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INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access. (AU)
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Intervenção Coronária PercutâneaRESUMO
BACKGROUND: A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. OBJECTIVES: This study analyzed 2-year outcomes to determine whether these benefits are maintained. METHODS: In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. RESULTS:At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045)...
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Stents , Stents Farmacológicos , TromboseRESUMO
BACKGROUND:Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.METHODS:In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.RESULTS:We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001)...
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Intervenção Coronária Percutânea , StentsRESUMO
Aims: Performing percutaneous coronary intervention (PCI) to multiple coronary lesions during the same procedurehas potential economic and social advantages. However comprehensive outcome data of real world practicein a large population is limited. We aimed to compare short- and long-term outcomes between patients with multivesselcoronary artery disease who either underwent single- or multivessel PCI within the e-SELECT registry.Methods and results: The e-SELECT registry combines data collected at 320 medical centres in 56 countrieswhere patients received CYPHER Select® or CYPHER Select® Plus sirolimus-eluting stent (SES). Rates of myocardialinfarction and major adverse cardiac event (MACE) (defined as any death, myocardial infarction or targetlesion revascularisation) were compared between patients undergoing single-vessel versus multivessel PCI. A totalof 15,147 patients who satisfied the inclusion criteria were included in the e-SELECT registry. Two thousand twohundred and seventy-eight (2,278) subjects (15%) underwent multivessel PCI and 12,869 (85%) had single-vesselPCI. The mean age was higher in the multivessel PCI group (63 vs. 62 years, p<0.001) and there was a higherprevalence of diabetes mellitus (32.4 vs. 30.0%, p=0.02). Lesions were more complex in the single-PCI groupwhile pre- and post-dilatation were less common in the multivessel PCI group. Myocardial infarction within thefirst 30 days post PCI was more common in the multivessel PCI group (1.9 vs. 0.8%, p<0.001) and most of theinfarctions were periprocedural (1.3 vs. 0.6%, p=0.001). Mortality and myocardial infarction at one-year werehigher in the multivessel PCI group resulting in a significantly higher MACE (6.1 vs. 4.6%, p=0.005)...
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Reestenose Coronária , Revascularização Miocárdica , Stents FarmacológicosRESUMO
BackgroundDrug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis,which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs withbioabsorbable polymer to reduce spatial and temporal polymer exposure.Methods and ResultsNEVO ResElution-I was a prospective randomized study in 394 patients with coronary arterydisease comparing the NEVO SES with the TAXUS Liberte´ paclitaxel-eluting coronary stent (TAXUS Liberte´ PES)stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronaryintervention (PCI), the primary end point favored NEVO SES (0.13 0.31 mm versus 0.36 0.48 mm, P 0.001 fornoninferiority and superiority). The study was not powered for clinical end points and showed no significant differencefor NEVO SES versus TAXUS Liberte´ PES: death: 0.5 versus 1.6%, P 0.36; myocardial infarction: 2.0 versus 2.6%,P 0.75; target lesion revascularization: 1.5 versus 3.2%, P 0.33; major adverse cardiac events: 4.0 versus 7.4%, P 0.19.No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberte´ PES. Intravascularultrasound showed lower percent volume obstruction for NEVO SES (5.5 11% versus 11.5 9.7%, P 0.016).ConclusionsThis trial proved the superiority of NEVO SES over TAXUS Liberte´ PES for the primary angiographic endpoint of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.
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Angioplastia , Reestenose Coronária , StentsRESUMO
BackgroundThe expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and ResultsBetween April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. ConclusionsThis analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.
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Diretório/estatística & dados numéricos , Doença das Coronárias , Revascularização Miocárdica , Stents , Trombose CoronáriaRESUMO
BackgroundThe expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and ResultsBetween April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. ConclusionsThis analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials
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Doença da Artéria Coronariana , Revascularização Miocárdica , Stents , TromboseRESUMO
Context Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective To compare the safety and efficacy of sirolimus-eluting vs paclitaxeleluting coronary stents. Design Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting Ninety hospitals in Europe, Latin America, and Asia. Patients A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. Intervention Patients were randomly assigned in a 1:1 ratio to receive a sirolimuseluting stent (n=701) or a paclitaxel-eluting stent (n=685). Main Outcome Measures The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or nonQ-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxeleluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, −0.22 mm; 95% CI, −0.26 to −0.18 mm; P .001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, −3.60%; 95% CI, −5.12% to −2.08%; P .001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69- 1.27; P=.73). Conclusion In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events.