[Role of new devices for angioplasty in the unprotected left main coronary artery].

OBJECTIVES: Angioplasty for the unprotected left main trunk remains controversial, but new procedures and devices such as directional coronary atherectomy and stenting have improved the results. We compared the results of angioplasty with the inflexible balloon and new devices. METHODS: The procedures were performed in 239 consecutive lesions in 160 patients between April 1986 and March 2000. This study excluded emergency cases and repeat angioplasty cases, and included 120 initial and elective cases. Initial and long-term results were compared between the balloon group (n = 29) and the new device group (n = 91). RESULTS: Lesion success rate was lower in the balloon group (90% vs 100%, p < 0.05), but there were no significant differences in in-hospital results including cardiac death (0% vs 0%), noncardiac death (0% vs 3.3%), Q-wave myocardial infarction (0% vs 2.2%), non-Q wave myocardial infarction (3.4% vs 6.6%), bypass surgery (0% vs 0%) and repeat angioplasty (6.9% vs 1.1%). Quantitative angiography showed significant improvements in minimal lumen diameter (mean 2.17 vs 3.16 mm, p < 0.001) and percentage diameter stenosis (mean 31% vs 13%, p < 0.001) in the new device group after the procedures. The minimum lumen diameter remained larger at 3 (p < 0.001) and 6 months (p < 0.05) in the new device group. Therefore, angiographic restenosis rate was higher in the balloon group (55% vs 21%, p < 0.005). Five-year survival rate showed no significant difference between the groups (75.0% vs 83.8%). CONCLUSIONS: New devices significantly improved the minimal lumen diameter after angioplasty for unprotected left main trunk disease, and lead to significant improvement of restenosis rate at follow-up.

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.

[Predictors of prognosis after angioplasty in the unprotected left main coronary artery].

OBJECTIVES: The short-term and long-term predictors of outcome after coronary angioplasty in the unprotected left main coronary artery were investigated. METHODS: The procedure was performed in 122 consecutive patients for de novo lesions without myocardial infarction in our hospital between April 1986 and October 1998, including 16 emergency cases. Procedures were directional coronary atherectomy (73 patients), balloon angioplasty (31 patients), and stent implantation (18 patients). There were 101 males and mean age was 68 +/- 10 years. Follow-up angiography was performed in 98% of discharged patients, and all patients were clinically followed up for more than 1 year. Clinical and angiographic predictors of in-hospital and long-term outcome were evaluated. RESULTS: The in-hospital mortality was 5.7% (7 of 122 patients). Multivariate analysis revealed that more patients were admitted as emergency cases (57% vs 10%, p = 0.0088), with left ventricular ejection fraction < or = 35% (57% vs 22%, p = 0.029) and renal failure (43% vs 3%, p = 0.0004) finally died. Mean follow-up period was 3.5 years. Estimated survival rate was 77.1%, and cardiac-death free survival rate was 81.0% at 5 years by the Kaplan-Meier method. Univariate analysis showed that the predictors of cardiac death were emergency angioplasty, renal failure, decreased left ventricular ejection fraction, multivessel disease and unstable angina and/or congestive heart failure. Cox's regression model showed that renal failure (p = 0.0004) and multivessel disease (p = 0.0075) were significant predictors of long-term prognosis. CONCLUSIONS: Renal failure was the strongest predictor of outcome after unprotected left main coronary artery angioplasty.

Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.

BACKGROUND: Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent. METHODS AND RESULTS: Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months. CONCLUSIONS: Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.

Initial and long-term results of angioplasty in unprotected left main coronary artery.

