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Invasive vs Conservative Strategy in Patients Over 80 Years with Non-ST-Elevation Myocardial Infarction or Unstable Angi

This study compared the benefits of an invasive strategy versus a conservative strategy in patients aged 80 years and older with non-ST-elevation myocardial infarction (NSTEMI) or unstable angina pectoris (UAP). The primary endpoint was a composite of myocardial infarction, urgent revascularization, stroke, and death. The study found that an invasive strategy was superior to a conservative strategy in reducing the composite endpoint, with no significant difference in complication rates.

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Invasive vs Conservative Strategy in Patients Over 80 Years with Non-ST-Elevation Myocardial Infarction or Unstable Angi

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  1. Invasive versus Conservative Strategy in Patients Over 80 Years with Non ST-Elevation Myocardial Infarction or Unstable Angina Pectoris:A Randomized Multicenter StudyAfter Eighty Study Nicolai Kloumann Tegn, Michael Abdelnoor, Lars Aaberge, Knut Endresen, Pål Smith, Svend Aakhus, Erik Gjertsen, Ola Dahl-Hofseth, Anette Hylen Ranhoff, Lars Gullestad, Bjørn Bendz, for the After Eighty Study Investigators Oslo University Hospital, Rikshospitalet, Norway Presenter disclosure information: Funded by the Norwegian Health Association

  2. Background • Elderly patients counts for approximately one third of all patients with Non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina Pectoris (UAP). • Patients  80 years are under-represented in clinical trials. • The role of an early invasive strategy, and even an invasive strategy at all, remains a subject of debate. • According to WHO / US National Center for Health Statistics, the life expectancy at the age of 80 years is ~ 9 years.

  3. RCTs with early invasive treatment

  4. Aim of the study • The aim of the present clinical trial was to investigate whether patients ≥80 years would benefit from an early invasive versus a conservative strategy when initially stabilized after NSTEMI or UAP. • The primary endpoint was a composite of myocardial infaction, need of urgent revascularization, stroke and death.

  5. Study centers Oslo 17 hospitals in the South-East Health Region of Norway covering a population of 2.7 mill.

  6. Inclusion and exclusion criteria Inclusion Exclusion Clinical unstable. Ongoing bleeding problems. Short life expectancy (less than 12 months) due to serious comorbidity. Significant mental disorder. • Patients  80 years. • NSTEMI or UAP, with/without ST-segment depression in ECG, and normal/elevated levels oftroponin T or I. • No chest pain or other ischaemic symptoms/signs after medical treatment and mobilization.

  7. Sample size calculation • This was an open label dynamic randomized trial. • Previous studies targeting this population were lacking when planning this study. • Considering the TACTICS study (Cannon et al, NEJM 2001) for a comparable population there was an incidence of composite endpoint (Death + MI) of 10.8% at 6 months. • A prior power analysis was performed based on the TACTICS study. Considering a type I error of 5% and a power of 80% to detect an absolute 10% reduction in composite endpoint, we calculated a need of 2*206 = 412 patients.

  8. 4187 patientswith NSTEMI or UAP Inclusion flow-chart • Not included; n=3730 • Short life expectancy; n=825 • Ongoing or recent bleeding; n=183 • Unable to comply with protocol; n=409 • Clinical unstable incl. ongoing ischemia; n=560 • Refused to participate; n=402 • Logistic reasons; n=1011 • Other reasons; n=103 228 included in the intention-to-treat analysis 457 randomized 229 assigned the invasive group 228 assigned the conservative group 5 dropouts 1 dropout 229 included in the intention-to-treat analysis

  9. Strategy flow-chart Randomization Conservative group Invasive group Optimal medicaltreatment in thecommunity hospitals beforedischarge Transported to the PCI centrethedayafterinclusion PCI: Returned to community hospital after ~ 6-18 hours No PCI: Returned to thecommunity hospital after ~ 4-6 hours Optimal medicaltreatment in thecommunity hospitals beforedischarge

  10. Baseline characteristics P values are ns

  11. Medical treatment during index

  12. Medical therapy at discharge

  13. Results Freedom of compocite endpoints Rate Ratio, 0.48 (95% CI, 0.37-0.63); p<0.00001

  14. Results Median follow-up of 1.51 years * P-values are two-tailed

  15. Bleeding complications P values are ns

  16. Conclusions • We have demonstrated that an invasive strategy is superior to a conservative strategy in patients ≥ 80 years with NSTEMI or UAP. • No differences in complication rates (i.e. bleedings) were seen between the two strategies.

  17. After Eighty Study investigators Steering committee Nicolai K. Tegn, Michael Abdelnoor, Lars Aaberge, Knut Endresen, Pål Smith, Svend Aakhus, Erik Gjertsen, Lars Gullestad, Bjørn Bendz (Chairman). Data and safety monitoring board Theis Tønnessen and Rune Wiseth Acknowledgements Aker Hospital, Akershus University Hospital, Bærum Hospital, Diakonhjemmet Hospital, Drammen Hospital, Elverum Hospital, Fredrikstad Hospital, Gjøvik Hospital, Hamar Hospital, Kongsberg Hospital, Lillehammer Hospital, Moss Hospital, Notodden Hospital, Ringerike Hospital, Skien Hospital and Vestfold Hospital.

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