Reduction In Angiographic Restenosis Research Articles

Outcomes of supraflex sirolimus eluting coronary stents

Background: The introduction of Sirolimus Eluting Coronary Stents (SES) was a major breakthrough in interventional cardiology. The large, randomized, clinical trials using SES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization (TVR) compared with bare-metal stents as well as other drug-eluting stents (DESs). However, there is only limited data on the outcome of Indian patients treated by DES of Indian origin. The purpose of the study was to evaluate the outcomes of the supraflex sirolimus-eluting coronary stents for the treatment of coronary artery disease and to determine major adverse cardiovascular and cerebrovascular events (MACCE). Materials and Methods: This was a single-centre, observational, nonrandomized study that enrolled unselected real-world patients at a tertiary care center who had undergone implantation with supraflex sirolimus-eluting stents. The primary end-point of the study was MACCE, which is a conglomeration of cardiac death, target lesion revascularization (TLR), TVR, cerebrovascular accident (CVA), and heart failure at 1-year follow-up. Results: A total of 100 patients were intervened successfully with sirolimus-eluting stents. Out of total patients, diabetes and hypertension were observed in 38% and 35% of patients. According to ACC/AHA classification, there were 68% Type B lesions and 32% Type C lesions. At 1-year follow-up, MACE was found to be 11%, which is a composite of 4% TLR, 3% TVR, 1% CVA, and 5% heart failure. Diabetes (P = 0.02), hypertension (P = 0.01), kidney dysfunction (P = 0.002), and LV function (P = 0.01) strongly correlate with outcome (MACCE). Conclusion: There was an acceptable rate of adverse events after implantation of the supraflex sirolimus-eluting stents, although it was slightly higher compared to other studies. Diabetes, hypertension, kidney dysfunction, and LV function strongly correlate with outcome (MACCE).

Angioplasty guided by intravascular ultrasound: meta-analysis of randomized clinical trials.

BackgroundThe impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results.ObjectiveSystematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution.MethodsA search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I2 test was used to quantify the consistency between the results of each study.ResultsA total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I2 = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I2 = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I2 = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I2 = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. ConclusionAngioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes.

Implante de Stent guiado por ultrassom intracoronariano melhora desfechos: meta-análise de ensaios randomizados

Intracoronary ultrasound (IVUS) has been used as an adjunctive method in order to optimize implantation of stents. However, the impact of this method in some outcomes is controversial.To systematically review the impact of routine IVUS-guided coronary stent as compared to angiographic-guided, on clinical and angiographic outcomes.A search of databases (MEDLINE, Cochrane CENTRAL, EMBASE) and references of published studies, from 1982 to 2010, was conducted. Randomized clinical trials (RCTs) that compared angiography plus IVUS-guided (IVUS) vs. angiography alone guided (ANGIO) coronary stent implantation were included. Minimum follow-up was 6 months and the outcomes assessed were major adverse cardiac events (MACE), target lesion revascularization (TLR) and angiographic restenosis. Two reviewers independently extracted the data. Summary risk ratio and 95% confidence intervals (CI) were calculated with random-effects models. The GRADE approach was used to determine the overall quality of evidence for each outcome.Out of 3,631 articles identified, 8 RCTs evaluating a total of 2,341 patients were included. There was a 27% reduction in angiographic restenosis (95%CI: 3%-46%) and a 38% reduction in TLR (95%CI: 17%-53%) in favor of IVUS vs. ANGIO. However, MACE were not reduced by IVUS (RR: 0.79; 95%CI: 0.61-1.03). The MACE data represent only 47% of the optimal information size required to reliably detect a plausible treatment effect.We observed that IVUS-guided coronary stenting provides significant reductions in TLR and angiographic restenosis compared to angiographically-guided stenting, but it does not reduce MACE.

