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.     

Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation

OBJECTIVES: This study was designed to compare the clinical and angiographic outcomes of sirolimus-eluting stent (SES) and bare metal stent (BMS) implantation for unprotected left main coronary artery (LMCA) stenosis. BACKGROUND: The safety and effectiveness of SES implantation for unprotected LMCA stenosis have not been ascertained. METHODS: Elective SES implantation for de novo unprotected LMCA stenosis was performed in 102 consecutive patients with preserved left ventricular function from March 2003 to March 2004. Data from this group were compared to those from 121 patients treated with BMS during the preceding two years. RESULTS: Compared to the BMS group, the SES group received more direct stenting, had fewer debulking atherectomies, had a greater number of stents, had more segments stented, and underwent more bifurcation stenting. The procedural success rate was 100% for both groups. There were no incidents of death, stent thrombosis, Q-wave myocardial infarction (MI), or emergent bypass surgery during hospitalization in either group. Despite less acute gain (2.06 +/- 0.56 mm vs. 2.73 +/- 0.73 mm, p < 0.001) in the SES group, SES patients showed a lower late lumen loss (0.05 +/- 0.57 mm vs. 1.27 +/- 0.90 mm, p < 0.001) and a lower six-month angiographic restenosis rate (7.0% vs. 30.3%, p < 0.001) versus the BMS group. At 12 months, the rate of freedom from death, MI, and target lesion revascularization was 98.0 +/- 1.4% in the SES group and 81.4 +/- 3.7% in the BMS group (p = 0.0003). CONCLUSIONS: Sirolimus-eluting stent implantation for unprotected LMCA stenosis appears safe with regard to acute and midterm complications and is more effective in preventing restenosis compared to BMS 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.     

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.     

Initial and long-term results of directional coronary atherectomy in unprotected left main coronary artery

Angioplasty in the unprotected left main coronary artery (LMCA) has been controversial. Recently, several studies have suggested that new procedures and devices such as directional coronary atherectomy (DCA) and stents may change this situation. Although there are many reports of unprotected LMCA stenting, there are few reports of DCA of this lesion. Therefore, initial and long-term results were evaluated in 101 patients who underwent DCA for unprotected LMCA in our hospital. Emergency procedures were performed in 15 patients and electively in 86 patients. Scheduled angiographic follow-up was routinely performed, and all patients were clinically followed for >4 months after DCA. Technical success was achieved in 99%, and in-hospital outcomes were cardiac death (2%), noncardiac death (4%), Q-wave myocardial infarction (1%), non-Q-wave myocardial infarction (8.9%), coronary artery bypass grafting (0%), and repeat angioplasty (4%). In-hospital results varied considerably, depending on presentation. In-hospital mortality was significantly higher in the emergency, left ventricular ejection fraction < or =35%, and high-risk surgical subgroups. The angiographic restenosis rate was 20.4% at follow-up, and its predictor was postminimal lumen diameter by multivariate analysis. Mean clinical follow-up was 2.8 years; estimated 1- and 3-year survival rates were 87% and 80.7%, respectively. The cardiac survival rate of the low-risk surgical subgroup was significantly higher than that of the high-risk surgical subgroup (p <0.05). Thus, our data show that DCA can be performed safely and effectively in unprotected LMCA with an acceptable low restenosis rate and high survival rate.     

