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Roxana Mehran

Publications and source records attributed to Roxana Mehran.

At least 37 records · Page 2Linked to original sources
PubMed2006

Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: results from the FIRE trial.

BACKGROUND: The filter-based FilterWire EX (Boston Scientific, Natick, MA) embolic protection system and the GuardWire (Medtronic, Santa Rosa, CA) balloon occlusion and aspiration device have been previously shown to reduce periprocedural complication rates of percutaneous coronary intervention for saphenous vein graft (SVG) disease and are considered the standard of care in this setting. The late clinical course after treatment with these devices has not been reported. METHODS: In the FIRE trial, 651 patients undergoing SVG intervention were randomized to either the FilterWire EX or GuardWire. Six-month rates of the primary end point (composite major adverse cardiac events [MACE]) and its components (death, myocardial infarction [MI], or target vessel revascularization) were studied. RESULTS: MACE at 30 days occurred in 9.9% of patients randomized to the FilterWire EX compared with 11.6% with the GuardWire, P = .53. By 6 months, MACE had increased to 19.3% and 21.9% in FilterWire EX and GuardWire groups, respectively, (relative risk 0.88, 95% CI 0.65-1.19; P = .44). All-cause 6-month mortality in the entire population was 3.5% (3.0% with FilterWire EX vs 4.1% with GuardWire, P = .53, with all deaths occurring after hospital discharge). MI occurred in 12.0% of patients at 6 months (12.1% vs 11.9% with the FilterWire EX and GuardWire, respectively, P = .99), and target vessel revascularization was required in 9.1% (8.2% vs 10.0%, respectively, P = .42). CONCLUSIONS: SVG intervention with the FilterWire EX and GuardWire distal protection devices resulted in similar outcomes at 6 months, although the clinical course after hospital discharge was not benign, with significant rates of death, MI, and repeat intervention.

Aged↗
PubMed2006

A multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting.

OBJECTIVES: The objective of this double-blind, randomized study was to determine the safety and efficacy of intracoronary radiation therapy (ICRT) with a dose of 17 Gray (Gy) compared to the currently recommended dose prescription of 14 Gy for the treatment of in-stent restenosis within bare metal stents. BACKGROUND: While gamma ICRT for in-stent restenosis has been proven efficacious, the optimal dose is unknown, and radiation failure due to recurrent neointimal hyperplasia remains a significant clinical problem for some patients. A higher radiation dose may improve outcomes, but may potentially increase adverse events. METHODS: Following coronary intervention, 336 patients with in-stent restenosis were randomly assigned to receive ICRT with either 14 Gy or 17 Gy at 2 mm from an 192-iridium source. RESULTS: At 8-month follow up, fewer patients in the 17 Gy group underwent target lesion revascularization (TLR = 15.2% versus 27.2%; p = 0.01), target vessel revascularization (21.3% versus 33.1%; p = 0.02), or reached the composite endpoint of death, myocardial infarction, thrombosis, or TLR (17.1% versus 28.4%; p = 0.02). There were no differences in late thrombosis or mortality between treatment groups. There was a strong trend toward reduced in-lesion late loss (0.36 +/- 0.63 mm vs. 0.51 +/- 0.64 mm; p = 0.09) and a significantly lower rate of binary restenosis (23.9% versus 38.1%; p = 0.031) in the high dose group. CONCLUSIONS: Gamma ICRT with 17 Gy is safe and, compared to 14 Gy, reduces recurrent stenosis and clinical events at 8-month follow up. An increase in the currently recommended gamma radiation dose prescription from 14 Gy to 17 Gy should be strongly considered.

Aged↗
PubMed2005

Outcomes of patients consented but not randomized in a trial of primary percutaneous coronary intervention in acute myocardial infarction (the CADILLAC registry).

