Association between tissue characteristics evaluated with optical coherence tomography and mid-term results after paclitaxel-coated balloon dilatation for in-stent restenosis lesions: a comparison with plain old balloon angioplasty.

AIMS: Morphological assessment of neointimal tissue using optical coherence tomography (OCT) is important for clarifying the pathophysiology of in-stent restenosis (ISR) lesions. The aim of this study was to determine the impact of OCT findings on recurrence of ISR after paclitaxel-coated balloon (PCB) dilatation compared with plain old balloon angioplasty (POBA). METHODS AND RESULTS: Between July 2008 and May 2012, we performed percutaneous coronary intervention for 214 ISR lesions using POBA + PCB (146 lesions, PCB group) or POBA only (68 lesions, POBA group). Morphological assessment of neointimal tissue using OCT, including assessment of restenotic tissue structure and restenotic tissue backscatter, was performed. We examined the association between lesion morphologies and mid-term (6-8 months) results including ISR and target lesion revascularization (TLR) rates. Both ISR and TLR rates of lesions with a homogeneous structure were significantly lower in the PCB group than those in the POBA group (ISR: 20.0 vs. 55.6%, P = 0.002, TLR: 12.7 vs. 37.0%, P = 0.019), but there was no difference between the two groups in ISR and TLR rates of lesions with a heterogeneous or layered structure. Both ISR and TLR rates of lesions with high backscatter were significantly lower in the PCB group than those in the POBA group (ISR: 19.8 vs. 52.5%, P < 0.001, TLR: 13.6 vs. 42.5%, P = 0.001), but there was no difference between the two groups in ISR and TLR rates of lesions with low backscatter. CONCLUSION: Morphological assessment of ISR tissue using OCT might be useful for identifying ISR lesions favourable for PCB dilatation.

Comparison of long-term outcome after percutaneous coronary intervention for stent thrombosis between early, late, and very late stent thrombosis.

BACKGROUND: Differences in long-term outcome between early stent thrombosis (EST), late stent thrombosis (LST), and very late stent thrombosis (VLST) are unknown. METHODS AND RESULTS: A total of 152 patients who had undergone percutaneous coronary intervention for stent thrombosis between January 2001 and October 2011 were enrolled, and the clinical outcome compared between EST (55 patients), LST (34 patients), and VLST (63 patients) after drug-eluting stent (DES) and bare-metal stent (BMS) implantation. Major adverse cardiac events (MACE), including cardiac death, recurrent stent thrombosis, non-fatal myocardial infarction, and target lesion revascularization (TLR), were evaluated at 5 years. The in-hospital mortality was similar between EST, LST, and VLST (P=0.37). The incidence of MACE was significantly lower in VLST (21.9%) than in EST (66.9%, P<0.001) and LST (66.6%, P<0.001), mainly because of a lower TLR rate after VLST (11.1%) than after EST (50.8%, P<0.001) and LST (52.2%, P<0.001). The 5-year mortality rate was also significantly lower in VLST (14.7%) than in EST (29.3%, P=0.049) and LST (41.6%, P=0.025). The incidence of MACE was similar between DES and BMS (46.2% vs. 50.0%, P=0.82), and this finding was observed in EST (P=0.83), LST (P=0.77), and VLST (P=0.57). CONCLUSIONS: Compared with EST and LST, long-term outcome was markedly better in VLST, mainly because of a lower TLR rate, whether after DES or BMS implantation.

Optimal treatment of recurrent restenosis lesions after drug-eluting stent implantation for in-stent restenosis lesions.

AIMS: Although the outcomes of various treatments for in-stent restenosis (ISR) after drug-eluting stent (DES) implantation have been reported, the optimal treatment of recurrent ISR lesions after DES implantation for ISR lesions was unknown. This study compared the efficacy between DES implantation and balloon angioplasty (BA) for recurrent ISR lesions after DES implantation. METHODS AND RESULTS: From 2003 to 2010, DES were implanted in 1,101 ISR lesions, of which 148 recurrent ISR lesions (142 patients) were treated with BA (76 lesions, 72 patients) and DES implantation (72 lesions, 70 patients). Clinical outcomes were evaluated for major adverse cardiac events (MACE), including a composite of death, myocardial infarction, and target lesion revascularisation (TLR). Angiographic outcomes were evaluated by follow-up angiography at six to eight months after procedure. At angiographic follow-up (94.4% of all patients), the binary restenosis rate was significantly lower in DES implantation (25.0%) than in BA (64.4%, p<0.001), whereas late lumen loss was similar between DES implantation and BA (0.80±0.78 mm vs. 0.87±0.79 mm, p=0.60). The incidence of four-year MACE was significantly higher in BA (75.2%) than in DES implantation (45.8%, p<0.001), mainly because of the lower TLR rate in DES implantation (60.5% vs. 27.6%, p<0.001). Multivariate analysis revealed that BA is an independent predictor of TLR, followed by non-focal lesion, non-intravascular ultrasound guidance, and dyslipidaemia. CONCLUSIONS: In the treatment of recurrent ISR lesions, DES implantation is markedly more effective with a lower incidence of TLR compared to BA.

Seven-year clinical outcomes of unprotected left main coronary artery stenting with drug-eluting stent and bare-metal stent.

