Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms.

OBJECTIVES: To evaluate the stent expansion of the durable-polymer Zotarolimus-eluting stent (dp-ZES), the durable-polymer Everolimus-eluting stent (dp-EES), and the bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in calcified coronary chronic total occlusions (CTO). BACKGROUND: The newer generation stents with ultrathin struts might raise concerns regarding reduced radial strength and higher stent recoil (SR) when implanted in calcified CTOs. METHODS: Between January 2017 and June 2021 consecutive patients with CTO undergoing percutaneous coronary intervention with dp-ZES, dp-EES, or bp-SES were evaluated. The analysis was performed in calcific and in noncalcific CTOs. Quantitative coronary angiography analysis was used to assess diameter stenosis (DS), absolute and relative SR, absolute and relative focal SR, absolute and relative balloon deficit (BD), and absolute and relative focal BD. The primary endpoint was DS. RESULTS: A total of 213 CTOs were evaluated, 115 calcific CTOs (dp-ZES:25, dp-EES:29, bp-SES:61) and 98 non-calcific CTOs (dp-ZES:41, dp-EES:11, bp-SES:46). In calcific CTOs, residual DS was lower in dp-ZES than in dp-EES and bp-SES (-1.00% [-6.50-6.50] vs. 13.00% [7.0-19.00] vs. 15.00% [5.00-20.00]; p < 0.001). Dp-ZES was also an independent predictor of residual DS ≤ 10% (OR 11.34, 95% CI 2.6-49.43, p = 0.001). Absolute and relative focal SR and absolute and relative SR were similar between dp-ZES, dp-EES, and bp-SES (p = 0.913, p = 0.890, p = 0.518, p = 0.426, respectively). In noncalcified CTOs, the residual DS was similar in the three groups (p = 0.340). High relative focal SR was less frequent in dp-ZES than in dp-EES and in bp-SES (19.5% vs. 54.5% vs. 37.0%; p < 0.048). CONCLUSIONS: The three stent platforms demonstrated an overall low residual DS when implanted in CTOs. However, dp-ZES was associated with the lowest residual DS and identified as independent predictor of residual DS ≤ 10% in patients with calcific CTOs. Dp-ZES was associated with a lower incidence of high relative focal stent recoil, in noncalcific CTOs. Balloon deficit might be considerate as a surrogate for stent expansion in calcified CTOs.

Angioscopic Comparison of Early- and Mid-Term Vascular Responses Following Treatment of ST-Elevation Acute Myocardial Infarction With Biodegradable vs. Durable Polymer Everolimus-Eluting Stents　- A Prespecified Subanalysis of the MECHANISM AMI RCT.

BACKGROUND: The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P>0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023). CONCLUSIONS: Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

Comparison of diagnostic accuracy of immediate angiography derived residual quantitative flow ratio after bioresorbable scaffold and drug eluting stent implantation.

BACKGROUND: Quantitative flow ratio (QFR) is a novel angiography derived fractional flow reserve (FFR) technique. However, its diagnostic accuracy has only be validated in native coronary lesions but not in vessels after bioresorbable scaffold (BRS) implantation. This study aims to evaluate the diagnostic accuracy of residual QFR in coronary vessels immediately post-BRS implantation. METHODS: This is a retrospective, two center, validation cohort study. 73 stable angina patients who received at least one de novo lesion of an everolimus eluting stent (EES)/BRS implantation with subsequent residual FFR assessment were screened. Patients with aorta-ostial stenoses, bridge vessels at the distal segment of targeted vessels, acute coronary syndrome, previous coronary artery bypass grafting, age <18 years, lack of ≥2 final angiographic projections were excluded. Contrast QFR assessment was performed blinded to FFR assessment. RESULTS: A good correlation (r = 0.680, p < 0.001) was found between residual QFR and FFR. In the EES implantation cohort, a good correlation (r = 0.769, p < 0.001) was found between residual QFR and FFR, and a moderate correlation (r = 0.446, p = 0.038) in the BRS cohort. The area under the Receiver operator characteristic (ROC) curve for detecting FFR ≤0.86 was 0.883 for all patients. CONCLUSION: Residual QFR assessment after BRS implantation is feasible, and has a moderate correlation and agreement with residual FFR. QFR may be a promising tool similar to FFR to evaluate post-BRS effect.

