Abstract: OBJECTIVE: To evaluate the prognostic role of postprocedural single-lead residual ST-segment deviation for electrocardiographic evaluation of myocardial perfusion in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. DESIGN: Prospective observational clinical cohort study. SETTING: Tertiary referral centre. PATIENTS: 1660 patients treated with primary angioplasty for STEMI. MAIN OUTCOME MEASURE: Mortality at 1-year follow-up. RESULTS: Single-lead ST-segment deviation significantly correlated with infarct size, predischarge ejection fraction, distal embolisation and myocardial blush grade 3. At 1-year follow-up, 63 patients had died. The method correlated well with 1-year mortality. At multivariate analysis, after correction for baseline demographic, clinical and angiographic variables, postprocedural single-lead ST-segment deviation showed better accuracy than residual single-lead ST-segment elevation or resolution and residual 12-lead ST-segment deviation. CONCLUSIONS: This study showed that maximal residual ST-segment deviation in a single lead at 3 hours after the procedure is an easy and accurate predictor of 1-year mortality after primary angioplasty for STEMI.
Abstract: BACKGROUND: The benefits of adjunctive mechanical devices to prevent distal embolization in patients with acute myocardial infarction (AMI) are still a matter of debate. The aim of this meta-analysis was to combine data from all randomized trials conducted with adjunctive mechanical devices to prevent distal embolization in AMI. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and Central) from January 1990 to October 2006, scientific session abstracts (from January 1990 to October 2006), and oral presentation and/or expert slide presentations (from January 2002 to October 2006) (on the Transcatheter Cardiovascular Therapeutics, American Heart Association, European Society of Cardiology, American College of Cardiology, and European Percutaneous Revascularization Web sites). We examined all randomized trials on adjunctive mechanical devices to prevent distal embolization in AMI. The following key words were used: randomized trial, myocardial infarction, reperfusion, primary angioplasty, rescue angioplasty, thrombectomy, thrombus aspiration, proximal or distal protection device, X-sizer, Diver, Export Catheter, Angiojet, Rescue catheter, Pronto catheter, PercuSurge, GuardWire, FilterWire, and SpideRX. Disagreements were resolved by consensus. RESULTS: A total of 21 trials with 3721 patients were included (1877 patients [50.4%] in the adjunctive mechanical device group and 1844 [49.6%] in the control group); 1502 patients (40.3%) were randomized in trials with distal protection devices, and 2219 patients (59.7%) were randomized in trials with thrombectomy devices. Adjunctive mechanical devices were associated with a higher rate of postprocedural TIMI 3 flow (89.4% vs 87.1%, P = .03), a significantly higher rate of postprocedural myocardial blush grade 3 (48.8% vs 36.5%, P < .0001), and less distal embolization (6.0% vs 9.3%, P = .008), without any benefit in terms of 30-day mortality (2.5% vs 2.6%, P = .88). No difference was observed in terms of coronary perforations (0.27% vs 0.07%, P = .24). CONCLUSIONS: This meta-analysis demonstrates that, among patients with AMI treated with percutaneous coronary intervention, the use of adjunctive mechanical devices to prevent distal embolization is associated with better myocardial perfusion and less distal embolization, but without an apparent improvement in survival.
Abstract: BACKGROUND: Optimal epicardial recanalization does not guarantee optimal myocardial perfusion. The aim of the current study was to evaluate angiographic and electrocardiographic markers of reperfusion in the prediction of infarct size in patients with STEMI undergoing successful primary angioplasty. METHODS: Our population is represented by 270 STEMI patients with ST successful primary angioplasty (postprocedural TIMI 3 flow and residual stenosis <50%) with available corrected TIMI frame count (cTFC), myocardial blush grade (MBG), ST-segment resolution and enzymatic infarct size (peak CK-MB) analyses. RESULTS: A significant linear relationship with enzymatic infarct size was observed for all markers of reperfusion, except for ST-segment resolution. These data were confirmed even when analyzed as continuous variables in case of cTFC (r=0.13, p=0.035), postprocedural residual cumulative ST-segment elevation (r=0.41, p<0.0001) and deviation (r=0.45, p<0.0001). At multivariate analysis applied to postprocedural angiographic and electrocardiographic markers of reperfusion, cumulative residual ST-segment deviation, myocardial blush grade, and corrected TIMI frame count were independent predictors of enzymatic infarct size. CONCLUSIONS: This study showed that, among patients with STEMI treated by primary angioplasty, cTFC, MBG and cumulative residual ST-segment deviation are independent predictors of infarct size. Therefore, angiography and electrocardiography may provide complementary information in the evaluation of myocardial perfusion.
