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August 16, 2010

Israeli Study Shows That DES Improve Long-Term PCI Outcomes

August 17, 2010—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that investigators at the Rabin Medical Center in Israel have determined that the use of drug-eluting stents (DES) improves the long-term clinical outcomes for patients undergoing percutaneous coronary intervention (PCI). Tamir Bental, MD, et al will publish results from this study in the upcoming September issue of SCAI's Catheterization and Cardiovascular Interventions.

According to SCAI, the study investigators examined the benefits and long-term risks of DES by evaluating the established pattern of DES versus bare-metal stent (BMS) use in routine clinical practice in Israel, where guidelines established by the Israel Heart Society and the Ministry of Health require DES be used preferentially in proximal main vessels, diabetic patients, and in long lesions to reduce restenosis.

The study population was composed of all consecutive cases of PCI with stent implantation over a 4-year period at the two hospitals of the Rabin Medical Center. The entire cohort consisted of 6,583 patients: 2,633 (40%) DES patients and 3,950 (60%) BMS patients. The minimal follow-up time was 6 months, and the maximal follow-up time was 5.2 years, with a mean follow-up time of 3 years.

The investigators used propensity score matching and stratified analysis to define the clinical effectiveness and safety profile of DES versus BMS among all comers treated at the center using carefully validated long-term follow-up mortality and morbidity endpoints. Propensity score matching was performed using an algorithm to match each DES patient to a BMS patient with the closest propensity score. Each pair was used once, and unpaired cases were not used in further analysis. The propensity-matched group consisted of 4,398 patients (2,199 matched pairs).

The usage pattern set by the Israel Ministry of Health directives was generally followed, with 40% of the procedures including a DES. Patients who received DES were slightly younger and more likely to be diabetic. Their index intervention was less likely to be emergent. The main features associated with the DES group were the use of longer or more stents per lesion and the treatment of more territories, more sites per territory, and more proximal main vessels. Of the patients with DES, 66% had a DES only, whereas 34% had a combination of a DES and a BMS.

Results show that DES use compared with BMS use reduced the occurrence of myocardial infarction (5.17% vs 5.83%) and the need for clinically driven target vessel revascularization (9.76% vs 12.28%). The mortality rate was significantly lower in the DES group, showing a persistent benefit of DES over time (23.38% for DES vs 26.07% for BMS).

“The main effect of DES is reduced restenosis, which is evident in our analysis,” concluded Dr. Bental. “This outcome was sustained over time and could certainly be a major factor contributing to the survival benefit of DES. We suggest that a possible additional factor contributing to our results could be the pattern of use of the DES in our practice—treatment of more territories and more sites per territory, probably leading to a more complete revascularization. Another salient feature was the preferential treatment of more proximal main vessel. Therefore, treatment of proximal lesions could contribute to a better outcome.”

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August 17, 2010

Biotronik Begins BIOSOLVE Study of Its Drug-Eluting Absorbable Metal Stent

August 17, 2010

Biotronik Begins BIOSOLVE Study of Its Drug-Eluting Absorbable Metal Stent


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