120例无保护左主干冠状动脉病变药物洗脱支架术的临床疗效和随访研究

目的探讨药物洗脱支架(DES)在无保护左主干冠状动脉(LMCA)病变的疗效。方法回顾性分析符合条件连续的120例无保护LMCA病变患者行DES的疗效,将其分为分叉病变组(80例)和非分叉病变组(40例)两组,根据病变特点行单支架术或双支架术,分析其支架术的操作特点,住院期间及出院后随访其主要心脏不良事件(MACE,包括死亡、非致死性心肌梗死及靶病变重建)及支架内血栓形成(ST)的情况。结果两组间的临床基线情况差异无统计学意义,共106(88.3%)例患者完成随访,分叉病变组更多使用血管内超声(IVUS)指导治疗(但P>0.05),分叉病变组33例行双支架术,非分叉病变组5例行双支架术(P=0.001),住院期间无MACE及支架内血栓(ST)发生,出院随访平均(26.3±14.5)个月,MACE11例(9.2%),总共死亡3例(2.8%),都是SYNTAX积分及EuroSCORE均属高危的患者,非致死性心肌梗死2例(1.9%),靶病变重建(TLR)6例(5.7%),造影再狭窄6例(占造影随访患者的15.8%),两组ST各1例,两组间MACE差异无统计学意义(7.5%比12.5%,χ2=0.801,P=0.503)。结论在选择性患者行DES治疗无保护LMCA病变不论是否分叉病变近远期的安全性和有效性可以接受。     

Long-term (three-year) outcomes after stenting of unprotected left main coronary artery stenosis in patients with normal left ventricular function

The purpose of this study was to analyze long-term follow-up information from patients treated with stenting for unprotected left main coronary artery (LMCA) stenosis. Stenting of unprotected LMCA stenosis is often performed in selected patients, but the long-term safety of this therapy is not yet established. Between January 1995 and September 2000, 270 consecutive patients with unprotected LMCA stenosis and normal left ventricular function who underwent treatment at 4 clinical centers were included in this study. Data were forwarded to the coordinating center using a standard case report form. The procedural success rate was 98.9%. There were no deaths, 3 stent thromboses, and 3 Q-wave myocardial infarctions during the hospitalization. Angiographic follow-up was performed in 237 patients (follow-up rate 87.8%), and the restenosis rate was 21.1%. The reference size was an independent predictor of binary restenosis (odds ratio 0.543, 95% confidence interval 0.308 to 0.957, p = 0.03). During the follow-up period (32.3 +/- 18.5 months), there were 20 deaths (8 cardiac, 12 noncardiac) and 5 nonfatal myocardial infarctions. Target and new lesion revascularizations were required in 45 (16.7%) and 31 (11.5%) patients, respectively. The cumulative probabilities free from major adverse cardiac events were 81.9 +/- 2.4%, 78.4 +/- 2.6%, and 77.7 +/- 2.7%, respectively, at 1, 2, and 3 years. Combined coronary artery disease and postprocedural minimal luminal diameter were the significant predictors of major adverse cardiac events. Thus, the long-term prognosis of patients after stenting of unprotected LMCA stenosis was favorable in selected patients with normal left ventricular function.     

Revascularization of chronic coronary artery occlusions using laser debulking followed by stent implantation

OBJECTIVE: Chronic total occlusions are considered unfavourable for percutaneous balloon angioplasty because of the low rate of success and the high rate of restenosis. Stent implantation after recanalization of chronic total occlusions has been shown to reduce restenosis and reocclusion rates compared with balloon angioplasty in recently published randomized trials. However, it is not well known whether laser debulking before stent implantation would improve the benefit of stenting in chronic total occlusions. METHODS AND RESULTS: We analysed procedural and long-term clinical and angiographic follow-up results of 48 patients who underwent laser angioplasty followed by stent implantation for chronic total occlusions. The procedure was completed successfully in 46 patients (95.8%) in whom the lesion was crossed with a guidewire. We implanted 51 stents in 46 chronic total occlusions following laser debulking. During in-hospital follow-up 1 patient (2.1%) had Q wave, and 4 patients (8.7%) had non-Q wave myocardial infarction. Nine patients (19.5%) had repeat angioplasty for restenosis and one (2.1%) underwent coronary bypass operation at 6 months follow-up. Death or Q wave myocardial infarction did not occur during 6-month follow-up. Thirty-nine patients (85%) had angiographic follow-up at 6 months, and stent restenosis was found in 17 (44%) patients. CONCLUSION: These high rates of restenosis and target vessel revascularization in our study suggest that laser debulking before stent implantation does not improve clinical and angiogragic outcomes in chronic total occlusions.     