Baseline features, management, and outcomes of patients who had acute myocardial infarction (AMI) and were excluded from randomized trials of primary percutaneous coronary intervention (PCI) have not been well described. We examined the baseline features and outcomes of patients who had AMI and were excluded due to angiographic ineligibility from a randomized trial of primary PCI. The CADILLAC trial evaluated 4 primary PCI strategies in patients who had AMI without cardiogenic shock. Of 2,681 patients who consented, 599 (22.3%) were subsequently excluded from randomization due to protocol-specified angiographic findings. These patients were enrolled in a formal in-hospital registry and were treated at the discretion of attending physicians. Registry versus randomized patients were older (median age 61.9 vs 59.0 years, p = 0.002), more frequently had 3-vessel disease (52.4% vs 15.6%, p = 0.0001), and more frequently had lower left ventricular ejection fraction (45% vs 50%, p = 0.002). Registry patients were treated with PCI (n = 234), coronary artery bypass grafting (n = 136), or medically only (n = 226). In-hospital mortality rate among all patients who consented was 2.2% and was higher among registry than among randomized patients (4.0% vs 1.6%, relative risk 2.45, p = 0.001). Within the registry, covariate-adjusted risk of mortality was lower among patients who were treated by PCI compared with those who were treated medically (odds ratio 0.21, p=0.03). In conclusion, angiographic ineligibility for randomization in a large, prospective, primary PCI trial was associated with numerous high-risk demographic characteristics and higher short-term mortality. Nonetheless, the overall survival of patients who were referred for primary PCI was excellent, and performance of primary PCI versus medical therapy was associated with increased survival among excluded patients.

Aged↗
PubMed2005

Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study).

Randomized clinical trials have shown that paclitaxel-eluting stents significantly reduce restenosis after percutaneous coronary intervention. The impact of lesion calcification on the efficacy of paclitaxel-eluting stents is unknown. In the TAXUS-IV trial, 1,314 patients who underwent percutaneous coronary intervention were randomly assigned to a bare-metal or paclitaxel-eluting stent. By core laboratory analysis, 247 lesions (19%) were moderately or severely calcified. At the 9-month angiographic follow-up examination, the paclitaxel-eluting stent had significantly reduced the amount of late loss compared with the control stent (0.26 +/- 0.56 vs 0.51 +/- 0.48 mm, p = 0.015) within the analysis segment in the calcific lesions. The analysis segment restenosis rate was similar in patients with calcified and noncalcified lesions after paclitaxel-eluting stent implantation (7.5% vs 8.0%, respectively; p = 1.0). The rate of ischemia-driven target lesion revascularization (TLR) at 1 year was reduced by 56% in patients with calcified lesions (11.9% vs 5.1%, p = 0.09) and by 75% in noncalcified lesions (15.7% vs 4.3%, p <0.0001). By interaction testing, the efficacy of the paclitaxel-eluting stent in reducing TLR at 1 year was similar in the calcified and noncalcified lesions (p = 0.30). Moreover, by multivariate analysis, implantation of the paclitaxel-eluting stent was a powerful independent predictor of freedom from TLR, with similar hazard ratios for efficacy in calcified and noncalcified lesions (0.30 and 0.26, respectively). In conclusion, implantation of paclitaxel-eluting stents in patients with de novo coronary lesions significantly reduced restenosis in patients with and without calcified lesions.

Angioplasty, Balloon, Coronary↗
PubMed2005

Effectiveness of the concomitant use of bivalirudin and drug-eluting stents (from the prospective, multicenter BivAlirudin and Drug-Eluting STents [ADEST] study).