Angioplasty of the unprotected left main coronary artery (LMCA) has been controversial. Although recent single-center studies suggest that new devices may change the situation, many questions and problems remain. Therefore, the results of unprotected left main coronary angioplasty of 175 procedures in 107 patients were analyzed to evaluate its feasibility and effectiveness. The treatment of the initial 107 cases included balloon angioplasty (39 cases, 36%), directional coronary atherectomy (53 cases, 50%), and stents (15 cases, 14%). They were divided into 3 major subgroups: (1) acute group (n = 14), in which LMCA angioplasty was performed in patients with acute myocardial infarction; (2) emergency group (n = 10); and (3) elective group (n = 83). In-hospital mortality was higher in the acute (35.7%) and emergency (40.0%) groups than in the elective group (3.6%; p <0.0001). Angiographic follow-up was routinely performed and the restenosis rate including in-hospital restenosis was 70% in the acute group, 37.5% in the emergency group, and 40% in the elective group (p = NS). The mean clinical follow-up period was 2.9 years, and the estimated 5-year survival rates of the acute and emergency groups were 50% and 48.2%, respectively. However the 5-year survival rate of the elective group was higher than that seen in the acute or emergency group (77.5%; p <0.05). Repeat LMCA angioplasty was performed in 37 of 68 patients with 8.8% mortality (38.5% of acute and emergency cases and 1.8% of elective cases). The results indicated that elective unprotected LMCA angioplasty is relatively feasible and effective under scheduled angiographic follow-up.

Effectiveness of tranilast on restenosis after directional coronary atherectomy.

Tranilast is an antiallergic drug used widely in Japan that also inhibits the migration and proliferation of vascular smooth muscle cells. This pilot study was undertaken to determine the effectiveness of tranilast on restenosis after successful directional coronary atherectomy. After the procedure, 40 patients (56 lesions, tranilast group) were treated with oral tranilast for 3 months, and 152 patients (188 lesions, control group) did not receive tranilast. Angiographic and clinical variables were compared between the two groups. The minimal lumen diameter was significantly larger in the tranilast group than in the control group at both 3-month (2.08 vs 1.75 mm, p = 0.004) and 6-month follow-up (2.04 vs 1.70 mm, p = 0.003). The diameter stenosis in the tranilast group was smaller than that in the control group both 3 months (28% vs 40%, p = 0.0007) and 6 months (30% vs 43%, p = 0.0001) after the procedure, with a lower restenosis rate (percent diameter stenosis > or =50) in the tranilast group at 3 months (11 % vs 26%, p = 0.03). The number of clinical events over the 12-month period after the procedure was significantly reduced by tranilast administration (p = 0.013). These findings suggest that the oral administration of tranilast strongly prevents restenosis after directional coronary atherectomy.

[Coronary arterial rupture during percutaneous transluminal coronary angioplasty: a case report].

A case who developed rupture in a diagonal branch of the left anterior descending coronary artery (LAD) during percutaneous transluminal coronary angioplasty (PTCA) is reported here. The present case was 80-year-old man with severe focal stenosis of the LAD at its junction with a diagonal branch. PTCA for the LAD lesion was successfully performed, but occlusion of the diagonal branch developed later. A subsequent ECG showed elevation of an ST segment in a VL, and PTCA for the diagonal branch was attempted. A 018 Hi-torque floppy guide wire was introduced into the occluded diagonal branch, and its dilatation was attempted using a 2 mm Simpson-Robert catheter. During a maximal pressure of 120 psi, a deformity was found at the distal end of the balloon. Post-PTCA angiograms showed rupture of the diagonal arterial branch, and mild to moderate pericardial effusion was observed by echocardiography. The patient experienced transient hypotension (60 mmHg at systolic), but his condition gradually stabilized after the administration of only a pressor medication. Neither pericardiocentesis nor emergency surgery was performed. The next day, follow-up angiograms showed diagonal branch occlusion at the proximal portion of the rupture site. His clinical course was satisfactory with spontaneous resolution of pericardial effusion and mild elevation of his cardiac enzymes (CPK = 243IU). In this case, it was concluded that the cause of coronary arterial rupture was the difference in diameters of the coronary artery (1 mm) and the balloon catheter (2 mm). This was the first rupture case experienced among 750 PTCA sites (0.13%).(ABSTRACT TRUNCATED AT 250 WORDS)