Abstract: BACKGROUND: Recurrent infarction after fibrinolytic therapy has been shown to be associated with increased mortality. The aim of this study was to analyze predictors and outcome of reinfarction in a consecutive series of patients undergoing primary angioplasty. METHODS: Our population is represented by a total of 1955 patients with ST-segment elevation myocardial infarction treated by primary angioplasty between 1997 to 2002. All clinical, angiographic, and follow-up data were prospectively collected. Early reinfarction was defined when two clinical criteria were satisfied within 30 days after the procedure: (1) recurrent ischemic symptoms for >15 minutes after resolution of symptoms from initial MI; (2) new ST-T-wave changes or new Q waves; (3) reelevation in creatine kinase (CK) or CK-MB to higher levels than normal (or by another 20% if already higher than normal). RESULTS: Early reinfarction was observed in 75 (3.8%) patients. At multivariate analysis, advanced Killip class (P = .002), poor preprocedural TIMI flow (P = .014), administration of IIb-IIIa inhibitors (P = .02), and diabetes (P = .038) were independent predictors of 30-day reinfarction. A total of 107 (5.6%) patients had died. Early reinfarction was associated with a significantly higher mortality (22.7% vs 4.9%, P < .001), even after adjustment for confounding factors (blood pressure, diabetes, Killip class, preprocedural TIMI flow, coronary stenting, multivessel disease, anterior infarct location, preprocedural stenosis, and administration of IIb-IIIa inhibitors) (HR 3.32, 95% CI 1.88-5.84, P < .0001). CONCLUSIONS: This study showed that, among patients undergoing primary angioplasty for ST-segment elevation myocardial infarction, advanced Killip class at presentation, poor preprocedural TIMI flow, the use of IIb-IIIa inhibitors, and diabetes are independently associated with 30-day reinfarction. Early reinfarction is an independent predictor of 1-year mortality.
Abstract: BACKGROUND: Primary stenting for ST-segment elevation myocardial infarction (STEMI) has been shown to improve the outcome because of the benefits in terms of restenosis. However, still controversial are the benefits in terms of reperfusion. In the Zwolle-6 randomized trial, a consecutive cohort of patients with STEMI was randomized to balloon angioplasty or stenting, without exclusion criteria. In this study, we analyzed data on myocardial perfusion and the extent of myocardial necrosis. METHODS: From April 1997 to October 2001, a total of 1683 consecutive patients with STEMI were randomized to stenting or balloon angioplasty. No exclusion criteria were applied. Myocardial perfusion was evaluated by myocardial blush grade and ST-segment resolution. The extent of myocardial necrosis was evaluated by enzymatic infarct size and predischarge ejection fraction. All data were prospectively collected. RESULTS: A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in balloon group underwent primary angioplasty. The 2 groups showed similar baseline characteristics. No difference was observed between stent and balloon in myocardial blush grade, complete ST-segment resolution, distal embolization, enzymatic infarct size, and predischarge ejection fraction at both intention-to-treat and actual treatment analysis, even when restricted to patients with anterior infarction. Time delay to treatment (earlier or later than 6 hours) did not affect the results. No difference was observed in 1-year mortality (6.0% vs 5.9%, P = NS). CONCLUSIONS: As compared with balloon angioplasty, routine stenting does not improve myocardial perfusion, the rate of distal embolization, and the extent of myocardial necrosis in a large cohort of unselected patients with STEMI.
Abstract: BACKGROUND: Primary angioplasty has been shown to improve outcomes in selected patients with ST-segment elevation myocardial infarction. However, no information has been reported so far in small vessels. In the Zwolle-6 randomized trial, consecutive patients with ST-segment elevation myocardial infarction were randomized to stenting or to balloon angioplasty without any exclusion criterion. In this study, we present data on patients with small vessels (< 3.0 mm). METHODS: From April 1997 to October 2001, 798 patients randomized to balloon angioplasty or to stenting before their initial angiogram underwent primary angioplasty of small vessels, defined according to a postprocedural reference diameter < or = 3 mm. One-year follow-up data were available from all patients. RESULTS: Three hundred eighty-seven patients were randomized to stent, whereas 411 were to balloon. The crossover rates from balloon to stent and from stent to balloon were 28% and 13.9%, respectively (P < .001). The groups were comparable in terms of postprocedural TIMI flow, myocardial blush grade, distal embolization, and ST-segment resolution. No difference was observed in 1-year mortality (7.2% vs 5.8%, P = not significant [NS]), target vessel revascularization (17.8% vs 22.1%, P = NS), and major adverse cardiac events (24.8% vs 29.0%, P = NS) between the groups. CONCLUSIONS: As compared with balloon angioplasty, routine stenting does not seem to improve clinical outcomes in patients undergoing primary angioplasty of small vessels. Future trials are certainly needed to evaluate the safety and benefits of drug-eluting stents in this high-risk subset of patients.