Differential impact of abluminal groove-filled biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stent on and off dual antiplatelet therapy.

BACKGROUND: Current guidelines recommend dual antiplatelet therapy (DAPT) following percutaneous coronary intervention for 6-12 months in patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS). Whether DAPT duration has a differential effect on outcomes following treatment of ischemic coronary disease with durable versus biodegradable drug-eluting stent (DES) is poorly defined. METHODS: The TARGET All Comer study was a randomized trial of patients with ischemic coronary artery disease assigned to treatment with either a biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE). This pre-specified TARGET AC sub-analysis sought to evaluate the 2-year clinical outcomes before and after DAPT discontinuation. The primary endpoint was target lesion failure (TLF). RESULTS: A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12 months, and 409 (31.6%) at 2 years. There was no difference in TLF between patients treated with Firehawk and XIENCE stents from index procedure to DAPT discontinuation (8.0 and 7.7%, p > .99) or after DAPT discontinuation (2.9 vs. 3.8%, p = .16). After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk. CONCLUSIONS: Although TLF was comparable for both Firehawk and XIENCE stent groups before and after DAPT discontinuation, after DAPT discontinuation, there was a trend for less target vessel myocardial infarction and ischemia-driven revascularization with the biodegradable polymer DES.

Comparison of 1-Month and 12-Month Vessel Responses Between the Polymer-Free Biolimus A9-Coated Stent and the Durable Polymer Everolimus-Eluting Stent.

BACKGROUND: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 µm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99). CONCLUSIONS: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.

Impact of statin therapy on late target lesion revascularization after everolimus-eluting stent implantation according to pre-interventional vessel remodeling and vessel size of treated lesion.

Clinical evidence demonstrating the impact of statins for preventing late target lesion revascularization (TLR) after newer-generation drug-eluting stent implantation and differences in the effect of statins on late TLR according to pre-interventional vessel remodeling and vessel size is limited. We retrospectively evaluated 1193 de novo lesions in 720 patients who underwent everolimus-eluting stent implantation using intravascular ultrasound from January 2010 to December 2012. The primary endpoint was late TLR. Lesions were divided into the statin group (n = 825) and non-statin group (n = 368). The incidence of late TLR was significantly lower in the statin than non-statin group (1.7% vs. 5.2%, respectively; p = 0.001), and within the statin group, it was significantly lower in the follow-up low-density lipoprotein cholesterol (LDL-C) < 100 than ≥ 100 mg/dL level subgroup (1.0% vs. 3.6%, respectively; p = 0.006). Furthermore, in positive remodeling lesions and non-small vessel size lesions, the incidence of late TLR was significantly lower in the statin than non-statin group (1.6% vs. 8.5% and 1.3% vs. 5.3%, respectively; p = 0.001 and p = 0.004). Lowering the LDL-C level using statins was more effective for preventing late TLR after everolimus-eluting stent implantation. Evaluating pre-interventional vessel remodeling patterns and vessel size might be helpful to stratify lesions at high risk of late TLR.

Predictors of Irregular Protrusion After Everolimus-Eluting Stent Implantation in Patients with Stable Coronary Artery Disease.

This study aimed to investigate clinical and preintervention optical coherence tomography (OCT) findings to predict irregular protrusion (IRP) immediately after stent implantation.We evaluated 84 lesions treated with cobalt-chromium everolimus-eluting stent (CoCr-EES) from the MECHANISM Elective study. Patients were divided into two groups according to the presence of IRP [IRP: n = 16, non-IRP: n = 68]. Optical coherence tomography images before intervention and immediately after stenting were evaluated with standard qualitative and quantitative OCT analyses.Total cholesterol and the prevalence of ruptured plaque before intervention were significantly higher in the IRP group than in the non-IRP group [199 ± 37 mg/dL versus 176 ± 41 mg/dL; P = 0.022, 31% versus 7%; P = 0.008]. Total lipid length tended to be longer in the IRP group than in the non-IRP group [19.6 ± 9.2 mm versus 15.5 ± 9.3 mm; P = 0.090]. The prevalence of ruptured plaque, and total cholesterol levels were independent predictors of IRP immediately after stenting by multivariate logistic regression analysis [OR: 4.6, 95% confidence interval: 1.01-21.23, P = 0.048, OR: 1.02, 95% confidence interval: 1.00-1.03, P = 0.046]. IRP post-CoCr-EES implantation was completely resolved at follow-up OCT.The prevalence of ruptured plaque before intervention and total cholesterol levels were independent predictors of IRP after CoCr-EES implantation in patients with stable coronary artery disease.

