Impact of Stent Type and Presence of Vasospastic Angina on Long-Term Prognosis.

BACKGROUND: Little is known about the impact of stent type on the prognosis of vasospastic angina (VSA) in patients who undergo stent implantation.Methods and Results:We evaluated consecutive patients undergoing coronary angiography with positive (n=650; VSA) and negative (n=2,872; non-VSA) ergonovine testing. Among them, 304 patients undergoing stent implantation for organic stenosis were classified for comparison into 3 respective VSA and non-VSA groups based on stent type (68 and 78 with bare-metal stent [BMS]; 21 and 49 with sirolimus-eluting stent [SES]; 26 and 62 with newer generation drug-eluting stent [N-DES]). The primary outcome was defined as target lesion revascularization, target vessel revascularization, emergency coronary angiography, and cardiac death. The 2-year cumulative incidence of the primary outcome was significantly higher in the VSA group than non-VSA group after SES implantation (38.1% vs. 16.1%, P=0.03), whereas there were no differences between the 2 groups after both BMS implantation and N-DES implantation. The difference in the percent diameter stenosis from mid-term to late-term follow-up was significantly higher in the VSA group than non-VSA group (10.0% vs. 2.3%, P=0.045) after SES implantation, whereas there were no differences between the 2 groups after both BMS implantation and N-DES implantation. CONCLUSIONS: The impact of VSA on clinical and angiographic outcomes was observed only in SES implantation, but not after N-DES or BMS implantation.

Clinical and angiographic outcomes of axial stent deformations in unrestricted real world patient population.

BACKGROUND: Prior reports have suggested that the design of the Promus Element stent is prone to longitudinal stent deformation (LSD). However, little is known about the clinical and angiographic outcomes of Promus Element stent axial deformations when implanted in unrestricted coronary lesions. METHOD AND RESULTS: Two independent reviewers retrospectively evaluated the procedure steps of 961 Promus Element stent (833 de novo lesions in 494 consecutive patients) implanted in unrestricted coronary lesions, between February 2012 and March 2013, and compared the prevalence, predictors, and the mid-term clinical and angiographic outcomes between lesions with and without stent deformation. Fifteen stents (1.56%) with LSD were observed (95% confidence interval [CI]: 0.78-2.34%). The proximal edge of the stent was deformed in 13 stents (86.6%). Ostial stenting (Adjusted Odds ratio [OR]: 9; 95%CI: 2.27-33.3; P = 0.002), and bifurcation lesions (Adjusted OR: 3; 95%CI: 1.03-8.8; P = 0.04) were independently associated with the occurrence of stent deformation. LSD led to unplanned stenting in (53%, 8 of 15) of the deformed stents, which consumed larger contrast volume and longer fluoroscopy time. At 8-month follow-up, there was no significant difference in binary restenosis rate and target lesions revascularization between both groups (P = 0.98, and P = 0.56, respectively), while death occurred in six patients of the non-LSD group (1.36%, 6 of 440) and none in the LSD group. All patients of the LSD group had no major adverse clinical events at 8-month follow-up. CONCLUSIONS: Axial stent deformation in Promus Element platform is an infrequent event, occurs following manipulation of the interventional tools. Other than unplanned stenting, the LSD was not associated with any adverse clinical events at 8-month follow-up.

Stent Fracture and Peri-Stent Contrast Staining After Everolimus-Eluting Stent Implantation　- 5-Year Outcomes.