Abstract: BACKGROUND: Statin therapy can reduce long-term mortality in several subgroups of patients with coronary artery disease, but the benefits after primary angioplasty for ST-segment elevation myocardial infarction (STEMI) have yet to be established. The aim of the current study was to determine whether statin therapy is associated with a reduction in mortality in patients with STEMI treated with primary angioplasty. METHODS: Our population is represented by a total of 1513 consecutive in-hospital survivors treated with primary angioplasty for STEMI between April 1997 and October 2001. Patients were divided in two groups according to statin therapy (statin group, n=893; control group, n=620) at discharge. Clinical follow-up was performed at 1 year. A propensity score, built on the basis of variables independently associated with statin prescription, was used to investigate the benefits from statin therapy in subgroups of patients that were homogeneous in terms of baseline clinical and angiographic characteristics. RESULTS: At 1-year follow-up statin therapy was associated with a significantly lower mortality (1.2% versus 7.1%, R(2) [95% CI]=0.16 [0.09-0.32], p<0.0001). These benefits were confirmed in all subgroups according to the propensity score, and at multivariate analysis (adjusted R(2) [95% CI]=0.24 [0.12-0.47], p<0.0001). CONCLUSIONS: Statin therapy at discharge was associated with a significant reduction in 1-year mortality after primary angioplasty for STEMI. Therefore, the use of statins is highly recommended in these patients.
Abstract: The aim of the present study was to evaluate the impact of interhospital delay on mortality in 616 patients with ST-segment elevation myocardial infarction transferred for primary angioplasty to our hospital. Longer interhospital delay was associated with impaired perfusion, larger infarct size, and higher 1-year mortality (adjusted RR 1.5, 95% confidence interval 1.07 to 2.12; p = 0.019). These results suggest that in patients with ST-segment elevation myocardial infarction transferred for primary angioplasty, all efforts should be made to reduce time to treatment.
Abstract: Patients with diabetes mellitus (DM) have an adverse prognosis after ST-segment elevation myocardial infarction (STEMI). Whether DM was associated with impaired myocardial reperfusion after successful primary percutaneous coronary intervention for STEMI was investigated. Myocardial reperfusion was assessed by ST-segment resolution and myocardial blush grade (MBG). A total of 386 patients were studied, of whom 64 (17%) had DM. These patients more frequently had reduced MBG (20% vs 10%, p = 0.02) and incomplete ST-segment resolution (55% vs 35%, p = 0.02) compared with patients without DM. After multivariate analysis, DM was still associated with impaired ST resolution (odds ratio 2.1, p = 0.03) and reduced MBG (odds ratio 2.2, p = 0.03).
Abstract: Several studies have shown that suboptimal myocardial perfusion may be observed despite optimal epicardial recanalisation in patients undergoing primary angioplasty for ST-segment elevation myocardial infarction (STEMI), resulting in unfavourable outcome. The aim of the current study was to evaluate the benefits in myocardial perfusion and mortality from adjunctive tirofiban administration in patients undergoing primary angioplasty for (STEMI). Atotal of 1,969 patients with STEMI treated by primary angioplasty represent the population of the current study. All clinical, angiographic and follow-up data were prospectively collected. Tirofiban was administrated in 481 patients (24.4%) (all before angioplasty). Tirofiban was associated with less distal embolisation (11.7% vs 16.1%, p = 0.048), better postprocedural MBG 3 (50.9% vs 39.7%, adjusted p < 0.0001) and a significant reduction in 1-year mortality (3% vs 6.4%, adjusted p = 0.045). The benefits in mortality were confirmed in all subgroups identified according to the quartiles of the propensity score. This study shows that, when compared to control group, adjunctive tirofiban before primary angioplasty for STEMI is associated with better myocardial perfusion and a reduction in 1-year mortality.
Abstract: AIMS: It is still unknown whether impaired myocardial perfusion helps to explain the higher mortality observed with ageing in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary angioplasty. METHODS AND RESULTS: In 1548 consecutive patients with STEMI treated with primary angioplasty, myocardial perfusion was evaluated by myocardial blush grade (MBG) and ST-segment resolution. All clinical and follow-up data were prospectively collected. Advanced age was associated with a significantly higher clinical and angiographic risk profile. We found a linear relationship between increasing age, decreased myocardial perfusion, and higher 1-year mortality. After adjustment for baseline potential confounding variables, increased age was still significantly associated with impaired myocardial blush (MBG 0-1) (P=0.028), and ST-segment resolution (<50%) (P=0.007). At multivariable analysis both age (P<0.0001) and poor myocardial perfusion (P<0.0001) were independent predictors of 1-year mortality. CONCLUSION: This study shows that impaired reperfusion is an additional determinant of the poor outcome observed with advanced age in patients with STEMI undergoing mechanical revascularization.