Clinical outcomes of complex lesions treated with an abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent.

BACKGROUND: The Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel biodegradable polymer sirolimus-eluting coronary stent has been evaluated in the randomized TARGET I trial in which low-risk patients were enrolled with strict eligibility criteria. Recently, the TARGET All Comers study has shown similar results of the Firehawk compared to the XIENCE stent (Abbott Vascular, Santa Clara). However, clinical outcomes in high-risk patients are unclear. METHODS: The TARGET All Comer study was a randomized trial that assigned patients to either Firehawk or XIENCE implantation. This TARGET AC subanalysis sought to evaluate the 2 year clinical outcomes of patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET I trial were classified as "low-risk," while their counterparts were classified as "high-risk." The primary endpoint was target lesion failure. RESULTS: A total of 1,585 patients were included, of which 1,334 (84%) were classified as high-risk. At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02). The Firehawk and XIENCE had no significant differences in TLF among both low-risk (3.1% vs. 4.2%, p = .66) and high-risk (9.9% vs. 9.1%, p = .57) patients. CONCLUSIONS: High-risk patients had worse clinical outcomes at 2 years in the TARGET All Comer study. Outcomes with the Firehawk were similar to the XIENCE stent among both low-risk and high-risk patients at 2 years.

Clopidogrel Monotherapy vs. Aspirin Monotherapy Following Short-Term Dual Antiplatelet Therapy in Patients Receiving Everolimus-Eluting Coronary Stent Implantation.

BACKGROUND: There is a scarcity of data on short-duration dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy as compared with aspirin monotherapy after percutaneous coronary intervention (PCI).Methods and Results:STOPDAPT-1 is a prospective trial enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation. STOPDAPT-2 is a randomized trial comparing 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after EES implantation. We compared the clinical outcomes of patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1. The current study population consisted of 1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding. Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98). After adjusting for confounders, there was no excess risk of STOPDAPT-2 relative to STOPDAPT-1 for the primary endpoint. Between 3 and 12 months, the cumulative incidence of primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (1.7% vs. 1.6%, P=0.77). CONCLUSIONS: The effect of 1-month DAPT followed by clopidogrel monotherapy on clinical outcomes was similar to that of 3-month DAPT followed by aspirin monotherapy in patients receiving PCI.

Small-vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus-eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post-Approval studies.

OBJECTIVE: We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. BACKGROUND: There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. METHODS: We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. RESULTS: We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. CONCLUSION: In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Long-Term Comparison of Platinum Chromium Everolimus-Eluting Stent vs. Cobalt Chromium Zotarolimus-Eluting Stent　- 3-Year Outcomes From the HOST-ASSURE Randomized Clinical Trial.

BACKGROUND: There are limited data on the long-term outcome of platinum chromium-based everolimus-eluting stents (PtCr-EES) vs. cobalt chromium-based zotarolimus-eluting stents (CoCr-ZES).Methods and Results:A total of 3,755 patients undergoing percutaneous coronary intervention (PCI) were randomized 2:1 to PtCr-EES or CoCr-ZES, and 96.0% of patients completed the 3-year clinical follow-up. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR). At 3 years, TLF occurred in 5.3% and in 5.4% of the PtCr-EES and CoCr-ZES groups, respectively (hazard ratio 0.978; 95% confidence interval 0.730-1.310, P=0.919). There were no significant differences in the individual components of TLF. Routine angiographic follow-up was performed in 38.9% of the total patients. In a landmark analysis of the subgroup that had follow-up angiography, the clinically-driven TLR rate of CoCr-ZES was significantly higher than PtCr-EES group during the angiography follow-up period (P=0.009). Overall definite and probable stent thrombosis rates were very low in both groups (0.5% vs. 0.6%, P=0.677). CONCLUSIONS: PtCr-EES and CoCr-ZES had similar and excellent long-term outcomes in both efficacy and safety after PCI in an all-comer population.

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with ST-elevation myocardial infarction.

