http://repub.eur.nl/res/aut/2086/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/34605/ 2011-12-01T00:00:00Z Because the bioresorption of the ABSORB bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) is characterized by a diminishing gray-level intensity of the struts over time, the evaluation of quantitative changes in hyperechogenicity can be useful to follow the in vivo degradation of the scaffold. Whereas the first ABSORB generation showed at 6 months a 50% reduction in hyperechogenicity, the second ABSORB generation (1.1), designed to prolong the duration of luminal scaffolding, showed a 15% and 20% reduction in hyperechogenicity at 6 and 12 months, respectively, compared with post-implantation. These findings confirm the value of the manufacturing changes and suggest a slower degradation rate of the scaffold. This study sought to investigate quantitative and homogeneity differential echogenicity changes of the ABSORB scaffold (1.1) during the first year after implantation. The imaging of the ABSORB bioresorbable vascular scaffold degradation by intravascular ultrasound (IVUS) has previously demonstrated diminishing gray-level intensity of the struts over time that can be evaluated by IVUS-based differential echogenicity. The first generation of ABSORB (1.0) showed a 50% reduction in hyperechogenicity at 6 months and restoration of the pre-ABSORB implantation values at 2 years. The second generation of ABSORB (1.1), investigated in the ABSORB B trial, was modified to prolong the duration of luminal scaffolding. A total of 63 patients were examined by IVUS immediately post-implantation and at 6-month (Cohort B1, n = 28) or 12-month (Cohort B2, n = 35) follow-up. IVUS-based tissue composition analysis software was used to quantify changes in hyperechogenicity over time in the scaffolded regions. Relative changes in hyperechogenicity were calculated as: 100 × (% hyperechogenicity at follow-up - % hyperechogenicity at baseline)/% hyperechogenicity at baseline. At 6- and 12-month follow-up, there was a 15% (from 22.58 ± 9.77% to 17.42 ± 6.69%, p = 0.001) and 20% (from 23.51 ± 8.57% to 18.25 ± 7.19%, p < 0.001) reduction in hyperechogenicity, respectively, compared with post-implantation values. No difference in hyperechogenicity changes were observed between the proximal, medial, or distal part of the scaffolded segment. Quantitative differential echogenicity changes of the ABSORB scaffold (1.1) during the first 12 months after implantation are lower compared with those previously observed with its first generation (1.0), confirming the value of the manufacturing changes and suggesting a slower degradation rate of the scaffold. http://repub.eur.nl/res/pub/34610/ 2011-11-01T00:00:00Z Objectives: This study sought to evaluate the long-term clinical outcome of patients with an angiographically intermediate left anterior descending coronary artery (LAD) stenosis in whom the revascularization strategy was based on fractional flow reserve (FFR). Background: When revascularization is based mainly on angiographic guidance, a number of hemodynamically nonsignificant stenoses will be revascularized. Methods: In 730 patients with a 30% to 70% isolated stenosis in the proximal LAD and no significant valvular disease, FFR measurements were obtained to guide treatment strategy. When FFR was <0.80, the patients (n = 564) were treated medically (medical group); when FFR was <0.80, the patients (n = 166) underwent a revascularization procedure (revascularization group; 13% coronary artery bypass graft surgery and 87% percutaneous coronary intervention). A 100% long-term clinical follow-up (median follow-up: 40 months) was obtained. The 5-year survival of the medical group was compared with that of a reference population. For each patient, 4 controls were selected from an age- and sex-matched control population. Results: The 5-year survival estimate was 92.9% in the medical group versus 89.6% in the controls (p = 0.74). The mean diameter stenosis was significantly smaller in the medical than in the revascularization group (39 ± 14% vs. 54 ± 13%, p < 0.0001), but there was a large overlap between both groups. The 5-year event-free survival estimates (death, myocardial infarction, and target vessel revascularization) were 89.7% and 68.5%, respectively (p < 0.0001). Conclusions: Medical treatment of patients with a hemodynamically nonsignificant stenosis (FFR <0.80) in the proximal LAD is associated with an excellent long-term clinical outcome with survival at 5 years similar to an age- and sex-matched control population. http://repub.eur.nl/res/pub/33904/ 2011-10-04T00:00:00Z Objectives: The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months. Background: With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months. Methods: Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up. Results: Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56). Conclusions: The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856) http://repub.eur.nl/res/pub/33911/ 2011-07-12T00:00:00Z Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background: BVS are a novel approach to treating coronary lesions and are untested in small vessels. Methods: The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Results: At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643). Conclusions: The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels. http://repub.eur.nl/res/pub/34486/ 2011-07-01T00:00:00Z Objectives: The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V® everolimus-eluting metal stent (EES, SPIRIT I and II). Methods: In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. Results: Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 ± 0.18 mm) was numerically higher than metallic EES (vs. 0.13 ± 0.21 mm) and similar to BVS 1.0 (0.20 ± 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% ± 7.1%, BVS 1.0: 6.9% ± 7.0%, BVS 1.1: 6.7% ± 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil. Conclusions: The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results. Copyright http://repub.eur.nl/res/pub/34633/ 2011-07-01T00:00:00Z Objectives: The aim of this study was to compare the angiographic changes in coronary geometry of the bioresorbable vascular scaffolds (BVS) and metallic platform stent (MPS) between baseline and follow-up. Background: Coronary geometry changes after stenting might result in wall shear stress changes and adverse events. The BVS have better conformability, compared with MPS, but still modify artery geometry. It is uncertain whether the BVS resorption can restore the coronary anatomical configuration at midterm follow-up. Methods: All patients of the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions) and SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials treated with a single 3.0 × 18 mm device and imaged at baseline and 6- to 12-month follow-up were eligible. Coronary geometry changes were assessed with quantitative angiography as changes in curvature and angulation. Curvature and angulation changes between systole and diastole were investigated to assess hinging movements of the coronary artery. Results: One hundred sixty-one patients (86 BVS, and 75 MPS) were included. Baseline angiographic characteristics were similar. From post-implantation to follow-up, curvature increased 8.4% (p < 0.01) with BVS and decreased 1.9% (p = 0.54) with MPS; p = 0.01. Angulation increased 11.3% with BVS (p < 0.01) and 3.8% with MPS (p = 0.01); p < 0.01. From pre-implantation to follow-up, BVS decreased 3.4% the artery curvature (p = 0.05) and 3.9% the artery angulation (p = 0.16), whereas MPS presented with 26.1% decrease in curvature (p < 0.01) and 26.9% decrease in angulation (p < 0.01), being larger with MPS (p < 0.01, both). Hinging movements in curvature from pre-implantation to follow-up decreased 19.7% with BVS and 39.0% with MPS (p = 0.27) and decreased 3.9% with BVS and 26.9% with MPS in angulation (p < 0.01). Conclusions: At midterm follow-up, the BVS tended to restore the coronary configuration and the systo-diastolic movements to those seen before implantation. The coronary geometry remained similar to that seen at after implantation with MPS. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856) http://repub.eur.nl/res/pub/23288/ 2011-02-21T00:00:00Z Fractional flow reserve (FFR) is an index of the physiological significance of a coronary stenosis. Patients who have lesions with a FFR of >0.80, even optimally treated with medication, have however a MACE rate ranging from 8 to 21%. Coronary plaques at high risk of rupture and clinical events can be also identified by virtual histology intravascular ultrasound (IVUS-VH) as plaques with high amount of necrotic core (NC) abutting the lumen. Aim of this exploratory study was to investigate whether the geometry and composition of lesions with FFR ≤ 0.80 were different from their counterparts. Fifty-five consecutive patients in whom FFR was clinically indicated on a moderate angiographic lesion, received also an imaging investigation on the same lesion with IVUS-VH. Data on plaque geometry and composition was analyzed. Patients were subdivided in two groups according to the value of FFR (> or ≤0.80). Lesions with a FFR ≤ 0.80 (n = 17) showed a slightly larger plaque burden than those with FFR > 0.80 (n = 38) (54.6 ± 0.7% vs. 51.7 ± 0.7% P = 0.1). In addition, they tend to have less content of necrotic core than their counterparts (14.2 ± 8% vs. 19.2 ± 10.2%, P = 0.08). No difference was found in the distribution of NC-rich plaques (fibroatheroma and thin-capped fibroatheroma) between groups (82% in FFR ≤ 0.80 vs. 79% in FFR > 0.80, P = 0.5). Although FFR ≤ 0.80 lesions have larger plaque size, they do not differ in composition from the ones with FFR > 0.80. Further exploration in a large prospective study is needed to study whether the lesions with FFR > 0.80 that are NC rich are the ones associated with the presence of clinical events at follow-up. http://repub.eur.nl/res/pub/23598/ 2011-01-20T00:00:00Z BACKGROUND: Atherosclerotic plaques that lead to acute coronary syndromes often occur at sites of angiographically mild coronary-artery stenosis. Lesion-related risk factors for such events are poorly understood. METHODS: In a prospective study, 697 patients with acute coronary syndromes underwent three-vessel coronary angiography and gray-scale and radiofrequency intravascular ultrasonographic imaging after percutaneous coronary intervention. Subsequent major