Combined and independent impact of diabetes mellitus and chronic kidney disease on residual platelet reactivity.

Patients with both chronic kidney disease (CKD) and diabetes mellitus (DM) are at increased risk for thrombotic events compared to those with one abnormality alone. Whether this can be attributed to changes in platelet reactivity among those with both CKD and DM is unknown. We prospectively studied 438 clopidogrel-naïve patients undergoing percutaneous coronary intervention (PCI). Platelet function tests were performed 4-6 hours after loading with 600 mg of clopidogrel. Platelet reactivity was assessed using the VerifyNow system and expressed as P2Y12 reaction units (PRU). High residual platelet reactivity (HRPR) was defined as PRU > 230. Patients were categorised into four groups by the presence or absence of CKD and DM. Among those without CKD or DM (n=166), DM alone (n=150), CKD alone (n=60) and both CKD and DM (n=62) the mean PRU levels were 201.6 ± 96.3, 220.5 ± 101.1, 254.9 ± 106.7 and 275.0 ± 94.5, respectively (p<0.001). Analogously, the prevalence of HRPR was 42.3%, 50.7%, 63.3% and 75.8%, respectively (p< 0.001). Associations between either CKD or DM alone and HRPR were attenuated after multivariable adjustment while the odds for HRPR associated with both CKD and DM remained significant (OR [95% CI]: 2.61 [1.16 - 5.86]). In conclusion, the presence of both CKD and DM confers a synergistic impact on residual platelet reactivity when compared to either condition alone. Whether more potent platelet inhibitors may improve outcomes among patients with both abnormalities warrants investigation.

Comparison of six risk scores in patients with triple vessel coronary artery disease undergoing PCI: competing factors influence mortality, myocardial infarction, and target lesion revascularization.

OBJECTIVES: To compare the discriminatory value of differing risk scores for predicting clinical outcomes following PCI in routine practice. BACKGROUND: Various risk scores predict outcomes after PCI. However, these scores consider markedly different factors, from purely anatomical (SYNTAX risk score [SRS]) to purely clinical (ACEF, modified ACEF [ACEFmod], NCDR), while other scores combine both elements (Clinical SYNTAX score [CSS], NY State Risk Score [NYSRS]). METHODS: Patients with triple vessel and/or LM disease with 12 month follow-up were studied from a single center PCI registry. Exclusion criteria included STEMI presentation, prior revascularization and shock. Clinical events at 12 months were compared to baseline risk scores, according to score tertiles and area under receiver-operating-characteristic curves (AUC). RESULTS: We identified 584 eligible patients (69.8±12.3yrs, 405 males). All scores were predictive of mortality, with the SRS being least predictive (AUC=0.66). The most accurate scores for mortality were the CSS and ACEF (AUC=0.76 for both: P = 0.019 and 0.08 vs. SRS, respectively). For TLR, while the SRS trended toward being positively predictive (P = 0.075), several scores trended towards a negative association, which reached significance for the NCDR (P = 0.045). The SRS and CSS were the only scores predictive of MI (both P < 0.05). No score was particularly accurate for predicting MACE (death+MI+TLR), with AUCs ranging from 0.53 (NCDR) to 0.63 (SRS). CONCLUSIONS: Competing factors influence mortality, MI and TLR after PCI. An increasing burden of comorbidities is associated with mortality, whereas anatomical complexity predicts MI. By combining these outcomes to predict MACE, all scores show reduced utility.

The Impella Recover 2.5 and TandemHeart ventricular assist devices are safe and associated with equivalent clinical outcomes in patients undergoing high-risk percutaneous coronary intervention.

OBJECTIVES: To compare the practical use, safety, and clinical outcomes associated with the TandemHeart (TH) versus Impella Recover 2.5 (IR2.5) devices when used for circulatory support during high-risk percutaneous coronary intervention (PCI). BACKGROUND: Small studies and registries suggest safety and efficacy for the TH and IR2.5 percutaneous-left ventricular assist devices (P-LVADs). However, these P-LVADs differ markedly in their insertion, operation, and manner of circulatory augmentation. To date, no study has compared these devices. METHODS: We identified 68 patients (49 males, 19 females; age 71.1 ± 12.1 years) from our single-center database that underwent "high-risk" PCI with P-LVAD support from April 2005 to June 2010 (32 with TH, 36 with IR2.5). Relevant data were extracted for analysis. RESULTS: Baseline demographics were similar, including low LVEF (overall mean 31.0 ± 13.7%) and elevated STS mortality risk score (4.2 ± 3.7%). Angiographic characteristics were also similar, with a mean of 2.4 ± 1.0 lesions treated per patient, and 29% undergoing left main PCI. PCI success rates were 99% in both groups, with similar in-hospital outcomes and a combined 7% major vascular access site complication rate. A single episode of left atrial perforation occurred during TH use. No patient required emergent CABG and no in-hospital deaths occurred. The 30-day MACE rate (death, myocardial infarction, target lesion revascularization) was 5.8%. There were no differences between the IR2.5 and TH groups with respect to short- or long-term clinical outcomes. CONCLUSIONS: The IR2.5 and TH assist devices are safe, equally effective, and associated with acceptable short- and long-term clinical outcomes in patients undergoing "high-risk" PCI.

Safety of temporary and permanent suspension of antiplatelet therapy after drug eluting stent implantation in contemporary "real-world" practice.

OBJECTIVES: To define the incidence of stent thrombosis (ST) and/or AMI (ST/AMI) associated with temporary or permanent suspension of dual antiplatelet therapy (DAPT) after coronary drug-eluting stent (DES) implantation in "real-world" patients, and additional factors influencing these events. BACKGROUND: Adherence to DAPT is critical for avoiding ST following DES implantation. However, the outcomes of patients undergoing antiplatelet therapy withdrawal following DES implantation remain to be clearly described. METHODS: Patients receiving DES from 05/01/2003 to 05/01/2008 were identified from a single-center registry. Complete follow-up data were available for 5,681 patients (67% male, age 66 ± 11 years, duration 1,108 ± 446 days) who were included in this analysis. RESULTS: Uninterrupted DAPT was maintained in 4,070/5,681 (71.6%) patients, with an annual ST/AMI rate of 0.43%. Antiplatelet therapy was commonly ceased for gastrointestinal-related issues, dental procedures or noncardiac/nongastrointestinal surgery. Temporary DAPT suspension occurred in 593/5,681 (10.4%) patients for 17.6 ± 74.1 days, with 6/593 (1.0%) experiencing ST/AMI during this period. Of patients permanently ceasing aspirin (n = 187, mean 338 ± 411 days poststenting), clopidogrel (n = 713, mean 614 ± 375 days) or both agents (n = 118, mean 459 ± 408 days), ST/AMI was uncommon with an annual rate of 0.1-0.2%. Overall, independent predictors of ST/AMI were unstable initial presentation, uninterrupted DAPT and lower left ventricular ejection fraction. Factors predicting uninterrupted DAPT included diabetes, unstable presentation, prior MI, left main coronary PCI, and multivessel coronary disease. CONCLUSIONS: In real-world practice, rates of ST/AMI following DES implantation are low, but not insignificant, following aspirin and/or clopidogrel cessation. Use of uninterrupted DAPT appears more common in high-risk patients.

Female gender and mortality after percutaneous coronary intervention: results from a large registry.

