Effectiveness of sirolimus-eluting stent implantation for the treatment of ostial left anterior descending artery stenosis with intravascular ultrasound guidance

OBJECTIVES: This study was designed to evaluate the clinical and angiographic outcomes of sirolimus-eluting stent (SES) implantation for ostial left anterior descending (LAD) lesions compared with bare-metal stent (BMS) implantation. BACKGROUND: The effectiveness of SES implantation for ostial LAD lesions is currently unknown. METHODS: Sirolimus-eluting stents were implanted in 68 consecutive patients with ostial LAD stenoses. The control group was composed of 77 patients treated with BMS during the preceding two years. In the SES group, for complete lesion coverage, stent positioning was intentionally extended into the distal left main coronary artery (LMCA) in 23 patients (34%) with intermediate LMCA narrowing. RESULTS: Compared with the BMS group, the SES group had more multivessel involvement, received fewer debulking atherectomies, underwent more direct stenting, had a greater number of stents, and had more segments stented. The procedural success rate was 100% in both groups. The six-month angiographic restenosis rate was significantly lower in the SES group than in the BMS group (5.1% vs. 32.3%, p < 0.001). During the one-year follow-up period, neither death nor myocardial infarction occurred in either group, but target lesion revascularization was less frequent in the SES group than in the BMS group (0% vs. 17%, p < 0.001). In the SES group, there were no restenoses in cases with LMCA coverage, compared with three restenoses (7.9%) in cases with precise stent positioning (p = NS). CONCLUSIONS: Sirolimus-eluting stent implantation in ostial LAD lesions achieved excellent results regarding restenosis and clinical outcomes compared with BMS implantation. This finding may be associated with reduced neointimal hyperplasia and complete lesion coverage.     

Impact of sirolimus-eluting stent on the outcome of patients with chronic total occlusions

Several randomized trials have demonstrated that stent implantation after successful recanalization of long-term total occlusions decreases restenosis and reocclusion rates. The sirolimus-eluting stent (SES) has recently proved its efficacy to decrease restenosis in selected patients. However, the efficacy of SES implantation in patients who have chronic total occlusions is currently unknown. Therefore, we investigated procedural and 6- and 12-month angiographic outcomes (analyzed by quantitative coronary angiography) and left ventricular function in 60 patients who received SESs and 120 patients who received bare metal stents (BMSs). Minimum luminal diameter did not differ immediately after recanalization (SES group 3.04 +/- 0.50 mm vs BMS group 3.12 +/- 0.48 mm). After 6 months, the SES group still had significantly larger luminal diameters (3.04 +/- 0.44 mm vs 1.94 +/- 0.98 mm) and significantly lower restenosis and reocclusion rates (2% and 0%, respectively) than did the BMS group (32% and 6%, respectively). Late loss was significantly smaller in the SES group than in the BMS group. At follow-up, the SES group had fewer cardiac events, including target lesion revascularization (p <0.001), than did the BMS group. In conclusion, SES implantation after recanalization of chronic total occlusion provides a better clinical outcome with less restenosis and target lesion revascularization after 6 months than does BMSs.     

Sirolimus- versus paclitaxel-eluting stent implantation for unprotected left main coronary artery stenosis

We performed this study in order to compare the immediate and mid-term outcomes of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in lesions of the unprotected left main coronary artery (LMCA). We assessed 54 patients from 5 centers who had undergone unprotected LMCA stenting (35 SES and 19 PES). The procedural success rates were 100 and 95%, respectively, in the SES and PES patients (p = 0.19). At the 6-month clinical follow-up, the event-free probability was 100% in the SES group, and 88% in the PES group (p = 0.07). At the 6-month angiographic follow-up (n = 24), the SES group exhibited a slightly lower late loss than did the PES group (0.24 +/- 0.44 vs. 0.65 +/- 0.60 mm, p = 0.09), and the restenosis rates were 8 and 9% (p = 0.94) in the SES and PES patients, respectively. In conclusion, both groups exhibited excellent in-hospital and 6-month outcomes with no significant differences between them.     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Serial angiographic follow-up of sirolimus-eluting stents for unprotected left main coronary artery revascularization.