Comparison of directional coronary atherectomy and stenting versus stenting alone for the treatment of de novo and restenotic coronary artery narrowing

Late lumen loss after directional coronary atherectomy (DCA) is mainly determined by arterial remodeling. We hypothesized that stent implantation after optimal lesion debulking could be an effective approach to reduce restenosis. A total of 753 patients with de novo or restenotic coronary lesions were prospectively randomized to DCA plus stenting (n = 381) or stenting alone (n = 372). The patients were followed for 12 months. Procedural success was achieved in 91.5% versus 97.3% (p = 0.0007) of patients treated with DCA plus stent versus stent alone. Optimal atherectomy (<20% residual stenosis) was achieved in 26.5% of patients. The final minimal luminal diameter and the acute gain were similar in the 2 groups. There was no increase in 30-day major adverse cardiac events in the DCA plus stent group (3.9% vs 2.4%, p = 0.30). The primary end point, angiographic restenosis at 8 months, occurred in 26.7% of patients treated with DCA plus stents and in 22.1% of patients treated with stents alone (p = 0.237). Clinical follow-up to 1 year showed no difference in mortality (1.3% vs 0.8%, p = 0.725), acute myocardial infarction (4.2% vs 3.5%, p = 0.706), and target vessel failure (composite of death, Q-wave myocardial infarction, and target vessel revascularization) (23.9% vs 21.5%, p = 0.487) between patients with DCA plus stents and those with stents alone. This study failed to support the hypothesis that DCA before stenting lowers the angiographic restenosis rate compared with stents alone. At 12-month follow-up, there were no significant differences between the 2 groups in rates of death, reinfarction, or target vessel failure.     

Results of percutaneous coronary intervention of the unprotected left main coronary artery in 143 patients and comparison of 30-day mortality to results of coronary artery bypass grafting

Percutaneous coronary intervention (PCI) of the unprotected left main coronary artery (LMCA) is controversial. In 143 patients who underwent PCI of the unprotected LMCA, 30-day mortality was compared with predicted cumulative risk-adjusted perioperative surgical mortality based on logistic European System for Cardiac Operative Risk Evaluation. One-year clinical follow-up was completed in all patients. The overall major adverse cardiac event rate at 1 year was 34.3%, reflecting the high-risk profile of the patient population. Twelve patients (8%) experienced an acute myocardial infarction and 16 (11%) underwent target lesion revascularization. In 31 patients (22%) who died during the first year, median logistic European System for Cardiac Operative Risk Evaluation was 30%. Calculated RRs showed significantly lower 30-day mortality using PCI compared with predicted surgical mortality (RR 0.54, 95% confidence interval 0.31 to 0.86). Angiographic follow-up in 90 of the 118 patients alive at 6 months showed binary restenosis of 6% in patients treated with drug-eluting stents versus 29% in patients receiving bare-metal stents (p < or =0.01). In conclusion, PCI for unprotected LMCA disease was associated with acceptable short- and medium-term outcomes in patients at low to intermediate risk of bypass surgery. Mortality remains high in very high-risk patients unsuitable for surgery. However, in selected indications, PCI of the LMCA can offer an alternative to surgery, especially when using drug-eluting stents.     

Drug‐eluting stents in bifurcation lesions: To stent one branch or both?

OBJECTIVES: The objective of this study was to compare two techniques to treat bifurcation lesions: a single drug-eluting stent (DES) implanted in the main branch combined with balloon dilatation for the side branch vs. stenting of both branches (double stent). BACKGROUND: Percutaneous coronary intervention in coronary bifurcation lesions remains challenging. Although DES reduce restenosis in lesions, the double stent procedure has not shown clear advantages over a single stent with balloon dilation. METHODS: Fifty-three symptomatic patients with true bifurcation lesions were treated using either the double stent technique (n = 25) or one stent in the parent vessel plus balloon angioplasty of the side branch (n = 28). Procedural results and major adverse cardiac event rates (MACE: cardiac death, myocardial infarction, target vessel revascularization (TVR)) were compared. RESULTS: Angiographic procedural success (residual stenosis <30% in both branches) was 75% in the single stent group and 100% in the double stent group (P = 0.01). All differences were due to residual stenosis of the side branch. Clinical follow-up (6-18 months) was available for all patients; 90.5% of patients had a coronary angiography or nuclear stress test. Three patients (11%) in the single stent group and two (8%) in the double stent group had ischemia-driven TVR (P = NS). Asymptomatic angiographic restenosis (>50% diameter stenosis) in the ostium of the side branch was seen in two patients in the double-stent group. At 6 months, MACE-free was comparable between groups (89.3% vs. 88%, P = 0.7). CONCLUSIONS: When treating bifurcation lesions with sirolimus-eluting stents, restenosis following a single stent procedure is comparable to stenting both parent and side branch vessels. Thus, stenting the main-branch lesion, coupled with balloon angioplasty in the side branch, produces a high success rate and good clinical outcomes at 6 months.     

