January 1, 2008Circulation JournalOpen Access

Clinical Safety of Drug-Eluting Stents in the Korea Acute Myocardial Infarction Registry

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Acute myocardial infarction (n=1541). Intervention: Sirolimus-eluting stent (Cypher) vs. Paclitaxel-eluting stent (Taxus). Primary outcome: Composite major adverse cardiac events (MACE) at 6 months (aOR 0.658, 95% CI 0.404-1.072, p=0.093).

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Key result

Sirolimus-eluting stents and paclitaxel-eluting stents showed no significant difference in the 6-month incidence of major adverse cardiac events (3.8% vs 5.2%, aOR 0.66) in patients with acute myocardial infarction.

Why the study?

Does sirolimus-eluting stent compared to paclitaxel-eluting stent improve composite MACE in patients with acute myocardial infarction undergoing primary PCI?

Population

1,541 surviving patients with acute myocardial infarction discharged alive after primary PCI, mean age ~62…

Comparison

Sirolimus-eluting stent implantation during… vs Paclitaxel-eluting stent implantation during…

Design

Cohort

Follow-up

6 months

Authors

SLSang Rok LeeInterventional / Structural Cardiology MJMyung Ho JeongInterventional Cardiology YAYoung Keun AhnChonnam National University Hospital

Discussion

Member takes

Implication

Comparable MACE rates with both stents in AMI; leaves open whether randomized trials would confirm equivalence.

Study Design

Type

Cohort (n=1,541)

Multicenter

Yes

Structured PICO

Does sirolimus-eluting stent compared to paclitaxel-eluting stent improve composite MACE in patients with acute myocardial infarction undergoing primary PCI?

Population

1,541 patients with acute myocardial infarction who survived to discharge and received either a sirolimus-eluting or paclitaxel-eluting stent, followed for 6 months.

Exposure

Sirolimus-eluting stent (SES) implantation during primary PCI (n=834), with standard post-PCI dual antiplatelet therapy (aspirin 100 mg daily for life and clopidogrel 75 mg daily for at least 6 months).

Comparator

Paclitaxel-eluting stent (PES) implantation during primary PCI (n=707), with standard post-PCI dual antiplatelet therapy (aspirin 100 mg daily for life and clopidogrel 75 mg daily for at least 6 months).

Outcome

Composite of major adverse cardiac events (MACE), including death, myocardial infarction, target lesion revascularization, and CABG, at both 1 and 6 months after survival discharge.composite

Main Result

Odds Ratio: 0.658 (95% CI 0.404–1.072)

Absolute Event Rate: 3.8% vs 5.2%

p-value: p=0.093

In real-world practice, sirolimus-eluting and paclitaxel-eluting stents showed comparable and relatively low rates of MACE and stent thrombosis at 6 months in patients with acute myocardial infarction.

Limitations

Exclusion of high-risk patients such as those who died in hospital limits generalizability.
Short follow-up duration of 6 months cannot confirm long-term safety regarding late stent thrombosis.
Did not analyze the use of glycoprotein IIb/IIIa receptor blockers, beta-blockers, ACE inhibitors, or clopidogrel compliance.
Lack of angiographic follow-up might have led to an underestimation of the incidence of MACE and stent thrombosis.
Low-risk patient population due to exclusion of in-hospital deaths
Short follow-up duration (6 months) preventing long-term safety confirmation
Lack of data on GP IIb/IIIa inhibitors, beta-blockers, ACE inhibitors, and clopidogrel compliance
Lack of angiographic follow-up potentially underestimating MACE and stent thrombosis

Cite This Study

Lee et al. (2008) conducted a cohort in Acute myocardial infarction (n=1,541). Sirolimus-eluting stent (Cypher) vs. Paclitaxel-eluting stent (Taxus) was evaluated on Composite major adverse cardiac events (MACE) at 6 months (aOR 0.658, 95% CI 0.404-1.072, p=0.093). Sirolimus-eluting stents and paclitaxel-eluting stents showed no significant difference in the 6-month incidence of major adverse cardiac events (3.8% vs 5.2%, aOR 0.66) in patients with acute myocardial infarction.

synapsesocial.com/papers/6a9cd67bccf76bb89d97a7bd https://doi.org/10.1253/circj.72.392

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