adverse cardiovascular events (death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina) were adjudicated to be related to either originally treated (culprit) lesions or untreated (nonculprit) lesions. The median follow-up period was 3.4 years. RESULTS: The 3-year cumulative rate of major adverse cardiovascular events was 20.4%. Events were adjudicated to be related to culprit lesions in 12.9% of patients and to nonculprit lesions in 11.6%. Most nonculprit lesions responsible for follow-up events were angiographically mild at baseline (mean [±SD] diameter stenosis, 32.3±20.6%). However, on multivariate analysis, nonculprit lesions associated with recurrent events were more likely than those not associated with recurrent events to be characterized by a plaque burden of 70% or greater (hazard ratio, 5.03; 95% confidence interval [CI], 2.51 to 10.11; P<0.001) or a minimal luminal area of 4.0 mm2 or less (hazard ratio, 3.21; 95% CI, 1.61 to 6.42; P = 0.001) or to be classified on the basis of radiofrequency intravascular ultrasonography as thin-cap fibroatheromas (hazard ratio, 3.35; 95% CI, 1.77 to 6.36; P<0.001). CONCLUSIONS: In patients who presented with an acute coronary syndrome and underwent percutaneous coronary intervention, major adverse cardiovascular events occurring during follow-up were equally attributable to recurrence at the site of culprit lesions and to nonculprit lesions. Although nonculprit lesions that were responsible for unanticipated events were frequently angiographically mild, most were thin-cap fibroatheromas or were characterized by a large plaque burden, a small luminal area, or some combination of these characteristics, as determined by gray-scale and radiofrequency intravascular ultrasonography. http://repub.eur.nl/res/pub/33721/ 2011-01-01T00:00:00Z BackgroundTranscatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.AimsPARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.Methods and resultsPrimary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7, P <0.0005) and more peripheral disease (49.3 vs. 16.4, P< 0.0001). Procedures were aborted in four TA (5.8) and six TF cases (9.8). Valve implantation was successful in the remaining patients in 95.4 and 96.4, respectively. Thirty days and 6 months survival were 81.2 and 58.0 (TA) and 91.8 and 90.2 (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8 of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7 had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.ConclusionThis first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes. http://repub.eur.nl/res/pub/27576/ 2010-11-30T00:00:00Z Background-: The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified. Methods and results-: Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5.4% on intravascular ultrasound. OCT showed at follow-up that 96.8% of the struts were covered and that malapposition of at least 1 strut, initially observed in 12 scaffolds, was detected at follow-up in only 3 scaffolds. Mean neointimal growth measured by OCT between and on top of the polymeric struts equaled 1.25 mm, or 16.6% of the scaffold area. Conclusion-: Modified manufacturing process of the polymer and geometric changes in the polymeric platform have substantially improved the medium-term performance of this new generation of drug-eluting scaffold to become comparable to those of current drug eluting stents. http://repub.eur.nl/res/pub/21827/ 2010-11-01T00:00:00Z Objectives The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. Background Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. Methods This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 × 18 mm device. Curvature and angulation were measured with dedicated software by angiography. Results Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm-1 vs. 0.056 cm-1, p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4° vs. 4.3°, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pre-treatment region curvature, the pre-treatment region angulation, and the used device. Conclusions Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation. http://repub.eur.nl/res/pub/28035/ 2010-03-16T00:00:00Z Objectives: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. Background: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. Methods: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. Results: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. Conclusions: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis. http://repub.eur.nl/res/pub/27668/ 2010-02-01T00:00:00Z Background: Animal models show impairment of arterial healing after drug-eluting stents (DES) compared with bare-metal stents (BMS). Virtual histology intravascular ultrasound (VH-IVUS) offers an opportunity to assess lesion morphology in vivo. Methods: We used VH-IVUS in 80 patients to assess long-term (median = 10 months) native artery vascular responses after 76 implantations of DES compared with 32 BMS. The presence of "necrotic core abutting the lumen" was evaluated at baseline and follow-up. Results: At baseline, necrotic core abutting the lumen through the stent struts was observed in 76% of DES and 75% of BMS. Although the percentage of necrotic core within the plaque behind the stents did not change during follow-up in DES (23% [18%, 28%] to 22% [17%, 27%], P = .57) or BMS (22% [19%, 27%] to 20% [12%, 26%], P = .29), necrotic core abutting the lumen through the stent struts decreased more in BMS (75% to 19%, P < .001) than DES (76% to 61%, P = .036) because of the lack of an overlying, protective neointima in DES-treated lesions. Furthermore, within the adjacent reference segments, the incidence of necrotic core abutting the lumen decreased in BMS-treated lesions (proximal 23% to 0%, P = .023; distal 21% to 0%, P = .023), but not in DES (proximal 22% to 17%, P = .48; distal 23% to 21%, P = .82). Conclusions: Serial VH-IVUS analysis of DES-treated lesions showed a greater frequency of unstable lesion morphometry at follow-up compared with BMS. The apparent mechanism was a suppression of the protective neointimal hyperplasia layer coupled with a lack of vulnerable plaque resolution at reference segments in DES compared with BMS. http://repub.eur.nl/res/pub/27282/ 2010-01-01T00:00:00Z Noncalcific attenuated plaques identified by grayscale intravascular ultrasound (IVUS) are often seen in patients with acute coronary syndromes and have been associated with no reflow and creatine kinase-MB elevation after percutaneous coronary intervention. Histopathology has shown cholesterol clefts, microcalcification, or organized thrombus. One hundred twenty-four vessels in 64 patients with acute coronary syndromes from the PROSPECT trial were identified for inclusion in the present analysis. After excluding 4 vessels with severe calcification, 9 vessels with <40% plaque burden, and 3 vessels with too few (<3) virtual histology (VH)-IVUS frames for analysis, complete grayscale IVUS and VH-IVUS was available for 108 vessels in 64 patients that contained 39 VH-IVUS thin-capped fibroatheromas (VH-TCFA), 40 thick-capped fibroatheromas (VH-ThFA), and 33 pathologic intimal thickening but no fibrotic or fibrocalcific plaques. Overall, there were 47 grayscale IVUS attenuated plaques in 43 vessels. Compared to the minimum luminal sites of the remaining 65 vessels (controls), attenuated plaques contained larger necrotic core areas (1.5 ± 0.9 vs 0.9 ± 0.8 mm2in controls, p = 0.001). Fibroatheromas (VH-TCFA or VH-ThFA) were more common at the sites of attenuated plaques than at control sites (VH-TCFA 42.5% vs 29.2%, VH-ThFA 53.2% vs 23.1%, pathologic intimal thickening 4.3% vs 47.7%, p <0.0001). In conclusion, grayscale IVUS attenuated plaques are associated with a large amount of VH-IVUS necrotic core and are markers of the presence of fibroatheromas (VH-TCFA or VH-ThFA). This may explain the biologic instability of these lesions. http://repub.eur.nl/res/pub/24893/ 2009-07-01T00:00:00Z Objective: The The Arterial Revascularization Therapies Study (ARTS)-II trial found no differences in survival or overall adverse events between sirolimus-eluting stents (SES) and the surgical arm of ARTS-I. Nevertheless, existing data suggest that patients with disease of the proximal left anterior descending artery (LAD) may derive particular benefit from coronary artery bypass grafting (CABG). We therefore analysed the clinical outcome of patients in ARTS-I and ARTS-II with proximal LAD involvement. Design: Multicentre observational study. Setting: Forty-five European academic hospitals. Patients: Patients with multivessel coronary artery disease. Interventions: Patients in ARTS-II with proximal LAD disease treated with SES (289/607, 48%) were compared with 187/600 (31%) bare metal stent patients (ARTS-I BMS) and 206/605 (34%) surgical patients (ARTS-I CABG) with proximal LAD involvement from ARTS-I. Main outcome measures: Major adverse cardiac and cerebrovascular events after 3 years. Results: The Arterial Revascularization Therapies study part 2 (ARTS-II) subgroup had better survival than both ARTS-I groups (ARTS-II 98.6% vs ARTS-I BMS 95.7%, p = 0.05 and vs ARTS-I CABG 94.7%, p = 0.01) and lower rates of the hard clinical composite endpoint of death or non-fatal myocardial infarction (ARTS-II 3.1% vs ARTS-I BMS 9.6%, p = 0.002 and vs ARTS-I CABG 9.7%, p = 0.002). Although the ARTS-I CABG patients had a lower need for repeat revascularisation than ARTS-II (5.3% vs 13.1%, p = 0.002), the overall composite adverse event rates (death, myocardial infarction, stroke or any repeat revascularisation) were not significantly different between the ARTS-I CABG and ARTS-II patients (15.0% vs 18.0%, p = 0.4). Conclusions: SES are not inferior to CABG or bare metal stents for the treatment of patients with multivessel coronary disease including involvement of the proximal LAD. http://repub.eur.nl/res/pub/35735/ 2007-09-01T00:00:00Z Aims: Exercise-induced mitral regurgitation (MR) bears a poor prognosis in patients with congestive heart failure (CHF). Cardiac resynchronization therapy (CRT) is associated with improved clinical outcome but its effects on exercise-induced MR remain undetermined. We investigated serial changes in functional MR in relation to left ventricular (LV) remodelling and cardiopulmonary performance after CRT. Methods and results: Twenty-eight patients with CHF (LV ejection fraction 25 ± 7%), broad QRS complex (171 ± 27 ms), and at least mild MR [effective regurgitant orifice (ERO) 0.25 ± 0.12 