Meta-analysis: Newer-Generation DES Safe, Effective vs. BMS in STEMI

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Newer-generation drug-eluting stents (DES) are safer and more effective in patients with ST-segment elevation myocardial infarction (STEMI) compared with bare-metal stents (BMS), according to a meta-analysis published online December 11, 2013, ahead of print in JACC: Cardiovascular Interventions. Results were originally presented at the Transcatheter Cardiovascular Therapeutics scientific symposium in October 2012.

Salvatore Brugaletta, MD, PhD, of the University of Barcelona (Barcelona, Spain), and colleagues conducted a pooled analysis of 2,665 STEMI patients enrolled in 2 multicenter, randomized trials comparing DES (n = 1,326) to BMS (n = 1,329):

  • EXAMINATION (n = 1,504): EES (Xience V; Abbott Vascular, Santa Clara, CA)
  • COMFORTABLE-AMI (n = 1,161): biolimus-A9-eluting stent (BioMatrix, Biosensors International, Morges, Switzerland)

At 1 year, DES reduced the device-oriented composite endpoint (cardiac death, TVR, and TLR) as well as the patient-oriented endpoint (all-cause death, any MI, and any revascularization). More specifically, patients treated with DES reported a lower risk of TLR, TVR, and definite and definite/probable stent thrombosis compared with BMS at 1 year (table 1).

Table 1. Clinical Outcomes at 1 Year: DES vs. BMS

 

RR (95% CI)

P Value

Device-Oriented Composite

0.58 (0.43-0.79)

0.004

Patient-Oriented Composite

0.78 (0.63-0.96)

0.02

TLR

0.33 (0.20-0.52)

< 0.001

TVR

0.36 (0.14-0.92)

0.03

Definite Stent Thrombosis

0.35 (0.16-0.75)

0.006

Definite/Probable Stent Thrombosis

0.53 (0.29-0.95)

0.03


There were no differences in all-cause or cardiac mortality between the 2 groups.

“In patients with STEMI, newer-generation DES improved safety and efficacy compared with BMS throughout 1 year,” Dr. Brugaletta and colleagues write. “It remains to be determined whether these differences in favor of newer-generation DES continue during long-term follow-up.”

Previous Trials Inadequately Powered for Rare Endpoints 

In an e-mail communication with TCTMD, Dr. Brugaletta said that while previous trials have demonstrated the safety and efficacy of newer-generation DES in STEMI patients, they were not adequately powered to “detect differences in rarely occurring adverse safety endpoints, such as stent thrombosis.” In comparison, the meta-analysis was adequately powered, he said. 

“The safety concerns, which were raised for first-generation DES in STEMI treatment, may be considered overcome by the introduction of these newer-generation DES, which on the contrary, appear to be even safer than BMS,” Dr. Brugaletta continued. “These findings, together with those coming from other meta-analyses, [should be part of the] discussion [in forming] the next STEMI treatment guidelines.” 

Combination of Studies Questionable 

In a telephone interview with TCTMD, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), said that many interventional cardiologists have looked at both trials separately and used the data to “feel better about treating these patients with newer-generation drug-eluting stents versus prior-generation drug-eluting stents and bare metal stents.”

However, the 2 devices included here are entirely different from one another, he reported. “One has a bioabsorbable polymer and the other has a durable polymer,” he said. “In some respects, these trials should only be combined in an exploratory way even though both studies did observe similar outcomes.”

Gregg W. Stone, MD, also of Columbia University Medical Center, agreed. In a telephone interview with TCTMD, he said, “It’s hard to argue that the 2 stents are similar enough to pool. They are very different.”

More Data Needed

Despite the limitations of combining the studies, the meta-analysis shows some promising advantages of using DES compared with BMS, Dr. Stone continued. However, “we need further data from larger and more appropriately powered studies to really know if a DES is superior to BMS in terms of safety,” he said.

Dr. Kirtane added that even though the meta-analysis found superior stent thrombosis outcomes with newer-generation DES, “it’s important that people realize that even with the combined data, the study is underpowered. We need a larger trial.”

The HORIZONS II AMI trial is currently evaluating different DES vs. BMS in approximately 8,000 patients, and “will be powered to answer very important questions about stent thrombosis and other major outcomes,” Dr. Stone reported.

HORIZONS II AMI will likely establish a firm conclusion as to whether new DES plus the best antiplatelet regimen is superior to BMS in STEMI patients, said Dr. Brugaletta.

“We have to start thinking about safety and efficacy of fourth-generation DES, such as drug-eluting bioresorbable scaffolds, in STEMI patients,” he added. These devices eliminate caging the artery and help restore physiologic vascular function, and may further improve treatment of STEMI patients, Dr. Brugaletta concluded.

Study Details

Dual antiplatelet therapy was more often used in those treated with DES than BMS (93.4% vs. 88.2%; P < 0.001).

 


Source:
Sabaté M, Räber L, Heg D, et al. Comparison of newer-generation drug-eluting stents with bare metal stents in patients with acute ST-segment elevation myocardial infarction: A pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials. JACC: Cardiovasc Interv. 2013;Epub ahead of print.

 

 

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Meta-analysis: Newer-Generation DES Safe, Effective vs. BMS in STEMI

Newer-generation drug-eluting stents (DES) are safer and more effective in patients with ST-segment elevation myocardial infarction (STEMI) compared with bare-metal stents (BMS), according to a meta-analysis published online December
Disclosures
  • Dr. Brugaletta reports no relevant conflicts of interest.
  • Dr. Kirtane reports receiving institutional research funding from Acumed, Boston Scientific, Medtronic, and St. Jude Medical.
  • Dr. Stone reports serving as a consultant to Boston Scientific.

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