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1.
JACC Cardiovasc Interv ; 13(1): 86-93, 2020 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-31918946

RESUMO

OBJECTIVES: This study sought to determine clinical outcomes between treatment groups over long-term follow-up. BACKGROUND: The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. METHODS: Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. RESULTS: A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). CONCLUSIONS: In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.

2.
EuroIntervention ; 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31793882

RESUMO

AIMS: Limited data exist regarding procedural and clinical outcomes of percutaneous coronary intervention (PCI) in patients with trifurcation disease of the distal left main (LM) coronary artery. METHODS AND RESULTS: Patients with distal LM bifurcation disease randomized to PCI with everolimus-eluting stents in the EXCEL trial were categorized into those with and without trifurcation involvement. Angiographic and procedural characteristics in addition to clinical events through 5-year follow-up after PCI were compared. Among 605 patients with site-reported distal LM disease, 61 patients (10.1%) were identified with trifurcation anatomy. The 5-year primary composite endpoint of death, myocardial infarction, or stroke occurred in 16.6% of patients with trifurcation disease compared with 22.5% of patients with distal bifurcation disease only (p=0.32). Ischemia-driven target lesion revascularization rates were also similar (11.9% versus 12.0%, p=0.94). No significant differences in definite or probable stent thrombosis were observed between treatment groups (1.7% versus 2.3%, p=0.76). CONCLUSIONS: Despite the greater inherent complexity, procedural and long-term clinical outcomes following PCI of distal LM trifurcations with everolimus-eluting stents in a modest-sized cohort from the EXCEL trial were similar compared with treatment of distal LM bifurcation disease without trifurcations. These findings support PCI as a treatment strategy for selected patients with distal LM trifurcation disease.

3.
Am J Cardiol ; 2019 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-31813531

RESUMO

The incidence, recurrence rate, and prognostic significance of atrial fibrillation or flutter (AF) following hospital discharge after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown. We sought to determine the 3-year incidence and clinical impact of postdischarge AF in patients with LMCAD treated with PCI or CABG. In the EXCEL trial, 1,905 patients with LMCAD were randomized to PCI versus CABG. We analyzed the occurrence of postdischarge AF through 3 years and its time-adjusted association with adverse outcomes. A total of 1,802 patients without AF at baseline comprised the study cohort. Within 3 years, 227 episodes of AF occurred (29 [12.8%] in the PCI arm and 198 [87.2%] in the CABG arm, p <0.0001); of those, 63 (27.7%) occurred following discharge from the index hospitalization in 57 patients. In-hospital AF predicted postdischarge AF (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.42 to 6.10, p = 0.004). By multivariable analysis, time-updated postdischarge AF was an independent predictor of 3-year cardiovascular death (HR 4.91, 95% CI 1.92 to 12.60, p = 0.0009), stroke (HR 4.87, 95% CI 1.12 to 21.12, p = 0.035), and the composite outcome of death, stroke or myocardial infarction (HR 3.09, 95% CI 1.56 to 3.6-6.11, p = 0.001). Among patients with postdischarge AF, the rate of the primary composite outcome did not vary according to presence or absence of in-hospital AF (21.0% vs 23.8%, p = 0.78). In conclusion, postdischarge AF following CABG or PCI for LMCAD is associated with increased mortality and stroke. In-hospital atrial fibrillation is an independent predictor of AF following discharge.

4.
Angiology ; : 3319719895178, 2019 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-31845593

RESUMO

The impact of peripheral artery disease (PAD) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We reviewed 3999 CTO PCIs performed in 3914 patients between 2012 and 2018 at 25 centers, 14% of whom had a history of PAD. We compared the clinical and angiographic characteristics and procedural outcomes of patients with versus without history of PAD. Patients with PAD were older (67 ± 9 vs 64 ± 10 years, P < .001) and had a higher prevalence of cardiovascular risk factors. They also had more complex lesions as illustrated by higher Japanese CTO score (2.7 ± 1.2 vs 2.4 ± 1.3, P < .001). In patients with PAD, the final crossing technique was less often antegrade wire escalation (40% vs 51%, P < .001) and more often the retrograde approach (23 vs 20%, P < .001) and antegrade dissection/reentry (20% vs 16%, P < .001). Technical success was similar between the 2 study groups (84% vs 87%, P = .127), but procedural success was lower for patients with PAD (81% vs 85%, P = .015). The incidence of in-hospital major adverse cardiac events was higher among patients with PAD (3% vs 2%, P = .046). In conclusion, patients with PAD undergoing CTO PCI have more comorbidities, more complex lesions, and lower procedural success.

