This past May, the EuroPCR 2009 meeting in Barcelona, Spain, offered reports ranging from early experimental results to mature data from ongoing trials. Stents using new technology held out the possibility of less vessel trauma or improved healing, while randomized trials provided fresh ideas to doctors and reassurance about current practices.
One of the most anticipated reports was the NEVO RES-ELUTION I study involving a novel stent embedded with tiny drug reservoirs. A once-promising earlier version of the device had been withdrawn after another study showed it to be inferior to paclitaxel-eluting stents. In the current study, the new stent—consisting of a cobalt chromium platform and a bioabsorbable polymer that releases the drug sirolimus—produced significantly less artery renarrowing at six months and appeared to improve clinical outcomes compared with a paclitaxel-eluting stent.
Another intriguing study, called POSTCON, focused on a technique called postconditioning. Patients with severe heart attacks were randomly assigned to receive either standard primary angioplasty alone or angioplasty followed by postconditioning, which consisted of a series of low-pressure balloon inflations and deflations inside the artery, each lasting 30 seconds. Patients who received postconditioning had 19% less heart muscle damage at three months compared to those who underwent conventional treatment. Moreover, the postconditioning group had fewer patients who developed heart failure.
Researchers also presented results from the SYNTAX-LE MANS substudy, which assessed paclitaxel-eluting stents and bypass surgery in patients with heart disease in their left main coronary artery. The study found that 92% of the patients who received paclitaxel stents had arteries that stayed open long term compared with 73% of patients who received surgery. Major complications including death, stroke, heart attack, and need for further surgery or angioplasty was 13% in the paclitaxel-eluting stent group and 9% in the surgery group. The majority of events in the paclitaxel stent group stemmed from the need for repeat procedures.
Attendees at EuroPCR 2009 also witnessed the debut of the Syntax score, which was developed in connection with the SYNTAX trial evaluating angioplasty vs. surgery for patients with advanced heart disease. The score characterizes each patient’s coronary anatomy based on criteria such as occlusion frequency, severity, and location. Higher Syntax scores, indicating more difficult disease and treatment challenges, suggest that surgery is the better option.
Three presentations addressed stent options in patients with heart attacks. Long-term results from the STRATEGY trial showed that when such patients received sirolimus-eluting stents and high doses of the anticoagulant drug tirofiban, they did better than those who received bare-metal stents and a similar drug called abciximab. And the TYPHOON trial found that sirolimus-eluting stents maintained their initial advantage over bare-metal stents through four years. The TITAX-AMI trial, which studied a bioactive titanium-nitride oxide stent, found that the new stent produced fewer major complications and blood clots than a paclitaxel-eluting stent over two years of follow-up.
Another new stent, covered with an anti-inflammatory thin film, showed promise in accelerating vessel healing after implantation. In the REVEAL study, patients were randomized to receive the new stent plus either a sirolimus-eluting, a paclitaxel-eluting, or a bare-metal stent. The study found early signs that the new stent seemed to result in better healing than the other stents.
In another presentation, researchers pooled together five-year results from several trials involving a zotarolimus-eluting stent. The analysis found that zotarolimus-eluting stents had durable benefits, with less need for repeat treatment after the first year compared to bare-metal stents and first-generation drug-eluting stents.
And in another study involving a zotarolimus-eluting stent, called the DATE registry, a course of dual antiplatelet therapy lasting only three months appeared safe following use of the zotarolimus-eluting stent in low-risk patients.
But EuroPCR 2009 also featured disappointing news on cell therapy. Researchers shared details from the SCAMI trial, which tested whether heart attack patients could benefit from bone marrow stem cells being injected into the heart. The study had to be stopped early when researchers discovered that the treatment failed to improve the pumping ability of the heart’s left ventricle over placebo.
