Maurizio Trapani

A Clinical Trial Comparing Primary Stenting of the Infarct-Related Artery With Optimal Primary Angioplasty for Acute Myocardial Infarction: Results From the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) Trial

OBJECTIVES This study sought to compare stenting of the primary infarct-related artery (IRA) with optimal primary percutaneous transluminal coronary angioplasty (PTCA) with respect to clinical and angiographic outcomes of patients with an acute myocardial infarction. BACKGROUND Early and late restenosis or reocclusion of the IRA after successful primary PTCA significantly contributes to increased patient morbidity and mortality. Coronary stenting results in a lower rate of angiographic and clinical restenosis than standard PTCA in patients with angina and with previously untreated, noncomplex lesions. METHODS After successful primary PTCA, 150 patients were randomly assigned to elective stenting or no further intervention. The primary end point of the trial was a composite end point, defined as death, reinfarction or repeat target vessel revascularization as a consequence of recurrent ischemia within 6 months of randomization. The secondary end point was angiographic evidence of restenosis or reocclusion at 6 months after randomization. RESULTS Stenting of the IRA was successful in all patients randomized to stent treatment. At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p=0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p=0.001). CONCLUSIONS Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.

Relation between ST-segment changes and myocardial perfusion evaluated by myocardial contrast echocardiography in patients with acute myocardial infarction treated with direct angioplasty

The aim of this study was to evaluate the relation between myocardial perfusion and ST-segment changes in patients with acute myocardial infarction treated with successful direct angioplasty. Thirty-seven patients, successfully treated with direct angioplasty, underwent myocardial contrast echocardiography before and after angioplasty. The sum of ST-segment elevation divided by the number of the leads involved (ST-segment elevation index) was calculated at 1, 5, 10, 20, and 30 minutes after restoration of a Thrombolysis In Myocardial Infarction trial grade 3 flow. After recanalization, myocardial reperfusion within the risk area was observed in 26 patients, whereas a no-reflow phenomenon occurred in 11. In patients with myocardial reperfusion, the ST-segment elevation index progressively declined, whereas in patients with no reflow, no significant change was observed. Reduction of > or = 50% in the ST-segment elevation index occurred in 20 of the 26 patients with reflow and in 1 of the 11 with no reflow (p = 0.0002). An additional increase of > or = 30% in the ST-segment elevation index occurred in 3 patients with reflow and in 7 with no reflow (p = 0.003). Sensitivity, specificity, positive and negative predictive values, and accuracy of the reduction in the ST-segment elevation index for predicting microvascular reflow were 77%, 91%, 95%, 62%, and 81%, respectively. The corresponding values of the increase in ST-segment elevation index for predicting no reflow were 64%, 88%, 70%, 85%, and 81%, respectively. In conclusion, after successful angioplasty, different patterns of myocardial perfusion are associated with different ST-segment changes. Analysis of ST-segment changes predicts the degree of myocardial reperfusion.

Systematic direct angioplasty and stent-supported direct angioplasty therapy for cardiogenic shock complicating acute myocardial infarction : In-hospital and long-term survival

