Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Authorship: from credit to accountability. Reflections from the Editors' Network.

The Editors' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Role of Intracoronary Adrenaline in the Treatment of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention.

The no-reflow phenomenon is defined as the failure to restore coronary flow demonstrated by the reduced or missing flow in angiography despite the patent artery. There are pharmacological strategies proposed and studied to manage the no-reflow phenomenon. The medication groups used are purine nucleoside (adenosine), calcium channel blockers (verapamil, nicardipine), beta 2 receptor agonists (adrenaline, nitroprusside), fibrinolytic agents (streptokinase, tissue plasminogen activators), glycoprotein IIb/IIIa inhibitors (abciximab, tirofiban). We present a case of a woman hospitalized in non-ST elevation myocardial infarction (NSTEMI) conditions. The patient underwent coronary angiography, in which a single vessel coronary artery disease (CAD); left anterior descending (LAD) stenosis of 90% was found. In this condition, the patient underwent percutaneous coronary intervention (PCI) of LAD. The no-reflow phenomenon occurred with thrombolysis in myocardial infarction (TIMI) flow grade of 0 during the procedure. As a consequence, the patient presented chest pain and important hypotension (BP of 70/45). Because of the hypotensive state of the patient, we decided to administer intracoronary (IC) adrenaline directly. In our case, we used adrenaline as a first-line treatment for the no-flow phenomenon due to the hypotensive state during the PCI procedure. Generally, we initially use IC nitrate or IC adenosine to resolve the phenomenon, and when the no-reflow persists we use IC adrenaline because of its side effects mentioned above. Anyway, we believe that in specific cases of hypotension and bradycardia, the use of adrenaline as the first line of therapy should be considered.

Gender Differences in Admissions and In-Hospital Outcomes of Patients With Acute Coronary Syndromes During the Coronavirus Disease 2019 Pandemic.

Background The incidence of acute coronary syndromes (ACS) decreased during the coronavirus disease 2019 (COVID-19) pandemic. Few studies have investigated gender differences in ACS admissions and outcomes during pandemics and have presented divergent results. This study aimed to investigate the effect of the COVID-19 pandemic on male and female hospitalizations and in-hospital outcomes in patients presenting with ACS. Methodology We designed a retrograde, single-center trial gathering data for ACS hospitalizations during the lockdown (March 9, 2020, to April 30, 2020) compared with the same timeframe of 2019. ACS hospitalizations were subgrouped as ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina (UA). We calculated the incidence rate ratio (IRR) to compare all-ACS and subgroups for male and female hospitalizations and the risk ratio (RR) to compare overall male/female mortality. Results This study included 321 ACS patients (238 males, 83 females) during the COVID-19 lockdown and 550 patients (400 males, 150 females) during 2019. The IRRs of all-ACS/males/females were significantly lower during the COVID-19 period at 0.58 (95% confidence interval (CI) = 0.44-0.76), 0.59 (95% CI = 0.43-0.75), and 0.55 (95% CI = 0.37-0.74), respectively. The IRR for STEMI was significantly lower among females (0.59 (95% CI = 0.39-0.89)), but not among males (0.76 (95% CI = 0.55-1.08)) The IRR for NSTEMI was not significantly lower, meanwhile it was significantly lower for UA among both males and females. The overall ACS mortality increased during the COVID-19 period (7.4% vs. 3.4%; RR = 2.16 (95% CI = 1.20-3.89)). Important increase was found in males (7.45% vs. 2.5%; RR = 3.02 (95% CI = 1.42-6.44)), but not in females (7.2% vs. 6%; RR = 1.20 (95% CI = 0.44-3.27). Conclusions The admissions of ACS reduced similarly in males and females during the COVID-19 pandemic. The admissions of STEMI reduced predominantly in females. We identified a substantial increase in the overall ACS mortality, but predominantly in males, reducing the differences between males and females. Further studies are necessary to better understand the increase in male mortality during the pandemic.

