Incidence Of Target Vessel Revascularization Research Articles

E0499 Long term clinical follow-up of patients with versus without overlapping drug eluting stents for long coronary lesions

BackgroundDrug-eluting stents (DSE) markedly reduce the rate of in stent restenosis, but limited data exists as to the long-term outcome in patients with long coronary lesions (≥40 mm) undergoing multiple...

Long-Term Prognostic Value of Preprocedural C-Reactive Protein After Drug-Eluting Stent Implantation

C-reactive protein (CRP) elevation is associated with an adverse cardiovascular prognosis after bare metal stent implantation. Data have suggested a similar association between preprocedural CRP and adverse events after drug-eluting stent (DES) implantation. The present study was designed to address whether such a relation exists after DES placement. After excluding patients presenting with an acute coronary syndrome with troponin I elevation, we analyzed the data from 936 consecutive patients who had undergone DES implantation from 2003 to 2007 and had a preprocedural CRP measurement. The patients were divided into 3 groups according to the preprocedural CRP level (<1.31, 1.31-3.76, and >3.76 mg/L). The primary end point was the composite of death and Q-wave myocardial infarction (QWMI) at 2 years of follow-up. Target vessel revascularization was also assessed. The rate of death/QWMI was not significantly different statistically among the CRP tertiles during the in-hospital period (0.6% vs 0.0% vs 0.6%, p = 0.5) or at 1 year of follow-up (1.9% vs 2.9% vs 4.5%, p = 0.2). At 2 years, death/QWMI had occurred in 2.9% of patients in the lowest, 5.2% in the middle, and 8.8% in the highest tertile (p = 0.006). The incidence of target vessel revascularization was similar in the 3 groups at 2 years of follow-up (13.2% vs 14.9% vs 16.9%, p = 0.5). On multivariate analysis, the upper tertile of CRP was an independent predictor of death/QWMI at 2 years (hazard ratio 2.5, 95% confidence interval 1.1 to 5.4, tertile 3 vs tertile 1, p = 0.006). In conclusion, high preprocedural CRP levels are associated with an increased risk of death and QWMI after DES implantation at long-term follow-up but not acutely. The CRP levels were not related to target vessel revascularization. Thus, an elevated CRP level in this population appears to be more of a marker of global cardiovascular risk than a predictor of post-DES-related complications.

Safety of drug eluting stents in patients on chronic anticoagulation using long‐term single antiplatelet treatment with clopidogrel

Use of triple therapy with aspirin, clopidogrel, and anticoagulants significantly increases bleeding, thus drug eluting stents (DES) are usually avoided in patients requiring anticoagulation. We tested use of DES vs. BMS using a long-term therapy with clopidogrel only and anticoagulants in this group of patients. We enrolled 165 consecutive patients, 79 receiving DES (age 67 +/- 9 years, 84% with atrial fibrillation) and 86 receiving bare metal stents (BMS) (age 70 +/- 11 years, 71% with atrial fibrillation). All patients received aspirin + clopidogrel + oral anticoagulants for 4 weeks, then aspirin was stopped and clopidogrel was continued during the 12-month follow-up. Primary end point was the combined incidence of major adverse coronary events and major bleedings. Incidence of the primary endpoint was 10.1% in patients with DES and 26.7% in patients with BMS (P = 0.01). There was a large difference in incidence of target vessel revascularization (8.1% for DES, 23.3% for BMS, P = 0.01), whereas incidence of myocardial infarction (3.8% in DES vs. 8.1% in BMS) and major bleeding (1.3% vs. 2.3%, respectively) were not significantly different. There were no cases of stent thrombosis. On multivariate Cox regression analysis, the only factor associated with a reduced risk of the primary endpoint was use of DES (hazard ratio 0.35 with 95% confidence interval 0.14-0.85, P = 0.02). Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation.

Effect of Intensive Statin Therapy on Clinical Outcomes Among Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndrome: PCI-PROVE IT: A PROVE IT–TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) Substudy

