Summary Background Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the ...underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. Methods The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov , number NCT00998127. Findings We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94–2·12; p=0·10) and to disruption was 1·50 (1·14–1.97; p=0·004). Within 7 days, 8–30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31–14·95), 2·17 (0·97–4·88), and 1·3 (0·97–1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 0·46–0·86). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. Interpretation In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Funding Bristol-Myers Squibb and Sanofi-Aventis.
Abstract Background Recent studies have demonstrated relatively high rates of percutaneous coronary interventions (PCIs) classified as “inappropriate.” The New York State Department of Health shared ...rates with hospitals and announced the intention of withholding reimbursement pending demonstration of clinical rationale for Medicaid patients with inappropriate PCIs. Objectives The objective was to examine changes over time in the number and rate of inappropriate PCIs. Methods Appropriate use criteria were applied to PCIs performed in New York in patients without acute coronary syndromes or previous coronary artery bypass graft surgery in periods before (2010 through 2011) and after (2012 through 2014) efforts were made to decrease inappropriateness rates. Changes in the number of appropriate PCIs were also assessed. Results The percentage of inappropriate PCIs for all patients dropped from 18.2% in 2010 to 10.6% in 2014 (from 15.3% to 6.8% for Medicaid patients, and from 18.6% to 11.2% for other patients). The total number of PCIs in patients with no acute coronary syndrome/no prior coronary artery bypass graft surgery that were rated as inappropriate decreased from 2,956 patients in 2010 to 911 patients in 2014, a reduction of 69%. For Medicaid patients, the decrease was from 340 patients to 84 patients, a decrease of 75%. For a select set of higher-risk scenarios, there were higher numbers of appropriate PCIs per year in the period from 2012 to 2014. Conclusions The inappropriateness rate for PCIs and the use of PCI for elective procedures in New York has decreased substantially between 2010 and 2014. This decrease has occurred for a large proportion of PCI hospitals.
Abstract Background Few recent studies have compared the outcomes of coronary artery bypass graft (CABG) surgery with percutaneous coronary interventions (PCIs) in patients with isolated (single ...vessel) proximal left anterior descending (PLAD) coronary artery disease in the era of drug-eluting stents (DES). Objectives The goal of this study was to compare outcomes in patients with PLAD who underwent CABG and PCI with DES. Methods New York’s Percutaneous Coronary Interventions Reporting System was used to identify and track all patients who underwent CABG surgery and received DES for isolated PLAD disease between January 1, 2008 and December 31, 2010, and who were followed-up through December 31, 2011. A total of 5,340 of 6,064 (88%) patients received DES. Patients were matched to vital statistics data to obtain mortality after discharge and matched to New York’s administrative data to obtain readmissions for myocardial infarction (MI) and stroke. To minimize selection bias, patients were propensity matched into 715 CABG and/or DES pairs, and 3 outcome measures were compared across the pairs. Results Kaplan-Meier estimates for CABG and DES did not significantly differ for mortality or mortality, MI, and/or stroke, but repeat revascularization rates were lower for CABG (7.09% vs. 12.98%; p = 0.0007). After further adjustment with Cox proportional hazards models, there were still no significant differences in 3-year mortality rates (CABG and/or DES adjusted hazard ratio (AHR): 1.14; 95% confidence interval CI: 0.70 to 1.85) or mortality, MI, and/or stroke rates (AHR: 1.15; 95% CI: 0.76 to 1.73), and the repeat revascularization rate remained significantly lower for CABG patients (AHR: 0.54; 95% CI: 0.36 to 0.81). Conclusions Despite the higher rating in current guidelines of CABG (Class IIa vs. Class IIb) for patients with isolated PLAD disease, there were no differences in mortality or mortality, MI, and/or stroke, although CABG patients had significantly lower repeat revascularization rates.
Several randomized controlled trials and observational studies have compared outcomes of percutaneous coronary interventions (PCIs) with drug-eluting stents (DESs) and coronary artery bypass grafting ...(CABG), but they have not thoroughly investigated the relative difference in outcomes for patients aged ≥75 years. In this study, a total of 3,864 patients receiving DES and CABG (1,932 CABG-DES pairs) with multivessel coronary disease were propensity matched using multiple patient risk factors and were compared with respect to 3 outcomes (mortality, stroke/myocardial infarction MI/mortality, and repeat revascularization) at 2.5 years with a mean follow-up of 18 months. The mortality rates (DES/CABG hazard ratio 1.06, 95% confidence interval 0.87 to 1.30) and the stroke/MI/mortality rates (DES/CABG hazard ratio 1.15, 95% confidence interval 0.97 to 1.38) for the 2 procedures were not significantly different. Repeat revascularization rates were significantly higher for patients who received DESs. In conclusion, older patients experienced similar mortality and stroke/MI/mortality rates for CABG and PCI with DES, although repeat revascularization rates were higher for patients undergoing PCI with DES.
