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Meta-analysis: DES More Effective Than BMS for STEMI with No Safety Trade-off

By L.A. McKeown

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Compared with their bare-metal counterparts, drug-eluting stents (DES) reduce target vessel revascularization (TVR) in patients with ST-segment elevation myocardial infarction (STEMI) without increasing the risk of stent thrombosis, according to results of a large meta-analysis published online August 6, 2013, ahead of print in Circulation: Cardiovascular Interventions. The data also suggest that among currently available DES, everolimus-eluting devices are associated with the lowest TVR rate and the best safety profile.

For the meta-analysis, researchers led by Sripal Bangalore, MD, MHA, of New York University School of Medicine (New York, NY), analyzed data from 28 randomized, controlled clinical trials including 14,740 STEMI patients and 34,068 patient-years of follow-up. All trials were published between 2003 and 2012 and involved comparison of any of the 5 US Food and Drug Administration-approved DES (SES, PES, EES, ZES, and ZES-Resolute [ZES-R]) against each other or BMS.

Lower TVR with DES

SES, PES, and EES, compared with BMS, were associated with a reduction in rates of TVR (53%, 31%, and 57%, respectively). There was a 67% and a 21% probability that ZES-R and EES, respectively, produced the lowest TVR rate compared with all other stent types (table 1). When ZES-R was excluded, there was a 58% probability that EES had the lowest TVR rate.

Compared with BMS, no DES (data were unavailable for the ZES-R) were associated with an increased risk of death.  There was a 64% probability that EES produced the lowest death rate compared with all other stent types.

Furthermore, compared with BMS, no DES were associated with an increased rate of MI. There was a 48% and a 44% probability that ZES-R and ZES yielded the lowest MI rate compared with all other stent types.

Compared with BMS, EES were associated with a 58% reduction in the rate of any stent thrombosis and 62% and 61% reductions compared with SES and PES, respectively. EES were comparable to other DES (table 1).

Table 1. Median Rates of TVR, Stent Thrombosis Per 1,000 Patient-Years of Follow-up

 

TVR
(95% CI)

Definite/Probable Stent Thrombosis
(95% CI)

BMS

64.00 (56.31-72.42)

16.60 (12.69-21.00)

SES

28.93 (23.26-35.5)

15.75 (11.43-21.23)

PES

44.38 (34.45-56.16)

18.46 (12.25-26.69)

EES

26.55 (16.89-39.71)

6.54 (2.95-13.42)

ZES

59.01 (30.27-124.60)

11.41 (3.88-25.34)

ZES-R

14.76 (1.77-81.13)

N/A


Moreover, none of the DES were associated with an increase in very late stent thrombosis compared with BMS. There was a 53% and a 42% probability, respectively, that EES and BMS had the lowest very late stent thrombosis rates compared with all other stent types.

Are Guideline Changes Warranted?

Currently, the American College of Cardiology/American Heart Association and European Society of Cardiology clinical guidelines give a class IIa recommendation for the use of a DES as an alternative to BMS for PCI in STEMI.

However, according to Dr. Bangalore and colleagues “given the superior efficacy and even safety of DES, especially EES and perhaps ZES-R, these stents should be considered a class I indication for patients with STEMI.” In addition, they say “the totality of data with results from cohorts, including non-acute coronary syndrome patients, patients with diabetes mellitus, and now patients with STEMI, suggest that DES (especially EES) should be the benchmark for both efficacy and safety for future clinical trials.”

The study authors do acknowledge, though, that they evaluated trial-level data only and therefore cannot account for between-group differences in adjunct therapies.

In a telephone interview with TCTMD, Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), said the study extends and confirms data from other meta-analyses and from HORIZONS-AMI showing that newer DES have the same or lower rates of stent thrombosis as BMS as well as the restenosis benefit.

“This study provides reassurance that certain DES are safe and effective in patients with STEMI undergoing primary PCI, especially the everolimus-eluting stents,” Dr. Stone said, adding that the most important message is the incremental benefits of long-term safety with EES vs. other stents. However, he noted that the finding is driven primarily by data from the EXAMINATION study (Bhatt DL. Lancet. 2012;380:1453-1455) and requires further confirmation in large randomized trials.

David E. Kandzari, MD, of the Piedmont Heart Institute (Atlanta, GA), told TCTMD in a telephone interview that another issue that requires further study is whether STEMI patients can maintain the necessary dual antiplatelet therapy for 6 months or longer.

DES Differ Among Themselves

With regard to any suggestion of a guidelines change, Drs. Stone and Kandzari both said each DES must be considered individually in terms of risks and benefits, especially since this meta-analysis and others suggest differences among the devices.

“While it’s easy to combine them into a class in a meta-analysis, before guidelines should give class I recommendations, you really need stand-alone trials powered for a single DES,” Dr. Stone commented.

In fact, he is heading one such trial, HORIZONS-AMI II, which will randomize 8,800 patients undergoing primary PCI to various DES or a BMS control. That study, he said, will be powered to look for meaningful differences in outcomes between the devices.

“Right now, I think the class IIa recommendation is still reasonable,” Dr. Stone said. “Perhaps you could consider a class I recommendation for lesions with a moderate to high likelihood of restenosis. I would support that.”

Dr. Kandzari added that there would likely be reluctance on the part of guidelines committees to endorse one particular DES over another for STEMI.

 

Source:
Bangalore S, Amoroso N, Fusaro M, et al. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment–elevation myocardial infarction: A mixed treatment comparison analysis of trial level data from 34,068 patient-years of follow-up from randomized trials. Circ Cardiovasc Interv. 2013;Epub ahead of print.

 

 

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Disclosures
  • Dr Bangalore reports serving as an advisory board member or consultant for Abbott, Abbott Vascular, Boehringer Ingelheim, Daiichi Sankyo, Gilead, and Pfizer.
  • Dr. Stone reports serving as a consultant for Boston Scientific.
  • Dr. Kandzari reports receiving research and grant support from Abbott, Boston Scientific and Medtronic and serving as a consultant for Boston Scientific and Medtronic.

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