New Results from SYNTAX, SPIRIT Trials Presented

MIAMI BEACH, FLA.—The DES Summit opened with updated data from the SYNTAX trial, a meta-analysis of SPIRIT II, III and IV trials and two-year updated data from PLATINUM.

SYNTAX

Patrick W. Serruys, MD, PhD, of Thoraxcenter, Rotterdam, the Netherlands, presented 5-year results of the SYNTAX trial that evaluated the optimal revascularization strategy in patients with three-vessel and/or left main disease. Patients deemed suitable for either CABG or PCI by a heart team were randomly assigned to CABG (n=897) or PCI with a paclitaxel-eluting stent (PES, Taxus Express, Boston Scientific; n=903). Remaining patients were enrolled in registries and received CABG (n=644) or PCI (n=192).

At 5-year follow-up, there was no difference in all-cause mortality or cerebrovascular accident (CVA) between CABG and PCI, but the CABG arm fared better in terms of cardiac mortality, MI, the safety composite of death, CVA and MI, repeat revascularization and MACCE (see Table 1).

When patients were stratified by SYNTAX score, MACCE rates were lower for CABG vs. PCI in the intermediate (P=.008) and high-risk terciles (P<.001), but similar for those in the low-risk tercile (P=.43). The MACCE rate for the CABG registry was 23.2% vs. 49.2% for the PCI registry.

According to Serruys, the data suggest that 71% of patients with complex multivessel disease are best treated with CABG, while PCI is an acceptable alternative for the remaining minority. 

SPIRIT

TCT Course Director Gregg W. Stone, MD, of Columbia University Medical Center, New York, presented a meta-analysis of the SPIRIT II, III and IV trials, which involved 4,989 patients. The trials compared an everolimus-eluting stent (EES, Xience V, Abbott Vascular) with PES (Taxus Express). 

At 3 years, the EES group fared better in terms of target lesion failure, all-cause mortality, MI, ischemia-driven TLR and Academic Research Consortium-defined definite or probable stent thrombosis (see Table 2).

Stone also provided an update on the second-generation Xience Prime stent, showing that at 2 years in the Core study (n=401), the newer stent had an overall TLF rate of 6.4%, with a 2.7% rate for the 2.25 mm size. The TLR result of 9.6% for the LONG STENT study (n=104; 33-mm and 38-mm long stents) was not as strong, he noted.

In two-year results from PLATINUM, the platinum chromium Promus Element EES (n=758) continues to show rates of TLF, the primary endpoint, comparable to those of the cobalt chromium Promus EES (n=749; 4.4% vs. 5.8%; P=.32). There also was no difference in death or MI.