The goal of this analysis was to determine whether intensive statin therapy, compared with moderate-dose statin therapy, leads to a reduction in major adverse cardiovascular events (MACE) among patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). When compared with moderate-dose statins, intensive statin therapy reduces MACE among patients with ACS. The role of intensive statin therapy specifically among patients who undergo PCI for ACS is unknown. Outcomes were compared in 2,868 patients who underwent PCI for ACS just prior to enrollment in the PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22) trial, which randomized patients to either atorvastatin 80 mg or pravastatin 40 mg daily. The incidence of the primary composite end point of all-cause mortality, myocardial infarction, unstable angina leading to hospitalization, and revascularization after 30 days and stroke was evaluated, as was the incidence of target vessel revascularization (TVR) and non-TVR during follow-up. Treatment with 80 mg atorvastatin reduced the incidence of the composite end point (21.5% vs. 26.5%, hazard ratio: 0.78, 95% confidence interval: 0.67 to 0.91, p=0.002) and lowered the incidence of both TVR (11.4% vs. 15.4%, p=0.001) and non-TVR (8.0% vs. 10.5%, p=0.017) compared with 40 mg pravastatin. After adjusting for on-treatment serum low-density lipoprotein cholesterol and C-reactive protein concentrations, the odds of TVR with high-dose statin therapy remained significant (odds ratio: 0.74, p=0.015) while the odds of non-TVR did not (odds ratio: 0.92, p=0.55). Among patients with ACS who undergo PCI, intensive statin therapy reduces MACE compared with moderate-dose statin therapy. The reduction in the incidence of TVR was independent of low-density lipoprotein cholesterol and C-reactive protein lowering and may therefore be due, at least in part, to a pleiotropic effect of high-dose statin therapy. (PROVE IT-TIMI 22; NCT00382460).

5-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation: Insights From a Patient-Level Pooled Analysis of 4 Randomized Trials Comparing Sirolimus-Eluting Stents With Bare-Metal Stents

Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials. A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents. In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870). At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001). In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144).

Noncardiac Surgery for Patients with Coronary Artery Stents

Physicians are increasingly being confronted with questions regarding the appropriate management of patients with recently implanted coronary stents who are in need of noncardiac surgery. Specifically, what is the optimal timing of elective procedures and how should antiplatelet therapy be managed in these patients, especially in those in need of emergent procedures? Continued antiplatelet therapy through the perioperative period might increase the risk of surgical bleeding while interruption of antiplatelet therapy predisposes to stent thrombosis, particularly in the setting of systemic hypercoagulation that frequently occurs after some surgeries.1 In this issue of Anesthesiology, two papers from the Mayo Clinic in Rochester, Minnesota provide further insight into these perplexing issues.2,3

Long‐Term Clinical Benefit of Sirolimus‐Eluting Stents Compared to Bare Metal Stents in the Treatment of Saphenous Vein Graft Disease

The purpose of this study was to evaluate the efficacy of sirolimus-eluting stents (SES) in the treatment of saphenous vein graft (SVG) disease. Percutaneous coronary intervention (PCI) of SVG lesions with bare metal stents (BMS) is associated with frequent in-stent restenosis, progression of disease in nonstented SVG segments, and suboptimal clinical outcomes. While SES have been shown to reduce restenosis rates in various native lesion subsets, the long-term clinical impact of SES use in SVG lesions is less clear. We compared our first 59 patients who underwent SES implantation in SVGs with 50 consecutive patients who received BMS in an equivalent time period prior to SES availability. Clinical outcomes were compared in both groups. Baseline clinical variables between the two groups were similar. Mean graft age in the SES cohort was older than that in the BMS cohort (12.9 years vs. 9.4 years). At follow-up, the SES group had a 24.6% absolute lower incidence of major adverse cardiac events (MACE) (25.4% vs. 50.0%), driven by a 20.7% absolute lower incidence of target vessel revascularization (TVR) (15.3% vs. 36.0%). The SES treatment group had a 24.1% lower rate of clinical restenosis (11.9% vs. 36.0%). The use of a SES was an independent negative predictor of MACE at a mean follow-up of 20 months (odds ratio [OR]= 0.48,P = 0.03). Despite the placement of longer stents in patients with older, smaller SVGs, the use of SES in the treatment of SVG lesions appears to be safe and is associated with less clinical restenosis and more favorable long-term clinical outcomes as compared with BMS.

Impact of renal insufficiency on clinical and angiographic outcomes following percutaneous coronary intervention with sirolimus‐eluting stents

