Background Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. Methods and results Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5–1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. Conclusions Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. Study registration http://clinicaltrials.gov NCT02497014.
Stenting of unprotected LMCA stenosis provided excellent immediate results, particularly in good CABG candidates. Medium-term results were good, with a restenosis rate of 23%, similar to that seen after stenting at other coronary sites. Stenting deserves to be considered a safe and effective alternative to CABG in institutions performing large numbers of PTCAs.
High radial force has become an essential feature of new coronary stents. These stents are expected to exhibit sufficient radial force and minimum radial recoil when deployed in atheromatous lesions of various morphologies. The aim of this study was to compare the radial force of 17 coronary stents in vitro (Anglodynamics, ACS Multilink, AVE Micro II and GFX, Bard XT, Biocompatibles PC, Cook GR II, Cordis Crossflex, Hexacath Freedom, Johnson & Johnson PS 153'PS 154, and Crown, Medtronic Wiktor and BeStent BEL‐15, Saint‐Côme SC 1616, Scimed Nir 7 and 9). Two in vitro mechanical tests were performed to assess the stent radial force. The first test measured the deformation of coronary stents in a V‐stand by using a deformation controlled by a dynamometer based on a longitudinal generatrix. The precision was of 1 micron. This comparative test highlighted the appreciable variation in behavior of the range of tested stents in terms of resistance to local compression. The line graphs obtained show a very small (and in some cases nonexistent) purely elastic behavior area in the stents, with this result reflecting a small (<0.4 Newtons) range of forces applied to all stents. Above this value, the stents did not return to their size before compression and the line graph remains approximately linear for a long period. It was therefore possible to distinguish between two families of stents on the basis of the presence or absence of this elastic area. In the second test, the stent was deployed in a 3.0‐mm elastic tube and a pressure gradient created between the interior and exterior of the tube. The precision was of 50 microns. A typical line graph of the pressure‐diameter relationship was recognizable for a given stent. No difference in behavior between the different coronary stents was noted up to 0.3 × 105 Pa; subsequently, after 0.3 × 105 Pa, sizable deformation differences were visible between the least resistant stent, the BeStent BEL‐15, and the most resistant stent, the Crossflex. Cathet. Cardiovasc. Intervent. 46:380–391, 1999. © 1999 Wiley‐Liss, Inc.
Subacute thrombosis of coronary stents may occur up to the end of the first month after their implantation and remains the major problem associated with the technique. A cohort of 238 patients with placement of one or more stents in 244 arteries was monitored for this period. All patients were given 500 mg/day of ticlopidine (started 3 days before) and a push dose of 10,000 IU of heparin during the procedure, then 1,000-1,500 IU/hr for 20 hr. Following removal of the arterial introducer, they were kept on subcutaneous heparin for 1 week and ticlopidine (500 mg/day) for 3-6 months. Nine patients (3.8%) showed evidence of thrombosis at 7 days. The overall thrombosis rate at 30 days was 4.2% (3.5% for elective stents, as compared with 7.9% associated with occlusive dissections). Emergency treatment by further angioplasty (8 cases) and intracoronary thrombolysis (5 cases) was undertaken. Complications were as follows: 5 deaths (2%), 3 MI (1.2%), 2 non-Q MI (1.7%). Three predictive factors for subacute thrombosis were identified: age < 70 (p = 0.00006), unstable angina (p = 0.006) and arterial diameter less than 3 mm (p = 0.043). The peripheral vascular complication rate was 4.6%. This study suggests that preventive treatment with ticlopidine appears to reduce the incidence of subacute thrombosis of stents in patients > 70 years of age. Furthermore, the combination of ticlopidine and heparin facilitates laboratory monitoring after stenting. Stenting is thought to represent definitive treatment in situations where placement for occlusive dissection is the indication.
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