Lower Risk Of Restenosis Research Articles

Identification of independent risk factors for restenosis following bare-metal stent implantation: Role of bare-metal stents in the era of drug-eluting stents

In the era of drug-eluting stents (DESs), the ability of clinicians to predict which patients have a low risk of coronary restenosis following bare-metal stent (BMS) implantion is likely to be of benefit. The study population consisted of 2,711 patients who underwent BMS implantation in 3,770 lesions between 1995 and 2004. With clinical and 6 month follow-up angiographic data, we retrospectively sought to identify the independent risk predictors of restenosis, applied a previously proposed prediction model and assessed the characteristics of patients with a low likelihood of coronary restenosis within 6 months of BMS implantation. A 6-month follow-up coronary angiography was performed in 65.0% of the patients who had undergone the BMS implantation and the rate of restenosis was 26.6%. Using multivariate analysis, diabetes [odds ratio (OR), 1.294; 95% confidence interval (CI), 1.094–1.483; P=0.005], current smoking (OR, 1.294; 95% CI, 1.094–1.483; P=0.002), a reference vessel diameter of <3.25 mm (OR, 1.238; 95% CI, 1.021–1.501; P<0.001), a lesion length of >30 mm (OR, 1.645; 95% CI, 1.336–2.026; P<0.001), ostial lesion (OR, 1.858; 95% CI, 1.437–2.402; P<0.001), post-stenting minimal luminal diameter (OR, 0.576; 95% CI, 0.484–0.685; P<0.001) and bifurcation lesion (OR, 1.353; 95% CI, 1.070–1.711; P=0.012) were identified as significant independent predictors of restenosis. However, the accuracy of the prediction obtained with the current model, which used the clinical and angiographic variables correlated with the risk of restenosis, was poor. Various clinical and angiographic independent risk variables were revealed to be correlated with the risk of restenosis following BMS implantation in the present large dataset. Certain groups of patients with a relatively low risk of restenosis may be considered for BMS implantation as an alternative to DESs. However, the prediction models used at present are incomplete and further studies are required.

Does Flow During Rest and Relaxation Suffice?

Andreas Gruentzig first reported that a pressure gradient ≤15 mm Hg after percutaneous coronary angioplasty is associated with a lower risk of restenosis ([1][1]). Several years later, in the mid 1980s, Pijls et al. ([2][2]) and Tonino et al. ([3][3]) introduced fractional flow reserve (FFR),

Clinical outcomes after bare‐metal stenting in diabetic patients with lesions carrying a low risk of restenosis

To evaluate the clinical results of diabetic patients undergoing percutaneous coronary intervention (PCI) for coronary artery lesions carrying a low risk of restenosis treated with a bare-metal stent (BMS). There is a discrepancy between current international guidelines on the use of BMS in diabetics with low risk of restenosis coronary artery lesions. Registry data from diabetic patients who underwent non-urgent PCI in a high-volume tertiary referral hospital in the Netherlands was used. The main outcomes were target lesion revascularization (TLR) and the composite of cardiac death, myocardial infarction, and target vessel revascularization at 1-year of follow-up. A total of 1,951 patients were included, of which 1,596 non-diabetics (non-DM), 231 non-insulin requiring diabetics (NIRDM), and 124 insulin requiring diabetics (IRDM).TLR rates in non-DM versus NIRDM were similar (6.3% vs. 5.6%; P = 0.68), whereas TLR in IRDM was higher (6.3% vs. 11.3%; P = 0.03). The composite of cardiovascular clinical outcomes was not significantly different in non-DM versus NIRDM (9.5% vs. 13.4%; P = 0.07), though in IRDM the incidence was higher (9.5% vs. 17.7%; P < 0.01). No differences were observed in TLR or composite clinical endpoint at 1-year between non-DM and NIRDM after BMS placement in coronary artery lesions carrying a low risk of restenosis. The presence of IRDM was associated with higher TLR rates when treated with BMS. These results imply that BMS placement may be considered in patients with NIRDM but further work is required to define treatment strategies and, more importantly, improve the outcomes in diabetics.