Sirolimus-eluting stents (SESs) reduce restenosis compared with bare metal stents. Safety issues with drug-eluting stents are particularly important given concerns of possible increased thrombogenicity. Compared with heparin plus glycoprotein IIb/IIIa inhibitors, the direct thrombin inhibitor bivalirudin has been shown to reduce the risk of hemorrhagic complications in patients receiving bare metal stents, with similar efficacy in preventing ischemic complications. The safety and efficacy of percutaneous coronary intervention (PCI) with SESs and bivalirudin anticoagulation have not been prospectively studied. This prospective study performed at 9 United States hospitals evaluated 1,182 patients referred for PCI with SESs in whom the procedural anticoagulant was bivalirudin. Clopidogrel was administered before PCI in 79% of patients, and only 5.3% received procedural glycoprotein IIb/IIIa inhibitors. At 30 days, major adverse cardiac events occurred in 7.1% of patients, including 0.3% mortality, 4.4% myocardial infarction (defined as creatine kinase-MB >3x normal), 1.7% target vessel revascularization, and 0.6% stent thrombosis. Major bleeding occurred in only 0.8% of patients. Thus, use of bivalirudin as the procedural anticoagulant to support SES implantation in a "real world" population of patients undergoing PCI results in low rates of major adverse cardiac events, stent thrombosis, and major bleeding.

Angioplasty, Balloon, Coronary↗
PubMed2005

Bifurcation coronary lesions treated with the "crush" technique: an intravascular ultrasound analysis.

OBJECTIVES: We report intravascular ultrasound (IVUS) findings after crush-stenting of bifurcation lesions. BACKGROUND: Preliminary results with the crush-stent technique are encouraging; however, isolated reports suggest that restenosis at the side branch (SB) ostium continues to be a problem. METHODS: Forty patients with bifurcation lesions underwent crush-stenting with the sirolimus-eluting stent. Postintervention IVUS was performed in both branches in 25 lesions and only the main vessel (MV) in 15 lesions; IVUS analysis included five distinct locations: MV proximal stent, crush area, distal stent, SB ostium, and SB distal stent. RESULTS: Overall, the MV minimum stent area was larger than the SB (6.7 +/- 1.7 mm2 vs. 4.4 +/- 1.4 mm2, p < 0.0001, respectively). When only the MV was considered, the minimum stent area was found in the crush area (rather than the proximal or MV distal stent) in 56%. When both the MV and the SB were considered, the minimum stent area was found at the SB ostium in 68%. The MV minimum stent area measured <4 mm2 in 8% of lesions and <5 mm2 in 20%. For the SB, a minimum stent area <4 mm2 was found in 44%, and a minimum stent area <5 mm2 in 76%, typically at the ostium. "Incomplete crushing"--incomplete apposition of SB or MV stent struts against the MV wall proximal to the carina--was seen in >60% of non-left main lesions. CONCLUSIONS: In the majority of bifurcation lesions treated with the crush technique, the smallest minimum stent area appeared at the SB ostium. This may contribute to a higher restenosis rate at this location.

Angioplasty, Balloon, Coronary↗
PubMed2005

Impact of in-hospital acquired thrombocytopenia in patients undergoing primary angioplasty for acute myocardial infarction.

Thrombocytopenia that develops after percutaneous coronary intervention (PCI) may result in hemorrhagic complications, requirement for blood product transfusions, and potentially thrombotic or ischemic complications. The incidence and prognostic significance of thrombocytopenia, in patients with acute myocardial infarction (AMI) who undergo primary PCI have not been evaluated. In the CADILLAC trial 2,082 patients who had AMI within 12 hours of onset without shock were prospectively randomized to receive balloon angioplasty with or without abciximab versus stenting with or without abciximab. Acquired thrombocytopenia, defined as a nadir platelet count <100 x 10(9)/L in patients who did not have baseline thrombocytopenia, developed in 50 of 1,975 qualifying patients (2.5%) after primary PCI. By multivariate analysis, acquired thrombocytopenia developed more frequently in patients who had non-insulin-requiring diabetes mellitus (odds ratio 3.88 [OR], p = 0.0002), previous statin administration (OR 3.28, p = 0.002), and use of abciximab (OR 2.06, p = 0.02) and less frequently in patients who had previous aspirin use (OR 0.26, p = 0.002), a higher baseline platelet count (OR 1.20, p < 0.0001), and greater body mass index (OR 0.90, p = 0.006). Patients who developed thrombocytopenia versus those who did not had higher in-hospital rates of major hemorrhagic complications (10.0% vs 2.7%, p = 0.01), greater requirement for blood transfusions (10.0% vs 3.9%, p = 0.05), longer hospital stay (median 4.8 vs 3.6 days, p = 0.008), and increased costs (median dollar 14,466 vs dollar 11,629, p = 0.001). All-cause mortality was markedly increased at 30 days (8.0% vs 1.6%, p = 0.0008) and at 1 year (10.0% vs 3.9%, p = 0.03) in patients who developed thrombocytopenia. In conclusion, thrombocytopenia that develops after primary PCI for AMI, although uncommon, is associated with increased hemorrhagic complications and decreased survival.

