Low frequency mechanical actuation accelerates reperfusion in-vitro.

BACKGROUND: Rapid restoration of vessel patency after acute myocardial infarction is key to reducing myocardial muscle death and increases survival rates. Standard therapies include thrombolysis and direct PTCA. Alternative or adjunctive emergency therapies that could be initiated by minimally trained personnel in the field are of potential clinical benefit. This paper evaluates a method of accelerating reperfusion through application of low frequency mechanical stimulus to the blood carrying vessels. MATERIALS AND METHOD: We consider a stenosed, heparinized flow system with aortic-like pressure variations subject to direct vessel vibration at the occlusion site or vessel deformation proximal and distal to the occlusion site, versus a reference system lacking any form of mechanical stimulus on the vessels. RESULTS: The experimental results show limited effectiveness of the direct mechanical vibration method and a drastic increase in the patency rate when vessel deformation is induced. For vessel deformation at occlusion site 95% of clots perfused within 11 minutes of application of mechanical stimulus, for vessel deformation 60 centimeters from the occlusion site 95% percent of clots perfused within 16 minutes of stimulus application, while only 2.3% of clots perfused within 20 minutes in the reference system. CONCLUSION: The presented in-vitro results suggest that low frequency mechanical actuation applied during the pre-hospitalization phase in patients with acute myocardial infarction have potential of being a simple and efficient adjunct therapy.

In-stent restenotic lesions can rupture--a case against plaque sealing.

We present a case of plaque rupture located inside a restenotic stent. Intravascular ultrasound defined a lesion with a minimal lumen area (MLA) of 3.59 cm², plaque burden of 72%, and reference vessel luminal diameter of 4.0 mm with an external elastic membrane lumen cross-section area of 12.6 mm². There was a clearly identified plaque rupture, with a flap-like dissection within the stented segment. Virtual histology intravascular ultrasound confirmed that the adjacent plaque had necrotic core with a thin overlying fibrous cap. The remaining tissue next to the dissection plane was fibrotic. This case illustrates that neointimal hyperplasia may organize into an unstable plaque, with a thin fibrous cap overlying a lipid-rich necrotic core-a so-called virtual histology thin-capped fibroatheroma. As defined in the PROSPECT trial, the in-stent stenotic lesion in our case conformed to the definition of a high-risk plaque-it had an MLA < 4 mm², plaque burden was ≥ 70%, and there was >10% necrotic core. It became unstable and ruptured. The demonstrated findings of this case may sway physicians against sealing hemodynamically nonsignificant unstable plaques.

Impact of coronary artery disease on outcomes after transcatheter aortic valve implantation.

BACKGROUND: Coronary artery disease (CAD) negatively impacts prognosis of patients undergoing surgical aortic valve replacement and revascularization is generally recommended at the time of surgery. Implications of CAD and preprocedural revascularization in the setting of transcatheter aortic valve implantation (TAVI) are not known. METHOD: Patients who underwent successful TAVI from January 2005 to December 2007 were retrospectively divided into five groups according to the extent of CAD assessed with the Duke Myocardial Jeopardy Score: no CAD, CAD with DMJS 0, 2, 4, and > or =6. Study endpoints included 30-day and 1-year survival, evolution of symptoms, left ventricular ejection fraction (LVEF), and mitral regurgitation (MR) and need of revascularization during follow-up. RESULTS: One hundred and thirty-six patients were included, among which 104 (76.5%) had coexisting CAD. Thirty-day mortality in the five study groups was respectively 6.3, 14.6, 7.1, 5.6, and 17.7% with no statistically significant difference between groups (P = 0.56). Overall survival rate at one year was 77.9% (95% CL: 70.9, 84.9) with no difference between groups (P = 0.63). Symptoms, LVEF, and MR all significantly improved in the first month after TAVI, but the extent of improvement did not differ between groups (P > 0.08). Revascularization after TAVI was uncommon. CONCLUSION: The presence of CAD or nonrevascularized myocardium was not associated with an increased risk of adverse events in this initial cohort. On the basis of these early results, complete revascularization may not constitute a prerequisite of TAVI. This conclusion will require re-assessment as experience accrues in patients with extensive CAD.