Stent choice and the hidden consequences of cost savings

Amin and colleagues have attempted to estimate the cost savings to the US health-care system if drug-eluting coronary stents were more selectively used in patients at low risk of restenosis. Their results and conclusions raise statistical, societal, and ethical issues that need to be considered before this approach should be widely embraced.

Use of Drug-Eluting Stents as a Function of Predicted Benefit

Benefits of drug-eluting stents (DES) in percutaneous coronary intervention (PCI) are greatest in those at the highest risk of target-vessel revascularization (TVR). Drug-eluting stents cost more than bare-metal stents (BMS) and necessitate prolonged dual antiplatelet therapy (DAPT), which increases costs, bleeding risk, and risk of complications if DAPT is prematurely discontinued. Our objective was to assess whether DES are preferentially used in patients with higher predicted TVR risk and to estimate if lower use of DES in low-TVR-risk patients would be more cost-effective than the existing DES use pattern. We analyzed more than 1.5 million PCI procedures in the National Cardiovascular Data Registry (NCDR) CathPCI registry from 2004 through 2010 and estimated 1-year TVR risk with BMS using a validated model. We examined the association between TVR risk and DES use and the cost-effectiveness of lower DES use in low-TVR-risk patients (50% less DES use among patients with <10% TVR risk) compared with existing DES use. There was marked variation in physicians' use of DES (range 2%-100%). Use of DES was high across all predicted TVR risk categories (73.9% in TVR risk <10%; 78.0% in TVR risk 10%-20%; and 83.2% in TVR risk >20%), with a modest relationship between TVR risk and DES use (relative risk, 1.005 per 1% increase in TVR risk [95% CI, 1.005-1.006]). Reducing DES use by 50% in low-TVR-risk patients was projected to lower US health care costs by $205 million per year while increasing the overall TVR event rate by 0.5% (95% CI, 0.49%-0.51%) in absolute terms. Use of DES in the United States varies widely among physicians, with only a modest correlation to patients' risk of restenosis. Less DES use among patients with low risk of restenosis has the potential for significant cost savings for the US health care system while minimally increasing restenosis events.

Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

BackgroundThe safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry. MethodsThe Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression. ResultsA total of 13,577 stents (Promus Element, n=2724, Cypher, n=782; Endeavor, n=747; Taxus Liberté, n=1393, Xience V/Promus, n=4832, Resolute, n=1566, Xience Prime, n=4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR:1.17, 95% CI: 0.75–1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26–0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025–1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08–0.67). ConclusionsIn a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST.

Determination of the cut-off plasma adiponectin level associated with a lower risk of restenosis in patients with stable angina

Hypoadiponectinemia is an independent predictor for the progression of coronary artery disease (CAD); however, the importance of plasma adiponectin levels in the midterm clinical outcome in patients with CAD who underwent percutaneous coronary intervention (PCI) has not been fully elucidated. The purpose of this study was to investigate the association between plasma adiponectin levels and midterm clinical outcome in patients with CAD who underwent PCI. A total of 112 patients (120 lesions) with stable angina who underwent PCI under intravascular ultrasound guidance, and who underwent follow-up coronary angiography about 8 months after PCI from August 2004 to December 2009 were enrolled in this study. Plasma adiponectin levels were significantly lower in the group with restenosis (n=13) than in the group without restenosis (n=107) (4.2±1.5 vs. 6.8±4.9 μg/ml, P<0.0001). A two-graph receiver operating characteristic curve analysis indicated that the cut-off point of adiponectin was 6.0 μg/ml. Although plasma adiponectin levels were independent of well-known risk factors of CAD, a multivariate logistic regression analysis indicated that the higher adiponectin group (patients with hyperadiponectinemia) was independently associated with lower risk of restenosis (odds ratio=0.21, 95% confidence interval=0.03-0.82). Hyperadiponectinemia (plasma adiponectin levels ≥6.0 μg/ml) is independently associated with a lower risk of restenosis. Thus, the plasma adiponectin level may be useful as a marker of restenosis independent of preinterventional intravascular ultrasound variables.