Abciximab↗
PubMed2005

Impact of platelet glycoprotein IIb/IIIa Inhibition on the paclitaxel-eluting stent in patients with stable or unstable angina pectoris or provocable myocardial ischemia (a TAXUS IV substudy).

Whether the benefits that glycoprotein IIb/IIIa inhibitors confer in patients who undergo bare metal stent implantation extend to drug-eluting stents is unknown. We performed a prespecified subgroup analysis of the TAXUS IV study population to examine the effect of procedural glycoprotein IIb/IIIa inhibition during paclitaxel-eluting stent implantation on periprocedural creatine kinase-MB (CK-MB) levels. Glycoprotein (GP) IIb/IIIa inhibitors were administered to 57.7% of patients who had been randomized to receive the TAXUS stent and to 56.7% of those who had been randomized to receive the control stent. Among patients who received the TAXUS stent, the rate of CK-MB increases of >3 times the normal level was 2.6-fold higher in those who received a GP IIb/IIIa inhibitor than in those who did not (11.4% vs 4.4%, p = 0.0015). Composite rates of major adverse cardiac events and target vessel failure were also higher at 1 month in the GP IIb/IIIa group. By multivariate analysis, use of GP IIb/IIIa inhibitors during stenting with the TAXUS stent was an independent predictor of CK-MB increases >3 times the normal level. Further studies are warranted.

Abciximab↗
PubMed2005

Impact and determinants of left ventricular function in patients undergoing primary percutaneous coronary intervention in acute myocardial infarction.

We evaluated the prognostic effect of baseline left ventricular function and the determinants of its recovery after acute myocardial infarction (AMI) treated by primary angioplasty. Left ventriculography was performed during the index procedure in 1,620 of 2,082 patients (78%) who underwent primary angioplasty for AMI in the CADILLAC trial. One-year survival rate was significantly lower in patients whose baseline left ventricular ejection fraction (LVEF) was <40% than in those whose LVEF was > or =40% (89.0% vs 97.2%, respectively, p <0.0001). The effect of baseline left ventricular dysfunction on mortality was confined to the first 3 months after AMI; thereafter, survival was independent of baseline LVEF. By multivariate analysis, baseline LVEF (hazard ratio 0.93, 95% confidence interval 0.90 to 0.97, p <0.001) and infarct zone regional wall motion (hazard ratio 2.67, 95% confidence interval 1.08 to 6.63, p = 0.03) were independent predictors of 1-year mortality. Seven-month convalescent LVEF was also directly related to baseline LVEF and inversely correlated with previous AMI, multivessel coronary disease, preprocedural Thrombolysis In Myocardial Infarction grade 0 to 2 flow, larger infarct artery diameter, and infarct artery restenosis at follow-up. In conclusion, baseline left ventricular function measured during the index procedure is a strong independent predictor of early and late survival after primary angioplasty. Simple clinical and angiographic features readily available at the time of primary angioplasty also predict convalescent LVEF and are thus of prognostic utility.