OBJECTIVES This prospective observational study was conducted to examine the apparent impact of a systematic direct percutaneous transluminal coronary angioplasty (PTCA) strategy on mortality in a series of 66 consecutive patients with acute myocardial infarction (AMI) complicated by cardiogenic shock, and to analyze the predictors of outcome after successful direct PTCA. BACKGROUND Previous studies have reported encouraging results with PTCA in patients with AMI complicated by cardiogenic shock, but a biased case selection for PTCA may have heavily influenced the observed outcomes. METHODS All patients admitted with AMI were considered eligible for direct PTCA, including those with the most profound shock, and no upper age limit was used. The treatment protocol also included stenting of the infarct-related artery for a poor or suboptimal angiographic result after conventional PTCA. RESULTS Between January 1995 and March 1997, 364 consecutive patients underwent direct PTCA, and in 66 patients AMI was complicated by cardiogenic shock. In patients with cardiogenic shock, direct PTCA had a success rate of 94%; an optimal angiographic result was achieved in 85%; primary stenting of the infarct-related artery was accomplished in 47%; and the in-hospital mortality rate was 26%. Univariate analysis showed that patient age, chronic coronary occlusion and completeness of revascularization were significantly related to in-hospital mortality. The mean follow-up period was 16 +/- 8 months. Survival rate at 6 months was 71%. Comparison of event-free survival in patients with a stented or nonstented infarct-related artery suggests an initial and long-term benefit of primary stenting. CONCLUSIONS Systematic direct PTCA, including stent-supported PTCA, can establish a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in the great majority of patients presenting with AMI and early cardiogenic shock. High performance criteria, including new devices such as coronary stents, should be considered in randomized trials where mechanical revascularization therapy is being tested.

Relation between preintervention angiographic evidence of coronary collateral circulation and clinical and angiographic outcomes after primary angioplasty or stenting for acute myocardial infarction

It is unknown if collateral circulation (CC) has a beneficial effect on outcomes of patients who undergo mechanical intervention in the first hours after onset of acute myocardial infarction (AMI). This study analyzes the relation between CC and outcome in patients with AMI who underwent primary angioplasty or stenting within 6 hours of symptom onset. The analysis was performed in a series of 1,164 consecutive patients. The contribution of clinical, angiographic, and procedural variables to the angiographic and clinical outcomes was evaluated by multivariate logistic regression analysis and the Cox proportional hazard model, respectively. Of 1,164 patients, 264 (23%) had angiographic evidence of CC. Patients with CC had a lower incidence of diabetes (11% vs 16%, p = 0.033), anterior AMI (41% vs 55%, p <0.001), cardiogenic shock (9% vs 14%, p = 0.029), anterograde TIMI grade flow >1 (10% vs 21%, p <0.001), and a greater incidence of preinfarction angina (43% vs 32%, p = 0.001), multivessel disease (59% vs 47%, p = 0.001), and total chronic occlusion (20% vs 10%, p <0.001). At 6 months, the mortality rate was lower in patients with CC compared with patients without CC (4% vs 9%, p = 0.011), whereas there were no differences in the incidence of reinfarction, target vessel revascularization, and angiographic restenosis. After multivariate analysis, CC did not emerge as a significant variable in relation to 6-month clinical and angiographic outcomes. CC does not exert a protective effect in patients who undergo mechanical intervention in the first 6 hours of AMI onset.

Restenosis after coronary stenting in current clinical practice

BACKGROUND Randomized trials have demonstrated that planned coronary stenting may lower restenosis rate in patients with de novo short lesions. In a prospective study we sought to determine the frequency of restenosis, reocclusion, and adverse cardiovascular events after coronary stenting in a series of 258 consecutive nonselected patients, including those with complex lesions not fulfilling past and ongoing randomized trial criteria for stent implantation. METHODS Criteria for stenting were as follows: (1) dissection associated with occlusion or threatened closure, (2) a residual percentage stenosis > 30% or nonocclusive dissection, (3) restenotic lesion or chronic total occlusion. RESULTS In most cases (89%) the target lesion had two or more unfavorable morphologic characteristics, whereas only 11% of target lesions could be classified as type A or B1 lesions. Overall, the 6-month restenosis rate was 23%. By use of subgroup analysis restenosis rate was found to range widely, from 11% to 46%. With multivariate analysis, only four variables were found to be independently related to restenosis: age > 63 years (odds ratio [OR] = 2.651, p = 0.011), female sex (OR = 3.807, p = 0.002), lesion length > 12 mm (OR 3.185, p = 0.002), and type C lesion (OR 2.527, p = 0.014). CONCLUSIONS Results from randomized trials on coronary stenting cannot be extrapolated to current clinical practice because most of the treated lesions do not fulfill the criteria adopted in these studies for stent implantation. The restenosis rate is nearly four times greater for long and complex lesions treated by multiple stent implantation as compared with simple lesions, and additional studies need to be performed to evaluate the efficacy of stenting on these lesions.