Hospitalizations and in-hospital outcomes in patients with ST-elevation myocardial infarction during the coronavirus disease 2019 pandemic: The Albanian experience.

OBJECTIVE: Global studies report a significant decline in ST-elevation myocardial infarction (STEMI) related hospitalization rates during the coronavirus disease 2019 (COVID-19) pandemic outbreak. However, there have been several divergent reports on hospital outcomes. In this study, we aim to investigate the impact of the COVID 19 outbreak on hospitalizations because of STEMI and in-hospital outcomes in Albania. METHODS: This was a retrograde study, collecting data for hospitalizations because of STEMI from March 9, (first COVID 19 case in our country) to April 30, 2020, (period of total lockdown) compared with the same period in 2019 at our center. The incidence rate ratio (IRR) was used to compare admissions because of STEMI and procedures and the risk ratio (RR) to compare mortality and other complication rates. RESULTS: Admissions for STEMI declined during the COVID-19 period from a total of 217 in 2019 to 156 in 2020 (-28.1%) representing IRR 0.719 (p=0.033). PCIs also reduced from 168 procedures in 2019 to 113 in 2020 (-33%), representing an IRR of 0.67, p=0.021. The time from symptom onset to arrival at our intensive care unit was significantly higher in 2020 compared to 2019 (925.6±1097 vs. 438.7±385 minutes, p<0.001). The STEMI death rate during the pandemic compared to the control period was significantly increased to 14.1% vs. 7.8% (RR=1.91 p=0.037, but with no significant increase in primary PCI-STEMI death rate (8.9% vs. 4.8% RR=1.85 p=0.217). Cardiogenic shock also increased during the pandemic to 21.2% from 12.4% in 2019 (RR=1.70 p=0.025). CONCLUSION: Hospitalizations and revascularization procedures for STEMI significantly reduced during the COVID-19 pandemic. We identified a substantial increase in the STEMI mortality rate and cardiogenic shock during the pandemic outbreak. Delayed timely reperfusion intervention might be responsible for the increased risk for complications.

Ongoing COVID-19 Pandemic Effects on Admissions and In-Hospital Outcomes in Patients With ST-Elevation Myocardial Infarction (STEMI): An Albanian Observational Study.

Background Multiple studies conducted worldwide and in Albania documented an important reduction of acute ST-elevation myocardial infarction (STEMI) admissions during the Coronavirus Disease 19 (COVID-19) pandemic. There are few studies regarding STEMI admissions and outcomes during the ongoing pandemic after the initial lockdown. We aimed to study STEMI admissions and in-hospital outcomes after the COVID-19 lockdown period. Methods A retrospective single-center study was conducted, collecting data for all consecutive STEMI admissions from March 9th, (the first COVID-19 case) until April 30th, the corresponding period of 2020 total lockdown, for years 2019 and 2021. The control period was considered the year 2019 [pre-pandemic (PP)] and the study period was in 2021 [ongoing pandemic (OP)]. The incidence rate ratio (IRR) 95% confidence interval (CI) was used to compare all-STEMI admissions, invasive procedures, and risk ratio (RR) 95% CI to compare the mortality and complications rate between the study and control period. Results The study included 217 STEMI patients admitted in 2019, and 234 patients during the 2021 period. The overall-STEMI admissions IRR is in a similar range during the 2021 OP compared to the 2019 PP period IRR=1.07 (95%CI 0.90-1.28). Similar invasive procedures were observed during OP compared to PP period, respectively for coronary-angiography IRR= 1.07; (0.87-1.31), for all-PCI [1.12 (0.92-1.35)], and primary percutaneous coronary interventions (PCI) [1.09 (0.89-1.34)]. The STEMI death rate during OP compared to PP period was similar (7.3 vs. 7.4%), RR=1.01 (0.53-1.96), and a non-significant lower primary-PCI-death rate (4.0 vs 4.8%), RR= 0.83 (0.30-2.3)]. Conclusions After the initial reduction of admissions and invasive procedures in STEMI patients during the 2020 lockdown period and the increase of all-STEMI mortality, the number of hospitalizations, invasive procedures, and mortality returned to a similar range during OP compared to the PP period despite a highly incident ongoing COVID-19 pandemic.

