Seiichiro Motohara

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.

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.

Histopathological findings of new in‐stent lesions developed beyond five years

We analyzed 14 cases of new lesions inside implanted bare‐metal stents. In every case, there was no angiographic restenosis within 3 years, but a new lesion was observed inside a stented segment at long‐term follow‐up (>5 years). Fourteen cases were evaluated: 9 with Wiktor stents, 2 with Palmaz‐Schatz stents, and 3 with ACS Multilink stents. The interval from stent implantation to follow‐up angiography was 63–147 months (89 ± 23). Thirteen lesions were treated by percutaneous coronary intervention (PCI) and stenotic tissue was obtained by directional coronary atherectomy (DCA) in 10 cases. All retrieved samples were composed of newly developed atherosclerosis facing the healed neointimal layer, and four samples showed histopathological findings of acute coronary syndrome. Stent struts were retrieved in four cases and no inflammation was observed surrounding them. Qualitative and quantitative analysis of stent struts was performed in two cases that showed no metal corrosion. These findings suggest that new atherosclerotic progression occurred inside the implanted stent without peristrut inflammation.

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.

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.

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.

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 2.46 ± 0.59 mm to 2.72 ± 0.65 mm (p < 0.0001) and percent diameter stenosis decreased significantly from 26 ± 14% to 19 ± 14% (p < 0.0001) 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, p < 0.005; ballooning, p < 0.005; stenting, p < 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)