Joseph Dens

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

A prospective randomized multicentre pilot trial, comparing stenting with balloon angioplasty as a treatment for coronary lesions, located in a bifurcation was performed. After balloon dilatation, with a < 30% residual stenosis in the main vessel and < 50% residual stenosis in the side branch, patients were randomized to stay in a "balloon-only" group or to stenting. The stents used were the AVE S 670 for the main vessel and the Bestent, if needed, for the side branch. The primary end point was the incidence of major adverse cardiac events (MACE) at 6 months, secondary end points were in-hospital MACE, acute angiographic results, use of materials and duration of the procedure. One hundred eleven patients were randomized: 55 in the balloon group, 56 in the stent group. No differences in MACE-rates were found at 6 months (22% versus 20%, p = 0.78). The target vessel revascularization rate was 16% in the balloon group and 12.5% in the stent group (p = 0.56). The acute angiographic results were significantly better in the stent group (residual stenosis 8% versus 26% [p < 0.05]). More materials were used, with a near doubling of the duration of the procedure in the stent group (p < 0.05). Although stenting resulted in better immediate angiographic results during percutaneous treatment of lesions located in a bifurcation, as compared to balloon angioplasty alone, clinical events were comparable in the two treatment arms.

To describe the characteristics and mortality rates of 132 cardiogenic shock patients treated with intra-aortic balloon counterpulsation at a university hospital. All patients underwent intra-aortic balloon counterpulsation. A total of 99 out of 132 patients were revascularized with angioplasty, surgery or were transplanted (intervention group), 33 out of 132 had no further intervention (no-intervention group). Overall mortality was 54.5% (72/132). In the intervention group mortality was 50.5% (50/99), in the no-intervention group mortality was 66.6% (22/33). The odds ratio for death comparing the intervention group with the no-intervention group was 0.533 (95% confidence interval 0.238-1.189, P = 0.122). By univariate analysis, diabetes and a left ventricular ejection fraction of less than 0.35 represented an increased odds ratio of death of 4.25 (1.813-9.965, P = 0.001) and 3.03 (1.22-7.54, P = 0.015), respectively. A lactate level greater than 2.5 mg/dl at baseline resulted in an increased odds ratio of death of 5.185 (1.988-13.525, P = 0.0001). Using a multivariate logistic regression analysis, a left ventricular ejection fraction less than 0.35 and diabetes remained significantly correlated with death. Mortality rates remain high in cardiogenic shock patients in need of intra-aortic balloon counterpulsation. The odds ratio for death tended to be lower in the intervention group compared with the no-intervention group, although the absolute difference in mortality as a result of an intervention was only 15.2%, and did not reach statistical significance probably because of the small sample size. Diabetes and an ejection fraction lower than 35% are significant predictors for a worse prognosis.

Background: Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions. Conversely, a meta-analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease. Objective: To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events. Design and setting: The NICOLE study (NIsoldipine in COronary artery disease in LEuven) is a single centre, randomised, double blind, placebo controlled trial with coronary angiography at baseline, six months, and three years of follow up. Patients: 826 patients who had undergone successful coronary angioplasty were randomised to nisoldipine 40 mg once daily or placebo. The intention to treat and per protocol population consisted of 819 and 578 patients, respectively. Results: In the per protocol population, 625 of the nisoldipine treated and 655 of the placebo treated patients (NS) showed angiographic progression in at least one coronary arterial segment, defined as an increase in diameter stenosis of ≥ 13%. The average minimum luminal diameter of the non-dilated lesions decreased by 0.163 mm and 0.167 mm in the nisoldipine and placebo groups, respectively (NS). The respective numbers of new lesions detected were 7 and 13 (NS). In the intention to treat population, the rates of death, stroke, and acute myocardial infarction were similar in both treatment groups. However, nisoldipine use was associated with fewer revascularisation procedures and thus the percentage of patients with any clinical event was lower (44.6% v 52.6%, p = 0.02). Conclusions: Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures.