Saman Rasoul

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

ObjectivePredictors 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. MethodsIndividual 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. ResultsAt 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. ConclusionDespite 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.

The importance of left ventricular function for long-term outcome after primary percutaneous coronary intervention

BackgroundIn the present study we sought to determine the long-term prognostic value of left ventricular ejection fraction (LVEF), assessed by planar radionuclide ventriculography (PRV), after ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI).MethodsIn total 925 patients underwent PRV for LVEF assessment after PPCI for myocardial infarction before discharge from the hospital. PRV was performed with a standard dose of 500 Mbq of 99mTc-pertechnetate. Average follow-up time was 2.5 years.ResultsMean (± SD) age was 60 ± 12 years. Mean (± SD) LVEF was 45.7 ± 12.2 %. 1 year survival was 97.3 % and 3 year survival was 94.2 %. Killip class, multi vessel-disease, previous cardiovascular events, peak creatin kinase and its MB fraction, age and LVEF proved to be univariate predictors of mortality. When entered in a forward conditional Cox regression model age and LVEF were independent predictors of 1 and 3 year mortality.ConclusionLVEF assessed by PRV is a powerful independent predictor of long term mortality after PPCI for STEMI.

Ongoing tirofiban in myocardial infarction evaluation (On-TIME) 2 trial: rationale and study design.

AIMS Delays in initiation of treatment because of transportation of high-risk patients with ST-elevation myocardial infarction (STEMI) are associated with worse clinical outcome. Glycoprotein IIb/IIIa receptor inhibitors improve initial patency of the infarct-related vessel and reduce thrombotic complications in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS The Ongoing Tirofiban In Myocardial infarction Evaluation (On-TIME) 2 trial is a randomised, double-blind, European clinical trial to evaluate the benefits of pre-hospital initiation of high-dose bolus of tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, on background therapy of aspirin, unfractionated heparin and high dose clopidogrel, for patients with STEMI who undergo primary PCI. Eligible patients will be randomised 1:1 to pretreatment with a 25 microg/kg bolus and 0.15 microg/kg/min maintenance infusion of tirofiban or placebo. The primary endpoint is the extent of residual ST-segment deviation (defined as percentage of patients with >3 mm deviation of ST segment) 1 hour after PCI. The key secondary endpoint is the combined occurrence of death, recurrent myocardial infarction, urgent target vessel revascularisation, or thrombotic bailout at 30 days. The trial will continue until 958 patients are randomly assigned to treatment. CONCLUSIONS The On-TIME 2 trial evaluates whether pre-hospital initiation of high-dose bolus tirofiban is effective for patients with STEMI who are candidates to undergo PCI. This placebo-controlled trial will provide important evidence regarding the benefit of initiating a GP IIb/IIIa inhibitor, in combination with high-dose clopidogrel and unfractionated heparin.

Circumflex artery-related acute myocardial infarction : limited ECG abnormalities but poor outcome

Background. Circumflex (CX) artery-related myocardial infarction (MI) is less well represented in trials on ST-elevation acute myocardial infarction (STEMI), most often due to the absence of significant ST-segment elevation, and therefore the outcome of these patients is less well known. We aimed to compare the outcome of patients with CX versus right coronary artery (RCA) related STEMI in a large cohort of patients treated with primary angioplasty.Methods. A total of 1683 consecutive patients with STEMI were studied. Patients who lacked STsegment elevation were also included if they had persistent chest pain with signs of ischaemia or regional wall motion abnormalities on echocardiography. Coronary angioplasty was performed according to standard procedures. After the intervention, all patients received aspirin and clopidogrel or ticlopidine.Results. The infarct-related vessel was the CX in 229 patients (14%) and the RCA in 600 patients (36%). No differences in baseline characteristics were present. Mean extent of ST-segment elevation or deviation was significantly higher in patients with the RCA as infarct-related vessel. Enzymatic infarct size was significantly higher in the CXrelated MI (1338±1117 IU/l vs. 1806±1498 IU/l, p<0.001). Left ventricular ejection fraction <45% was more often present in patients with CXrelated MI (37 vs. 26%, p<0.01). Both short- and long-term mortality were significantly higher in the CX-related MI.Conclusion. This study emphasises the fact that CX-related infarction has a worse prognosis compared with RCA-related infarction. (Neth Heart J 2007;15:286-90.)

Impact of out-of-hospital cardiac arrest due to ventricular fibrillation in patients with ST-elevation myocardial infarction admitted for primary percutaneous coronary intervention: Impact of ventricular fibrillation in STEMI patients

Objective: Pre-hospital life-threatening ventricular tachycardia/fibrillation (VT/VF) is relatively common in the acute phase of ST-elevation myocardial infarction (STEMI). We evaluated the prognostic impact of out-of-hospital cardiac arrest (OHCA) due to VT/VF in non-selected patients with STEMI admitted for primary percutaneous coronary intervention (PCI). Methods: Prospective hospital registry was used to collect data of consecutive STEMI patients admitted to our hospital between 2005 and 2010. Patients with OHCA were identified from this registry, and their medical records were reviewed. Results: During the study period, 4653 patients were admitted with STEMI. Data regarding OHCA due to VT/VF was available in 4643 patients (99.8%). A total of 326 patients (7.0%) had OHCA due to VT/VF. Patients with OHCA were younger (60.3 ± 11.8 vs. 64.1 ± 12.9 year, p<0.001), less often had diabetes (5.2% vs. 12.4%, p<0.001) but more often presented with signs of heart failure (Killip class >1:17.5% vs. 7.7%, p<0.001) and cardiogenic shock (29.6% vs. 2.5%, p<0.001). Coronary angiography was performed in 97.5% of the patients. Coronary angiography and primary PCI were performed equally in both groups. In patients with OHCA, the left main artery (2.3% vs. 1.0%, p=0.04) and LAD (49.2% vs. 41.2%, p=0.01) were more often the culprit artery. In-hospital mortality was significantly higher among patients with OHCA (13.80% vs. 3.4%, p<0.001). However, in patients who were discharged alive from the hospital, the one-year mortality and the combined incidence of death and appropriate ICD therapy were similar in patients with and without OHCA. Conclusion: In a large non-selected STEMI patient population admitted for primary PCI, OHCA due to VT/VF was associated with higher in-hospital mortality but did not affect the long-term prognosis.

