Goodbye BMS? New DAPT Analysis Shows Less Stent Thrombosis With DES

Not only do patients treated with DES have fewer stent thromboses than those treated with BMS over almost 3 years, but the safety of the 2 devices is otherwise comparable, according to a propensity-matched analysis of the DAPT Study published in the October 2015 issue of JACC: Cardiovascular Interventions.

This is “a nail in the coffin” for BMS, Dean J. Kereiakes, MD, of the Christ Hospital (Cincinnati, OH), told TCTMD in a telephone interview. “I struggle with the well-rooted ignorance that has been fostered by lack of data, that even very good interventionists still defer to a BMS,” he said, adding that using BMS in the current era has become a “a ‘cover your ass’ move.... The guidelines need to change.”

The primary DAPT results, published in the New England Journal of Medicine in 2014, showed that continuation of dual antiplatelet therapy (DAPT) beyond 1 year is associated with lower risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) but a higher risk of bleeding in almost 10,000 DES-treated patients randomized to short- or long-term therapy. For the overall study, BMS were 3 times more likely to be used in STEMI patients (36.1% vs 10.5%).

For the subanalysis, Dr. Kereiakes and colleagues propensity-matched (8:1) 10,206 DES- (n = 8,308) and BMS-treated patients (n = 1,718) from the overall DAPT cohort—including some not randomized in the original trial. There was no more than a 10% difference for all baseline clinical- and lesion-related variables after the matching between the groups, with STEMI patients making up 27.6% of both groups.

Patients treated with BMS had a higher rated of definite/probable stent thrombosis within 33 months of stent implantation than those who received DES. Additionally, DES met noninferiority criteria for MACCE (death, MI, or stroke) compared with BMS at 33 months (P < .001 for noninferiority), with no differences seen between any of the individual components (table 1).

The biggest risk differences for both stent thrombosis (P = .002) and MACCE (P = .01) were seen between BMS and DES within the first year after treatment.

Additionally, there were no disparities between any of the individual 4 DES types used compared with BMS for MACCE, but the risk difference for stent thrombosis was not evident between the Taxus paclitaxel-eluting stent (Boston Scientific) and BMS.

In Line With Past Findings

Even though this study was not randomized, Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital (Boston, MA), said he is “willing to believe” this analysis because of its concordance with so much past research. For example, he told TCTMD in a telephone interview, the EXAMINATION trial showed less stent thrombosis in an everolimus-eluting stent compared with BMS in acute MI patients.

Acute MI “is the most thrombotic milieu where you’d be particularly worried about stent thrombosis occurring,” Dr. Bhatt explained, adding that the paper mysteriously did not seem to gain much traction within the interventional community.

Adding on, Dr. Kereiakes said that there are now at least 2 randomized controlled trials and several registries—from Munich and SCAAR—as well as 4 large-network meta-analyses comparing DES vs BMS, and all show reduced stent thrombosis with the former. Moreover, the same has been seen even in patients who need to stop DAPT for noncardiac surgery, he said.

“If there was variability in the data, I would say maybe there’s a contest, but there is now uniformity of data that is locked down by this best-ever propensity analysis,” Dr. Kereiakes said. “It’s hard to justify putting in a BMS at this point.” In the event that a patient cannot go on DAPT, he or she should not even receive a stent “because putting in a bare-metal stent is not doing them any big favors,” he continued.

Unwarranted Hysteria?

Jeffrey W. Moses, MD, of Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview that the subanalysis “shows in retrospect that so much of the safety hysteria that was built around DES was unwarranted.”

While the study authors report that only 20% of MACCE were stent-related, Dr. Moses said he would have liked to see more detailed numbers relating to restenosis and mortality for the individual DES. But together with the TUXEDO trial, this report also “shows you how much of the concerns about DES were driven by the Taxus stent itself and how different it was.”

Echoing Dr. Kereiakes’ sentiment, Dr. Moses said the “irony” of the current situation is that BMS are now only used in patients who need short-term dual antiplatelet therapy, “but if you put this together with LEADERS FREE trial… there’s going to be very little basis for BMS.”

Even cost-savings is no longer enough justification, he said. “You can’t trade cost for safety. If you use BMS you are.”

LEADERS FREE—presented at TCT 2015 and simultaneously published in the New England Journal of Medicine—showed superior safety and efficacy results with a nonpolymer DES compared with BMS in patients at high bleeding risk. Dr. Moses said the advent of even newer DES like this, as well as the Synergy stent, is shifting the “efficacy equations.”

“The perception at the time of the study was that [BMS] were safe and less thrombogenic and consequently we used more [of them] in highly thrombogenic substrates,” he explained. “It turned out that was completely wrong.”

Going forward, the field will likely see more “stent-by-stent analyses… and this whole huge quandary about the ability to stop DAPT, which is such a frequent dilemma in clinical practice, may be a thing of the past,” Dr. Moses concluded.

No More ‘Hall Pass’

“At this point in time, other than concerns about potentially violating the guidelines or medical/legal concerns, I couldn’t think of a clinical reason why I wouldn’t use a second-generation DES vs a BMS,” Dr. Bhatt said, adding that while he would change his clinical practice based on current data, “the levels of evidence need to be revisited” on devices currently available in the United States before the guidelines will officially change.

Dr. Kereiakes, however, thinks the numbers are clear. “BMS should not continue to be given a hall pass,” he said. “Now we have data from randomized trials…. In fact, at this point, I think they should be noted to have a higher risk of stent thrombosis through at least 2 years’ follow-up compared with new-generation DES.”


CORRECTION: An earlier version of this story mistakenly stated that the LEADERS FREE study showed similar safety and efficacy results with a nonpolymer DES to the comparator BMS.

Source: 
Kereiakes DJ, Yeh RW Massaro JM, et al. Stent thrombosis in drug-eluting or bare-metal stents in patients receiving dual antiplatelet therapy. J Am Coll Cardiol Intv. 2015;8:1552-1562.

Disclosures:

• The study was sponsored by Harvard Clinical Research Institute and funded by Abbott, Boston Scientific, Cordis, Medtronic, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, Eli Lilly, Daiichi Sankyo, and the U.S. Department of Health and Human Services.
• Drs. Kereiakes and Moses report no relevant conflicts of interest.
• Dr. Bhatt reports receiving research funding from AstraZeneca, Bristol-Myers Squibb, Medtronic, and Sanofi. 

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• DAPT Study Shows Benefit of Long-Term Treatment After DES Implantation
• Timing of Stent Thrombosis Influences Its Relationship With Mortality
• SCAAR: Lower Risk of Early, Late Stent Thrombosis with Newer DES vs BMS in STEMI