BACKGROUND: Stent fracture (SF) and peri-stent contrast staining (PSS) after sirolimus-eluting stent implantation are reported to be risk factors of adverse events. However, the effect of these after everolimus-eluting stent (EES) implantation on long-term outcomes remains unclear.Methods and Results:The study sample comprised 636 patients (1,081 lesions) undergoing EES implantation in 2010 and follow-up angiography within 1 year. The 5-year cumulative rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE: a combination of all-cause death, myocardial infarction, and TLR) were compared between patients with and without SF or PSS. SF was observed in 2.7%, and PSS in 3.0%. The cumulative rates of MACE and TLR were significantly higher in the SF group than in the non-SF group (51.7% vs. 27.5% and 48.3% vs. 13.4%, respectively), but showed no significant differences between the PSS and non-PSS groups. In a landmark analysis, the rate of TLR within 1 year was significantly higher in the SF group than in the non-SF group (44.8% vs. 7.2%), but beyond 1 year showed no significant difference (6.3% vs 6.7%). CONCLUSIONS: The 5-year clinical outcomes suggested that SF after EES implantation is related to increased risk of MACE and TLR, especially within 1 year after the procedure, but PSS after EES implantation is unrelated.

Relationship between n-3 Polyunsaturated Fatty Acids and Extent of Vessel Disease in Patients with ST Elevation Myocardial Infarction.

A relationship between serum polyunsaturated fatty acids (PUFAs) and cardiovascular disease has been reported; however, the existence of a relationship between serum PUFAs and extent of vessel disease (VD) in patients with ST elevation myocardial infarction (STEMI) remains unclear.Between July 2011 and June 2015, 866 consecutive STEMI patients underwent emergent percutaneous coronary intervention, 507 of whom were enrolled and classified into three groups according to the initial angiograms: 1VD, 294 patients; 2VD, 110 patients; and 3VD/left main trunk disease (LMTD), 103 patients. Serum levels of PUFAs, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid, and other laboratory data during hospitalization were evaluated.The serum EPA level in the 3VD/LMTD group was significantly lower than that in the 1VD group (55.5 ± 22.1 versus 66.2 ± 28.7, P = 0.002) and was slightly lower than that in the 2VD group (55.5 ± 22.1 versus 65.2 ± 28.9, P = 0.0167). Multivariate adjustment analysis revealed that age ≥ 70 years (odds ratio, 1.72; 95% confidence interval, 1.03-2.89; P = 0.038) and a low serum EPA level (odds ratio, 0.98; 95% confidence interval, 0.99-1.00; P = 0.023) were independent risk factors for 3VD/LMTD, while a low serum DHA level was not.A low serum EPA level may be more strongly related than a low serum DHA level to the extent of VD in STEMI patients. Age ≥ 70 years and a low serum EPA level may be independent risk factors for 3VD/LMTD.

Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion.

UNLABELLED: Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation. METHODS: The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days). RESULTS: The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion. CONCLUSIONS: Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.

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.

Thirty-day outcome of transcatheter aortic valve implantation with the edwards SAPIEN XT prosthesis via the transiliofemoral approach.

BACKGROUND: Few data exist on the results of transcatheter aortic valve implantation (TAVI) via the transfemoral approach in small slightly built Japanese patients with severe aortic stenosis who are ineligible or at high-risk for conventional surgical aortic valve replacement (SAVR). Therefore, the purpose was to investigate the early outcomes of TAVI using the transiliofemoral approach in Japan. METHODS AND RESULTS: Between June 2010 and June 2013, 21 consecutive patients (mean age, 81.0 years; 81.0% female) underwent TAVI with Edwards SAPIEN XT valves using the transiliofemoral approach. The mean body surface area was 1.44±0.15m(2). The device success rate was 90.5%. Although 2 patients did not meet the echocardiographic criteria for device success, no failure to deliver and deploy a valve occurred. The mean effective aortic valve area increased from 0.54±0.12cm(2) at baseline to 1.46±0.29cm(2) after the procedure (P<0.001), and the mean aortic transvalvular pressure gradient decreased from 51.0±15.6 at baseline to 11.2±3.6 after the procedure (P<0.001). The 30-day mortality and combined safety endpoint rates were 0% and 4.8%, respectively. All patients achieved New York Heart Association functional class I or II at 30 days. CONCLUSIONS: Early outcome of TAVI with the Edwards-SAPIEN XT valve via the transiliofemoral approach at Kurashiki Central Hospital is satisfactory for patients who are ineligible or at high risk for SAVR.

