Real-World Experience With Antiplatelet Agents After Percutaneous Coronary Intervention in Patients With an Indication for an Oral Anticoagulant.

ABSTRACT: Patients undergoing percutaneous coronary intervention (PCI) with a clinical indication for oral anticoagulation (OAC) in addition to antiplatelet therapy (APT) necessitate rigorous evaluation of bleeding and ischemic risk to guide therapy. The optimal OAC/APT drug combination and duration of treatment is not known. This study aimed to evaluate the incidence of patients undergoing PCI with an OAC indication and the rationale for post-PCI combined OAC/APT selection in clinical practice. Consecutive patients undergoing PCI with an indication for combined OAC/APT were included in a 12-month retrospective case series. Patient demographics, clinical characteristics, prescribed OAC/APT regimens, and rationale for drug selection were reviewed. PCI was performed in 1650 patients during the study period, with an indication for OAC/APT in 133 (8.1%). A combination of aspirin, P2Y12 inhibitor, and OAC was the most frequently prescribed regime on discharge (n = 103, 81%). Dual antiplatelet therapy (DAPT) in combination with OAC was continued for a mean duration of 6.4 ± 4.4 weeks (range 3-52 weeks) before one antiplatelet was discontinued. There was no significant difference between the mean CHA2DS2-VASc or HAS-BLED score of patients with atrial fibrillation discharged on OAC/DAPT compared with alternate combinations (DAPT alone or OAC/single APT), 3.6 ± 1.3 versus 3.8 ± 1, P = 0.37 and 2.04 ± 0.7 versus 2.05 ± 1.0, P = 0.98, respectively. This case series identifies high variability in OAC/APT treatment duration and limited application of risk scoring systems and high-risk PCI characteristics in the selection of OAC/APT regimens. A more systematic patient assessment is needed to help standardize OAC/APT prescribing for this important patient cohort.

Percutaneous treatment of periprosthetic mitral valve leaks: is it just a futile exercise?

We report the percutaneous exclusion of a mitral peri-prosthetic valvular leak performed with the Amplatzer vascular plug. Device dislodgement occurred a few days later and surgical repair was ultimately required.

Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice.

OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.

Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies.

BACKGROUND: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. METHODS AND RESULTS: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group). CONCLUSIONS: The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.

Troponin T elevation after coronary bypass surgery: clinical relevance and correlation with perioperative variables.

OBJECTIVE: Elevation in markers of myocardial necrosis is a common feature following coronary artery bypass surgery, but its relevance is unclear. The objective of this study was to evaluate the association between postoperative troponin T elevation, perioperative variables and clinical outcomes. METHODS: We evaluated 100 low-risk patients undergoing first-time elective on-pump coronary artery bypass surgery. The mean age was 62 +/- 9.8 years and 83% were male; patients with diabetes mellitus, renal failure and impaired left ventricular function (ejection fraction < 40%) were excluded. Troponin levels were measured at baseline and 12 and 24 h following the onset of cardiopulmonary bypass. Predefined clinical endpoints included death, new Q waves on 12-lead electrocardiogram and inotropic requirement. RESULTS: Postoperative troponin elevation occurred in 95%. Troponin T elevation was related to the duration of cardiopulmonary bypass (P = 0.0001) and aortic cross-clamp time (P = 0.0003). There was also an inverse relationship with perioperative core temperature (P = 0.0001). There was no association between postoperative troponin elevation and clinical outcomes. CONCLUSIONS: Postoperative troponin T elevation occurs in the majority of patients undergoing elective on-pump coronary artery bypass surgery. In this low-risk cohort, troponin T elevation was associated with procedural duration but not with clinical outcome.

Preoperative atrial histological changes are not associated with postoperative atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) remains the most common complication of cardiac surgery. Prophylactic therapies have been studied, but their utility has been limited by the inability to accurately identify patients who will develop this complication. Recent studies have suggested that atrial myolysis and lipofuscin pigmentation are associated with post-coronary artery bypass grafting (CABG) AF. We sought to determine whether there is an association between preoperative atrial histology and subsequent post-CABG AF. METHODS: Samples of right atrial appendage were obtained from 94 patients undergoing CABG. Tissue was formalin fixed and paraffin embedded. Sections 4 mum thick were cut, stained with hematoxylin and eosin, and examined for the following parameters: fibrosis, myolysis, inflammation, nuclear size, pericardial exudates, lipofuscin pigment, arteriolar hypertrophy, contraction banding, mesothelial hyperplasia, and atrial diverticula. Results were graded as absent, mild, moderate, or severe by two independent observers who were blinded to the clinical outcomes. Univariate and multivariate analyses were carried out. RESULTS: Thirty-six (38%) patients developed AF. No correlation was found between the 10 features assessed, including myolysis and lipofuscin pigmentation, and the development of AF. CONCLUSION: Simple morphology of right atrial appendages does not predict the development of postoperative AF.

Impact of sirolimus-eluting and Paclitaxel-eluting stents on outcome in patients with diabetes mellitus and stenting in more than one coronary artery.

Randomized trials have shown that implantation of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) reduce the incidence of major adverse cardiac events (MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs (147 patients) or PESs (113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0 +/- 1.3 versus 2.8 +/- 1.2 lesions were treated in the SES and PES groups, respectively (p = 0.34), with a mean stented length per patient of 73 +/- 43 versus 61 +/- 36 mm (p = 0.08). No significant difference was observed between the SES and PES groups for in-hospital (6.1% vs 3.5%, p = 0.34) or 9-month MACE (24.5% vs 19.5%, p = 0.34) rates or for subacute (1.4% vs 0.9%, p = 0.72) or late (0.7% vs 0.9%, p = 0.85) stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital (4.7% vs 7.7%, p = 0.57) and 9-month (28.0% vs 38.4%, p = 0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs (odds ratio 2.68, 95% confidence interval 1.46 to 4.89, p = 0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.

