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See detailOne-year clinical outcomes after sirolimus-eluting coronary stent implantation in diabetics enrolled in the worldwide e-SELECT registry.
Bartorelli, Antonio L.; Egidy Assenza, Gabriele; Abizaid, Alexandre et al

in Catheterization and Cardiovascular Interventions (2015)

BACKGROUND: Diabetes mellitus has worse outcome after percutaneous coronary intervention. AIM: We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year ... [more ▼]

BACKGROUND: Diabetes mellitus has worse outcome after percutaneous coronary intervention. AIM: We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry. METHODS: From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of >/= 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee. RESULTS: Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co-morbidities, and triple-vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 +/- 0.46 vs. 2.93 +/- 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow-up, without significant difference among subgroups. CONCLUSIONS: In the e-SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co-morbidities and complex coronary lesions. Although 1-year follow-up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. (c) 2015 Wiley Periodicals, Inc. [less ▲]

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See detailDrug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry.
Sabate, Manel; Brugaletta, Salvatore; Abizaid, Alexandre et al

in International Journal of Cardiology (2013), 168(3), 2522-7

BACKGROUND: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. METHODS: A total of 7651 patients were selected among 15,147 ... [more ▼]

BACKGROUND: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. METHODS: A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. RESULTS: The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 +/- 9.9 vs.62.9 +/- 10.7, P<0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P<0.04 and P<0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p=0.4). CONCLUSIONS: Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB. [less ▲]

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See detailOne-year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-SELECT registry.
Gao, Runlin; Abizaid, Alexandre; Banning, Adrian et al

in Journal of Interventional Cardiology (2013), 26(2), 163-72

OBJECTIVES: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the ... [more ▼]

OBJECTIVES: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the international e-SELECT registry. BACKGROUND: Large-scale registry data are lacking on DES outcomes in SmVD treatment. METHODS: There were 4,700 SmVD (at least one vessel with estimated reference vessel diameter [RVD] < 2.5 mm, excluding 283 patients with unknown RVD vessels) and 10,139 NSmVD only patients. RESULTS: The SmVD population was older, with more women, diabetics, and vessels treated, higher mean Charlson Comorbidity Index score (CCI), shorter lesions, and less STEMI presentation. The 1-year stent thrombosis (ST) rate (primary end-point), was significantly higher (1.3% vs. 0.7%) in SmVD versus NSmVD, mainly driven by early events. One-year major adverse cardiac event (MACE), myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) rates were significantly higher in SmVD although death and major bleeding rates were similar in both groups. Complication rates were similar between pure (3,188 patients; only RVD < 2.5 mm) and mixed (1,795 patients; some RVD < 2.5 mm or unknown RVD) SmVD. Multivariate predictors for 1-year MACE in SmVD included saphenous vein graft or bifurcation lesions, major bleeding, any antiplatelet therapy discontinuation within 1 month, age, number of stents implanted, CCI, acute coronary syndrome, and insulin-dependent diabetes mellitus. CONCLUSION: SES implantation for SmVD occurs more frequently in women, diabetics, and those with multivessel disease and comorbidities. One-year ST, MACE, MI, and clinically indicated TLR rates are higher, although low overall, in SmVD or mixed SmVD patients while death rates are similar to NSmVD. [less ▲]

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See detailOne-year clinical outcomes after sirolimus-eluting coronary stent implantation for acute myocardial infarction in the worldwide e-SELECT registry.
Worthley, Stephen G.; Abizaid, Alexandre; Banning, Adrian et al

in Journal of Interventional Cardiology (2012), 25(3), 253-61

BACKGROUND: The aim was to ascertain the 1-year clinical outcomes of 1,234 patients who underwent implantations of sirolimus-eluting stents (SES) for acute myocardial infarction (MI) in the multinational ... [more ▼]