Sirolimus-eluting stents (SES) have been demonstrated to reduce restenosis. However, there have been few studies evaluating the impact of renal insufficiency on the angiographic as well as clinical outcomes after SES implantation. This study was composed of 304 consecutive patients having 361 lesions who underwent percutaneous coronary intervention with SES. The patients were divided into 3 groups according to renal function (group 1 [n = 204]; creatinine clearance (Ccr) > or = 60 ml/min, group 2 [n = 69]; Ccr < 60 ml/min, group 3 [n = 31]; hemodialysis). Clinical and angiographic follow-up were evaluated at 8 months. Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 283 patients (93.1%). Patients in group 3 showed a higher incidence of previous coronary artery bypass graft surgery, and there were more female gender, hypertensive, and less hyperlipidemia in this group. Late lumen loss at 8 months was significantly different among the 3 groups (group 1; 0.16 +/- 0.46 mm, group 2; 0.44 +/- 0.62 mm, group 3; 0.81 +/- 0.88 mm, P < 0.0001). Major adverse cardiac events (MACE) were documented in 22 patients (10.8%) in group 1, 13 patients (18.8%) in group 2, and 12 patients (38.7%) in group 3, respectively (P = 0.0002). Neointimal growth following SES implantation is more pronounced in patients with renal insufficiency, especially those undergoing dialysis, compared with patients with normal renal function. Regardless of the beneficial effect of SES, the increased risk of MACE mainly due to high incidence of target vessel revascularization in the subgroup of patients with renal insufficiency should be taken into account.

Acute Coronary Syndrome May Occur With In-Stent Restenosis and Is Associated With Adverse Outcomes (The PRESTO Trial)

Patients with de novo acute coronary syndromes (ACSs) have a higher rate of adverse cardiac events and recurrent revascularization after percutaneous coronary interventions compared with patients who have stable angina. However, it is not known if an ACS presentation in patients with in-stent restenosis (ISR) is associated with a worse prognosis. Using the large PRESTO database of patients with ISR, we compared outcomes after successful percutaneous coronary intervention in 824 patients who presented with ACS with 617 patients who had stable angina. In-hospital and 9-month follow-up for myocardial infarction, target vessel revascularization, death, and a combined outcome of major adverse cardiac events (MACEs) were obtained. Follow-up angiographic results were also compared in those patients included in the angiographic substudy (140 patients with ACS and 99 with stable angina). Patients with ISR who presented with ACS were older and less often men, with higher incidences of diabetes, hypertension, tobacco use, previous coronary artery bypass graft surgery, and congestive heart failure. In-hospital complications were rare and similar in the 2 groups. At follow-up, patients with ACS had higher incidences of target vessel revascularization (33% vs 21%, p <0.001), MACEs (35% vs 22%, p <0.001), and angiographic restenosis (> or =50% narrowing, 56% vs 42%, p = 0.043). In multivariate analysis, after adjusting for baseline differences, an ACS presentation was associated with a higher incidence of long-term MACEs (odds ratio 1.66, 95% confidence interval 1.27 to 2.18, p <0.001). In conclusion, an ACS presentation in patients with ISR is associated with a higher incidence of recurrent adverse cardiovascular events and angiographic restenosis.

Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis: The Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study

The purpose of this study was to assess the role of oral rapamycin in decreased restenosis after bare metal stent implantation. Small observational studies suggest that the administration of oral rapamycin reduces angiographic restenosis after bare metal stent implantation. Between September 2003 and September 2004, 100 patients were randomized to either oral rapamycin (6-mg loading dose given 2.7 h before intervention followed by 3 mg/day for 14 days) plus diltiazem 180 mg/day or no therapy after the implantation of a coronary bare metal stent design. The primary study end point was incidence of angiographic binary restenosis and late loss at nine months. The secondary end points were target lesion revascularization, target vessel revascularization, and incidence of major adverse cardiovascular events at 1 year. Angiographic follow-up was completed in 87% of patients. In the rapamycin group, the drug was well tolerated (26% minor side effects) and was maintained in 96% of patients. At 9 months, the in-segment binary restenosis was reduced by 72% (11.6% rapamycin vs. 42.8% no-therapy group, p = 0.001) and the in-stent binary restenosis was reduced by 65% (12% rapamycin vs. 34.6% no-therapy group, p = 0.009). The in-segment late loss was also significantly reduced with oral therapy (0.66 vs. 1.13 mm, respectively; 43% reduction, p < 0.001). At 1 year, patients in the oral rapamycin group also showed a significantly lower incidence of target vessel revascularization (8.3% vs. 38%, respectively, p < 0.001), target lesion revascularization (7.6% vs. 37.2%, respectively, p < 0.001), and major adverse cardiovascular events (20% vs. 44%, respectively, p = 0.018). This randomized, controlled, and unblinded study showed that the administration of oral rapamycin during 14 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis.

Impact of Chronic Renal Insufficiency on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention With Sirolimus-Eluting Stents Versus Bare Metal Stents

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

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.

Sirolimus-Eluting Stent or Paclitaxel-Eluting Stent vs Balloon Angioplasty for Prevention of Recurrences in Patients With Coronary In-Stent Restenosis

In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis. To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent. Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003. After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group). Primary end point: angiographic restenosis (diameter stenosis > or =50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents. Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients. In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.

