BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Drug eluting stents have become a mainstream in the treatment of coronary heart disease. Implementation of this technology into medical practice has resulted in a dramatic reduction in restenosis rates and late loss, which in turn is reflected in a significant reduction in MACE events due predominantly to a reduction in the need of a new re-intervention in the treated vessel. Historical comparisons between surgical results and the recently published studies with drug eluting stents shows that survival free of major events and the need of new revascularization are about the same in both groups of patients.

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

Hypertrophic cardiomyopathy is a relative frequent disease and probably the most common genetic transmitted cardiovascular disease. Fortunately, the more aggressive varieties of the disease represent the less common manifestation of it. Outflow left ventricular obstruction is present in about 25 to 30% of the cases. Recently, septal ablation by means of the selective alcohol injection in left anterior descendent septal branches was introduced as a therapeutic alternative in cases associated with left ventricular outflow obstruction. Results with this technique have been encouraging with a success rate over 90%, and a low rate incidence of complications and mortality. These results are similar to those of surgical myectomy. We review indications, technique, and results obtained with this procedure.

Percutaneous balloon mitral valvotomy has become the first choice option for the treatment of mitral stenosis. Any patient with the disease is a candidate for the procedure. However there are patient's subgroups which the procedure success will reach a 100% accordingly to a meticulous selection of the cases. Long-term results has been excellent and may be compared with those of surgical closed mitral commissurotomy. We report our long-term follow-up experience of 127 patients followed during a mean of five years in which results have been very favorable.

To assess the incidence of in-hospital major adverse cardiac events (MACE), we analyzed 694 procedures in 613 consecutive patients during one year period. Patient population included 550 (79.2%) patients with unstable angina, 43 (6.2%) with stable angina and 101 (14.5%) with acute myocardial infarction. Elective percutaneous transluminal coronary angioplasty (PTCA) was performed in 593 (85.4%) patients, rescue PTCA in 7 (1%), and primary PTCA in 94 (13.5%). Angiographic lesion morphology was as follows: type A 30%; type B 58%; type C 12%. We compared patient population who received stent with PTCA-balloon only. Technical success was 95% and clinical success was achieved in 80% of the cases. Overall mortality was 1% in the stent group and 3% in the conventional PTCA. The incidence of MACE was 4% and 15.1% in the stent and angioplasty balloon groups respectively. We found a dramatic impact on reduction of the incidence of acute complications in the groups with stenting for unstable angina (p = 0.0001) and acute myocardial infarction (p = 0.0001). The major clinical advantage of stenting over balloon angioplasty was a lower need for repeated procedures.

A prospective, observational, comparative study of 100 patients with acute myocardial infarction and primary angioplasty was performed to establish if there was statistically difference between the lag of time when symptoms begin and the time of the emergency admission to the time of arrival at the catheterization suite during working hours vs the "on call" hours. Patients were allocated in two groups accordingly to morning hours or on call hours. Time of onset of symptoms to the catheterization suite arrival between the two groups was no significantly different. Time from emergency room arrival to catheterization suite arrival was significant different < 0.05, however success rate between groups 86% vs 80% and complications rate were statistically non significant between both groups. We conclude that primary angioplasty is a highly effective method of reperfusion. Even though the time from the emergency room arrival to the catheterization suite arrival was significantly less during day than the on call hours, there is no difference between the success rate and complications incidence in both groups.

The no-reflow phenomenon refers to the inability to reperfuse myocardial tissue despite removal of an occlusion of a coronary artery. No reflow is a complication that may occur after revascularization of patients. This study examined the incidence and, clinical characteristics of no-reflow in a patient population treated with conventional percutaneous transluminal coronary angioplasty at the Instituto Nacional de Cardiología "Ignacio Chávez". We reviewed 204 elective angioplasties and 62 direct angioplasties; 14 patients were included (4 from the first group and 10 from the second group). No-reflow were more frequently in men, the mean age was 56 years and diabetes and smoking were the risk factors more frequently reported. No-reflow was found in left anterior descending coronary artery in 7 patients, the time of reperfusion, in direct angioplasty, was 10.6 hours (mean) and the strategy most frequently used to reestablish normal anterograde flow was intracoronary verapamil. The overall incidence of no-reflow for the two modalities was 5.2%(16.12% for direct angioplasty and 1.9% for elective angioplasty). The current study shows that the no-reflow phenomenon is not uncommon after angioplasty; no-reflow appears higher than the previous reports for both modalities of treatment.

From December 1995 to March 1997 fifty patients with acute myocardial infarction, had 57 stents implanted. Mean time since the beginning of symptoms to the procedure was 3.7 +/- 2.9 hours. Twenty-four stents were implanted "de novo", 17 for "sub-optimal" results, 5 for threatened closure and eleven for complex dissection. The arteries treated with stent were left anterior descending in 42%, right coronary in 42%, circumflex in 10%, vein grafts in 4%, intermedial branch in 1% and marginal obtuse branch in 1%. Stent used in most of the cases was AVE in 67% followed by Palmaz-Schatz, Wiktor, Crown, Gianturco-Roubin and Wallstent. Before procedure, coronary flow was TIMI 0 in 66% TIMI 1 in 10% and TIMI 2 in 24%. After procedure, TIMI 3 coronary flow was achieved in 92% of the arteries and other four had "no-reflow" phenomenon. Mean stenosis before procedure was 96%+/- 3.1 and after stenting was 1.76%+/- 2.6 with a stent/artery diameter rate of 1.01. Technical success was 100% and clinical success was achieved in 96% of the cases. Two cases were not successfully due to acute thrombotic closure in one patient and in another one because of cardiogenic shock after two days of a technical successful implantation of stent in LAD artery. There were not recurrent ischemic events (CABG, re-infarction or new coronary angioplasty procedure). Other two patients died for non-cardiac events (acute pancreatitis in one and by septic shock in other). At the time of discharge 96% of patients were treated with aspirin and ticlopidine. Major hematoma was evident in only one case. At a mean follow-up time of 5.6 months +/- 4.2 in 45 patients showed that 73% were in functional class I and none of them had re-infarction, death or needed a new revascularization. Conclusion: Stent implantation in acute myocardial infarction is feasible and safe procedure with a low rate of ischemic recurrent events.

Between October 1991 and August 1996 two-hundred coronary stents were implanted (s) in 166 patients (pts)(1.27 s/pt). One hundred thirty-five lesions "de novo" were approached with stent, 44 because of a sub-optimal result post-angioplasty, 15 for restenosis and 17 for dissection. In thirty-six patients the indication of stenting was stable angina, in 68 unstable angina, in 37 for angina after myocardial infarction, in 11 for asymptomatic ischemia after myocardial infarction and in 14 during an acute myocardial infarction. Mean stenosis before stent implantation in all cases was 85 +/- 15%. Type of lesion in seventy cases was A, in 112 was B and 29 was C. Stents used were AVE in 146 lesions, Palmaz-Schatz in 33, Wiktor in 23, Gianturco-Roubin in 8 and Wallstent in one case. Medical treatment in 140 pts.(84.3%) after stent implantation was only with aspirin and ticlopidine. Technical success in all patients was 98.6%(208/211 pts) and primary success was 94.6%(157-166 pts). Unsuccessful procedures were because of sub-acute occlusion in three patients (1.8%), death in 3 pts.(1.8%) and urgent CABG was necessary in one pt.(0.5%). Major hematoma was a complication in 5 pts (3%). Mean residual stenosis after stent implantation in all cases was 2.2%. CONCLUSION: Stent implantation in our laboratory is a very safe procedure with a high rate of primary success with lowest complications in a great population of unstable angina.