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1.
Circ Cardiovasc Interv ; 12(11): e007982, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31672031

RESUMO

BACKGROUND: Smoking is a potent risk factor for coronary artery disease; however, prior studies describe increased platelet inhibition with clopidogrel among smokers, and some studies report improved outcomes among smokers, a finding described as the smoker's paradox. This study assessed the relationship between platelet reactivity and clinical outcomes after percutaneous coronary interventions among current smokers and nonsmokers. METHODS: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. Platelet reactivity was assessed by the VerifyNow point-of-care assay; high on-treatment platelet reactivity (HPR) was defined as P2Y12 reaction units >208. A propensity-adjusted multivariable analysis was performed to determine the relationship between current smoking, platelet reactivity, and subsequent adverse events. RESULTS: Among 8582 patients, 22.6% were active smokers at the time of their percutaneous coronary intervention procedure. Current smokers were younger and had fewer comorbidities compared with nonsmokers. Current smokers had lower mean P2Y12 reaction units and lower rates of HPR compared with nonsmokers. Current smokers had similar rates of adverse events compared with nonsmokers. HPR was associated with higher rates of adverse events for both smokers and nonsmokers; however, there was evidence of interaction between smoking status and the effect of HPR. Smokers with HPR had significantly higher rates of stent thrombosis. Adverse event rates were highest among current smokers with HPR. CONCLUSIONS: Current smoking was associated with lower P2Y12 reaction units and lower rates of HPR on average; however, the combination of current smoking and HPR was associated with high rates of stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

2.
Thromb Res ; 185: 43-48, 2019 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-31756574

RESUMO

AIMS: We sought to investigate the thrombogenicity of different DES and BMS in an in vitro system of stent perfusion. MATERIAL AND METHODS: The experimental model consisted of a peristaltic pump connected to 4 parallel silicone tubes in which different stents were deployed. Blood was drawn from healthy volunteers and the amount of stent surfaced-induced thrombus deposition was determined using 125I-fibrinogen. RESULTS: Compared to Resolute, Biomatrix and Vision, Xience was associated with the lowest amount of stent surface-induced thrombus formation, with a significant difference compared to Vision (125I-fibrinogen median value deposition [IQ range]: 50 ng [25-98] versus 560 ng [320-1520], respectively, p < 0.05), but not to other DES. In the second set of experiments Fluoropolymer-coated BMS not eluting drug was associated with a significant 3-fold reduction in 125I-fibrinogen deposition (245 ng [80-300]) compared to Vision (625 ng [320-760], p < 0.05), but a 7-fold increase compared to Xience (35 ng [20-60], p < 0.05). Finally Xience was associated with a significantly greater absorption of albumin compared to BMS. CONCLUSIONS: In an in vitro system of stent perfusion, Xience was associated with the lowest amount of stent surface-induced thrombus formation compared with Resolute, Biomatrix and Vision, with a noted synergistic effect between the fluoropolymer and the drug.

3.
J Am Coll Cardiol ; 74(21): 2572-2584, 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31753202

RESUMO

BACKGROUND: To date, no specific drug-eluting stent (DES) has fully proven its superiority over others in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. OBJECTIVES: The purpose of this study was to compare the safety and efficacy of coronary artery stents in STEMI patients in a patient-level network meta-analysis. METHODS: Eligible studies were dedicated randomized controlled trials comparing different stents in STEMI patients undergoing percutaneous coronary intervention with at least 12 months of clinical follow-up. Of 19 studies identified from the published data, individual patient data were collected in 15 studies with 10,979 patients representing 87.7% of patients in the overall network of evidence. The primary endpoint was the composite of cardiac death, reinfarction, or target lesion revascularization. RESULTS: Overall, 8,487 (77.3%) of 10,979 STEMI patients were male and the mean age was 60.7 years. At a median follow-up of 3 years, compared with bare-metal stents (BMS), patients treated with paclitaxel-, sirolimus-, everolimus-, or biolimus-eluting stents had a significantly lower risk of the primary endpoint (adjusted hazard ratios [HRs]: 0.74 [95% confidence interval (CI): 0.63 to 0.88], 0.65 [95% CI: 0.49 to 0.85], 0.70 [95% CI: 0.53 to 0.91], and 0.66 [95% CI: 0.49 to 0.88], respectively). The risk of primary endpoint was not different between patients treated with BMS and zotarolimus-eluting stents (adjusted HR: 0.83 [95% CI: 0.51 to 1.38]). Among patients treated with DES, no significant difference in the risk of the primary outcome was demonstrated. Treatment with second-generation DES was associated with significantly lower risk of definite or probable stent thrombosis compared with BMS (adjusted HR: 0.61 [95% CI: 0.42 to 0.89]) and first-generation DES (adjusted HR: 0.56 [95% CI: 0.36 to 0.88]). CONCLUSIONS: In STEMI patients, DES were superior to BMS with respect to long-term efficacy. No difference in long-term efficacy and safety was observed among specific DES. Second-generation were superior to first-generation DES in reducing stent thrombosis. (Clinical Outcomes After Primary Percutaneous Coronary Intervention [PCI] Using Contemporary Drug-Eluting Stent [DES]: Evidence From the Individual Patient Data Network Meta-Analysis; CRD42018104053).