OBJECTIVES: This study was performed to evaluate the clinical and serial angiographic outcomes of patients undergoing sirolimus-eluting stent (SES) implantation for unprotected left main coronary artery (LMCA) stenosis. BACKGROUND: The efficacy of SES has led to their expanded use for off-label indications, including LMCA disease. METHODS: Unprotected LMCA intervention with SES was attempted in 50 patients. Surveillance angiography was performed at three and nine months' follow-up. RESULTS: The target lesion involved the distal LMCA in 47 patients (94%). In-lesion restenosis occurred in 21 patients (42%), was focal in 85% of cases, and in 82% involved the branch ostia, sparing the LMCA itself. Target lesion revascularization (TLR) occurred in 19 patients (38%) over a mean follow-up of 276 +/- 57 days; TLR was ischemia-driven in 7 patients (14%). Late loss was significantly greater within the left circumflex (LCX) ostium compared to the parent vessel (PV) of the LMCA bifurcation (0.83 +/- 0.89 mm vs. 0.49 +/- 0.72 mm, p = 0.04). Late loss continued to increase between three- and nine-month follow-up. Final minimal luminal diameter and maximal balloon pressure were independent predictors of restenosis of the PV. CONCLUSIONS: Restenosis is a frequent finding when serial angiographic follow-up is performed after SES implantation for unprotected distal LMCA lesions. Restenosis is usually focal, most often involves the LCX ostium, and often occurs without symptoms.     

Limitation on efficacy of sirolimus-eluting stent implantation in patients on hemodialysis

BACKGROUND: Patients receiving chronic hemodialysis develop complicated coronary lesions with tortuosity and calcification, which make stent delivery or expansion difficult. Restenosis rates are also higher than in patients without hemodialysis. Furthermore, there is a risk of polymer rubbing from the surface of a sirolimus-eluting stent(SES)placed across a calcified lesion. This study investigated the efficacy of SES for patients on hemodialysis compared with bare metal stent (BMS). METHODS AND RESULTS: Forty-two patients on hemodialysis underwent percutaneous coronary intervention for 46 de novo lesions treated with SES (SES group). Seventy-four patients with 78 de novo lesions were treated with BMS (BMS group). The mean age was 65.8 +/- 9.3 yr in the SES group, and 65.0 +/- 8.7 yr in the BMS group. The mean hemodialysis period was significantly longer in the SES group (9.2 +/- 7.9 vs 6.5 +/- 7.7 yr, p < 0.01). Angiographic characteristics and acute results showed no significant difference between the two groups. At 6 months follow-up, late loss was significantly smaller in the SES group (0.60 +/- 0.97 vs 1.60 +/- 1.15 mm, p < 0.05). Binary restenosis and target lesion revascularization were similar (34% vs 43%, 25% vs 36%, respectively, p = NS). Major adverse cardiac events, composite of death, myocardial infarction, and target vessel revascularization were also similar (23% vs 36%, p = NS). CONCLUSIONS: Our study could not demonstrate the superiority of SES implantation in patients with hemodialysis compared to BMS implantation, which suggests the limitations of using SES.     

Comparison of simple and complex stenting techniques in the treatment of unprotected left main coronary artery bifurcation stenosis

