BARCELONA, Spain – "A worrisome trend is that the cardiovascular community is becoming sceptical regarding the true clinical value of 'evidence' derived from current research," said Jean Marco, MD, the founder of the EuroPCR congress for cardiac interventionalists being held here this week.

Even as coronary stent manufacturers unleashed another wave of studies at EuroPCR 2009 promoting the clinical benefits of their products, Marco was joined on the podium for the opening plenary session by the influential and activist president of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), William Wijns, MD, in an effort to put a stop to studies that he said "are all too often of limited clinical relevance and for which the generalization of the results is questionable."

In other words, enough is enough.

Drs. Marco and Wijn formally announced the creation of the European Clinical Research Renaissance to unite "the best European intellectual forces and develop an innovative concept of European clinical trials."

At the Presidential Dinner on the first night of EuroPCR, they said they will rally the heads of Europe's national cardiology societies around what they have called the EuroTrials project.

"We have the intellectual capacity and the required infrastructure to reach this innovative objective," said Marco.

"As it stands, individual initiatives are often chaotic, redundant or dispersed, and will never provide the productive strength of a coordinated European research plan, of a European Research Federation," he said.

The EuroTrials project, he said, would use the existing structures that in recent years have proven to be European leaders in interventional cardiology domains, though he did not flesh out the details of any action ahead of his meeting with the professional society presidents.

In a manifest, Wijns and Marco were joined by leading surgeon Patrick Serruys, MD, the editor-in-chief of the professional publication EuroIntervention, the three leading lights of European coronary intervention said they had the support of the European Society of Cardiology (Sophia Antipolis, France), and that the European Association for Cardio-thoracic Surgery (EACTS) would participate on a founding council.

They added that a place at the table has been reserved for "industry" through the participation of Eucomed (Brussels, Belgium), the European trade association for medical device manufacturers.

Syntax study scores points as rating method

Even before the formal announcement that criteria used for rating the complexity of coronary artery disease would be formally adopted as an industry standard, physicians discussing cases throughout EuroPCR could be heard referring to the Syntax Score of a patient.

"Doctors have been eager get this tool for their daily practice," said Serruys during a press conference explaining how a Boston Scientific (Natick, Massachusetts) CD-ROM loaded with software to help cardiologists evaluate angiographs of patients had found its way into the publication he oversees, EuroIntervention.

Boston Scientific announced it had also launched during the first day of EuroPCR a website dedicated to the Syntax Score.

Developed in connection with the Syntax trial, the Syntax Score was used to characterize coronary anatomy based on nine anatomic criteria, including lesion frequency, complexity and location,andthen assign a score to each patient.

The higher the rating the more complex the patient's disease and the challenges for treatment.

The Syntax Score and the web site with its interactive calculations, the grading system for lesion complexity and links to relevant reference data in the Syntax trial were developed under the direction of the trial steering committee and made possible by support from Boston Scientific.

The site and the CD-ROM distributed to the 11,000 participants at EuroPCR also includes a detailed tutorial on the use of the Syntax Score calculator, including definitions and example cases, together with Syntax data presentations and publications.

The EuroIntervention web site, which links to the Syntax Score web site, is approaching one million visitors per month, Serruys reported in a separate presentation.

The formal adoption of the Syntax tools as a clinical standard represents an unprecedented score for Boston Scientific.

Ironically, the results of the Syntax trial, that compared percutaneous coronary intervention (PCI) using the Boston Scientific drug-eluting stent (DES) Taxus Express2 to traditional coronary artery bypass graft (CABG) surgery tended to favor open surgery.

Keith Dawkins, associate chief medical officer of Boston Scientific, said, "Patients enrolled in Syntax have exceptionally complex anatomy and advanced disease, representing an unprecedented study group for a stent trial. Ongoing findings from this study will continue to be used to enhance the value of the Syntax Score in this high-risk patient population."

Long-term view favorable for Endeavor

Calling the Endeavor stent the "dark horse" in the competition for drug-eluting stents, Dan Beach, director of communications for Medtronic Cardiovascular, told Medical Device Daily, "We are coming up on Johnson & Johnson [J&J; New Brunswick, New Jersey], challenging their position as third-ranked for sales globally."

Market leader Boston Scientific "has a huge heritage" that assures it will hold onto the top spot for years to come, he said while second-ranked Abbott Laboratories (Abbott Park, Illinois) is not threatened by Medtronic in the near term.

According to Dan Rose, marketing manager for Medtronic Cardiac Surgery in Western Europe, counting European sales of both the Endeavor and Resolute stent, which is not available for sale in the U.S., Medtronic already has overtaken J&J's Cordis division on the Continent.

The discussion with Medtronic marketing executives followed on the presentation of data showing long-term safety and efficacy for Endeavor.

While the presentation was squeezed into the "Late Breaking Trials" session at EuroPCR 2009, and while it had all the proper clinical credentials for the analysis of data, the study was more relevant to marketing than medical practice.

Medtronic pooled the data sets from six previous Endeavor clinical trials to study the long-term outcomes that are "beyond the primary endpoint,' according to Dr. David Kandzari of the Scripps Clinic (La Jolla, California), who presented the results.

While short-term outcomes of DES trials have served as a benchmark for efficacy, he said, this study objective was to mine the available data to reveal longer term safety.

Not surprisingly, the results favor the zotarolimus-eluting Endeavor stent .

Yet data also showed a promising phenomenon where target lesion revascularization (TLR), or the likelihood a patient needs to undergo a second procedure to unblock a re-blocked artery, leveled off to a reassuring stability after the first year.

In the combined data sets, 5.4% of patients were likely to need a second procedure after one year with the stent.

The rate of revascularization then plateaued, creeping up over the next four years to reach 7% of patients by the fifth year.

The TLR rate was more favorable for Endeavor than other stents in the six different studies, which include Metronic's Driver bare-metal stent, as well as Taxus from Boston Scientific and Cypher from J&J.

A feature of the "Late Breaking Trials" session at EuroPCR is a critique of the presented study by an independent physician, as opposed to the presenters who are typically paid consultants for the manufacturer.

Leif Thuesen, MD, a dry Dane with the department of cardiology at Aarhus University Hospital (Skejby, Denmark), thanked the authors for the emphasis on long-term data then quickly underlined the obvious, saying that these six studies are not homogenous in methods, and added, "it is problematic pooling data like this and then generalizing the results."

He pointed out that patients for all the studies were selected, and not "all-comers," a inclusion methodology that more closely reflects a real-world patient population.

His next, and final statement, was either kind or cutting, depending on whether you are from the medical or marketing group at Medtronic: "the findings are quite favorable for Endeavor over Taxus and Cypher."