5.
EuroIntervention ; 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31763982

RESUMO

AIMS: The impact of final kissing balloon inflation FKBI after percutaneous coronary intervention (PCI) of bifurcation lesions on long-term clinical outcomes remains controversial. We sought to determine the impact of FKBI on 4-year outcomes after PCI of distal left main (LM) bifurcation lesions. METHODS AND RESULTS: The EXCEL trial compared PCI with everolimus-eluting stents and coronary artery bypass graft surgery in patients with LM disease. We examined 4-year clinical outcomes after PCI of distal LM bifurcation lesions according to use of FKBI. The primary endpoint was the composite rate of death, myocardial infarction (MI), or stroke. The major secondary endpoint was the composite rate of death, MI, stroke, or ischemia-driven revascularization (IDR). Among 948 patients randomized to PCI, 759 had distal LM lesions treated, 430 of which were treated with 1 stent and 329 of which were treated with 2 or more stents. The 4-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the 1-stent and ≥2-stent groups in both unadjusted and adjusted analyses. CONCLUSIONS: In the EXCEL trial, the performance of FKBI after PCI of distal LM bifurcation lesions was not associated with improved 4-year clinical outcomes regardless of whether 1 stent or ≥2 stents were implanted.

6.
EuroIntervention ; 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31638578

RESUMO

AIMS: The retrograde approach is critical for achieving high success rates in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), but has been associated with higher risk of complications. METHODS AND RESULTS: We compared the technical and procedural outcomes of retrograde (n=1,515) and antegrade-only CTO PCIs (n=2,686) in a contemporary multicenter CTO registry. The mean age of patients undergoing retrograde PCI was 65±10 years and 86% were men, with high prevalence of prior myocardial infarction (51%), prior PCI (71%), and coronary artery bypass graft surgery (45%). The mean J-CTO (3±1 vs 2±1 p<0.001) was higher in retrograde PCIs. The most commonly used collateral channels were septals (65%), epicardials (32%), saphenous venous grafts (14%) and left internal mammary artery grafts (2%). Overall technical (79% vs 91%, p<0.001) and procedural (75% vs 90%, p<0.001) success rates were lower with the retrograde approach, and patients had higher in-hospital major complications rate than antegrade-only PCIs (5.1% vs 0.8%, p<0.001), due to higher mortality (1.1% vs. 0.1%, p<0.001), acute myocardial infarction (1.9% vs 0.2%, p<0.001), repeat-PCI (0.7% vs 0.1%, p=0.001), and pericardiocentesis (1.7% vs 0.3%, p<0.001). CONCLUSIONS: In summary, retrograde approach to CTO PCI is performed in higher complexity lesions and is associated with lower success and higher major complications rates.

7.
Circ Cardiovasc Interv ; 12(9): e008007, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31495220

RESUMO

BACKGROUND: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (Pinteraction=0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction=0.03). CONCLUSIONS: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

8.
Artigo em Inglês | MEDLINE | ID: mdl-31512377

RESUMO

BACKGROUND: Limited research has detailed the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with independent core laboratory and event adjudication. This study examined procedural, clinical, and patient-reported health status outcomes among patients undergoing CTO PCI with specific focus on outcomes for those treated with zotarolimus-eluting stents (ZES). METHODS: Among 500 consecutive patients undergoing attempted CTO PCI, procedural and in-hospital clinical outcomes were examined in addition to the 1-year composite endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events, MACE). In a pre-specified cohort of 250 patients, health status measures were ascertained at baseline and 1 year. A powered secondary endpoint was 1-year MACE among patients treated with ZES compared with a performance goal. RESULTS: Demographic, lesion, and procedural characteristics for the overall population included prior bypass surgery, 29.8%; diabetes, 35.2%; occlusion length >20 mm, 71.3%; J-CTO score, 2.5 ± 1.1; and primary retrograde strategy, 30.8%. Overall guidewire crossing was 90.9%; clinical success following guidewire crossing, 94.3%; and 1-year MACE rate, 12.1%. One-year health status significantly improved from baseline with successful CTO-PCI (angina frequency, 72.7 ± 26.5 at baseline to 96.0 ± 10.8, p < .0001). Compared with a performance goal derived from prior CTO DES trials (1-year hierarchal MACE, 25.2%), treatment with ZES was associated with significantly lower MACE (18.2%, one-sided upper CI, 23.6%, p = .017). CONCLUSIONS: Favorable procedural success, health status improvements and late-term clinical outcomes inform the relative risks and benefits of CTO PCI when performed in a clinically indicated, complex patient population representative of those treated in clinical practice.