We assessed the safety and feasibility of various stenting techniques using the sirolimus-eluting stent (SES) in the treatment of unprotected left main coronary artery (LMCA) bifurcation stenoses. One hundred sixteen patients with unprotected LMCA bifurcation stenoses underwent SES implantation. A simple stenting technique (simple group, n = 67) across the left circumflex artery (LCx) and a complex technique (complex group) comprising "kissing" stenting (n = 24) or a "crush" (n = 25) technique were used. Baseline clinical and angiographic characteristics were similar for the 2 groups, except for more multivessel involvement and narrower LCxs in the complex group. The procedural success rate was 100%. Angiographic restenosis rate at 6 months was lower in the simple group (5.3%) than in the complex group (24.4%, p = 0.024). In the complex group, restenosis rates were similar for the kissing (25.0%) and crush (23.8%) techniques (p = 1.0). There were no incidents of death or myocardial infarction during follow-up (median 18.6 months). Target lesion revascularization was performed in 6 patients only in the complex group (0% vs 12.2%, p = 0.005). At 18 months, survival rates without target lesion revascularization were 100 +/- 0% in the simple group and 85.7 +/- 5.6% in the complex group (p = 0.004). In conclusion, SES implantation for unprotected LMCA bifurcation stenoses appears to be safe and effective. Compared with the complex stenting technique, the simple technique was technically easier and appeared to be more effective in improving long-term outcomes in patients with normal LCxs.     

Vascular response to sirolimus-eluting stents delivered with a nonaggressive implantation technique: comparison of intravascular ultrasound results from the multicenter, randomized E-SIRIUS, and SIRIUS trials.

BACKGROUND: The effectiveness of SES to reduce the risk of restenosis was initially demonstrated in short lesions using stent implantation with routine pre-dilatation and post-dilatation. This intravascular ultrasound (IVUS) substudy of the E-SIRIUS trial sought to evaluate local arterial responses to sirolimus-eluting stents (SES) delivered with a stent implantation technique allowing direct stenting and only selectively applying high-pressure post-dilatation. METHODS AND RESULTS: IVUS was performed immediately after intervention and at 8-month follow-up in 51 patients randomised to either bare-metal stents (BMS; Bx-Velocitytrade mark; N=20) or SES (Cyphertrade mark N=31). Direct stenting was allowed (24%) and post-dilation was performed only selectively (32%). Lumen dimensions, intimal hyperplasia and vessel remodeling were compared between SES and BMS. Subsequently, results of SES in the E-SIRIUS IVUS substudy (N=31) were compared to those of SES in the IVUS substudy of the SIRIUS trial (N=137). SES in SIRIUS IVUS substudy were delivered with 100% pre-dilatation and 77% post-dilatation. Baseline stent and reference segment measurements were similar between BMS and SES in E-SIRIUS IVUS patients. Using SES there was a 96% reduction in intimal hyperplasia volume within the stented segment (1.8+/-4.9 vs 50.6+/-39.7 mm3, P<0.001) and a significantly larger minimal lumen cross sectional area at 8-month follow-up (4.5+/-1.1 vs 2.3+/-0.9 mm2, P<0.001). No vessel remodeling was observed with the use of SES. The applied stent implantation technique resulted in a minimal stent/reference vessel area ratio of 0.75+/-0.17 in E-SIRIUS SES as compared to 0.84+/-0.23 in SIRIUS SES (P=0.046). Mean intimal hyperplasia cross-sectional area at follow-up was 0.1+/-0.2 mm2 in the SES group of E-SIRIUS and 0.5+/-0.8 mm2 in the SES group of SIRIUS (P=0.003). CONCLUSIONS: An implantation technique of SES which includes direct stenting and minimizes the use of high-pressure post-dilatation results in less optimal stent expansion. However, follow-up results compare very favourable to those of BMS and are characterised by even less intimal hyperplasia than after a more forceful implantation of SES.     

Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study

OBJECTIVES: We sought to determine the predictors of stent thrombosis after sirolimus-eluting stent (SES) implantation. BACKGROUND: A number of cases of stent thrombosis have been reported after commercial release of the SES in the "real world," such that the U.S. Food and Drug Administration issued a warning. METHODS: Fifteen patients who developed stent thrombosis after successful SES implantation were analyzed and compared with 45 matched control patients who had no evidence of stent thrombosis. RESULTS: Minimum stent cross-sectional area (MSA) (4.3 +/- 1.6 mm(2) vs. 6.2 +/- 1.9 mm(2), p < 0.001) and stent expansion (0.65 +/- 0.18 vs. 0.85 +/- 0.14, p < 0.001) were significantly smaller in the stent thrombosis group than in the matched control patients. There was no significant difference in the rate of SES malapposition between the groups. However, the presence of a significant residual reference segment stenosis was more common in the stent thrombosis group compared with the matched control group (67% vs. 9%, p < 0.001). Independent predictors of stent thrombosis were stent underexpansion (p = 0.03) and a significant residual reference segment stenosis (p = 0.02). CONCLUSIONS: Stent underexpansion and residual reference segment stenosis are associated with stent thrombosis after successful SES implantation.     

Elective stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance

OBJECTIVES: We sought to evaluate: 1) the long-term outcomes of 127 selected patients receiving unprotected left main coronary artery (LMCA) stenting; and 2) the impact of the debulking procedure before stenting and intravascular ultrasound (IVUS) guidance on their clinical outcomes. BACKGROUND: The long-term safety of stenting of unprotected LMCA stenoses has not been established yet. METHODS: A total of 127 consecutive patients with unprotected LMCA stenosis and normal left ventricular function were treated by elective stenting. The long-term outcomes were evaluated between two groups: IVUS guidance (n = 77) vs. angiographic guidance (n = 50); and debulking plus stenting (debulking/stenting; n = 40) vs. stenting only (n = 87). RESULTS: Angiographic restenosis was documented in 19 (19%) of 100 patients. The lumen diameter after stenting was significantly larger in IVUS-guided group (p = 0.003). The angiographic restenosis rate was significantly lower in the debulking/stenting group (8.3% vs. 25%, p = 0.034). The reference artery size was the only independent predictor of angiographic restenosis. During follow-up (25.5 +/- 16.7 months), there were four deaths, but no nonfatal myocardial infarctions occurred. The survival rate was 97.0 +/- 1.7% at two years. CONCLUSIONS: These data suggest that stenting of unprotected LMCA stenosis might be associated with a favorable long-term outcome in selected patients. Guidance with IVUS may optimize the immediate results, and debulking before stenting seems to be effective in reducing the restenosis rate. However, we need a large-scale, randomized study.     

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions.

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). METHODS AND RESULTS: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. CONCLUSION: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.     

Comparison of six-month angiographic and three-year outcomes after sirolimus-eluting stent implantation versus brachytherapy for bare metal in-stent restenosis

To evaluate long-term effectiveness of sirolimus-eluting stent (SES) implantation for diffuse bare metal in-stent restenosis (ISR), we compared 6-month angiographic and long-term (3-year) clinical outcomes of SES implantation and intracoronary brachytherapy (ICBT). SES implantation for diffuse ISR was performed in 120 consecutive patients and their results were compared with those from 240 patients treated with beta-radiation with balloons filled with rhenium-188 and mercaptoacetyltriglycine. The radiation dose was 15 or 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was 3-year major adverse cardiac events including myocardial infarction, cardiac death, and target lesion revascularization. The 2 groups were similar in baseline clinical and angiographic characteristics. Lesion lengths were 25.1 +/- 14.2 mm in the SES group and 24.5 +/- 10.4 mm in the ICBT group (p = 0.15). In-stent acute gain was greater in the SES group than in the ICBT group (2.23 +/- 0.62 vs 1.91 +/- 0.54 mm, p <0.001). We obtained 6-month angiographic follow-up in 287 patients (79.7%). In-segment angiographic restenoses were 7.4% (7 of 94) in the SES group and 26.4% (51 of 193) in the ICBT group (p <0.05). Two myocardial infarctions (1 in each group) and 5 deaths (4 in SES group, 1 in ICBT group) occurred during 3-year follow-up. At 3 years, survival rates without target lesion revascularization (94.1 +/- 2.2% vs 84.6 +/- 2.3%, p = 0.011) and major adverse cardiac events (92.5 +/- 2.4% vs 84.2 +/- 2.4%, respectively, p = 0.03) were higher in the SES than in the ICBT group. In conclusion, compared with ICBT, SES implantation for diffuse ISR is more effective in decreasing recurrent restenosis and improving long-term outcomes.     

