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Alexandra J Lansky

Publications and source records attributed to Alexandra J Lansky.

At least 19 recordsLinked to original sources
PubMed2006

Usefulness of routine unfractionated heparin infusion following primary percutaneous coronary intervention for acute myocardial infarction in patients not receiving glycoprotein IIb/IIIa inhibitors.

We evaluated the utility of a routine postprocedure course of unfractionated heparin after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in patients not receiving glycoprotein IIb/IIIa inhibitors. In the CADILLAC study, 2,082 patients with AMI who underwent primary PCI were randomized to receive stents versus percutaneous transluminal coronary angioplasty (PTCA), each with or without abciximab. In a subset of 976 patients who did not receive abciximab, we compared outcomes of patients who received postprocedural heparin (n = 758; 78%; median duration 2 days) with those who did not. In 421 patients treated with PTCA, postprocedural heparin use was associated with lower in-hospital major adverse cardiac events (MACEs; 5.3% vs 11.4%, p = 0.069), 1-year MACEs (22% vs 31%, p = 0.08), and decreased in-hospital moderate/severe bleeding (2.3% vs 8.9%, p = 0.01). By multivariate analyses, heparin use correlated with freedom from in-hospital and 1-year MACEs in patients after PTCA. In contrast, in 555 patients who underwent stenting, postprocedural heparin use was associated with increased bleeding and hospitalization costs without a decrease in early or late MACEs. In conclusion, in patients with AMI treated with coronary stenting without glycoprotein IIb/IIIa inhibitors, routine postprocedural heparin was not associated with any significant benefits and may be safely omitted. However, in a subset of patients treated with PTCA, postprocedural heparin use was independently associated with fewer in-hospital and 1-year MACEs.

Abciximab↗
PubMed2006

Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis.

The neointimal hyperplasia (IH) distribution pattern of in-stent restenotic lesions after sirolimus-eluting stent (SES) implantation has not been well described. We identified 48 in-stent restenotic lesions (41 patients) after SES implantation and performed volumetric intravascular ultrasound analyses. Lumen area, stent area, and IH area at the minimal lumen area site were 2.7 +/- 1.0, 5.4 +/- 1.9, and 2.7 +/- 1.4 mm(2), respectively. IH area at the minimal lumen site was larger in the group with a stent area > or =5.0 mm(2) than the group with a stent area <5.0 mm(2) (3.7 +/- 1.3 vs 1.9 +/- 0.8 mm(2), p <0.001). There were fewer visualized stent struts in lesions with a minimum stent area > or =5.0 mm(2) at the minimum lumen site compared with those with a stent area <5.0 mm(2) (0.69 +/- 0.25 vs 0.83 +/- 0.16, p = 0.04). When we compared lesions in patients with diabetes mellitus with patients without diabetes, minimum lumen areas, percent IH at minimal lumen area, percent IH, and neointima-free stent length were identical. In conclusion, (1) lesions without SES underexpansion at the minimum lumen site had more IH and greater nonuniform stent strut distribution compared with restenotic SESs that were underexpanded, and (2) the IH response did not appear to be more aggressive in patients with diabetes mellitus than in those without diabetes mellitus.

Aged↗
PubMed2006

Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions.

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.

Blood Vessel Prosthesis Implantation↗
PubMed2006

Outcome after acute incomplete sirolimus-eluting stent apposition as assessed by serial intravascular ultrasound.

We investigated the fate of postprocedural incomplete stent apposition (ISA) after sirolimus-eluting stent (SES) implantation by evaluating long-term intravascular ultrasound findings in 168 consecutive patients (182 de novo lesions). Postprocedural ISA was defined as > or = 1 stent strut that was clearly separated from the vessel wall with evidence of blood speckle behind the strut without overlapping a side branch. After SES implantation, there were 61 ISA sites in 46 stents in 31 patients (23 at the proximal edge, 7 at the distal edge, and 31 within the stent body). There were no clinical, procedural, or intravascular ultrasound measurement differences between patients and lesions with versus without ISA. At follow-up, 15 acute ISA sites (25%) in 11 patients completely resolved and 40 sites (75%) in 20 patients persisted, although 32 of 46 persisting ISA sites (70%) decreased. There was a greater decrease in effective lumen area and a greater increase in peristent plaque area in the complete-resolution group than in the persistent-ISA group. No lesion developed stent thrombosis or in-stent restenosis (angiographic diameter stenosis > 50%). Six acute ISA sites were also associated with new, late acquired ISA, only 1 of which resulted in aneurysm formation. Although most ISAs after SES implantation do not resolve completely, the incidence of restenosis or thrombosis is not affected.

