Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor™ SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor™ SES.

ARNI in cardiovascular disease: current evidence and future perspectives.

Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers are the mainstay of therapy for cardiovascular disease and heart failure (HF). The angiotensin receptor II blocker - neprilysin inhibitor (ARNI), sacubitril-valsartan has an established role in treatment of patients with HF with reduced ejection fraction (HFrEF) based on the results of PARADIGM-HF trial. This trial has provided a strong evidence base for treatment of HFrEF in various subsets of patients. Several studies are done using ARNI in various indications such as HFrEF, HFrEF, patients hospitalized with acute decompensated HF, HF with preserved EF, AMI with LVEF <40%, hypertension, chronic kidney disease, pulmonary hypertension, obstructive sleep apnea, so on and so forth. This review provides an update of current literature and future perspective on ARNI in various cardiovascular disorders.

Association of serum 25-hydroxyvitamin D levels with primary hypertension: a study from south India.

Hypertension is a major risk factor for cardiovascular and cerebrovascular disease. Recent studies have identified an association between low vitamin D levels and hypertension. We investigated the association between vitamin D levels and hypertension in the general population. We recruited 400 hypertensive subjects and compared them with 400 age- and sex-matched normotensive subjects. This study was carried out at Yashoda Hospital, Hyderabad, India from January 2015 to December 2017. Both groups underwent risk factor evaluation, estimation of serum 25-hydroxyvitamin D levels, and C-reactive protein (CRP) and liver function tests. Out of the 400 hypertensive subjects, 164 (40.2%) had serum 25-hydroxyvitamin D deficiency, compared with 111 (27.7%) normotensive subjects (p = 0.0001). Deficiency of serum 25-hydroxyvitamin D in hypertensive subjects was significantly associated with CRP positivity, low levels of mean serum calcium, low levels of mean serum phosphorous, high levels of mean alkaline phosphatase (p < 0.0001), and abnormal alanine transaminase (ALT) (p = 0.0015) compared with the same parameters in the normotensive subjects. After adjustment in the multiple logistic regression analysis, serum 25-hydroxyvitamin D deficiency (odds: 1.78; 95% CI: 1.31-2.41), CRP positivity (odds: 1.48; 95% CI: 1.48-2.32) and abnormal ALT (odds: 1.2; 95% CI: 0.98-1.94) were significantly associated with hypertension. Serum 25-hydroxyvitamin D deficiency was significantly associated with hypertension.

Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents.

BACKGROUND: Stent thrombosis (ST) is a serious complication of drug-eluting stent (DES) implantation regardless of the timing (acute, subacute, or late). The correlates of ST with DES are not yet completely elucidated. METHODS AND RESULTS: From a total cohort of 2974 consecutive patients treated with DES since April 2003, we identified 38 patients who presented with angiographic evidence of ST (1.27%). The ST occurred acutely in 5 patients, subacutely (< or =30 days) in 25 patients, and late (>30 days) in 8 patients. The clinical, angiographic, and procedural variables of these patients were compared with the remaining 2936 consecutive patients who underwent DES implantation and did not experience ST during a follow-up of 12 months. Logistic regression analysis was conducted to determine the correlates of ST. Compared with patients without ST, patients with ST had a higher frequency of diabetes, acute postprocedural renal failure, and chronic renal failure. There were more bifurcation lesions, type C lesions, and a trend for smaller-diameter stents. Discontinuation of clopidogrel was higher in these patients (36.8% versus 10.7%; P<0.0001). The mean duration to ST from the stent implantation was 8.9+/-8.5 days in subacute and 152.7+/-100.4 days in late thrombosis cases. Mortality was significantly higher in patients with ST compared with those without ST at 6 months (31% versus 3%; P<0.001). Multivariate analysis detected cessation of clopidogrel therapy, renal failure, bifurcation lesions, and in-stent restenosis as significant correlates of ST (P<0.05). CONCLUSIONS: ST continues to be a serious complication of contemporary DES use. Careful management is warranted in patients with renal failure and in those undergoing treatment for in-stent restenosis and bifurcations. Special focus on clopidogrel compliance may minimize the incidence of ST after DES implantation.

Comparison of clinical outcomes of overlapping sirolimus- versus paclitaxel-eluting stents in patients undergoing percutaneous coronary intervention.

Sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation for the treatment of single coronary lesions has proved to be effective and durable. However, the safety and efficacy of overlapping drug-eluting stents for the treatment of long lesions have not been well established. In total, 114 patients who received overlapping drug-eluting stents were identified, 55 of whom received overlapping SESs and 59 received overlapping PESs. Baseline clinical and angiographic characteristics were balanced. In-hospital complications were similar between the 2 groups. At 30-day and 6-month follow-ups, all clinical outcomes were also similar. In addition, the event-free survival rate was comparable (p = 0.71). Implantation of overlapping drug-eluting stents for the treatment of long, native coronary lesions is feasible and effective. In conclusion, in this observational study, clinical outcomes appeared similar in patients treated with overlapping SES implantation compared with those treated with overlapping PES implantation.

Effect of a rapid intra-arterial infusion of dextrose 5% prior to coronary angiography on frequency of contrast-induced nephropathy in high-risk patients.

Contrast-induced nephropathy (CIN) is a common complication of coronary angiography that is associated with significant morbidity and mortality. Preexisting renal dysfunction is the most important risk factor for the development of CIN. A novel strategy of infusing 1 L of 5% dextrose immediately before catheterization is associated with a lower rate of CIN in those at high risk (creatinine clearance < or = 60 ml/min). CIN occurred in 47 patients (5.7%) in the control group and 2 patients (1.4%) in the group treated with 5% dextrose. The relative risk decrease was 73% (p = 0.03). This is an effective, quick, and inexpensive method of improving outcomes in patients who undergo percutaneous coronary interventions.

Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention.

Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. We examined the efficacy and safety of sirolimus-eluting stents (SESs; Cypher) compared with bare metal stents (BMSs) in SVG intervention. Forty-eight patients who had 50 SVG lesions and underwent standard percutaneous coronary intervention with SESs (SES group) were compared with 57 patients who had 64 SVG lesions and underwent intervention with BMSs (BMS group). All patients received distal protection devices during SVG intervention. In-hospital, 30-day, 6-month, and 1-year clinical outcomes in the 2 groups were compared. Baseline clinical and procedural characteristics were balanced between groups. There were no deaths or Q-wave myocardial infarctions during the index hospitalization, but compared with the BMS group, patients in the SES group had significantly fewer non-Q-wave myocardial infarctions (4% vs 21%, p = 0.01), which was mainly attributed to increased periprocedural creatine kinase-MB levels. At 30-day, 6-month, and 1-year follow-ups, all clinical outcomes were similar between groups. Event-free survival at 1 year was also similar between groups (p = 0.84). In conclusion, the use of SESs in patients who undergo SVG intervention with a distal protection device is clinically safe and feasible but is not associated with decreased clinical events up to 1 year compared with BMSs.

Impact of three or more versus a single sirolimus-eluting stent on outcomes in patients who undergo percutaneous coronary intervention.

This retrospective analysis compared clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SESs) with those who received a single SES. SES (Cypher) implantation for single vessels is proved to be effective and durable, but knowledge regarding the safety and effectiveness of multiple stenting with SESs is currently limited. In total, 929 consecutive patients who received SESs were identified; 63 received > or =3 SESs (multi group) and 866 received 1 SES (single group). The multi group had more non-Q-wave myocardial infarctions (MIs) during the index hospitalization (p = 0.02). At 30-day follow-up, death, Q-wave MI, subacute thrombosis, and major adverse cardiac events were higher in the multi group than in the single group. At 6 months, death, Q-wave MI, target lesion revascularization, and major adverse cardiac events continued to be higher in the multi group. Using multivariate analysis, > or =3 SES implantations, American College of Cardiology/American Heart Association type C lesions, and cardiogenic shock were identified as independent predictors for 6-month major adverse cardiac events. In addition, patients in the multi group had a significantly lower survival rate than patients in the single group (p <0.0001). Patients who required > or =3 SES implantations developed increased periprocedural non-Q-wave MI and worse adverse clinical outcomes at 30 days and 6 months compared with patients who required a single SES implantation. In conclusion, when patients present with multiple coronary lesions, percutaneous coronary intervention with multiple SESs should be undertaken with great caution.

Impact of chronic renal insufficiency on clinical outcomes in patients undergoing percutaneous coronary intervention with sirolimus-eluting stents versus bare metal stents.