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.

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 presentations and related angiographic findings among early, late, and very late sirolimus-eluting stent failures requiring target lesion revascularization.

BACKGROUNDS: The difference in clinical presentations (acute coronary syndrome [ACS] and stable coronary artery disease [SCAD]) and related angiographic morphologies of sirolimus-eluting stent (SES) failure requiring target lesion revascularization (TLR) during early-term (<1year), late-term (1-5years), and very late-term periods (>5years) remains unknown. METHODS: Among 4484 lesions undergoing SES implantation, clinically-driven TLR was performed on 105 lesions during early-term, 169 lesions during late-term, and 147 lesions during very late-term period. Angiographic morphological patterns were divided into focal or non-focal patterns and stent-edge or stent-body patterns. RESULTS: The proportion of ACS substantially increased in very late TLR lesions (57.1%) from early (40.0%, p=0.01) and late TLR lesions (36.7%, p<0.001). The proportions of both stent-edge and non-focal patterns were higher in very late TLR lesions than in early and late TLR lesions. Although the stent-edge pattern tended to be more prevalent in SCAD lesions than in ACS lesions during the early- and late-term periods, it was more frequently observed in ACS lesions than in SCAD lesions during the very late-term period (65.5% vs. 47.6%, p=0.04). The non-focal pattern was more frequent in ACS lesions than in SCAD lesions during all 3 periods. However, the proportion of the non-focal pattern in ACS lesions was extremely high during the very late-term (90.5%) compared with the early- (47.6%, p<0.001) and late-term periods (48.4%, p<0.001). CONCLUSIONS: Stent-related ACS became more common beyond 5years after SES implantation. Stent-edge and non-focal patterns were the main angiographic morphologies of very late SES failure, particularly causing ACS.

Five-Year Outcomes After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting Stent Restenosis.

The long-term outcomes of patients who underwent paclitaxel-coated balloon (PCB) angioplasty for drug-eluting stent restenosis (DES-ISR) remain unclear. We investigated the 5-year safety and efficacy outcomes of PCB angioplasty for DES-ISR. The study included 185 patients with 216 DES-ISR lesions who underwent PCB angioplasty from September 2008 to December 2010. Two serial angiographic follow-ups were routinely scheduled at 6 and 18 months after the index procedure. Five-year clinical outcomes were investigated. The mean duration of follow-up was 2,052 ± 352.5 days, and 94.1% of the patients completed the 5-year follow-up. Recurrent restenosis was observed in 48 lesions (22.2%) at the 6-month follow-up and late restenosis was observed in 22 lesions (14.3%) at the 18-month follow-up. Very late restenosis was observed in 6 lesions (6.8%), and target lesion revascularization (TLR) was performed for 8 lesions (13.6%) beyond 24 months after the procedure. The cumulative rates of TLR at 1, 2, and 5 years were 16.4%, 28.9%, and 34.1%, respectively. In patients who underwent TLR, 87% (52 of 60 patients) underwent TLR within the first 2 years after the index procedure. Multivariable analysis revealed that in-stent occlusion lesion (odds ratio [OR] 2.21; 95% confidence interval [CI] 1.09 to 4.47; p = 0.03), postprocedural percent diameter stenosis >35% (OR 3.19; 95% CI 1.54 to 6.68; p = 0.001), and right coronary artery ostial lesions (OR 5.56; 95% CI 1.40 to 24.9; p = 0.01) were independent predictors of recurrent restenosis. In conclusion, our results suggest that long-term outcomes after PCB angioplasty are acceptable; however, close follow-up during the first 2 years following this procedure may be necessary.

Long-term (8-10†years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation.

OBJECTIVE: Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8-10 years) clinical and angiographic outcomes after BP-BES implantation. METHODS: Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years). RESULTS: The median follow-up duration was 9.4 years (IQR 8.2-10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort. CONCLUSIONS: The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.

Paclitaxel-coated balloon catheter compared with drug-eluting stent for drug-eluting stent restenosis in routine clinical practice.

