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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., Competing Interests: Declaration of competing interest All authors have none to declare., (Copyright © 2020 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)

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.

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.

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.

This study examined the outcomes of patients who underwent sirolimus-eluting stent (SES) implantation for the treatment of heavily calcified coronary lesions (HCCL) with and without the use of rotational atherectomy (rotablator). We investigated 150 consecutive patients with angiographic evidence of HCCL who underwent SES implantation. Sixty-nine patients underwent SES implantation without the need of rotablator (SES), and 81 patients required rotational atherectomy to modify the plaque and facilitate the delivery of the stent (SES + rotational atherectomy). Clinical success was equivalent in both groups (>98%) and there were no in-hospital outcome differences. At 6 months, the target lesion revascularization rate was 4.9% in SES vs. 4.2% in SES + rotational atherectomy groups, respectively (P = NS). Mortality at 6 months was 7.9% in the SES group vs. 6.8% in the SES + rotational atherectomy group (P = NS). SES performs well in patients with complex HCCL, with a relative low event rate. Lesions requiring rotational atherectomy to facilitate dilation and stenting had similar outcomes after SES implantation to those that could be stented without the need for rotablator.

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.

Objective: We aimed to determine the safety and efficacy of biobasorbable magnesium alloy stents in porcine coronary arteries. Bioabsorbable magnesium stents carry the potential to overcome the limitations posed by permanent metallic stents such as chronic inflammation, late stent thrombosis, prolonged antiplatelet therapy, and artifacts when imaged by multislice-computed tomography or magnetic resonance imaging., Methods: Magnesium alloy stents or stainless steel stents were randomly deployed in coronary arteries of domestic or minipigs. Domestic pigs were sacrificed at 3 days (n = 2) or 28 days, and minipigs at 3 months., Results: At 3 days, magnesium alloy stents were intact, but started to show signs of degradation by 28 days. There was no evidence of stent particle embolization, thrombosis, excess inflammation, or fibrin deposition. At 28 days and 3 months, neointimal area was significantly less in magnesium alloy stent segments (2.44 +/- 0.88 mm(2) and 1.16 +/- 0.19 mm(2)) as compared with the stainless steel stent segments (5.03 +/- 1.5 mm(2) and 1.72 +/- 0.68 mm(2), P < 0.001 and 0.02). Quantitative coronary analysis indicates that percentage area stenosis and percentage diameter stenosis in magnesium alloy stent segments improved significantly at 3 months as compared to 28 days. Despite decreased neointimal hyperplasia, lumen area of the magnesium alloy stented vessels did not improve significantly., Conclusion: Magnesium alloy stents are safe and are associated with less neointima formation; however, reduced neointima did not result in larger lumen.

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.

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.

Drug-eluting stents (DESs) have shown the ability to reduce restenosis and major adverse cardiac events in de novo lesions when compared with bare metal stents in randomized studies. Enthused by the results of these trials, DESs are being used in other difficult lesion subsets, such as bifurcation lesions, in-stent restenosis, vein graft lesions and chronic total occlusions. They are also being used in difficult patient subsets, such as diabetes and acute myocardial infarction. Not all DES are equal, however, and research is now focused on understanding the differences between these stents. This review discusses the DESs that are US FDA-approved and currently available in the USA, namely Cypher (Cordis Corporation) and Taxus (Boston Scientific), and whether they are comparable.