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.

Sirolimus-eluting stents versus Paclitaxel-eluting stents in the treatment of coronary artery disease in patients with diabetes mellitus.

This study was performed to compare the safety and efficacy of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) on the outcomes of diabetic patients. Recent data with drug-eluting stents have shown improved clinical outcomes in diabetic patients. This study compared outcomes between the 2 available drug-eluting stents, SESs and PESs. From the prospective drug-eluting stent registries at the investigators' institution, 1,320 consecutive diabetic patients treated with SESs (n=873, 1,293 lesions) and PESs (n=447, 733 lesions) were identified and their in-hospital and 1- and 6-month clinical outcomes compared. Baseline characteristics showed more men, more patients with previous coronary bypass surgery, and smaller ejection fractions in the PES group and more obese patients in the SES group. Procedural characteristics were similar except for more left anterior descending artery and proximal lesions and the greater use of glycoprotein IIb/IIIa inhibitors in the SES group and more type C lesions, direct stenting, and stents per patient in the PES group. In-hospital complications were similar. Clinical follow-up at 1 month was also similar between the 2 groups, including subacute stent thrombosis. At 6 months, the 2 groups had similar mortality (7% vs 7%), myocardial infarctions (18% vs 21%), target lesion revascularization, target vessel revascularization, major adverse cardiac events (11% vs 12%), and late thrombosis (0.3% vs 0%). Subanalysis of insulin-treated diabetic patients showed no significant differences in outcomes in the 2 groups. No significant differences were found between SESs and PESs on Cox regression analysis for hazard ratios. In conclusion, SESs and PESs are associated with similar efficacy and safety with regard to repeat revascularization rates, major adverse cardiac events, and stent thrombosis up to 6 months for the treatment of coronary artery disease in patients with diabetes mellitus regardless of insulin therapy.

Frequency and severity of plaque prolapse within Cypher and Taxus stents as determined by sequential intravascular ultrasound analysis.

We used intravascular ultrasound to evaluate the incidence, characteristics, and clinical sequel of plaque prolapse within drug-eluting stents. The influence of stent design on plaque prolapse has not been studied. Drug-eluting stents were serially expanded, first at 14 atm and then at 20 atm, with intravascular ultrasound imaging after each inflation. The stent, lumen, and maximum plaque prolapse areas were measured. The residual lumen area and percentage of plaque prolapse burden (maximum plaque prolapse area/stent area) were calculated. Plaque prolapse was divided into grades 1 (<5%), 2 (5% to 10%), and 3 (10% to 20%). Eighty patients (83 lesions, 41 Cypher and 42 Taxus Express stents) were studied. The incidence of plaque prolapse was 41% (17 of 41 lesions) with the Cypher stents versus 24% (10 of 41 lesions) with the Taxus stents after 14 atm (p = 0.096) and 35% (14 of 40) in Cypher stents versus 17.8% (5 of 28) in Taxus stents after 20 atm (p = 0.17). However, the maximum plaque prolapse area was never >20% of the stent area. The frequency and amount of plaque prolapse neither increased nor decreased at higher (20 atm) inflation pressures. Lesions with prolapse were longer (p = 0.004), with a larger external elastic membrane area and greater plaque burden (each p <0.0001) and a larger remodeling index (p = 0.013). Conversely, nonprolapsed plaques had a higher incidence of superficial calcium (p = 0.001). Creatinine kinase-MB elevation was higher with plaque prolapse, and the magnitude of creatinine kinase-MB elevation correlated with the extent of plaque prolapse (r = 0.664, p = 0.002). Multiple logistic regression analysis indicated that a longer lesion length (p = 0.012), and smaller minimal luminal area (p = 0.031) had higher risks of plaque prolapse. In conclusion, plaque prolapse was frequently observed in Cypher and Taxus stents. However, sequential intravascular ultrasound imaging showed that the frequency and amount of plaque prolapse were neither increased nor decreased by additional higher pressure inflations.

Bivalirudin versus unfractionated heparin in patients undergoing percutaneous coronary intervention after acute myocardial infarction.

