Metabolic Alterations and Drug Interactions: The Role of the Association between Antipsychotics / Mood Stabilizers and Cognitive Deficits.

Alterations in the metabolic profile are one of the main consequences of the use of drug therapies in psychiatric patients. In particular, dysfunction of the metabolic profile (lipid and glycidic) is very frequent in patients taking antipsychotics, especially second-generation ones, and antidepressants. Similar alterations, albeit, to a lesser extent, were highlighted with the use of mood stabilizers. There are some clinical conditions in which clinicians add antipsychotics and mood stabilizers. Our study analyzed this interaction in 116 inpatients. Data showed an overall increase in metabolic parameters in all patients analyzed. However, no statistically significant differences were found in some subgroups of patients. The correlation between metabolic alterations and cognitive dysfunctions in these patients was also analyzed (not statistically significant).

Coronary atherosclerosis burden by coronary computed tomography in type II diabetes with preclinical non-obstructive carotid atherosclerosis and without inducible myocardial ischemia.

AIMS: To quantify cardiovascular risk in persons with type-2 diabetes (DM) and established carotid atherosclerosis, without inducible myocardial ischemia by stress imaging. METHODS: We selected clinically healthy DM and subjects without DM (nonDM, controls) with non-obstructive carotid atherosclerosis and without significant coronary artery disease (CAD) by stress echocardiography. Coronary flow velocity reserve (CFR) was assessed during stress echocardiography. In those with negative stress imaging, coronary artery calcium (CAC) assessment by computed tomography (CT) was proposed. Outcome at 180-day follow-up was performed by visits or telephone interview. RESULTS: Total CAC was greater in DM (n=19) than in nonDM (n=19, CAC: 225±158 vs 78±65Agatston units, 156±161 vs 53±51 in the left anterior descendent artery, both p<0.05). Coronary stenosis burden was greater in DM than in nonDM, albeit <75% in all cases; CFR was lower in DM than nonDM (p<0.05). Mean age was slightly higher (69±6 vs 64±12, p>0.2), and male gender tended to be less frequent (63 vs 79%) with DM than with nonDM; all subjects showed dyslipidemia, and almost all had arterial hypertension. Based on CAC, a 10-year cardiovascular risk was 10-20% in 78% of the DM and in 28% of the non-DM, and was >20% in 11% of the DM but in none of the nonDM. A single non-fatal myocardial infarction was recorded within 180days from test, among DM. CONCLUSIONS: Based on CAC, in the presence of non-obstructive carotid atherosclerosis, asymptomatic DM may show significantly higher CAD burden than nonDM even in the absence of inducible myocardial ischemia.

Long-term results of the randomized comparison of everolimus-eluting stents and sirolimus-eluting stent in patients with ST elevation myocardial infarction (RACES-MI trial).

BACKGROUND: Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES), especially in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). New generation DES have demonstrated reduction in ST at mid-term follow-up, however no data are available on long-term follow-up. Therefore, the aim of this study was to report long-term results of the RACES-MI trial conducted to compare Everolimus-Eluting Stent (EES) vs Sirolimus-Eluting Stent (SES) in patients undergoing primary PCI. METHODS: The RACES-MI trial enrolled consecutive STEMI patients admitted within 12h of symptom onset, undergoing primary PCI with stent implantation at a tertiary center with 24-hour primary PCI capability, who were randomly assigned to SES or EES. Primary endpoint of this analysis is major adverse cardiac events (MACE) at long-term follow-up. Secondary endpoints are 1) death; 2) reinfarction; 3) definite or probable ST; 4) target-vessel revascularization (TVR) at long-term follow-up. RESULTS: From April 2007 to May 2009 500 patients with STEMI were randomized to EES (n=250) or SES (n=250). No difference was observed between the groups either in baseline clinical characteristics, in the number of implanted stent or total stent length per patient. However, a larger reference diameter was observed with SES (3.35±0.51 mm vs 3.25±0.51 mm, p=0.001), whereas patients randomized to EES received Gp IIb-IIIa inhibitors more often (54.4% vs 42.4%, p=0.006). At long-term follow-up (2132±528 days), EES was associated with a significant reduction in MACE (23.8 vs 34.1%, adjusted p=0.028), ST (2.5% vs 7.7%, adjusted p=0.009), without any difference in death (8.7% vs 11.4%, adjusted p=0.47), reMI (9.3% vs 13.1%; adjusted p=0.18) and TVR (8.6% vs 12.3%, adjusted p=0.31). CONCLUSIONS: This study shows that among STEMI patients undergoing primary PCI EES, as compared to SES, is associated with significant reduction in MACE and ST at long-term follow-up.

