One-year Major Adverse Cardiac Events Research Articles

Clinical Significance of On-Treatment Triglyceride Level in Patients Treated by Percutaneous Coronary Intervention for Non-ST-Segment Elevation Acute Coronary Syndrome

Background/AimsThe use of statins in patients with acute coronary syndrome (ACS) has increased, and reduced levels of low-density lipoprotein cholesterol (LDL-C) lead to lower coronary event rates. We studied the effect of lipid levels during statin treatment on prognosis in patients with ACS and percutaneous coronary intervention (PCI).MethodsBetween January 2005 and May 2007, 325 ACS patients who underwent PCI and received statins were evaluated. We measured serum lipid levels at baseline and 4 weeks. The relationships between on-treatment levels of triglyceride (TG) and LDL-C and one-year major adverse cardiac events (MACE) were assessed.ResultsAt 4 weeks, the mean LDL-C level was 72.5±23.8 mg/dL and the mean TG was 123.2±62.8 mg/dL. MACE occurred in 41 cases (12.6%). Baseline serum lipid levels were similar between the patients with and those without MACE. However, the patients with MACE showed significantly higher TG level at 4 weeks (149.6±81.4 vs. 119.3±58.9 mg/dL, p=0.026) than those without. High on-treatment TG level (≥150 mg/dL) were associated with increased adverse events compared to lower TG level in a univariate analysis (hazard ratio [HR], 3.3; p<0.001). In a multivariate analysis, high 4-week TG level after statin treatment was an independent predictor for MACE (HR, 4.01; 95% confidence interval, 1.85 to 9.06; p=0.001), however, baseline TG and LDL-C levels were not.ConclusionsHigh on-treatment TG level (≥150 mg/dL) was associated with a higher risk of MACE. This finding supports the concept that achieving low TG levels may be an important therapeutic parameter in statin-treated patients following ACS and PCI.

Pre-procedural C-reactive protein levels and clinical outcomes after percutaneous coronary interventions with and without abciximab: pooled analysis of four ISAR trials

Objective: To assess the prognostic value of the baseline C-reactive protein (CRP) level in patients undergoing percutaneous coronary intervention (PCI) after pre-treatment with 600 mg of clopidogrel and whether there...

Outcomes of primary percutaneous coronary intervention for acute ST-elevation myocardial infarction in patients aged over 75 years

The optimal reperfusion strategy in elderly patients with ST-elevation myocardial infarction (STEMI) remains unclear. The purpose of this study was to evaluate the safety, in-hospital and one-year clinical outcomes for patients > 75 years of age with STEMI receiving primary percutaneous coronary intervention (PCI), compared with those treated by conservative approach. One hundred and two patients > 75 years of age with STEMI presented < 12 hours were randomly allocated to primary PCI (n = 50) or conservative therapy only (n = 52). The baseline characteristics, in-hospital outcome and major adverse cardiac events (MACE), including death, non-fatal myocardial infarction and target vessel revascularization at one-year clinical follow-up were compared between the two groups. Age, gender distribution, risk factors for coronary artery disease, infarct site and clinical functional status were similar between the two groups, but the patients in primary PCI group received less low-molecular-weight heparin during hospitalization. Compared with conservative group, the patients in primary PCI group had significantly lower occurrence rate of re-infarction and death and shortened hospital stay. The composite endpoint for in-hospital survivals at 30-day follow-up was similar between the two groups, but one-year MACE rate was significantly lower in the primary PCI group (21.3% and 45.2%, P = 0.029). Left ventricular ejection fraction was not significantly changed in both groups during follow-up. Multivariate analysis revealed that primary PCI (OR = 0.34, 95% CI: 0.21 - 0.69, P = 0.03) improved MACE-free survival rate for STEMI patients aged > 75 years. Our results indicated that primary PCI was safe and effective in reducing in-hospital mortality and one-year MACE rate for elderly patients with STEMI.

