Blood group types and clinical, procedural, and adverse outcomes in ST-elevated myocardial infarction patients: A 3-year cohort in Iran.

Background: The objectives of this study were to assess the relation of blood groups and the rate of successful angioplasty in patients with ST-elevated myocardial infarction (STEMI) and also to investigate long-term adverse outcomes follow-up. Materials and Methods: In this study, 500 eligible patients with definitive diagnosis of STEMI who underwent primary percutaneous coronary intervention (PCI) were followed up for 3 years. The patient's angiography images were examined and thrombolysis in myocardial infarction (TIMI) flow rate and coronary artery patency rate were evaluated in different ABO blood groups. All patients were followed up after 3 years based on major adverse cardiovascular events. Results: There was no significant difference in coronary artery patency rate between the patients of the different blood types with respect to TIMI flow before (P = 0.19) and after revascularization (P = 0.69). The incidence of atrial fibrillation (AF) in blood Group A was the highest. Death in the blood Groups AB and O was significantly higher than the other groups. No significant differences were seen in different blood groups in the frequency of mortality (P = 0.13), myocardial infarction (P = 0.46), heart failure (P = 0.83), re-hospitalization, angiography (P = 0.90), PCI (P = 0.94), coronary artery bypass graft (P = 0.26), implantable cardioverter defibrillator (ICD) implantation (P = 0.26), and mitral regurgitation (P = 0.88). Conclusion: The incidence of AF in blood Group A and inhospital mortality in blood Groups AB and O were the highest. The blood group may be considered in assessment of clinical risk in STEMI patients.

Ischemic time is a better predictor than door-to-balloon time for mortality and infarct size in ST-elevation myocardial infarction.

BACKGROUND: Current guidelines for ST-elevation myocardial infarction (STEMI) recommend early revascularization with optimal ischemic time (IT) < 120 min and door-to-balloon (D2B) time < 90 min. The focus of most studies has been D2B time, while IT is not frequently reported. We tested the hypothesis that total IT is a better predictor than D2B time for mortality and infarct size. METHODS AND RESULTS: Between December 2008 and April 2013, 786 patients with STEMI were treated in our STEMI center, and 262 of these had cardiac magnetic resonance imaging 3-5 days after the index event. Total IT was defined as time from symptom onset to device activation, while D2B time was defined as hospital arrival to device activation. Patients were divided into three groups according to IT (<120, 120-239, ≥240 min) and into four groups according to D2B time (<30, 30-59, 60-89, ≥90 min). Baseline demographics including age, cardiac risk factors, and LAD infarct location were similar between groups. The 30-day mortality rate significantly increased across IT groups but did not correlate with D2B time groups. Similarly, infarct size significantly increased across IT groups but did not correlate with D2B time groups. CONCLUSIONS: In STEMI patients, IT was a better predictor than D2B time for 30-day mortality and infarct size. Our findings suggest that the focus of STEMI care should be directed at early initiation of therapy and minimizing IT rather than on D2B time alone. The potential impact of IT reporting in current STEMI registries merits further consideration. © 2015 Wiley Periodicals, Inc.

The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty.

OBJECTIVES: This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 µg/mm(2)paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions. BACKGROUND: Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 µg/mm(2) formulated differently have shown promising results with reduced restenosis. Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics. RESULTS: Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 1.13 mm) than for the control group (1.09 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUC(all)) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%. CONCLUSIONS: Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)

Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

OBJECTIVES: This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means of a network meta-analysis. BACKGROUND: Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth. METHODS: Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. RESULTS: Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES. CONCLUSIONS: In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.

Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery).

OBJECTIVES: This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. BACKGROUND: PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. METHODS: A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. RESULTS: Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. CONCLUSIONS: Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis.

OBJECTIVES: The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) using a network meta-analysis. BACKGROUND: The relative safety of DES and BMS in patients with STEMI continues to be debated, and whether advances have been made in this regard with second-generation DES is unknown. METHODS: Randomized controlled trials comparing currently U.S. approved DES or DES with BMS in patients with STEMI were searched using MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. RESULTS: Twenty-two trials including 12,453 randomized patients were analyzed. At 1-year follow-up, cobalt-chromium everolimus eluting stents (CoCr-EES) were associated with significantly lower rates of cardiac death or myocardial infarction (MI) and stent thrombosis (ST) than BMS. Differences in ST were apparent as early as 30 days and were maintained for 2 years. CoCr-EES were also associated with significantly lower rates of 1-year ST than paclitaxel-eluting stents (PES). Sirolimus-eluting stents (SES) were also associated with significantly lower rates of 1-year cardiac death/myocardial infarction than BMS. CoCr-EES, PES, and SES, but not zotarolimus-eluting stents, had significantly lower rates of 1-year target vessel revascularization (TVR) than BMS, with SES also showing lower rates of TVR than PES. CONCLUSIONS: In patients with STEMI, steady improvements in outcomes have been realized with the evolution from BMS to first-generation and now second-generation DES, with the most favorable safety and efficacy profile thus far demonstrated with CoCr-EES.