PARIS — Patients with acute coronary syndrome (ACS) and high bleeding risk do better with a drug-coated stent than a bare metal stent (BMS), a LEADERS FREE substudy found.
Recipients of the BioFreedom biolimus-coated stent had greatly reduced rates of clinically-driven target lesion revascularization at 1 year when compared with those getting the Gazelle BMS (3.9% versus 9.0%, HR 0.41, 95% CI 0.21-0.82). In both groups, DAPT was limited to 1 month because of the high bleeding risk.
Major adverse cardiovascular events — a composite of cardiac death, myocardial infarction, stent thrombosis — were also less frequent in this group (9.3% versus 18.5%, HR 0.48, 95% CI 0.31-0.75).
The difference in adverse events was mainly driven by cardiac death (P=0.048) and myocardial infarction (P=0.005), Christoph K. Naber, MD, PhD, of University Hospital Essen, Germany, told the audience here at the EuroPCR meeting.
“I believe that current guidelines should be reconsidered for high bleeding risk patients presenting with an ACS,” he said, citing the current European recommendations for this population (drug-eluting stent [DES] implantation with 3 to 6 months dual antiplatelet therapy [DAPT] or BMS with 1-month DAPT).
“BMS can no longer be recommended in these patients,” Naber concluded. His report was simultaneously published online in the European Heart Journal.
Donald E. Cutlip, MD, of Beth Israel Deaconess Medical Center in Boston, expressed agreement, telling MedPage Today that the LEADERS FREE substudy raises “serious questions regarding any role for BMS, even among patients at high bleeding risk who can be subjected to very limited duration of DAPT.”
Cutlip continued: “I think the major message is that BMS performs poorly and that selection of a BMS based on concerns regarding DAPT duration may not be warranted.”
“In the past we were advised to implant a BMS and go for a short DAPT duration such as 1 month,” said Marco Valgimigli, MD, PhD, of Switzerland’s Bern University Hospital. The LEADERS FREE series, “together with the ZEUS trial, are clearly showing that BMS is no longer a viable option and at least some second-generation drug eluting stents (DES) should be used instead,” he told MedPage Today.
Indeed, when Thomas Cuisset, MD, PhD, of CHU Timone, France, shared his take on Naber’s investigation, he told attendees that what remains unknown is how the drug-coated stent compares with newer-generation DES. “In 2016, BMS are no longer the ‘gold standard’ in high-bleeding-risk patients,” he said.
Naber’s analysis included the 662 ACS patients out of the 2,466 higher-risk patients overall in the trial who were randomized to get PCI with the biolimus-coated BioFreedom stent or Gazelle BMS.
Cuisset noted that just because drug-coated stents may be a good option for patients with mandatory short DAPT “does not mean” that short DAPT is safe for all patients getting the BioFreedom.
Likewise, “the study compared two different stents, not two different drug regimens, and so does not add much to current practice or provide much impetus to change guidelines about DAPT duration in patients with high bleeding risk,” commented John A. Bittl, MD, of Munroe Regional Medical Center in Ocala, Fla.
Bittl told MedPage Today: “It should be noted that the [BMS] was made of stainless steel and had a strut thickness of 112 microns. Many experts would like to know whether event rates could have been lower if a platinum-chromium BMS with a strut thickness of 81 microns had been in used in place of the Gazelle stent.”
And as the BioFreedom stent was polymer-free, “many experts would like to know whether a stent lined with a thromboresistant fluoropolymer with rapid drug delivery could have performed just as well,” he continued.
Nonetheless, Valgimigli told MedPage Today that the present study “provides reassuring data on the most challenging patient population.”
Because “whether in these patients ideal DAPT is really 1 month or longer remain unknown,” Valgimigli pointed to his group’s MASTER DAPT investigation — still in its early stages — as a potential source of answers.
Naber disclosed holding shares in CERC.
Cuisset reported consulting for AstraZeneca, Daiichi Sankyo, Eli Lilly; and receiving lecture fees from Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific, Cordis, Daiichi Sankyo, Edwards Lifesciences, Eli Lilly, Hexacath, Iroko Cardio, Medtronic, Servier, and Terumo.
Bates reported no relevant conflicts of interest.
Valgimigli declared serving as principal investigator of the MASTER DAPT study supported by Terumo.
Cutlip reported institutional funding from Medtronic and Boston Scientific, as well as serving as co-principal investigator for the Celonova Cobra polyzene F nanocoated coronary stent clinical trial.
Naber CK, et al “Biolimus A9 drug-coated stent vs. bare metal-stent in patients presenting with ACS - a prespecified LEADERS FREE ACS substudy” EuroPCR 2016.