9.
N Engl J Med ; 381(19): 1820-1830, 2019 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-31562798

RESUMO

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea , Idoso , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Isquemia Miocárdica/terapia , Razão de Chances , Acidente Vascular Cerebral/epidemiologia
10.
Catheter Cardiovasc Interv ; 94(4): 509-515, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31444897

RESUMO

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

12.
Circ Cardiovasc Interv ; 12(7): e007734, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31288561

RESUMO

BACKGROUND: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. METHODS AND RESULTS: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively ( Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. CONCLUSIONS: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

13.
JACC Cardiovasc Interv ; 12(12): 1095-1105, 2019 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-31221299

RESUMO

Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.

14.
EuroIntervention ; 15(6): e531-e538, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31186220

RESUMO

AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Oclusão de Enxerto Vascular , Intervenção Coronária Percutânea/métodos , Acidente Vascular Cerebral/epidemiologia , Humanos , Prognóstico , Fatores de Tempo , Resultado do Tratamento
15.
Eur Heart J ; 40(42): 3483-3485, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31203371
16.
J Am Coll Cardiol ; 73(13): 1616-1628, 2019 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-30947913

RESUMO

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

17.
Catheter Cardiovasc Interv ; 94(4): 564-568, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31033148

RESUMO

BACKGROUND: Coronary artery perforation during percutaneous revascularization is associated with considerable morbidity and mortality. The PK Papyrus covered stent provides a physical barrier to seal perforated arteries and prevent associated complications including death. METHODS: In a survey of patients treated for coronary artery perforation with the PK Papyrus stent in 16 countries, procedural and in-hospital outcomes were ascertained. Procedural variables included device delivery, sealing of the perforation, and complications related to the covered stent. RESULTS: Among 80 patients with coronary perforation, Ellis classification was characterized as grade III or III-cavity spilling in 50.0% and 17.5% of events, respectively. The mean (±SD) number of stents attempted for use per patient was 1.25 ± 0.61. The PK Papyrus stent was successfully delivered to the site of perforation in 76 patients (95.0%), and successful sealing was reported in 73 patients (91.3%). Pericardiocentesis was performed in seven patients (8.8%), and in-hospital death occurred in eight patients (10.0%). Among patient deaths, Ellis grade III perforations were reported in all instances (data not reported in one patient), and two cases were associated with unsuccessful sealing of the perforation site. CONCLUSIONS: The PK Papyrus covered stent is designed to overcome limitations of existing therapies and to facilitate device delivery and effectively treat coronary artery perforations. Initial experience demonstrates favorably high rates of successful delivery to and sealing of the perforation site. Despite treatment, in-hospital mortality remains high for patients experiencing Ellis grade III coronary perforations.

18.
Am J Cardiol ; 123(11): 1765-1771, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-30926144

RESUMO

PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-comers study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 "real-world" patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11% were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11%). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of "real-world" clinical practice.

19.
Circ Cardiovasc Interv ; 12(3): e007338, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30871357

RESUMO

BACKGROUND: We examined the procedural outcomes of chronic total occlusions (CTO) percutaneous coronary interventions in patients with prior coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the clinical, angiographic characteristics and outcomes of 3486 CTO interventions performed in patients with (n=1101) and without (n=2317) prior CABG at 21 centers. Prior CABG patients (32% of total cohort) were older (67±9 versus 63±10 years; P<0.001) and had more comorbidities and lower left ventricular ejection fraction (50% [40-58] versus 55% [45-60]; P<0.001). The CTO target vessel in prior CABG patients was the right coronary artery (56%), circumflex (26%), and left anterior descending artery (17%). The mean J-CTO (2.9±1.2 versus 2.2±1.3; P<0.001) and PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention; 1.5±1.1 versus 1.2±1.0; P<0.001) score was higher in prior CABG patients. Retrograde (53% versus 30%, P<0.001) and antegrade dissection reentry (35% versus 28%; P<0.001) techniques were used more frequently in prior CABG patients. Prior CABG patients had lower technical (84% versus 89%; P<0.001) and procedural (82% versus 87%, P<0.001) success, but similar incidence of in-hospital major complications (3.1% versus 2.5%; P=0.287). In-hospital mortality (1% versus 0.4%; P=0.016) and coronary perforation (7.1% versus 3.1%; P<0.001) occurred more frequently in prior CABG patients, however, CABG patients had a lower incidence of pericardial tamponade (0.1% versus 1.0%; P=0.002) and pericardiocentesis (0% versus 1.3%; P<0.001). CONCLUSIONS: In a large multicenter CTO percutaneous coronary interventions registry, prior CABG patients had lower success rate but similar overall risk for complications, although mortality was higher and the incidence of tamponade was lower. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02061436.

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