Sex‐specific outcomes following revascularization with zotarolimus‐eluting stents: Comparison of angiographic and late‐term clinical results

We examined angiographic and late-term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus-eluting stents (ZES). Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first-generation drug-eluting stents. Clinical and angiographic outcomes among ZES-treated patients were evaluated by sex using propensity score modeling in a patient-level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS). Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8-month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES-treated patients, 2-year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late-term safety and efficacy outcomes are similar, if not lower, among women compared to men.

Development and performance of the zotarolimus-eluting Endeavor® coronary stent

Given statistically significant and clinically meaningful reductions in angiographic restenosis and repeat revascularization, treatment with drug-eluting stents (DESs) has become established as a standard of care in percutaneous coronary revascularization. However, despite their superior efficacy compared with conventional bare metal stents, experiences with first-generation DESs from both clinical trials and real-world practice have raised attention to the late safety risk of stent thrombosis that may be related to biologic incompatibility, delayed vessel healing and/or impaired endothelial function. To address the outstanding needs related to DES safety and deliverability while maintaining efficacy, the Endeavor® zotarolimus-eluting stent (Medtronic CardioVascular, CA, USA) is distinguished by favorable safety and efficacy demonstrated in clinical trials and usual practice. The purpose of this article is to describe the mechanical and pharmacologic features of the Endeavor stent, provide an overview of comparative trial results of the Endeavor stent with bare metal stents and alternative DESs, and detail recent and developing trials specific to the Endeavor stent that provide further insight to stent biocompatibility and safety.

Efficacy of Cilostazol in reducing restenosis in patients undergoing contemporary stent based PCI: a meta-analysis of randomised controlled trials

Cilostazol has been associated with reduction in restenosis in patients undergoing coronary and peripheral arterial angioplasty. Our objective was to evaluate the impact of cilostazol on restenosis in patients undergoing contemporary PCI with bare metal (BMS) or drug eluting stents (DES) and treated with aspirin and thienopyridine. Ten randomised trials (n=2,809 patients) comparing triple antiplatelet therapy (aspirin, thienopyridine and cilostazol) with standard dual antiplatelet therapy were included. Summary risk ratios for restenosis, late loss, target lesion revascularisation (TLR) and target vessel revascularisation (TVR) were calculated using fixed-effects models. Cilostazol was associated with a significant reduction in late loss in BMS (mean difference 0.24 mm, 95% CI 0.15-0.33, p<0.001) and DES groups (mean difference 0.12 mm, 95% CI 0.07-0.18, p<0.001). Cilostazol therapy was associated with a significant reduction in angiographic restenosis (Odds ratio [OR] 0.52, 95% CI 0.41- 0.66, p<0.001) with consistent benefits in patients treated with BMS (OR 0.49, 95% CI 0.35-0.70, p<0.001) or DES (OR 0.54, 95% CI 0.38-0.76, p=0.001). Addition of cilostazol to dual antiplatelet therapy was associated with a significant reduction in TLR (OR 0.38, 95% CI 0.25-0.58, p<0.001), with no difference in subacute stent thrombosis (OR 1.91, 95% CI 0.33-11.08, p=0.47), or major bleeding (OR 0.87, 95% CI 0.44-1.74, P=0.69) but with an increased risk of skin rash (OR 3.67, 95% CI 1.86-7.24, p<0.001). Cilostazol in addition to dual antiplatelet therapy is associated with a reduction in angiographic restenosis in patients undergoing stent based PCI. This inexpensive drug may be particularly beneficial in patients who are at high risk of restenosis and it should undergo further evaluation in large, definitive randomised controlled trials.

