No ‘Real-World’ Difference Between PES and SE
Rates of MI at nine months were identical.
Taxus (Boston Scientific) and Cypher (Cordis/Johnson & Johnson) stents performed similarly in a randomized, prospective trial of nearly 2,100 Danish patients who received percutaneous coronary intervention (PCI) and were followed up in a “real-world” setting.
“We were not able to detect a difference between the two groups within nine months,” Anders M. Galløe, MD, PhD, of Gentofte University Hospital, in Hellerup, Denmark, said of the SORT OUT II comparator trial.
The researchers did not find a significant difference between the two types of stents with respect to primary or secondary study endpoints. Major adverse cardiac events (the primary endpoint) occurred in 7.8% of the Cypher group and in 8.6% of the Taxus patients (Figure). There was also no significant difference found between groups in overall mortality (1.8% in both populations) and cardiac death (1.2% with Cypher vs. 1.1% with Taxus).
Other cardiac (secondary) endpoints included acute MI (2.4% for sirolimus vs. 2.0% for paclitaxel), target lesion revascularization (3.8% vs. 4.5%), target vessel revascularization (5.1% vs. 5.8%) and target vessel failure (6.2% vs. 7.1%).
Real-world trial
The trial was designed to mimic real-world treatment as close as possible, Galløe said. Patients were recruited at five centers throughout Denmark without any scheduled follow-up. Endpoint data on cardiac events were collected based on reports to the country’s National Death Registry and the National Hospital Registry.
“In other words, the patients went to see the doctor for a serious reason. The events were really clinically driven. It is a trial mimicking real life and observing the real course of disease,” said Patrick W. Serruys, MD, PhD, head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center in Rotterdam, The Netherlands.
During the same session, Serruys raised the question of why the trial was able to recruit only 2,098 patients, representing less than 20% of the potential participants identified during the study period. A total of 11,749 potential subjects were identified during recruitment between August 2004 and January 2006.
Galløe explained that although five centers across the country took part in the study, not all of them performed equally. Two of the centers alone were responsible for recruiting 1,800 of the study participants.
There were also some questions raised about whether the study was big enough to show a small difference between the stents. The presentation did not include 95% confidence interval ratios or angiographic data on stent thrombosis.
Populations similar
The two groups were closely matched in terms of demographic factors (average age 64; 75% men) and indications for PCI, with stable angina being the most common indication.
A total of 2,889 lesions were stented (1,477 in the Cypher group and 1,412 in the Taxus group). Lesions were a median 18 mm in length and 3 mm in diameter in both groups. There was also no significant difference between the groups in types or number of lesions.