AIMS: The aim of this study was to compare the efficacy between paclitaxel-coated balloon (PCB) and drug-eluting stent (DES) implantation for the treatment of DES restenosis in complex situations. METHODS AND RESULTS: Data of patients who received revascularisation for DES restenosis between 2004 and 2011 were collected. A total of 683 patients with 777 lesions were analysed in this study (306 lesions treated by PCB, 471 lesions by DES). The use of PCB or DES was at the discretion of the operator. Angiographic outcomes at six to eight months and clinical outcomes at 12-month follow-up were compared between groups. The primary outcome was binary restenosis. Cox regression analysis with propensity score adjustment suggested that there were no significant differences between the two groups with respect to binary restenosis, target lesion revascularisation (TLR), and major adverse cardiac events. As for the angiographic endpoints, subgroup analysis was performed for several parameters. There was a significant trend favouring PCB with respect to binary restenosis and TLR in non-focal type lesions and bifurcation lesions. CONCLUSIONS: Angiographic and clinical outcomes in the PCB group were similar to those in the repeat DES group. PCB seemed to offer more favourable results in non-focal type lesions and bifurcation lesions.

Late Restenosis After Both First-Generation and Second-Generation Drug-Eluting Stent Implantations Occurs in Patients With Drug-Eluting Stent Restenosis.

BACKGROUND: There are currently inadequate data about whether late restenosis occurs after drug-eluting stent (DES) implantation in patients with DES restenosis. METHODS AND RESULTS: We collected data for 608 patients who received revascularization for DES restenosis between 2004 and 2012 and analyzed 688 lesions: 359 lesions treated with a first-generation DES (first DES) and 329 lesions treated with a second-generation DES (second DES). Two serial angiographic follow-ups were routinely planned for the patients (at 8 and 20 months after the procedure). Early follow-up angiography was performed for 620 lesions (90.1%), and recurrent restenosis occurred in 84 lesions (25.8%) in the first DES group and in 72 lesions (24.5%) in the second DES group (P=0.78). Target lesion revascularization was performed for 69 lesions (21.2%) in the first DES group and for 48 lesions (16.3%) in the second DES group (P=0.15). Late follow-up angiography was performed for 438 (87.1%) of the remaining 503 lesions (excluding target lesion revascularization lesions), and late restenosis was found in 35 lesions (15.8%) in the first DES group and in 28 lesions (14.7%) in the second DES group (P=0.79). Nonfocal-type restenosis, percentage diameter stenosis after the procedure, previous stent size ≤2.5 mm, and right coronary artery ostial lesion were independent predictors of early restenosis. Nonfocal-type restenosis, percentage diameter stenosis at early follow-up, and stent fracture were independent predictors of late restenosis. CONCLUSIONS: Late restenosis occurs after both first DES implantation and second DES implantation for DES restenosis.

Incidence, predictive factors, and clinical impact of stent recoil in stent fracture lesion after drug-eluting stent implantation.

BACKGROUND: Stent fracture (SF) after drug-eluting stent (DES) implantation was reported to be associated with target lesion revascularization (TLR). We have noted abnormal late acquired stent axial deformation in lesions after DES implantation, especially in SF lesions, and defined it as stent recoil (SR). We evaluated the incidence, predictive factors, and clinical impact of SR in SF lesions. METHODS: Between 2003 and 2012, 5456 patients (11,712 lesions) underwent DES implantations and follow-up angiography within one year after the index procedure. SR was defined as an axial recoil deformation less than 80% of the stent diameter and SF was defined as the separation of stent segments or stent struts. SF and SR were confirmed by follow-up angiography. The primary endpoint was defined as clinically driven TLR. RESULTS: SF was observed in 494 lesions (4.2%) and SR in 138 of SF lesions (27.9%). According to multinomial logistic regression analyses, severe calcification and ostial lesion in the right coronary artery were stronger predictive factors of SF with SR lesions. The cumulative incidences of any and clinically driven TLR at 5years were both significantly higher in the SF with SR group than in the SF without SR group (51.7% versus 35.0%, P<0.001; 22.2% versus 12.8%, P=0.019; respectively). CONCLUSIONS: SR in SF lesions after DES implantation could be related to the lesion characteristics. SF with SR was highly associated with subsequent TLR compared with SF without SR.