Mid-term angiographic benefit of sirolimus-eluting stents compared with paclitaxel-eluting stents in patients with acute myocardial infarction

We compared angiographic and clinical outcomes among different drug-eluting stents (DESs) in Korean acute myocardial infarction (AMI) patients. A total of 109 consecutive AMI patients who underwent percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES, n=56 pts) or paclitaxel-eluting stents (PES, n=53 pts) were enrolled from August 2004 to December 2006. The angiographic outcomes at 6 months and clinical outcomes at 1 year were compared between the two groups. Baseline clinical and procedural characteristics were similar between the two groups. At 6 months, the rate of binary restenosis was 17.0% in the PES group compared with 3.6% in the SES group (p=0.026). Percent restenosis was 24.9+/-28.6% in the PES group compared with 11.2+/-17.6% in the SES group (p=0.004). Length of restenosis segment was 3.21+/-9.02 mm in the PES group compared with 0.89+/-2.38 mm in the SES group (p=0.048). Late loss was 0.73+/-0.89 mm in the PES group compared with 0.28+/-0.37 mm in the SES group (p=0.001). However, there were no differences in clinical outcomes at 1 year including mortality, myocardial infarction, repeat PCI, and major cardiac adverse events between two groups. SES implantation in patients with AMI was associated with reduction in angiographic restenosis at 6 months compared with PES, however, these angiographic benefits were not translated into better clinical outcomes in real world clinical practice.

Clinical and Angiographic Outcomes With Sirolimus-Eluting Stents in Total Coronary Occlusions: The ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) Trial

We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization. Despite evaluation of drug-eluting stents beyond approved indications, few studies have evaluated their clinical benefit in TCO revascularization. Among 15 centers in North America, 200 consecutive TCO patients (78.8% >6 weeks TCO age) were enrolled for treatment with SES. The primary end point was 6-month angiographic binary restenosis within the treated segment. Patient characteristics included: diabetes, 24.5%; prior infarction, 33.5%; and stent length, 45.9 mm median (quartile 1, 30.2 mm; quartile 2, 62.1 mm). A total of 199 patients (99.5%) were treated with SES, and procedural success was 98.0%. The 6-month binary restenosis rates were 9.5% in-stent, 12.4% in-segment, and 22.6% in-"working length" representing the entire treatment segment. Rates of 1-year target lesion revascularization, myocardial infarction, and target vessel failure were 9.8%, 1.0%, and 10.9%, respectively. Stent thrombosis occurred in 2 patients (1.0%). Using logistic regression modeling with propensity score adjustment, the absolute reduction in binary restenosis with SES compared with a historical bare-metal stent control was 37.7% (95% confidence interval [CI]: 27.2% to 48.3%, p < 0.001; odds ratio: 0.17, 95% CI: 0.09 to 0.30, p < 0.0001). Among 32 patients (16%) identified with stent fracture, target lesion revascularization was more common than patients without fracture (25.0% vs. 6.7%, p = 0.005). Despite greater lesion complexity than prior TCO trials, percutaneous revascularization with SES appears safe and results in substantial reductions in angiographic restenosis and failed patency and a low rate of repeat revascularization. These findings support the use of SES in TCO revascularization. (The ACROSS/TOSCA Trial; NCT00378612).

Comparative safety and efficacy of a sirolimus-eluting versus paclitaxel-eluting stent: A meta-analysis

Drug-eluting stents have emerged as the favored device for percutaneous coronary intervention. It is not clear if there are differences in the currently available drug-eluting stents. We performed a meta-analysis to systematically evaluate currently available data comparing sirolimus-eluting stents (SESs) with paclitaxel-eluting stents (PESs) in patients with coronary artery disease. We searched the MEDLINE, Embase, ISI Web of Knowledge, Current Contents, and International Pharmaceutical Abstracts databases, and the Cochrane Central Register of Controlled Trials, as well as scientific meeting abstracts up to November 30, 2006. All randomized controlled trials comparing SES with PES and providing follow-up data of > or = 6 months were eligible for inclusion in our analysis. Data from 12 trials (number of patients 7455) were pooled. There was no difference in death (summary odds ratio [OR] 0.88, 95% CI 0.61-1.25, P = .46), myocardial infarction (summary OR 0.92, 95% CI, 0.71-1.19, P = .51), or stent thrombosis (summary OR 0.75, 95% CI 0.40-1.40, P = .37) between SES and PES. The use of SES was associated with a significant reduction in angiographic restenosis (summary OR 0.64, 95% CI 0.52-0.78, P < .001), target vessel revascularization (5.66% vs 7.70%, summary OR 0.72, 95% CI 0.59-0.88, P = .002), or target lesion revascularization (summary OR 0.67, 95% CI 0.53-0.84, P = .001). Patients treated with SES appear to have a significantly lower risk of restenosis and need for target vessel revascularization compared with those treated with PES. There is no significant difference between the 2 stents with respect to mortality, myocardial infarction, or early stent thrombosis.

