CCI: DES best BMS for CTO revascularization
A systematic review of the medical evidence has determined that drug-eluting stents (DES) outperform bare-metal stents (BMS) for revascularization of chronic total occlusions (CTOs). The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs, according to a study in the February issue of Catheterization and Cardiovascular Interventions.
CTOs routinely represent the most challenging type of coronary lesion in interventional cardiology. Despite specialized guidewires and advanced techniques, high rates of restenosis and re-occlusion remain a challenge.
"Although BMS reduce restenosis rates compared with balloon angioplasty alone, the incidence of both clinical restenosis and re-occlusion remain unacceptably high compared with treatment of nonocclusive lesions, likely in part related to the extensive lesion length and complex lesion morphology associated with CTOs," the researchers wrote.
However, while "DES may significantly reduce the risk for in-stent restenosis and the incidence of repeat revascularization following CTO recanalization, only one prospective, randomized-controlled trial has directly compared DES with BMS in this setting."
To determine the performance of DES implantation in CTOs, Bilal Saeed, MD, from the University of Toledo, Ohio, and colleagues performed a systematic review of medical literature. They found 17 published studies that reported outcomes for sirolimus- or paclitaxel-eluting stents (Cypher, Cordis; and Taxus, Boston Scientific, respectively) and BMS implantation for coronary occlusions.
The review of the literature demonstrated three findings:
"Our findings confirm that treatment of total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis, compared with BMS," said senior author Emmanouil S. Brilakis, MD, PhD, of VA North Texas Healthcare System and the University of Texas Southwestern Medical Center in Dallas.
Analysis of angiographic outcomes in the studies revealed less restenosis with DES implantation compared to BMS (odds ratio 0.15). At six to 12 months, target lesion and vessel revascularization were also consistently lower among DES-treated patients (odds ratio 0.13 and 0.18, respectively).
In addition, in a 19-month follow-up period, the cumulative incidence of mortality, heart attack or stent thrombosis was similar between DES and BMS in all studies.
"A benefit from using DES in CTOs is anticipated, as CTOs are frequently long lesions in diffusely-diseased vessels, requiring implantation of multiple stents, with high restenosis rates if BMS are used. Yet, the consistency of the direction and magnitude of the angiographic and clinical benefit is remarkable across the published studies," researchers concluded.
They called for prospective trials that could offer additional information on the role of DES in CTO, and could determine if second-generation DES might provide even more favorable outcomes.
Currently, four such studies are underway:
CTOs routinely represent the most challenging type of coronary lesion in interventional cardiology. Despite specialized guidewires and advanced techniques, high rates of restenosis and re-occlusion remain a challenge.
"Although BMS reduce restenosis rates compared with balloon angioplasty alone, the incidence of both clinical restenosis and re-occlusion remain unacceptably high compared with treatment of nonocclusive lesions, likely in part related to the extensive lesion length and complex lesion morphology associated with CTOs," the researchers wrote.
However, while "DES may significantly reduce the risk for in-stent restenosis and the incidence of repeat revascularization following CTO recanalization, only one prospective, randomized-controlled trial has directly compared DES with BMS in this setting."
To determine the performance of DES implantation in CTOs, Bilal Saeed, MD, from the University of Toledo, Ohio, and colleagues performed a systematic review of medical literature. They found 17 published studies that reported outcomes for sirolimus- or paclitaxel-eluting stents (Cypher, Cordis; and Taxus, Boston Scientific, respectively) and BMS implantation for coronary occlusions.
The review of the literature demonstrated three findings:
- DES consistently reduced angiographic restenosis;
- DES reduced target lesion and target vessel revascularization; and
- DES appear to be safe with similar rates of death, MI and stent thrombosis.
"Our findings confirm that treatment of total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis, compared with BMS," said senior author Emmanouil S. Brilakis, MD, PhD, of VA North Texas Healthcare System and the University of Texas Southwestern Medical Center in Dallas.
Analysis of angiographic outcomes in the studies revealed less restenosis with DES implantation compared to BMS (odds ratio 0.15). At six to 12 months, target lesion and vessel revascularization were also consistently lower among DES-treated patients (odds ratio 0.13 and 0.18, respectively).
In addition, in a 19-month follow-up period, the cumulative incidence of mortality, heart attack or stent thrombosis was similar between DES and BMS in all studies.
"A benefit from using DES in CTOs is anticipated, as CTOs are frequently long lesions in diffusely-diseased vessels, requiring implantation of multiple stents, with high restenosis rates if BMS are used. Yet, the consistency of the direction and magnitude of the angiographic and clinical benefit is remarkable across the published studies," researchers concluded.
They called for prospective trials that could offer additional information on the role of DES in CTO, and could determine if second-generation DES might provide even more favorable outcomes.
Currently, four such studies are underway:
- The "Prospective, Randomized Comparison of Sirolimus-Eluting Stent Versus bare metal Stent in Chronic Total Coronary Occlusions: The Gruppo Italiano di Studio Sullo Stent Nelle Occlusioni Coronariche: The GISSOC II Study," which will randomized 150 patients to a DES or a BMS in 22 centers in Italy.
- The "Non-Acute Coronary occlusion Treated By Everolimus-Eluting Stent" non-inferiority trial comparing the everolimus-eluting stent (Xience V, Abbott Vascular) with the sirolimus-eluting stent in Spain. The study plans to enroll 208 patients.
- The third is the ongoing "Randomized Comparison of Sirolimus-Eluting Stent Implantation with Zotarolimus-Eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions: The PRISON III Trial" at two centers in the Netherlands, which is randomizing 300 patients to either a sirolimus-eluting stent or zotarolimus-eluting stent (Endeavor, Medtronic) arm.
- Finally, the "AngiographiC evaluation of the Everolimus-eluting stent in Chronic Total Occlusions" study, that is assessing 100 patients receiving an everolimus-eluting stent at VA North Texas healthcare System.