Sex-based differences in clinical and angiographic outcomes after primary angioplasty or stenting for acute myocardial infarction.

A paucity of data exists on the importance of gender in contributing to the mortality rate after primary angioplasty, although it is has been shown that women with acute myocardial infarction (AMI) are less likely than men to undergo reperfusion treatments. This study analyzes gender-related differences in 6-month clinical and angiographic outcomes in nonselected patients with AMI who underwent primary angioplasty or stenting. We compared clinical and angiographic outcomes of 230 women and 789 men who underwent primary angioplasty or stenting from January 1995 to August 1999. The women were older than the men, and had a greater incidence of diabetes and cardiogenic shock. The 6-month mortality rate was 12% in women and 7% in men (p = 0.028). Nonfatal reinfarction occurred in 3% of the women and in 1% of the men (p = 0.010). There were no differences in repeat target vessel revascularization rates. After multivariate analysis, gender did not emerge as a significant variable in relation to 6-month mortality or to the combined end point of death, reinfarction, and repeat target vessel revascularization. Both women and men with stented infarct arteries had lower restenosis rates (29% and 26%, respectively) than patients without stents (52% and 39%, repectively). The results of outcome analysis in nonselected patients suggest that sex is not an independent predictor of mortality after primary angioplasty for AMI, and that the benefit of primary stenting is similar in men and women.

Clinical and angiographic outcome after coronary arterial stenting with the Carbostent

The Carbostent is a new balloon-expandable, stainless steel, tubular stent with innovative multicellular design and unique turbastratic carbon coating (Carbofilm). This open nonrandomized 2-center study assesses the immediate and long-term clinical and angiographic outcomes after Carbostent implantation in patients with native coronary artery disease. The Carbostent was implanted in 112 patients with 132 de novo lesions. Most patients (55%) had unstable angina, and 38% of lesions were type B2-C. The mean lesion length was 12.5 +/- 7.0 mm, and 29% of lesions were > 15 mm in length. No stent deployment failure occurred, as well as acute or sub-acute stent thrombosis. The 6-month event-free survival was 84 +/- 4%. One patient with a stented right coronary artery and no restenosis at the angiographic follow-up died after 6 months of fatal infarction due to abrupt closure of a nontarget vessel. In-hospital non-Q-wave myocardial infarction occurred in 1 patient, and 11 patients had repeat target lesion revascularization (target lesion revascularization rate 10%). The 6-month angiographic follow-up was obtained in 108 patients (96%) (127 lesions). Angiographic restenosis rate was 11%. The loss index was 0.29 +/- 0.28. The results of this study indicate a potential benefit of Carbostent for the prevention of stent thrombosis and restenosis in these relatively high-risk patients. A larger trial is being planned to confirm these promising results.

Rapid reduction of ST-segment elevation after successful direct angioplasty in acute myocardial infarction.

The aim of this study was to evaluate whether assessment of ST-segment changes in the 12-lead electrocardiogram from admission to 30 minutes after successful direct coronary angioplasty can predict myocardial damage and functional outcome in patients with acute myocardial infarction (AMI). Of 158 consecutive patients, 117 (92 men, aged 61 +/- 11 years) were prospectively classified into 2 groups: group 1, <50% reduction in ST-segment elevation in a single selected lead (42 patients); group 2, > or =50% reduction in ST-segment elevation (75 patients). Baseline characteristics were similar except for anterior wall AMI and Killip class >2, which were more prevalent in group 1. Peak creatine kinase was significantly higher in group 1 (3,690 +/- 2,809 vs 2,592 +/- 1,960 U/L; p = 0.018). One-month echocardiograms were obtained in 102 patients (87%). Infarct zone wall motion score index decreased in both groups, but this reduction was higher in group 2 (p <0.001). Functional recovery (>0.22 decrease in infarct zone wall motion score index) was observed in 34% of group 1 and in 78% of group 2 patients (p <0.001). One-month left ventricular ejection fraction was higher in group 2 (p <0.001). At multivariate analysis, reduction of ST-segment elevation was the only independent predictor of functional recovery (p <0.001). In conclusion, ST-segment analysis provides rapid and inexpensive information allowing identification of patients who are likely to benefit the most from myocardial reperfusion as early as 30 minutes after the last balloon inflation.