Zotarolimus-Eluting Stents in Patients with Native Coronary Artery Disease: Clinical and Angiographic Outcomes in 1,317 Patients

Early studies of a cobalt-based alloy stent coated with the novel antiproliferative agent zotarolimus and a phosphorylcholine polymer have demonstrated significant reductions in angiographic restenosis and target vessel revascularization compared with bare metal stents. However, the generalizability of the angiographic outcomes and clinical benefit of zotarolimus-eluting stents (ZESs) to a more real-world patient population is undetermined. Clinical and angiographic outcomes in 1,317 patients treated with the ZES in the first 4 trials of the Endeavor ZES (Medtronic Vascular, Santa Rosa, CA) clinical trials program were pooled for systematic analysis. Protocol-specified follow-up angiography was performed at 8 or 12 months for a subset of 750 of these patients, and clinical follow-up was performed at 9 months after the index procedures in all patients. Diabetes mellitus was present in 22.5% of patients, the mean reference vessel diameter was 2.73 mm, and the mean lesion length was 14.59 mm. At 8 months (12 months for ENDEAVOR I), mean +/- SD in-stent late luminal loss was 0.61 +/- 0.49 mm. In-stent late luminal loss was greatest in larger caliber (>2.9 mm) vessels (0.65 +/- 0.49 mm) and longer (>16.3 mm) lesions (0.70 +/- 0.52 mm) but did not statistically vary according to diabetic status. At 9 months, overall rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) were 4.9% and 7.7%, respectively. The rate of TLR at 12 months was not significantly different relative to diabetes and lesion length >16.3 mm (7.2% and 7.7%, respectively), although TLR was significantly more common when reference vessel diameter was <2.5 mm (8.5%; p = 0.013). At 24 months, overall rates of TLR and MACE were 6.5% and 9.9%, respectively. The overall 24-month rate of stent thrombosis was 0.3%, with no events occurring >14 days after the procedure. Despite varied clinical and angiographic characteristics, treatment with the ZES is associated with consistently low rates of TLR and overall major adverse events, including stent thrombosis. Although these findings indicate the efficacy and safety of the ZES over the time course of the first 4 ENDEAVOR clinical trials, additional ongoing study with more open patient inclusion criteria (including long lesions, small vessels, bifurcations, etc) will be important for discerning whether comparable clinical outcomes can be extended to lesion subsets of higher complexity.

Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT—A double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary interventions after pretreatment with a high loading dose of clopidogrel