Acute Disease↗
PubMed2006

Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials).

The everolimus-eluting stent (EES) has been shown to significantly decrease neointimal proliferation at 6 months compared with the bare metal stent (BMS) in patients with de novo coronary lesions. We report mid-term outcomes based on different vessel sizes in the combined FUTURE I and II trials. In the prospective, randomized, FUTURE I trial (single center) and expanded FUTURE II trial (multicenter), 106 patients (107 lesions) were randomized to EESs (n = 49 lesions) or BMSs (n = 58 lesions). Patients were categorized into 3 groups based on preprocedure reference diameter as assessed by quantitative coronary angiography (small vessel < 2.75 mm, medium vessel 2.75 to 3.25 mm, and large vessel > 3.25 mm). At 6-month follow-up, EESs decreased in-stent late lumen loss (decreased rate range of 78% to 94%), resulting in significantly larger minimum lumen area as assessed by intravascular ultrasound (increased range of 34% to 42%) compared with the BMS across all vessel sizes. There were no cases of in-stent restenosis with EESs at any vessel size but 8 cases with BMSs (5 in small vessels). No stent thrombosis, aneurysm formation, or late stent incomplete apposition was observed in any group. The EES appears to be effective for treatment of de novo coronary lesions in decreasing neointimal proliferation at 6-month follow-up compared with BMSs, regardless of vessel size.

Aged↗
PubMed2006

Treatment of coronary artery perforations complicating percutaneous coronary intervention with a polytetrafluoroethylene-covered stent graft.

Coronary artery perforation is a rare, but dreaded, complication of percutaneous coronary intervention. Conventional treatment, including reversal of anticoagulation and prolonged balloon inflation, is associated with a high incidence of death, Q-wave myocardial infarction, and emergency coronary bypass surgery. Although a number of case reports have demonstrated the feasibility of sealing coronary perforations with synthetic material-covered stent grafts, the efficacy of this treatment has not been reported in a large, multicenter series. We used a retrospective international registry to examine the outcomes of the polytetrafluoroethylene-coated JOSTENT coronary stent graft (CSG) in 41 cases of coronary perforations. Perforations were relatively severe: 16.7% Ellis grade 1, 54.2% grade 2, and 29.1% grade 3. Of the 41 patients, > 1/3 (n = 14) experienced life-threatening complications before stent graft implantation, including pericardial tamponade (12.2%), cardiogenic shock (9.8%), and cardiac arrest (2.4%). A total of 52 CSGs were used to treat the 41 perforations (mean 1.3 per lesion). All CSGs were placed successfully, with 92.9% of the perforations sealed completely and 7.1% partially. One patient developed abrupt vessel closure after CSG deployment, resulting in an overall procedure success rate of 96.4%. No in-hospital Q-wave myocardial infarctions, emergency coronary bypass surgeries, or deaths resulted. The CSG may be a reliable and highly effective treatment option for sealing coronary perforations complicating percutaneous coronary interventions.

Aged↗
PubMed2006

Comparative early and late outcomes after primary percutaneous coronary intervention in ST-segment elevation and non-ST-segment elevation acute myocardial infarction (from the CADILLAC trial).