Primary percutaneous coronary intervention for ST-elevation myocardial infarction: From clinical trial to clinical practice

BACKGROUND More than 10 years ago, survival benefit of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) was demonstrated in several randomized trials. Since then, primary PCI has been implemented in routine daily practice and is in the guidelines of the preferred reperfusion therapy for patients with STEMI. We aimed to assess time-dependent changes in baseline characteristics, concomitant treatment and prognosis in patients with STEMI treated with primary PCI. METHODS Individual patient data from all 4732 patients admitted for primary PCI for STEMI between 1994 and 2004 in our hospital were recorded. Patient characteristics, concomitant treatment and one-year outcome were evaluated. RESULTS During the 11-year period, mean age and proportion of female were increasing, whereas door to balloon time decreased. Stent implantation rates increased from 2% to 84%. At discharge, prescription of aspirin, beta-blockers, statins, and ADP receptor blockers increased significantly. From 1994 to 2004, hospital stay shortened from 10.4 to 4.5 days p<0.001. Hospital and one-year mortality decreased, from 6.7% to 1.4% and 9% to 4.9% (both p<0.001), respectively. CONCLUSIONS Between 1994 and 2004, utilization of stents and recommended pharmacotherapies increased remarkably. Hospital stay and both hospital and one-year mortality decreased significantly.

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

BACKGROUND β-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 β-blockers reduces the infarct size in the current era is unknown. HYPOTHESIS We postulate that the early administration of β-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 β-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 elevated cardiac troponin T on admission in ST-segment elevation myocardial infarction

Background: In patients with ST-segment elevation acute myocardial infarction (STEMI), elevated cardiac troponin T (cTnT) on admission is associated with poorer outcomes despite early reperfusion. Presentation delay is thought to be the most important factor for the elevation of cTnT on admission. We evaluated presentation delay and other potential predictors of elevated cTnT on admission in patients treated with primary percutaneous coronary interventions (PCI) for STEMI. Methods: CTnT was measured upon arrival in the PCI centre in 444 patients with acute STEMI. An elevated cTnT was defined as > 0.05 μg/L. Results: The mean age was 61.7 years and patients were admitted at a median of 155 min after symptom onset. Almost 50% had an elevated cTnT on admission. Patients with a positive cTnT on admission were less likely to have successful primary PCI (87 versus 93%, P=0.048) and had significantly higher rates of one-year mortality (4.9 versus 1.3%, P=0.031). There was a significant association between presentation delay and the prevalence of elevated admission cTnT, but even patients with early presentation (<120 min after symptom onset) still had a high prevalence of elevated cTnT (33%). After multivariate analysis, apart from presentation delay, anterior MI location and higher age were independent predictors of elevated cTnT on admission. Conclusion: In patients with STEMI, the prevalence of elevated cTnT on admission is high, even in patients with early presentation. Independent predictors of elevated cTnT on admission are presentation delay, increasing age and anterior MI location.

External validity of ST elevation myocardial infarction trials: the Zwolle studies.

Background: Guidelines are mainly based upon results of randomised controlled clinical trials. However, due to low external validity of these trials, their results can not reasonably be applied to all patients in routine practice. In our hospital, all patients with ST‐elevation myocardial infarction (STEMI) are eligible for inclusion in one of our ongoing trials or registries. To asses differences between patients enrolled versus not‐enrolled in a trial or registry, we evaluated all patients with a discharge diagnose of STEMI during the study period. Methods: Retrospectively, individual patient data from all patients with a discharge diagnosis of STEMI between Jan 2001 and Dec 2001 were evaluated. Follow‐up data were obtained until Dec 2004. Results: A total of 583 patients were discharged with a diagnosis of STEMI. About 455 (78%) patients were enrolled in one of the ongoing clinical trials or registry and 128 were not. Not‐enrolled patients were significantly older; more often had a history of previous MI and had higher risk profiles. Multivariate analysis revealed that higher age was the only independent predictor for non enrolment. Not‐enrolled patients were more often treated conservatively and had a higher mortality rate (36% vs. 6%, P << 0.001). After multivariate analysis, nonenrolment (OR: 95% CI) 4.02 (1.98–8.16), age 1.07 (1.04–1.12), and diabetes 2.39 (1.17–4.89) were the only independent predictors of long term mortality. Conclusions: This study shows important differences in baseline characteristics, treatment, and prognosis between patients with STEMI who were enrolled or not in a trial. To better reflect daily clinical practice, guidelines should also consider results of observational studies of unselected patients.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

Objective The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. Methods ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. Results 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. Conclusions In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163. Trial registration number 39230163; Post-results.