cm2] were studied with quantitative exercise echocardiography and cardiopulmonary exercise testing prior, within 1 week, and 3 months after CRT. Early after CRT, a decrease in LV dyssynchrony (from 54 ± 21 to 19 ± 7 ms, P < 0.001) and in MR at rest (ERO from 0.25 ± 0.12 to 0.20 ± 0.10 cm2, P = 0.047) was observed. However, no change in exercise-induced increase in MR was observed (ERO from 0.34 ± 0.12 to 0.31 ± 0.16 cm2, NS). Three months after CRT, a decrease in the mitral valve tenting area (from 3.3 ± 1.2 to 2.0 ± 0.6 cm2, P < 0.001) and an increase in LV sphericity index (from 1.5 ± 0.3 to 1.8 ± 0.5, P < 0.001) were paralleled by an attenuation of exercise-induced MR (ERO 0.19 ± 0.06 cm2, P = 0.001 vs. prior CRT). This was associated with an increase in LV ejection fraction (from 25 ± 7 to 35 ± 9%, P < 0.001), peak oxygen uptake (from 11.7 ± 2.4 to 13.7 ± 3.8 mL/kg/min, P = 0.001), and a decrease in Nt-pro-BNP (from 2777 ± 1681 to 1963 ± 1361 pg/mL, P = 0.067). Conclusion: CRT is associated with acute decrease in resting MR but does not immediately attenuate exercise-induced MR. In contrast, only late, CRT-induced reversed LV remodelling and reduced mitral apparatus deformation are associated with a reduction in both resting and exercise-induced MR and with an improvement in cardiopulmonary performance. http://repub.eur.nl/res/pub/36204/ 2007-05-29T00:00:00Z Objectives: The purpose of this study was to investigate the appropriateness of stenting a functionally nonsignificant stenosis. Background: Percutaneous coronary intervention (PCI) of an intermediate stenosis without evidence of ischemia is often performed, but its benefit is unproven. Coronary pressure-derived fractional flow reserve (FFR) is an invasive index used to identify a stenosis responsible for reversible ischemia. Methods: In 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 5 years. Results: There were no differences in baseline clinical characteristics between the 3 groups. Complete follow-up was obtained in 98% of the patients. Event-free survival was not different between the Defer and Perform groups (80% and 73%, respectively; p = 0.52), but was significantly worse in the Reference group (63%; p = 0.03). The composite rate of cardiac death and acute myocardial infarction in the Defer, Perform, and Reference groups was 3.3%, 7.9%, and 15.7%, respectively (p = 0.21 for Defer vs. Perform group; p = 0.003 for the Reference vs. both other groups). The percentage of patients free from chest pain at follow-up was not different between the Defer and Perform groups. Conclusions: Five-year outcome after deferral of PCI of an intermediate coronary stenosis based on FFR ≥0.75 is excellent. The risk of cardiac death or myocardial infarction related to this stenosis is <1% per year and not decreased by stenting. http://repub.eur.nl/res/pub/35471/ 2007-04-15T00:00:00Z The Syntax score (SXscore) was recently developed as a comprehensive angiographic scoring system aiming to assist in patient selection and risk stratification of patients with extensive coronary artery disease undergoing contemporary revascularization. A validation of this angiographic classification scheme is lacking. We assessed its predictive value in patients who underwent percutaneous intervention (PCI) for 3-vessel disease and explored its performance in comparison with the modified lesion classification system of the American Heart Association/American College of Cardiology. The SXscore, applied to 1,292 lesions in 306 patients who underwent PCI for 3-vessel disease in the Arterial Revascularization Therapies Study Part II, was 4 to 54.5, and after a median of 370 days (range 274 to 400) predicted the rate of major adverse cardiac and cerebrovascular events (hazard ratio 1.08/U increase, 95% confidence interval 1.05 to 1.11, p <0.0001), with patients in the highest SXscore tertile having a significantly higher event rate (27.9%) than patients in the lowest tertile (8.7%, hazard ratio 3.5, 95% confidence interval 1.7 to 7.4, p = 0.001). By multivariable analyses, SXscore independently predicted outcome with an almost fourfold adjusted increase in the risk of major adverse cardiac and cerebrovascular events in patients with high versus low values based on the discrimination level provided by classification and regression tree analysis. Compared with the modified lesion classification scheme of the American Heart Association/American College of Cardiology, SXscore showed a greater discrimination ability (c-index 0.58 ± 0.08 vs 0.67 ± 0.08, respectively, p <0.001) and a better goodness of fit with the Hosmer-Lemeshow statistic. In conclusion, the SXscore is a promising tool to risk stratify outcome in patients with extensive coronary artery disease undergoing contemporary PCI. http://repub.eur.nl/res/pub/36223/ 2007-01-30T00:00:00Z Objectives: We sought to evaluate the impact of unstable coronary artery disease (CAD) on short- and mid-term outcomes in patients with multivessel disease treated by multiple sirolimus-eluting stents (SES) as part of ARTS II (Arterial Revascularization Therapies Study Part II). Background: The differential safety/efficacy profile of SES when implanted in patients with unstable angina (UA) in comparison with stable angina (SA) undergoing multivessel intervention is largely unknown. Methods: Between February 2003 and November 2003, 607 patients at 45 participating centers were treated; 221 of them (36%) presented with UA. Results: At 30 days, the cumulative rate of death, myocardial infarction-defined as any creatine kinase (CK)/CK-myocardial band elevation beyond the upper limit of normal-cerebrovascular accident, and repeat revascularization (i.e., major adverse cardiac and cerebrovascular events [MACCEs]) was 19.9% in both groups. Angiographic subacute stent occlusion was documented in 1 (0.5%) and 4 (1%) patients in the UA and SA groups, respectively. At 1 year, the cumulative incidence of MACCEs was 27.1% in the UA and 24.9% in the SA group (p = 0.56). Two late occlusions occurred, both in the SA group. After adjustment for baseline and procedural characteristics, the presence of UA was not identified as an independent predictor of MACCE (hazard ratio 0.94; 95% confidence interval 0.41 to 2.12; p = 0.88). These findings remained consistent after increasing the CK/CK-myocardial band threshold to define periprocedural myocardial infarction up to at least 3 or 5 times the upper limit of normal. Conclusions: In ARTS II, an unstable clinical presentation did not exert a negative impact on short- and mid-term outcome after SES implantation for multivessel disease. (ARTS II Trial; http://clinicaltrials.gov/ct/show/NCT00235170?order=1; NCT00235170). http://repub.eur.nl/res/pub/10021/ 2002-12-01T00:00:00Z INTRODUCTION: Quantitative angiographic assessment after balloon angioplasty is a poor predictor of immediate and long-term outcome. However, the measurement of blood flow velocity during angioplasty has been proved clinically useful. AIMS: To analyse the value of the maximal stenotic flow velocity and the presence of stenotic flow velocity acceleration (aSV) for the long-term outcome after balloon angioplasty. METHODS AND RESULTS: Patients undergoing single lesion angioplasty within the DEBATE trial were included. aSV was defined as acceleration in the stenotic coronary flow velocity >50% baseline velocity assessed at a reference site of the target vessel. After balloon angioplasty diameter stenosis, minimal lumen diameter (MLD) and coronary flow velocity reserve were similar between the aSV (n=54) and non-aSV group (n=125). At follow-up, the aSV group had a higher restenosis rate (52% vs 30%, P=0.006) The presence of aSV was the strongest independent predictor of restenosis (OR 3.08, 95% CI 1.35 to 7.05, P=0.008). The best predictive cut-off value of SV was 101cm.s(-1) (sensitivity of 46%, specificity of 81%, positive predictive value of 85% and a negative predictive value of 58%). CONCLUSION: Following angioplasty, SV appears to be exquisitely sensitive to the changes experienced at the treated area without depending on the status of the microcirculation. http://repub.eur.nl/res/pub/13002/ 2002-01-01T00:00:00Z AIMS: This study was conducted to analyse flow velocity parameters and predictors of a suboptimal coronary flow reserve (<2.5) following balloon angioplasty. METHODS: Two hundred and twenty-five patients underwent sequential intracoronary Doppler as part of the DEBATE I study. Of these, 183, with complete angiography and Doppler at the 6-month follow-up, were included. Univariate and multivariate logistic analysis was performed to identify independent predictors of post-procedural suboptimal coronary flow reserve, defined as coronary flow reserve <2.5. RESULTS: Forty-eight per cent (n=88) of the patients achieved a suboptimal coronary flow reserve. These patients had higher baseline velocities (cm.s(-1)) before balloon angioplasty (18+/-9 vs 14+/-6, P=0.004), after balloon angioplasty (22+/-11 vs 14+/-5, P<0.001) and at follow-up (19+/-9 vs 16+/-6, P=0.011) than the optimal coronary flow reserve group. Although the suboptimal group had lower hyperaemic velocities (cm.s(-1)) after balloon angioplasty than the optimal group (42+/-17 vs 49+/-16, P=0.008), these velocities became similar at follow-up. Increasing age (odds ratio, OR 1.071, P=0.0002), female gender (OR 2.52, P=0.014) and increasing pre-procedural baseline average peak velocities (OR 1.056, P<0.001) were found to be independent predictors of a suboptimal coronary flow reserve following balloon angioplasty. CONCLUSION: A suboptimal coronary flow reserve was associated with (1) a chronically elevated baseline average peak velocity (2) a transient deficit in the hyperaemic average peak velocity (3) the elderly, and female gender. http://repub.eur.nl/res/pub/9882/ 2002-01-01T00:00:00Z BACKGROUND: Because heterogeneous results have been reported, we assessed coronary flow velocity changes in individuals who underwent percutaneous transluminal coronary angioplasty (PTCA) and examined their impact on clinical outcome. METHODS AND RESULTS: As part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II study, 379 patients underwent Doppler flow-guided angioplasty. All patients were evaluated according to their coronary flow velocity reserve (CFVR) results (> or =2.5 or < 2.5) at the end of the procedure. A CFVR < 2.5 after angioplasty was associated with an elevated baseline blood flow velocity in both the target artery and reference