Objectives This study sought to develop a percutaneous coronary intervention (PCI) risk score for in-hospital/30-day mortality. Background Risk scores are simplified linear scores that provide ...clinicians with quick estimates of patients' short-term mortality rates for informed consent and to determine the appropriate intervention. Earlier PCI risk scores were based on in-hospital mortality. However, for PCI, a substantial percentage of patients die within 30 days of the procedure after discharge. Methods New York's Percutaneous Coronary Interventions Reporting System was used to develop an in-hospital/30-day logistic regression model for patients undergoing PCI in 2010, and this model was converted into a simple linear risk score that estimates mortality rates. The score was validated by applying it to 2009 New York PCI data. Subsequent analyses evaluated the ability of the score to predict complications and length of stay. Results A total of 54,223 patients were used to develop the risk score. There are 11 risk factors that make up the score, with risk factor scores ranging from 1 to 9, and the highest total score is 34. The score was validated based on patients undergoing PCI in the previous year, and accurately predicted mortality for all patients as well as patients who recently suffered a myocardial infarction (MI). Conclusions The PCI risk score developed here enables clinicians to estimate in-hospital/30-day mortality very quickly and quite accurately. It accurately predicts mortality for patients undergoing PCI in the previous year and for MI patients, and is also moderately related to perioperative complications and length of stay.
Abstract Background Many studies have shown that drug-eluting stents (DESs) are associated with better outcomes for patients receiving coronary stents, and earlier studies showed disparities in use ...by race and payer. It is of interest to know whether these differences persist in an era of higher use of DESs and to examine DES use differences across providers. Methods New York State's percutaneous coronary intervention registry was used to identify significant predictors of DES vs bare-metal stent use among patients receiving stents, including race, ethnicity, sex, payer, and numerous patient clinical risk factors in 2011-2012. Variations in DES use across hospitals and operators were also examined. Results African Americans (adjusted odds ratio AOR, 0.70; 95% confidence interval CI, 0.66-0.75) and Hispanics (AOR, 0.80; 95% CI, 0.74-0.85) were less likely to receive DESs than their counterparts. Patients with private insurance were more likely to receive DESs than patients in all other payer categories. More than one third of the 60 hospitals in the study had significantly lower adjusted use of DESs than the mean rate of 83%. For these hospitals, adjusted rates ranged from 52%-80%, and 5 of these hospitals had adjusted rates < 70%. Twenty-five percent of the total variation in the use of DESs was related to differences across hospitals that were unrelated to patient characteristics. Conclusions Disparities by race, ethnicity, and insurance status persist in the use of DESs among patients receiving coronary stents. There are also large differences in use among hospitals that are unrelated to patient clinical characteristics and demographics.
Objectives The aim of this study was to assess the influence of pro-inflammatory interleukin (IL)-1 genotype status on the risk for coronary artery disease (CAD), defined as >50% diameter stenosis, ...and cardiovascular events mediated by oxidized phospholipids (OxPLs) and lipoprotein (Lp) (a). Background OxPLs are pro-inflammatory, circulate on Lp(a), and mediate CAD. Genetic variations in the IL-1 region are associated with increased inflammatory mediators. Methods IL-1 genotypes, OxPL on apolipoprotein B-100 (OxPL/apoB), and Lp(a) levels were measured in 499 patients undergoing coronary angiography. The composite genotype termed IL-1(+) was defined by 3 single-nucleotide polymorphisms in the IL-1 gene cluster associated with higher levels of pro-inflammatory cytokines. All other IL-1 genotypes were termed IL-1(−). Results Among IL-1(+) patients, the highest quartile of OxPL/apoB was significantly associated with a higher risk for CAD compared with the lowest quartile (odds ratio OR: 2.84; p = 0.001). This effect was accentuated in patients age ≤60 years (OR: 7.03; p < 0.001). In IL-1(−) patients, OxPL/apoB levels showed no association with CAD. The interaction was significant for OxPL/apoB (OR: 1.99; p = 0.004) and Lp(a) (OR: 1.96; p < 0.001) in the IL-1(+) group versus the IL-1(−) group in patients age ≤60 years but not in those age >60 years. In IL-1(+) patients age ≤60 years, after adjustment for established risk factors, high-sensitivity C-reactive protein, and Lp(a), OxPL/apoB remained an independent predictor of CAD. IL-1(+) patients above the median OxPL/apoB presented to the cardiac catheterization laboratory a mean of 3.9 years earlier (p = 0.002) and had worse 4-year event-free survival (death, myocardial infarction, stroke, and need for revascularization) compared with other groups (p = 0.006). Conclusions Our study suggests that IL-1 genotype status can stratify population risk for CAD and cardiovascular events mediated by OxPL. These data suggest a clinically relevant biological link between pro-inflammatory IL-1 genotype, oxidation of phospholipids, Lp(a), and genetic predisposition to CAD and cardiovascular events.
