Takuji Nakamura

Biodegradable stents as a platform to drug loading.

Despite technical and mechanical improvement in coronary stents the incidence of restenosis caused by in-stent neointimal hyperplasia remains high. Oral administration of numerous pharmacological agents has failed to reduce restenosis after coronary stenting in humans, possibly owing to insufficient local drug concentration. Therefore, drug-eluting stents were developed as a vehicle for local drug administration. The authors developed a new drug-eluting polymer stent that is made of poly-l-lactic acid polymer mixed with tranilast, an anti-allergic drug that inhibits the migration and proliferation of vascular smooth muscle cells induced by platelet-derived growth factor and transforming growth factor->1. Polymer stents might be superior to polymer-coated metallic stents as local drug delivery stents in terms of biodegradation and the amount of loaded drug. Drug-mixed polymer stents can be loaded with a larger amount of drug than can drug-coated metallic stents because the polymer stent struts can contain the drug. Clinical application is required to assess the safety and efficacy of drug-eluting polymer stents against stent restenosis.

New technique for superior guiding catheter support during advancement of a balloon in coronary angioplasty: The anchor technique

To get superior guiding catheter support, we tried a new method called the anchor technique. By inflating a balloon in a nontarget vessel and holding its shaft with backward force while advancing another balloon, the anchor effect for the guiding catheter could be obtained and it appeared to be helpful for a balloon or a stent to cross the target lesion. Cathet Cardiovasc Intervent 2003;59:482–488.

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.

Intravascular ultrasound-guided directional coronary atherectomy for unprotected left main coronary stenoses with distal bifurcation involvement

Stent implantation in unprotected left main coronary artery (LMCA) bifurcation lesions may improve procedural and late clinical outcomes. However, concerns regarding stent-related complications, such as stent jail, subacute thrombosis, and in-stent restenosis remain. Optimal debulking by directional coronary atherectomy (DCA) with intravascular ultrasound (IVUS) guidance may be effective in this complex lesion subset, but this strategy has not yet been established. Our objective was to evaluate the safety and efficacy of IVUS-guided DCA for unprotected LMCA stenoses with distal bifurcation involvement. A total of 67 consecutive patients were included in this study and procedural success was achieved in all cases. Two cardiac deaths (2.9%) were noted and 3 patients (4.5%) underwent repeat angioplasty during hospitalization. There was no Q-wave myocardial infarction or emergency bypass surgery. Non-Q-wave myocardial infarction (creatine kinase-MB >3 times normal) occurred in 13.4% of patients. Stent implantation was necessary in 17 cases (25.4%) to achieve an optimal result. IVUS showed an improved lumen cross-sectional area and a low plaque burden in the LMCA after intervention. All-cause mortality, angiographic restenosis, and the target lesion revascularization rates at 6 months were 7.4%, 23.8%, and 20.0%, respectively. With IVUS guidance, aggressive DCA can be performed safely in unprotected LMCA bifurcation lesions, and optimal angiographic and IVUS results can be achieved with low residual plaque burden, which leads to a low restenosis rate. Optimal lesion debulking by DCA does not necessarily need adjunctive stenting in this specific anatomic subset.

Comparison of the self-expanding Radius stent and the balloon-expandable Multilink stent for elective treatment of coronary stenoses: a serial analysis by intravascular ultrasound.

We compared the outcome of the self‐expanding Radius stent and the balloon‐expandable Multilink stent serially by angiography and intravascular ultrasound. Successful stent deployment was achieved in 66 lesions of 56 stable angina patients (34 lesions with Radius stents and 32 lesions with Multilink stents). At follow‐up, there were no significant differences in minimal lumen diameter or percent diameter stenosis between the groups, nor in restenosis rates, although the Radius stent group rate was slightly lower (23.5% vs. 31.3%). In the Radius stent group, stent cross‐sectional area (CSA) increased gradually after implantation until the 6‐month follow‐up (8.37 ± 1.83 to 10.16 ± 2.59 mm2; n = 15), giving a larger CSA (P = 0.03) than the Multilink stent group, which decreased (9.00 ± 2.05 to 8.27 ± 2.15 mm2; n = 17). The lumen CSA was also slightly larger (6.82 ± 3.06 vs. 5.84 ± 1.85 mm2; P = 0.29) in the Radius stent group. These findings indicated that the Radius stent enlarged progressively after implantation, which might be useful for prevention of restenosis. Cathet Cardiovasc Intervent 2002;56:40–45.