BACKGROUND: Bivalirudin is replacing heparin as the anticoagulant agent of choice for elective percutaneous coronary intervention (PCI). This study aimed to assess the safety and clinical outcomes of bivalirudin versus unfractionated heparin (UFH) in patients undergoing PCI for acute myocardial infarction (AMI). METHODS: A cohort of 672 consecutive patients presenting with AMI without prior thrombolytic therapy were treated with either bivalirudin (216 patients) or UFH (456 patients). Platelet glycoprotein IIb/IIIa inhibitors were administered at the operator's discretion. The in-hospital, 30-day, and 6-month outcomes of the two groups were compared. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. In-hospital complications were similar, although there was a trend of a less major hematocrit drop in the bivalirudin group (0.9% vs. 3.1%, P=.09). All clinical outcomes were similar between the groups at 30-day and 6-month follow-ups. There was no statistical significance for acute thrombosis and subacute thrombosis between the groups, and there was no late thrombosis from either group. The event-free survival rate was similar between the groups (P=.41). CONCLUSION: The use of bivalirudin in patients undergoing PCI after AMI is safe and feasible. Bivalirudin should be considered as an alternative anticoagulant agent during PCI to treat patients presenting with AMI.

Metabolic syndrome in patients with acute myocardial infarction is associated with increased infarct size and in-hospital complications.

BACKGROUND: Metabolic syndrome (MS), the combination of hypertension, obesity, dyslipidemia, and insulin resistance, is a precursor of diabetes mellitus (DM) and highly prevalent among patients with acute myocardial infarction (AMI). Diabetes mellitus is associated with larger infarct size and worse outcomes after AMI. This study examined infarct size and short-term outcomes among nondiabetic patients with MS following contemporary treatment of AMI. METHODS: Four hundred five consecutive patients with AMI treated with primary percutaneous coronary intervention were evaluated. Patients with diabetes (n=105) were excluded. Those with MS (n=167) included patients with three or more of the following criteria: hypertension, elevated fasting blood glucose, hypertriglyceridemia, low high-density lipoprotein, and obesity [body mass index (BMI)> or =30]. The control group (n=133) included patients without MS or DM. RESULTS: Baseline characteristics were similar except for hypertension, BMI, and dyslipidemia, which by study design were higher in the MS group. The MS group had larger infarct size as determined by peak creatine kinase-MB (79.8+/-133.8 vs. 30.84+/-51.5, P<.001). Overall in-hospital complications were higher in patients with MS (21.1% vs. 9.2%, P=.003). Metabolic syndrome is associated with a 10-fold increased risk of acute renal failure after myocardial infarction (7.9% vs. 0.8%, P=.007). CONCLUSION: Metabolic syndrome in nondiabetic patients with AMI is associated with larger infarct size, more in-hospital complications, and a marked increase of acute renal failure. Awareness of MS and preventative measures is crucial in this population to minimize infarct size and decrease morbidity after AMI.

Oral rapamycin to inhibit restenosis after stenting of de novo coronary lesions: the Oral Rapamune to Inhibit Restenosis (ORBIT) study.

OBJECTIVES: The aim of this study was to establish safety and feasibility of oral Rapamycin at two doses-2 mg and 5 mg-in achieving low rates of repeat target lesion revascularization (TLR) in de novo native coronary artery lesions. BACKGROUND: Drug-eluting stents have shown the ability to limit restenosis. Oral Rapamycin is an alternative strategy that can target multiple coronary lesions suitable for treatment with any approved metal stent and at potentially lower cost. METHODS: The Oral Rapamune to Inhibit Restenosis (ORBIT) study is an open-label study of 60 patients with de novo lesions treated with bare metal stents in up to two vessels. After a loading dose of 5 mg, patients received a daily dose of 2 mg (n = 30) and 5 mg (n = 30) for 30 days. Six-month angiographic, intravascular ultrasound (IVUS), and clinical follow-up were conducted. RESULTS: Baseline clinical and procedural characteristics were similar: 10% of patients in the 2-mg group and 30% in the 5-mg group did not complete the course; 43% in the 2-mg group and 66% in the 5-mg group had side effects. At six-month follow-up, late loss (0.6 +/- 0.5 mm vs. 0.7 +/- 0.5 mm; p = NS), in-stent binary restenosis (7.1% vs. 6.9%; p = NS), in-stent percent volume obstruction by IVUS (29% vs. 24%; p = NS), and clinically driven TLR (14.3% vs. 6.9%; p = NS) were similar in 2-mg and 5-mg groups. CONCLUSIONS: Oral Rapamycin for the prevention of restenosis is safe, feasible, and associated with low rates of repeat revascularization. Although associated with certain side effects, it may be considered for patients undergoing multivessel stents if proven in larger randomized studies.

