AT TCT 2017

DENVER (FRONTLINE MEDICAL NEWS) – Percutaneous coronary intervention using a contemporary drug-eluting stent on a shortened regimen of dual antiplatelet therapy proved significantly more effective and equally safe as a bare metal stent in elderly patients in the randomized, multicenter SENIOR trial.

“I think BMS [bare metal stents] should no longer be used as a strategy to reduce DAPT [dual antiplatelet therapy] duration in the elderly,” Olivier Varenne, MD, concluded in presenting the SENIOR findings at the Transcatheter Cardiovascular Therapeutics annual educational meeting.

A panel of discussants felt that declaration didn’t go far enough.

“This trial adds to what I think is now a very large body of evidence showing that DES [drug-eluting stents] are the way to go, pretty much across the board, putting aside the economic factors that might come into play in certain regions of the world,” Deepak L. Bhatt, MD, commented at the meeting sponsored by the Cardiovascular Research Foundation.

“I think in general there’s really no good reason to use a BMS. I’d use a DES. I think DES is a winning strategy, whether it’s for a thrombotic lesion or an older patient,” added Dr. Bhatt, professor of medicine at Harvard Medical School in Boston and executive director of international cardiovascular programs at Brigham and Women’s Hospital.

Martin B. Leon, MD, concurred.

“I cannot think of any indication for using a BMS anymore, other than cost considerations. I think this study is yet another nail in the coffin of BMS. I think they should be relegated to the past because they really have very little role in environments where DES – which are becoming much more cost-efficient – can be used,” said Dr. Leon, professor of medicine at Columbia University and director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center, New York. Yet in contemporary practice many cardiologists turn to BMS for percutaneous coronary intervention (PCI) in elderly patients with coronary artery disease (CAD), reasoning that the shorter DAPT duration recommended for BMS in the practice guidelines is attractive as a means of minimizing the risk of bleeding complications, which is typically high in the elderly.

The SENIOR trial demonstrates that using a modern DES in combination with the shortened 1- or 6-month DAPT duration typically reserved for BMS recipients results in fewer major adverse cardiac and cerebrovascular events with no increase in bleeding, compared with BMS. This is a finding of high clinical relevance because so many elderly patients undergo PCI; indeed, today one in four PCI patients in the United States is over age 75, explained Dr. Varenne of Cochin Hospital in Paris.

SENIOR was a single-blind, randomized trial of 1,200 PCI patients age 75 and older at 44 centers in nine countries. Their mean age was 81.4 years. This was essentially an all-comers trial: 45% of participants had an acute coronary syndrome, 55% had stable or silent CAD. If they had stable CAD, they were slated for 1 month of DAPT. If they had ACS, they got 6 months of DAPT. All participants were then randomized to PCI with either the thin-strut everolimus-eluting bioabsorbable polymer Synergy DES or the thin-strut Omega or Rebel BMS.

The primary composite efficacy endpoint was the 1-year rate of all-cause mortality, acute MI, stroke, or ischemia-driven target lesion revascularization. The rate was 11.6% in the DES group and 16.4% in the BMS group, for a 29% reduction in favor of the DES strategy and a favorably low number-needed-to-treat of 21. The difference in outcome was driven mainly by a higher ischemia-driven target lesion revascularization rate in the BMS group.

The 1-year rate of bleeding complications was 5% in each group. Probable or definite stent thrombosis occurred in 0.5% of the DES group and 1.4% of the BMS group at 1 year. Ten of the 11 cases of stent thrombosis in the study occurred during the first 30 days after PCI while the patients were on DAPT; the other case occurred on day 31, the day after DAPT was stopped.

Discussant Eric D. Peterson, MD, applauded Dr. Varenne and his coinvestigators for conducting a study focused on elderly individuals, an understudied population largely excluded from the landmark clinical trials in interventional cardiology.

He found the study convincing: “My takeaway is DES is better than BMS. As it is in young people, it continues in old.”

But the study leaves two important questions unanswered: Is the Synergy stent the best DES in the elderly, and what is the best duration of DAPT therapy? Ideally, the SENIOR trial would have included a study arm with the standard 6- and 12-month DAPT durations recommended in the American guidelines for DES recipients with stable and unstable CAD, respectively, observed Dr. Peterson, professor of medicine at Duke University in Durham, N.C., and director of the Duke Clinical Research Institute.

Dr. Varenne replied that SENIOR wasn’t designed as a DAPT duration trial. DAPT duration wasn’t randomized. But other planned and ongoing studies are attempting to define the best DAPT durations in various patient subsets.

Dr. Bhatt said he believes the superiority of contemporary DES over modern BMS is a class effect.

The SENIOR trial was funded by Boston Scientific. Dr. Varenne reported receiving lecture fees from that company as well as Abbott Vascular, AstraZeneca, and Servier within the past year.

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