Impact of diabetes on the benefits from everolimus-eluting stent as compared to first-generation drug-eluting stent in patients with ST elevation myocardial infarction.

BACKGROUND: Drug-eluting stent has been shown to reduce the risk of repeated revascularization. However, as shown for first-generation drug-eluting stent, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction patients. In addition, diabetes has been shown to be an independent predictor of poor survival and repeated target vessel revascularization. No data have been reported so far on the long-term benefits and safety of new-generation drug-eluting stent in ST-segment elevation myocardial infarction according to diabetes. Therefore, the aim of this study was to evaluate whether diabetes may impact on the benefits from everolimus-eluting stent versus first-generation drug-eluting stent in patients undergoing primary angioplasty. METHODS: We combined data from two randomized trials (PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty and randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction) including consecutive ST-segment elevation myocardial infarction patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation at a tertiary centre with 24-h primary percutaneous coronary intervention capability. Primary endpoint of this study was major adverse cardiac events at 3-year follow-up. Secondary endpoints were as follows: (1) death, (2) reinfarction, (3) definite or probable ST and (4) target vessel revascularization at 3-year follow-up. No patient was lost to follow-up. RESULTS: Our population is represented by 680 ST-segment elevation myocardial infarction patients treated with drug-eluting stent (180 enrolled in the PaclitAxel or Sirolimus-Eluting Stent vs Bare-Metal Stent in Primary Angioplasty trial, treated with first-generation drug-eluting stent, and 500 patients in the randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction, randomized to everolimus-eluting stent or sirolimus-eluting stent). Diabetes was observed in a total of 178 patients (26.1%) and associated with higher major adverse cardiac events, mortality, reinfarction, stent thrombosis and target vessel revascularization. Similar outcome was observed in terms of overall major adverse cardiac events, mortality, recurrent myocardial infarction, target vessel revascularization, with everolimus-eluting stent as compared to first-generation drug-eluting stent in both diabetic and non-diabetic patients, whereas everolimus-eluting stent was associated with a significantly lower rate of stent thrombosis only in diabetic patients (1.6% vs 9.6%, hazard ratio (95% confidence interval) = 0.15 (0.02-0.98), p = 0.04) whereas no difference was observed in non-diabetic patients. CONCLUSION: This study shows that among ST-segment elevation myocardial infarction patients undergoing primary angioplasty, diabetes is associated with a significantly worse outcome at 3-year follow-up. A similar outcome was observed between everolimus-eluting stent and first-generation drug-eluting stent in non-diabetic patients, whereas among diabetic patients everolimus-eluting stent was associated with a significant reduction in stent thrombosis.

Impact of DRG billing system on health budget consumption in percutaneous treatment of mitral valve regurgitation in heart failure.

OBJECTIVE: Percutaneous correction of mitral regurgitation (MR) by MitraClip (Abbot Vascular, Abbot Park, Illinois, USA) trans-catheter procedure (MTP) may represent a treatment for an unmet need in heart failure (HF), but with a largely unclear economic impact. RESEARCH DESIGN AND METHODS: This study estimated the economic impact of the MTP in common practice using the disease-related group (DRG) billing system, duration and average cost per day of hospitalization as main drivers. Life expectancy was estimated based on the Seattle Heart Failure Model. Quality-of-life was derived by standard questionnaires to compute quality-adjusted year-life costs. RESULTS: Over 5535 discharges between 2012-2013, HF as DRG 127 was the main diagnosis in 20%, yielding a reimbursement of €3052.00/case; among the DRG 127, MR by ICD-9 coding was found in 12%. Duration of hospitalization was longer for DRG 127 with than without MR (9 vs 8 days, p < 0.05). HF in-hospital management generated most frequently deficit, in particular in the presence of MR, due to the high costs of hospitalization, higher than reimbursement. MTP to treat MR allowed DRG 104-related reimbursement of €24,675.00. In a cohort of 34 HF patients treated for MR by MTP, the global budget consumption was 2-fold higher compared to that simulated for those cases medically managed at 2-year follow-up. Extrapolated cost per quality-adjusted-life-years (QALY) for MTP at year-2 follow-up was ∼ €16,300. CONCLUSIONS: Based on DRG and hospitalization costing estimates, MTP might be cost-effective in selected HF patients with MR suitable for such a specific treatment, granted that those patients have a clinical profile predicting high likelihood of post-procedural clinical stability in sufficiently long follow-up.

Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial.

OBJECTIVES: The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty. BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI. METHODS: Consecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up. RESULTS: From April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035). CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982).

Accuracy and feasibility of simplified Doppler-based left ventricular ejection fraction.

Calculation of left ventricular (LV) ejection fraction (EF) by Doppler stroke volume and end-diastolic volume (EDV) derived from LV diastolic diameter (LVIDD) could be reliable and feasible in clinical practice. In subjects with a wide range of LV volumes and EFs, magnetic resonance imaging (MRI) was used to evaluate the accuracy of common formulas (Teichholz and Z method) to estimate EDV from LVIDD (EDVTeich; EDVZ) versus volumetric EDV. The accuracy of simplified Doppler-EF was tested in a separate study sample versus real-time 3-dimensional (RT3D) echocardiography and versus bidimensional Simpson's method. A new equation to calculate EDV from LVIDD was derived using MRI and tested in the RT3D echo samples. Feasibility of Doppler-EF was tested in a third sample of consecutive inpatients and outpatients. In the MRI sample, EDVTeich was greater whereas EDVZ was smaller than volumetric EDV (both p <0.01); however, a quadratic equation estimated EDV from LVIDD with accuracy (R² = 0.97). In the echocardiographic sample, independent of severe segmental wall motion abnormalities, EDVTeich was greater whereas EDV using Simpson's method was smaller than RT3D EDV (all p <0.05); Doppler-EF using EDVTeich was lower compared with EF by Simpson's rule or by RT3D-EF (all p <0.01). However, RT3D-EF showed no differences compared with Doppler-EF when EDV was calculated by the novel MRI-derived equation. Feasibility was 95% for Doppler-EF and 72% using Simpson's method. In conclusion, equations estimating EDV from LVIDD affect the accuracy of simplified Doppler-EF. However, Doppler-based EF may be accurate and feasible even in the presence of LV contractile asynergy.

Sustained ventricular tachycardia in renal cell carcinoma metastatic to anterior-apical wall of the left ventricle.

A 50-year-old man with a history of renal cell carcinoma was admitted with ventricular tachycardia. Echocardiography showed a mass in the apex of the left ventricle. Cardiac magnetic resonance confirmed a mass infiltrating the anterior-apical wall of the left ventricle. This is the first case describing an association between ventricular tachycardia and renal cell carcinoma metastatic to the left ventricle.

Addition of atropine to submaximal exercise stress testing in patients evaluated for suspected ischaemia with SPECT imaging: a randomized, placebo-controlled trial.

PURPOSE: To evaluate the effects of the addition of atropine to exercise testing in patients who failed to achieve their target heart rate (HR) during stress myocardial perfusion imaging with single-photon emission computed tomography (SPECT). METHODS: The study was a prospective, randomized, placebo-controlled design. Patients with suspected or known coronary artery disease who failed to achieve a target HR (≥85% of maximal predicted HR) during exercise SPECT imaging were randomized to receive intravenous atropine (n=100) or placebo (n=101). RESULTS: The two groups of patients did not differ with respect to demographic or clinical characteristics. A higher proportion of patients in the atropine group achieved the target HR compared to the placebo group (60% versus 3%, p<0.0001). SPECT imaging was abnormal in a higher proportion of patients in the atropine group as compared to the placebo group (57% versus 42%, p<0.05). Stress-induced myocardial ischaemia was present in more patients in the atropine group as compared to placebo (47% versus 29%, p<0.01). In both groups of patients, no major side effects occurred. CONCLUSION: The addition of atropine at the end of exercise testing is more effective than placebo in raising HR to adequate levels, without additional risks of complications. The use of atropine in patients who initially failed to achieve their maximal predicted HR is associated with a higher probability of achieving a diagnostic myocardial perfusion study.

