Lablanche, J.M.

Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial (Article)

2002-01-01T00:00:00Z

BACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI. METHODS AND RESULTS: In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76+/-0.77 mm in the placebo group, which was not different from MLD in the tranilast groups (1.72 to 1.78+/-0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72). CONCLUSIONS: Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

The "Ermonville" classification of observations at coronary angioscopy - evaluation of intra- and inter-observer agreement (Article)

1994-01-01T00:00:00Z

A European coronary angioscopy working group has been established to create and evaluate a classification system for angioscopic observation. The 'Ermenonville' classification features items, graded in 3-5 categories, such as lumen diameter, shape of narrowing, colours of surface, atheroma, dissection, thrombus, etc. Inter- and intra-observer agreement on the interpretation of angioscopic images, using this classification system, was studied within the working group. Kappa values for chance-corrected intra-observer agreement of the diagnostic items were 0.51-0.67. The mean kappa values for inter-observer agreement were very low at 0.13-0.29. The important items, such as red thrombus and dissection were studied after recoding as either present or absent. These items proved to have a good intra-observer agreement, and an acceptable inter-observer agreement after recoding. Other angioscopic diagnoses should be made with caution. Multicentre angioscopy studies should make use of an angioscopy core laboratory. A set of definitions for coronary angioscopy is proposed, and this working group will re-evaluate observer agreements using these definitions.

Usefulness of quantitative and qualitative angiographic lesion morphology, and clinical characteristics in predicting major adverse cardiac events during and after native coronary balloon angioplasty (Article)

1993-07-01T00:00:00Z

Major, adverse cardiac events (death, myocardial infarction, bypass surgery and reintervention) occur in 4 to 7% of all patients undergoing coronary balloon angioplasty. Prospectively collected clinical data, and angiographic quantitative and qualitative lesion morphologic assessment and procedural factors were examined to determine whether the occurrence of these events could be predicted. Of 1,442 patients undergoing balloon angioplasty for native primary coronary disease in 2 European multicenter trials, 69 had major, adverse cardiac procedural or in-hospital complications after ≥1 balloon inflation and were randomly matched with patients who completed an uncomplicated in-hospital course after successful angioplasty. No quantitative angiographic variable was associated with major adverse cardiac events in univariate and multivariate analyses. Univariate analysis showed that major adverse cardiac events were associated with the following preprocedural variables: (1) unstable angina (odds ratio [OR] 3.11; p < 0.0001), (2) type C lesion (OR 2.53; p < 0.004), (3) lesion location at a bend >45 ° (OR 2.34; p < 0.004), and (4) stenosis located in the middle segment of the artery dilated (OR 1.88; p < 0.03); and with the following postprocedural variable: angiographically visible dissection (OR 5.39; p < 0.0001). Muttivariate logistic analysis was performed to identify variables independently correlated with the occurrence of major adverse cardiac events. The preprocedural multivariate model entered unstable angina (OR 3.77; p < 0.0003), lesions located at a bend >45 ° (OR 2.87; p < 0.0005), and stenosis located in the middle portion of the artery dilated (OR 1.95; p < 0.04). If all variables were included, then angiographically visible dissection (OR 6.58; p < 0.0001), unstable angina (OR 3.46; p < 0.002) and lesions located at a bend >45 ° (OR 2.54; p < 0.006) were independent predictors of major adverse cardiac events.

Percutaneous transluminal coronary rotary ablation with rotablator (European experience) (Article)

1992-01-01T00:00:00Z

This study reports the results from 3 European centers using rotary ablation with Rotablator, a device that is inserted into the coronary artery and removes atheroma by grinding it into millions of tiny fragments. Rotary ablation was performed in 129 patients. Primary success (reduction in percent luminal narrowing greater than 20%, residual stenosis less than 50%, without complications) was achieved by rotary angioplasty alone in 73 patients (57%). An additional 38 patients (29%) had successful adjunctive balloon angioplasty. Thus primary success was achieved in 111 patients (86%) at the end of the procedure. Acute occlusion occurred in 10 patients (7.7%). Recanalization was achieved by balloon angioplasty in 7: urgent bypass grafting was undertaken in 2. Q-wave and non-Q-wave myocardial infarction occurred in 3 and 7 patients, respectively. No deaths occurred. Follow-up angiography was performed in 74 patients (60%). Restenosis, defined as the recurrence of significant luminal narrowing (greater than 50%) occurred in 17 of 37 patients (46%) who underwent rotary ablation alone, and 11 of 37 patients (30%) who had adjunctive balloon angioplasty. The overall angiographic restenosis rate was 37.8%. In conclusion, rotary ablation is technically feasible, and relatively safe in the coronary circulation. The low primary success rate reflects the limited size of the device, which can be introduced through available guiding catheters, and limits the use of rotary ablation as a stand-alone procedure to lesions in small arteries or in distal locations. No reduction in restenosis was seen, but the role of this device combined with balloon angioplasty in larger arteries needs to be further defined.

Contribution of dynamic vascular wall thickening to luminal narrowing during coronary arterial vasomotion (In Book)

1984-01-01T00:00:00Z

Contribution of dynamic vascular wall thickening to luminal narrowing during coronary arterial vasomotion (Article)

1983-01-01T00:00:00Z

The hypothesis has been developed that increased coronary artery vasomotor tone superimposed on a preexisting obstruction is a possible mechanism responsible for resting and exertional angina. In 18 patients (22 stenotic lesions), the maximal changes in coronary artery diameter (mm) induced by an ergometrine test followed by an injection of isosorbide dinitrate were assessed by a quantitative computer-based angiographic system. If we assume that there is no change in the length of the artery as the result of changes in its diameter, then at any point of the artery the area of the arterial wall on a transverse cross section of the vessel will be constant regardless of its state of its contraction or dilatation. As vasoconstriction occurs, the luminal diameter decreases proportionally more than the outer diameter of the vessel and the wall thickness increases. Using elementary geometric principles, we calculated and reconstructed the changes that might occur at the stenotic sites as the result of vasomotion acting on the entire coronary segment. From the reference diameter in the control state (Ri:3.7 +/- 1.1 mm) and after vasoconstriction (Ric: 3.3 +/- 1.0 mm) and the obstruction diameter in the control state (ri: 2.2 +/- 0.9 mm), the minimal obstruction diameter after vasoconstriction (ric: 1.0 +/- 0.8 mm) was derived using the following equation: ric2 = ri2 - Ri2 + Ric2. In four of 22 lesions, the decrease in diameter of the lumen of the normal vessel was fully translated to the stenotic point and the decrease in diameter at the stenosis was correctly predicted.(ABSTRACT TRUNCATED AT 250 WORDS)