BACKGROUND: The aim was to ascertain the 1-year clinical outcomes of 1,234 patients who underwent implantations of sirolimus-eluting stents (SES) for acute myocardial infarction (MI) in the multinational e-SELECT registry. METHODS: Fifteen thousand and one hundred and forty-seven patients treated with SES were entered in the e-SELECT registry, of whom 1,234 presented within <24 hours of onset of acute MI. RESULTS: At 1 year, the rates of major adverse cardiac events (MACE) (5.5% vs. 4.8%; P = 0.28) were similarly low in the acute and no acute MI groups. The rates of definite/probable stent thrombosis (ST) were higher in the acute MI group (2.1%vs; 0.88%, P < 0.001). ST was a strong independent predictor of death at 1 year (HR 13.4; 95% CI 5.0, 36.0; P < 0.001) and MI (HR 58.9; 95% CI 26.9, 129.1; P < 0.001). Dual antiplatelet therapy (DAPT) compliance at 6 months was 96.0% in the acute MI versus 94.5% in the no acute MI group (P = 0.03). CONCLUSION: In selected patients presenting within <24 hours of acute MI onset and highly compliant with DAPT, SES implantation was associated with similar rates of MACE, though higher rates of ST, as compared to no acute MI patients. [less ▲]

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See detailThe sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.
Abizaid, Alexandre; Costa, J. Ribamar Jr; Banning, Adrian et al

in JACC. Cardiovascular Interventions (2012), 5(1), 64-71

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 ... [more ▼]

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. [less ▲]

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See detailSirolimus-eluting coronary stents in octogenarians: a 1-year analysis of the worldwide e-SELECT Registry.
Hong, Young Joon; Jeong, Myung Ho; Abizaid, Alexander et al

in JACC. Cardiovascular Interventions (2011), 4(9), 982-91

OBJECTIVES: The aim of this study was to identify the worldwide practice of Cypher Select (Cordis Corporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients 80 ... [more ▼]

OBJECTIVES: The aim of this study was to identify the worldwide practice of Cypher Select (Cordis Corporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients 80 years of age (octogenarian) and to identify clinical outcomes in this patient population. BACKGROUND: The use of drug-eluting stents in elderly patients may have different features compared with younger patients. METHODS: Between 2006 and 2008, 15,147 patients from 320 hospitals in 56 countries were enrolled in a registry. Initial implantation and follow-up outcome information obtained at 1-year follow-up in 675 octogenarian patients were compared with those in 14,472 nonoctogenarian patients. RESULTS: Octogenarians had significantly more comorbidities and had higher Charlson comorbidity index scores (1.5 +/- 1.6 vs. 1.0 +/- 1.3, p < 0.001). Rates of cardiac death (3.3% vs. 0.9%, p < 0.001), myocardial infarction (2.3% vs. 1.9%, p = 0.021), and definite or probable stent thrombosis (2.3% vs. 0.9%, p = 0.0002), and major bleeding (2.0% vs. 0.9%, p = 0.015) were significantly higher in octogenarians at 1 year; however, there was no significant difference in the rate of target lesion revascularization between the 2 groups (3.2% vs. 2.2%, p = 0.12). In octogenarians, a high Charlson comorbidity index was an independent predictor of death and stent thrombosis up to 360 days from the index procedure (hazard ratio: 1.3, 95% confidence interval: 1.1 to 1.5, p < 0.001, and hazard ratio: 1.5, 95% confidence interval: 1.3 to 1.8, p < 0.001, respectively). CONCLUSIONS: Stenting with SES may be an effective therapeutic option in elderly patients, with acceptable rates of complications and a very low rate of repeat revascularization as demonstrated by this e-SELECT (A Multi-Center Post-Market Surveillance Registry) subgroup analysis. [less ▲]

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See detailStent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.
Urban, Philip; Abizaid, Alexandre; Banning, Adrian et al

in Journal of the American College of Cardiology (2011), 57(13), 1445-54

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 ... [more ▼]

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). [less ▲]

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