OBJECTIVES: To investigate if previously reported gender-based outcome disparities following percutaneous coronary intervention (PCI) are applicable in a large and racially-diverse cohort in the drug eluting stent (DES) era. BACKGROUND: It is generally believed that women suffer inferior outcomes compared to men after PCI. However, various strategies have evolved that may have mitigated this imbalance, including improved medical therapy, attention to risk-factors, and procedural advances of PCI including DES. METHODS: We identified 13,752 patients (4,761 female, 34.6%) with complete follow-up data who underwent de novo lesion PCI from 04/2003 to 04/2009. Relevant data were extracted from an IRB-approved registry. RESULTS: Compared to males, females were significantly older (69.0 vs. 64.8 years) and more frequently from a minority or non-Caucasian background. Females smoked less, but more were hypertensive and/or diabetic. Women had higher HDL, but also higher LDL cholesterol levels. More women presented with an unstable coronary syndrome and required left anterior descending artery PCI. While unadjusted post-PCI mortality rates were higher in females versus males (30 days, 1.3 vs. 0.8%, P = 0.009; 1 year, 6.1 vs. 4.8%, P = 0.001; 3 year, 10.4 vs. 8.4%, P < 0.0001), multivariable regression analyses failed to identify female gender as an independent predictor of mortality. Propensity-adjusted modeling confirmed that females were not at intrinsically higher risk for mortality after PCI. CONCLUSIONS: Females undergoing PCI exhibit more comorbidities and adverse prognostic factors than males. However, risk-adjusted analyses identified that gender is not an independent predictor of mortality after PCI in the DES era.

Inverse relationship between body mass index and coronary artery calcification in patients with clinically significant coronary lesions.

AIMS: Mounting data support a 'calcification paradox', whereby reduced bone mineral density is associated with increased vascular calcification. Furthermore, reduced bone mineral density is prevalent in older persons with lower body mass index (BMI). Therefore, although BMI and coronary artery calcification (CAC) exhibit a positive relationship in younger persons, it is predicted that in older persons and/or those at risk for osteoporosis, an inverse relationship between BMI and CAC may apply. We sought to explore this hypothesis in a large group of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: We accessed our single-center registry for 07/01/1999 to 06/30/2009, extracting data on all patients that underwent PCI. To minimize bias we excluded those at the extremes of age or BMI and non-Black/Hispanic/Caucasians, leaving 9993 study subjects (age 66.6±9.9 years). Index lesion calcification (ILC) was analyzed with respect to BMI. Comparing index lesions with no angiographic calcification to those with the most severe, mean BMI decreased by 1.11 kgm(-2); a reduction of 3.9% (P<0.0001). By multivariable modeling, BMI was an independent inverse predictor of moderate-severe ILC (m-sILC; odds ratio [OR] 0.967, 95% CI 0.953-0.980, P<0.0001). Additional fully adjusted models identified that, compared to those with normal BMI, obese patients had an OR of 0.702 for m-sILC (95% CI 0.596-0.827, P<0.0001). CONCLUSIONS: In a large group of PCI patients, we identified an inverse correlation between BMI and index lesion calcification. These associations are consistent with established paradigms and suggest a complex interrelationship between BMI, body size and vascular calcification.

A randomized pilot trial for aggressive therapeutic approaches in aspirin-resistant patients undergoing percutaneous coronary intervention.

BACKGROUND: There is great variability among individual patients in platelet inhibition after aspirin intake. Aspirin resistance has been associated with a higher incidence of ischemic events after percutaneous coronary intervention (PCI). The optimal antiplatelet therapy in aspirin-resistant patients undergoing PCI is unknown. The objective of this study was to evaluate whether aggressive antiplatelet therapy would reduce ischemic events in aspirin-resistant patients after PCI. METHODS: A total of 330 patients undergoing PCI (with bivalirudin) were screened for aspirin responsiveness. The resulting 36 aspirin-resistant patients were randomized into two arms: 1) conventional strategy patients received 325 mg aspirin orally and a loading dose of 600 mg clopidogrel at the time of the procedure; and 2) aggressive strategy patients received similar amounts of aspirin and clopidogrel, with the addition of an intravenous glycoprotein IIb/IIIa inhibitor bolus intraprocedurally. The primary outcome was an elevation of cardiac enzymes within 24 hours post procedure. The secondary outcome was a composite of major adverse cardiac events including death, myocardial infarction, stent thrombosis and urgent revascularization, and bleeding up to 30 days. RESULTS: Primary outcome occurred in 22% of the conventional strategy group and 11% of the aggressive strategy group (p = 0.36). The secondary outcome was reached in 27.8% of the conventional group and 5.5% of the aggressive strategy group (p = 0.17), which is suggestive of a statistical trend toward more ischemic events with conventional therapy. Importantly, there were 2 cases of definite stent thrombosis in the conventional strategy group. CONCLUSION: In aspirin-resistant patients, aggressive antiplatelet therapy tended to show better outcomes after PCI, without an increase in bleeding. These findings need validation in a large, randomized study.

