EuroPCR 2010 has recently been organized and plentyful of studies have been reported which are directly relevant for interventional cardiologists. Among the most important are surely the RESOLUTE All Comers study, the SPIRIT V Diabetes trial, and the TALENT study.
The RESOLUTE All Comers trial has compared the zotarolimus-eluting Endeavor Resolute stent versus the everolimus-eluting Xience/Promus stent in 2300 patients undergoing percutaneous coronary intervention. After a follow-up of 12 months, Endeavor Resolute was non-inferior to the Xience/Promus stent, with, respectively, 8.2% versus 8.3% target lesion failure. Despite this encouraging result for the primary end-point, stent thrombosis was significantly more frequent with Endeavor Resolute (1.2% versus 0.3%, p=0.01), thus calling into question previous assumptions of greater safety of the Endeavor platform.
The SPIRIT V Diabetes trial focused on 324 diabetics undergoing percutaneous coronary interventio and randomized to implantation of Xience/Promus versus the paclitaxel-eluting Taxus Liberté stent. After 9 months, the primary end-point of angiographic in-stent late lumen loss was significantly lower with Xience/Promus than with Taxus Liberté (0.19 mm versus 0.39 mm, p=0.001). Yet, this angiographic superiority did not translate into significant reductions in repeat revascularizations, which actually appeared to favor Taxus Liberté, with target lesion revascularization in, respectively, 8.4% versus 3.8% (p=0.16). Nonetheless, Xience/Promus was associated with non-significantly fewer myocardial infarctions, suggesting that thinner struts may confer clinically relevant benefits in patients with diffuse disease (0.5% versus 1.9% for Q-wave myocardial infarction, 2.8% versus 6.7% for non-Q-wave myocardial infarction).
Finally, Sciahbasi et al reported on the TALENT trial, which randomized 1540 patients to right versus left trans-radial access for percutaneous coronary procedures (both diagnostic and interventional). They intriguely found that left radial access reduced fluoroscopy time (average difference of 19 seconds, p=0.0025) and dose-area product (average difference 1.4 Gray/cm2, p=0.004) for diagnostic procedures. However, statistical significance was no longer maintained when focusing on interventional procedures only or case performed only by experience operators. Thus, left radial access could be proposed as the access site of choice for trainees and/or cases unlikely to need intervention.

How is ST segment elevation myocardial infarction managed in Europe nowadays? A report from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of a collaborative analysis from national working groups recently published by Widimski et al investigated acute reperfusion therapy in 30 countries, finding that primary percutaneous coronary intervention (PCI) is the preferred treatment in 16 countries. However, thrombolysis is still preferred in as much as 8 countries, preferentially located in the Balkans and Southern Europe. As expected, primary PCI, whenever feasible, was associated with lower in-hospital mortality. The superiority of primary PCI over thrombolysis was maintained after many years. Nonetheless, time from first medical contact to needle/balloon was higher in primary PCI patients, and the much desired 2 hours or less are still a mirage in many countries.
An update of the largest randomized study on this topic with the longest follow up available, the DANAMI-2 trial, has been recently reported by Nielsen et al. After nearly 8 years, the interventional approach to ST segment elevation myocardial infarction still overcomes pharmacologic treatment for the composite primary endpoint of all-cause mortality or myocardial infarction. Nielsen and colleagues concluded that primary PCI should be the preferred reperfusion strategy, but stressed the importance of inter-hospital time delay to be less than 120 minutes. We absolutely agree with this point.
And now, we cannot omit our daily bread, so let's give a look at one of the most interesting meta-analysis recently disclosed. Lee and colleagues recently published on the results of a well done and sleek review on drug-eluting stents (DES) and bare-metal stents (BMS) for saphenous vein graft (SVG) interventions. A total of 19 studies including 3420 patients was analyzed, and the results rewarded the DES because patients in this group experienced fewer revascularizations, myocardial infarctions and had a strong trend towards higher survival after an average follow-up of 20 months. To note, only 2 out of 19 studies were randomized. Thus, DES use in SVG interventions now seems encouraging... awaiting another randomized clinical trial, maybe with newer generation DES.