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.     

药物洗脱支架在冠心病无保护左主干病变中的应用

目的评价药物洗脱支架治疗经选择冠心病无保护左主干病变的安全性和有效性。方法2003年1月~2005年6月间,共有48例经选择的冠心病患者,年龄39~81岁,经冠状动脉造影证实为无保护左主干病变(左主干狭窄均≥75%)行介入治疗置入药物洗脱支架。结果48例患者介入治疗均获得成功,共置入药物洗脱支架75枚(51 Cypher,18 Taxus,6 Firebird)。其中左主干开口部狭窄5例(10.4%,5/48),体部狭窄6例(12.5%,6/48),远端分叉部位狭窄37例(77.1%,37/48)。37例远端分叉部位狭窄患者中,主支支架加边支经皮冠状动脉介入治疗(PCI)10例,双支架术27例,最后成功对吻球囊扩张30例(81.1%,30/37)。所有患者治疗后临床症状明显缓解或消失,住院及6个月随访期间无严重心血管事件发生,43例患者术后6个月行冠状动脉造影随访,2例患者再狭窄(均为分叉病变)行冠状动脉旁路移植术(CABG),冠状动脉造影随访率89.6%,再狭窄率4.7%。结论药物洗脱支架介入治疗冠心病无保护左主干病变安全有效,近中期效果良好。     

Percutaneous therapy of bifurcation lesions with drug‐eluting stent implantation: the Culotte technique revisited

INTRODUCTION: The most effective strategy for bifurcation stenting is currently undefined. The Culotte technique was developed as a method that ensures complete bifurcation lesion coverage. However, it went out of favour due to a high rate of restenosis when utilizing bare metal stents. Drug‐eluting stents reduce the rate of restenosis and need for repeat lesion revascularization compared with bare metal stents; we re‐evaluated this technique with drug‐eluting stent implantation. METHODS: Between April 2002 and October 2003, 207 patients were treated for at least one bifurcation lesion with drug‐eluting stent implantation to both the main vessel and side branch. Of these, 23 were treated with the Culotte technique (11.1%) for 24 lesions. Sirolimus‐eluting stents were used in 8.3%, and paclitaxel‐eluting stents in the remaining 92.7%. RESULTS: Clinical follow‐up was obtained in 100%. One patient had a myocardial infarction at 14 days (maximum rise in creatine kinase 872IU/L) related to thrombosis occurring in another lesion, and underwent repeat revascularization. There were no episodes of stent thrombosis in the Culotte lesions. At eight months follow‐up, there were no deaths and no further myocardial infarction. One patient required target lesion revascularization (TLR), and a second underwent target vessel revascularization. The cumulative rates of survival‐free of TLR and major adverse cardiac events were 94.7% and 84.6% respectively. Angiographic follow‐up was obtained in 16 patients (69.6%) at a mean period of 8.3±4.3months. The late lumen loss for the main vessel and side branch were 0.48±0.56?mm and 0.53±0.33?mm respectively, with binary restenosis rates of 18.8% and 12.5%.

CONCLUSIONS: In this small study of bifurcation stenting utilizing the Culotte technique with drug‐eluting stent implantation, there was a low rate of major adverse events and need for target lesion revascularization at eight months, when compared with historical data of bifurcation stenting with bare metal stents. Further re‐evaluation of this technique utilizing drug‐eluting stents, is warranted in the setting of larger randomized studies.     

