In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).
Background There are conflicting data regarding optimal treatment of non-culprit lesions detected during primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD). We aimed to investigate whether ischaemia-driven early invasive treatment improves the long-term outcome and prevents major adverse cardiac events (MACE). Methods 121 patients with at least one non-culprit lesion were randomised in a 2:1 manner, 80 were randomised to early fractional flow reserve (FFR)-guided PCI (invasive group), and 41 to medical treatment (conservative group). The primary endpoint was MACE at 3 years.Results Three-year follow-up was available in 119 patients (98.3 %). There was no significant difference in all-cause mortality between the invasive and conservative strategy, 4 patients (3.4 %) died, all in the invasive group (P00.29). Re-infarction occurred in 14 patients (11.8 %) in the invasive group versus none in the conservative group (p00.002). Re-PCI was performed in 7 patients (8.9 %) in the invasive group and in 13 patients (32.5 %) in the conservative group (P00.001). There was no difference in MACE between these two strategies (35.4 vs 35.0 %, p00.96). Conclusions In STEMI patients with MVD, early FFRguided additional revascularisation of the non-culprit lesion did not reduce MACE at three-year follow-up compared with a more conservative strategy. The rate of MACE in the invasive group was predominantly driven by death and re-infarction, whereas in the conservative group the rate of MACE was only driven by repeat interventions.
Objective: To evaluate the impact of routine stenting, compared with balloon angioplasty, in unselected patients presenting with ST segment elevation myocardial infarction (STEMI). Design: Randomised trial. Setting: Tertiary referral centre. Participants: All patients presenting with STEMI randomly assigned to stenting or balloon angioplasty. No exclusion criteria were applied. Main outcome measure: The primary end point was combined death or reinfarction at one year's follow up.Results: 1683 consecutive patients with STEMI were randomly assigned before angiography to stenting (n = 849) or balloon angioplasty (n = 834). A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in the balloon group actually underwent primary angioplasty. The groups were comparable in terms of postprocedural TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and distal embolisation. No difference was observed in clinical outcome at both intention to treat (14% v 12.5%, not significant) and actual treatment analyses (12.4% v 11.3%, not significant). Conclusions: Compared with balloon angioplasty, routine stenting does not seem to reduce death and reinfarction in a large cohort of unselected patients with STEMI.
Objectives: To investigate the long-term impact of multivessel coronary artery disease (MVD) on causespecific mortality in patients with ST elevation myocardial infarction (STEMI) treated with reperfusion therapy. Methods and results: Patients with STEMI (n = 395) treated with primary angioplasty or thrombolysis in the setting of a randomised clinical trial were enrolled in the study. Follow up was 8 (2) years. For patients who died all available records were reviewed to assess the specific cause of death. MVD was present in 57% of patients. Patients with MVD were older and more of them had diabetes and previous myocardial infarction. Compared with the non-MVD group, residual left ventricular ejection fraction was lower (45.9% v 49.6%, p = 0.001) and total mortality was higher in patients with MVD (32% v 19%, p = 0.002). After adjustment for potential confounders this association was not significant (hazard ratio 1.4, 95% confidence interval (CI) 0.9 to 2.2). When the specific cause of death was considered, sudden death was comparable between patients with and without MVD (10% v 8%, p = 0.49) but death caused by heart failure was significantly higher in patients with MVD (hazard ratio 7.4, 95% CI 1.7 to 32.2). Conclusion: Patients with STEMI and MVD have a higher long-term mortality than do patients with non-MVD. MVD is not an independent predictor of long-term total mortality or sudden death. However, MVD is a very strong and independent predictor of long-term death caused by heart failure.
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