We determined the outcomes of patients with acute ST-segment elevation (STE) myocardial infarction (STEMI) and non-STEMI (NSTEMI) after primary percutaneous coronary intervention (PCI). The prognosis after primary PCI in STEMI has been extensively studied and defined. Outcomes of patients who undergo primary PCI for NSTEMI are less well established. In total, 2,082 patients with ongoing chest pain for > 30 minutes consistent with acute MI were randomized to balloon angioplasty versus stenting, each with/without abciximab. Of 1,964 patients, STEMI was present in 1,725 (87.8%) and NSTEMI in 239 (12.2%). Compared with STEMI, those with NSTEMI were more likely to have delayed time-to-hospital arrival (2.4 vs 1.8 hours, p = 0.0002) and increased door-to-balloon time (3.2 vs 1.9 hours, p < 0.0001). Patients with NSTEMI were more likely to have Thrombolysis In Myocardial Infarction grade 3 flow at baseline (37.3% vs 19.4%, p < 0.0001) and higher ejection fraction (58.7% vs 55.8%, p = 0.001), but similar rates of postprocedural Thrombolysis In Myocardial Infarction grade 3 flow. At 1 year, patients with NTEMI had similar mortality (3.4% vs 4.4%, p = 0.40) but higher rates of major adverse cardiac events (24.0% vs 16.6%, p = 0.007) that was driven by more frequent ischemic target vessel revascularization (21.8% vs 11.9%, p <0.0001). In conclusion, patients with acute MI without STE who are treated with primary PCI have marked delays to treatment, similar late mortality, and increased rates of ischemic target vessel revascularization compared with patients with STEMI, despite more favorable angiographic features at presentation and similar reperfusion success. The adverse prognosis of patients with NSTEMI should be recognized and efforts made to decrease reperfusion times.

Abciximab↗
PubMed2006

Drug-eluting stents in the treatment of intermediate lesions: pooled analysis from four randomized trials.

OBJECTIVES: To address the safety and efficacy of drug-eluting stents (DES) in the treatment of intermediate lesions, we performed a pooled analysis of four randomized DES versus bare-metal stent (BMS) trials and assessed outcomes among patients with intermediate lesions. BACKGROUND: Before the introduction of DES, intermediate coronary lesions were commonly managed based on physiologic or anatomic assessment of lesion severity. The DES may challenge this paradigm. METHODS: The study population involved 167 of 2,478 randomized patients (6.7%) with intermediate lesions (diameter stenosis <50% [mean 44%] by quantitative coronary angiography) from the Sirolimus-coated Bx Velocity Balloon Expandable Stent in the Treatment of Patients with De Novo Coronary Artery Lesions (SIRIUS), TAXUS-IV, and the First and Second First Use to Underscore Restenosis Reduction with Everolimus (FUTURE-I and -II) trials. End points examined included early (in-hospital and 30-day) and late (1-year) major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis, and follow-up angiographic restenosis. RESULTS: Patients with intermediate lesions randomized to DES versus BMS had low rates of 30-day MACE (1.1% vs. 4.0% respectively; p = 0.22). At one-year follow-up, patients treated with DES versus BMS had similar rates of cardiac death (0% vs. 2.7%, respectively; p = 0.11) and MI (3.4% vs. 5.4%; p = 0.49) but markedly lower rates of TVR (3.4% vs. 20.3%; p = 0.0004), MACE (5.6% vs. 25.4%; p = 0.0003), and binary angiographic restenosis (1.8% vs. 34.0%; p < 0.0001). No patient in either group developed stent thrombosis. CONCLUSIONS: Compared with BMS, treatment of intermediate lesions with DES appears safe and results in a marked reduction in clinical and angiographic restenosis. The efficacy of DES may require a reevaluation of current treatment paradigms for intermediate lesions.

Coronary Restenosis↗
PubMed2006

Intravascular ultrasonic differences between aorto-ostial and shaft narrowing in saphenous veins used as aortocoronary bypass grafts.

Previous studies have reported differences in interventional complication rates that depend on saphenous vein graft (SVG) lesion location. However, little is known about morphologic differences between lesions in different SVG locations. We evaluated preintervention intravascular ultrasound (IVUS) images of 75 de novo SVG lesions (aorto-ostial, n = 15; shaft, n = 60) in 63 patients. IVUS data were measured at the minimal lumen area and at 2 proximal and 2 distal references. Positive remodeling was defined as a lesion site SVG area that was larger than the average of the 2 distal references. Shaft lesions more often contained soft plaque (60.0% vs 26.7%, p = 0.02). Minimal lumen areas were identical (4.5 +/- 2.9 vs 4.3 +/- 1.5 mm2, p = 0.3); however, plaque burden at the minimal lumen area was greater in shaft locations (79.3 +/- 9.4% vs 72.1 +/- 9.2%, p = 0.01). The frequency of positive remodeling in shaft versus aorto-ostial lesions was 70.2% versus 26.7% (p = 0.002). SVG shaft lesions have more soft plaque and larger plaque burdens and undergo positive remodeling more frequently than SVG aorto-ostial lesions. These IVUS differences may account for some of the location-specific differences in interventional complications.