Effectiveness of drug-eluting stent implantation for patients with unprotected left main coronary artery stenosis

This study was aimed to evaluate outcomes of patients with unprotected left main coronary artery (LMCA) stenosis who were treated with drug-eluting stents. Sixty-three consecutive patients with unprotected LMCA stenosis were treated with sirolimus-eluting stents in 52 (83%) patients and paclitaxel-eluting stents in 11 (17%) patients, in whom percutaneous intervention was considered the sole alternative because of high surgical risk and/or patient preference. Urgent percutaneous coronary intervention within 24 hours after angiography was performed in 6 (10%) patients. The patients were predominantly at high surgical risk with 35 (56%) having EuroSCORE >6 and 39 (62%) having Parsonnet score >15. Involvement of the distal LMCA was observed in 46 (73%) patients. Procedural success was achieved in all patients. Intravascular ultrasound was used in 51 (81%) patients. Single-stenting strategy was adopted in 36 (78%) patients with bifurcation stenosis. There were no death, Q-wave myocardial infarction, stent thrombosis, or urgent repeat revascularization events during hospitalization. Over a mean follow-up of 11.7 +/- 7.7 months, 18 (29%) patients experienced major adverse cardiac events, including 3 (5%) deaths, 7 (11%) myocardial infarctions, and 10 (16%) target lesion revascularizations. Stent thrombosis developed in 1 (0.6%) patient at 35 days after the procedure. Bifurcation involvement was an independent predictor of major adverse cardiac events by multivariate analysis (hazard ratio 12.90, 95% confidence interval 1.36 to 122.45, p = 0.0259). In conclusion, drug-eluting stent placement for unprotected LMCA stenosis may be a feasible therapeutic alternative in patients at high surgical risk. However, bifurcation stenosis remains a significant predictor of unfavorable clinical outcome.     

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.     

One-year clinical outcomes of protected and unprotected left main coronary artery stenting.

AIMS: To evaluate outcomes for left main coronary artery (LMCA) stenting and compare results between protected (left coronary grafted) and unprotected LMCA stenting in the current bare-metal stent era. METHODS: We reviewed outcomes among 142 consecutive patients who underwent protected or unprotected LMCA stenting since 1997. All-cause mortality, myocardial infarction (MI), target-lesion revascularization (TLR), and the combined major adverse clinical event (MACE) rates at one year were computed. RESULTS: Ninety-nine patients (70%) underwent protected and 43 patients (30%) underwent unprotected LMCA stenting. In the unprotected group, 86% were considered poor surgical candidates. Survival at one year was 88% for all patients, TLR 20%, and MACE 32%. At one year, survival was reduced in the unprotected group (72% vs. 95%, P<0.001) and MACE was increased in the unprotected patients (49% vs. 25%, P=0.005). CONCLUSIONS: In the current era, stenting for both protected and unprotected LMCA disease is still associated with high long-term mortality and MACE rates. Stenting for unprotected LMCA disease in a high-risk population should only be considered in the absence of other revascularization options. Further studies are needed to evaluate the role of stenting for unprotected LMCA disease.     

Unprotected left main coronary artery stenting: immediate and medium-term outcomes of 140 elective procedures

OBJECTIVES: We sought to evaluate immediate and late outcomes after stenting for left main coronary artery (LMCA) stenosis. BACKGROUND: Conventional percutaneous transluminal coronary angioplasty (PTCA), for which coronary artery bypass grafting (CABG) has been the gold standard therapy for years, has yielded poor results in unprotected LMCA lesions. The development of coronary stents, together with their dramatic patency improvement provided by new antiplatelet regimens and their validation against restenosis, warrants a reappraisal of angioplasty in LMCA stenosis. METHODS: From January 1993 to September 1998, 140 consecutive unselected patients with unprotected LMCA stenosis underwent elective stenting. Group I included 47 high-CABG-risk patients, and group II included 93 low-CABG-risk patients. Ticlopidine without aspirin was routinely started at least 72 h before the procedure and continued for one month. Patients were reevaluated monthly. A follow-up angiography was requested after six months. RESULTS: The procedure success rate was 100%. One-month mortality was 9% (4/47) in group I and 0% in group II. A follow-up angiography was obtained in 82% of cases, and target lesion revascularization was required in 17.4%. One-year actuarial survival was 89% in the first 29 group I patients and 97.5% in the first 63 group II patients. CONCLUSIONS: 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.     

