More randomized trials needed for confirmation
The need for a shorter period of dual antiplatelet therapy (DAPT) is no reason for bare metal stents (BMS) to be preferred over drug-eluting stents (DES) given the technological advances of the latter, a meta-analysis suggested.
Pooling three randomized trials in which patients were on a single month of DAPT after stenting because of a high bleeding risk (n=3,943), investigators found that DES outperformed BMS in 1-year outcomes:
- Major adverse cardiac events: OR 0.68, 95% CI 0.57-0.82
- Target lesion revascularization: OR 0.38, 95% CI 0.22-0.67
- Target vessel revascularization: OR 0.50, 95% CI 0.38-0.65
- MI: OR 0.51, 95% CI 0.31-0.83
DES were not only safe but worked better than BMS with a single month of DAPT, concluded the research team led by Rahman Shah, MD, of the University of Tennessee in Memphis, reporting online in JAMA Cardiology.
"These results suggest that guidelines recommendations regarding the routine use of BMS for patients with high bleeding risk or those who are uncertain candidates for DAPT (with the sole goal of shortening DAPT duration) are no longer warranted with the availability of current-generation DES, particularly those optimized for biocompatibility," they wrote.
Commenting on the study in an editor's note, Ajay Kirtane, MD, SM, of New York-Presbyterian Hospital/Columbia University Irving Medical Center in New York City, said: "There is no doubt that the current generation of DES devices are more efficacious and safer than predecessor devices, having been optimized for biocompatibility with thinner and thinner struts to reduce turbulent flow and specially designed polymers that serve to regulate the delivery of antirestenotic drug therapy."
Yet it's still debatable whether these developments have pushed out the BMS in today's practice, Kirtane maintained. Some very rare clinical scenarios -- active severe bleeding, need for expedited surgical procedures, or a clear inability of a patient to take medications for a month, say -- may require DAPT durations of even less than 1 month.
"Whether percutaneous coronary intervention is indicated at all in these scenarios is always a legitimate question, but for the very short term (until newer DES data and/or device approvals emerge), I personally would grant a respite to the extremely rare case of BMS implantation that might occur in these extreme scenarios," he said.
More prospective, randomized data are needed to clearly establish the safety of shorter DAPT
with current-generation DES, Kirtane emphasized.
The meta-analysis included the LEADERS FREE, ZEUS, and SENIOR trials, which compared BMS to the BioFreedom, Endeavor Sprint, and Synergy devices, respectively. Participants tended to be older patients (average age in the trials ranging 75.7 to 81.4 years) given their high bleeding risk.
Stent thrombosis rates at 1 year trended numerically lower with DES (1.8% versus 2.8%, P=0.13). There were no differences between groups in their risk of all-cause mortality, cardiac mortality, or bleeding, Shah's group noted.
The investigators cautioned that they lacked patient-level data for their meta-analysis and relied on subgroups from the trials included. Varying inclusion criteria and definitions employed among the studies were other caveats to the current analysis.
Notably, the BioFreedom and Endeavor DES are also not available in the U.S., Kirtane added.
"Further, the myths of BMS being more suitable for patients with larger vessels and shorter lesions has been objectively dispelled by multiple studies," he said.
Shah disclosed no conflicts of interest.
One study co-author reported grants and personal fees from Medtronic.
Kereiakes has received personal fees for consulting for Abbott Vascular, Boston Scientific, Caliber Therapeutics/Orchestra BioMed, Micell Technologies, Sino Medical Sciences Technologies, and Svelte Medical Systems, and is a major stock shareholder of Ablative Solutions.
Kirtane declared having received institutional grants from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical.
Source Reference: Shah R, et al “Efficacy and safety of drug-eluting stents optimized for biocompatibility vs bare-metal stents with a single month of dual antiplatelet therapy: A meta-analysis” JAMA Cardiol 2018; DOI: 10.1001/jamacardio.2018.3551.
Source Reference: Kereiakes DJ “The myths of the bare-metal stent” JAMA Cardiol 2018; DOI: 10.1001/jamacardio.2018.3573.
Source Reference: Kirtane AJ “Is there any current role for bare-metal coronary stents?” JAMA Cardiol 2018; DOI: 10.1001/jamacardio.2018.3660.
Read the original article on Medpage Today: Meta-Analysis: BMS Lags in Safety, Efficacy Even With Short DAPT