Aged↗
PubMed2006

A prospective registry to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions using the "crush technique".

The "crush technique" has been proposed as an alternative approach to treat bifurcation lesions because of its predictability and high procedural success rate. However, few data are available regarding its safety and long-term efficacy. We report the long-term clinical outcomes of patients with coronary bifurcation lesions treated with sirolimus-eluting stents using the crush technique. From April 2003 to May 2004, 120 patients with coronary bifurcation lesions were treated with sirolimus-eluting stents using the crush technique. Six months of clinical follow-up was completed in 95.8% of patients. Mean patient age was 64 years; 36% had diabetes mellitus, and the left anterior descending artery/diagonal was the most frequent bifurcation location (69%). Final kissing balloon inflation was performed in 87.5% of patients. Compared with the main vessel, side branch lesions were shorter, with a smaller reference diameter and final in-stent minimum lumen diameter. Procedural success was achieved in 97.5%. At 30 days of follow-up, 1 patient had died of noncardiac causes and 2 patients (1.7%) had subacute stent thrombosis. At 6 months of follow-up, target lesion revascularization was required in 13 patients (11.3%), all of whom had focal restenosis predominantly at the side branch ostium. In conclusion, the crush technique with final kissing balloon inflation can be safely used by experienced operators to treat highly complex bifurcation lesions with sirolimus-eluting stents. The safety profile of this technique is similar to that of other bifurcation stenting techniques reported thus far. Nonetheless, despite the excellent patency rates of the main vessel, the need for revascularization at the ostium of the side branch was not fully eliminated.

Angioplasty, Balloon, Coronary↗
PubMed2006

Prognostic implications of creatine kinase elevation after primary percutaneous coronary intervention for acute myocardial infarction.

OBJECTIVES: We examined the prognostic implications of the absolute level and rate of increase of creatine kinase (CK) elevation after primary percutaneous coronary intervention (PCI). BACKGROUND: Peak creatine kinase (CK(peak)) and the rate of CK increase are related to reperfusion success and clinical outcomes after thrombolytic therapy for acute myocardial infarction (AMI). The utility of routine serial CK monitoring after primary PCI, in which normal antegrade blood flow is restored in most patients, is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 1,529 patients with AMI randomized to either stenting or balloon angioplasty, each with or without abciximab, had CK levels determined at baseline and at 8 +/- 1 h, 16 +/- 1 h, and 24 +/- 1 h after PCI. RESULTS: The CK(peak) occurred at baseline in 3.9% of patients, at 8 +/- 1 h in 69.6%, at 16 +/- 1 h in 20.0%, and at 24 +/- 1 h in 6.5%. The CK levels at all post-procedural time points were significantly higher in patients who died compared with the one-year survivors, as was CK(peak) (mean, 2,865 U/l vs. 1,885 U/l, respectively, p < or = 0.001). By multivariate analysis, CK(peak) was a significant predictor of one-year mortality (hazard ratio = 2.15, p = 0.0002), independent from post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow. Both the improvement in left ventricular ejection fraction from baseline to seven months and its absolute level were inversely correlated with CK(peak) (p < 0.001 for both). In contrast, the time to CK(peak) was not an independent predictor of mortality or myocardial recovery. CONCLUSIONS: The CK(peak) after primary PCI is a powerful predictor of one-year mortality independent of other clinical and angiographic measures.

Angioplasty, Balloon, Coronary↗
PubMed2006

Serial angiographic follow-up of sirolimus-eluting stents for unprotected left main coronary artery revascularization.

