Better Results With Newer Generation DES in Complex CAD Pave the Way for CABG Comparisons
A new registry study bolsters concerns that trial results supporting CABG over drug-eluting stents in patients with complex coronary disease are not applicable in the era of newer-generation stents. Although the study only compared first-generation DES with a next-generation device not currently in use in the United States, its results add to the growing chorus calling for updated stent-versus-CABG comparisons to guide clinical decision-making.
In the ERACI IV registry of patients with multivessel disease including left main stenosis, rates of adverse outcomes with a second-generation DES were very low and significantly better than results from an earlier registry that used a first-generation device, report Carlos Haiek, MD (Sanatorio de la Trinidad Quilmes, Buenos Aires, Argentina), and colleagues.
“Prior randomized trials of PCI versus CABG for multivessel disease and left main disease all used first-generation DES. The outcomes with second-generation DES have markedly improved in terms of both safety and efficacy,” Gregg Stone, MD (Columbia University Medical Center, New York, NY), commented. “The ERACI IV observational study suggests that this may make PCI much more competitive with surgery for patients with the most complex CAD.”
In the new study, which was published online March 7, 2016, ahead of print in Catheterization and Cardiovascular Interventions, 225 patients enrolled in the ERACI IV registry were treated with the second-generation, sirolimus-eluting Firebird 2 stent (MicroPort; Shanghai, China) at 15 sites in Argentina. A conservative PCI strategy—in which only lesions with at least 70% stenosis in vessels with a diameter of at least 2 mm were treated—was used. The goal was to achieve complete functional revascularization.
Those patients were compared with an equal number of patients from the ERACI III registry who were treated with first-generation DES.
In both registries, complete anatomic revascularization was achieved in about half of patients and complete functional revascularization was accomplished in more than 80%.
The primary endpoint of MACCE (all-cause death, MI, cerebrovascular accident, and unplanned revascularization) occurred at a lower rate with second- versus first-generation DES at 2 years (6.7% vs 16.9%; P = 0.001). PCI with second-generation DES also resulted in lower rates of death/MI/cerebrovascular accident, unplanned revascularization, and stent thrombosis. Results were similar in diabetic and nondiabetic patients.
After multivariate adjustment, use of first-generation DES was independently associated with a higher risk of MACCE (RR 2.46; 95% CI 1.25-4.75).
The researchers further accounted for differences between patient groups with propensity matching. In that analysis, outcomes remained better with second-generation DES.
The low event rates seen with second-generation DES are consistent with those of other studies comparing newer and older devices, the authors note. “The second- and third-generation DES showed significant improvement in stent design, polymer characteristics, drug release, and stent struts coverage, and all of these new features significantly enhanced the safety/efficacy compared to previous ones,” they say.
They also point out that prior trials comparing first-generation DES with CABG used an aggressive PCI strategy to achieve more complete revascularization.
“Therefore, the potential flaw of these studies would be both stent design used and the PCI strategy selected,” they write.
In ERACI IV, a more conservative approach was used. “The 6.7% MACCE rate reported here at 2 years suggested that we don’t have any penalty with this PCI strategy for each of the primary endpoints, including repeat revascularization procedures either in the treated or nontreated vessels and that included those patients with intermediate nonstented lesions,” the authors write. “However, whether this more conservative strategy will result in lower 5-year MACCE rates is presently unknown.”
According to Stone, the previous trials “are essentially obsolete. Fortunately, we have two new trials of second-generation DES vs CABG for patients with left main with or without multivessel disease that will report later this year, EXCEL and NOBLE.”
- Haiek C, Fernández-Pereira C, Santaera O, et al. Second vs. first generation drug eluting stents in multiple vessel disease and left main stenosis: two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry. Catheter Cardiovasc Interv. 2016;Epub ahead of print.
- Haiek and Stone report no relevant conflicts of interest.