Abstract: The aim of the present study was to evaluate the additional prognostic effect of ST-depression resolution in 610 patients who had ST-elevation myocardial infarction and underwent successful primary angioplasty (postprocedural Thrombolysis In Myocardial Infarction 3 flow and complete resolution of ST-segment elevation). Incomplete resolution of ST-segment depression (<70%) was observed in 50 patients (8.2%). These patients were older, had a higher Killip's class at presentation, had larger infarcts, and had an increased 1-year mortality (10% vs 2%, p = 0.0004). At multivariate analysis, incomplete resolution of ST-segment depression was an independent predictor of 1-year mortality (p = 0.028).
Abstract: CONTEXT: The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate. OBJECTIVE: To combine data from all randomized trials conducted with abciximab in STEMI. DATA SOURCES: Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004. STUDY SELECTION: We examined all completed, published, randomized trials of abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and abciximab. DATA EXTRACTION: Information on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus. DATA SYNTHESIS: Eleven trials were analyzed, involving 27115 patients (12,602 [46.5%] in the abciximab group, 14,513 [53.5%] in the control group). When compared with the control group, abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36). CONCLUSIONS: This meta-analysis shows that, when compared with the control group, adjunctive abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with abciximab in association with fibrinolysis.
Abstract: 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.
Abstract: The present study investigated any seasonal variation in myocardial perfusion, enzymatic infarct size, and 1-year mortality in 1,548 patients who underwent primary angioplasty for ST-segment elevation myocardial infarction. No seasonal variation was observed in patients' demographic and clinical characteristics. No difference was observed in the prevalence of heart failure at presentation and in myocardial perfusion, enzymatic infarct size, and 1-year mortality.
Abstract: BACKGROUND: The analysis of ST-segment resolution is a well established and easy method to assess myocardial perfusion after reperfusion therapy for ST-segment elevation myocardial infarction (STEMI). The aim of the current study was to identify an easy and practical instrument for patients' prognostic stratification after angioplasty for STEMI by the use of only postprocedural ST-segment analysis. METHODS: Our population is represented by a total of 1286 patients treated with primary angioplasty for STEMI. Residual ST-segment elevation and deviation were analyzed at 3 hours after revascularization. One-year follow-up data were collected prospectively in all patients. RESULTS: Patients with impaired ST-segment normalization were older, with larger prevalence of diabetes, anterior infarction, hypertension, signs of heart failure at presentation, lower rate of postprocedural thrombolysis in myocardial infarction 3 flow, myocardial blush grades 2 to 3, and successful reperfusion. A linear relationship was found between both residual cumulative ST-segment elevation and deviation with 1-year mortality. At multivariate analysis, postprocedural residual cumulative ST deviation (RR 1.31, 95% CI 1.06-1.63, P = .014), but not residual cumulative ST elevation (RR 0.95, 95% CI 0.55-1.67, P = .87), was an independent predictor of 1-year mortality. Furthermore, we found that residual cumulative ST-segment deviation provides better prognostic information (area receiver operating characteristic [ROC] = 0.733) than ST-segment elevation resolution (area ROC = 0.636) or ST-segment deviation resolution (area ROC = 0.660) in terms of 1-year mortality. These data were confirmed for both anterior and nonanterior infarct location. CONCLUSION: This study showed that postprocedural residual cumulative ST-segment deviation is an independent prognostic parameter in patients treated with primary angioplasty, providing even better prognostic information than ST-segment resolution.
Abstract: BACKGROUND: To evaluate the impact of adjunctive high-dose glucose-insulin-potassium (GIK) on ST-segment elevation resolution in patients with ST-segment elevation myocardial infarction (MI). METHODS: As part of a randomized controlled trial of GIK versus no GIK in patients treated with primary percutaneous coronary intervention (PCI) for ST-elevation MI in a tertiary referral center, we analyzed ST-segment elevation resolution. Paired electrocardiographic recordings (baseline and 3 hours after primary PCI) were available in 612 (65%) of 940 patients. RESULTS: We analyzed paired electrocardiograms of 310 patients randomized to GIK and 302 control patients. Baseline characteristics of the groups were comparable. Combined complete (>70%) and partial (30%-70%) resolution was more commonly observed in the GIK group (87%) when compared with the control group (78%), odds ratio 1.92 (95% CI 1.23-3.02, P = .004); 1-year mortality was lower in patients with combined complete and partial resolution compared with patients without resolution (3.8% vs 10.3%, P = .011). There was no difference in 1-year mortality between GIK and control patients (5.5% vs 4.3%, P = .58). CONCLUSIONS: In patients with ST-elevation MI treated with primary PCI, addition of GIK is associated with improved ST-segment elevation resolution. ST-segment elevation resolution is related to improved 1-year survival. No benefit of GIK on 1-year outcome was observed. Future trials should investigate whether GIK-induced improvement of ST-segment elevation resolution results in more favorable clinical outcome.
