Major Finding: Acute myocardial infarction patients treated with drug-eluting coronary stents had a 16% mortality rate during 5 years of follow-up, significantly better than the 20% mortality rate in patients treated with bare-metal stents.
Data Source: Review of 12,005 New Jersey patients treated with primary percutaneous coronary intervention during 2003-2004.
Disclosures: Dr. Vagaonescu said that he had no disclosures.
NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.
Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the meeting.
“These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe,” said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.
“Our data show that preventing the need for revascularization by using drug-eluting stents [DES] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event,” he said in an interview.
The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.
Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the DES recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with DES also occurred in both the subset of patients with ST-elevation myocardial infarction and in patients with non–ST-elevation myocardial infarction, Dr. Vagaonescu reported.
He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents (see graph).
Another aspect of the analysis showed the dramatic shift toward use of DES for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a DES, especially patients who prematurely stopped dual-antiplatelet therapy.
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Jury Out on First-Generation DES
A major concern when using drug-eluting coronary stents to treat acute myocardial infarction is the risk of late stent thrombosis, especially with the first-generation drug-eluting stents, the sirolimus-eluting Cypher and the paclitaxel-eluting Taxus stents.
For several years, since evidence established a link between long-term dual-antiplatelet therapy and reduced stent thrombosis, the issue has been can an acute myocardial infarction patient reliably remain on dual-antiplatelet therapy for at least 1 year. This information is often difficult to know in the emergency department at the time of primary percutaneous coronary intervention.
This concern has been balanced by the very respectable performance of bare-metal stents when placed in acute myocardial infarction patients. Experience has taught us that when you have doubt about a patient's willingness or ability to remain on dual-antiplatelet therapy, there is nothing wrong with using a bare-metal stent.
What's unclear is the potential role for the second-generation drug eluting stents for primary percutaneous coronary interventions. The everolimus-eluting stents seem to have a reduced risk for late thrombosis, compared with the first-generation stents in patients without an acute myocardial infarction. We'd like to know the performance of second-generation drug-eluting stents in myocardial infarction patients, but we currently have no evidence about this.