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SENIOR: PCI with DES, short DAPT confers improved outcomes in older patients
Older patients who underwent PCI with a bioabsorbable polymer drug-eluting stent and a short duration of dual antiplatelet therapy had fewer instances of MI, all-cause mortality, ischemia-driven target lesion revascularization and stroke compared with those with a bare-metal stent, according to data presented at TCT 2017.
“The SENIOR trial gives you the opportunity in these patients to reduce the duration of DAPT while you’re still offering a benefit of a lower revascularization rate with the latest-generation drug-eluting stent,” Olivier Varenne, MD, PhD, of Hôpital Cochin in Paris and the cardiology department at Université Paris Descartes, said during a press conference.
Researchers analyzed data from 1,200 patients aged at least 75 years with CAD and either stable angina, silent ischemia or ACS.
“The elderly patients are an important portion of the population both in the U.S. and Western countries,” Varenne said. “They have severe cardiovascular disease and, especially, coronary artery disease.”
Patients were on DAPT for 1 month if they were stable (57%) or 6 months if they were unstable (43%), then assigned to a DES (Synergy, Boston Scientific; n = 596; mean age, 81 years; 62% men) or BMS (Omega or Rebel, Boston Scientific; n = 604; mean age, 81 years; 63% men). Follow-up was conducted for 1 year for MACCE.
The primary endpoint was all-cause mortality, stroke, MI and ischemia-driven TLR.
The transradial approach was used in 79.8% of patients in the DES group and 81.3% of the BMS group. The lesion location was well-balanced except for the left main, which was more frequent in patients assigned a DES (3.9%) vs. a BMS (1.3%).
DAPT duration was similar in both groups (P = .77). MACCE occurred in 16.4% of patients in the BMS group and 11.6% in the DES group (P = .016) with a 29% reduction. The number needed to treat for the primary endpoint was 21.
Ischemia-driven TLR was seen more in patients assigned BMS (5.9%) compared with those assigned DES (1.7%; P = .0002). Rates were similar for mortality, stroke and MI between the two groups, and there was no difference for bleeding. Stent thrombosis occurred in 1.4% of patients in the BMS group and 0.5% in the DES group (P = .13), which was “not significant even if the DAPT was short,” Varenne said during the press conference.
“I strongly believe that BMS should no longer be used, at least as a strategy to reduce DAPT duration in elderly patients,” Varenne said.
“If SENIOR had prospectively included a frailty index in these patients, more information would have been provided than was provided,” Robert T. Gerber, PhD, MBBS, and Anthony H. Gershlick, MD, both of Conquest Hospital in East Sussex, United Kingdom, wrote in a related editorial. “The chronological-biological age mismatch is something that clinicians use on a daily basis, and so the question that they ask is what should they do with elderly (> 85 years of age) female patients with diabetes who present with acute coronary syndrome and have atrial fibrillation? SENIOR has helped to somewhat answer this question, but as many unknowns exist as knows.” – by Darlene Dobkowski
References:
Gerber RT, et al. Lancet. 2017;doi:10.1016/S0140-6736(17)32803-9.
Varenne O, et al. Lancet. 2017;doi:10.1016/S0140-6736(17)32713-7.
Varenne O, et al. Late-Breaking Clinical Trials 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.
Disclosure: The study was funded by Boston Scientific. Varenne reports he receives lecture fees from Abbott Vascular, AstraZeneca, Boston Scientific and Servier.
Perspective
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The utility of BMS continues to wane, and the SENIOR trial may have served as the proverbial nail in the coffin. After assigning 1,200 patients over the age of 75 to 1 month or 6 months of DAPT, patients were randomly assigned to DES (n = 596) or BMS (n = 604). The primary endpoint was a composite of all-cause mortality, target lesion revascularization, stroke, or MI. Perhaps equally important were the secondary endpoints of bleeding and stent thrombosis at one year.
The primary composite endpoint was significantly lower in the DES group (11.6% vs. 16.4%; P = .016), driven mostly by increased rate of TLR (1.7% vs 5.9%; P = .0002), while bleeding complications and stent thrombosis were low and similar in both groups.
The above results demonstrate that in elderly patients undergoing PCI with a short duration of DAPT, DES yield lower adverse events at 1 year without risk for stent thrombosis. For many of us who implant stents, it is nice to know that we do not have to sacrifice potential long-term benefits of DES compared to BMS in patients at high-risk for bleeding and that we can safely stop DAPT if needed.
Perspective
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The SENIOR study demonstrates that there is no difference between a contemporary DES and a BMS in terms of stent thrombosis, but a significant difference in restenosis rates. Unique to this trial was the equal and early discontinuation of DAPT regardless of the stent implanted, meaning planned discontinuation of DAPT at 1 month or 6 months for patients with stable angina or ACS, respectively.
The previously axiomatic concept that DES implantation mandates longer periods of DAPT than BMS to prevent late stent thrombosis is no longer applicable to contemporary DES. The modern second- or third-generation DES is much more biocompatible than the first-generation DES. We have multiple studies that have shown no excess in stent thrombosis with contemporary DES, with stent thrombosis rates below 0.5%. A large network meta-analysis for the cobalt chromium everolimus-eluting stent showed that it had a reduced rate of stent thrombosis compared with BMS.
The fear of late stent thrombosis that drove extended periods of DAPT is no longer justifiable. Many recent trials, including the OPTIMIZE trial, have suggested that the shorter-duration DAPT is safe and effective in reducing stent thrombosis. Extended DAPT has a role in secondary prevention, as the DAPT trial has shown, but this should remain optional rather than mandatory.
All of the modern DES have the similar qualities of being more biocompatible with a low risk for stent thrombosis. There’s no evidence that using a BMS is any safer than a contemporary DES, while it is clear that BMS is inferior to DES in terms of restenosis. Now this is one study and the incidence of stent thrombosis is so low as to make these studies always underpowered, so you can take some caution in that. However, the stent thrombosis rates are low enough across multiple trials that an adequately powered trial would be neither feasible nor necessary.
This overall suggests that the role of BMS is very small and that the rate of BMS use, which is already less than 10% in many centers, is probably going to decline even further. I use BMS in less than 3% of cases at this point. Even for someone on anticoagulation or who is planning on having surgery after 1 month, DES with a short duration of DAPT would likely still be preferable over BMS.
This study answers the clinical question that continues to bother my referring physicians and fellows. They continue to instruct me: “Please don’t put in a DES” in patients who are on anticoagulants, who might need nonurgent knee surgery or who are at higher risk for bleeding. Data like those from SENIOR need to be disseminated widely to show that contemporary DES are not the same DES that we used 10 years ago, and that they now probably confer lower risk for stent thrombosis than BMS. For years, we did a good job training people that DAPT was necessary long term after DES to prevent a dire complication. Now we need to reeducate them that not only can DAPT durations be shortened, but that BMS is no longer any safer than DES.