Objectives: We aimed to compare clinical outcomes of octogenarians > or =80 years of age after coronary drug-eluting stent (DES) implantation., Background: Although octogenarians constitute a fast-growing portion of cardiovascular patients, they are not adequately represented in current clinical revascularization trials., Methods: We analyzed the data of 3,166 consecutive patients who underwent percutaneous coronary intervention (PCI) and DES implantation since March 2003. Periprocedural events, 1- and 6-month clinical outcomes were compared between octogenarians (n = 339) and patients <80 years of age (n = 2,827)., Results: Baseline characteristics revealed a higher prevalence of females (P < 0.001), Caucasians (P = 0.004), chronic renal failure (P < 0.001), heart failure (P < 0.001), number of diseased vessels (P = 0.009), and lower ejection fraction (P = 0.03) in octogenarians. Patients <80 years showed more positive family history (P < 0.001), hyperlipidemia (P = 0.006), smoking (P < 0.001), and obesity (P < 0.001). Clinical presentation and procedural success were similar in both groups as were death, myocardial infarction (MI), and repeat revascularization in-hospital. At 6 months, restenosis rates were low and comparable. In the subgroup of octogenarians who presented with acute coronary syndrome, mortality (15% vs. 3%, P < 0.001) and Q-wave MI occurred more often. Multivariate analysis revealed age >80 (P = 0.008), cardiogenic shock (P < 0.001), Q-wave MI at presentation (P = 0.003), and length of hospital stay (P = 0.003) to be independent predictors of mortality., Conclusions: PCI with DES in octogenarians results in a similar reduction of restenosis rates when compared to patients <80 years. Yet in octogenarians who presented with acute coronary syndrome, incidence of mortality and Q-wave MI at 6 months was higher as compared to younger patients., (Copyright 2006 Wiley-Liss, Inc.)

Objectives: The purpose of this study was to examine the clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SES) when compared with those treated with > or =3 paclitaxel-eluting stents (PES)., Background: Drug-eluting stent (DES) implantation for single coronary lesions is proven to be effective and durable., Methods: A total of 126 patients who received DES were identified, of which 66 patients received > or =3 SES (SES group) and 60 patients received > or =3 PES (PES group)., Results: The baseline clinical and angiographic characteristics were compatible between the two study groups. During the index hospitalization, all clinical outcomes were similar between the two groups. There were no deaths or Q-wave myocardial infarctions (MIs) in either group. At 30 days' and 6 months' follow-up, all clinical outcomes, including death, Q-wave MI, non-Q-wave MI, target lesion revascularization, target vascular revascularization, and major adverse cardiac events, were compatible between both groups. There were 2 patients (3.0%) with subacute thrombosis in the SES group and 1 patient (1.7%) in the PES group, but there was no statistical significance. There was no late thrombosis from either group. In addition, patients in the SES group had similar event-free survival rates as compared with those in the PES group (P = 0.56)., Conclusions: Patients who require > or =3 DES implantations experienced increased adverse clinical events as compared with historical single stent implantation. However, there were no differences in safety and efficacy among the patients treated with SES as compared with those treated with PES., (Copyright 2006 Wiley-Liss, Inc.)

Objectives: We aimed to compare the clinical outcomes of dialysis versus nondialysis patients after coronary drug-eluting stent (DES) implantation., Background: The revascularization of ischemic heart disease in dialysis patients has remained controversial due to consistent exclusion of this population from major trials, especially in the context of percutaneous coronary interventions (PCI) with DES., Methods: We analyzed the data on 3,442 consecutive patients who underwent PCI and DES implantation since March 2003. Periprocedural events, 1- and 6-month clinical outcomes were then compared between dialysis (n = 72) and nondialysis patients (n = 3,370)., Results: Baseline characteristics revealed a higher prevalence of female gender (p = 0.03), African Americans (p < 0.001), hypertension (p < 0.001), diabetes mellitus (p < 0.001), number of diseased vessels (p = 0.04), lower ejection fraction (p < 0.001), and a higher prevalence of acute myocardial infarction (MI) (p = 0.04) in dialysis patients. Nondialysis patients showed more history of smoking (p < 0.001) and obesity (p = 0.02). Procedural success was higher (p = 0.05), while there was a trend toward a lower mortality rate, in the nondialysis group during hospitalization. At 6 months, the restenosis rate was low and comparable, but mortality occurred more often (16% vs. 3.8%; p < 0.001) in dialysis patients. Multivariate analysis revealed cardiogenic shock (p = 0.04) to be an independent predictor of mortality., Conclusions: PCI with DES in dialysis patients is safe and feasible, with a similar reduction of repeat revascularization when compared with nondialysis patients. There was, however, a higher incidence of mortality in dialysis patients at 6 months, mostly influenced by contributing comorbidities and more severe conditions at presentation.