Abstract: BACKGROUND: Little is known about whether the physiological factors that determine the circadian variation in ST-segment elevation myocardial infarction (STEMI) onset and thrombolysis efficacy may affect myocardial perfusion and long-term outcome of patients with STEMI treated with primary angioplasty. METHODS: Our study population consisted of 1548 consecutive patients with STEMI treated by primary angioplasty between April 1997 and October 2001. All clinical, angiographic, and follow-up data were collected. RESULTS: Most of the patients (65.2%) were treated at daytime (between 8 AM and 8 PM). Patients treated between 1 PM and midnight had a lower prevalence of anterior infarction and longer door-to-balloon time, whereas the shortest ischemic time and the largest use of stent were observed in patients treated between midnight and 4 AM Patients treated between 4 and 8 AM showed the worst outcome in terms of myocardial perfusion, enzymatic infarct size, and 1-year outcome, whereas patients treated between 8 AM and 4 PM had the best myocardial perfusion and lowest 1-year mortality rate. After correction for baseline confounding factors, the time of treatment (between 4 and 8 AM) was still significantly associated with 1-year mortality (relative risk 1.92, 95% CI 1.13-3.26, P = .016). CONCLUSIONS: This is the first study showing a significant relationship between the time of treatment, myocardial perfusion, and long-term mortality in patients with STEMI undergoing mechanical reperfusion.
Abstract: BACKGROUND: Several studies have shown that patency of the epicardial vessel does not guarantee optimal myocardial perfusion in patients undergoing primary angioplasty for ST-segment elevation myocardial infarction (STEMI). The aim of the current study was to identify clinical and angiographic correlates of unsuccessful reperfusion by the use of myocardial blush grade in a large consecutive cohort of STEMI patients. METHODS: Our population is represented by a total of 1,548 consecutive patients with STEMI treated by primary angioplasty at our institution. All clinical and angiographic data were prospectively collected. Successful reperfusion was defined as postprocedural thrombolysis in myocardial infarction (TIMI) 3 flow with myocardial blush grades 2 to 3. RESULTS: Poor myocardial reperfusion was observed in 358 patients (23.1%) and was associated with a significantly larger infarct size (1838 [350-3387] vs 1187 [607-2257], P < .0001) and lower ejection fraction (41 [31-48.2] vs 65 [36.5-52.5] P < .0001). At multivariate analysis, preprocedural TIMI flow 0 to 1, anterior infarction, ischemic time, postprocedural residual stenosis, advanced Killip class at presentation, and age were identified as independent predictors of poor myocardial reperfusion. At 1-year follow-up, a total of 92 patients (5.9%) had died. At multivariate analysis, including clinical and angiographic variables, unsuccessful reperfusion was an independent predictor of 1-year mortality (relative risk 3.11, 95% CI 1.99-4.87, P < .0001). CONCLUSIONS: The prevalence of poor myocardial reperfusion is relatively high in patients undergoing primary angioplasty for STEMI, with a significant impact on 1-year mortality. Preprocedural TIMI flow, anterior infarction, ischemic time, Killip class at presentation, and age were independently associated with unsuccessful reperfusion. Future research should be focused on these high-risk patients, and treatment strategies should be developed to improve myocardial perfusion and clinical outcome.
Abstract: BACKGROUND: Although the benefits of primary angioplasty for ST-segment elevation myocardial infarction (STEMI) have been demonstrated, the prognostic role of early recanalization in these patients has yet to be investigated. The aim of the study was to evaluate the impact of preprocedural Thrombolysis in Myocardial Infarction (TIMI) flow on the extent of myocardial reperfusion in patients with anterior STEMI treated with primary angioplasty. METHODS: Our population consisted of 754 consecutive patients with anterior STEMI treated by primary angioplasty from April 1997 to October 2001. All angiographic, clinical, and follow-up data were prospectively collected. RESULTS: Preprocedural TIMI flow was related to postprocedural TIMI 3 flow (P < .0001), ST-segment resolution (P = .009), myocardial blush grade (P < .0001), enzymatic infarct size (P < .0001), and predischarge ejection fraction (P < .0001), even in the analysis restricted to patients with postprocedural TIMI 3 flow. These data explain the observed significant impact of preprocedural TIMI flow on 1-year mortality. CONCLUSIONS: This study shows that in patients with anterior STEMI, poor preprocedural TIMI flow is associated with impaired perfusion, larger infarct size, and 1-year mortality. This study suggests that all efforts should be made to obtain optimal restoration of antegrade flow as early as possible before angioplasty. Further studies are needed to investigate the impact of early adjunctive pharmacological therapy on preprocedural TIMI flow and mortality in these high-risk patients.
