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The SYNTAX trial is the first randomized, controlled clinical trial tocompare PCI using drug-eluting stents (DES) to CABG in patients with left maindisease and three-vessel disease. These patient groups are typically treatedwith CABG and represent a population with far more complex anatomy andadvanced disease than those studied in prior DES clinical trials. The goal ofthe trial is to expand the body of knowledge of PCI use and help informphysicians on appropriate treatment options for the sickest patients.
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"For PCI patients to do so well with such complex anatomy and advanceddisease is extraordinary," said Keith Dawkins, M.D., Associate Chief MedicalOfficer of Boston Scientific. "These patients, the majority of whom arenormally treated with surgery, are the most challenging group ever studied ina DES clinical trial."
The SYNTAX trial also demonstrated a significant decrease in the rate ofstroke for patients treated with PCI as compared to CABG.
"The significant difference in the stroke rate between the PCI and theCABG groups is an important finding," said Dr. Dawkins. "Physicians and theirpatients will now have the necessary information to weigh the risk of strokeassociated with CABG versus the known higher rate of revascularization withPCI. We were also surprised to find that the rate of symptomatic graftocclusion in the CABG group was equivalent to the rate of stent thrombosis inthe PCI group."
The patients recruited in SYNTAX are a unique study group in the PCIfield, given their exceptionally complex anatomy and advanced disease. Theaverage SYNTAX 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 patient profile includes 33 percent ofpatients with >100 mm stented length, 84 percent with bi/trifurcations, 22percent with chronic total occlusions, and 39 percent with left main disease.Some of the sickest patients in the trial were not eligible for surgery andwere treated with drug-eluting stents.
The results announced today showed comparable safety for the two treatmentgroups, with a combined rate of all-cause death, stroke and MI of 7.6 percentfor PCI and 7.7 percent for CABG (p=0.98). The rate of stroke itself was 0.6percent for PCI as compared to 2.2 percent for CABG (p=0.003). Overall 12-month MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate,including all-cause death, stroke, MI and repeat revascularization) wassignificantly higher for PCI (17.8 percent compared to 12.1 percent for CABG,p=0.0015).
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.
SYNTAX is breaking new ground by scientifically defining a new measure foranatomical complexity - the SYNTAX Score - which se