Brachytherapy and bivalirudin evaluation study.

BACKGROUND: Bivalirudin is shown to be a competent substitute for heparin in percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in patients undergoing PCI and vascular brachytherapy (VBT) are not known. This study aimed to assess the safety and efficacy of bivalirudin as a single antithrombotic agent in patients undergoing PCI and VBT. METHODS: A total of 152 patients enrolled in the Brachytherapy and Bivalirudin Evaluation Study underwent PCI and VBT with either gamma (n = 8) or beta radiation (n = 144). The main outcome measures were in-hospital events and 30-day clinical outcomes. All patients were treated with bivalirudin (0.75 mg/kg bolus and 1.75 mg/kg per hour infusion for beta radiation, 1 mg/kg bolus and 2.5 mg/kg per hour infusion for gamma radiation) as a single antithrombotic agent during the entire procedure. RESULTS: Baseline clinical and angiographic characteristics were similar between the 2 groups. More than 90% of the patients received beta radiation. In-hospital events showed a higher prevalence of acute procedural intracoronary thrombosis in patients treated with gamma- vs beta radiation (25% vs. 0.7%, P < .001). Thirty-day outcomes including death, Q-wave, and non-Q-wave myocardial infarctions, subacute stent thromboses, and repeat revascularizations were similar in both groups. CONCLUSION: Bivalirudin, as a single antithrombotic agent during PCI and VBT with beta emitters, may be used safely, but its use in the setting of PCI and gamma radiation may not be acceptable due to an increased incidence of acute procedural intracoronary thrombosis.

Impact of treatment of coronary artery disease with sirolimus-eluting stents on outcomes of diabetic and nondiabetic patients.

Patients with diabetes mellitus are at increased risk for repeat interventions and mortality after coronary angioplasty and stenting. The efficacy of sirolimus-eluting stents (SESs) to improve the outcomes of these patients is a focus of interest. In the first 1,407 patients treated with SESs at our institution, 492 were diabetic (insulin dependent diabetes mellitus [IDDM], n = 160 and non-insulin-dependent DM [NIDDM], n = 332). The in-hospital and 1- and 6-month clinical outcomes were compared with those of 915 patients without DM (non-DM). The baseline characteristics were similar, except for more women, obesity, previous myocardial infarction, coronary artery bypass grafting, and renal insufficiency in the DM group (p <0.001). Compared with non-DM patients, DM patients had higher in-hospital (p <0.05) and 1-month mortality (p = 0.02). IDDM patients had more in-hospital renal failure (p = 0.04) and Q-wave myocardial infarctions (1.6% vs 0%, p = 0.04) compared with NIDDM patients, and higher mortality (3.1% vs 0.8%, p = 0.04) and subacute stent thromboses (2.3% vs 0.5%, p = 0.07) than non-DM patients at 30 days. At 6 months, DM patients had a higher incidence of Q-wave myocardial infarction, target lesion revascularization-major adverse cardiac events, and composite of death and Q-wave myocardial infarction than non-DM patients (6.0% vs 2.7%, p = 0.01). Late outcomes between the IDDM and NIDDM groups were similar. Multivariate analysis showed diabetes and acute renal failure as independent predictors of target lesion revascularization-major adverse cardiac events. In conclusion, our data showed that, despite a reduction in repeat revascularization, coronary intervention with SESs in diabetic patients is limited by higher mortality at 1 month and a higher incidence of Q-wave myocardial infarction and target lesion revascularization-major adverse cardiac events at 6 months compared with non-DM patients. Careful surveillance is required in IDDM patients undergoing SES implantation.

Bivalirudin versus heparin as an antithrombotic agent in patients who undergo percutaneous saphenous vein graft intervention with a distal protection device.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions, and data on its usage in saphenous vein graft interventions are limited. This retrospective, observational study evaluated the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients who underwent saphenous vein graft intervention with distal protection devices. We found that bivalirudin use is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

Impact of continued hospitalization in patients pre-treated with clopidogrel prior to coronary angiography and undergoing coronary artery bypass grafting.