BACKGROUND: The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) 7 years after unprotected left main coronary artery (LMCA) stenting has not been investigated. METHODS AND RESULTS: From 2003 to 2005, 182 patients underwent stent implantation for unprotected LMCA disease (DES, 96 patients; BMS, 86 patients; acute coronary syndrome cases excluded), and the 7-year clinical outcomes between the DES and BMS groups were compared. The incidence of cardiac death or non-fatal myocardial infarction was similar between the DES and BMS groups (11.0% vs. 13.5%, P=0.78). The incidence of target lesion revascularization (TLR) at 7 years was significantly lower in the DES group than in the BMS group (26.4% vs. 40.5%, P=0.009); the incidence from 1 to 4 years and that beyond 4 years were similar between the DES and BMS groups (8.9% vs. 7.9%, P=0.97; 10.0% vs. 8.7%, P=0.74, respectively). Among patients with bifurcation lesions, whereas the incidence of 7-year TLR was significantly lower in the DES group than the BMS group in patients undergoing single-stent procedures (15.9% vs. 48.6%, P=0.002), it was similar between the 2 groups in patients undergoing 2-stent procedures (38.5% vs. 39.3%, P=0.49). CONCLUSIONS: With the exception of the 2-stent procedure, the 7-year outcomes after DES implantation for LMCA disease were superior to those after BMS implantation because of the lower TLR rate, when considering TLR during the late phase.

Difference in clinical and angiographic characteristics of very late stent thrombosis between drug-eluting and bare-metal stent implantations.

BACKGROUND: Limited data are available with which to compare the clinical characteristics of patients with very late stent thrombosis (VLST) after drug-eluting stent (DES) or bare-metal stent (BMS) implantation. The purpose of this study was to investigate the differences in the characteristics of VLST after DES and BMS implantation by reviewing the clinical and angiographic data. METHODS AND RESULTS: A total of 28 patients (30 lesions) with VLST after DES implantation and 33 patients (33 lesions) with VLST after BMS implantation were identified. The occurrence of VLST after BMS implantation (2,647±996 days) was much later than that after DES implantation (1,194±558 days, P<0.001). The number of VLST after DES implantation increased gradually each year; however VLST after BMS implantation started to occur >50 months later, and its number increased subsequently. The prevalence of VLST related to surgical procedures involving discontinuation of antiplatelet therapy in VLST patients was higher after DES implantation (14.3%) than after BMS implantation (0%, P=0.039). Angiographic stent fracture was seen in 36.7% of VLST lesions after DES implantation at different times (464-2,102 days after procedure), while none was seen in VLST lesions after BMS implantation (P<0.001). CONCLUSIONS: The timing of VLST was different after DES and BMS implantation. Stent fracture was a specific finding of VLST after DES implantation.

Optical coherence tomography findings in lesions after sirolimus-eluting stent implantation with peri-stent contrast staining.

BACKGROUND: We have sometimes noted abnormal angiographic coronary dilatation, <50% of the reference vessel, at the site of sirolimus-eluting stent implantation, suggesting contrast staining outside the stent struts and named this finding peri-stent contrast staining (PSS). Little was known about optical coherence tomography findings of lesions with PSS. METHODS AND RESULTS: Between May 2008 and March 2010, we performed optical coherence tomography for 90 in-stent restenosis lesions after sirolimus-eluting stent implantation. We found PSS in 20 of the 90 lesions by coronary angiography. The differences in optical coherence tomography findings, including incomplete stent apposition, multiple interstrut hollows (MIH), strut coverage, and thrombus, were compared between lesions with PSS and those without PSS. PSS is defined as contrast staining outside the stent contour extending to >20% of the stent diameter measured by quantitative coronary angiography. MIH is defined as multiple hollows (the maximum depth >0.5 mm) existing between and outside well-apposed stent struts. Both incomplete stent apposition (60.0% versus 10%; P<0.001) and MIH (85.0% versus 25.7%; P<0.001) were frequently observed in lesions with PSS than in lesions without PSS. Among the 20 lesions with PSS, there was only 1 lesion in which we found neither MIH nor incomplete stent apposition, but only minor dissection. Uncovered struts (11.6% versus 3.9%; P=0.001), malapposed struts (2.0% versus 0.0%; P<0.001), and red thrombus (35% versus 10%; P=0.012) were frequently observed in lesions with PSS than in lesions without PSS. CONCLUSIONS: PSS might be closely associated with 2 different optical coherence tomography findings, MIH and incomplete stent apposition, in lesions after sirolimus-eluting stent implantation.

Serial clinical and angiographic follow-up after phosphorylcholine-coated stent implantation.

The efficacy of drug-eluting stents (DES) has been proven, but concerns about late complications after DES have been raised. Polymers that do not increase inflammatory or hypersensitivity reactions which may contribute to late complications are needed for new generation DES. To evaluate the safety and efficacy of phosphorylcholine-polymer coating, we investigated serial clinical and angiographic outcomes after phosphorylcholine-coated stent placement. Seventy-five consecutive patients treated with a BiodivYsio phosphorylcholine-coated stent for de novo lesions at our institute between October 2001 and August 2002 were enrolled. Six-month follow-up angiography was performed in 71 lesions (94.7%), and angiographic restenosis was found in 19 lesions (26.8%). Target lesion revascularization (TLR) was performed in 10 lesions (14.1%). Eighteen-month follow-up angiography was performed in 58 (95.1%) of the remaining 61 lesions (excluding TLR lesions), and angiographic restenosis was found in only 3 lesions. The cumulative MACE-free survival rate was 86.3%, 83.6%, and 78.6% at 6-month, 18-month, and 8-year follow-up, respectively. There were no episodes of stent thrombosis. Late loss decreased significantly from 0.74 ± 0.40 mm (6-months) to 0.51 ± 0.46 mm (18-months) (P < 0.0001). Phosphorylcholine-coated stent implantation was associated with acceptable clinical and angiographic results. Phosphorylcholine-coating may be an ideal polymer for new generation DESs.

Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis.

OBJECTIVES: The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis. BACKGROUND: Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown. METHODS: This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up. RESULTS: At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%; p = 0.0001) and target lesion revascularization (4.3% vs. 41.7%; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96% vs. 60%; p = 0.005). CONCLUSIONS: In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA.