DENVER, CO — A head-to-head comparison of PCI with a drug-eluting stent (DES) or a bare-metal stent as a strategy to reduce dual antiplatelet therapy (DAPT) in patients 75 and older “puts another nail into the coffin of bare-metal stents,” some interventional cardiologists say[1].
In the SENIOR trial, including 1200 patients 75 and older with coronary artery disease, the composite end point of major adverse cardiovascular and cerebrovascular events (MACCE) during the first year of follow-up occurred in 16.4% of patients assigned to receive a contemporary thin-strut bare-metal stent (Omega or Rebel, Boston Scientific) compared with 11.6% of those assigned to receive an everolimus-eluting polymer DES (Synergy, Boston Scientific).
“PCI with a contemporary bioabsorbable-polymer DES is more effective and as safe as bare-metal stent in elderly patients with CAD on a short DAPT [course] tailored to their clinical presentation,” lead author Dr Olivier Varenne (Hôpital Cochin, Assistance Publique—Hôpitaux de Paris, and Université Paris Descartes, Sorbonne Paris-Cité, Paris, France) said at TCT 2017.
In 2016, 25% of PCI procedures performed in the US were in patients 75 and older, a population that has both a high proportion of moderate to severe cardiovascular disease and a high risk for bleeding complications on DAPT compared with younger patients.
Although second- and third-generation DES are associated with lower revascularization rates and lower incidence of stent thrombosis compared with bare-metal stents, many centers still favor bare-metal stents for elderly patients, because the bare-metal devices require a shorter course of DAPT than drug-eluting stents.
SENIOR Details
In the SENIOR trial, results of which are published online in the Lancet, investigators examined whether use of a bioabsorbable-polymer DES and a short course of DAPT in elderly patients would be associated with a lower rate of MACCE at 1 year than bare-metal stents, with similar risks of bleeding and stent thrombosis.
They recruited 1200 patients aged 75 years and older with CAD and, prior to randomization, assigned them to either a 1-month course of DAPT (57%) or a 6-month course, based on each patient’s clinical presentation.
The patients were then randomized to PCI with either the DES (596 patients) or the bare-metal stent (604). Twelve patients in each study arm withdrew or were lost to follow-up, leaving 1176 for the 1-year efficacy and safety analyses.
Slightly more than half of all patients in each trial arm had stable CAD, either stable angina or silent ischemia. Approximately 25% in each arm had non-ST-elevation MI, 10% had STEMI, and about 9% had unstable angina. The mean patient age was 81.4 years in each arm, 62% of patients in each arm were male, 26% had diabetes, and about 52% had hypercholesterolemia.
Angiography was performed with a transradial approach in approximately 80% of all cases in each cohort. About one-third of all patients had multiple vessel disease. The mean number of stents implanted was similar between the groups, 1.7 in the DES arm, 1.6 in the bare-metal-stent arm.
The duration of DAPT was virtually identical in each arm, with a drop around 1 month as patients with stable disease stopped taking their assigned antiplatelet agents, and a further decline at 6 months as acute coronary syndrome (ACS) patients stopped taking antiplatelet agents. Slightly more than 15% of patients in each trial arm remained on DAPT past 6 months.
The primary end point of all-cause mortality, MI, stroke, and ischemia-driven target lesion revascularization (TLR) significantly favored the DES group (11.6% vs. 16.4%, P=0.02).
The DES advantage for MACCE was accounted for largely by ischemia-driven TLR, which occurred in 1.7% of patients with the DES vs 5.9% of those on the bare-metal device (P=0.0002). There were no significant differences in either all-cause mortality, stroke, or MI.
There were also no significant differences between the trial arms in either Bleeding Academic Research Consortium (BARC) scores of 2 to 3 or 3 to 5 or in definite or probable stent thrombosis. The latter event occurred in 0.5% of patients with the DES and 1.4% with the bare-metal stent, but as noted, this difference was not significant.
In a subgroup analysis of the primary end point, the DES was better or trended better in categories of age, ACS, and sex, but among patients with atrial fibrillation, there was a nonsignificant trend favoring the bare-metal stent, Varenne noted.