TCT-86: Similar Target Lesion Revascularization In Non-insulin Dependent Diabetic Compared with Non-diabetic Patients After Bare Metal Stenting In Lesions Carrying a Low Risk Of Restenosis

TCT-86: Similar Target Lesion Revascularization In Non-insulin Dependent Diabetic Compared with Non-diabetic Patients After Bare Metal Stenting In Lesions Carrying a Low Risk Of Restenosis

Percutaneous coronary intervention of unprotected left main coronary artery disease

Data have emerged demonstrating the safety and efficacy of percutaneous coronary intervention (PCI) of the unprotected left main (ULM) artery. The 2009 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions focused guidelines for PCI no longer state that ULM PCI is contraindicated in patients with anatomic conditions that are associated with a low risk of procedural complications and clinical conditions that predict an increased risk of adverse surgical outcomes. ULM PCI should be performed by operators with experience in the management of the anatomic complexities of left main and multivessel disease, specifically in issues relating to bifurcation disease, calcification, and hemodynamic support. Patients with ostial or shaft disease have lower risk of restenosis compared with distal bifurcation disease. Drug-eluting stents (DES) should be used whenever possible as they reduce clinical restenosis. Intravascular ultrasound is an integral component of the procedure as it provides accurate assessment of lesion severity and can confirm optimal stent expansion and apposition. Compliance with dual antiplatelet therapy for at least 12 months is essential if DES are used. A collaborative, multidisciplinary approach with a "Heart Team" represented by a cardiac surgeon, interventional cardiologist, and non-invasive cardiologist may optimize patient education and objective decision making when obtaining informed consent. Application of clinical and angiographic variables into risk models facilitates appropriate patient selection. Randomized clinical trials will address unanswered issues and help build consensus between cardiology and surgical societies to inform clinical decision making and optimize the outcomes for patients with ULM coronary artery disease.

Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3mm and lesion length ≤15mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0mm or lesion length >15mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p=0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

A retrospective analysis of consecutive patients undergoing nonurgent percutaneous coronary intervention comparing bare metal stents with drug-eluting stents using the National Institute for Clinical Excellence criteria

In the National Institute for Clinical Excellence (NICE) guidelines, lesions with a reference vessel diameter of less than 3.0 mm or lesions with a length of greater than 15 mm are considered carrying a high risk of restenosis. In contrast, lesions with a reference vessel diameter of at least 3.0 mm or a lesion length of 15 mm or less are considered at low risk of restenosis. We performed a retrospective analysis of consecutive patients undergoing nonurgent percutaneous coronary intervention (PCI) comparing bare metal stent (BMS) with drug-eluting stent (DES) using the NICE guidelines. Between 2003 and 2007, a total of 3883 patients underwent a nonurgent PCI for a de-novo coronary lesion; 2050 patients were considered to be at low risk and 1833 patients were considered at high risk of restenosis according to the NICE criteria. In the low-risk group, the 1-year composite of cardiac death, myocardial infarction, and target vessel revascularization was 10.5% in the BMS group and 11.1% in the DES group (P=0.85). Target lesion revascularization (TLR) was 5.3% by PCI and 1.6% by coronary artery bypass grafting (CABG) in the BMS group and 4.0 and 3.0% in the DES group (P=0.59 and P=0.24). In the high-risk group, the composite of cardiac death, myocardial infarction, and target vessel revascularization was 12.1 and 11.0% in the BMS and DES groups (P=0.48). TLR was 6.7% by PCI and 1.3% by CABG in the BMS group and 3.9 and 2.8% in the DES group (P=0.01; P=0.02). Definite stent thrombosis (ST) was 0.8% in the BMS-treated patients and 1.7% in the DES-treated patients (P=0.09). In patients with lesions carrying a low risk of restenosis, no differences were observed between BMS and DES in composite end points, TLR, or ST at 1-year follow-up. In patients with lesions carrying a high risk of restenosis, patients treated with BMS had a significantly higher rate of TLR by PCI, but a significantly lower rate of TLR by CABG compared with patients treated with DES. A nonsignificant lower rate of definite ST was observed in the BMS group compared with the DES group.