Background Although platelet function and pharmacogenomic testing have been studied in clinical trials, their adoption into contemporary practice is unknown. Methods We studied patterns of platelet ...function and pharmacogenomic testing among 10,048 patients with acute myocardial infarction treated with percutaneous coronary intervention at 226 US hospitals in the TRANSLATE-ACS observational study between April 2010 and October 2012, excluding those receiving research protocol-mandated testing. Inverse probability–weighted propensity adjustment was used to compare 1-year bleeding and major adverse cardiac event risks between patients with and without testing. Results Overall, 337 (3.4%) patients underwent predischarge platelet function testing, whereas 85 (0.9%) underwent pharmacogenomic testing; 82% and 93% of hospitals never performed any platelet function or pharmacogenomic testing, respectively. Patients undergoing testing were more likely to be on an adenosine diphosphate receptor inhibitor preadmission or to have percutaneous coronary intervention of a previously treated lesion. Tested patients were more likely than nontested patients to be switched from clopidogrel to prasugrel/ticagrelor (25.7% vs 9.7%, P < .001) and were more likely to be on prasugrel/ticagrelor 6 months postdischarge (33.8% vs 25.1%, P < .001). No significant differences in 1-year bleeding and major adverse cardiac event risks were observed between tested and nontested patients (adjusted hazard ratios 1.06 95% CI 0.68-1.65 and 1.21 95% CI 0.94-1.54, respectively). Conclusions Platelet function and pharmacogenomic testing are rarely performed in contemporary myocardial infarction patients in the United States. When tested, patients were more likely to be treated with higher-potency adenosine diphosphate receptor inhibitors, yet no significant differences in longitudinal outcomes were observed.
STEMI Care in Poland and the United States Berger, Peter B., MD; Perini, Molly, BA; Becker, Lance B., MD
JACC. Cardiovascular interventions,
03/2017, Letnik:
10, Številka:
5
Journal Article
Objectives This study sought to determine the utilization and outcomes for radial access for percutaneous coronary intervention (PCI) for ST-segment elevation acute myocardial infarction (STEMI) in ...common practice. Background Radial access for PCI has been studied considerably, but mostly in clinical trials. Methods All patients undergoing PCI for STEMI in 2009 to 2010 in New York were studied to determine the frequency and the patient-level predictors of radial access. Differences in in-hospital/30-day mortality between radial and femoral access were also studied. Results Radial access increased from 4.9% in the first quarter of 2009 to 11.9% in the last quarter of 2010. Significant independent predictors were higher body surface area, non-Hispanic ethnicity, Caucasian race, stable hemodynamic state, ejection fraction <30% and ≥50% onset of STEMI from 12 to 23 h before the index procedure, and peripheral vascular disease. Mortality was not related to access site after adjustment for covariates (for radial vs. femoral access, adjusted odds ratio: 0.86, 95% confidence interval: 0.59 to 1.25), but the radial access site was trending toward lower mortality for the 9 hospitals that used it for more than 10% of their patients (adjusted odds ratio: 0.61, 95% confidence interval: 0.36 to 1.02). Conclusions The use of a radial access site for PCI in STEMI patients increased between 2009 and 2010, but was still infrequent in 2010, and was used for lower-risk STEMI patients. There was no significant difference in mortality by access site, but there was a trend toward a mortality advantage for patients with a radial access site among hospitals that used it relatively frequently.
PDF