Unprotected left main stenting,short- and long-term outcomes

Abstract

Background: Coronary bypass surgery is recommended for the treatment of left main coronary stenosis. Recently a percutaneous approach has been described as a feasible option. Objectives: To present the in-hospital and long-term clinical and angiographic outcome of a consecutive group of patients undergoing stenting for unprotected left main coronary artery (LMCA) disease, and to compare the clinical and angiographic outcomes of drug-eluting stent (DES) versus metal stent (BMS). Methods: 238 consecutive patients underwent unprotected LMCA stenting. 165 received BMS and 73 received DES. Most patients (88.7%) presented with acute coronary syndrome. Clinical (100%) and angiographic (84%) follow-up was obtained. Results: Patients’ presentation: STEMI (7.2%), non-STEMI (13.5%), unstable angina (67.6%), stable angina (11.7%). Procedural success rate was 100%. In-hospital mortality was 2.1%, all in patients presented with unstable hemodynamic conditions. None of the patients needed emergent CABG. In the long-term follow-up (average three years) there were 12 deaths (5%), 3 patients required CABG and 25 patients required TVR. The overall angiographic LM restenosis rate show a trend toward lower rate in the DES group than the BMS group (9.6% versus 13.8%, P = 0.08). There was no difference in one year mortality (4.1% versus 4.2%) and AMI (2.7% versus 2.8%) between DES and BMS. Conclusions: Stenting for LM stenosis can be performed safely with acceptable in hospital and long-term outcome. Reconsideration of current guidelines should be considered. Drug-eluting stent implantation for unprotected LMCA stenosis appears safe with regard to acute and long-term complications and is more effective in preventing restenosis compared to BMS implantation.     

Long-term outcome of simultaneous kissing stenting technique with sirolimus-eluting stent for large bifurcation coronary lesions.

OBJECTIVES: This study was conducted to evaluate the outcomes of simultaneous kissing stenting with sirolimus-eluting stent (SES). BACKGROUND: Percutaneous intervention for bifurcation coronary lesions is still challenging. METHODS: This study was designed to evaluate the long-term outcomes of 36 consecutive patients with large bifurcation coronary lesions who underwent simultaneous kissing stenting with SES. RESULTS: Lesion location was unprotected left main in 29 patients (81%) and anterior descending artery in 7 (19%). The patients received a combination of aspirin and clopidogrel for 6 months and cilostazol for 1 month. Mean proximal reference diameter was 4.05 +/- 0.68 mm. Compared with the side branch (SB), the main vessel (MV) involved longer lesions (25.8 +/- 17.0 mm vs. 10.2 +/- 10.8 mm, P < 0.001) and smaller preprocedural minimal lumen diameters (1.02 +/- 0.53 mm vs. 1.46 +/- 0.78 mm, P = 0.006) and was treated with larger stents (3.1 +/- 0.3 mm vs. 3.0 +/- 0.3 mm, P = 0.006). Angiographic success rate was 100%. Over the follow-up of 26.7 +/- 8.6 months, no deaths, myocardial infarctions or stent thromboses occurred. Target lesion revascularization was performed in five patients (14%). Overall angiographic restenosis occurred in 5/30 patients (17%), consisting of 4 (13%) at MV and 3 (10%) at SB. At follow-up angiography, a membranous diaphragm at the carina was identified in 14 patients (47%), but only one of whom was associated with angiographic restenosis. CONCLUSION: Simultaneous kissing stenting with SES appears a feasible stenting technique in large bifurcation coronary lesions. However, a new angiographic structure of carinal membrane developed in a half of patients at follow-up and its influence needs to be further investigated.     