artery. CFVR before PTCA and CFVR in the reference artery were independent predictors of an optimal CFVR after balloon angioplasty (CFVR before PTCA: odds ratio [OR], 2.26; 95% confidence interval [CI], 1.57 to 3.24; CFVR in reference artery: OR, 1.90; 95% CI, 1.21 to 2.98; both P<0.001) and stent implantation (before PTCA: OR, 2.54; 95% CI, 1.47 to 4.36; reference artery: OR, 1.97; 95% CI, 1.07 to 3.87; both P<0.05). A low CFVR at the end of the procedure was an independent predictor of major adverse cardiac events (MACE) at 30 days (OR, 4.71; 95% CI, 1.14 to 25.92; P=0.034) and at 1 year (OR, 2.06; 95% CI, 1.16 to 3.66; P=0.014). After excluding MACE at 30 days, no difference in MACE at 1 year was observed between the patients with and without a CFVR < 2.5 at the end of the procedure. CONCLUSIONS: A low postprocedural CFVR was associated with a worse periprocedural outcome (which was related to microcirculatory disturbances), but there was no significant difference at late follow-up. http://repub.eur.nl/res/pub/12947/ 2001-09-01T00:00:00Z BACKGROUND: There are limited data regarding the immediate and long-term effect of balloon angioplasty on the coronary flow reserve evaluated in a multicentre setting. METHODS AND RESULTS: A total of 86 patients with one-vessel disease and normal left ventricular function were analysed before and after optimal balloon angioplasty (diameter stenosis <35%) and at 6-month follow-up. Coronary flow reserve was assessed with a Doppler guide wire. A low coronary flow reserve (<or=2.5) after PTCA, due to an increased baseline blood flow velocity, was encountered in 42 of the 86 patients (49%). Recurrence of angina and target lesion revascularization were more frequent in these patients than in patients with a coronary flow reserve >2.5 (46% vs 23% and 36% vs 16%, respectively; P<0.05) due to a trend towards restenosis (29% vs 16%; P=0.15) or a low coronary flow reserve at follow-up due to persistent elevated baseline blood flow velocity. Patients without restenosis showed a decrease or increase of coronary flow reserve during follow-up, determined by alterations of hyperaemic blood flow velocity. CONCLUSIONS: Patients with an impaired coronary flow reserve directly after optimal balloon angioplasty showed a higher target lesion revascularization rate compared to patients with a coronary flow reserve >2.5. This patient group consists of patients prone to develop restenosis, while other patients are characterized by a persistently low coronary flow reserve, probably secondary to disturbed autoregulation and/or diffuse mild coronary atherosclerosis. Coronary flow reserve alterations in patients without restenosis were related to changes in hyperaemic blood flow velocity, suggesting that this phenomenon relates to epicardial remodelling. http://repub.eur.nl/res/pub/4831/ 2001-07-01T00:00:00Z Background The coronary flow velocity acceleration at the stenotic site (SVA), defined as a ≥50% increase in resting stenotic velocity when compared with the reference segment, has been shown to be highly sensitive and specific for the diagnosis of a hemodynamically significant stenosis. In this study, we describe the value of postprocedural SVA for the prediction of a lack of improvement in functional activity at long-term follow-up balloon angioplasty (BA). Methods We investigated the improvement in functional activity in patients undergoing single native vessel angioplasty and intracoronary Doppler (before BA, after BA, and again at 6-month follow-up) as part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) I trial. Lack of improvement was defined as no change in Duke Activity Status Index (DASI) at 6-month follow-up, whereas SVA was defined as ≥50% elevation in resting velocity at the treated area compared with the distal measurement. Results SVA was found more frequently in patients without improvement in DASI (45% vs 31%, P = .03). Similar percent diameter stenosis and coronary flow velocity reserve were observed in patients with and those without improvement in DASI at follow-up. By multivariate regression analysis, the presence of SVA (P = .029; odds ratio, 1.97; 95% confidence interval, 1.07 to 3.63) and an elevated DASI at baseline (P < .001; odds ratio, 1.05; 95% confidence interval, 1.03 to 1.07) were associated with a lack of improvement at follow-up. Conclusions The detection of SVA was associated with failure of improvement in functional activity at follow-up after coronary intervention. http://repub.eur.nl/res/pub/8301/ 2001-01-01T00:00:00Z OBJECTIVE: To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome. METHODS: 523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection. RESULTS: Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was < 2.5 or >/= 2.5 after balloon angioplasty. CONCLUSIONS: Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome. http://repub.eur.nl/res/pub/8449/ 2001-01-01T00:00:00Z BACKGROUND: Beta radiation is effective in reducing vascular neointimal proliferation in animals after injury caused by balloon angioplasty. However, the lowest dose that can prevent restenosis after coronary angioplasty has yet to be determined. METHODS: After successful balloon angioplasty of a previously untreated coronary