Acute and long-term clinical and angiographic outcome after S-Stent implantation: S-Stent multicenter safety and efficacy trial (original) (raw)
Related papers
2010
The purpose of this study was to test the hypothesis that stent implantation in de novo coronary artery lesions would result in lower restenosis rates and better long-term clinical outcomes than balloon angioplasty. BACKGROUND Placement of an intracoronary stent, as compared with balloon angioplasty, has proven to reduce the rate of restenosis. However, the long-term clinical benefit of stenting over angioplasty has not been assessed in large randomized trials. METHODS We randomly assigned 452 patients with either stable (129 patients) or unstable (323 patients) angina pectoris to elective stent implantation (229 patients) or standard balloon angioplasty (223 patients). Coronary angiography was performed at baseline, immediately after the procedure and six months later. End points were the rate of restenosis at six months and a composite of death, myocardial infarction (MI) and target vessel revascularization over four years of follow-up. RESULTS Procedural success rate was achieved in 84% and 95% (balloon angioplasty vs. stent, respectively). The increase in the minimal luminal diameter was greater in the stent group both after the intervention (2.02 Ϯ 0.6 mm vs. 1.43 Ϯ 0.6 mm in the angioplasty group; p Ͻ 0.0001), and at six-month follow-up (1.98 Ϯ 0.7 mm vs. 1.63 Ϯ 0.7 mm; p Ͻ 0.001). The corresponding restenosis rates were 22% and 37%, respectively (p Ͻ 0.002). After four years, no differences in mortality (2.7% vs. 2.4%) and nonfatal MI (2.2% vs. 2.8%) were found between the stent and the angioplasty groups, respectively. However, the requirement for further revascularization procedures of the target lesions was significantly reduced in the stent group (12% vs. 25% in the angioplasty group; relative risk 0.49, 95% confidence interval 0.32 to 0.75, p ϭ 0.0006); most of the repeat procedures (84%) were carried out within six months of entry into the study. CONCLUSIONS Patients who received an intracoronary stent showed a lower rate of restenosis than those treated with conventional balloon angioplasty. The benefit of stenting was maintained four years after implantation, as manifested by a significant reduction in the need for repeat revascularization.
Catheterization and Cardiovascular Diagnosis, 1992
We studied 100 patients who had coronary implantation of Palmaz-Schatz stents in our institution from November 1989 until March 1991. A total of 126 standard and 6 short stents were implanted. The patients' mean age was 58 ± 5 years, and 97 were males. The indications were lesions with high risk of restenosis (29 patients), restenosis (27 patients), suboptimal result of angioplasty (24 patients), dissection (16 patients), and recanalized chronic total occlusion (6 patients). In 17 patients a brachial cut-down approach was used. Stents were correctly placed in 98 patients. Stent related complications occurred in 9 patients: major ischemic complications in 7 patients (acute myocardial infarction in 2 patients, emergency bypass surgery in 3 patients and emergency angio-plasty in 2 patients); in 3 of these patients there was a subacute closure of the stent and in 2 patients there were delivery problems. Vascular complications at the site of arterial puncture occured in 3 patients (some patients had more than one complication). A learning curve was observed. There was a decrease in the complication rate with the higher number of patients treated: 28% for the first 50 patients and 6% for the last 50 patients. Clinical follow-up was available in all patients. Of the 92 patients eligible for follow-up (7 ± 2 months), 69 patients were asymptomatic and 23 had recurrence of angina: 19 patients for stent restenosis and 4 patients for coronary artery disease progression. Follow-up angiogram was done in 79/92 (86%) patients: 21 had restenosis (27%). Restenosis rate was higher in patients with multiple stents 40% (6/15) than with the single stent 23% (15/64), and when the indications were for dissection 35% (6/17). These differences did not reach statistical significance. The global incidence of restenosis appears to be lower when compared to balloon coronary angloplasty, although there is no garantee these populations are comparable. Stenting seems to be a good alternative to coronary angioplasty in lesions which are not considered ideal for the balloon dilatation and to treat occlusive dissections. The use of multiple and partial overlapping stents is associated with a high restenosis rate. These impressions need to be tested in a large, randomized, multicenter study. © 1992 Wiley-Liss, Inc.
Catheterization and …, 2001
The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 ؎ 0.32 before to 2.73 ؎ 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 ؎ 0.50 mm. The loss index was 0.45 ؎ 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate. Cathet Cardiovasc Intervent 2001;54:276 -282.