Impact of baseline renal function on mortality after percutaneous coronary intervention with sirolimus-eluting stents or bare metal stents

Renal impairment is an important predictor of mortality after percutaneous coronary intervention and may increase the restenosis rate. However, the relation between restenosis and the risk of death in patients who have renal impairment remains unclear. We evaluated the incidences of repeat revascularization and mortality in patients who had renal impairment and those who did not and who received sirolimus-eluting stents or bare stents. A total of 1,080 consecutive patients treated for 1 year had available data to calculate baseline creatinine clearance. Patients received bare stents (first 6 months, n = 543) or sirolimus-eluting stents (last 6 months, n = 537) and were grouped according to the presence or absence of renal impairment (creatinine clearance <60 ml/min). Patients who had renal impairment had a higher mortality rate at 1 year (7.6% vs 2.5%, hazard ratio 3.14, 95% confidence interval 1.68 to 5.88, p <0.01), with no differences in mortality between patients who received bare stents and those who received sirolimus-eluting stents (hazard ratio 0.91, 95% confidence interval 0.49 to 1.68, p = 0.8). The incidence of target vessel revascularization decreased significantly in patients who were treated with sirolimus-eluting stents and did not have renal impairment (hazard ratio 0.59, 95% confidence interval 0.39 to 0.90, p = 0.01) and in those who had decreased renal function (hazard ratio 0.37, 95% confidence interval 0.15 to 0.90, p = 0.03). Thus, sirolimus-eluting stents compared with conventional stents decreased clinical restenosis in patients who had renal impairment. However, this benefit was not paralleled by a decrease in the risk of death in this population. It seems unlikely that restenosis could be a contributing factor that influenced the increased mortality of patients who had impaired renal function.

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 …

Optimal glycemic control is associated with a lower rate of target vessel revascularization in treated type II diabetic patients undergoing elective percutaneous coronary intervention

ObjectivesWe examined the association between glycemic control determined by preprocedural hemoglobin A1c (A1c) and the incidence of target vessel revascularization (TVR) in diabetic patients undergoing elective percutaneous coronary intervention (PCI). BackgroundPatients with diabetes mellitus (DM) have increased rates of restenosis and a worse clinical outcome after PCI than patients without DM. MethodsA total of 239 patients (60 without DM and 179 with DM) were enrolled in this study. Optimal glycemic control was defined as A1c ≤7%, and suboptimal control was defined as A1c >7%. Follow-up was performed at six and 12 months after the index intervention. ResultsDiabetic patients with optimal glycemic control had a rate of 12-month TVR similar to that of nondiabetic patients (15% vs. 18%, p = NS). Diabetic patients with A1c >7% had a significantly higher rate of TVR than those with A1c <7% (34% vs. 15%, p = 0.02). In a multiple logistic regression analysis, A1c >7% was a significant independent predictor of TVR (odds ratio 2.87, 95% confidence interval 1.13 to 7.24; p = 0.03). Optimal glycemic control was associated with a lower rate of cardiac rehospitalization (15% vs. 31%, p = 0.03) and recurrent angina (13% vs. 37%, p = 0.002) at 12-month follow-up. ConclusionsIn diabetic patients undergoing elective PCI, optimal glycemic control (A1c ≤7%) is associated with a lower rate of TVR, cardiac rehospitalization, and recurrent angina. These data suggest that aggressive treatment of DM to achieve A1c ≤7% is beneficial in improving the clinical outcome after PCI.

Drug-eluting stents: cost versus clinical benefit.

The publication in January 2001 of the first-in-man results showing zero restenosis after sirolimus-eluting stent implantation produced enormous excitement in the cardiological community.1 The long-awaited tool—a safe, restenosis-proof, easy-to-use stent—had been found. It was not too long thereafter that paclitaxel-eluting stents also demonstrated their capability to decrease restenosis. Today, both sirolimus- and paclitaxel-eluting stents have been shown in randomized trials to reduce restenosis as compared with conventional metallic stents (Figure 1).2–6 Most of these studies have been recently released in the form of abstracts during medical meetings and are still unpublished.3,5,6 In addition to sirolimus and paclitaxel, other agents have shown promising early results in recent studies, enlarging the body of evidence demonstrating the potential benefits of what are known as drug-eluting stents.7 Regulatory agencies have been very active in evaluating some of these devices in the United States, Europe, South America, and Asia. The sirolimus-eluting stent has been available for routine use in Europe, South America, and Asia since the first half of 2002 and received approval from the US Food and Drug Administration to be marketed in April 2003. Paclitaxel-eluting stents have also received CE (Conformite Europeenne) marking for commercialization in Europe and are now beginning to be commercialized. Figure 1. Randomized trials showing reduction of binary restenosis with drug-eluting stents.2–6 The case seemed to be closed. Restenosis, the Achilles’ heel of percutaneous revascularization, appeared defeated. However, since the sirolimus-eluting stents became available, very little has changed in the everyday life of almost all interventional laboratories in Europe. Why? Has the new treatment presented any undesirable effect? Was the desire to defeat restenosis not as great as supposed? The answer is none of the above. The limitation currently impeding more widespread use of the new technology is nontechnical, nonmedical, and nonbiological. The …

Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial

ObjectivesWe tested the hypothesis that thinner-strut stents are associated with a reduced rate of restenosis when comparing two stents with different design. BackgroundWe have previously shown that, for two stents with similar design, the risk for restenosis is dependent on the strut thickness. It is unknown whether strut thickness preserves its relevance as a determinant of restenosis even in the presence of different stent designs. MethodsA total of 611 patients with symptomatic coronary artery disease were randomly assigned to receive either the thin-strut ACS RX Multilink stent (Guidant, Advanced Cardiovascular Systems, Santa Clara, California) (strut thickness 50 μm, interconnected ring design; n = 309) or the thick-strut BX Velocity stent (Cordis Corp., Miami, Florida) (strut thickness 140 μm, closed cell design; n = 302). The primary end point was angiographic restenosis (≥50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of target-vessel revascularization (TVR) and the combined rate of death and myocardial infarction (MI) at one year. ResultsThe incidence of angiographic restenosis was 17.9% in the thin-strut group and 31.4% in the thick-strut group, relative risk, 0.57 (95% confidence interval, 0.39 to 0.84), p < 0.001. A TVR due to restenosis was required in 12.3% of the thin-strut group and 21.9% of the thick-strut group, relative risk, 0.56 (95% confidence interval, 0.38 to 0.84), p = 0.002. No significant difference was observed in the combined incidence of death and MI at one year. ConclusionsWhen two stents with different design are compared, the stent with thinner struts elicits less angiographic and clinical restenosis than the thicker-strut stent.

Long-term clinical outcomes after coronary angioplasty using long stents in small coronary vessels.

The role of coronary stenting in challenging situations, such as small vessels and long lesions, remains controversial. The aim of this study was to examine the procedural, in-hospital, and long-term clinical outcomes of patients undergoing angioplasty with long stents in small coronary vessels. We evaluated the procedural success rate and clinical outcomes in 252 consecutive subjects treated by means of the implantation of a single coronary stent in vessels with a mean reference diameter of < 2.5 mm; 128 patients received a short stent (< or = 16 mm) and 124 a long stent (> or = 18 mm). Lesion morphology was more complex in patients treated with long stents (P < 0.05). The mean stent length was 14 +/- 2 mm in the short-stent group and 25 +/- 3 mm in the long-stent group (P < 0.001). The overall procedural success rate (98.4% vs. 97.6%; P = NS) and the rate of major in-hospital adverse events (death, acute myocardial infarction, or target vessel revascularization; 1.6% vs. 2.4%; P = NS) was similar in the two groups. After 11.7 +/- 7 months of follow-up, there was no difference in the incidence of mortality and myocardial infarction (5% vs. 6.6%; P = NS), but revascularization tended to occur more frequently in the patients treated with long stents (21.7% vs. 13.9%; P = NS). In conclusion, the procedural success rate of single short or long stents in small coronary vessels was similar. Although the incidence of target vessel revascularization tended to be higher in the patients treated with longer stents, 2-year event-free survival was equivalent in the two groups (65% vs. 70%; P = NS).

Short- and long-term outcomes of compromised side branches after Multi-Link stent implantation.

The Multi-Link stent is superior to other stents in terms of low rates of restenosis and target vessel revascularization. However, few data exist regarding short- and long-term outcomes for side branches after stenting. We evaluated short and long clinical outcomes and angiographic predictors of side-branch occlusion after the deployment of 137 Multi-Link stents. Thirty-four (25%) of the 137 side branches occluded immediately after stenting. We attempted reangioplasty for the side branches and our success rate was 85%. The incidence of side branches with intrinsic ostial disease was more than 50% before stenting and origination from the stented midsegment was a powerful angiographic predictor of side-branch occlusion. Side-branch patency is well maintained long-term. The incidence of restenosis within and near the stented segment of the parent vessel was 19%, and the incidence of target vessel revascularization was 15%. We recommend the use of Multi-Link stents regardless of the presence of side branches in the vicinity of the stenosis.