Per Mølstad

Stenting in chronic coronary occlusion (SICCO): A randomized, controlled trial of adding stent implantation after successful angioplasty

OBJECTIVES This study investigated whether stenting improves long-term results after recanalization of chronic coronary occlusions. BACKGROUND Restenosis is common after percutaneous transluminal coronary angioplasty (PTCA) of chronic coronary occlusions. Stenting has been suggested as a means of improving results, but its use has not previously been investigated in a randomized trial. METHODS We randomly assigned 119 patients with a satisfactory result after successful recanalization by PTCA of a chronic coronary occlusion to 1) a control (PTCA) group with no other intervention, or 2) a group in which PTCA was followed by implantation of Palmaz-Schatz stents with full anticoagulation. Coronary angiography was performed before randomization, after stenting and at 6-month follow-up. RESULTS Inguinal bleeding was more frequent in the stent group. There were no deaths. One patient with stenting had a myocardial infarction. Subacute occlusion within 2 weeks occurred in four patients in the stent group and in three in the PTCA group. At follow-up, 57% of patients with stenting were free from angina compared with 24% of patients with PTCA only (p < 0.001). Angiographic follow-up data were available in 114 patients. Restenosis (> or = 50% diameter stenosis) developed in 32% of patients with stenting and in 74% of patients with PTCA only (p < 0.001); reocclusion occurred in 12% and 26%, respectively (p = 0.058). Minimal lumen diameter (mean +/- SD) at follow-up was 1.92 +/- 0.95 mm and 1.11 +/- 0.78 mm, respectively (p < 0.001). Target lesion revascularization within 300 days was less frequent in patients with stenting than in patients with PTCA only (22% vs. 42%, p = 0.025). CONCLUSIONS Stent implantation improved long-term angiographic and clinical results after PTCA of chronic coronary occlusions and is thus recommended regardless of the primary PTCA result.

Stenting in small coronary arteries (SISCA) trial. A randomized comparison between balloon angioplasty and the heparin-coated beStent.

OBJECTIVES The purpose of this study was to assess the clinical and angiographic benefits of elective stenting in coronary arteries with a reference diameter of 2.1 to 3.0 mm, as compared with traditional percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND The problems related to small-vessel stenting might be overcome using modern stents designed for small vessels, combined with effective antiplatelet therapy. METHODS In five centers, 145 patients with stable or unstable angina were randomly assigned to elective stenting treatment with the heparin (Hepamed)-coated beStent or PTCA. Control angiography was performed after six months. The primary end point was the minimal lumen diameter (MLD) at follow-up. Secondary end points were the restenosis rate, event-free survival and angina status. RESULTS At follow-up, there was a trend toward a larger MLD in the stent group (1.69 +/- 0.52 mm vs. 1.57 +/- 0.44 mm, p = 0.096). Event-free survival at follow-up was significantly higher in the stent group: 90.5% vs. 76.1% (p = 0.016). The restenosis rate was low in both groups (9.7% and 18.8% in the stent and PTCA groups, respectively; p = 0.15). Analyzed as treated, both the MLD and restenosis rate were significantly improved in patients who had stents as compared with PTCA. CONCLUSIONS In small coronary arteries, both PTCA and elective stenting are associated with good clinical and angiographic outcomes after six months. Compared with PTCA, elective treatment with the heparin-coated beStent improves the clinical outcome; however, there was only a nonsignificant trend toward angiographic improvement.

Sustained benefit of Stenting Chronic Coronary occlusion : Long-term clinical follow-up of the Stenting in Chronic Coronary occlusion (SICCO) study

