Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus.

OBJECTIVE: Deferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. METHODS: All DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). RESULTS: A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40-9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34-9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64-17.30, p = 0.15) was observed. CONCLUSIONS: This study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.

Rationale and design of a double-blind, multicenter, randomized, placebo-controlled clinical trial of early administration of intravenous ß-blockers in patients with ST-elevation myocardial infarction before primary percutaneous coronary intervention: EARLY ß-blocker administration before primary PCI in patients with ST-elevation myocardial infarction trial.

BACKGROUND: ß-Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions (STEMIs), as they are associated with a reduced mortality, recurrent myocardial infarction, life-threatening arrhythmias, and with prevention of unfavorable left ventricular remodeling. Whether early administration before primary percutaneous coronary intervention (PCI) of intravenous ß-blockers reduces the infarct size in the current era is unknown. HYPOTHESIS: We postulate that the early administration of ß-blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging (MRI) at 30 days. DESIGN: In a multinational, multicenter, double-blind, placebo-controlled, randomized trial, patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol (5 mg twice daily) administration or placebo. Before admission, study treatment will be started as soon as possible after the diagnosis of STEMI. After admission, primary PCI will be performed as per standard of care. After primary PCI, medical treatment will occur as per current guidelines in all patients, including the use of oral ß-blockers. The primary end point is the myocardial infarct size as assessed by MRI at 30 days. Based on a superiority design and assuming an 18% relative infarct size reduction (from 28% to 23.5%), 408 patients are required to be enrolled, accounting for 20% drop-out (α = .05 and power = 80%). SUMMARY: The EARLY-BAMI trial is a multinational, multicenter, double-blind, placebo-controlled, randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days.

Predictors of 30-day and 1-year mortality after primary percutaneous coronary intervention for ST-elevation myocardial infarction.

OBJECTIVE: Predictors of 30-day mortality may differ from predictors of mortality at 1 year among 30-day survivors of ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). We aimed to evaluate the predictors of 30-day and 1-year mortality in unselected patients with STEMI treated with PCI. METHODS: Individual patient data from 4732 patients with STEMI, who were treated with primary PCI during an 11-year study period, were recorded prospectively. Patient characteristics, 30-day, and 1-year outcome were evaluated. RESULTS: At 30-day follow-up, 219 patients (4.6%) died; and out of the 4513 30-day survivors, 109 patients (2.8%) died at 1 year. Patients who died were older, had a higher risk profile. Higher rates of Killip class greater than 2 on admission, multivessel disease, and, more often, lower left ventricular ejection fraction were observed in patients who died. Mortality rate was 7.6% at 30 days among the females when compared with 3.7 among the males, P value less than 0.001. Age and sex-adjusted multivariate analysis revealed that previous myocardial infarction, diabetes, Killip class greater than 2, post-PCI thrombolysis in myocardial infarction flow less than 3, and left ventricular ejection fraction less than 30% were strong predictors of both 30-day and 1-year mortality. However, multivessel disease, anterior myocardial infarct location and in-hospital reinfarction, ischemic time, and pre-PCI thrombolysis in myocardial infarction flow less than 3 were particularly strong predictors of 30-day mortality. CONCLUSION: Despite the fact that most characteristics of 30-day and 1-year mortality among 30-day survivors are similar, we found that variables that affect mortality beyond the acute phase may not necessarily be the same as those that influence early mortality.

Facilitation of primary coronary angioplasty by early start of a glycoprotein 2b/3a inhibitor: results of the ongoing tirofiban in myocardial infarction evaluation (On-TIME) trial.

AIM: Although primary angioplasty is effective despite additional transportation delay, improved patency before PCI might be obtained by starting pharmacological pre-treatment before transportation. METHODS AND RESULTS: From June 2001 to November 2002, 507 patients with acute myocardial infarction, who were transferred to a PCI centre, were randomised to early, pre-hospital initiation of Tirofiban (Early) or to initiation in the catheterisation laboratory (Late). The primary end-point was TIMI flow grade 3 of the infarct-related vessel (IRV) at initial angiography, as assessed by an independent core-lab. The effect of Tirofiban on each TIMI flow component, the presence of thrombus at initial angiography and pre-PCI myocardial blush grade were secondary end-points. A large proportion of patients (41%) was diagnosed and randomised in the ambulance, without intervention of a physician. In the Early group, Tirofiban was administered a median of 59 min (range 11-178 min) earlier than in the Late group. At initial angiography, TIMI 3 flow was present in 19% the Early group and in 15% in the Late group (P = 0.22). The combined incidence of TIMI 2 or 3 flow was present in 43% in the Early group and in 34% in the Late group, respectively (P = 0.04). Thrombus or a fresh occlusion was present in 60% and 73% in the Early and Late group, respectively (P = 0.002). A pre-PCI myocardial blush grades 2 or 3 was more often present in the Early group (30% vs. 22%, P = 0.04). However, no difference in TIMI 3 flow or myocardial blush grade was found between the groups, post-PCI. At one-year follow-up, the combined incidence of death or recurrent MI was not different between the groups (7.0% vs. 7.0%, P = 0.99). CONCLUSION: Early initiation of Tirofiban did not improve initial TIMI 3 flow of the IRV significantly. Despite a better patency (TIMI 2 or 3 flow), a lower prevalence of thrombus or fresh occlusion and a better myocardial perfusion in the infarct-related region pre-PCI, no beneficial effect on post-PCI angiographic or clinical outcome was found, as compared to initiation of Tirofiban in the catheterisation laboratory.