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 improvement in left ventricular function after initially successful angioplasty of unprotected left main coronary artery stenoses.

BACKGROUND: Percutaneous coronary intervention (PCI) has been increasingly applied to unprotected left main coronary artery (LMCA) lesions, with varied procedural success and clinical outcomes. However, the effect of PCI on left ventricular performance is still unclear, and there are no clinical studies assessing factors that influence left ventricular ejection fraction (LVEF) in these cases. METHODS: Between April 1986 and August 2002, de novo PCI was performed for unprotected LMCA stenoses in 199 patients. Close clinical and angiographic follow-up were conducted after the procedure. RESULTS: One hundred eighty patients survived over six months and analysis of paired left ventriculography was possible in 175 patients. Improvement in LVEF was observed in the entire population (52.9u2005±u200515.7% to 56.1u2005±u200514.3%, pu2005= 0.048). The LVEF change was 6.7u2005± 9.5% (pu2005<u20050.01) in group with baseline LVEFu2005≤⃒u200550% and 0.7u2005±u20056.7 % (pu2005=u2005NS) in group with LVEFu2005>u200550%. There was significant intergroup difference (pu2005<u20050.001). Patients with baseline diameter stenosis ≥60% had an improvement of 5.3u2005±u20058.3% (pu2005<u20050.05) whereas those with stenosisu2005<u200560% had no improvement (2.0u2005±u20058.4%, pu2005=u2005NS). CK-MB elevation ≥3 times normal after PCI had a significant inverse association with improvement in LVEF (pu2005<u20050.05). Multivariate analysis revealed baseline LVEF ≤⃒50% was the only independent predictor of improvement in LVEF (standard estimateu2005=u20053.509, 95% CI: 2.164-4.854, pu2005<u20050.001). CONCLUSIONS: Successful PCI procedure is associated with significant improvement in LVEF, especially in patients with depressed left ventricular function. (Int J Cardiovasc Intervent 2004; 6: 119-127)

Lesion regression after percutaneous coronary intervention for unprotected left main trunk disease

BACKGROUND: Although some studies have documented the six-month angiographic outcomes of percutaneous coronary intervention (PCI) with new devices for unprotected left main trunk disease (ULMTD), a long-term angiographic analysis is mandatory to evaluate the safety and effectiveness of this procedure. This study aims to assess a long-term (one year or more) angiographic analysis after PCI for this lesion. METHODS: PCI was performed for 225 ULMTD with de novo or restenotic lesions. There were 19 deaths and 12 repeat PCIs during the hospital stay. The remaining 194 lesions were followed, and 126 lesions showed no angiographic restenosis or target lesion revascularization within six months. Finally, long-term quantitative angiographic follow-up was completed in 78 lesions (mean 2.4 years, maximum 7.5 years after PCI). RESULTS: Minimal lumen diameter increased significantly from 2.46u2005± 0.59u2005mm to 2.72u2005±u20050.65u2005mm (pu2005< 0.0001) and percent diameter stenosis decreased significantly from 26u2005± 14% to 19u2005±u200514% (pu2005<u20050.0001) between the six-month and the long-term follow-ups. No additional restenosis or new lesions were found at long-term follow-up, and significant lesion regression was ascertained in each procedure (directional coronary atherectomy, pu2005<u20050.005; ballooning, pu2005<u20050.005; stenting, pu2005< 0.05).</emph> CONCLUSIONS: These findings support the safety and effectiveness of PCI for ULMTD during the long-term period. (Int J Cardiovasc Intervent 2003; 5: 132-136)