Abstract: This study analyzed the effect of beta-blocker therapy at discharge on 1-year mortality rate in a large, unselected cohort of patients who had ST-segment elevation myocardial infarction that was treated by primary angioplasty. Our population is represented by 1,513 patients. At 1-year follow-up, beta blockers at discharge were associated with a significant decrease in mortality rate (2.9% vs 8.5%, RR 0.33, 95% confidence interval [CI] 0.18 to 0.59, p <0.0001), particularly in patients who had anterior wall infarction (3.9% vs 13.4%, RR 0.28, 95% CI 0.14 to 0.54, p <0.0001), whereas nonsignificant benefits were observed in patients who had nonanterior wall infarction (2.0% vs 3.3%, RR 0.6, 95% CI 0.17 to 2.07, p = NS). Benefits in terms of mortality rate that were conferred by beta blockers were confirmed at multivariate analysis that was restricted to patients who had anterior wall infarction (RR 0.43, 95% CI 0.21 to 0.86, p = 0.022).
Abstract: OBJECTIVES: The aim of the study was to evaluate the impact of preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow on one-year mortality in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. BACKGROUND: Although there is an excellent outcome conferred by primary angioplasty in patients with STEMI, the prognostic role of early recanalization in these patients has yet to be investigated. METHODS: Our population is composed of 1,791 patients with acute myocardial infarction treated by primary angioplasty at our institution from 1994 to 2001. All angiographic, clinical, and follow-up data were prospectively collected. According to the TIMI risk score, patients were stratified in low- and high-risk groups. RESULTS: Preprocedural TIMI flow was related to postprocedural TIMI flow grade 3 (p = 0.002), myocardial blush grade 2 to 3 (p < 0.001), enzymatic infarct size (p < 0.001), predischarge ejection fraction (p < 0.001), and one-year mortality (p < 0.05). Multivariate analysis showed that preprocedural TIMI flow grade 3 was an independent predictor of one-year survival in high-risk patients (p < 0.05). CONCLUSIONS: This study shows that preprocedural TIMI flow grade 3 is an independent predictor of one-year survival in high-risk patients with acute myocardial infarction treated by primary angioplasty. These data suggest that all efforts should be made to obtain early and optimal restoration of antegrade flow, particularly in high-risk patients and when transportation to tertiary centers, with a conceivable further time delay, is required.
Abstract: BACKGROUND: Although the relationship between mortality and time delay to treatment has been demonstrated in patients with acute ST-segment elevation myocardial infarction (STEMI) treated by thrombolysis, the impact of time delay on prognosis in patients undergoing primary angioplasty has yet to be clarified. The aim of this report was to address the relationship between time to treatment and mortality as a continuous function and to estimate the risk of mortality for each 30-minute delay. METHODS AND RESULTS: The study population consisted of 1791 patients with STEMI treated by primary angioplasty. The relationship between ischemic time and 1-year mortality was assessed as a continuous function and plotted with a quadratic regression model. The Cox proportional hazards regression model was used to calculate relative risks (for each 30 minutes of delay), adjusted for baseline characteristics related to ischemic time. Variables related to time to treatment were age >70 years (P<0.0001), female gender (P=0.004), presence of diabetes mellitus (P=0.002), and previous revascularization (P=0.035). Patients with successful reperfusion had a significantly shorter ischemic time (P=0.006). A total of 103 patients (5.8%) had died at 1-year follow-up. After adjustment for age, gender, diabetes, and previous revascularization, each 30 minutes of delay was associated with a relative risk for 1-year mortality of 1.075 (95% CI 1.008 to 1.15; P=0.041). CONCLUSIONS: These results suggest that every minute of delay in primary angioplasty for STEMI affects 1-year mortality, even after adjustment for baseline characteristics. Therefore, all efforts should be made to shorten the total ischemic time, not only for thrombolytic therapy but also for primary angioplasty.