Awaiting the EuroPCR congress and recovering from the exciting news of the American College of Cardiology Scientific Sessions, two important and thought-provoking studies have been reported. Both studies challenge apparent dogmas in cardiovascular disease, and should be thus carefully read and analyzed.
Fowkes et al have provided another blow to the hypothesis that aspirin can be beneficial at large in the primary prevention of cardiovascular disease, by randomizing over 29,000 patients with peripheral artery disease to low-dose aspirin or placebo, and following them for more than 8 years. Despite such large sample size and long-term follow-up, no significant change in the rate of cardiovascular events occurred in favor of aspirin, despite an evident trend for an increase in bleeding. Thus, given also the indidivual patient data meta-analysis by Patrono et al, aspirin cannot be recommended any longer in the primary prevention of cardiovascular disease. Nonetheless, we do recommend to consider and discuss individually wiht patients the risks and benefits of aspirin (as well as in the near future of generic clopidogrel), as patients at high thrombotic risk but low bleeding risk may still benefit from antiplatelet therapy in primary prevention.
Patel et al also poignantly challenge a common approach in cardiovascular medicine, i.e. diagnostic coronary angiography in patients with suspected coronary artery disease. In their cross-sectional work including almost 400,000 patients, they show that coronary angiography disclosed absence of or only mild coronary artery disease in almost 40% of subjects. Thus, they conclude that a substantial portion of these tests are unnecessary and thus should be preceded by more thorough risk stratification. Whereas risk stratification is always beneficial, as long as it does not inappropriately delay life-saving treatment, the idea that negative coronary angiograms are non-contributory is wrong, as many tests in the whole realm of medicine are ordered to exclude a disease or a condition, rather than just to confirm it. Indeed, evidence based medicine experts, including those of the Centre for Evidence Based Medicine do recommend both tests with high specificity to rule in disease (SpIn) and tests with high sensitivity, such as coronary angiography, to rule out disease (SnOut).

This year American College of Cardiology Scientific Sessions have confirmed their role as probably one of the most authoritative North American cardiological conferences. Among the key trials just recently reported, a number have provided very important and seminal findings.
Specifically, the ACCORD trial compared a target of systolic blood pressure lower than 120 mm Hg versus a target of 140 mm Hg in 4733 patients with diabetes mellitus at high risk of cardiovascular events. The investigators found no important difference in the rate of death, but a sensible reduction in the risk of stroke with a more stringent blood pressure control, despite more frequent serious adverse events.
The fenofibrate substudy of the very same ACCORD trial compared fenofibrate versus placebo on top of simvastatin in 5518 patients with type 2 diabetes mellitus at high risk of cardiovascular events, finding no meaningful benefit of fenofibrate on the risk of death, or on the composite end-point of death, myocardial infarction or stroke.
The twin randomized trials by Park et al have begun addressing the issue of the most appropriate duration of dual antiplatelet therapy following drug-eluting stent implantation. Despite a sound rationale for the superiority of a treatment regimen lasting more than 12 months after revascularization, this trial did not show any significant benefits of continuing clopidogrel plus aspirin beyond 1 year.
The EVEREST II trial has provided much awaited results of percutaneous mitral valve repair versus surgical repair in 279 patients with mitral regurgitation. The study demonstrated that percutaneous repair with the MitraClip device has similar safety and efficacy in comparison to open surgery, thus providing a momentous paradigm shift in the management of this frequent cardiovascular condition.
Finally, the RACE II Investigators have confirmed the benefit of a conservative approach in the management of heart rate in patients with chronic atrial fibrillation. Specifically, 614 patients were randomized to a soft rate-control strategy (resting rate less than 110 beats per minute) versus a strict one (resting rate less than 80 beats per minute), and following the patients for 2 years. The rate of adverse clinical events was similar in the two groups, thus demonstrating that there is no need to routinely pursue a low heart rate in stable patients with permanent atrial fibrillation.