Expansion of the Multilink-Tristar stent after direct implantation and predilatation: comparison of clinical,angiography and intravascular ultrasound parameters

Coronary stenting has become the primary therapeutic option for many coronary lesions. As opposed to conventional stenting the advantages of direct stenting are a reduction of procedural time, radiation exposure and costs. However, data about the incidence of in-stent restenosis are so far not available. It was the aim of this prospective study to compare the expansion of the Multilink stent after direct stenting and predilatation by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). Between January 2000 and June 2001, 82 patients were assigned to direct stenting (46 lesions) or predilatation (40 lesions) in lesions of coronary arteries > 3 mm. The procedural success rate was 92% in patients undergoing direct stenting. The baseline clinical characteristics were similar in both groups. The comparison of the angiographic data shows that direct stenting was performed in lesions with a lower degree of stenosis (71 +/- 12% vs 79 +/- 11%, p = 0.01) and that significantly shorter stents were used (14.4 +/- 3.0 vs 17.8 +/- 4.1 mm, p = 0.0007). The mean stenosis length was not significantly different in either group (10.5 +/- 3.4 vs 11.7 +/- 4.3 mm, n.s.). The QCA data after stent implantation show no differences of either implantation technique. Stent expansion was assessed by IVUS estimation of the proximal, distal and minimal in stent area. The minimal in-stent area (9.53 +/- 3.23, mm2 vs 8.65 +/- 1.96 mm2, n.s.) and the stent symmetry index (0.88 vs 0.88 n.s.) were not different in either patient group. These results indicate that in this subset of selected coronary lesions > 3 mm, elective stent implantation with and without predilatation effectively can achieve comparable stent expansion as assessed by QCA and IVUS. In comparison to conventional stent implantation stents, which were implanted without predilatation, were significantly shorter to cover the same lesion length.     

Effect of statin therapy on restenosis after coronary stent implantation

The effect of statins on the development of restenosis and clinical outcome after coronary stent implantation was assessed in a retrospective analysis of 525 consecutive patients. Baseline clinical, angiographic, and procedural characteristics did not differ between 258 patients with and 267 patients without statin therapy. Statin therapy was associated with a significantly (p<0.04) improved survival free of myocardial infarction and a significant reduction in repeat target vessel revascularization procedures (27.9% vs. 36.7%, p<0.05) during 6-month follow-up. Minimal lumen diameter was significantly larger (1.98+/-0.88 vs. 1.78+/-0.88 mm, p = 0.01), late lumen loss was significantly less (0.64+/-0.8 vs. 0.8+/-0.8 mm, p = 0.032), and net gain significantly increased (1.2+/-0.88 vs. 0.98+/- 0.92 mm, p = 0. 009) in patients receiving statin therapy. Dichotomous angiographic restenosis (> or =50%) rates were significantly lower, with 25.4% in the statin group compared with 38% in the no-statin group (p<0.005). Multivariate analysis identified statin therapy (p = 0.005), minimal lumen diameter immediately after stenting (p = 0.02), and stent length (p = 0.02) as independent predictors for subsequent restenosis development. Thus, statin therapy is associated with reduced recurrence rates and improved clinical outcome after coronary stent implantation.     

Comparison with conventional therapies of repeated sirolimus-eluting stent implantation for the treatment of drug-eluting coronary stent restenosis

This study compared the safety and efficacy of repeat percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SESs) with conventional therapies for restenosis after drug-eluting stent placement. Fifty-five consecutive patients with 58 restenotic lesions (31 treated with SESs and 27 treated with paclitaxel-eluting stents) underwent PCI using SESs (33 lesions) or conventional therapies comprising cutting balloon angioplasty alone (11 lesions) or intracoronary brachytherapy (14 lesions). Baseline characteristics were similar for the 2 groups, except for greater edge involvement (75.8% vs 36.0%, p = 0.002) and less stent expansion (0.74 +/- 0.17 vs 0.95 +/- 0.21, p = 0.006) in the SES group than in the conventional group. The SES group achieved a greater postprocedural luminal gain than the conventional group (1.98 +/- 0.50 vs 1.22 +/- 0.48 mm, p <0.001). Follow-up angiography showed that late luminal loss (0.27 +/- 0.56 vs 0.76 +/- 0.84 mm, p = 0.021) and recurrent angiographic restenosis rate (3.6% vs 35.0%, p = 0.006) were lower in the SES group than in the conventional group. The repeated target lesion revascularization-free survival rates at 1 year were 96.7 +/- 3.2% for the SES group and 91.7 +/- 5.6% for the conventional group (p = 0.399). In conclusion, use of SESs was associated with a lower recurrent restenosis rate compared with conventional therapies.     