Abciximab therapy improves survival in patients with acute myocardial infarction complicated by early cardiogenic shock undergoing coronary artery stent implantation

The impact of abciximab therapy on mortality in patients with acute myocardial infarction (AMI) who are undergoing infarct-related artery (IRA) stent implantation, which is complicated by cardiogenic shock (CS) due to predominant ventricular failure has not been established, whereas concluded randomized trials comparing IRA stenting plus abciximab with IRA stenting alone in patients with AMI have produced conflicting results. Moreover, these trials have excluded patients with CS from randomization. This study sought to determine whether IRA stenting plus abciximab treatment has an impact on 1-month mortality compared with IRA stenting alone in consecutive patients with AMI complicated by CS due to predominant ventricular failure. Of 77 patients with CS and IRA stenting, 44 had abciximab therapy, whereas 33 underwent primary IRA stenting alone. There were no differences between groups in major baseline characteristics except for a higher incidence of women in the stent alone group compared with the abciximab group (36% vs 14%, p = 0.020). The 1-month overall mortality rate was 18% in the abciximab group and 42% in the stent alone group (p <0.020). There were no differences between groups in reinfarction and target vessel revascularization rates. Multivariate analysis showed that abciximab therapy was the only variable that was independently related to 1-month mortality (odds ratio 0.36; 95% confidence intervals 0.15 to 0.86, p = 0.021). The results of this study support the use of abciximab in patients with AMI complicated by CS who are undergoing IRA stent implantation. The mechanism of the clinical benefit of abciximab at 1 month was not related to the patency of the IRA.

Five year outcome after primary coronary intervention for acute ST elevation myocardial infarction : results from a single centre experience

Objectives: To analyse the five year outcome of unselected patients with acute myocardial infarction (AMI) treated by primary percutaneous coronary intervention (PCI). Setting: High volume PCI tertiary centre. Design and results: The study was based on a sample of 1009 consecutive patients with ST elevation AMI treated by primary PCI. The mean (SD) clinical follow up was 51 (21) months and the follow up rate was 97.8%. The overall mortality was 20% and cardiac mortality was 16%. Non-fatal reinfarction rate was 5% and additional revascularisation procedure rate was 19%. Hospitalisation for heart failure was needed by 42 patients (4%). The variables related to mortality in multivariate Cox analysis were age (hazard ratio (HR) 1.054, 95% confidence interval (CI) 1.039 to 1.069, p < 0.0001), cardiogenic shock (HR 2.985, 95% CI 2.157 to 4.129, p < 0.0001), previous myocardial infarction (HR 1.696, 95% CI 1.199 to 2.398, p  =  0.0003), and the presence of multivessel coronary artery disease (HR 1.820, 95% CI 1.317 to 2.514, p  =  0.0003). Each additional high risk feature was associated with a relative risk for five year death of 2.328 (95% CI 2.048 to 2.646, p < 0.0001). Conclusions: The satisfactory results of routine mechanical revascularisation strategy in AMI were maintained during several years of follow up. Patients at risk of death during long term follow up may be identified by simple clinical and angiographic characteristics, such as old age, cardiogenic shock, previous myocardial infarction, and multivessel coronary artery disease. The risk of death progressively increases with the number of these high risk features.