ISAR-REACT was a trial designed to evaluate whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention (PCI) with stent placement after pretreatment with a 600 mg loading dose of clopidogrel. Objective for the angiographic substudy was to determine the impact of abciximab on angiographic restenosis after coronary stent placement. Previous analyses have suggested a reduction in the incidence of restenosis after the administration of abciximab. The angiographic substudy comprises 1885 of 2159 patients enrolled in ISAR-REACT: 994 patients were randomly assigned to abciximab and 941 patients to placebo. All patients were scheduled for a routine angiographic follow-up after 6 months (performed in 80% of eligible patients). End points for the angiographic substudy were the rates of angiographic restenosis (> or = 50% diameter stenosis) and target lesion revascularization. The incidence of angiographic restenosis was 27% in the abciximab group and 29% in the placebo group (relative risk 0.92, 95% CI 0.79-1.06, P = .27). Late angiographic lumen loss was 0.95 +/- 0.68 and 0.99 +/- 0.70 mm, respectively (P = .25). Similar results were obtained in a subgroup analysis focusing on high-risk subsets. The rate of target lesion revascularization procedures was 22% in the abciximab group and 23% in the placebo group (relative risk 0.94, 95% CI 0.79-1.12, P = .52). In low- to intermediate-risk patients who undergo elective PCI after pretreatment with a high loading dose of clopidogrel >2 hours before PCI, the additional administration of the glycoprotein IIb/IIIa inhibitor abciximab is not associated with a significant reduction in angiographic restenosis.

Drug-eluting Stent Utilisation and Outcomes in Acute Coronary Syndromes: Evidence-based Practice Without the Evidence?

In both randomised trials, compared with bare metal coronary stents, and in observational registries, treatment with drug-eluting stents (DES) has been associated with considerable reductions in angiographic restenosis and the need for repeat coronary revascularisation procedures. Despite these established benefits in selected patient populations, relatively little is known regarding the safety and efficacy of DES in patients with acute coronary syndromes (ACS).

Treatment of unprotected left main coronary artery disease with drug-eluting stents: is it time for a randomized trial?

The treatment of unprotected left main coronary artery disease by percutaneous intervention represents a considerable challenge for interventional cardiologists. The American College of Cardiology/American Heart Association guidelines currently recommend surgical revascularization for this disorder and percutaneous interventions have thus far been performed only in exceptional cases, albeit with positive results in some patients. Technical limitations, however, including stent restenosis, limit the application of this technique at present. The availability of drug-eluting stents, which are associated with a reduction in angiographic restenosis, might change this situation. Preliminary results show that the implantation of drug-eluting stents for unprotected left main coronary artery lesions is a feasible and safe approach. Randomized clinical trials comparing the use of drug-eluting stents with coronary artery bypass surgery for unprotected left main coronary artery disease are the next step, but can such trials be contemplated at this stage? In this review we present an overview of the findings to date and discuss the direction that research should now take.

Drug-eluting stent: a review and update

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. However, neointimal hyperplasia occurring within the stent leading to in-stent restenosis is a main obstacle in the long-term success of percutaneous coronary intervention (PCI). The recent introduction of drug-eluting stents (DES) contributes a major breakthrough to interventional cardiology. Many large randomized clinical trials using DES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization when compared with bare metal stents. The results of these trials also appear to be supported by evidence from everyday practice and non-controlled clinical trials. However, the expanded applications of DES, especially in treating complex lesions such as left main trunk, bifurcation, saphenous vein graft lesions, or in-stent restenosis, are still under evaluation with ongoing studies. With the availability of different types of DES in the market, the issue of cost should not be a deterrent and DES will eventually be an economically viable option for all patients. The adoption of DES in all percutaneous coronary intervention may become a reality in the near future. In this review article, we summarize the recent development and progress of DES as well as compare and update the results of clinical trials.

Evolution of vascular brachytherapy over time: Data from the RENO-registry analysis