Grim Metaphor
The results both confirm the superiority of DES and support the strategy of shorter duration DAPT in appropriate patients, commented Dr Martin Leon (Columbia University Medical Center, New York City), an invited discussant.
“I cannot think of any indication for using a bare-metal stent anymore, other than cost considerations,” Leon said. “I think this is yet another nail in the coffin of bare-metal stents, and I think they should be relegated to the past, because they have very little role in an environment where drug-eluting stents, which are becoming much more cost efficient, can be used.”
Leon’s remarks were echoed, almost verbatim, by Dr Dean S Kereiakes (Christ Hospital Heart & Vascular Center, Cincinnati, OH), who comoderated a briefing where Varenne presented SENIOR data prior in a late-breaking abstract session.
“I think this is one more nail in the coffin of bare-metal stents,” he said. “We now have at least four clear-cut randomized trials where bare-metal stents are less safe and less effective.”
Dr Gary S Mintz (Cardiovascular Research Foundation, New York City), who also moderated the briefing, said that he wouldn’t say with 100% certainty that he’d never again use a bare-metal stent, “because there’s always an exception.”
“Perhaps if you could do bare-metal stents without any antiplatelet therapy at all, then you might have a different paradigm,” he said.
In the abstract session, comoderator Dr Eric D Peterson (Duke Clinical Research Institute, Durham, North Carolina) applauded Varenne and colleagues for conducting a clinical trial in elderly patients.
“Early on in my career we published papers about how few randomized clinical trials included any elderly patients,” he said.
He added, however, that it’s still uncertain whether the Synergy DES is the right stent or whether another third-generation DES would do better. In addition, the trial was not designed to answer the optimal duration of DAPT.
Peterson and comoderator Dr Robert A Harrington (Stanford University, Stanford, California) also remarked that the trend toward better performance of the bare-metal stent in patients with AF warrants further exploration.
In an editorial[2] accompanying the study in the Lancet, Drs Robert T Gerber and Anthony H Gershlick (Conquest Hospital, Saint Leonards-on-sea, East Sussex, UK), noted that 37% of patients in SENIOR were between the ages of 75 and 79, “a group by modern standards considered not elderly.”
“This factor then poses the question as to whether or not this trial is sufficient in its own right to recommend informal (ie, interventionists alter practice) or formal change in guidelines? We feel it is not, as it is a single trial with only two variables and a small number of patients with a median age of 81 years. However, what it might do is suggest that if an elderly patient at high bleeding risk is having PCI, then a DES might now be considered with the knowledge that a shorter duration of DAPT may not lead to more ischemic events and will probably reduce the risk of bleeding,” they write.
The SENIOR trial was funded by Boston Scientific. Varenne disclosed receiving lecture fees from Boston Scientific, Vascular, AstraZeneca, and Servier. Disclosures for the coauthors are listed in the paper. Gerber reports Medtronic consultancy fees related to DES use and advisory board attendance for Sanofi and AstraZeneca outside the submitted work. Gershlick reports speakers’ fees, advisory board attendance, and sponsorship for travel from Medtronic and Abbott Vascular outside the submitted work. Leon disclosed grant support and consultant fees with the Boston Scientific and others. Kereiakes has previously reported receiving consultant fees or honoraria from or serving on the speakers’ bureau for Harvard Clinical Research Institute, Boston Scientific, Abbott Vascular, Micell Technologies, Sino Medical Sciences Technology, Caliber Therapeutics, and Svelte Medical Systems and having equity in Ablative Solutions. Harrington discloses receiving grants or research contracts from AstraZeneca, the Medicines Company, Portola, St Jude Medical, Sanofi, Novartis, Bristol-Myers Squibb, and Jannsen; consulting or serving on speaker’s bureaus for Amgen, Gilead, Medscape, MyoKardia, the Medicines Company, and Bayer; and having equity interest in MyoKardia, Element Science, and Scanadu. Mintz disclosed research support and fees from Boston Scientific and has previously reported receiving grants from St Jude, grants and personal fees from Boston Scientific and Volcano, and personal fees from Acis. Peterson reported having no relevant financial relationships.
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