NATICK, Mass. and WASHINGTON, Oct. 14 BostonScientific Corporation (NYSE: BSX) today announced 12-month left main andthree-vessel disease subset data from its landmark SYNTAX trial comparingpercutaneous coronary intervention (PCI) using the TAXUS(R) Express2(TM)Paclitaxel-Eluting Coronary Stent System to contemporary coronary arterybypass graft (CABG) surgery. The results reinforced previously announced datademonstrating no overall statistically significant differences between PCI andCABG in rates of death or myocardial infarction (MI). The Company alsopresented an analysis of the data based on the SYNTAX Score, a new tool thatseeks to provide guidance to physicians on optimal treatment options for thishigh-risk group of patients, showing similar safety and efficacy outcomes fortwo thirds of SYNTAX randomized patients. The Company made the announcementsat the Cardiovascular Research Foundation's (CRF) annual TranscatheterCardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
The SYNTAX trial is the first large scale randomized, controlled clinicaltrial comparing PCI using drug-eluting stents (DES) to CABG in patients withleft main disease and three-vessel disease. These patient groups aretypically treated with CABG and represent a population with far more complexanatomy and advanced disease than those studied in prior DES clinical trials.The goal of the trial is to expand the body of knowledge of PCI use and helpinform physicians and patients on appropriate treatment options for thesickest patients.
"The data announced today will provide important additional informationfor doctors as they evaluate treatment options for complex coronary patients,"said Keith Dawkins, M.D., Associate Chief Medical Officer of BostonScientific. "The comparable safety and efficacy outcomes with PCI and CABG inpatients with left main disease in this trial indicate PCI is a good treatmentalternative for this patient population. Physicians will also be able toconsider the SYNTAX Score analysis, demonstrating no difference in safety andefficacy outcomes between PCI and CABG in approximately two-thirds of theSYNTAX patient population, when assessing the appropriate treatment for theirpatients."
The SYNTAX Score is breaking new ground by scientifically defining a newmeasure for anatomical complexity that seeks to provide guidance to physicianson optimal treatment options for this high-risk group of patients. The SYNTAXScore characterizes coronary anatomy based on lesion frequency, complexity andlocation, relying on data from the SYNTAX trial, and assigns a score to eachpatient. The analysis of the raw SYNTAX Score data presented todaydemonstrated that PCI and CABG patients whose scores fell into the lower orintermediate terciles of complexity had similar rates of MACCE (Major AdverseCardiovascular or Cerebrovascular Event rate, including all-cause death,stroke, MI and repeat revascularization) at 12 months. For patients whoseSYNTAX Score fell into the upper tercile -- those with the greatest lesioncomplexity -- there was a significant increase in MACCE for PCI patientscompared with CABG patients.
The 12-month subset results for patients with left main disease reportedcomparable rates of overall MACCE for the CABG group and the PCI group (13.6percent for CABG versus 15.8 percent for PCI, p=0.44), as well as similaroverall safety outcomes (death, stroke, MI) for the two groups (9.1 percentfor CABG versus 7.0 percent for PCI, p=0.29). As expected, the rate ofrevascularization was significantly higher in the PCI group (12.0 percent forPCI versus 6.7 percent for CABG, p=0.02), while the rate of stroke wassignificantly higher in the CABG group (2.7 percent for CABG versus 0.3percent for PCI, p=0.009). The subset results for patients with three-vesseldisease reported comparable overall safety outcomes for the two groups (6.4percent for CABG versus 7.9 percent for PCI, p=0.39), an expected higher rateof revascularization for PCI (14.7 percent for PCI versus 5.4 percent forCABG, p=<0.001) driving higher overall MACCE for the PCI group (19.1 percentversus 11.2 percent for CABG, p=<0.001).
The patients enrolled in SYNTAX are a unique study group in the PCI field,given their exceptionally complex anatomy and advanced disease. The averageSYNTAX PCI patient received 4.6 stents, with one patient having 14. Bycontrast, the average number of stents implanted in a PCI patient in everydaypractice is 1.5. In addition, the PCI patient profile includes 33 percent ofpatients with >100 mm stented length, 73 percent with bifurcations, 11 percentwith trifurcations, 22 percent with chronic total occlusions, and 39 percentwith left main disease. Some of the sickest patients in the trial were noteligible for surgery and were treated with drug-eluting stents.
The SYNTAX trial enrolled 1,800 patients in its randomized arm, using aninnovative consecutive enrollment methodology. All patients were assessed bya multidisciplinary team including an interventional cardiologist and acardiac surgeon. If both the cardiologist and surgeon felt they could offerequivalent complete revascularization, patients were randomized 1:1 into oneof the two treatment methods (PCI or CABG). If either the cardiologist orsurgeon felt that PCI or CABG was the preferred option, then patients wereplaced in one of two parallel registries for PCI or CABG.
The safety and effectiveness of the TAXUS Express2 Stent System has notbeen established in patients with left main, multi-vessel disease, chronictotal occlusion, lesions at a bifurcation/trifurcation, >28mm in length orrequiring multiple stents.
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.
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