Design and rationale of the TRI-stent Adjudication Study (TRIAS) Program

In the treatment of coronary artery disease, a "pro-healing" approach for prevention of in-stent restenosis and late stent thrombosis is intuitively favored over the use of cytotoxic or cytostatic drugs released from a drug-eluting stent (DES). Promoting accelerated endothelial coverage of the stent surface, the endothelial progenitor cell (EPC) capturing stent has shown its safety and efficacy in the HEALING observational studies; however, randomized trials evaluating the device are lacking. The multicenter, randomized, controlled, 2-armed TRIAS program aims to include a total of 2560 patients. In the TRIAS Low Risk trial, a total of 1300 patients with lesions carrying a low risk of restenosis are randomized between the EPC capturing stent and a bare metal stent, assuming superiority in the incidence of target lesion failure (TLF) at 1 year. In the TRIAS High Risk trial, 1260 patients with lesions carrying a high risk of restenosis are randomized, assuming the noninferiority in TLF at 1 year of the EPC capturing stent as compared to DES. TLF is defined as the composite of cardiac death, myocardial infarction, and clinically driven target lesion revascularization. In addition, the duration of clinical follow-up is extended to 5 years to capture late events. Angiographic follow-up at 13 months is performed as part of the TRIAS Program ancillary study. The results of the TRIAS Program will provide information on a relevant patient population with coronary artery lesions, comprising the full spectrum of low risk and high risk of restenosis treated with a novel stent technology in a randomized, controlled manner (TRIAS Low Risk trial: ISRCTN 47701105 and TRIAS High Risk trial: ISRCTN 74297220).

Outcome of patients treated by a novel thin‐strut cobalt‐chromium stent in the drug‐eluting stent era: Results of the SKICE (Skylor in real world practice) registry

To investigate the outcome of patients undergoing percutaneous coronary interventions (PCI) with implantation of a new thin-strut cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. Despite the contemporary penetration of DES in the clinical practice, a relevant percentage of patients are still treated by BMS. Data on clinical outcome of novel BMSs are lacking. This is a single-centre-registry enrolling patients treated by Skylor stent implantation. During the study, the criteria for BMS selection adopted at our institution ("internal" criteria) were as follows: (1) limited compliance to prolonged double antiplatelet therapy, (2) ST-elevation myocardial infarction (STEMI) or saphenous vein grafts (SVG) interventions, and (3) in the absence of these conditions, noncomplex (no bifurcations, no chronic total occlusions) lesions considered at low restenosis risk on the basis of arbitrary angiographic criteria (short lesions, large vessels). Primary and secondary end-points were respectively major adverse cardiovascular events (MACE) and target vessel failure (TVF) up to 9-month. A total of 150 patients were treated with Skylor stent on 169 lesions. At 9-month follow-up, MACE occurred in 12 patients (8.0%) and TVF in 21 lesions (12.4%). By multivariable analysis, the predictors of MACE were Euroscore>or=9 and ejection fraction < 30% while the predictors of TVF were the absence of the angiographic criteria of low restenosis risk and ejection fraction < 30%. In the DES era, the use of a last-generation BMS in patients with limited compliance to double antiplatelet therapy, STEMI or SVG interventions, and noncomplex angiographic lesions may be associated with acceptable clinical outcome.