Objective To study the evolution of procedural variations in vascular brachytherapy (VBT) and their relationship to medium-term outcome. Methods and Results The RENO (European Surveillance Registry with Novoste Beta-Cath™) prospectively collected procedural and clinical outcome data on 1098 patients treated with VBT. Patients were divided for this analysis into Group-I, the first 50% registered, and Group-II, the last 50% registered. Shorter 30-mm source trains were more commonly used in Group-I ( p<0.001) while longer 40-mm ( p=NS) and 60-mm ( p<0.001) source trains were more commonly used in Group-II. Mean dwell time for radiation seeds was longer in Group-II compared to Group-I (4.20±1.48 min vs. 4.14±1.44 min; p<0.05). Mean radiation dose was higher in Group-II (19.73±3.33 Gy vs. 17.92±2.68 Gy; p<0.001). Cutting balloons were more frequently used in Group-II ( p<0.001). There was significant drop in the incidence of geographic miss in Group-II (3.2% vs. 9%; p<0.00005). There were nonsignificant trends towards reduction in angiographic restenosis, target vessel (TV) revascularisation, death and major adverse cardiac events (MACE). Conclusion There has been a learning curve and evolution of VBT techniques over time. In general, there has been an increase in radiation source length, use of cutting balloons, dwell time and radiation dose. This has resulted in significant reduction of geographic miss and a trend towards improve clinical outcomes. Continued development may result in further improvement in the treatment of patients with in-stent restenosis (ISR).

Effect of bare metal stenting on angiographic and clinical outcomes in diabetic and nondiabetic patients undergoing percutaneous coronary intervention of nonacute occluded coronary arteries: A report from the total occlusion study of Canada (TOSCA)

The outcome after PTCA and coronary stenting of nonacute total coronary occlusions in the diabetic population is unknown. The main objective of the present report was to compare the angiographic and 1-year clinical outcomes in the diabetic and nondiabetic patients who were enrolled in the Total Occlusion Study of Canada (TOSCA), a prospective randomized controlled multicenter trial of primary stenting versus PTCA alone in nonacute native coronary artery occlusions. Of the 410 patients enrolled, 68 (16.5%) were diabetics. At 6-month follow-up, stenting resulted in significant improvement in angiographic outcome compared to PTCA alone in both diabetic and nondiabetic populations. Angiographic restenosis was significantly reduced by stenting in the nondiabetic population (69.3% vs. 55.2%; P = 0.009). A reduction in restenosis of a similar magnitude was observed with stenting in the diabetic population (71.1% vs. 59.3%; P = NS). At 1-year clinical follow-up, composite adverse cardiac event rates were similar for both strategies regardless of diabetic status. Target vessel revascularization was reduced by stenting compared to PTCA in diabetics (20% vs. 31.6%) and nondiabetics (21.5% vs. 30%). A significant reduction for any vessel revascularization following stenting compared to PTCA was observed in the nondiabetic population (28.5% vs. 38.8%; P = 0.05) but not in the diabetic subgroup (36.7% vs. 42%; P = NS). In conclusion, stenting appeared to be superior to PTCA alone, resulting in similar magnitude of reduction in angiographic restenosis and target vessel revascularization rates in diabetics and nondiabetics. Restenosis rates in all groups remain high. This analysis forms an important background for future studies that are needed to examine the effect of stenting with drug-eluting stents in diabetics as well as nondiabetics with nonacute coronary occlusions.

Diabetes, Coronary Intervention, and Platelet Glycoprotein IIb/IIIa Blockade

Diabetes mellitus is associated with inferior outcome after percutaneous coronary intervention (PCI).1 Platelet glycoprotein IIb/IIIa (GP IIb/IIIa) inhibition is an important adjunctive therapy during PCI and may be particularly so in patients with diabetes mellitus.2 Platelet GP IIb/IIIa inhibitors are potent antithrombotic agents, and in several large-scale clinical trials with balloon angioplasty and coronary stenting, these agents have produced a consistent and marked reduction in both 30-day ischemic events and long-term (up to 1 to 3 years) mortality.3 In most cases, a greater magnitude of survival benefit with abciximab has been observed in patients with diabetes as compared with patients without diabetes.3–5 Furthermore, clinical risk stratification with diabetes and other variables reliably predicts abciximab benefit for late survival, thereby validating the important mortality benefits (nearly 3 lives saved per 100 patients treated) with abciximab use in high-risk patients during PCI.6 This large body of evidence has led to the widespread acceptance of platelet GP IIb/IIIa inhibitors to neutralize the excessive mortality associated with PCI among patients with diabetes as compared with patients without diabetes. See p 3627 The introduction of clopidogrel has changed the landscape of clinical outcomes in PCI. In patients with diabetes, clopidogrel has been shown to be superior to aspirin in reducing recurrent ischemic events.7 The use of preprocedural clopidogrel can attenuate the increase in C-reactive protein and other inflammatory markers after PCI, even in the presence of abciximab.8,9 Pretreatment with clopidogrel (300 to 600 mg) has been suggested to reduce ischemic events during PCI, and long-term (1 year) clopidogrel therapy has been shown to reduce long-term clinical events.10 Recently, the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment) study found no benefit with abciximab therapy versus placebo in low- and intermediate-risk patients undergoing PCI who …