Prevention of lesion recurrence in chronic total coronary occlusions by paclitaxel-eluting stents

The aim of this research was to assess the efficacy of paclitaxel-eluting stents in chronic total coronary occlusions (CTO). Percutaneous coronary interventions for CTOs are characterized by a high target vessel failure rate. In 48 consecutive patients, paclitaxel-eluting stents (Taxus, Boston Scientific Corp., Natick, Massachusetts) were implanted after successful recanalization of a CTO (duration >2 weeks). Patients underwent an angiography after 6 months and were followed clinically for 12 months. They were compared with 48 lesion- and risk-matched patients with CTOs treated with bare metal stents (BMS). Primary clinical end point was the one-year incidence of major adverse cardiac events (MACE) (death, myocardial infarction, repeat revascularization); secondary end points were the rate of restenosis and re-occlusion. In-hospital MACE was 4.2% with Taxus, and 2.1% with BMS (p = NS). The one-year MACE rate was 12.5% in the Taxus group, and 47.9% in the BMS group (p < 0.001), which was due to a reduced need for repeat revascularization. The angiographic restenosis rate was 8.3% with Taxus versus 51.1% with BMS (p < 0.001). There was only one late re-occlusion with Taxus (2.1%) as compared with 23.4% with BMS (p < 0.005). The late loss was reduced in the Taxus group by 84% as compared with BMS. All nonocclusive restenoses in the Taxus group were focal and successfully treated by implanting an additional Taxus stent. The treatment of CTOs with a paclitaxel-eluting stent drastically reduces MACE and restenosis, and almost eliminates re-occlusion, which is typically frequent with BMS in CTOs. Chronic total coronary occlusion should be a preferred indication for drug-eluting stents.

Actinomycin-eluting stent for coronary revascularizationA randomized feasibility and safety study: The ACTION trial

We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novonative coronary esions. Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 μg/cm 2 of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Actinomycin-eluting stent for coronary revascularization: A randomized feasibility and safety study: The ACTION trial

We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary lesions. Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 microg/cm(2) of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

New frontiers in cardiology: drug-eluting stents: Part II.

In this second part of the article, we will complete the review of drug-eluting stent technologies (Table 1) and discuss methodological and technical aspects of drug-eluting stents. View this table: TABLE 1. Drug-Eluting Stent Platforms Under Investigation ### Biological Agents (Continued) #### (1) Stents Eluting Antiproliferative Agents A number of antineoplastic medications have been considered for the prevention of restenosis. Paclitaxel and its derivatives have been the most investigated compounds of this group. ##### (a) Paclitaxel-Eluting Stents Paclitaxel (Taxol; Bristol-Myers Squibb) is a microtubule-stabilizing agent with potent antitumor activity.1 Many different platforms that use polymer coating or surface modifications to adhere paclitaxel onto the stents have been utilized over the past 2 years. ###### Preclinical Data Unlike other antimitotic agents, paclitaxel shifts the cytoskeleton equilibrium toward assembly, leading to reduced vascular cell proliferation, migration, and signal transduction.2 Paclitaxel is highly lipophilic, resulting in a rapid cellular uptake and a long-lasting effect in the cell.3 NIR stents (Boston Scientific Corp) coated with poly(lactide-co-Σ-caprolactone) copolymer and paclitaxel (200 μg/stent) were placed in porcine coronary arteries. Paclitaxel-eluting stents showed a marked reduction in neointimal and medial cell proliferation at all time points (7, 28, 56, and 180 days).4 However, arteries treated with paclitaxel showed incomplete healing, late persistence of a large number of macrophages, and fibrin deposition. Similar findings were observed with a stent platform coated with cross-linked biodegradable polymer (chondroitin sulfate and gelatin) and 42.0, 20.2, 8.6, or 1.5 μg of paclitaxel in rabbit iliac arteries.5 These studies indicate the need for a more controlled drug release of paclitaxel due to the narrow toxic-therapeutic window and high hydrophobic character of this compound. ###### Clinical Data: De Novo Lesions The QuaDS drug-eluting stent (Quanam Medical Corp) was the first drug-eluting stent implanted in human coronary arteries. This slotted tube stent has 50% of its surface area covered by multiple nonbiodegradable polyacrylate sleeves that release 7-hexanoyltaxol (called QP2 or taxane). Approximately 800 μg of the …