NATICK, Mass. and CHICAGO, March 29 BostonScientific Corporation (NYSE: BSX) today announced results from an analysis oftwo-year data from more than 7,000 patients in the TAXUS ARRIVE Registryprogram. The study was designed to evaluate the safety performance of theTAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System in patientstreated in "real-world" practice. Outcomes through two years in the simple-use (single vessel/stent) patient group confirmed the favorable results seenin similar patients enrolled in previous TAXUS randomized clinical trials (theclinical trial cohort). Results in the more complex expanded-use group alsocontinued the expected slightly higher event rates than simple-use patients,but were still favorable through two years compared to the published outcomesof other treatment modalities for such patients. Analysis of the data waspresented by John M. Lasala, M.D., Ph.D., at the SCAI Annual ScientificSessions in Partnership with the ACC/i2 Summit in Chicago.
"The extensive ARRIVE data show favorable and consistent outcomes in high-risk groups representing some of the most complex patients and lesions," saidDr. Lasala, Professor of Medicine, Washington University School of Medicine inSt. Louis. "Outcomes in the simple-use patients in ARRIVE are consistent withresults from the TAXUS Stent cohorts in the TAXUS randomized clinical trialprogram, indicating that the ARRIVE methodology is very efficient in capturingadverse event outcomes. Overall, then, these results support the long-termperformance of the TAXUS Stent across the broad range of patients studied inthese trials and registries."
The pooled analysis included two-year outcomes for 7,033 patients in theARRIVE 1 and 2 registries, including those with long lesions, bifurcations,graft stenting, significant calcifications, and multi-vessel stenting. Therewere no differences in two-year safety rates (all death, Q-wave myocardialinfarction (MI), or ARC definite/probable stent thrombosis) between ARRIVEsimple-use patients and the clinical trial cohort. Adverse event rates at oneyear were expectedly higher for expanded-use versus simple-use ARRIVEpatients, and included all death (4.2% vs. 2.3%, respectively), all MI (1.8%vs. 1.2%), target lesion revascularization (TLR) (6.2% vs. 3.4%), and ARCstent thrombosis (2.2% vs. 0.9%). However, TAXUS Stent-related adverse eventrates during the second year of follow-up were lower for both expanded-use andsimple-use patients than in the first year. Overall rates for TAXUS Stent-related events in ARRIVE were within expected ranges given the patientcomplexity.
Through two years, medically treated diabetic patients had a higher rateof all death (9.7% vs. 5.1%, p<0.0001) compared to non-diabetic patients butsimilar rates of TLR (8.1% vs. 7.7%, p=0.63), MI (2.5% vs. 2.2%, p=0.40), andARC stent thrombosis (3.0% vs. 2.4%, p=0.13). Patients with graft stenting orstenting of bifurcation lesions had significantly higher rates of ARC stentthrombosis and TLR through two years, as expected given the complexity of thelesions treated.
"Our ARRIVE registry data provide valuable insights into the benefits ofthe TAXUS Stent in treating the broad spectrum of disease seen in real-worldinterventional practice," said Paul LaViolette, Chief Operating Officer atBoston Scientific. "The analysis reinforces data observed in our randomizedclinical trials, showing positive long-term performance of the TAXUS Stent."
The safety and effectiveness of the TAXUS Express Stent has not beenestablished in lesions longer than 28mm, bifurcations, saphenous vein grafts,multi-vessel stenting or diabetics.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.