Percutaneous coronary intervention and 30-day mortality: the British Columbia PCI risk score.

OBJECTIVES: To construct a calculator to assess the risk of 30-day mortality following PCI. BACKGROUND: Predictors of 30-day mortality are commonly used to aid management decisions for cardiac surgical patients. There is a need for an equivalent risk-score for 30-day mortality for percutaneous coronary intervention (PCI) as many patients are suitable for both procedures. METHODS: The British Columbia Cardiac Registry (BCCR) is a population-based registry that collects information on all PCI procedures performed in British Columbia (BC). We used data from the BCCR to identify risk factors for mortality in PCI patients and construct a calculator that predicts 30-day mortality. RESULTS: Patients (total n = 32,899) were divided into a training set (n = 26,350, PCI between 2000 and 2004) and validation set (n = 6,549, PCI in 2005). Univariate predictors of mortality were identified. Multivariable logistic regression analysis was performed on the training set to develop a statistical model for prediction of 30-day mortality. This model was tested in the validation set. Variables that were objective and available before PCI were included in the final risk score calculator. The 30-day mortality for the overall population was 1.5% (n = 500). Area under the ROC curve was 90.2% for the training set and 91.1% for the validation set indicating that the model also performed well in this group. CONCLUSIONS: We describe a large, contemporary cohort of patients undergoing PCI with complete follow-up for 30-day mortality. A robust, validated model of 30-day mortality after PCI was used to construct a risk calculator, the BC-PCI risk score, which can be accessed at www.bcpci.org.

Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: the Rinspiration international registry.

BACKGROUND: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. METHODS: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was >or=50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous electrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). RESULTS: Mean symptom-to-PCI time was 4.7 +/- 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush >or=2 in 78%. Rates of STR >or= 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. CONCLUSIONS: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit.

Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial.

BACKGROUND: On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents. METHODS AND RESULTS: TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54+/-2.1 mm2) and MR (-0.88+/-1.9 mm2) groups compared with the BMS (-1.02+/-1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91+/-2.0 mm2, P<0.0001); this decrease was significantly attenuated with SR (0.08+/-2.0 mm2) and MR (-0.19+/-1.7 mm2) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48+/-2.2 mm2, P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents. CONCLUSIONS: The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

Local intracoronary administration of antisense oligonucleotide against c-myc for the prevention of in-stent restenosis: results of the randomized investigation by the Thoraxcenter of antisense DNA using local delivery and IVUS after coronary stenting (ITALICS) trial.

OBJECTIVE: This study was designed to determine whether antisense oligodeoxynucleotides (ODN) directed against the nuclear proto-oncogene c-myc could inhibit restenosis when given by local delivery immediately after coronary stent implantation. BACKGROUND: Failure of conventional pharmacologic therapies to reduce the incidence of coronary restenosis after percutaneous revascularization techniques has prompted interest in the use of agents that target intracellular central regulatory mechanisms. METHODS: Eighty-five patients were randomly assigned to receive either 10 mg of phosphorothioate-modified 15-mer antisense ODN or saline vehicle by intracoronary local delivery after coronary stent implantation. The primary end point was percent neointimal volume obstruction measured by computerized analysis of electrocardiogram-gated intravascular ultrasound (IVUS) at six-month follow-up. Secondary end points included clinical outcome and quantitative coronary angiography analysis. RESULTS: Analysis of follow-up IVUS data was performed on 77 patients. In-stent volume obstruction was similar between groups (44 +/- 16% and 46 +/- 14%, placebo vs. ODN; p = 0.57; 95% confidence interval: -1.13 to 0.85). Minimum luminal diameter increased from 0.84 +/- 0.36 and 0.90 +/- 0.45 (p = 0.55) to 2.70 +/- 0.37 and 2.80 +/- 0.37 (p = 0.28) after stent implantation, which decreased to 1.50 +/- 0.61 and 1.50 +/- 0.53 (p = 0.98) by six months, yielding similar loss indexes (placebo vs. ODN, respectively). There were no differences in angiographic restenosis rates (38.5 and 34.2%; p = 0.81; placebo vs. ODN) or clinical outcome. CONCLUSIONS: Treatment with 10 mg of phosphorothioate-modified ODN directed against c-myc does not reduce neointimal volume obstruction or the angiographic restenosis rate in this patient population.

Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial.

OBJECTIVES: The purpose of this study was to assess whether the early discontinuation of eptifibatide infusion in nonemergent percutaneous coronary intervention (PCI) is associated with a higher frequency of periprocedural ischemic myonecrosis. BACKGROUND: The recommended regimen for eptifibatide is a double bolus followed by an infusion for 18 h. It is not known whether the infusion can be shortened if the PCI is uncomplicated. METHODS: We enrolled 624 patients with stable angina, acute coronary syndrome, or recent ST-segment elevation myocardial infarction (>48 h) who underwent successful coronary stenting and received eptifibatide. Patients were randomly assigned to receive either an 18-h infusion or an abbreviated infusion of <2 h. The primary end point was the incidence of periprocedural myonecrosis defined as troponin-I elevation >0.26 microg/l. Secondary end points included death, myocardial infarction, urgent target vessel revascularization at 30 days, and in-hospital major bleeding using the REPLACE-2 (Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events) trial criteria. RESULTS: The incidence of periprocedural myonecrosis was 30.1% in the <2-h group versus 28.3% in the 18-h group (mean difference: 1.8%; upper bound of 95% confidence interval: 7.8%; p < 0.012 for noninferiority). The 30-day incidence of myocardial infarction, death, and target vessel revascularization was similar in both groups (p = NS). Major bleeding was less frequent in the <2-h group (1.0% vs. 4.2%, p = 0.02). CONCLUSIONS: After uncomplicated PCI, eptifibatide infusion can be abbreviated safely to <2 h. It is not inferior to the standard 18-h infusion in preventing ischemic outcome, and it may be associated with less major bleeding. (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention [BRIEF PCI]; NCT00111566).

Redefining the normal angiogram using population-derived ranges for coronary size and shape: validation using intravascular ultrasound and applications in diverse patient cohorts.

OBJECTIVES: To develop a method for quantitating coronary angiographic abnormalities of segmental size and shape (tapering) in comparison to gender- and segment-specific, population derived, normal values. BACKGROUND: In the absence of obvious focal stenoses, remodeling renders the angiogram insensitive to the presence of atherosclerosis and invalidates use of a "normal reference segment" for calculation of percent diameter stenosis. METHODS: Equations were created for detection of size/shape abnormalities of coronary angiographic segments. After validation using intravascular ultrasound (IVUS), the equations were applied to a cohort of segments judged to be completely normal by a panel of highly experienced, core laboratory technicians; and a cohort of patients judged by an experienced interventionalist to have completely normal coronaries. RESULTS: In patients assessed by core technicians, 53% (162/303) of males, 39% (209/538) of normal segments in males, 60% (56/94) of females, and 40% (81/205) of normal segments in females had quantifiable abnormalities. In patients with normal coronaries as judged by an experienced interventionalist, 100% of males (n = 14) and females (n = 19), 37% (67/182) of segments in males and 43% (105/247) of segments in females had abnormalities. The left main segment was most commonly abnormal. CONCLUSIONS: We propose a set of equations validated using IVUS and based on gender- and segment-specific normal values for coronary angiographic size and shape that markedly improves the sensitivity of the coronary angiogram for detection of abnormalities. The method should replace the unfounded practice of labeling coronary angiograms as "normal" based solely on the failure to detect focal stenoses.

Initial experience with a novel coronary rinsing and thrombectomy system: "Rinspiration".