Does surgical correction of coarctation of the aorta in adults reduce established hypertension?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether surgical correction of coarctation of the aorta in adults (>16 years) results in reduction in established hypertension. Altogether 484 relevant papers were identified using the below mentioned search, 11 papers represented the best evidence to answer the question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. We conclude that surgical repair of coarctation of the aorta in adult patients is superior to conservative management in the reduction of established hypertension, with one meta-analysis and several retrospective reviews reporting low morbidity and low risk of re-stenosis. The reduction in blood pressure postoperatively has been demonstrated consistently, with most patients reported as normotensive without medication and the remainder having reduced requirements for antihypertensive medications. In all the papers included here (except one), there was no early mortality and no procedure-related late mortality during mean follow-up ranging from 2 to 14 years. Thus, surgical correction of aortic coarctation is a relatively safe procedure.

Effectiveness of Drug-Eluting Stents in Real-World Patients

DRUG-ELUTING STENTS ARE A MAJOR ADVANCE IN PERcutaneous coronary intervention (PCI) because they reduce the need for repeat target lesion revascularization several-fold compared with bare-metal stents. Early randomized clinical trials separately testing sirolimus-eluting stents and paclitaxel-eluting stents against their bare-metal counterparts demonstrated that rates of target lesion revascularization were reduced from approximately 10% to 15% to approximately 4% to 5%, whereas the rates of death, myocardial infarction, and stent thrombosis were similar between bare-metal and drug-eluting stents. Because these studies were performed for device regulatory approval, they enrolled patients and lesions with relatively low risk for restenosis and adverse events. Subsequent head-to-head trials of sirolimusand paclitaxel-eluting stents in cohorts with a broader risk profile have provided inconsistent results; some trials have suggested equivalent rates of target lesion revascularization for these stents, whereas others have reported superiority of sirolimus-eluting stents. Initial clinical trials in any area of medicine are primarily designed to test efficacy (ie, is the drug or device beneficial under ideal conditions?) rather than to test effectiveness or relevance (ie, is the drug or device beneficial in everyday practice?). Phase 4 (postapproval) studies are expected to be conducted to help bridge this gap while monitoring safety. The sirolimus-eluting stent was the first to become clinically available, and early postapproval data from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry showed that the unrestricted use of sirolimus-eluting stents in the real world was safe and effective in reducing target lesion revascularization as well as major adverse cardiac events at 1 year compared with bare-metal stents—findings similar to the regulatory approval studies. Subsequently, observational data from the Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry suggested that the unrestricted use of paclitaxel-eluting stents was safe and associated with a similar adjusted outcome when indirectly compared with sirolimus-eluting stents. There was an “inferior trend” in crude outcome observed with paclitaxel-eluting stents—although this finding was attributed to higher-risk characteristics among patients receiving such stents, since practice had become comfortable with a wider application of drug-eluting stents over time. Thereafter, a number of small, direct-comparison trials were reported, with most individually observing a similar outcome for patients receiving sirolimusvs paclitaxeleluting stents. On the other hand, a meta-analysis of 16 such randomized head-to-head trials determined sirolimuseluting stents to be superior to paclitaxel-eluting stents with regards to target lesion revascularization and stent thrombosis. Likewise, a collaborative network meta-analysis of 38 trials including 18 023 patients and having a follow-up of up to 4 years also suggested that sirolimus-eluting stents provided a clinical advantage over paclitaxel-eluting stents. The discordance in findings among some trials and subsets of patients (eg, those with diabetes) has been confusing and challenging to interpret. In this issue of JAMA, Galloe and colleagues aim to add clarity and relevance to the issue by comparing outcome among patients randomized to receive sirolimusvs paclitaxel-eluting stents in a study design reflecting everyday clinical practice by including unselected patients and by using symptom-driven clinical end points. They report in this large-scale practical randomized trial that there were no significant differences in clinical outcomes between patients receiving sirolimusand paclitaxel-eluting stents. Their preliminary data were included in the recent meta-analyses and can now be further examined. A noteworthy feature of the study by Galloe et al is that it is the largest randomized direct comparison of these drug-eluting stents; yet with low event rates and the challenges presented by enrollment of all-comers, it has several limitations that need to be considered. First, the study randomized less than a third (27.7%) of potentially eligible patients, which suggests that the cohort may not be as unselected as the authors intended. This raises some concern of selection bias and generalizability of the results and is compounded by the observation that clinical outcomes were worse among patients who were eligible for en-