Abstract: BACKGROUND: The aim of the present study was to investigate the prognostic implication of myocardial perfusion in patients with ST-segment-elevation myocardial infarction (STEMI) and signs of heart failure, treated with primary angioplasty. METHODS AND RESULTS: Our population is represented by 1548 consecutive patients undergoing primary angioplasty for STEMI. Congestive heart failure was defined as Killip class >1 at admission. Killip class was linearly associated with myocardial perfusion, enzymatic infarct size, predischarge ejection fraction, and 1-year mortality rate. Myocardial blush was an independent predictor of 1-year mortality (RR [95% CI]=2.92 [1.37 to 6.23], P=0.005) in patients with advanced Killip class at presentation. CONCLUSIONS: Our study shows that patients with heart failure complicating STEMI have impaired myocardial perfusion, which accounts for the poor outcome observed in these patients. Further efforts should be aimed at improving myocardial perfusion, beyond epicardial recanalization, to further improve the outcome of these high-risk patients.
Abstract: BACKGROUND: The aim of this study was to create a practical score for risk stratification in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary angioplasty and to assess the feasibility of early discharge in low-risk patients. METHODS AND RESULTS: A prognostic score was built according to 30-day mortality rates in 1791 patients undergoing primary angioplasty for STEMI. For the identified low-risk patients without any contraindication to early discharge, we estimated and compared the costs of conventional care (prolonged 24-hour hospitalization) with the costs of shifting the care from inpatient to outpatient setting (early discharge) between 48 and 72 hours. Independent predictors of 30-day mortality included in the score were age, anterior infarction, Killip class, ischemic time, postprocedural Thrombolysis In Myocardial Infarction (TIMI) flow, and multivessel disease. This score was able to identify a large cohort (73.4%) of low-risk (score < or =3) patients, with a good discriminatory capacity (c statistic=0.907). The mortality rate was 0.1% at 2 days and 0.2% between 2 and 10 days in patients with a score < or =3. The incremental cost-effectiveness ratio for late discharge in low-risk patients was estimated at 1949.33. Therefore, this policy would save 1 life per 1097 low-risk patients, at additional costs of 194 933.33, in comparison with an early discharge policy. CONCLUSIONS: This score is a practical and useful index for risk stratification after primary angioplasty for STEMI, with a significant impact on clinical decision-making and the related costs. It reliably identifies a large group of patients at very low risk, who may safely be discharged early after primary angioplasty.
Abstract: BACKGROUND: Vitamin therapy to lower homocysteine levels has recently been recommended for the prevention of restenosis after coronary angioplasty. We tested the effect of a combination of folic acid, vitamin B6, and vitamin B12 (referred to as folate therapy) on the risk of angiographic restenosis after coronary-stent placement in a double-blind, multicenter trial. METHODS: A total of 636 patients who had undergone successful coronary stenting were randomly assigned to receive 1 mg of folic acid, 5 mg of vitamin B6, and 1 mg of vitamin B12 intravenously, followed by daily oral doses of 1.2 mg of folic acid, 48 mg of vitamin B6, and 60 microg of vitamin B12 for six months, or to receive placebo. The angiographic end points (minimal luminal diameter, late loss, and restenosis rate) were assessed at six months by means of quantitative coronary angiography. RESULTS: At follow-up, the mean (+/-SD) minimal luminal diameter was significantly smaller in the folate group than in the placebo group (1.59+/-0.62 mm vs. 1.74+/-0.64 mm, P=0.008), and the extent of late luminal loss was greater (0.90+/-0.55 mm vs. 0.76+/-0.58 mm, P=0.004). The restenosis rate was higher in the folate group than in the placebo group (34.5 percent vs. 26.5 percent, P=0.05), and a higher percentage of patients in the folate group required repeated target-vessel revascularization (15.8 percent vs. 10.6 percent, P=0.05). Folate therapy had adverse effects on the risk of restenosis in all subgroups except for women, patients with diabetes, and patients with markedly elevated homocysteine levels (15 micromol per liter or more) at baseline. CONCLUSIONS: Contrary to previous findings, the administration of folate, vitamin B6, and vitamin B12 after coronary stenting may increase the risk of in-stent restenosis and the need for target-vessel revascularization.
Abstract: Controversy still surrounds the question, which antiplatelet drug should be added to aspirin in patients undergoing coronary stent implantation. The aim of the current study was to compare ticlopidine and clopidogrel in a consecutive series of patients with ST-segment elevation myocardial infarction (STEMI) treated with primary stenting. Our population is represented by 883 consecutive patients with STEMI undergoing primary stenting from April 1997 to October 2001. All clinical, angiographic, and follow-up data were prospectively collected. A total of 523 patients on clopidogrel were compared with 360 patients on ticlopidine after primary stenting. Except for age and statin therapy, no difference in demographic and clinical characteristics was observed between the two groups. Patients on clopidogrel had a higher rate of successful reperfusion (80.7% vs 73.1%, p = 0.008). No difference was observed between the two groups at both 30-day and 1-year follow-up. These data were confirmed after correction for age, successful reperfusion and statin therapy. This study shows no difference in long-term clinical outcome between clopidogrel and ticlopidine as adjunctive antiplatelet therapy in patients with STEMI undergoing stent implantation.
Abstract: BACKGROUND: Several studies have found that among patients with ST-elevation myocardial infarction (STEMI) treated by thrombolysis, female sex is associated with a worse outcome. The aim of this study was to investigate sex-related differences in clinical and angiographic findings and in long-term outcome in patients with STEMI treated with primary angioplasty. METHODS: Our population is represented by 1548 consecutive patients with STEMI treated by primary angioplasty from April 1997 to October 2001. All clinical, angiographic, and follow-up data were prospectively collected. RESULTS: Among 1548 patients, 353 were women (22.8%). Female sex was associated with more advanced age, higher prevalence of diabetes, hypertension, more advanced Killip class, longer ischemia time, and smaller vessel caliber. No difference was observed in terms of procedural success, postprocedural epicardial flow, myocardial perfusion, ST-segment resolution, and enzymatic infarct size. At 1-year follow-up, female sex was associated with a significantly higher 1-year mortality rate at univariate (9.3% vs 4.9 %, RR [95% CI] = 1.79 [1.14 to 2.8], P = .002) but not at multivariate analysis (RR [95% CI] = 1.41 [0.86 to 2.32], P = NS). CONCLUSIONS: This study shows that in patients with STEMI treated by primary angioplasty, women are associated with higher mortality rate in comparison with men, mainly because of their high-risk profile and angiographic features. Female sex did not emerge as an independent predictor of death.
Abstract: AIMS: The prognostic role of time-to-treatment in primary angioplasty is still a matter of debate. The aim of our study was to evaluate the relationship between time-to-treatment and myocardial perfusion in patients with ST-segment-elevation myocardial infarction (STEMI) treated by primary angioplasty. METHODS AND RESULTS: Our study population consisted of 1072 patients with STEMI treated by primary angioplasty from 1997 to 2001. Myocardial perfusion was evaluated by using ST-segment resolution and myocardial blush grade. Time-to-treatment was defined as the time from symptom-onset to the first balloon inflation. Time-to-treatment was significantly associated with the extent of ST-segment resolution, myocardial blush grade, enzymatic infarct size, and 1-year mortality. After adjustment for baseline confounding factors, time-to-treatment was still associated with impaired ST-segment resolution (adjusted OR [95% CI]=1.01 [1.01-1.02], p<0.001) and myocardial blush (adjusted OR [95% CI]=1.01 [1.01-1.02], p<0.0001). CONCLUSIONS: This study shows that in patients with STEMI treated by primary angioplasty prolonged ischaemic time is associated with impaired myocardial perfusion, larger infarct size, and higher 1-year mortality. Therefore, all efforts should be made to shorten ischaemic time as much as possible to achieve better myocardial perfusion and myocardial salvage in primary angioplasty for STEMI.
Abstract: OBJECTIVES: The aim of the study was to evaluate the relationship between symptom-onset-to-balloon time and one-year mortality in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. BACKGROUND: Despite the prognostic implications demonstrated in patients with STEMI treated with thrombolysis, the impact of time-delay on prognosis in patients undergoing primary angioplasty has yet to be established. METHODS: Our study population consisted of 1,791 patients with STEMI treated by primary angioplasty from 1994 to 2001. All clinical, angiographic and follow-up data were collected. Subanalyses were conducted according to patient risk profile at presentation and preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow. RESULTS: A total of 103 patients (5.8%) had died at one year. Symptom-onset-to-balloon time was significantly associated with the rate of postprocedural TIMI 3 flow (p = 0.012), myocardial blush grade (p = 0.033), and one-year mortality (p = 0.02). A stronger linear association between symptom-onset-to-balloon time and one-year mortality was observed in non-low-risk patients (p = 0.006) and those with preprocedural TIMI flow 0 to 1 (p = 0.013). No relationship was found between door-to-balloon time and mortality. At multivariate analysis, a symptom-onset-to-balloon time >4 h was identified as an independent predictor of one-year mortality (p < 0.05). CONCLUSIONS: This study shows that, in patients with STEMI treated by primary angioplasty, symptom-onset-to-balloon time, but not door-to-balloon time, is related to mortality, particularly in non-low-risk patients and in the absence of preprocedural anterograde flow. Furthermore, a symptom-onset-to-balloon time >4 h was identified as independent predictor of one-year mortality.