OBJECTIVES: This study was performed to evaluate the clinical and serial angiographic outcomes of patients undergoing sirolimus-eluting stent (SES) implantation for unprotected left main coronary artery (LMCA) stenosis. BACKGROUND: The efficacy of SES has led to their expanded use for off-label indications, including LMCA disease. METHODS: Unprotected LMCA intervention with SES was attempted in 50 patients. Surveillance angiography was performed at three and nine months' follow-up. RESULTS: The target lesion involved the distal LMCA in 47 patients (94%). In-lesion restenosis occurred in 21 patients (42%), was focal in 85% of cases, and in 82% involved the branch ostia, sparing the LMCA itself. Target lesion revascularization (TLR) occurred in 19 patients (38%) over a mean follow-up of 276 +/- 57 days; TLR was ischemia-driven in 7 patients (14%). Late loss was significantly greater within the left circumflex (LCX) ostium compared to the parent vessel (PV) of the LMCA bifurcation (0.83 +/- 0.89 mm vs. 0.49 +/- 0.72 mm, p = 0.04). Late loss continued to increase between three- and nine-month follow-up. Final minimal luminal diameter and maximal balloon pressure were independent predictors of restenosis of the PV. CONCLUSIONS: Restenosis is a frequent finding when serial angiographic follow-up is performed after SES implantation for unprotected distal LMCA lesions. Restenosis is usually focal, most often involves the LCX ostium, and often occurs without symptoms.

Aged↗
PubMed2006

Impact of body mass index on outcomes after primary angioplasty in acute myocardial infarction.

BACKGROUND: The prognostic importance of obesity after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) is unknown. We therefore sought to investigate the impact of body mass index (BMI) in patients with AMI undergoing primary PCI. METHODS: In the CADILLAC trial, 2082 patients of any age with AMI within 12 hours onset undergoing primary PCI were randomized to balloon angioplasty versus stenting, each +/-abciximab. Outcomes were stratified by baseline BMI. RESULTS: Baseline BMI was measured in 2035 (98%) randomized patients; 552 (27%) patients have normal weight (BMI < 25 kg/m2), 915 (45%) were overweight (> or = 25 to < 30 kg/m2), and 568 (28%) were obese (> or = 30 kg/m2). Compared with normal-weight patients, obese patients were younger and more frequently had diabetes, hyperlipidemia, hypertension, non-anterior myocardial infarction, and higher creatinine clearance. Obese patients were less likely to develop thrombocytopenia (1.8% vs 4.2%), moderate hemorrhagic complications (1.4% vs 3.3%), or required blood product transfusions (3.2% vs 6.3%) (all P < or = .04). Obese compared with normal-weight patients had lower inhospital mortality (0.9% vs 2.7%, P = .03) at 30 days (1.1% vs 3.8%, P = .02) and 1 year (1.8% vs 7.5%, P < .0001). Independent predictors of 30-day and 1-year mortality included lower ejection fraction, advanced age, 3-vessel disease, anterior AMI, and lower creatinine clearance, but not BMI. CONCLUSIONS: Obese patients with AMI have an improved prognosis after primary PCI compared with normal-weight patients, a finding attributable to AMI onset at younger age, with better renal function and less anterior infarction.

Aged↗
PubMed2006

Impact of treatment delays on outcomes of primary percutaneous coronary intervention for acute myocardial infarction: analysis from the CADILLAC trial.

BACKGROUND: The impact of treatment delays on outcomes after primary percutaneous coronary intervention for acute myocardial infarction is controversial. METHODS: The CADILLAC trial randomized 2082 patients with acute myocardial infarction to stenting versus percutaneous transluminal coronary angioplasty, each with or without abciximab. RESULTS: Earlier reperfusion (<3 vs 3-6 vs >6 hours) was associated with lower 1-year mortality (2.6% vs 4.3% vs 4.8%, P = .046 for <3 vs > or = 3 hours), more frequent grade 2 to 3 myocardial blush (55% vs 53% vs 44%, P = .003), more frequent complete ST-segment resolution (64% vs 68% vs 47%, P = .006), and greater improvement in left ventricular function. Early reperfusion (<3 vs 3-6 vs > or = 3 hours) was associated with lower mortality in high-risk patients (3.8% vs 6.9% vs 7.0%, P = .051 for <3 vs > or = 3 hours) but not in low-risk patients (1.4% vs 0.6% vs 1.0%, P = .63). Door-to-balloon times were independently correlated with mortality in patients presenting early after the onset of symptoms (< or = 2 hours, hazard ratio 1.24, P = .013) but not late (>2 hours, heart rate 0.88, P = .33). CONCLUSIONS: Early reperfusion results in superior clinical outcomes, enhanced microvascular reperfusion, and better recovery of left ventricular function. Incremental treatment delays impact mortality more in high-risk versus low-risk patients and more in patients presenting early versus late after the onset of symptoms. These data emphasize the importance of minimizing treatment delays and have implications regarding patient triage for primary percutaneous coronary intervention.