Long-term follow-up of drug-eluting stents when inserted for on- and off-label indications

This study reports long-term follow-up of the on- and off-label implantation of drug-eluting stents (DESs) in a retrospective study of 1,044 patients. Off-label implantation of DESs was performed for left main coronary artery lesions, bifurcation lesions, bare metal stent restenosis, ostial disease, chronic total occlusions, saphenous vein graft lesions, internal mammary artery graft lesions, left ventricular ejection fraction <30%, and acute myocardial infarction. End points examined were procedural complications, in-hospital myocardial infarction, and acute stent thrombosis; end points examined at follow-up were subacute stent thrombosis, late stent thrombosis, target vessel revascularization, myocardial infarction, death, and major adverse clinical events (MACEs; a composite of death, myocardial infarction, and target vessel revascularization). The study included 364 patients who received a DES on an on-label basis and 680 patients who received a DES on an off-label basis. Patient characteristics were not significantly different between the 2 groups, and there was no difference in procedural complications or acute stent thrombosis (on-label, 0%; off-label, 0.3%; p=0.55). There were no significant differences in subacute stent thrombosis (0% vs 0.6%, p=0.3), late stent thrombosis (1.4% vs 1.2%, p=0.78), death at follow-up (4.9% vs 4.1%, p=0.53), or myocardial infarction (1.9% vs 2.4%, p=0.83). Off-label DES implantation was associated with higher rates of target vessel revascularization (13.2% vs 24.1%, p=0.0001) and MACEs (17.6% vs 28.2%, p=0.0001). Multivariate analysis showed associations between target vessel revascularization and MACEs (respective p values) with bare metal stent restenosis (p=0.001 and p=0.001), diabetes mellitus (p=0.002 and p=0.001), and previous coronary artery bypass grafting (p=0.04 and p=0.01), but not off-label DES implantation (p=1.36 and p=1.16). In conclusion, DES use in the off-label situations studied was safe and was not associated with increased stent thrombosis, myocardial infarction, or death. Multivariate analysis showed that off-label DES implantation was not a risk factor for target vessel revascularization or MACEs.     

Direct stenting compared to conventional stenting in Diabetic Patients Undergoing Elective Angioplasty for Coronary Artery Disease (DECIDE): a multicenter, open label, randomized, controlled efficacy study

Background

Direct stenting (DS) has been shown to be associated with reduced radiation exposure and procedural costs but has a restenosis rate and clinical outcomes similar to conventional stenting (CS) with balloon predilatation. Whether DS confers benefit in diabetic patients, who have been shown to have high restenosis risk after stent implantation, remains unknown.

Methods

In a multicenter randomized trial, diabetic patients undergoing elective coronary stent implantation for a de novo lesion in a native coronary artery between April 2001 and October 2002 were randomized into DS or CS treatment groups. All patients received NirElite stents (SciMed, Boston Scientific, Maple Grove, Minn). They were scheduled to undergo a 6-month angiographic follow-up with quantitative coronary analysis evaluation. The primary end point was a 6-month binary restenosis rate and the secondary end point involved 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates.

Results

A total of 128 diabetic patients were randomized into DS or CS treatment groups (n = 64, both groups). The 2 groups were well matched in baseline and lesion characteristics. The procedural success rate was similar (DC vs CS; 98.4% vs 96.9%). Nineteen patients (29.7%) crossed over from DS to CS. Six-month angiographic follow-up showed similar restenosis rates, minimum luminal diameter and late lumen loss. The binary restenosis rate was 43% in DS and 52% in CS groups (P = NS). The 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates were also similar in both groups.

Conclusions

Among diabetic patients undergoing elective coronary stent implantation, DS is safe and feasible. However, it is not associated with reduction in restenosis rate or improvement in clinical outcomes when compared with CS.