Circulation, 2001
MD; for the BESMART (BeStent in Small Arteries) Trial Investigators* Background-Stenting has been demonstrated to be superior to balloon angioplasty in de novo focal lesions located in large native vessels. However, in small vessels, the benefit of stenting remains questionable. Methods and Results-A total of 381 symptomatic patients with de novo focal lesion located on a small coronary segment vessel (Ͻ3 mm) were randomly assigned to either stent implantation (192 patients; 197 lesions) or standard balloon angioplasty (189 patients; 198 lesions). The primary end point was the angiographic restenosis rate at 6 months, as determined by quantitative coronary angiography. On intention-to-treat analysis, angiographic success rate and major adverse cardiac events were comparable: 97.9% and 4.6% versus 93.9% and 5.8% in the stent group and the balloon group, respectively. After the procedure, a larger acute gain was achieved with stent placement (1.35Ϯ0.45 versus 0.94Ϯ0.47 mm, Pϭ0.0001), resulting in a larger minimal lumen diameter (2.06Ϯ0.42 versus 1.70Ϯ0.46 mm, Pϭ0.0001). At follow-up (obtained in 91% of patients), angiographic restenosis rate was 21% in the stent group versus 47% in the balloon group (Pϭ0.0001), a risk reduction of 55%. Repeat target lesion revascularization was less frequent in the stent group (13% versus 25%, Pϭ0.0006). Conclusions-Elective stent placement in small coronary arteries with focal de novo lesions is safe and associated with a marked reduction in restenosis rate and subsequent target lesion revascularization rate at 6 months. (Circulation. 2001; 104:1604-1608.)
1994
One hundred and thirty-four consecutive patients undergoing elective coronary stenting were studied to assess the relative performance of Palmaz-Schatz (PS), Gianturco-Roubin (GR), and Wiktor (W) stents. Eighty-six percent of patients underwent follow-up angiography. Initial and follow-up angiograms were assessed by a central angiographic core laboratory. Attempts were made to place 81 Palmaz-Schatz (PS) stents, 21 Gianturco-Roubin (GR), and 32 Wiktor (W) stents. PS stents were less frequently successfully deployed (88% PS vs. 100% GR vs. 97% W; P = 0.03). The final percent stenosis was greater with the GR stent (32% GR vs. 14% PS vs. 19% W; P < 0.001). The restenosis rate was lower in the PS group (PS 48.2% vs. GR 66.7% and W 68.4Oh; P = 0.044). After accounting for the effect of prior restenosis (P = 0.005) and saphenous vein site (P = 0.006) in multivariate testing, lesion severity at follow-up was still less with the Palmaz-Schatz stent (P = 0.037).
Long-Term Follow-Up After Angiographically Successful Coronary Stenting
Japanese Heart Journal, 2004
The purpose of the study was to compare the impacts of angiographically successful direct stent implantation and conventional stent implantation (stent implantation following predilatation) on long-term major cardiac events. The authors prospectively studied 40 patients who had successful direct stent implantation and 46 patients who had successful conventional stent implantation. The end-point of the study was defined as the occurrence of a major cardiac event, including recurrent angina, acute myocardial infarction, death, and target vessel revascularization. The demographic and clinical characteristics of the study groups were similar, except the indication of percutaneous angioplasty, which was more frequently unstable angina in the conventional stent group (63% vs 38%, P: 0.03). Procedural minor complications were more frequent in conventional stent implantation, and there was also a positive correlation between the conventional stent implantation and procedural minor complications (r = 0.231, P: 0.03), and postprocedural troponin elevation (r = 0.221, P: 0.04). The incidences of major cardiac events including recurrent angina, acute myocardial infarction, death, death or myocardial infarction, and target vessel revascularization were not different between the study groups during the long-term follow-up period (21 ± 7.1 months for direct stent group and 20 ± 7.5 months for conventional stent group). Overall end-points occurred in 9 patients (22%) in the direct stent group and in 9 patients (19%) in the conventional stent group. Kaplan-Meier survival analysis showed that there was no difference in event-free survival between the patients treated with direct stent implantation and conventional stent implantation (log-rank: 1.52, P = 0.21). Two-vessel intervention and hypertension were found to be related with long-term major cardiac events (r = 0.214, P: 0.048, r = 0.206, P: 0.04, respectively). In addition to the procedural advantages, direct stent implantation may also provide comparable results with conventional stent implantation concerning the late cardiac events following successful percutaneous coronary angioplasty.