The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial.

OBJECTIVES: The purpose of the SCANDSTENT study was to evaluate the use of sirolimus-eluting stents (SES) in complex coronary lesions. BACKGROUND: The use of SES improves angiographic and clinical outcomes compared with bare-metal stents (BMS) in simple coronary artery lesions, but there is limited evidence of their safety and efficacy when implanted in complex lesions. METHODS: We randomly assigned 322 patients with symptomatic complex coronary artery disease to receive either SES or BMS. The lesions were occluded (36%), bifurcational (34%), ostial (22%), or angulated (8%) in morphology. The primary end point was the difference in minimal lumen diameter six months after stent implantation. RESULTS: The patients were well matched in terms of demographic and angiographic baseline characteristics; 18% had diabetes. The reference vessel diameter was 2.86 mm in mean, and the lesion length 18.0 mm. At follow-up, patients who received SES had a minimal lumen diameter of 2.48 mm compared with 1.65 mm in those who received BMS (p < 0.001), a diameter stenosis of 19.3% versus 43.8% (p < 0.001), and 2.0% versus 31.9% developed restenosis (p < 0.001). The rate of major adverse cardiac events was 4.3% with SES versus 29.3% with BMS (p < 0.001), and stent thrombosis was observed in 0.6% in the SES group versus 3.1% in the BMS group (p = 0.15). CONCLUSIONS: The use of SES markedly reduced restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of stent thrombosis.     

Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation.

AIMS: In many countries, drug-eluting stent implantation is the dominant interventional strategy. We evaluated the clinical, angiographic, procedural, and intravascular ultrasound (IVUS) predictors of angiographic restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: SES implantation was successfully performed in 550 patients with 670 native coronary lesions. Six-month follow-up angiography was performed in 449 patients (81.6%) with 543 lesions (81.1%). Clinical, angiographic, procedural, and IVUS predictors of restenosis were determined. Using multivariable logistic regression analysis, the only independent predictors of angiographic restenosis were post-procedural final minimum stent area by IVUS [odds ratio (OR)=0.586, 95% confidence interval (CI) 0.387-0.888, P=0.012] and IVUS-measured stent length (OR=1.029, 95% CI 1.002-1.056, P=0.035). Final minimum stent area by IVUS and IVUS-measured stent length that best separated restenosis from non-restenosis were 5.5 mm2 and 40 mm, respectively. Lesions with final minimum stent area<5.5 mm2 and stent length>40 mm had the highest rate of angiographic restenosis [17.7% (11/62)], P<0.001 compared with other groups. CONCLUSION: Independent predictors of angiographic restenosis after SES implantation were post-procedural final minimum stent area by IVUS and IVUS-measured stent length. The angiographic restenosis rate was highest in lesions with stent area<5.5 mm2 and stent length>40 mm.     

Randomized comparison of coronary stent implantation and balloon angioplasty in the treatment of de novo coronary artery lesions (START): a four-year follow-up.

OBJECTIVE: 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 +/- 0.6 mm vs. 1.43 +/- 0.6 mm in the angioplasty group; p < 0.0001), and at six-month follow-up (1.98 +/- 0.7 mm vs. 1.63 +/- 0.7 mm; p < 0.001). The corresponding restenosis rates were 22% and 37%, respectively (p < 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 = 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.