5.
Artigo em Inglês | MEDLINE | ID: mdl-31721430

RESUMO

OBJECTIVES: We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD. BACKGROUND: Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI. METHODS: Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208. RESULTS: Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (Pinteraction = .78). CONCLUSIONS: Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.

6.
Am J Cardiol ; 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31759517

RESUMO

The development of aortic valve stenosis is strongly associated with older adults. Patients who undergo transcatheter aortic valve implantation (TAVI) for severe aortic stenosis frequently have heart failure (HF). We investigated the predictors of mortality after TAVI according to the presence of HF, and specifically HF with preserved ejection fraction (HFpEF) versus HF with reduced ejection fraction (HFrEF). Patients were identified from the Nationwide Inpatient Sample registry from January 2011 to September 2015 using the ICD-9 codes. Patients with HF who underwent TAVI were classified according to whether they were diagnosed with HFrEF or HFpEF. The principal outcome of interest was in-hospital mortality. Multivariable analysis was used to adjust for potential baseline confounders. Among 11,609 patients undergoing TAVI, 6,368 (54.9%) had baseline HF, including 4,290 (67.4%) with HFpEF and 2,078 (32.6%) with HFrEF. In TAVI patients with HF, in-hospital mortality was also not significantly different in those with HFrEF compared with HFpEF (3.66% vs 3.17%, respectively; adjusted odds ratio 1.14, 95% confidence interval 0.84 to 1.53; p = 0.38). Polyvalvular heart disease was an additional independent predictor of in-hospital mortality in HFrEF, whereas age, liver disease, and the absence of depression and anemia were additional independent predictors of mortality in HFpEF. In conclusion, baseline HF in patients undergoing TAVI is prevalent and is more commonly due to HFpEF than HFrEF. Mortality is similar in those with HFrEF and HFpEF. Knowledge of the specific predictors of mortality after TAVI in HF patients may be useful for patient selection and prognostic guidance.

7.
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.

8.
Circ Cardiovasc Qual Outcomes ; 12(11): e006002, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31718297

RESUMO

BACKGROUND: Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described. METHODS AND RESULTS: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]). CONCLUSIONS: In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.

9.
Am J Cardiol ; 2019 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-31735328

RESUMO

The prognostic impact of resting heart rate (RHR) following revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with left main coronary artery disease (LMCAD) is unknown. We aimed to assess the effect of RHR at discharge on 3-year cardiovascular outcomes following PCI and CABG for LMCAD. In the EXCEL trial, 1,905 patients with LMCAD were randomized to PCI with everolimus-eluting stents versus CABG. RHR was measured at discharge following the index hospitalization. The principal outcome measure was the composite endpoint of death, myocardial infarction (MI) or stroke at 3 years. Among 1,303 patients in sinus rhythm with available ECGs, the median (IQR) discharge RHR was 72 (62to 81) bpm. Median discharge RHR was higher after CABG versus PCI (78 [IQR 70 to 86] versus 65 [IQR 59 to 74] bpm, p <0.0001). At 3 years, 107 patients (8.2%) had a primary composite endpoint event including 61 patients (4.7%) who died. By multivariable analysis, discharge RHR assessed as a continuous variable (per 5 bpm) was an independent predictor at 3 years of the primary composite endpoint of death, MI, or stroke (hazard ratio [HR] 1.15, 95% confidence interval [CI] 1.06 to 1.25, p = 0.0006); the secondary composite endpoint of death, MI, stroke, or ischemia-driven revascularization at 3 years (HR 1.12, 95% CI 1.05 to 1.19, p = 0.0007); all-cause mortality (HR 1.18, 95% CI 1.07 to 1.31, p = 0.002); and cardiovascular death (HR 1.16, 95% CI 1.00 to 1.33, p = 0.046). No significant interactions were present between RHR and treatment with PCI versus CABG for the primary (pint = 0.20) or secondary (pint = 0.47) composite endpoints. In patients with LMCAD undergoing revascularization, an increased RHR at discharge was associated with a higher risk for adverse cardiovascular outcomes at 3 years, irrespective of treatment modality.

10.
J Am Coll Cardiol ; 74(16): 2102-2112, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31623769

RESUMO

Most major clinical trials in cardiology report time-to-event outcomes using the Cox proportional hazards model so that a treatment effect is estimated as the hazard ratio between groups, accompanied by its 95% confidence interval and a log-rank p value. But nonproportionality of hazards (non-PH) over time occurs quite often, making alternative analysis strategies appropriate. This review presents real examples of cardiology trials with different types of non-PH: an early treatment effect, a late treatment effect, and a diminishing treatment effect. In such scenarios, the relative merits of a Cox model, an accelerated failure time model, a milestone analysis, and restricted mean survival time are examined. Some post hoc analyses for exploring any specific pattern of non-PH are also presented. Recommendations are made, particularly regarding how to handle non-PH in pre-defined Statistical Analysis Plans, trial publications, and regulatory submissions.