Percutaneous treatment with drug-eluting stent implantation versus bypass surgery for unprotected left main stenosis: a single-center experience.

BACKGROUND: Improvements in results with percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may extend their use in patients with left main coronary artery (LMCA) stenosis. METHODS AND RESULTS: Two hundred forty-nine patients with LMCA stenosis were treated with PCI and DES implantation (n=107) or coronary artery bypass grafting (CABG) (n=142), in a single center, between March 2002 and July 2004. A propensity analysis was performed to adjust for baseline differences between the two cohorts. At 1 year, there was no statistical difference in the occurrence of death in PCI versus CABG both for the unadjusted (OR=0.291; 95% CI=0.054 to 1.085; P=0.0710) and adjusted analyses (OR=0.331; 95% CI=0.055 to 1.404; P=0.1673). PCI was correlated to a lower occurrence of the composite end points of death and myocardial infarction (unadjusted OR=0.235; 95% CI=0.048 to 0.580; P=0.0002; adjusted OR=0.260; 95% CI=0.078 to 0.597; P=0.0005) and death, myocardial infarction, and cerebrovascular events (unadjusted OR=0.300; 95% CI=0.102 to 0.617; P=0.0004; adjusted OR=0.385; 95% CI=0.180 to 0.819; P=0.01). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular event at the unadjusted (OR=0.675; 95% CI=0.371 to 1.189; P=0.1891) and adjusted analyses (OR=0.568; 95% CI=0.229 to 1.344; P=0.2266). CONCLUSIONS: At 1 year, in this single-center, retrospective experience, there was no difference in the degree of protection against death, stroke, myocardial infarction, and revascularization between PCI with DES and CABG for LMCA disease.

Brain natriuretic peptide elevation and the development of atrial fibrillation following coronary artery bypass surgery.

The study was designed to determine whether the development of atrial fibrillation is associated with post-operative left ventricular dysfunction and subsequent left atrial stretch. We recruited 133 patients with well preserved pre-operative left ventricular function undergoing bypass surgery. Brain natriuretic peptide was measured at baseline, 24 and 48 h after the onset of cardiopulmonary bypass, and patients were monitored for 72 h after surgery. Atrial fibrillation occurred in 65 patients. Median 48 h brain natriuretic peptide levels were greater in the atrial fibrillation group (440 pg/ml (AF) and 319 pg/ml (non AF) P=0.001). As atrial fibrillation can cause an elevation in brain natriuretic peptide we divided the subjects into early atrial fibrillation (<48 h) and late (>48 h). In those with early atrial fibrillation there was no difference in the 24 h brain natriuretic peptide levels (381 pg/ml and 365 pg/ml P=0.73). In those with late atrial fibrillation the median 48 h brain natriuretic peptide level was greater than in the control group (405 pg/ml and 319 pg/ml, respectively, P=0.02). Brain natriuretic peptide levels rise significantly following bypass surgery. This increase was more evident in those who develop late atrial fibrillation which may suggest a role for atrial stretch in this arrhythmia.

Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions.

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.

Safety and feasibility of Bivalirudin with either Cypher and Taxus drug-eluting stent during percutaneous coronary intervention.

OBJECTIVE: This open label, prospective, non-comparative trial is the first to evaluate the safety and feasibility of bivalirudin (Angiomax(R), the Medicines Company, Parsippany, NJ), during PCI with implantation of the sirolimus eluting stent (Cypher, Cordis a J & J, Warren, NJ) or the paclitaxel eluting stent (Taxus, Boston Scientific, Natick, MA). METHODS: Patients who were referred for elective PCI suitable for stent implantation were recruited. Bivalirudin was administrated as a bolus of 1.0 mg/kg followed by 2.5 mg/kg/hour infusion for up to 4 hours in the first 68 patients. Following REPLACE 2 study, patients were treated with a lower dose of bivalirudin (0.75 mg/kg followed by 1.75 mg/kg/hour infusion). RESULTS: 111 patients with 139 lesions were included in the study. Thirty-one (27.9%) were diabetics, 14 (12.6%) had unstable angina and 79 (66.6%) had multivessel disease. Complex lesion morphology was present in 65 (46.7%), in-stent restenosis in 32 (23%), total occlusion 7 (5%) and bifurcations 22 (15.8%). Activated clotting time (ACT) was verified to be therapeutic following bivalirudin administration. During the index procedure no patients required provisional use of glycoprotein (GP) IIb/IIIa inhibitors. One patient had intracoronary thrombosis which resolved after stenting. An additional 2 patients had non-Q wave myocardial infarction (MI). No patients died, had major bleeding, required transfusions or sustained vascular complications. 1 patient developed thrombosis at 4 months with a documented MI. At 6 month follow-up, 3 (2.7%) patients died and 12 (10.8%) patients had target lesion revascularization (1 CABG and 11 re-PCI). Angiographic follow-up was achieved in 98 patients (89.9%). CONCLUSIONS: This study indicates the safety and feasibility of Cypher or Taxus stent implantation in conjunction with bivalirudin administration, with no elective use of GP IIb/IIIa inhibitors.