What is the clinical evidence from this study?

Study design: Observational. Population: Patients treated with coronary drug-eluting stents (n=4154). Intervention: Clopidogrel discontinuation within the first 3 months vs. Continued clopidogrel treatment. Primary outcome: Major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or definite stent thrombosis) (HR 2.06, 95% CI 1.08-3.93).

What does this research mean for the field?

Discontinuation of clopidogrel within the first 3 months after drug-eluting stent implantation is associated with a significantly increased rate of major adverse cardiovascular events at 1-year follow-up. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

August 13, 2014Open Access

Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study

TTTroels ThimAarhus University MJMartin Berg JohansenVitrolife (Sweden)GCGro Egholm ChisholmAarhus University

Key Result

Discontinuation of clopidogrel within the first 3 months after drug-eluting stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (HR 2.06).

Study Design

Type

Observational (n=4,154)

Multicenter

Yes

Structured PICO

Does discontinuation of clopidogrel within the first year after coronary drug-eluting stent implantation increase the risk of major adverse cardiovascular events?

Population

4,154 patients treated with first-generation coronary drug-eluting stents (sirolimus-eluting or paclitaxel-eluting) in Western Denmark. Key inclusion: first PCI procedure with implantation of one or more coronary DES. Key exclusion: treated with balloon angioplasty without stenting or with bare metal stents alone.

Intervention

Discontinuation of clopidogrel (defined as a gap between prescription redemptions of more than 14 days) within the first year after PCI, specifically analyzed at 0-3 months, 3-6 months, and 6-12 months.

Comparator

Continued use of clopidogrel (no gap >14 days between prescription redemptions) during the corresponding time periods.

Outcome

Major adverse cardiovascular events (MACE), defined as the first occurrence of cardiac death, myocardial infarction, or definite stent thrombosis at 12 months follow-up, adjudicated by a blinded committee of cardiac specialists.composite

Discontinuation of clopidogrel within the first 3 months after first-generation drug-eluting stent implantation is associated with a significantly increased risk of major adverse cardiovascular events, highlighting the critical importance of early adherence to dual antiplatelet therapy.

Main Result

Effect estimate: HR 2.06 (95% CI 1.08-3.93)

Limitations

Patients may have redeemed prescriptions without taking the tablets
Temporary discontinuations of less than 14 days were not detected
Aspirin use could not be completely assessed as it is available without a prescription
Cannot exclude residual confounding despite adjustment for comorbidities
The positive effect of compliance may be lower than estimated from observational studies
Decline in adherence was likely a combination of medical decisions and lack of patient compliance
Results are limited to first-generation drug-eluting stents

Abstract

BACKGROUND: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. METHODS: We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. RESULTS: Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation. CONCLUSIONS: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients treated with drug-eluting stents. The increase was statistically significant within the first 3 months after drug-eluting stent implantation but not after 3 to 12 months.

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