stenosis, 181 patients were randomly assigned to receive 9, 12, 15, or 18 Gy of radiation delivered by a centered yttrium-90 source. Adjunctive stenting was required in 28 percent of the patients. The primary end point was the minimal luminal diameter six months after treatment, as a function of the delivered dose of radiation. RESULTS: At the time of follow-up coronary angiography, the mean minimal luminal diameter was 1.67 mm in the 9-Gy group, 1.76 mm in the 12-Gy group, 1.83 mm in the 15-Gy group, and 1.97 mm in the 18-Gy group (P=0.06 for the comparison of 9 Gy with 18 Gy), resulting in restenosis rates of 29 percent, 21 percent, 16 percent, and 15 percent, respectively (P=0.14 for the comparison of 9 Gy with 18 Gy). At that time, 86 percent of the patients had had no serious cardiac events. In 130 patients treated with balloon angioplasty alone, restenosis rates were 28 percent, 17 percent, 16 percent, and 4 percent, respectively (P=0.02 for the comparison of 9 Gy with 18 Gy). Among these patients, there was a dose-dependent enlargement of the lumen in 28 percent, 50 percent, 45 percent, and 74 percent of patients, respectively (P<0.001 for the comparison of 9 Gy with 18 Gy). The rate of repeated revascularization was 18 percent with 9 Gy and 6 percent with 18 Gy (P=0.26). CONCLUSIONS: Intracoronary beta radiation therapy produces a significant dose-dependent decrease in the rate of restenosis after angioplasty. An 18-Gy dose not only prevents the renarrowing of the lumen typically observed after successful balloon angioplasty, but actually induces luminal enlargement. http://repub.eur.nl/res/pub/12838/ 2000-03-15T00:00:00Z AIMS: Evaluation of angiographical and intracoronary Doppler-derived parameters of coronary stenosis severity. METHODS AND RESULTS: A total of 225 patients with one-vessel disease were studied before PTCA and at 6 months follow-up. Exercise electrocardiography was performed to document presence (n = 157) or absence (n = 138) of an ST segment shift (> or =0.1 mV). Intracoronary blood flow velocity analysis was performed to determine the proximal/distal flow velocity ratio, the distal diastolic/systolic flow velocity ratio and coronary flow velocity reserve. Receiver operator characteristic curves were calculated to assess the predictive value of these variables compared with the exercise test. The distal coronary flow velocity reserve demonstrated the best linear correlation for both percentage diameter stenosis and minimum lumen diameter (r = 0.67 and r = 0.66; P<0.01), compared to the diastolic/systolic flow velocity ratio (r = 0.19 and r = 0.14; P<0.01) and the proximal/distal flow velocity ratio (r = 0.03 and r = 0.07; not significant). The areas under the curve were 0. 84+/-0.02; 0.82+/-0.03 and 0.83+/-0.03 for diameter stenosis, minimum lumen diameter and coronary flow velocity reserve, respectively. Logistic regression analysis revealed that the percentage diameter stenosis or minimum lumen diameter and coronary flow velocity reserve were independent predictors for the result of stress testing. CONCLUSIONS: The distal coronary flow velocity reserve is the best intracoronary Doppler parameter for evaluation of coronary narrowings. Angiographical estimates of coronary lesion severity and distal coronary flow velocity reserve are good and independent predictors for the assessment of functional severity of coronary stenosis, emphasizing the complementary role of these parameters for clinical decision making. http://repub.eur.nl/res/pub/9552/ 2000-01-01T00:00:00Z BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty. http://repub.eur.nl/res/pub/4973/ 1997-01-01T00:00:00Z Background The aim of this prospective, multicenter study was the identification of Doppler flow velocity measurements predictive of clinical outcome of patients undergoing single-vessel balloon angioplasty with no previous Q-wave myocardial infarction. Methods and Results In 297 patients, a Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty. In 225 patients with an angiographically successful percutaneous transluminal coronary angioplasty (PTCA), postprocedural distal coronary flow reserve (CFR) and percent diameter stenosis (DS%) were correlated with symptoms and/or ischemia at 1 and 6 months, with the need for target lesion revascularization, and with angiographic restenosis (defined as DS 50% at follow-up). Logistic regression and receiver operator characteristic curve analyses were applied to determine the prognostic cutoff value of CFR and DS separately and in combination. Optimal cutoff criteria for predictors of these clinical events were DS, 35%; CFR, 2.5. A distal CFR after angioplasty >2.5 with a residual DS 35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% versus 19%, P=.149) and at 6 months (23% versus 47%, P=.005), a low need for reintervention (16% versus 34%, P=.024), and a low restenosis rate (16% versus 41%, P=.002) compared with patients who did not meet these criteria. Conclusions Measurements of distal CFR after PTCA, in combination with DS%, have a predictive value, albeit modest for the short- and long-term outcomes after PTCA, and thus may be used to identify patients who will or will not benefit from additional therapy such as stent implantation.