Safety and efficacy of alcohol septal ablation in patients with symptomatic concentric left ventricular hypertrophy and outflow tract obstruction.

BACKGROUND: Transcoronary septal ablation is efficacious for patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) and outflow-tract gradient (OTG). However, while patients with symptomatic concentric left ventricular hypertrophy (CLVH) may develop OTG, the safety and efficacy of septal ablation in these patients is unknown. OBJECTIVES: To determine the potential safety and efficacy of transcoronary alcohol septal ablation in refractory, symptomatic patients with CLVH and significant OTG. METHODS: We identified 9 patients (all female; age, 67.6 ± 8.7 years) with CLVH and OTG who underwent septal ablation on a compassionate basis and for symptomatic relief, with CLVH defined as left ventricular wall thickness > 15 mm in the absence of asymmetric septal hypertrophy. CLVH patients were compared with age-, sex- and OTGmatched HOCM patients (resting OTG, 56.7 ± 22.4 versus 58.3 ± 33.5 mmHg, respectively; p = 0.91). RESULTS: In CLVH patients, mean resting OTG decreased to 22.8 ± 12.5 mmHg (p < 0.0005 versus baseline), which was comparable to the change in HOCM patients (p = 0.45 CLVH versus HOCM). Peak inducible OTG in CLVH patients also decreased following septal ablation (142.2 ± 36.3 to 36.1 ± 16.2 mmHg; p < 0.0001). Baseline left ventricular end-diastolic pressure (LVEDP) was similar between CLVH (17.7 ± 3.7 mmHg) versus HOCM (16.3 ± 4.0 mmHg; p = 0.50). Following ablation, LVEDP decreased by 3.4 ± 1.9 mmHg in CLVH (p < 0.001 versus baseline) and 3.0 ± 2.2 mmHg in HOCM patients (p = 0.67 CLVH versus HOCM). Complication rates were similar between groups. Baseline New York Heart Association class was 3.6 ± 0.5 for CLVH versus 3.3 ± 0.5 for HOCM (p = 0.51). Both groups experienced symptomatic improvement following ablation (p < 0.0005), and at long-term follow up (34.9 ± 23.9 months), these changes were similar and sustained. CONCLUSION: Septal ablation holds promise for the management of symptomatic CLVH with OTG.

Outcomes of patients discharged the same day following percutaneous coronary intervention.

OBJECTIVES: This study evaluated the outcomes of patients discharged the day of percutaneous coronary intervention (PCI) by analyzing the data from a single-center, large, multioperator registry of interventions. BACKGROUND: Although same-day discharge is likely safe after interventions on low-risk stable patients, there is limited data to guide selection of a broader population of patients. Due to numerous patient variables and physician preferences, standardization of the length of stay after PCI has been a challenge. Most of the reported studies on same-day discharge have strict inclusion criteria and hence do not truly reflect a real-world population. METHODS: We analyzed the outcomes of consecutive same-day discharge in 2,400 of 16,585 patients who underwent elective PCI without any procedural or hospital complication. Composite end point included 30-day major adverse cardiac cerebral events and bleeding/vascular complications. RESULTS: The mean age of the study population was 57.0 +/- 23.7 years with 12% aged over 65 years. Twenty-eight percent received glycoprotein IIb/IIIa inhibitor with closure devices in 90.5%. Clinical and angiographic success was noted in 97% of all PCIs. The average length-of-stay following PCI was 8.2 +/- 2.5 h. The composite end point was reached in 23 patients (0.96%). Major adverse cardiac cerebral events occurred in 8 patients (0.33%) and vascular/bleeding complications in the form of Thrombolysis In Myocardial Infarction minor bleeding in 14 patients (0.58%) and pseudoaneurysm in 1 patient (0.04%). CONCLUSIONS: When appropriately selected, with strict adherence to the set protocol, same-day discharge after uncomplicated elective PCI is safe despite using femoral access in a wide spectrum of patients.