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1.
Cardiovasc Revasc Med ; 13(5): 265-71, 2012.
Article in English | MEDLINE | ID: mdl-22796496

ABSTRACT

AIMS: Percutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES). METHODS AND RESULTS: The Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n=129 pts) or BMS (n=96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P=.003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P=.003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P=.005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P=.05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P=.13), MACE was 18.6% in DES vs. 13.2% in PEB (P=.29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P=.14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18) CONCLUSIONS: Diabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Artery Disease/therapy , Diabetes Mellitus/epidemiology , Paclitaxel/administration & dosage , Stents , Aged , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Argentina/epidemiology , Chi-Square Distribution , Coronary Artery Disease/epidemiology , Coronary Artery Disease/mortality , Diabetes Mellitus/mortality , Drug-Eluting Stents , Female , Humans , Incidence , Kaplan-Meier Estimate , Logistic Models , Male , Metals , Middle Aged , Multivariate Analysis , Myocardial Infarction/epidemiology , Myocardial Infarction/mortality , Proportional Hazards Models , Prospective Studies , Prosthesis Design , Registries , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
2.
JACC Cardiovasc Imaging ; 2(9): 1072-81, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19761985

ABSTRACT

OBJECTIVES: We sought to explore the relationship between established parameters of reperfusion and the extent of myocardial damage measured by the delayed enhancement (DE) of iodinated contrast by multidetector computed tomography (MDCT) immediately after primary percutaneous coronary intervention (PCI). BACKGROUND: Early detection of myocardial viability should be valuable for risk stratification of patients with reperfused acute myocardial infarction (AMI). METHODS: Consecutive patients without a history of previous AMI who underwent primary PCI for an ST-segment elevation AMI were examined by DE-MDCT without an additional contrast injection immediately after completion of PCI. No medication was administrated to lower the heart rate. Dose modulation lead to an approximate mean radiation dose of 5.5 mSv. RESULTS: Thirty patients constituted the study population. Mean age was 61.4 +/- 15.6 years, 24 (80%) were men, and 4 (13%) were diabetic. Although post-procedural Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved in all patients, DE was detected in 14 (47%) patients. Age, sex, hypertension, diabetes, smoking history, serum creatinine levels, and pain duration were not associated with the presence of DE. Door-to-balloon time (DE 70.3 +/- 33.6 min vs. non-DE 98.3 +/- 70.7 min, p = 0.19) and lesion crossing time (DE 18.6 +/- 11.4 min vs. non-DE 16.4 +/- 9.6 min, p = 0.58) did not differ between groups. The TIMI myocardial perfusion grade (0 to 1 vs. 2 to 3) after stent implantation and electrocardiogram ST-segment resolution (<50% or >/=50%) were associated with the presence of DE (p = 0.001 and p = 0.02, respectively). Pre-discharge left ventricular ejection fraction was lower in DE than in non-DE patients (44.6 +/- 12.4% vs. 54.1 +/- 10.3%, respectively, p = 0.05). Hospitalization days (DE 5.6 +/- 3.8 vs. non-DE 4.8 +/- 1.0, p = 0.41) and 6-month cardiac events (DE 3 of 14 vs. non-DE 1 of 16, p = 0.22) did not differ between groups. CONCLUSIONS: Early detection of myocardial viability immediately after primary PCI by the use of DE-MDCT is related to clinical and angiographic parameters of myocardial reperfusion.


Subject(s)
Angioplasty, Balloon, Coronary , Contrast Media , Coronary Circulation , Myocardial Infarction/therapy , Myocardial Reperfusion Injury/diagnostic imaging , Myocardium/pathology , Tomography, X-Ray Computed , Aged , Angioplasty, Balloon, Coronary/adverse effects , Biomarkers/blood , Creatine Kinase/blood , Electrocardiography , Female , Humans , Length of Stay , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/physiopathology , Myocardial Reperfusion Injury/etiology , Myocardial Reperfusion Injury/physiopathology , Myocardium/enzymology , Necrosis , Predictive Value of Tests , Recovery of Function , Recurrence , Stroke Volume , Time Factors , Tissue Survival , Tomography, Emission-Computed, Single-Photon , Treatment Outcome , Ventricular Function, Left
3.
J Invasive Cardiol ; 21(8): 378-82, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19652248

ABSTRACT

BACKGROUND: Semisynthetic coating of the Camouflage bare-metal stent (BMS) (Eucatech AG, Rheinfelden, Germany) mimics luminal endothelial cell glycocalix, potentially preventing the activation of the coagulation system. Purpose. We sought to determine in a clinical registry the acute and long-term clinical and angiographic outcomes of this BMS design in patients with acute coronary syndromes (ACS) or who were unable to be on long-term clopidogrel therapy. METHODS: From March 2007 to December 2008, 150 patients undergoing coronary stent implantation at three centers in Buenos Aires, Argentina, were included in our registry. Patients with ACS, including non-ST-elevation myocardial infarction (NSTEMI) and STelevation MI (STEMI), or those unable to be on long-term dual antiplatelet therapy were considered for inclusion. The primary endpoint was a major adverse cardiovascular event (MACE) defined as the incidence of cardiac death, MI or target lesion revascularization (TLR). The incidence of acute and late stent thrombosis (ST) was also analyzed. Angiographic late loss and the presence of late stent malapposition (LSM) was recorded at 9-month follow up. Clopidogrel was prescribed for 1 month. RESULTS: 54.7% of patients had acute MI, 36% had STEMI and 20.7% of patients were ineligible for long-term clopidogrel therapy because of previously planned non-vascular or general surgery within 30 days after percutaneous coronary intervention. During 11.5 months of clinical follow up, 2% suffered cardiac death, 4% had a MI, 8.9% underwent TLR and the overall cumulative major adverse cardiac event rate was 15.3%. No patient developed acute or late ST. There were no in-hospital complications for patients who underwent surgery. Intravascular ultrasound studies did not detect the presence of late malapposition. CONCLUSION: In this high-risk thrombotic patient population, the Camouflage coated stent design demonstrated a very good safety profile, as reflected by the low incidence of hard adverse cardiac events including ST at follow up.


Subject(s)
Coated Materials, Biocompatible , Coronary Disease/therapy , Coronary Thrombosis/prevention & control , Equipment Design , Registries , Stents , Aged , Argentina , Clopidogrel , Coated Materials, Biocompatible/adverse effects , Coronary Angiography , Coronary Thrombosis/epidemiology , Equipment Design/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Prospective Studies , Retrospective Studies , Risk Factors , Stents/adverse effects , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic use , Treatment Outcome
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