Scant data are available on the relation between ST-segment elevation (STE) resolution and 30-day mortality in patients with STE acute myocardial infarction treated with percutaneous coronary ...intervention in contemporary, real world, clinical practice. Furthermore, whether the prognostic value of STE resolution is influenced by the patient clinical risk profile or postprocedural Thrombolysis In Myocardial Infarction (TIMI) flow has never been investigated. Lombardima was an observational registry implemented in Lombardy, a Northern Italian region. The clinical characteristics, electorcardiographic parameters, and procedural data were prospectively entered into a Web-based database. In the present study, we enrolled 3,403 patients. STE resolution occurred in 2,452 patients (group 1) and did not in 951 patients (group 2). The mortality rate was 2.4% in group 1 and 11.3% in group 2 (p <0.001). After stratifying patients according to their TIMI risk index, we observed that STE resolution was an independent predictor of 30-day mortality across all spectrum of clinical risk. Furthermore, in patients with TIMI 3 flow, STE resolution remained an independent predictor of 30-day mortality (p <0.0001). In conclusion, STE resolution was a strong and independent predictor of 30-day mortality in patients with STE acute myocardial infarction undergoing percutaneous coronary intervention across all spectrum of clinical risk.
The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) ...in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non–ST-segment elevation myocardial infarction who underwent DES (n = 611) or BMS (n = 238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals CI 0.59 to 1.38, p = 0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p = 0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p = 0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p = 0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS.
Objectives The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary ...artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). Background Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. Methods We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. Results At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). Conclusions In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.
Procedure Volume and Outcome Navarese, Eliano Pio, MD; Castriota, Fausto, MD; De Servi, Stefano, MD
Journal of the American College of Cardiology,
04/2011, Letnik:
57, Številka:
16
Journal Article
In this study we investigated the impact of acute coronary syndromes (ACSs) on clinical outcomes in patients with unprotected left main coronary artery (ULMCA) stenosis treated with drug-eluting ...stents (DESs). In this multicenter, retrospective, observational study we enrolled 1,101 patients with ULMCA stenosis treated with DESs. Six hundred eleven patients presented with ACS and 490 had stable coronary artery disease. ACS was defined as the presence of unstable angina or non–ST-segment elevation myocardial infarction (MI). During 2-year follow-up, the adjusted hazard ratio of cardiac mortality and MI of patients with ACS versus stable patients was 2.42 (95% confidence interval 1.37 to 4.28, p = 0.002). We observed a stepwise risk increase, namely patients with stable coronary disease had the lowest risk, patients with unstable angina an intermediate risk, and patients with non–ST-segment elevation MI the highest risk. The increased risk of cardiac mortality and MI of patients with ACS was concentrated in the first year after DES implantation. In conclusion, patients with ULMCA stenosis and ACS treated with DESs have an increased risk of cardiac mortality and MI during the first year after the intervention compared to stable patients.
First of all, literature research and inclusion process of the observational studies are incomplete for a meta-analysis largely driven by nonrandomized data.
Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitäts Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly ...after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with ≥3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only patients with left main or bypass graft disease, in-stent restenosis or stent thrombosis, in need of nonheart surgery, at increased bleeding risk, without compliance/consent are excluded. All patients are treated with dual antiplatelet therapy for 12 months. The primary end point will be cardiac death/nonfatal myocardial infarction after 24 months with further follow-up up to 5 years. Results By June 12, 229 patients (10% of the planned total) were included with a baseline risk similar to that of the same subgroup of BASKET (n = 588). Conclusions This study will answer several important questions of contemporary stent use in patients with large native vessel stenting. The 2-year death/myocardial infarction—as well as target vessel revascularization—and bleeding rates in these patients with a first- versus second-generation drug-eluting stent should demonstrate the benefit or harm of these stents compared to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12- versus 6-month dual antiplatelet therapy on these outcomes.
Longest Available Clinical Outcomes After Drug-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Disease: The DELFT (Drug Eluting stent for LeFT main) Registry Emanuele Meliga, ...Hector Manuel Garcia-Garcia, Marco Valgimigli, Alaide Chieffo, Giuseppe Biondi-Zoccai, Andrew O. Maree, Stephen Cook, Lindsay Reardon, Claudio Moretti, Stefano De Servi, Igor F. Palacios, Stephen Windecker, Antonio Colombo, Ron van Domburg, Imad Sheiban, Patrick W. Serruys We investigated the long-term safety and efficacy of percutaneous coronary intervention with drug-eluting stent (DES) implantation for unprotected left main coronary artery (ULMCA) disease in a population of 358 consecutive patients analyzed in 7 European and U.S. tertiary care centers. After 3 years, major adverse cardiovascular event-free survival in the whole population was 73.5%. Cardiac death occurred in 9.2% of patients and reinfarction, target lesion revascularization, and target vessel revascularization occurred in 8.6%, 5.8%, and 14.2% of patients, respectively. Routine DES implantation in ULMCA disease seems encouraging, with favorable long-term clinical results.
Impact of Stable Versus Unstable Coronary Artery Disease on One-Year Outcome in Elective Patients Undergoing Multivessel Revascularization With Sirolimus-Eluting Stents: A Subanalysis of the ARTS II ...Study Marco Valgimigli, Keith Dawkins, Carlos Macaya, Bernard de Bruyne, Emmanuel Teiger, Jean Fajadet, Richardt Gert, Stefano De Servi, Angelo Ramondo, Kristel Wittebols, Hans-Peter Stoll, Tessa A. M. Rademaker, Patrick W. Serruys We sought to address the impact of clinical presentation on outcome when 607 patients with multivessel disease in whom sirolimus-eluting stents were implanted, of whom 221 (36%) presented with unstable angina, were considered as part of a subanalysis of the ARTS II study. The actual cumulative rate of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (i.e., major adverse cardiac and cerebrovascular events) was similar at both 30 days and 1 year in patients with unstable as compared with stable angina patients. After adjustment for baseline and procedural characteristics, the clinical presentation failed to be identified as an independent predictor of major adverse cardiac and cerebrovascular events (hazard ratio 0.94, 95% confidence interval 0.41 to 2.12, p = 0.88).
Background Transradial intervention (TRI) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding ...complications in patients with acute coronary syndromes (ACS). Although bleeding is thought to be associated with worse outcomes, it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management. Hypotheses The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared, respectively, with transfemoral coronary intervention (MATRIX access site) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors, (MATRIX antithrombin) decrease the 30-day incidence of an ischemic (ie, death, myocardial infarction or stroke) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients, including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention (MATRIX treatment duration). Study design The MATRIX (NCT01433627) study, which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up ≤1 year, is a large-scale, multicenter study with blind event adjudication conducted at approximately 100 European sites. With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens, this study will have ≥85% power for the primary end points. Summary The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management.
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