BACKGROUND: Intracoronary thrombus is often problematic during percutaneous coronary intervention. Rinspiration is a new thrombectomy catheter system designed to mechanically disrupt and remove intravascular thrombus. METHODS: Rinspiration thrombectomy was performed in 15 patients with angiographically visible thrombus in native coronary arteries (10 cases) and in saphenous grafts (5 cases). Indications included acute myocardial infarction in 11 patients and postinfarction ischemia in 4 patients. RESULTS: The Rinspiration system appeared relatively simple to use. There were no device-related complications. Thrombectomy resulted in an improvement in thrombus grade from 3.8 +/- 1.6 to 2.5 +/- 1.7 (p = 0.02), and TIMI flow from 1.5 +/- 1.3 to 2.2 +/- 1.0 (p = 0.047). Stenting further improved thrombus grade to 0.8 +/- 1.6 and TIMI flow to 2.6 +/- 0.8. At 30-day follow up all patients remained free of repeat revascularization and reinfarction; 1 patient died from hemorrhagic stroke. CONCLUSIONS: The Rinspiration system appears capable of safely removing intracoronary thrombus and warrants further evaluation.

Proximal protection during saphenous vein graft angioplasty: the Kerberos embolic protection system.

Percutaneous intervention in the setting of aortocoronary saphenous vein graft disease is associated with a significant risk of distal embolization. Devices intended to minimize the clinical impact of embolization have primarily utilized distally placed occlusive balloons or filters. Although such systems are often effective, distal protection does have limitations. We report a novel proximal embolic protection and rinsing system intended to overcome some of these limitations.

Procedural efficacy and complications of X-Sizer thrombectomy in de novo and stented lesions.

Angiographic thrombus is associated with poorer procedural and clinical outcomes. We report our experience with the X-Sizer thrombectomy device (EndiCOR Medical) from March 2001 to December 2002. Indications for use in 44 patients (33 male; mean age, 60) included myocardial infarction (27), unstable angina (6), periprocedural thrombosis (2), acute (< 24 hr) stent thrombosis (1), and subacute (> 24 hr) stent thrombosis (8). Three cases involved vein grafts. Deployment was successful in 42/44. Difficulty traversing the stent occurred in 5/9 cases of in-stent thrombosis. Median TIMI flow increased from 1 to 2 (P = 0.01) postthrombectomy. Median final TIMI flow was 3. Complications included dissection (1), perforation, device jam on stent (1), disruption of a covered stent (1), distal macro-embolization (4), and transient no-reflow (5). The X-Sizer thrombectomy device improves TIMI flow but does not always prevent distal embolization. Care is needed when treating in-stent thrombosis.

Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation. A post hoc analysis of TAXUS II.

BACKGROUND AND METHOD: Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26). RESULTS: In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 +/- 0.36 vs. 0.33 +/- 0.30 mm) or intravascular ultrasound-(IVUS-)measured volume obstruction (7.95 +/- 9.84% vs. 5.61 +/- 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 +/- 0.30 vs. 0.80 +/- 0.62 mm) or IVUS-measured volume obstruction (5.61 +/- 7.91% vs. 22.50 +/- 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent. CONCLUSION: Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.

First clinical experience with the R Stent: a new highly flexible stainless steel tube intracoronary stent.