A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease.

BACKGROUND: There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. METHODS: Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. RESULTS: No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P = .01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P = .83) and stent thrombosis (HR 1.00 [0.31-3.30], P = .67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P = .79). CONCLUSIONS: In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

Influence of involvement of anterior leaflet versus posterior leaflet on residual regurgitation as assessed by transesophageal echocardiography in patients undergoing valve repair for mitral regurgitation due to mitral valve prolapse.

BACKGROUND: Repair of anterior leaflet prolapse is technically more challenging and this might influence outcomes as compared to the repair of posterior leaflet prolapse in patients undergoing surgical correction of mitral regurgitation. We investigated the association of anterior leaflet prolapse with minor residual mitral regurgitation (MR) in patients with mitral valve prolapse (MVP) who underwent valve repair. METHODS: Eligible for this study were consecutive patients with severe MR due to MVP, who underwent mitral valve repair with residual MR by postpump transesophageal echocardiography

Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes.

AIMS: Percutaneous treatment of coronary bifurcation disease remains challenging. In patient subsets in which a two-stent strategy is necessary, the culotte technique is a widely used method. We sought to examine the clinical and angiographic outcomes of patients treated in this manner at our institution. As quantitative coronary angiographic analysis using standard measurement programmes is problematic, we used a dedicated bifurcation analysis system. METHODS AND RESULTS: We prospectively enrolled patients undergoing culotte stenting with drug-eluting stents (Cypher, Endeavor, polymer-free rapamycin-eluting, Taxus) in two German centres. Lesions were classified according to the Medina classification. Angiographic follow-up was scheduled between 6 and 12 months post-index procedure. Clinical follow-up was available up to 12 months. Culotte technique was used in 134 lesions in 132 patients. Of these, 124 (92.5%) represented 'true bifurcation' lesion morphology. Kissing balloon inflation was used in 62% of patients. Procedural angiographic success was achieved in all lesions. Follow-up coronary angiography was performed in 108 (81.8%) patients. Median (IQR) late lumen loss was 0.10 (-0.04-0.38) mm in the proximal main vessel, 0.34 (0.03-0.66) mm in the distal main branch, and 0.30 (-0.01-0.72) mm in the side branch. The incidence of binary angiographic restenosis was 22% for the whole bifurcation lesion, 0% in the proximal main vessel, 9.1% in the distal main branch, and 16% in the side branch. At 12 months, 28 of 132 (21%) patients had undergone target lesion revascularization. The incidence of stent thrombosis (at 1 year) was 1.5%. Predictors of angiographic restenosis were older age, increasing bifurcation angle, more severe distal main branch stenosis, and smaller side branch reference diameter; kissing balloon post-dilatation tended to have a protective effect. CONCLUSION: The culotte stenting technique is associated with high procedural success and a relatively low risk of angiographic restenosis. Safety results in our cohort were favourable in terms of a low risk of stent thrombosis.

Authorship: From credit to accountability - Reflections from the Editors' network.

The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Authorship: From Credit to Accountability Reflections From the Editors´ Network.

The Editors´ Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Authorship: from credit to accountability. Reflections from the Editors' Network.

The Editors' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Authorship: From credit to accountability - Reflections from the Editors' network.