Intracoronary irradiation for the prevention of restenosis

Restenosis after coronary angioplasty is a major limitation of an otherwise highly effective and safe procedure for the treatment of atherosclerotic coronary artery disease. Although the advent of coronary stenting has reduced restenosis rates for selected patients, an overall restenosis rate of 20% to 25% remains. Despite numerous trials, no effective pharmacologic therapy has been found. Intracoronary irradiation is a new technique proposed to prevent restenosis after angioplasty. In animal models of restenosis after balloon injury, there is marked reduction of neointimal proliferation when the injured vessel is irradiated, using a variety of radiation sources and delivery systems. Early human trials have underscored the importance of careful source calibration and dosimetry. A small, randomized, double-blind, placebo-controlled study of intracoronary irradiation to prevent recurrent restenosis recently reported striking reductions in angiographic restenosis as well as clinical event rates. A number of important issues remain unresolved, such as defining which component of the arterial wall serves as the target tissue for radiation, the minimal effective dose, the maximum tolerable dose, and user-friendly radiation delivery systems. Further studies are needed to define the safety, efficacy and the ultimate usefulness of intracoronary irradiation as an adjunct to current procedures in interventional cardiology.

Intracoronary irradiation for the prevention of restenosis

Restenosis after coronary angioplasty is a major limitation of an otherwise highly effective and safe procedure for the treatment of atherosclerotic coronary artery disease. Although the advent of coronary stenting has reduced restenosis rates for selected patients, an overall restenosis rate of 20% to 25% remains. Despite numerous trials, no effective pharmacologic therapy has been found. Intracoronary irradiation is a new technique proposed to prevent restenosis after angioplasty. In animal models of restenosis after balloon injury, there is marked reduction of neointimal proliferation when the injured vessel is irradiated, using a variety of radiation sources and delivery systems. Early human trials have underscored the importance of careful source calibration and dosimetry. A small, randomized, double-blind, placebo-controlled study of intracoronary irradiation to prevent recurrent restenosis recently reported striking reductions in angiographic restenosis as well as clinical event rates. A number of important issues remain unresolved, such as defining which component of the arterial wall serves as the target tissue for radiation, the minimal effective dose, the maximum tolerable dose, and user-friendly radiation delivery systems. Further studies are needed to define the safety, efficacy and the ultimate usefulness of intracoronary irradiation as an adjunct to current procedures in interventional cardiology.

Indications and Use of the Palmaz-Schatz Coronary Stent

Restenosis prevention has been the 'holy grail' of contemporary interventional cardiology. Even though balloon angioplasty has become the standard treatment for ischemic syndromes, it is still plagued by a definite incidence of restenosis. This recidivism has prompted the search for newer, catheter-based modalities of treatment to address this issue. The proliferation of newer devices for intervention has increased the number of options for the interventional cardiology; however, until recently, none has had a significant impact on restenosis. The randomized trials (STRESS and BENESTENT) have both shown a significant reduction in angiographic restenosis with the Palmaz-Schatz stent in de novo coronary lesions. Nonrandomized trials suggest additional benefit in saphenous vein bypass grafts.