What is the clinical evidence from this study?

Study design: Observational. Population: ST-Segment Elevation Myocardial Infarction (n=806). Intervention: Direct stenting vs. Conventional stenting. Primary outcome: All-cause mortality at 15 years (aHR 0.74, 95% CI 0.58-0.93, p=0.010).

January 19, 2022Open Access

Very Long-Term Clinical Outcomes After Direct Stenting in Patients Presenting With ST-Segment Elevation Myocardial Infarction

Q: What does this research mean for the field?

Direct stenting reduces 15-year all-cause mortality and mid-term major adverse cardiac events compared to conventional stenting in patients presenting with ST-segment elevation myocardial infarction, particularly in those with initial TIMI flow 0-1. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Resultado clave

Direct stenting reduced 15-year all-cause mortality (aHR 0.74) compared to conventional stenting in patients presenting with ST-segment elevation myocardial infarction.

Diseño del estudio

Tipo

Observational (n=806)

Multicéntrico

PICO estructurado

Does direct stenting reduce long-term mortality and major adverse cardiac events in patients with STEMI undergoing percutaneous coronary intervention compared to conventional stenting?

Población

806 consecutive patients diagnosed with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES), mean age 59.1 years, 21.2% female, based in the Netherlands. Excluded: patients with non-quantifiable thrombus burden.

Intervención

Direct stenting (stent positioning and deployment without prior balloon pre-dilation of the stenosis, either before or after thrombus aspiration)

Comparador

Conventional stenting (stenting after balloon pre-dilation of the stenosis)

Resultado

All-cause mortality at 15 years and Major Adverse Cardiac Events (MACE: composite of all-cause death, repeat myocardial infarction, and target vessel revascularization) at 10 yearscomposite

Direct stenting during primary PCI for STEMI is associated with reduced 15-year all-cause mortality compared to conventional stenting, particularly in patients with impaired baseline TIMI flow.

Resultado numérico

Estimación del efecto: aHR 0.74 (95% CI 0.58-0.93)

Tasa de eventos absoluta: 35% vs 45.3%

valor p: p=0.010

Limitaciones

Single center observational study with inherent selection bias
Treatment strategy including the decision to proceed with thrombus aspiration was per individual operator's discretion
Only first generation DES were implanted
Left anterior descending infarct related artery was more common in the conventional stenting strategy
Variables such as left ventricular ejection fraction, lesion characteristics, stent length and diameter were not available
Rescue PCI occurred in 10% of the population, preventing assessment of potential thrombus burden modification

Resumen

BACKGROUND/PURPOSE: Direct Stenting (DS) could be associated with reduced distal embolization and improved reperfusion in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of DS on long-term outcomes remains unclear, therefore we evaluated the impact of DS on very long-term clinical outcome in STEMI. METHODS/MATERIALS: Between April 2002 and December 2004, patients presenting with STEMI undergoing percutaneous coronary intervention were investigated. The study population was divided into two groups: DS and conventional stenting (CS) and stratified according to initial TIMI flow. Major adverse cardiac events (MACE) were assessed at 10 years and all-cause mortality at 15 years. Cox proportional hazards models were used. When the proportional hazards assumption was not satisfied, landmark analysis at mid-term (2 years) was performed. RESULTS: A total of 812 consecutive patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 450 (55.8%) underwent DS and 356 (44.2%) CS. At 15 years follow-up, DS was associated with a reduction in all-cause mortality (DS 35.0% vs. CS 45.3%, aHR 0.74, 95% CI 0.58-0.93, p = 0.010). The landmark analysis at 2 years identifies reduced 2-year MACE in DS compared with CS (6.8% vs.14%, aHR 0.67, 95% CI 0.49-0.93, p = 0.015) and beyond 2 years no significant differences were found between the groups (27.4% vs. 29.3%, aHR 1.00, 95% CI 0.74-1.36, p = 0.999). In patients with baseline TIMI 0-1, DS was associated with lower 10-year MACE and 15-year mortality compared with CS (aHR0.71, 95%CI 0.55-0.92, p = 0.010 and aHR0.65, 95%CI 0.50-0.84, p = 0.001, respectively). CONCLUSIONS: DS was associated with reduced 15-year all-cause mortality and reduced mid-term MACE rate in patients with STEMI. Clinical events reduction associated with DS was particularly relevant in patients with initial TIMI flow 0-1.

Preguntar a la IA

Me gusta

Guardar

Ver artículo completo