Aged↗
PubMed2005

Intravascular ultrasound study of patterns of calcium in ruptured coronary plaques.

Coronary calcium is intimately associated with coronary atherosclerotic plaque development, although it is controversial as to whether coronary calcium is associated with plaque instability. We analyzed 101 IVUS-detected ruptured plaques and compared them with 101 computer-matched control plaques without evidence of plaque rupture. The arc of calcium was measured every 0.5 mm within 10-mm-long segments that spanned the minimum lumen cross-sectional area, and the number and length of calcium deposits were assessed. Ruptured plaques had a significantly larger number of individual calcium deposits than control plaques (3.5 +/- 1.7 vs 1.8 +/- 1.1, p <0.001). However, the arc of the largest calcium deposit was smaller and the length of the largest calcium deposit in each plaque was shorter in ruptured plaques compared with control plaques (67.3 degrees +/- 41.4 degrees vs 114.9 degrees +/- 77.4 degrees , p <0.001, and 1.6 +/- 1.3 vs 4.0 +/- 2.7 mm, p <0.001, respectively). There was no difference in the number of superficial calcium deposits between the 2 groups, although ruptured plaques had significantly smaller arcs of superficial calcium compared with control plaques (56.2 degrees +/- 35.5 degrees vs 95.8 degrees +/- 65.2 degrees , p <0.001). Conversely, the number of deep calcium deposits was significantly larger in ruptured plaques than in control plaques (1.8 +/- 1.4 vs 0.3 +/- 0.6, p <0.001), although the arc of deep calcium was similar in the 2 groups. Ruptured plaques had quantitatively less calcium, especially superficial calcium, but a larger number of small calcium deposits, especially deep calcium deposits. In conclusion, ruptured plaques are associated with a larger number of calcium deposits within an arc of <90 degrees , a larger number of deep calcium deposits, and a remodeling index.

Aged↗
PubMed2005

Intravascular ultrasonic assessment of stent diameters derived from manufacturer's compliance charts.

We used intravascular ultrasound (IVUS) to assess the accuracy of manufacturers' stent balloon compliance charts. Many interventional cardiologists rely on manufacturers' compliance charts to select stent size and optimize stent diameters according to inflation pressures during percutaneous procedures. We randomly selected 212 patients who had de novo coronary lesions that had been treated with a single, bare metal, > or =3.0-mm stent (Bx velocity, NIR, TETRA/PENTA, S660/S670/S7) under IVUS guidance. Cases of stent overlap and postdilatation with another balloon were excluded. Predicted stent diameters were derived from each manufacturer's compliance charts, and stent size and final maximal deployment pressures were derived from each physician's report. IVUS-measured minimum stent diameters (range 1.4 to 4.0 mm, mean 2.79 +/- 0.48) were smaller than predicted diameters (range 3.1 to 4.57 mm, mean 3.79 +/- 0.44). The ratio of IVUS to predicted diameters ranged from 44% to 97% (mean 74 +/- 10%). This finding was common to all 3 stent sizes: 74 +/- 12% for 3.0 mm, 73 +/- 9% for 3.5 mm, and 74 +/- 9% for 4.0-mm stents (p = 0.9). This finding was also common to all 4 stent manufacturers, 72 +/- 8% for Boston Scientific, 76 +/- 11% for Guidant, 73 +/- 9% for Cordis, and 74 +/- 11% for Medtronic (p = 0.13), and to different stent lengths. Only 3.8% of the stents achieved 90% of the predicted minimum stent diameters, and only 24.6% achieved 80% of the predicted minimum stent diameters. In conclusion, in human coronary arteries, minimal stent diameter measured by IVUS is significantly smaller than that predicted by in vitro compliance charts. These differences are independent of stent manufacturer, length, diameter, and deployment pressure.

Aged↗
PubMed2005

Prediction of mortality after primary percutaneous coronary intervention for acute myocardial infarction: the CADILLAC risk score.

