To the Editor: In recent years, the introduction (1) of drugeluting stents (DES) during percutaneous coronary interventions (PCI) has been one of the major breakthroughs in interventional procedures. Several observational and randomized studies have shown a significantly lower restenosis rate with DES compared with bare-stent technology. Sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) stents also substantially reduce the need for repeat revascularization procedures compared with standard stent technology (2-5). However, late safety outcome of these new devices is not well established. Late stent thrombosis, not seen in the first series of studies (1-5), has been recently reported (6,7) and was associated with major adverse cardiac events. Even though a meta-analysis of randomized studies and registries confirmed the efficacy and safety of DES (8), these studies were not powered to detect any increase in late-stent thrombosis. Furthermore, in those studies, stent thrombosis (SET) was not equal and appropriately defined; more importantly, none of the cited studies included SET as a prespecified end point. Therefore, we sought to investigate the incidence of SET in a DES population (9) included prospectively in the multicenter and controlled Argentine Randomized Trial of Coronary Stents versus Bypass Surgery (ERACI III) trial.From June 2002 to December 2004, 225 patients treated with PCI and DES in five centers in Buenos Aires meeting the clinical and angiographic criteria of the ERACI II trial (10) were prospectively and consecutively included in the ERACI III study. The inclusion criteria of the ERACI studies were previously reported (10). All patients had multiple-vessel disease and were treated with at least one DES, SES, or PES in equal proportion (Cypher, Cordis, Johnson and Johnson, Miami Lakes, Florida; and TAXUS, Boston Scientific Corp., Natick, Massachusetts). The end points of the ERACI III study were to compare major and minor cardiac adverse events at one, two, three, and five years of follow-up between the ERACI III DES patients (n ϭ 225) and ERACI II PCI (n ϭ 225) and ERACI II CABG study patients (n ϭ 225). Comparison of coronary stent thrombosis (SET) between the ERACI III and ERACI II PCI study arm (bare stent) was one of the secondary end points of this study. The purpose of this study was to analyze the incidence of SET during the first 30 days and during follow-up in the ERACI III study patients.Stent thrombosis was defined as follows: 42 LM ϭ left main coronary artery.
Accurate assessment of suspected prosthetic valve dysfunction is critically important as reoperation carries high risk. Noninvasive methods of hemodynamic assessment of patients with both aortic and mitral mechanical valves continue to be frustrated by the interference created by prosthetic material and direct left ventricular puncture may be required for definitive hemodynamic assessment. We report the hemodynamic and angiographic results and outcomes of 38 consecutive patients with double valve replacement who underwent left ventricular puncture as part of evaluation of possible prosthetic dysfunction. These results were compared with those obtained by noninvasive testing. We found noninvasive assessment alone to be unsatisfactory as measurements of regurgitation and stenosis correlated poorly with those obtained by direct left ventricular puncture. Important information that altered patient management was obtained from invasive assessment in 68% of cases with an acceptable rate of complications. Therefore, hemodynamic and angiographic assessment using transthoracic left ventricular puncture should be entertained in patients with mitral and aortic valve replacement presenting with congestive heart failure and suspected prosthesis dysfunction.
This randomized, controlled, and unblinded study showed that the administration of oral rapamycin during 14 days after stent implantation significantly reduces angiographic and clinical parameters of restenosis.
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