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.

Background: Saphenous vein graft (SVG) intervention is associated with a significantly increased rate of periprocedural complications and late clinical and angiographic restenosis. In the contemporary drug-eluting stent (DES) era, the comparison of the efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) in SVG interventions is currently unknown. We conducted this retrospective analysis to investigate this issue., Methods and Results: Forty-seven patients with 50 SVG lesions who underwent standard percutaneous coronary intervention (PCI) with SES (SES group) were compared with 42 patients with 45 SVG lesions with PES (PES group). All patients received distal protection devices (DPDs) during the interventions. The in-hospital, 30-day, and 6-month clinical outcomes in both groups were compared. Baseline clinical and procedural characteristics were balanced between both groups except for the proximal and mid lesions. There were no deaths or Q-wave myocardial infarctions (MIs) during the index hospitalization. Non-Q-wave MI was similar between the two groups (SES vs PES, 4.3% vs 7.1%, P=0.55). At 30-day and 6-month follow-ups, all the clinical outcomes were similar between the two groups. There was no subacute thrombosis (SAT) or late thrombosis in either group. The event-free survival at 6 months was also similar between both groups (P=0.75)., Conclusions: The use of DES in patients undergoing SVG intervention with a DPD is clinically safe and feasible. As compared to SES, PES have the same efficacy and clinical outcomes in SVG interventions up to 6 months.

Background: Sirolimus-eluting stent (SES) implantation for the treatment of single coronary lesions is proven to be effective and durable. However, the safety and efficacy of overlapping SES for the treatment of long lesions have not been well established., Objectives: We conducted a retrospective analysis to compare the clinical outcomes of overlapping versus nonoverlapping SES., Methods: Fifty-five patients who received overlapping SES were compared with 39 patients who received nonoverlapping SES., Results: The baseline clinical and angiographic characteristics were balanced between the two study groups. The in-hospital complications were similar between groups, except that non-Q-wave myocardial infarction was significantly higher in the Overlapping SES group when compared with the Nonoverlapping SES group (23.6% vs. 7.7%, P = 0.04). This higher rate of myonecrosis is due to periprocedural side branch compromises, including side branch narrowing, occlusion, and flow reduction. At 30 days and 6 months follow-up, all clinical outcomes were similar between the study groups. In addition, the event-free survival rate was similar between groups (P = 0.87)., Conclusions: The implantation of overlapping SES for the treatment of long, native coronary lesions is feasible and effective but is associated with an increased rate of periprocedural myonecrosis. This phenomenon is caused primarily by side branch compromises, but does not have any adverse impact on late clinical events.

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.

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.

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.

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.

Sirolimus-eluting stents (SESs) are currently being used in patients undergoing percutaneous coronary intervention (PCI). SESs have not been evaluated in the treatment of acute myocardial infarction by primary angioplasty. We report our initial experience with SESs implanted during primary angioplasty. One hundred and three patients were treated within 12 hr after onset of acute myocardial infarction (AMI) with primary angioplasty and SES implantation. Those patients were compared to 504 patients treated with bare metal stents (BMSs). Angiographic success (TIMI flow grade 3 and residual stenosis < 50%) was completed in 98% of patients with SESs and no subacute stent thrombosis was reported. In-hospital outcomes were similar in the SES and BMS groups. At 6 months, major cardiac events were less frequent in the SES group than in the BMS group (9% vs. 24%, respectively; P < 0.001), driven by a lesser need for repeat revascularization with SESs (1% vs. 10.3% with BMSs; P = 0.014). Mortality at 6 months was 7% with SESs and 11% with BMSs (P = 0.14). SESs are safe and effective for the treatment of AMI by primary angioplasty. As compared to BMSs, SESs improve long-term outcome after AMI, mainly by reducing the need for repeat revascularization.

Sirolimus-eluting stents (SESs; Cypher) have demonstrated a significant reduction in restenosis rates when compared to bare metal stents (BMSs). The purpose of this study was to evaluate the strategy of exclusive use of two SESs versus the combination of one BMS and one SES for two-vessel coronary artery disease (CAD). It was found that the selective use of one SES combined with one BMS in patients undergoing percutaneous coronary intervention that requires more than one stent is safe, feasible, and associated with favorable procedural, 30-day, and 6-month clinical outcomes when compared to the exclusive use of SESs.

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.

Intracoronary radiation therapy (IRT) is well established in clinical practice as an effective treatment for in-stent restenosis. We aimed to determine if the 6-month clinical outcome of patients treated postapproval for marketing [commercial radiation (CR)] is equivalent to those patients enrolled in the Washington Radiation for In-Stent Restenosis Trials [Gamma WRIST and Beta WRIST; investigational radiation (IR)]. The 6-month clinical outcome of 110 consecutive patients with 125 lesions who received IRT (gamma, (192)Ir, 15-18 Gy, n = 6; or beta, (32)P, 20 Gy, n = 20; or (90)Sr/Y, 18.4-23.0 Gy, n = 99) in CR was compared with the 6-month clinical outcome of 117 patients with 117 lesions who received IRT ((192)Ir, 15 Gy, n = 65, in Gamma WRIST; and (90)Y, 20.6 Gy, n = 52, in Beta WRIST) in IR. Patients in CR were treated with wider radiation margins. The CR received antiplatelet therapy for at least 6 months and the IR for 1 month. The baseline characteristics of both groups were similar. Use of atheroablation devices was less in CR than IR (15.2% vs. 32.8%, respectively; P = 0.001). The overall major adverse cardiac events (death, Q-wave myocardial infarction, and target vessel revascularization; 18.2% vs. 29.1% in IR; P = 0.05) were significantly lower in the CR when compared with patients in the IR. The real-world clinical practice of IRT demonstrates lower events and better clinical outcomes. This is most likely a result of implementation of the lessons learned from the clinical trials such as optimizing the dosimetry by using a higher dose, treating wider margins to minimize edge effect, and administering prolonged antiplatelet therapy to abolish late thrombosis.

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions. This retrospective, observational study aimed to evaluate the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients treated with sirolimus-eluting stents (Cypher) and found that bivalirudin is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.

Anticoagulation during percutaneous coronary intervention (PCI) requires the monitoring of activated clotting time (ACT) to protect from periprocedural ischemic and bleeding complications; however, the optimal ACT values have not been established when PCI is performed with bivalirudin. After 495 consecutive patients treated for coronary artery disease with PCI received bivalirudin as a single anticoagulation agent, it was found that ACT is reproducible when bivalirudin is used during PCI and does not correlate with clinical events.

Background: The advent of drug-eluting stents has provided the interventional cardiologist an effective new tool in treating coronary restenosis. There remains, however, a small group of patients that still require intervention following drug-eluting stent therapy. Currently, intravascular brachytherapy (IVBT) is approved for use in the treatment of in-stent restenosis (ISR). This study investigated the effect of gamma and beta radiation doses typically used in IVBT on the performance of the TAXUS Express(2) paclitaxel-eluting stent., Methods and Results: It was determined that there were no statistically significant changes to in vitro paclitaxel release from stent exposed to radiation compared to controls subjected to the same conditions except for the radiation exposure. The molecular weight of the Translute polymer carrier matrix and the level of paclitaxel degradants were not changed following exposure to radiation doses up to twice what is typically used in IVBT. Beta and gamma radiation doses typically used in IVBT had no significant effect on the Translute polymer carrier, paclitaxel degradation, or paclitaxel release in this in vitro model., Conclusion: The data are encouraging and support further evaluation of the use of IVBT in the treatment of ISR in the presence of drug-eluting stents.