Atypical response of class IC atrial flutter to adenosine.

We report the case of a 67-year-old female with a wide QRS complex tachycardia at 180 bpm. A diagnosis of class IC atrial flutter with aberrant ventricular conduction caused by flecainide therapy was formulated. Intravenous adenosine administration resulted in adequate slowing of the ventricular rate and normalization of QRS complexes. Restoration of sinus rhythm was achieved with intravenous amiodarone. The response to adenosine confirmed the diagnosis of supraventricular tachycardia with aberrant conduction, but the transition from arrhythmia onset to restoration of sinus rhythm showed interesting peculiarities.

Direct imaging of viable myocardium by gated SPECT in patients with ischaemic left ventricular dysfunction.

PURPOSE: The aim of the study was to evaluate a novel polar map of myocardial viability obtained by gated SPECT imaging to predict functional recovery after revascularization in patients with ischaemic left ventricular (LV) dysfunction. METHODS: The study group comprised 17 patients (15 men, mean age 58 +/- 9 years) with ischaemic LV dysfunction (ejection fraction

Osborn waves in severe accidental hypothermia secondary to prolonged immobilization and malnutrition.

We report the case of a 77-year-old man, in whom accidental hypothermia was secondary to prolonged immobilization and malnutrition. The electrocardiogram showed typical Osborn waves, which disappeared with the rewarming of the patient. The diagnosis of hypothermia is easy in patients with a history of prolonged exposure to a cold environment but accidental hypothermia may also occur as a consequence of prolonged immobilization and malnutrition. ECG analysis is very important for a correct and fast diagnosis.

Impact of diabetes on long-term outcome in STEMI patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors and BMS or DES.

Diabetes has been shown to be associated with worse survival and repeat revascularization (TVR) after primary angioplasty. Drug-eluting stent (DES) may offer benefits in terms of TVR, that may be counterbalanced by an higher risk of stent thrombosis, especially among STEMI patients. Aim of the current study was to evaluate the impact of diabetes on 5-year outcome in patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors in the era of DES. Our population is represented by STEMI patients undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary PCI capability within 12 h of symptom onset. All patients received glycoprotein IIb-IIIa inhibitors. No patient was lost to follow up. From 2003 to 2005, 270 STEMI patients were treated with DES (n = 180), or BMS (n = 90). A total of 69 patients had history of diabetes at admission (25.5%). At a follow-up of 1510 +/- 406 days, diabetes was associated with a higher rate of death (29.5 vs. 5.1%, P < 0.0001), reinfarction (24.1 vs. 9.1%, P < 0.0001), TVR (19.1 vs. 13.1%, P = 0.052), IST (17.2 vs. 6.8%, P < 0.001) and MACE (51.9 vs. 25.1%, P < 0.001). These results were confirmed in both patients receiving BMS or DES, except for TVR, where no difference was observed between diabetic and non-diabetic patients. This study shows that among STEMI patients undergoing primary angioplasty with Gp IIb-IIIa inhibitors, diabetes is associated with worse long-term mortality, reinfarction, and IST, even with DES implantation, that, however, were able to equalize the outcome in terms of TVR as compared to non diabetic patients.

Tako-tsubo cardiomyopathy in a patient with pacemaker syndrome.

We report the case of a 71-year-old woman, with a dual chamber pacemaker (PM), in whom a PM syndrome, due to loss of atrial sensing and pacing, was associated with a tako-tsubo cardiomyopathy (TTC). The repositioning of the atrial lead immediately improved symptoms, whereas complete regression of left ventricular wall motion abnormalities occurred after 1 month. We hypothesize that haemodynamic and hormonal responses associated with a PM syndrome, such as increased levels of catecholamines, may account for TTC in our patient.

Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.

BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty. METHODS AND RESULTS: Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization. CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.

Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.

BACKGROUND: Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. METHODS: Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up. RESULTS: From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR. CONCLUSIONS: This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.

The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial.

OBJECTIVES: The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty. BACKGROUND: Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients. METHODS: We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months. RESULTS: From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively). CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850).