Aged↗
PubMed2006

Relationship between infarct artery location, epicardial flow, and myocardial perfusion after primary percutaneous revascularization in acute myocardial infarction.

BACKGROUND: The association between infarct artery location, reperfusion success, and clinical outcomes after primary percutaneous coronary intervention (PCI) has not been characterized. We examined the infarct artery-specific impact of epicardial and myocardial flow and reperfusion after primary PCI for acute myocardial infarction. METHODS: Among 2082 patients undergoing primary PCI in the CADILLAC trial, myocardial blush grade, TIMI flow grade, ST-segment resolution, and clinical outcomes were analyzed according to the infarct artery. RESULTS: Baseline clinical characteristics did not significantly differ between patients experiencing infarction in the left anterior descending (LAD, 37%) versus left circumflex (18%) and right coronary artery (46%) distributions. Baseline left ventricular function was reduced, and collateral flow was less commonly present in patients with infarction involving the LAD. Achievement of final TIMI-3 flow, grade 3 myocardial blush, and ST-segment resolution >70% was also significantly less common in anterior infarction. Patients with anterior versus nonanterior infarction had significantly higher mortality at 30 days (3.4% vs 1.3%, P = .0006) and 1 year (6.5% vs 2.9%, P < .0001) and had increased 1-year rates of reinfarction (3.6% vs 1.7%, P = .009) and ischemic target vessel revascularization (16.1% vs 11.7%, P = .006). By multivariate analysis, LAD infarction was a powerful independent predictor of 1-year mortality (odds ratio 2.45, P = .009). CONCLUSIONS: Acute myocardial infarction involving the LAD distribution is associated with reduced left ventricular function, less frequent collateral flow, impaired myocardial perfusion and decreased reperfusion success, findings associated with reduced survival, and increased major adverse cardiac events compared with other vascular territories. These data provide mechanistic insights to the adverse prognosis of patients with anterior infarction.

Aged↗
PubMed2006

Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention: a subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial.

BACKGROUND: Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points. OBJECTIVES: The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial. METHODS: A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted. RESULTS: Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality. CONCLUSIONS: Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.

Aged↗
PubMed2006

Predictors of recurrent in-stent restenosis after beta-radiation: An analysis from the START 40/20 trial.

OBJECTIVE: The purpose of this study was to identify potential predictors, including clinical, procedural, angiographic, and intravascular ultrasound (IVUS) parameters, for recurrent in-stent restenosis (ISR) following beta-radiation 90Strontium/Yttrium (90Sr/Y) in a large multicenter trial. BACKGROUND: Although adjunct brachytherapy reduces recurrent ISR after primary catheter-based intervention, recurrence of stenosis after brachytherapy still occurs. METHODS: We analyzed 185 IVUS cohort patients in the STent And Restenosis Therapy (START) 40/20 trial where a 40-mm, 90Sr/Y, radioactive source train was exclusively used for treatment of ISR to be treatable with a 20-mm balloon. RESULTS: Thirty-nine patients underwent target lesion revascularization. Preliminary univariate analysis showed that age, smoking, balloon/artery ratio, geographic miss, minimum lumen diameter, and diameter stenosis at baseline were associated with target lesion revascularization, while none of IVUS variables were (minimum lumen area, minimum stent area, or residual plaque burden). The multivariate logistic regression analysis showed that younger age, lower balloon/artery ratio, and presence of geographic miss were independent predictors of target lesion revascularization. CONCLUSIONS: Even with adjunct beta-radiation therapy, initial mechanical optimization, such as appropriate balloon sizing and positioning, may be critical for the prevention of recurrent ISR.

Adult↗