Meta-analysis Confirms Advantage of New-Generation DES in STEMI

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Predictors of poor outcomes for patients with ST-segment elevation myocardial infarction (STEMI) have remained steady from the early to contemporary eras of primary percutaneous coronary intervention (PCI), according to a meta-analysis published online July 18, 2014, ahead of print in EuroIntervention. Even so, newer-generation drug-eluting stents (DES) are associated with a lower risk not only of revascularization but also definite stent thrombosis compared with their bare-metal counterparts.

The findings suggest that “DES should be considered the standard of care in STEMI patients undergoing primary PCI,” Stephan Windecker, MD, of Bern University Hospital (Bern, Switzerland), and colleagues write.

 

Methods
The researchers looked at pooled data from the COMFORTABLE AMI and EXAMINATION trials, both of which compared newer-generation DES with BMS in patients with STEMI and showed lower risks of repeat revascularization, reinfarction, and stent thrombosis out to 1 year with DES. The current analysis includes data from 2,655 patients (average age 61 years; 81% men).
COMFORTABLE AMI randomized patients at 11 sites in Europe and Israel to either a biolimus-eluting stent with a biodegradable-polymer coating (BioMatrix; Biosensors Europe SA; Morges, Switzerland) or a BMS (Gazelle; Biosensors Europe SA). EXAMINATION randomized patients at 12 European sites to an everolimus-eluting stent with a durable-polymer coating (Xience V; Abbott Vascular; Santa Clara, CA) or a BMS (Multi-Link Vision; Abbott Vascular). The trials were conducted between December 2008 and January 2011.

 

Outcomes Generally Favorable but Some Patients Still at Risk

Through 1 year of follow-up, the rate of all-cause death or any reinfarction was 5.4%, which is “relatively low in the contemporary primary PCI era,” according to the authors. Rates of definite stent thrombosis and TLR were 1.3% and 3.6%, respectively.

Multivariable analysis identified several predictors of all-cause death or any reinfarction (table 1).

Table 1. Independent Predictors of All-Cause Death or Any Reinfarction

 

Adjusted OR

95% CI

Killip Class III or IV

5.11

2.48-10.52

LVEF < 30%

4.77

2.10-10.82

Final TIMI Flow 0-2

1.93

1.05-3.54

Hypertension

1.69

1.11-2.59

Age, per 10-year increase

1.68

1.41-2.01

CK Peak Value

1.25

1.02-1.54

 

A Killip class of III or IV also was the most potent predictor of definite stent thrombosis (adjusted OR 7.74; 95% CI 2.87-20.93) and TLR (adjusted OR 2.88; 95% CI 1.17-7.06).

Stent Thrombosis Findings ‘Surprising’

The predictors of all-cause death or any reinfarction are similar to those seen in prior studies conducted before the current era of primary PCI, study coauthor Giulio G. Stefanini, MD, of Bern University Hospital, told TCTMD in an email.

More surprising, he said, was the lower risk of definite stent thrombosis observed in patients who received DES instead of BMS (adjusted OR 0.35; 95% CI 0.16-0.74). That contrasts with prior research of earlier-generation DES—which showed that BMS carried a lower risk in STEMI—but is consistent with morerecent analyses in patients receiving newer DES.

The lower risk of stent thrombosis with newer DES “has been explained, at least in part, by a lower degree of thrombogenicity… observed in vitro, which might be of particular relevance in STEMI patients due to their prothrombotic status,” Dr. Stefanini explained.

“The fact that third-generation DES have lower stent thrombosis rates has been shown in the past, but since STEMI patients are hypercoagulable and may have severe LV dysfunction, which predisposes them to stent thrombosis, it is important to recognize which patients are at risk and make attempts to reduce this risk,” Cindy L. Grines, MD, of Detroit Medical Center (Detroit, MI), told TCTMD in an email. “The fact that BMS were predictive of stent thrombosis in the STEMI population should serve as a reason to revise the [ACC/AHA] guidelines (they currently state to use BMS in patients who may be noncompliant with antiplatelet meds or who are at risk of bleeding).”

DES Preferred Over BMS in STEMI?

Antonio Colombo, MD, of San Raffaele Scientific Institute (Milan, Italy), called the study “provocative” because typically BMS are less thrombogenic than DES and data supporting the opposite were unexpected. The rationale may be related to the fluoropolymer covering the Xience stent. I have no reasonable explanation for the BioMatrix stent,” he told TCTMD in an email.

Although the study raises the question of whether DES should be used routinely instead of BMS in STEMI, Dr. Colombo highlighted the fact that patients treated with both DES and BMS received dual antiplatelet therapy for up to 1 year.

“Would the results reported in these 2 studies be the same if—for both stents—dual antiplatelet therapy was given for 1 month only?” he asked. “This question remains without an answer, and BMS remain the first choice for patients who cannot take prolonged dual antiplatelet therapy.”

But the choice is clear overall for Dr. Stefanini, who said, “New-generation drug-eluting stents are associated not only with improved effectiveness but also with improved safety as compared with bare metal stents. [They] should therefore be considered by interventional cardiologists as the standard of care for STEMI patients undergoing primary PCI.”

 


Source:

Taniwaki M, Stefanini GG, Räber L, et al. Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials. EuroIntervention. 2014;Epub ahead of print.

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Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …

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Disclosures
  • Dr. Windecker reports receiving institutional research grants from Biotronik and St. Jude.
  • Dr. Grines reports serving on the advisory board of Abbott Vascular.
  • Drs. Stefanini and Colombo report no relevant conflicts of interest.

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