Late Restenosis After Paclitaxel-Coated Balloon Angioplasty Occurs in Patients With Drug-Eluting Stent Restenosis.

BACKGROUND: There are currently inadequate data on whether "late restenosis" occurs after paclitaxel-coated balloon (PCB) angioplasty for in-stent restenosis (ISR) lesions. OBJECTIVES: To evaluate the long-term safety and efficacy of PCB angioplasty, we investigated serial clinical and angiographic outcomes after PCB angioplasty for ISR lesions. METHODS: Between September 2008 and December 2012, PCB angioplasty was performed in 468 patients with 550 ISR lesions (bare-metal stent restenosis [BMS-ISR]: 114 lesions, drug-eluting stent restenosis [DES-ISR]: 436 lesions). Two serial angiographic follow-ups were routinely planned for the patients (at 6 and 18 months after the procedure). RESULTS: Early follow-up (6 months) angiography was performed for 488 lesions (89%), and recurrent restenosis occurred in 13 lesions (13.0%) in the BMS-ISR group and in 82 lesions (21.1%) in the DES-ISR group. Target lesion revascularization was performed for 7 lesions (7.0%) in the BMS-ISR group and 54 lesions (13.9%) in the DES-ISR group. Late follow-up (18 months) angiography was performed for 377 (88%) of the remaining 427 lesions (excluding target lesion revascularization lesions), and late restenosis was found in 2 lesions (2.5%) in the BMS-ISR group and 50 lesions (16.8%) in the DES-ISR group. Delayed late lumen loss was significantly larger in the DES-ISR group. Previous stent size ≤2.5 mm, percentage diameter stenosis after the procedure, and in-stent occlusion lesion were independent predictors of early restenosis. DES-ISR, percentage diameter stenosis at early follow-up, and hemodialysis were independent predictors of late restenosis. CONCLUSIONS: Late restenosis occurs after PCB angioplasty for DES-ISR lesions.

Stent Fracture After Sirolimus-Eluting Stent Implantation: 8-Year Clinical Outcomes.

BACKGROUND: Stent fracture (SF) after sirolimus-eluting stent implantation is reported to be associated with target lesion revascularization (TLR) and stent thrombosis. We aimed to assess the clinical impact of SF at 8 years. METHODS AND RESULTS: Between 2002 and 2005, 972 patients (1795 lesions) underwent sirolimus-eluting stent implantation and follow-up angiography within 1 year after index procedure. SF, defined as the complete separation of stent segments or stent struts at follow-up angiography, was observed in 105 lesions (5.8%). The study sample comprised 954 patients (1630 lesions), excluding 147 lesions undergoing TLR and 18 patients (18 lesions) who died or in whom stent thrombosis developed within 1 year after sirolimus-eluting stent implantation. The median follow-up duration was 9.1 years (the first and third quarters, 8.7 and 9.4 years). The primary end point was defined as any TLR. The 8-year cumulative rates of adverse events were estimated by Kaplan-Meier methods with P values from log-rank tests. Between patients with and without SF, there were no significant differences in the cumulative rates of all-cause death (23.5% versus 27.6%, P=0.35) and cardiac death (4.7% versus 9.1%, P=0.14), whereas patients with SF had significantly higher cumulative rates in myocardial infarction (10.1% versus 3.3%, P=0.001), very late stent thrombosis (6.8% versus 0.7%, P<0.001), any TLR (38.1% versus 10.8%, P<0.001), and clinically driven TLR (26.2% versus 6.6%, P<0.001). CONCLUSIONS: SF after sirolimus-eluting stent implantation was consistently associated with higher rates of adverse cardiac events during the 8-year follow-up.