Cobalt-chromium everolimus-eluting stent (CoCr EES) is associated with a lower rate of stent thrombosis even in patients with ST-elevation myocardial infarction (STEMI). However, the time-serial changes of endothelial coverage of the stent struts in the extremely early period have never been reported, especially in patients with STEMI. The aim of this study was to compare the vessel healing process between CoCr EES and cobalt-chromium bare metal stent (CoCr BMS) implantations using optical coherence tomography (OCT) in patients with STEMI. Sixty-three patients who had primary emergent percutaneous coronary intervention (PCI) with CoCr EES (42 patients) or CoCr BMS (21 patients) were enrolled in this study for 3 years. OCT was performed just after, 2 and 12 weeks after EES or BMS implantations. Time-serial changes in the neointimal coverage (NIC), the neointimal thickness, and malapposition of stent struts were evaluated. NIC of stent struts did not differ between CoCr EES (23.2%, 99.4%) and CoCr BMS (24.0%, 97.8%) at 2 weeks and 12 weeks after PCI, respectively. Thicknesses of the neointima on the stent strut was significantly thinner in CoCr EES (34.0 ± 13.8, 107.0 ± 32.4 µm) than in CoCr BMS (40.0 ± 14.6, 115.7 ± 33.8 µm) at 2 weeks and 12 weeks after PCI (p = 0.011, p = 0.008), respectively. The malapposition did not differ just after PCI, and was completely resolved at 12 weeks after PCI in both groups. Thrombus was significantly less in CoCr EES than in CoCr BMS at 2 weeks (19.0% vs 42.9%, p < 0.01), and decreased over time in both groups, but at 12 weeks, disappeared only in CoCr EES (CoCr EES: 0% vs. CoCr BMS: 4.8%, p = 0.56). This study demonstrated that NIC and apposition of the stent struts almost completed at 12 weeks after EES and BMS implantations, while the neointimal thickness on the stent struts were thinner in EES than in BMS. Moreover, thrombus was significantly less in EES than in BMS implantations 2 weeks after PCI, which may explain the lower rate of acute and subacute stent thrombosis of EES compared with BMS.

Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study.

BACKGROUND: The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. OBJECTIVES: We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. METHODS: We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group). RESULTS: The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270). CONCLUSIONS: At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Four-year comparative effectiveness of bare-metal and everolimus-eluting stents in New York.

OBJECTIVES: To study four-year outcomes for patients receiving either bare-metal stents (BMS) or everolimus-eluting stents (EES) and to evaluate the comparative effectiveness of BMS versus EES in six "off-label" and two "high-risk" patient subgroups. BACKGROUND: BMS and EES (a second generation of drug-eluting stent) are used in contemporary practice to treat coronary artery disease. However, little is known about long-term comparative effectiveness between BMS and EES. METHODS: Using the New York State (NYS) cardiac registries, statewide hospital discharge data, the National Death Index, and the U.S. Census file, we assessed four-year outcomes of BMS versus EES in patients receiving either BMS or EES from July 2008 through December 2009. The outcomes included all-cause mortality, acute myocardial infarction (AMI), target-lesion PCI (TLPCI), and target-vessel coronary artery bypass graft (TVCABG) surgery for a follow-up period of four years (median follow-up of 3.6 years). We compared 9,290 propensity score matched pairs with further adjustment using Cox proportional hazards regression. RESULTS: Compared with patients receiving BMS, patients receiving EES had a lower rate of four-year mortality (adjusted hazard ratio : 0.58, 95% confidence interval : 0.54-0.63), AMI (AHR: 0.68, 95% CI: 0.61-0.76), TLPCI (AHR: 0.67, 95% CI: 0.60-0.75), and TVCABG (AHR, 0.53, 95% CI: 0.43-0.65). For "off-label" and "high-risk" subgroups, EES was associated with decreased mortality and generally better AMI, TLPCI, and TVCABG outcomes relative to BMS. CONCLUSIONS: Compared with BMS use, EES use was associated with better four-year outcomes.

Comparison of clinical outcomes of coronary artery stent implantation in patients with end-stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer-EES, platinum chromium-EES, and cobalt chrome-EES.