BACKGROUND: Coronary stents have been used with increasing frequency and in increasingly complex coronary disease. A new 316 LVM stainless steel coronary stent, the R Stent, has been designed to provide maximum flexibility for tracking and high radial strength post-deployment. PURPOSE: To assess the clinical feasibility of the R Stent in a tertiary referral population of patients with coronary heart disease. Specific objectives are to assess the R Stent's deployment success, angiographic and procedural success (<20% residual stenosis and >TIMI 2 flow), safety (absence of complications), and 30-day clinical success (angiographic/procedural success plus no major adverse coronary events). METHODS: Between April and November 1998, stent deployment was attempted in 27 patients with stable (46%) or unstable (54%) angina pectoris who qualified for percutaneous transluminal coronary angioplasty. Eighty per cent of patients had a pre-existing history of myocardial infarction, coronary bypass surgery or percutaneous transluminal coronary angioplasty, and several of the lesions were anatomically complex (totally occluded, n 32; thrombus present, n 32; heavily calcified, n 33; ostial, n 31; >20 mm long, n 39; angulation >45 degrees, n 37). Lesions in aortocoronary saphenous vein grafts were excluded. Adjunctive medical management included intraprocedural aspirin and heparin and post-procedural aspirin and ticlopidine. After deployment, patients were followed up in the hospital and at 30 days post procedure. RESULTS: Stent deployment was achieved in 32 of 33 attempts (26 of 27 patients). There was one deployment failure in a long, calcified ostial and proximal left coronary lesion. In the 26 successful deployments, TIMI 3 flow was achieved. One other patient experienced a painless increase in creatine kinase to 375 (CK-MB of 59) at 12 h without ECG changes. At 30 days, there were no deaths, no myocardial infarctions, no subacute thromboses, no repeat interventions, no bypass surgeries and no bleeding complications. Only the patient with post-procedural CK-MB elevation experience recurrence of CCS class 2 angina within the 30 days. CONCLUSION: The R Stent is a promising new device for the treatment of complex coronary heart disease. A larger, more broadly-based study is warranted.

Clinical and angiographic results with the NIR stent: First International NIR Endovascular Stent Study (FINESS-II).

BACKGROUND: Although safety and efficacy of the NIR trade mark stent have been reported, the long-term angiographic and clinical outcomes have yet to be investigated. The FINESS-II study (First International NIR Endovascular Stent Study) was designed to assess the procedural safety of single 9 and 16 mm NIR stent implantation, the six-month restenosis rate and finally the six- and 12-month clinical outcome of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >3 and <5 mm diameter were included in this multicentre, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary endpoint included major adverse cardiac events (death, myocardial infarction and target lesion revascularization) within 30 days after the procedure. Major bleeding complications and subacute stent thrombosis within the first 30 days were also reported as specific endpoints. Secondary endpoints were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. RESULTS: A total of 156 patients (81% male, mean age 60 +/- 10 years), with stable (54%), unstable (40%) angina pectoris or silent ischemia (6%) were enrolled. The target vessel diameter was 2.94 +/- 0.54 mm. The minimal lumen diameter pre, post and at follow-up was 1.04 +/- 0.32 mm, 2.64 +/- 0.42 mm and 1.88 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six month follow-up was 19% (26/136). At 12 months, the event-free survival rate was 83% (two deaths, one Q-wave and three non-Q-wave myocardial infarctions, four bypass surgery and 17 target lesion revascularizations), while 87% of the patients were free of angina pectoris. CONCLUSION: the outcome of the FINESS-II trial is comparable to those observed in previous stent trials (Benestent II), indicating that the coronary NIR stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.

Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial.

BACKGROUND: Although safety and efficacy of the beStent (Medtronic Inc., Santa Rosa, CA, USA) have been described, the long-term angiographic and clinical outcomes have yet to be investigated. The ROSE (Registry for Optimal beStent Evaluation) trial was designed to assess the procedural safety of single 15 mm beStent implantation, and the six-month angiographic and 12-month clinical outcomes of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of >/=2.75 mm diameter were included in this multicenter, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary end-point included major adverse cardiac events (death, myocardial infarction and target lesion revascularization), major bleeding complications, and thrombotic occlusions at one-month follow-up. Secondary end-points were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. A total of 120 patients (80% male, mean age 58.6 +/- 10.6 years) with stable (48%) or unstable (44%) angina pectoris were allocated. The target vessel reference diameter pre-procedure was 2.85 +/- 0.52 mm. RESULTS: Minimal lumen diameter pre/post and at follow-up was 0.97 +/- 0.28 mm, 2.53 +/- 0.40 mm and 1.86 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six-month follow-up was 21.5%. At 12 months, the event-free survival rate was 75% (no deaths, two Q-wave and seven non-Q-wave infarctions, five bypass surgery interventions and 16 target lesion revascularizations), whilst 87% of the patients were free of angina pectoris. CONCLUSION: Despite the relatively high percentage of small vessels, the outcome of the ROSE trial is comparable to those observed in previous stent trials, indicating that the coronary beStent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.