Pair of Studies Show Positive Stent Results at ACC

SAN FRANCISCO, CA—An everolimus-eluting stent (EES) is noninferior to a zotarolimus-eluting stent (ZES) in an all-comers population, while a new self-expanding stent shows promise in patients with ST-segment elevation myocardial infarction (STEMI), according to 2 separate studies presented March 9, 2013, at the American College of Cardiology Scientific Session/i2 Summit. 

Assurance for Promus Element 

For the all-comers HOST-ASSURE trial, Hyo-Soo Kim, MD, PhD, of Seoul National University Hospital (Seoul, Korea), and colleagues randomized 3,755 patients to PCI with the Resolute ZES (Medtronic, Minneapolis, MN; n = 1,252) or the Promus Element EES (Boston Scientific, Natick, MA; n = 2,503) at 40 Korean hospitals.

With regard to the primary endpoint of target lesion failure (TLF; composite of cardiac death, target vessel-related MI, and ischemia-driven TLR) at 12 months, Promus Element proved noninferior to Resolute. All individual clinical outcomes were similar between the study arms (table 1).

Table 1.  Clinical Events at 12 Months

 

 

Promus Element
(n = 2,503)

Resolute
(n = 1,252)

HR (95% CI)

P Value

TLF

2.88%

2.88%

1.00 (0.67-1.50)

0.02a

Cardiac Death

1.36%

1.36%

1.00 (0.56-1.79)

0.997

Target Vessel-related MI

0.96%

1.04%

0.93 (0.47-1.82)

0.822

TLR

1.24%

1.20%

1.04 (0.56-1.93)

0.900

Patient-oriented Composite (All-cause Death, MI, Repeat Revascularization)

5.39%

4.39%

1.24 (0.90-1.69)

0.187

a P for noninferiority.

The results were maintained in all prespecified subgroups, with the exception of vessel diameter: smaller vessels favored Promus Element and larger vessels favored Resolute (P for interaction = 0.030). There was also no difference in definite or probable stent thrombosis between Promus Element and Resolute (0.36% vs. 0.67%; P = 0.229).

Out of 5,007 lesions, 7 instances (0.21%) of longitudinal stent deformation were reported, all in patients implanted with Promus Element, but the difference was not significant (P = 0.104).

“Both stents demonstrated outstanding safety as well as efficacy,” Dr. Kim said, adding that “longitudinal stent deformation was very rare . . . and was not associated with future adverse clinical events.”

New Stent for STEMI 

Gilles Montalescot, MD, PhD, of Pitié-Salpêtrière Hospital (Paris, France), presented the results of the APPOSITION III (A Post-market Study to Assess the STENTYS Self-expanding Coronary Stent in Acute Myocardial Infarction in Real Life) trial, which looked at 965 STEMI patients at 50 hospitals in 14 countries. Patients were all implanted with the bare or paclitaxel-eluting, self-expanding nitinol Stentys stent (Stentys, Princeton, NJ). 

The primary endpoint of MACE (cardiac death, target vessel MI, and clinically-driven TLR) at 12 months was low (9.3%; n = 86). In addition, the composite of cardiac death or target vessel MI was observed in 30 patients (3.2%); 19 patients (2.0%) died of cardiac causes. 

There was a trend for less MACE in patients who received post-dilatation (8.4%) compared with those who did not (11.3%; P = 0.14). More specifically, post-dilatation resulted in less cardiac death or target vessel MI (2.4% vs. 5.0%; P = 0.03) and definite stent thrombosis (1.9% vs. 5.0%; P = 0.01). 

Compared with 19,767 patients included in similar previous studies of stenting in STEMI patients since 2006, APPOSITION III reported less MACE (9.3% vs. 11.1%) and cardiac mortality (2.0% vs. 3.9%) at 1 year. 

“The self-apposing Stentys stent shows good long-term clinical outcomes in a real-life STEMI population,” Dr. Montalescot said. “These results support the hypothesis that correct stent sizing and elimination or malapposition after primary PCI lead to good long-term results.”

  

 


 

Sources:1. Kim H-S. Platinum Chromium-based Everolimus-Eluting Stent Versus Cobalt Chromium-based Zotarolimus-Eluting Stent in All-Comers Receiving Percutaneous Coronary Intervention: The HOST-ASSURE Randomized Trial. Presented at: American College of Cardiology Scientific Session/i2 Summit; March 9, 2013; San Francisco, CA.

 

2. Montalescot G. One Year Clinical Results on 1,000 STEMI Patients Treated With a Self-Expanding Coronary Stent (APPOSITION III). Presented at: American College of Cardiology Scientific Session/i2 Summit; March 9, 2013; San Francisco, CA.

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Disclosures
  • Dr. Kim reports receiving honoraria from Boston Scientific and Medtronic.
  • Dr. Montalescot reports receiving consulting fees/honoraria and research grants from multiple pharmaceutical and device companies.

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