The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

La Red de Editores de la Sociedad Europea de Cardiología (SEC) proporciona un foro dinámico para debates editoriales y respalda las recomendaciones del Comité Internacional de Editores de Revistas Médicas (ICMJE) para mejorar la calidad científica de las revistas biomédicas. La autoría confiere crédito e importantes recompensas académicas. Recientemente, sin embargo, el ICMJE enfatizó que la autoría también requiere responsabilidad y compromiso. Estos problemas ahora están cubiertos por el nuevo (cuarto) criterio de autoría. Los autores deben aceptar ser responsables y garantizar que las preguntas sobre la precisión y la integridad de todo el trabajo será abordado adecuadamente. Esta revisión discute las implicaciones de este cambio de paradigma en requisitos de autoría con el objetivo de aumentar la conciencia sobre las buenas prácticas científicas y editoriales.

Authorship: From credit to accountability. Reflections from the Editors' Network.

The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.

BACKGROUND: Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. It is not known whether there are differences in the effectiveness of currently approved drug-eluting stents in the high-risk subgroup of patients with diabetes mellitus. METHODS: We enrolled 250 patients with diabetes and coronary artery disease: 125 were randomly assigned to receive paclitaxel-eluting stents, and 125 to receive sirolimus-eluting stents. The primary end point was in-segment late luminal loss. Secondary end points were angiographic restenosis (defined as in-segment stenosis of at least 50 percent at follow-up angiography) and the need for revascularization of the target lesion during a nine-month follow-up period. The study was designed to show noninferiority of the paclitaxel stent as compared with the sirolimus stent, defined as a difference in the extent of in-segment late luminal loss of no more than 0.16 mm. RESULTS: The extent of in-segment late luminal loss was 0.24 mm (95 percent confidence interval, 0.09 to 0.39) greater in the paclitaxel-stent group than in the sirolimus-stent group (P=0.002). In-segment restenosis was identified on follow-up angiography in 16.5 percent of the patients in the paclitaxel-stent group and 6.9 percent of the patients in the sirolimus-stent group (P=0.03). Target-lesion revascularization was performed in 12.0 percent of the patients in the paclitaxel-stent group and 6.4 percent of the patients in the sirolimus-stent group (P=0.13). CONCLUSIONS: In patients with diabetes mellitus and coronary artery disease, use of the sirolimus-eluting stent is associated with a decrease in the extent of late luminal loss, as compared with use of the paclitaxel-eluting stent, suggesting a reduced risk of restenosis.

Predictive factors of restenosis after coronary implantation of sirolimus- or paclitaxel-eluting stents.

BACKGROUND: The efficacy of drug-eluting stents in reducing restenosis risk has not been uniform across patient subsets. Identifying predictive factors of restenosis may help improve outcomes after percutaneous coronary interventions. METHODS AND RESULTS: All patients who underwent successful implantation of sirolimus- or paclitaxel-eluting stents in native vessels for de novo lesions between August 2002 and December 2004 were eligible for this study. All data were prospectively collected. Angiographic restenosis was defined as diameter stenosis > or =50% at follow-up in the in-segment area. Target lesion revascularization was defined as any revascularization procedure involving the target lesion. Included in this study were 1845 patients with 2093 target lesions. Multivariable analysis showed that vessel size, final diameter stenosis, and drug-eluting stent type were the strongest predictors of restenosis. A 0.5-mm decrease in vessel size was associated with adjusted odds ratios (ORs) of 1.74 (95% CI, 1.31 to 2.32) for angiographic restenosis and 1.65 (95% CI, 1.22 to 2.23) for target lesion revascularization. A 5% increase in final diameter stenosis was associated with adjusted ORs of 1.30 (95% CI, 1.15 to 1.47) for angiographic restenosis and 1.18 (95% CI, 1.03 to 1.35) for target lesion revascularization. Compared with paclitaxel-eluting stent, sirolimus-eluting stent was associated with adjusted ORs of 0.60 (95% CI, 0.44 to 0.81) for angiographic restenosis and 0.67 (95% CI, 0.49 to 0.91) for target lesion revascularization. CONCLUSIONS: Vessel size and drug-eluting stent type are the most important predictors of angiographic and clinical restenosis, with drug-eluting stent type having a particular impact on restenosis of small coronary vessels.

Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss.

BACKGROUND: Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis. METHODS AND RESULTS: To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (P=0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups). CONCLUSIONS: The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.

Randomized clinical trial of abciximab in diabetic patients undergoing elective percutaneous coronary interventions after treatment with a high loading dose of clopidogrel.

BACKGROUND: Diabetic patients are at increased risk of adverse outcomes after percutaneous coronary interventions. Although subset analyses suggest particular benefit from the administration of abciximab in diabetic patients, no dedicated large randomized trials have been performed in diabetic patients undergoing percutaneous coronary intervention, and certainly not after pretreatment with a high loading dose of clopidogrel. METHODS AND RESULTS: This study (Intracoronary Stenting and Antithrombotic Regimen: Is Abciximab a Superior Way to Eliminate Elevated Thrombotic Risk in Diabetics [ISAR-SWEET] Study) enrolled 701 diabetic patients with coronary artery disease who underwent an elective percutaneous coronary intervention after pretreatment with a 600-mg dose of clopidogrel >2 hours before the procedure: 351 patients were randomly assigned to abciximab and 350 patients to placebo. The primary end point of the trial was the composite incidence of death and myocardial infarction at 1 year. The frequency of angiographic restenosis (diameter stenosis > or =50%) was the secondary end point. The incidence of death or myocardial infarction was 8.3% in the abciximab group and 8.6% in the placebo group (P=0.91), with a relative risk of 0.97 (95% CI, 0.58 to 1.62). The incidence of angiographic restenosis was 28.9% in the abciximab group and 37.8% in the placebo group (P=0.01), with a relative risk of 0.76 (95% CI, 0.62 to 0.94). The incidence of target lesion revascularization was 23.2% in the abciximab group and 30.4% in the placebo group (P=0.03). CONCLUSIONS: The findings of this study do not support a significant impact of abciximab on the risk of death and myocardial infarction in diabetic patients undergoing percutaneous coronary interventions after pretreatment with a 600-mg loading dose of clopidogrel at least 2 hours before the procedure. The present findings suggest, however, that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stents.

Thrombolysis in myocardial infarction myocardial perfusion grade in angiography correlates with myocardial salvage in patients with acute myocardial infarction treated with stenting or thrombolysis.

OBJECTIVES: We sought to assess the relationship between the Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion (TMP) grade and myocardial salvage as well as the usefulness of TMP grade in comparing two different reperfusion strategies. BACKGROUND: The angiographic index of TMP grade correlates with infarct size and mortality after thrombolysis for acute myocardial infarction (AMI). Its relationship to myocardial salvage and its usefulness in comparing different reperfusion strategies are not known. METHODS: We analyzed the TMP grade on angiograms obtained at one to two weeks after treatment in 267 patients enrolled in two randomized trials that compared stenting with thrombolysis in AMI. Patients were classified into two groups: 159 patients with TMP grade 2/3 and 108 patients with TMP grade 0/1. Two scintigraphic studies were performed: before and one to two weeks after reperfusion. The salvage index was calculated as the proportion of the area at risk salvaged by reperfusion. RESULTS: Patients with TMP grade 2/3 had a higher salvage index (0.49 +/- 0.42 vs. 0.34 +/- 0.49, p = 0.01), a smaller final infarct size (15.4 +/- 15.5% vs. 22.1 +/- 16.2% of the left ventricle, p = 0.001), and a trend toward lower one-year mortality (3.8% vs. 8.3%, p = 0.11) than patients with TMP grade 0/1. The relationship between TMP and salvage index was independent of the form of reperfusion therapy. The proportion of patients with TMP grade 2/3 was significantly higher after stenting than after thrombolysis (70.9% vs. 48.1%, p = 0.001). CONCLUSIONS: These findings show that the TMP grade is a useful marker of the degree of myocardial salvage achieved with reperfusion and a sensitive indicator of the efficacy of reperfusion strategies in patients with AMI.