A Medical Device Daily

Patients who receive the Johnson & Johnson (J&J; New Brunswick, New Jersey) Cypher sirolimus-eluting coronary stent were less prone to experience heart attacks (Q-wave myocardial infarctions) or blood clots (stent thromboses) than patients treated with Boston Scientific 's (Natick, Massachusetts) Taxus stent, according to two-year data from a prospective, randomized, multi-center study presented at the annual meeting of the World Congress of Cardiology (WCC; Antipolis, France) being held in Barcelona, Spain through today.

Earlier data from the trial, funded by Cypher manufacturer Cordis (Miami Lakes, Florida), a J&J unit – failed to prove a benefit for the Cypher over Taxus. It missed its primary endpoint of a significant reduction in eight-month binary restenosis. Cypher produced a rate of 9.6% vs. 11.1% for Taxus.

What a difference 16 months make. The latest data show that less than 1% (0.9%) of the patients in the Cypher stent arm of the REALITY trial experienced stent thrombosis. In contrast, 2.5% of the patients in the Taxus stent arm suffered a blood clot.

In addition, patients treated with the Cypher stent suffered a Q-wave myocardial infarction (a heart attack affecting the full thickness of the heart wall) much less frequently than those receiving the Taxus stent (0.1% vs. 1.5%).

Major adverse cardiac events (MACE) – which in this study were defined to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions (heart attacks that do not involve the full thickness of the heart wall), target lesion revascularizations (re-interventions to reopen an artery) using bypass surgery or angioplasty – were also tracked. A composite of these, however, did not show a statistical difference between the two drug-eluting stents.

“Drug-eluting stents have made it possible for more patients to receive less invasive treatments for cardiovascular disease,” said Antonio Colombo, MD, from San Raffaele Hospital and Centro Cuore Columbus Hospital (Milan, Italy), one of the REALITY investigators and the presenter of the results. “As discussions over the safety of these devices take place, studies such as REALITY, can help physicians select the best treatment option for their patients.”

The trial involved 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the Cypher stent or the Taxus stent. In the end, the Cypher was used in 684 patients and 970 artery blockages, while the Taxus was used in 669 patients and 941 artery blockages.

In other news from the WCC meeting

• Abbott Laboratories (Abbott Park, Illinois) reported positive six-month results of its SPIRIT II clinical trial of the Xience V everolimus-eluting coronary stent system.

Results of the trial, which was conducted in Europe and Asia Pacific, demonstrated superiority of the Xience V stent system compared to the Taxus paclitaxel-eluting coronary stent system with respect to the study's primary endpoint, which was angiographic in-stent late loss at six months (0.11 +/- 0.27 mm for Xience V vs. 0.36 +/- 0.39 mm for Taxus).

Secondary endpoints of the trial also demonstrated positive results for the Xience V stent system, including a statistically significant reduction in percent diameter stenosis from 21% for Taxus to 16% for Xience V.

The in-stent angiographic binary restenosis rate for Xience V was 1.3% compared to 3.5% for the Taxus control.

The six-month MACE rate for the Xience V was 2.7%, vs. 6.5%or the Taxus.

As defined in SPIRIT II, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the six-month period.

The study also showed a stent thrombosis rate for Xience V of 0.5% at six months compared to 1.3% for that of Taxus. The device and procedural success rates for the Xeince V stent system were 98.8% and 99.1%, respectively.

“The excellent results demonstrate that in this trial, the Xience V stent was not only non-inferior but was also superior to the TAXUS stent, and confirm the positive results from the SPIRIT FIRST study,” said Patrick Serruys, MD, of the Thoraxcenter, Erasmus University Hospital (Rotterdam, the Netherlands), principal investigator of the SPIRIT II clinical trial.

Under a deal it cut with Abbott, Boston Scientific will also be able to sell a private label version of the Xience stent –dubbed Promus, although the late loss superiority of the new stent over Taxus could pose something of a dilemma.

• SonoSite (Bothell, Washington), a developer of hand-carried ultrasound, said that John Postley, MD, of the New York Physicians Group presented results from his study demonstrating that vascular ultrasound screening can be a more accurate means of risk stratification for heart attack, particularly among women, than the Framingham Risk Score, which has been the traditional method of identifying cardiovascular risk.

Postley used SonoSite hand-carried ultrasound systems in his study, titled “Gender Differences in the Relationship of Ultrasound Identified Atherosclerosis to Framingham Risk Score.” A total of 120 patients were examined with ultrasound for the presence of carotid and femoral arterial plaque and the measurement of carotid intimal medial thickness (CIMT).

Among the 50 women in the study, Postley found no correlation between Framingham Risk Scoring (FRS) and the thickening of the endothelial lining of the carotid artery, or CIMT, a surrogate for cardiovascular disease events.

Additionally, while 72% of these women were at low risk for heart attack according to FRS, 50% of this group had incidence of plaque. Even in the absence of other risk factors, presence of plaque is a proven precursor to heart attack and stroke.

“Atherosclerosis, as it ultimately leads to heart attack and stroke, is the leading cause of death in the United States and the mortality rate associated with the first heart attack or stroke is very high,” said Postley. “Clearly, a better method for risk-stratifying patients is needed so that preventive treatment can begin for those who need it most. Screening for CIMT and plaque with vascular ultrasound can uncover at-risk patients with greater accuracy than traditional methods, and should allow for earlier intervention to prevent the progression of disease.”

All CIMT measurements were made with a SonoSite TITAN system and SonoCalc IMT automated edge detection software.