OBJECTIVES This study assessed the long-term clinical outcome of stenting chronic occlusions. BACKGROUND In the Stenting in Chronic Coronary Occlusion (SICCO) study, patients were randomized to additional stent implantation (n = 58) or not (n = 59) after successful recanalization and dilation of a chronic coronary occlusion. Palmaz-Schatz stents were used with full anticoagulation. The previously published 6-month angiographic follow-up results showed reduction of the restenosis rate from 74% to 32%. METHODS The primary end point was the occurrence of major adverse cardiac events (cardiac death, lesion-related acute myocardial infarction, repeat lesion-related revascularization or angiographic documentation of reocclusion). RESULTS Late clinical follow-up was obtained in all patients at 33 +/- 6 months. Major adverse cardiac events occurred in 14 patients (24.1%) in the stent group compared with 35 patients (59.3%) in the percutaneous transluminal coronary angioplasty (PTCA) group (odds ratio 0.22, 95% confidence interval 0.10 to 0.49, p = 0.0002). Target vessel revascularization (including failed PTCA attempts) was performed in 24% of the stent group and in 53% of the PTCA group (p = 0.002). There were no events in the stent group after 8 months, whereas events continued to occur in the PTCA group. By multivariate analysis, allocation to the PTCA group, left anterior descending coronary artery lesion and lesion length were significantly related to the development of major adverse cardiac events. CONCLUSIONS These data demonstrate the long-term safety and clinical benefit of stenting recanalized chronic occlusions. There is a continued risk of late clinical events related to nonstented lesions. Implantation of an intracoronary stent should therefore be considered after successful opening of a chronic coronary occlusion.

Limited usefulness of non-invasive coronary angiography with 16-detector multislice computer tomography at a community hospital.

Objectives. To evaluate the usefulness of coronary angiography by 16-detector multislice spiral computed tomography (MSCT) in community hospital outpatients. Design. MSCT was performed at the community hospital in 157 of 218 consecutive outpatients with suspected significant coronary disease, before referral for invasive coronary angiography. Results. 101 patients had interpretable MSCT angiograms (64 men, age 62±10 years, calcium score 373±678, heart rate 56±7 beats/min, beta-blocker used by 91%). Coronary stenoses >50% were identified by invasive angiography in 49 patients. Only 79% of all segments could be assessed by MSCT due to heavy coronary calcification (12%) and blurred images (9%) in the remaining. By interpreting non-assessable segments as negative results 79 patients were correctly classified by MSCT. Sensitivity, specificity, positive and negative predictive values at patient level was 82%, 75%, 75% and 81%. By interpreting non-assessable segments as positive findings, the corresponding values were 100%, 29%, 57% and 100%, with correct diagnoses in 63% of patients. Conclusions. Limited diagnostic accuracy, non-interpretable scans and radiation exposure restrict the usefulness of coronary MSCT in a community hospital setting.

Reproducibility of quantitative coronary analysis, Assessment of variability due to frame selection, different observers, and different cinefilmless laboratories.

Because of limited storage capacity for digital images, angiographic laboratories without cinefilm are dependent on locally performed quantitative coronary angiography (QCA) in clinical studies. In the present study the intra-and interobserver variability, as well as variability between different laboratories and variability due to frame selection was analyzed. A total of 20 coronary lesions were studied in two different digital laboratories 12±8 days apart. Images were analyzed on-line and after being transferred to a Cardiac Work Station (CWS). There was no significant difference between the measurement situations. For minimal luminal diameter (MLD) precision (SD of signed errors) ranged from 0.12 mm to 0.20 mm, for reference diameter (RD) from 0.15 mm to 0.28 mm, and for percent diameter stenosis (DS) from 4.2% to 5.8%. Overall relative precision was obtained by normalizing the QCA parameters, and was 11.9% for MLD, 7.0% for RD and 8.5% for DS (p<0.001, RD and DS compared to MLD). The overall variability in the interobserver and in the interlaboratory comparisons was 11.2% and 10.4%, respectively (n.s.) (n.s.). Thus the variability of QCA performed in cinefilmless, digital laboratories is small, and within a range making it an useful tool for clinical practice and group comparisons in clinical studies. However, the error range of QCA measurements must be taken into consideration when judging results from individual patients.

Variability of quantitative coronary angiography: an evaluation of on-site versus core laboratory analysis

To assess the validity of locally performed off-line quantitative coronary angiography (QCA) measurement in clinical trials, we carried out a comparative study between on-site QCA analysis and analysis performed at an independent external core laboratory. One local operator analyzed the pre, post and follow-up angiograms of 116 patients participating in the Stenting in Small Coronary Arteries Study (SISCA) prior to final QCA analysis in the core laboratory. The mean values of the reference diameter (RD), minimal lumen diameter (MLD) and diameter stenosis (DS) showed acceptable agreement between study site and core laboratory. However, on the level of individuals the interobserver differences were large, affecting the outcome of restenosis rate significantly, and in a such way that the conclusions in the SISCA trial might have come out differently if a core laboratory had not been used. This emphasizes the importance of using independent core laboratories in coronary interventional trials.

