Implantation of a second-generation drug-eluting stent (DES) can be safe for high bleeding risk individuals when coupled with a month-long regimen of dual antiplatelet therapy (DAPT), a ZEUS substudy found.
Among patients with high bleeding risk, the composite risk of death, myocardial infarction, or target vessel revascularization at 1 year post-stenting was lower in those implanted with a zotarolimus-eluting device than their bare metal stent (BMS) counterparts (22.6% versus 29.0%, hazard ratio 0.75, 95% confidence interval 0.57-0.98), reported Marco Valgimigli, MD, PhD, of Bern University Hospital in Switzerland, and colleagues.
Myocardial infarction was especially lower in the DES cohort (3.5% versus 10.4%, HR 0.33, 95% CI 0.18-0.60), as were target vessel revascularization (5.9% versus 11.4%, HR 0.50, 95% CI 0.30-0.81) and stent thrombosis (2.6% versus 6.2%, HR 0.42, 95% CI 0.21-0.85).
In these patients, the zotarolimus-eluting stent “as compared with conventional BMS followed by 3o-day DAPT regimen provides superior efficacy and safety,” the authors reported online in JACC: Cardiovascular Interventions.
Valgimigli’s study knocked out one of the last few supports left for BMS use by challenging their clinical utility in high bleeding risk patients, David E. Kandzari, MD, of Piedmont Heart Institute in Atlanta, wrote in an accompanying editorial.
“Providing clarity to one of the last remaining clinical settings in which BMS are still commonly used yet unstudied, these data add to an emerging evidence base that challenges existing standards and brands the utility of BMS more a misperception than a reality,” according to Kandzari.
ZEUS was a randomized trial comparing BMS or the Endeavor Sprint zotarolimus-eluting stent in some 1,600 patients considered uncertain for DES. The substudy examined 828 of the participants with high bleeding risk .
By 1 year, neither DES nor BMS patients had an advantage in major or minor bleeding events (2.4% versus 3.2%, P=0.46). Both groups also shared similar rates of all-cause death (15.8% versus 17.3%, P=0.60).
BMS patients received longer DAPT than the DES recipients (median 31 months versus 30 months, P=0.009).
“By design, our study does not address the topic of optimal DAPT duration after stenting,” Valgimigli and colleagues acknowledged, adding, however, that their findings nonetheless “challenge the current wisdom that BMS is per se a safer coronary device as compared with DES under a similarly short DAPT duration.”
“It remains to be seen whether other permanent or bioresorbable polymer-based DES could be safely employed after a 30-day DAPT regimen,” the authors added.
Kandzari agreed with Valgimigli’s group.
“Because the zotarolimus-eluting Endeavor Sprint stent demonstrates more rapid drug dissolution and greater in-stent neointimal hyperplasia (and therefore considered to more closely resemble a BMS phenotype rather than iterative-generation DES), whether similar safety and greater efficacy in like patients translate to other commercially available DES is speculative,” he wrote, pointing to the ongoing GLOBAL LEADERS as one such trial seeking to answer that question in the setting of newer-generation stents.
Nonetheless, “that uncertainty regarding stent selection and DAPT duration might still persist now despite numerous randomized trials is not surprising, especially as most studies have not explored what might be considered the ‘minimum acceptable’ antiplatelet therapy regimen in selected patients,” Kandzari wrote in the editorial. “Even societal guidelines advocate conflicting DAPT durations and are vague regarding the definition of bleeding risk.”
“In many ways, these apparent inconsistencies underscore the unspoken reality that an ‘optimal’ DAPT duration does not exist for all patients, making uniform recommendations impractical,” he continued.
“Recognizing that societal guidelines do not provide treatment options for this unique but commonly encountered patient population and are based more on opinion and inferential evidence, the ZEUS study instead informs treatment decisions for patients common to clinical practice yet underrepresented by evidence-based medicine,” Kandzari concluded.
The ZEUS study was supported in part by Medtronic.
Valgimigli reported no relevant conflicts of interest.
Kandzari disclosed receiving research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Medinol, and Medtronic; as well as consulting for Boston Scientific and Medtronic.
JACC: Cardiovascular Interventions
Ariotti S, et al “Is bare-metal stent implantation still justifiable in high bleeding risk patients undergoing percutaneous coronary intervention? A pre-specified analysis from the ZEUS trial” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2015.11.015.
JACC: Cardiovascular Interventions
Kandzari DE “Can’t bare it any longer” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2015.12.277.