Objectives The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). ...Background Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. Methods The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. Results The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. Conclusions In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919 )
The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental ...studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 ± 0.48 mm (from 1.02 ± 0.38 mm before to 2.69 ± 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 ± 11.3% before to 18.9 ± 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 ± 0.69 mm and a loss index of 0.48 ± 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent.
We report clinical outcomes following transcatheter aortic valve implantation (TAVI), using the CoreValve revalving system (18 Fr transfemoral or subclavian) or the Edwards Sapien valve (22 Fr ...transfemoral or 24 Fr transapical) as part of a Belgian prospective non-randomized multicentre registry. All 15 Belgian centres performing TAVI participated to this registry (seven exclusively Edwards Sapien, eight exclusively CoreValve). All consecutive high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVI. Three hundred and twenty-eight patients underwent TAVI with CoreValve (n = 141; eight subclavian and 133 transfemoral) or Edwards Sapien (n = 187; 99 transfemoral and 88 transapical) up to April 2010. Procedural success was 97%. One-month survival was 88% for the Edwards and 89% for the CoreValve treated patients. One-month mortality was both related to cardiac and non-cardiac reasons. Overall one-year survival was 78% in the CoreValve transfemoral treated patients, 100% in the CoreValve subclavian treated patients, 82% in the Edwards transfemoral treated patients and 63% in the Edwards transapical treated patients. This mid-term mortality was mainly related to age-related, non-cardiac complications.
Objectives This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the ...treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. Background There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. Methods The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Results Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Conclusions Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
To determine whether there are gender-based differences in in-hospital outcomes among patients undergoing percutaneous coronary intervention (PCI).
We studied a large cohort using clinical data from ...a registry of 130,985 PCI procedures in Belgium, from January 2006 to February 2011. Compared to males, females were significantly older (70.3 vs. 64.8 years), and were more frequently diabetic or hypertensive. Men smoked more and more frequently had previous myocardial infarction (MI), previous PCI or previous coronary artery bypass graft (CABG) surgery. Coronary artery disease (CAD) was less severe in women, and PCI to the left anterior descending artery was more common in female patients. Unadjusted in-hospital mortality rates were higher in females versus males (2.5% for women and 1.6% for men, p<0.0001). After multivariable analysis, female gender remained an independent predictor of mortality (odds ratio 1.35, 95% CI: 1.22-1.49, p<0.0001).
Gender-based differences in hospital mortality rates after PCI were observed in this large registry. Female sex remained an independent predictor of mortality after multivariable adjustment.
Objectives Currently, the prevalence of abdominal aortic aneurysm (AAA) in patients with coronary artery disease (CAD) and the correlation between CAD severity and AAA prevalence are not clearly ...known. We conducted a prospective study to determine the prevalence of AAA in patients undergoing coronary angiography and to determine the risk factors and a coronary profile associated with AAA. Methods Over an 18-month period, abdominal aortic ultrasound was performed on 1,000 patients undergoing coronary angiography for suspected or known CAD, or prior to valve surgery. Clinical characteristics and coronary profile were collected from the patients. Results The overall number of previously repaired, already diagnosed, and new cases of AAA in the study population was 42, yielding a prevalence of 4.2%. Among the patients with newly detected AAAs, only two had an AAA diameter of >54 mm and were therefore treated surgically. In men aged ≥65 years, the prevalence reached 8.6%, while in men with three-vessel CAD it was 14.4%. Multivariate analysis showed that age ≥65 years ( p = .003), male gender ( p = .003), family history of AAA ( p = .01), current smoking ( p = .002), and three-vessel CAD ( p < .001) were significantly associated with a higher prevalence of AAA. Conclusion The prevalence of AAA was high in men aged ≥65 years and in those with three-vessel CAD regardless of age. While our findings do not prove the cost-effectiveness of screening for AAA in these high risk patients, they do support the usefulness of a quick ultrasound examination of the abdominal aorta during routine transthoracic echocardiography in such patients.
High-sensitivity C-reactive protein predicts future cardiovascular events in both healthy individuals and patients with unstable and stable coronary syndromes. Few data are available about the ...incidence and the relation to inflammation of troponin elevation following percutaneous coronary intervention (PCI), a potential predictor of longterm outcome. We sought to confirm the impact of embolization on long-term outcome and evaluate the ability of baseline inflammation to predict troponin elevation induced by PCI. We prospectively analyzed 200 patients treated by PCI for stable or Braunwald IIA class unstable angina. The patients were recruited between January 1997 and May 1999, and the population was followed during a mean follow-up of 32 months. Major adverse cardiac events (MACEs) were defined as the occurrence of death, myocardial infarction or recurrent angina requiring repeat PCI, or coronary artery bypass grafting. During the follow-up period, 58 MACEs were observed. By multivariate analysis, independent predictors for the occurrence of MACEs were unstable angina and troponin I level after PCI (
P
< 0.0001 for both). No correlation was found between baseline inflammation and significant troponin I elevation post PCI and by multivariate analysis, no biological variable was a predictor of troponin I elevation post PCI. Baseline inflammation cannot predict onset of minor myonecrosis damage (expressed by troponin elevation) induced by PCI, a significant predictor of long-term outcome in this setting.
PDF