Drug-Eluting Stent Update 2007

Randomized trials have largely demonstrated that percutaneous coronary intervention (PCI) with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) results in a significant reduction in the occurrence of angiographic restenosis and revascularization compared with bare metal stents (BMS).1–4 The benefit of drug-eluting stents (DES) also has been confirmed in “real-world” scenarios. In this setting, when the analysis was focused on high-risk patient and lesion subgroups, a benefit still existed despite the presence of restenosis.5–7 These expanded indications do not yet cover many other types of complex lesions for which only registries or randomized trials, not yet published, are available so far (Tables 1 through 7⇓⇓⇓⇓⇓⇓). This topic is discussed in detail in this review. An important clarification is that the lack of proof is most probably due to the difficulty in performing randomized trials in high-risk groups using BMS as controls. It will be no surprise to find that the field in which DES perform best compared with BMS is likely to be complex lesions and patients8 (Figure 1). View this table: TABLE 1. DES in Unprotected Left Main Stenosis View this table: TABLE 2. DES in Bifurcation Lesions View this table: TABLE 3. DES in Chronic Total Occlusions View this table: TABLE 4. DES in Small-Vessel Disease and Long Lesions View this table: TABLE 5. DES in SVGs View this table: TABLE 6. DES in Acute MI View this table: TABLE 7. DES in Multivessel Disease Figure 1. Lesion complexity and stent performance in the BMS and DES eras. Adapted from Edelman et al.8 Current American Heart Association/American College of Cardiology (AHA/ACC) and European Society of Cardiology (ESC) guidelines consider the presence of a stenosis in the unprotected left main coronary artery (LMCA) a class IIa or IIb indication, respectively, for PCI if coronary artery bypass grafting (CABG) is not a viable option.9,10 Moreover, according to the AHA/ACC 2005 guidelines, in …

Stenting des bifurcations

The optimal treatment of coronary bifurcation lesions remains a challenging theoretical and technical area for percutaneous coronary intervention. Questions remain unanswered regarding the optimal technique and devices to be used in order to achieve and maintain a safe and effective clinical result. Many studies or registries have shown that treatment of bifurcation lesions with drug eluting stents was associated with a lower risk of restenosis and reintervention. An increased risk of drug eluting stent thrombosis in bifurcation lesions has been shown but it seems that it is more related to a problem of optimal treatment than bifurcation or drug eluting stent by itself. Today there is a consensus for a “provisional side branch stenting approach with final kissing balloon inflation” and the remaining question is when and how to stent the side branch. Dedicated devices are now emerging as new tools which may solve some technical problems and improve the quality and reproducibility of treatment.

Do the Majority of Patients Receive Drug-Eluting Stents in Australian Private Hospitals In Contemporary Practice?

Background: The benefit of drug-eluting stents (DES) in reducing the need for repeat percutaneous coronary intervention (PCI) may be limited in patients with a low risk of restenosis. Also, it emerged in September 2006 that there may be increased risk of late stent thrombosis with DES. The aim of this study was to assess the contemporary use of DES in the Australian private health system.

Sirolimus-Eluting Stents vs Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease: Meta-analysis of Randomized Trials

CONTEXT: Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear. OBJECTIVE: To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. DATA SOURCES: PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005. STUDY SELECTION: Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months. DATA EXTRACTION: Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest. DATA SYNTHESIS: Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23). CONCLUSIONS: Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.

Drug-Eluting Stents Compared With Thin-Strut Bare Stents for the Reduction of Restenosis: A Prospective, Randomized Trial

Aim Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (Cypher™) as compared with that of bare stents with thin struts (BeStent™ 2). Methods and results A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter ≥50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19–0.56), P <0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22–0.66), P <0.001]. For smaller vessels (<2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent ( P <0.001). For larger vessels (≥2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent ( P =0.52). Conclusion The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.