherosclerotic disease. The progression of atherosclerosis, traditionally measured by angiography, is predictive of future clinical events and is a valid surrogate marker of cardiovascular (CV) disease. There is growing interest in using novel surrogate end points in clinical trials to expedite the development of new CV therapies. Innovative imaging technologies, such as intravascular ultrasound (IVUS), may carry advantages for the evaluation of coronary atherosclerotic burden and disease progression. Unlike angiography, which displays only the opacified luminal “silhouette,” IVUS provides transmural imaging of the entire arterial wall and permits both detection of early-stage atherosclerosis and accurate cross-sectional and even 3-dimensional quantification of plaques. Intravascular ultrasound is now used to guide therapeutic interventions and for diagnostic purposes, primarily for the evaluation of ambiguous lesions and left main coronary artery disease. In addition, clinical studies are using IVUS serially to measure plaque progression, which appears to be related to future CV events. Although the probative force of clinical end point studies still is stronger, IVUS is catching up. Currently, several trials of CV therapies use IVUS-determined plaque progression as the end point. The rationale for using IVUS-based surrogate end points in clinical trials is discussed in the present review. Key advantages of using IVUS-based surrogate end points versus clinical outcome include smaller patient numbers and substantially shorter trial durations; this reduces costs and may expedite the development and testing of new drugs. We expect in the near future a further increase of the use of IVUS-based surrogate end points in trials that evaluate novel CV therapies targeting on coronary atherosclerosis

Ultrasound and light: friend or foe? On the role of intravascular ultrasound in the era of optical coherence tomography

More than 20 years after its introduction, intravascular ultrasound (IVUS) has outlived many other intracoronary techniques. IVUS was useful to solve many interventional problems and assisted us in understanding the dynamics of atherosclerosis. It serves as an established imaging endpoint in large progression-regression trial and as an important workhorse in many catheterization laboratories. Nowadays, increasingly complex lesions are treated with drug-eluting stents. The application of IVUS during such interventions can be very useful. Recently, optical coherence tomography (OCT), a light-based imaging technique, has entered the clinical arena. The “omnipresence” of OCT during scientific sessions and live courses with PCI may raise in many the question: Does IVUS have a future in the “era of OCT”? Three review articles, highlighted by this editorial, demonstrate the broad spectrum of current IVUS applications and underline the significant role of IVUS during the last two decades. OCT, the much younger technique, still has to prove its value. Yet OCT is likely to take over some of the current indications of IVUS as a research tool. In addition, OCT is currently gaining clinical significance for stent optimization during complex interventional procedures. Nevertheless, there is little doubt that IVUS still has a major role in studies on coronary atherosclerosis and for guidance of coronary stenting. Thus, ultrasound and light—are they friend or foe? In fact, both methods are good in their own rights. They are complementary rather than competitive. Moreover, in combination, at least for certain indications, they could be even better