Coronary heart disease in women: Less extensive disease and improved long-term survival compared to men

Objectives. The aim of the study was to compare extent of coronary disease and subsequent long-term survival in women compared to men adjusted for baseline differences in demographics and morbidity. Design. In the database at Feiring Heart Clinic 18 767 patients had a coronary angiographic examination in the period from March 1999 to December 31, 2006. Their survival status as of May 31, 2007 was ascertained through the Norwegian National Registry. Survival was compared using age stratified analyses and Cox regression adjusting for baseline differences. Results. Significantly more women than men had no coronary disease (28.7 vs. 10.5%, p <0.001), while three vessel disease was more frequently present in men (38.7 vs. 21.8%, p <0.001), as judged by coronary angiography. Covariate adjusted survival was significantly better in women compared to men with an overall hazard ratio of 1.29 (p <0.001), but with no significant difference in the subgroup with high left ventricular end diastolic pressure. Conclusions. At the time of referral to invasive examination women had less extensive coronary artery disease than men as judged by coronary angiography and improved long-term survival when baseline differences were accounted for.

Survival after percutaneous coronary intervention and coronary artery bypass grafting in a single centre.

Objectives. Comparison of survival after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with coronary disease. Design. Feiring Heart Clinic treated 10 815 patients with a coronary intervention (6366 PCI, 4449 CABG) from March 1999 to December 31, 2005. Their survival status as of May 31, 2006 was ascertained through the Norwegian National Registry. Survival in PCI and CABG cohorts was compared using Cox regression and propensity analysis. Results. Covariate adjusted survival was significantly improved by CABG compared to PCI in patients with three vessel disease with and without diabetes, with hazard ratios of 0.40 and 0.61, respectively. The difference was of borderline significance in patients with one/two vessel disease with diabetes, and no difference in survival between the strategies in patients with one/two vessel disease without diabetes. Propensity analysis supported these observations. Improved survival for the PCI cohort was observed in the last quintile of procedure times. Conclusions. Patients with three vessel disease with or without diabetes seem to have a survival benefit with CABG compared to PCI treatment.

Coronary heart disease in diabetics: Prognostic implications and results of interventions

Objectives. The aim of the present study was to compare the extent of coronary disease and subsequent survival in diabetics and non-diabetics. Design. From the database at Feiring Heart Clinic 13 511 patients were identified with no previous revascularization and were examined with coronary angiography in the period from March 1999 to December 31, 2005. In the cohort 1 475 patients were diabetics. Their survival status of May 31, 2006 was ascertained through the Norwegian National Registry. Results. Diabetics were more symptomatic and had a more severe coronary artery disease at the time of referral with more than 40% having three vessel disease. The unadjusted survival was lower in the diabetics. After adjustment through Cox regression, diabetes mellitus remained a risk factor for subsequent death (overall hazard ratio 1.33), with the excess mortality mainly residing in smoking diabetics. Conclusions. Diabetics were more severely diseased at the time of referral. In Cox regression diabetes mellitus remained a significant risk factor for death in smokers except in the cohort treated with CABG.

Stenting small coronary arteries using two second-generation slotted tube stents: acute and six-month clinical and angiographic results.

This prospective study assessed the feasibility, safety, as well as clinical and angiographic outcome after 6 months in 96 patients (100 lesions) treated by stent implantation after a suboptimal balloon angioplasty result in coronary arteries < 3 mm and with a lesion length < 25 mm. The lesions were randomized to treatment with BeStent small or NIR‐7. Final quantitative coronary angiography was performed off line. Baseline reference diameter was 2.58 ± 0.22 mm. Complex lesions constituted 52%, and 23% had unstable angina. Angiographic and procedural success was achieved in 98% and 94%, respectively. At follow‐up, 88.5% were free of major adverse cardiac events. The overall restenosis rate was 22.5% (89% angiographic follow‐up). There were no statistically significant differences between the stents regarding predefined endpoints. Thus, provisional stent treatment of small coronary arteries using BeStent small or NIR‐7 is feasible, safe, and has a favorable clinical and angiographic mid‐term outcome. Cathet. Cardiovasc. Intervent. 50:307–313, 2000.