Eagerly awaiting upcoming scientific conferences such as JIM, ACC, and EuroPCR, February should not be considered an interlocutory month. In fact, scientific journals keep on publishing the results of very interesting studies in our area of interest. The reader will thus understand how, as usual, the selection is not easy.
First of all, we would like to highlight the results of a well conducted meta-analysis from Valgimigli et al published in the European Heart Journal (2010;31:35-49). These authors sought to evaluate the impact of tirofiban versus placebo or abciximab on the outcome of 20,000 patients with acute coronary syndrome undergoing percutaneous coronary intervention, and found that tirofiban significantly reduced mortality and mortality plus myocardial infarction in comparison to placebo. When tirofiban was compared to abciximab, it showed similar results regarding 30-day mortality (confidence interval: 0.53-1.54, p=0.70), however a trend towards an increase of death or myocardial infarction was found in the tirofiban group (confidence interval: 0.96-1.45, p=0.11). The investigators hypothesized this result was due to the "old" regimen of drug used in less recent trials such as TARGET, as in fact no differences were found when a 25 mg/kg bolus regimen was used. Both minor bleeds (but not major) and thrombocytopenia were reduced in the tirofiban group.
It is worth mentioning the 1-year results of the multicenter prospective randomized trial CARDIA, just published in the Journal of the American College of Cardiology by Kapur et al (2010;55:432-40), where 510 patients with multivessel coronary artery disease and diabetes were randomized to bypass grafting or percutaneous coronary intervention. The primary study end-point was a composite of mortality, myocardial infarction, or stroke at 12 months and resulted similar in the two arms (10.5% versus 13%, confidence interval: 0.75-2.09), although the prespecified 1.3 noninferiority margin of confidence interval was exceeded. Those patients who were treated with drug-eluting stents, however, (70% of the total) well matched with the bypass population (11.6% versus 12.4%, confidence interval: 0.51-1.71).
Finally, we want to disclose the results of a study from De Labriolle et al, European Heart Journal 2010, that investigated the impact of platelet drop in an all-comers single-center population of patients undergoing percutaneous coronary intervention. Authors interestingly discovered that moderate (25-49%) or severe (?50%) thrombocytopenia developed in 16% of patients, and these patients experienced a significantly higher risk of death or myocardial infarction at 30-day and 1-year follow up. As expected, the worst performance was achieved in the severe thrombocytopenia arm. The authors concluded that among the risk factors for thrombocytopenia, some are modifiable, as thigh-osmolar contrast agents and bivalirudin seem to reduce this risk.

The new year has just begun, yet few major novel studies have been reported in the last few weeks on interventional cardiology topics.
These include the COMPARE trial, by Kedhi and colleagues, which has shown that, among 1800 unselected patients with coronary artery disease, everolimus-eluting stents proved significantly superior to paclitaxel-eluting stents in terms of the composite rate of major adverse cardiac events (6% versus 9% at 12 months), as well of stent thrombosis (1% versus 3%), myocardial infarction (3% versus 5%), and repeat revascularization (2% versus 6%), despite similar rates of all-cause death (2% versus 2%). We also wish nonetheless to focus the attention of visitors of this website on 2 recent publications which can prove very interesting. In the first article, Holmes et al provide a thorough viewpoint on the importance and details of the mentor-mentee relationship, crucial in both clinical practice and clinical research, and often disregarded or approached in an inappropriately informal way, especially in European countries. The other interesting work is the study by Hannan et al, comparing the clinical suggestions given by interventional cardiologists after completion of coronary angiography to those of other colleagues. This study poignantly shows that, among 16142 patients with significant coronary artery disease, those managed by interventional cardiologist were more likely to receive recommendations for percutaneous revascularization and fewer recommendations for coronary artery bypass surgery, often in disagreement with explicit American College of Cardiology/American Heart Association guidelines.
Finally, we wish to compliment ourselves with Hlatky et al, authors of the meta-analysis entitled "Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials", and winner of the 2009 METCARDIO Award, explicitly aimed at awarding the most influential and rigorous meta-analysis published in 2009 on interventional cardiology topics.