11.
Artigo em Inglês | MEDLINE | ID: mdl-31620778

RESUMO

OBJECTIVES: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. METHODS: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. RESULTS: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG. CONCLUSIONS: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality.

12.
EuroIntervention ; 2019 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-31659983

RESUMO

AIMS: To evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularization. METHODS AND RESULTS: In 13 randomized trials 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5≤BMI<25, used as reference), overweight (25≤BMI<30), and obese (Class I [30≤BMI<35], Class II [35≤BMI<40], or Class III [BMI≥40]). The primary endpoint was all-cause death at 5 years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularization (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality vs normal weight (HR 0.83; 95%CI 0.71-0.96 and HR 0.83; 95%CI 0.69-0.96 respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77; 95% CI 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62; 95%CI 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95%CI 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis. CONCLUSIONS: Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.

13.
Circulation ; 2019 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-31564137

RESUMO

Background: The COAPT trial demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) using the MitraClip resulted in reduced mortality and heart-failure hospitalizations and improved quality of life when compared with maximally-tolerated guideline-directed medical therapy (GDMT) in heart-failure patients with 3-4+ secondary mitral regurgitation (SMR). Whether TMVr is cost-effective compared with GDMT in this population is unknown. Methods: We used data from the COAPT trial to perform a formal, patient-level economic analysis of TMVr + GDMT vs. GDMT alone for patients with heart failure and 3-4+ SMR from the perspective of the US health care system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated based on medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline, 1, 6, 12 and 24 months using the SF-6D. Results: Initial costs for the TMVr procedure and index hospitalization were $35,755 and $48,198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26,654 vs. $38,345; p=0.018), cumulative 2-year costs remained higher with TMVr due to the up-front cost of the index procedure ($73,416 vs. $38,345; p<0.001). When intrial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life-expectancy by 1.13 years and quality-adjusted life-years (QALYs) by 0.82 years at a cost of $45,648, yielding a lifetime incremental cost-effectiveness ratio of $40,361/life-year gained and $55,600/QALY gained. Conclusions: For symptomatic heart-failure patients with 3-4+ SMR, TMVr increases lifeexpectancy and quality-adjusted life-expectancy compared with GDMT at an incremental cost per QALY gained that represents acceptable economic value based on current U.S. thresholds. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01626079.

14.
Nat Rev Cardiol ; 16(12): 702-703, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31597955
15.
J Am Coll Cardiol ; 2019 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-31574303

RESUMO

BACKGROUND: In the COAPT trial among patients with heart failure (HF) and moderate-to-severe (3+) or severe (4+) secondary mitral regurgitation (SMR), patients treated with the transcatheter mitral valve replacement (TMVR) had reduced rates of HF hospitalization and mortality compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: To describe the echocardiographic patient qualification process for COAPT, baseline echocardiographic characteristics, changes over time, and the interaction between treatment group and echocardiographic parameters on clinical outcomes. METHODS: A novel echocardiographic algorithm was implemented for grading MR severity during the screening process. Standardized echocardiograms were obtained at baseline and during regular follow-up intervals through 2 years, and analyzed by a core laboratory. RESULTS: A total of 614 patients were randomized to TMVR plus maximally- tolerated GDMT or GDMT alone. Mean baseline left ventricular ejection fraction (LVEF) was 31.3±9.3%, LV end-diastolic volume was 192.7±71 ml, and effective regurgitant orifice area was 0.41±0.15 cm2. The beneficial effect of TMVR compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation or individual MR characteristics. The LVEF decreased and the LV volumes progressively increased in both groups during follow-up, although less after TMVR (P<0.05). CONCLUSIONS: HF patients in the COAPT trial with 3+ or 4+ SMR, selected using strict echocardiographic criteria, benefitted from TMVR with reduced 2-year rates of death and HF hospitalization. Strict application of these echocardiographic criteria should enable the COAPT results to be translated to clinical practice.

16.
JACC Cardiovasc Interv ; 12(20): 1991-2001, 2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31648761

RESUMO

OBJECTIVES: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). BACKGROUND: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. METHODS: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. RESULTS: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. CONCLUSIONS: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367).

19.
JACC Cardiovasc Interv ; 12(19): 1927-1937, 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31521645

RESUMO

OBJECTIVES: The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions. BACKGROUND: The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study. METHODS: A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score. RESULTS: At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk. CONCLUSIONS: Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).

20.
JACC Cardiovasc Interv ; 12(19): 1941-1950, 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31521646

RESUMO

OBJECTIVES: This study examined the smoker's paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation. BACKGROUND: Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results. METHODS: Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared. RESULTS: Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005). CONCLUSIONS: The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.

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