We aimed to study the consequences and late outcomes of patients who experienced peripheral vascular complications (PVCs) following percutaneous coronary interventions (PCI). A retrospective analysis of the medical records of 10,669 patients who underwent PCI and experienced PVC between 1995 and 2002 was conducted. One thousand ninety-six patients (10.27% of the study cohort) had PVC post-PCI. After PCI, patients with PVC had higher rates of in-hospital complications (P < 0.001) when compared to patients without PVC, including Q-wave myocardial infarction (MI; 1.2% vs. 0.3%), coronary artery bypass grafting (CABG; 3.8% vs. 0.6%), and death (4.0% vs. 1.0%). At 1-year follow-up, late complications of MI (37.4% vs. 25.4%), non-Q-wave MI (34.9% vs. 22.7%), death (12.9% vs. 5.9%), and CABG (5.7% vs. 4.5%) were higher (< 0.001) in patients with PVC compared to those without. Multivariate analysis identified PVC as a significant predictor of 1-year mortality (P = 0.045). This study underscores the need to make diligent efforts to minimize PVC and follow up these patients for future coronary events., (Copyright 2004 Wiley-Liss, Inc.)

Bivalirudin is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. Cases of intracoronary thrombosis have been reported with beta-radiation when bivalirudin is used as an anticoagulant. We report two cases of intracoronary thrombosis with gamma-radiation when bivalirudin is used., (Copyright 2004 Wiley-Liss, Inc.)

Background: Nonionic radiographic contrast media (CM) is reported to be thrombogenic while performing diagnostic or interventional procedures. To avoid thrombosis, heparin is often added to the CM. Bivalirudin, used to replace heparin during percutaneous coronary intervention (PCI), is reported to be associated with reduced bleeding complications. We aimed to evaluate the impact of adding heparin to the CM during PCI in patients (pts) who underwent sirolimus-eluting stent (SES) implantation when bivalirudin was utilized as the sole antithrombotic agent., Methods: A total of 664 pts with 756 lesions underwent standard PCI with SES for various coronary artery lesions. Pts were treated with either bivalirudin only (the bivalirudin group; 0.75 mg/kg bolus and 1.75 mg/kg/h infusion, n = 323 pts) or bivalirudin (same dose) plus low-dose heparin added to the CM (the heparin mix group; mean dose = 2101.8+/-882.5 U, n = 341 pts) during PCI. The periprocedural, in-hospital, and 30-day clinical outcomes were compared., Results: Baseline clinical and angiographic parameters were similar between both groups. Periprocedural, in-hospital, and 1-month clinical outcomes, including thrombotic complications, were similar between the two groups. There was no difference in the periprocedural thrombosis rate between the groups. In the heparin mix group, the overall incidence of hematoma was significantly higher (3.8% vs. 8.5%, P = .01), there was a trend toward higher rates of blood transfusion (2.6% vs. 6.6%, P = .06) and overall vascular complications (0.01% vs. 5.3%, P <.001), including pseudoaneurysm (PSA; 0.0% vs. 2.6%, P = .004), and pts who required surgical repair (0.3% vs. 1.8%, P = .07)., Conclusions: The routine addition of low-dose heparin to CM during contemporary PCI does not add any protection value and is associated with higher rates of bleeding and vascular complications.

Cellular proliferation and migration are fundamental processes that contribute to the injury response in major blood vessels. The resultant pathologies are atherosclerosis and restenosis. As we begin to understand the cellular changes associated with vascular injury, it is critical to determine whether the inhibition of growth and movement of cells in the vasculature could serve as a novel therapeutic strategy to prevent atherosclerosis and restenosis., (Copyright 2004 Elsevier Inc.)