BACKGROUNDS: New-generation bioresorbable polymer-everolimus eluting stents (BP-EES) are available. This study aimed to compare the clinical outcomes for BP-EES compared to more established stent designs, namely the platinum chromium-EES (PtCr-EES) and cobalt chrome-EES(CoCr-EES) in patients with the end-stage chronic kidney disease (CKD) including hemodialysis (HD). METHODS: One-hundred-forty-one consecutive stents (BP-EES [n = 44], PtCr-EES [n = 45], and CoCr-EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow-up coronary angiography at 12 months after implantation. End-stage CKD was defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 , or the need for HD. The following outcome variables were compared among the three stent groups after implantation and the 12-month follow-up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter-stenosis (%DS) were measured using quantitative coronary angiography. RESULTS: The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12-month follow-up, a tendency towards higher TLR was observed for the BP-EES group (22.7%) compared with the PtCr-EES (8.8%) and CoCr-EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP-EES (0.51 ± 0.64 mm) group than either the PtCr-EES (0.20 ± 0.61 mm) and CoCr-EES (0.25 ± 0.70 mm) groups (P = 0.03). CONCLUSIONS: BP-EES might increase the risk of in-stent restenosis in patients with end-stage of CKD or the need for HD.

Impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent: five-year follow-up optical coherence tomography study.

The impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent (CoCrEES) remains unclear. We sought to evaluate them using optical coherence tomography (OCT). A total of 47 patients with 58 lesions treated only with CoCrEES and no target-vessel events within 5 years after implantation were prospectively enrolled and underwent 5-year follow-up OCT. Quantitative parameters and qualitative characteristics of the neointima were evaluated using multilevel logistic or linear regression models with random effects at three levels: lesion, cross-section (CS), and strut. According to the lesion complexity, the lesions were classified into the two groups: the complex lesion (CL) and non-CL group. The CL was defined as having at least 1 high-risk feature such as acute coronary syndrome lesion, lesion length > 20 mm, severe calcification requiring rotational atherectomy, and chronic total occlusion at the index procedure. A total of 11,034 struts (CL, n = 6240; non-CL, n = 4794) and 1202 (CL, n = 683; non-CL, n = 519) CSs were analyzed. The percentage of uncovered and malapposed struts did not differ significantly between the CL and non-CL groups (0.90 vs. 0.54%, P = 0.78; 0.56 vs. 0.10%, P = 0.16, respectively). The incidence of neoatherosclerosis was comparable between both groups in the CS- and lesion-level analysis (3.5 vs. 4.6%, P = 0.91; 32.0 vs. 24.2%, P = 0.52, respectively). At 5 years, CoCrEES shows an excellent vascular healing and similar frequency of neoatheroslerosis in patients without target-vessel events, regardless of the lesion complexity.

Vascular Healing Response after Everolimus-Eluting Stent Implantation in Acute Coronary Syndrome Culprit Lesions: Comparison with Implantation in Stable Angina Pectoris.

BACKGROUND: To evaluate the neointimal conditions of everolimus-eluting stents (EESs) implanted in culprit lesions of patients with acute coronary syndrome (ACS) compared with stable angina pectoris (SAP) using optical coherence tomography (OCT). EESs are second-generation drug-eluting stents that have recently been shown to be useful in patients with ACS as well as in patients with SAP. However, few studies have analyzed the intra-stent conditions of EESs that can lead to favorable results in such ACS lesions. METHODS: We evaluated 41 ACS patients with EES implantation (age, 66.7 ± 10.3 years) and 59 SAP patients enrolled as controls (age, 68.3 ± 10.7 years). OCT examinations were performed after 9 months of follow-up after stent implantation, and the condition of the neointimal coverage over every stent strut was assessed in 1-mm intervals. In addition, neointimal thickness (NIT) over each strut was measured and tissue characteristics were examined. RESULTS: There was no significant difference in mean NIT between the ACS (90.8 ± 88.2 mm) and SAP (87.3 ± 74.2 mm, p = 0.11) group. The rate of uncovered struts was significantly lower in the ACS group (11.5%) than in the SAP group (12.5%, p = 0.03). Neointimal tissue characteristics were also similar between groups. CONCLUSIONS: Vascular responses after EES implantation differed significantly between ACS and SAP lesions using OCT. However, these differences were considered small in clinical terms. Our OCT data support the favorable results of patients with EES implantation at mid-term follow-up, even in those with ACS.

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.