OBJECTIVES: We sought to develop a simple risk score for predicting mortality after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: Accurate risk stratification after primary PCI is important. Previous risk scores after reperfusion therapy have incorporated clinical +/- angiographic variables but have not considered baseline left ventricular function. Moreover, prior studies have not been validated against independent databases or studies. METHODS: The databases from the two largest multicenter, randomized AMI trials of primary PCI were utilized for score derivation (the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications [CADILLAC] trial, n = 2,082) and subsequent validation (the Stent-Primary Angioplasty in Myocardial Infarction [Stent-PAMI] trial, n = 900). Logistic regression and the jackknife procedure were used to select correlates of one-year mortality that were subsequently weighted and integrated into an integer scoring system. RESULTS: Seven variables selected from the initial multivariate model were weighted proportionally to their respective odds ratio for one-year mortality (age >65 years [2 points], Killip class 2/3 [3 points], baseline left ventricular ejection fraction <40% [4 points], anemia [2 points], renal insufficiency [3 points], triple-vessel disease [2 points], and post-procedural Thrombolysis In Myocardial Infarction flow grade [2 points]). Three strata of risk were defined (low risk, score 0 to 2; intermediate risk, score 3 to 5; and high risk, score >/=6) with excellent prognostic accuracy for survival in the derivation and validation sets (c statistics = 0.83 and 0.81 for 30-day mortality and 0.79 and 0.78 for 1-year mortality, respectively). CONCLUSIONS: In AMI patients treated with primary PCI, seven risk factors readily available at the time of intervention accurately predict short- and long-term mortality. Of note, measurement of baseline left ventricular function is the single most powerful predictor of survival and should be incorporated into risk score models.

Aged↗
PubMed2005

Influence of stent length to lesion length ratio on angiographic and clinical outcomes after implantation of bare metal and drug-eluting stents (the TAXUS-IV Study).

Longer bare metal stent lengths have been associated with greater restenosis. However, the effect of the ratio of stent length to lesion length on clinical and angiographic restenosis after implantation of bare metal and drug-eluting stents has not been clearly defined. Patients in the TAXUS-IV study who underwent single-study stent placement were categorized into tertiles based on ratios of stent length to lesion length. Clinical results at 1 year and angiographic outcomes at 9 months were compared across the 3 groups. The median ratios of stent length to lesion length were 1.20, 1.58, and 2.27 in the 3 tertiles. Analysis segment restenosis rates at 9 months were similar across the 3 tertiles with bare metal stents (24.7% vs 26.7% vs 23.8%, respectively, p = 0.90 for trend) and paclitaxel-eluting stents (11.7% vs 6.5% vs 5.4%, respectively, p = 0.24). Similarly, there were no differences in 1-year rates of target lesion revascularization across the 3 tertiles for bare metal stents (14.6% vs 14.8% vs 13.7%, respectively, p = 0.91) or paclitaxel-eluting stents (6.1% vs 3.6% vs 4.0%, respectively, p = 0.38). By multivariate analysis, the ratio of stent length to lesion length was an independent predictor of neither 9-month angiographic restenosis nor 1-year target lesion revascularization in the bare metal stent arm (odds ratio 1.21, p = 0.36, and hazard ratio 0.80, p = 0.31, respectively) or in the paclitaxel-eluting stent arm (odds ratio 0.86, p = 0.76, and hazard ratio 0.58, p = 0.21, respectively). These data do not support the arbitrary use of larger ratios of stent length to lesion length in patients who undergo implantation of drug-eluting stents.

Angioplasty, Balloon, Coronary↗
PubMed2005

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial.

OBJECTIVES: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). BACKGROUND: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. METHODS: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. RESULTS: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). CONCLUSIONS: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.

Antineoplastic Agents↗
PubMed2005

Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.

OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation. BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes. CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.

Antineoplastic Agents↗