Pre-treatment of patients with clopidogrel prior to coronary angiography (CAG) and possible percutaneous coronary intervention (PCI) is a standard practice. Candidates for coronary artery bypass surgery (CABG) are discharged or remain in the hospital until CABG after clopidogrel is discontinued. We investigated whether any differences exist in the rates of surgical complications and outcomes between these two groups of patients. We conclude that continued hospitalization of clopidogrel pre-treated patients does not confer any safety benefit with regard to post-operative complications and 30-day mortality. Discharging these patients after CAG may reduce hospitalization costs.

Optimizing dosimetry with high-dose intracoronary gamma radiation (21 Gy) for patients with diffuse in-stent restenosis.

BACKGROUND: The efficacy of intracoronary gamma radiation (IRT-gamma) in reducing recurrent in-stent restenosis (ISR) is well established using doses of 14-18 Gy. We sought to examine whether an escalation in dose to 21 Gy is safe and confers additional benefit in reducing repeat revascularization and major adverse cardiac events (MACE) in patients with diffuse ISR. METHODS: Forty-seven patients with diffuse ISR (lesion length 20-80 mm) in native coronary arteries (n=25) and saphenous vein grafts (n=22) underwent percutaneous transluminal coronary angioplasty and/or additional stents followed by IRT-gamma using the Checkmate system (Cordis) with a dose of 21 Gy. All patients were discharged with clopidogrel for 12 months and aspirin indefinitely. Six-month angiographic and 12-month clinical outcomes of these patients were compared to 120 patients treated with 18 Gy using the same system. RESULTS: At baseline, patients in the 21-Gy group had more multivessel, vein graft disease and history of prior myocardial infarctions and coronary artery bypass grafts (P<.001). The use of debulking devices and stents was less in this group (P<.001). Procedural and in-hospital complications were similar. Follow-up at 6 months revealed nonsignificant but lower late loss (in-stent, 0.33+/-0.7 mm; in-lesion, 0.41+/-0.6 mm) in the 21-Gy group compared to the 18-Gy group; follow-up at 12 months revealed a trend toward less overall myocardial infarction, although repeat revascularization and MACE rates were similar. CONCLUSIONS: IRT-gamma therapy for diffuse ISR lesions with a 21-Gy dose is clinically safe and feasible with marked reduction in late loss but does not confer additional benefit with regard to repeat revascularization and MACE when compared to a dose of 18 Gy.

Bivalirudin compared with IIb/IIIa inhibitors in patients with in-stent restenosis undergoing intracoronary brachytherapy.

BACKGROUND: Bivalirudin is replacing heparin in percutaneous coronary interventions (PCIs), including vascular brachytherapy (VBT). The aim of the study was to compare bivalirudin with eptifibatide in patients with in-stent restenosis (ISR) undergoing PCI and VBT. METHODS: One hundred forty-four patients treated with bivalirudin as a single antithrombotic agent were compared with 150 patients treated with eptifibatide. Bivalirudin as a bolus of 0.75 mg/kg followed by 1.75 mg/kg/h infusion until the end of the procedure, and eptifibatide as a double bolus of 180 microg/kg followed by 2 microg/kg/min infusion for 18 h after the procedure were used. The main outcome measures were in-hospital events and 30-day clinical outcomes. RESULTS: Baseline clinical characteristics were similar except that patients in the eptifibatide group were younger (P=.02) and had more saphenous vein graft lesions (P<.001). Patients in the bivalirudin group had a higher number of lesions in the right coronary artery (P<.001) and a higher number of vessels treated (P<.001). Postprocedure creatinine phosphokinase (CPK)-MB levels were significantly lower in the bivalirudin group (P<.03). In-hospital events showed significantly less minor bleeding (P=.01) and a trend toward lower major bleeding and major adverse cardiac events (MACE) in the bivalirudin group (P=.06). Thirty-day outcomes showed a significantly lower incidence of non-Q-wave myocardial infarction (MI) in the bivalirudin group (P=.004). CONCLUSION: Bivalirudin, as a single antithrombotic agent during PCI and VBT, is associated with significantly lower postprocedural CPK-MB elevation, minor bleeding complications, 30-day non-Q-wave MI rates, and a trend toward lower major bleeding and in-hospital MACE when compared with eptifibatide.