sirolimus and Calcinosis

Long-term data concerning the efficacy of different polymer-coating strategies of new-generation drug-eluting stents (DES) in patients with coronary artery calcification (CAC) are scant.. We aimed to investigate 10-year outcomes by degree of CAC after new-generation DES implantation with different polymer-coating strategies.. We analysed individual patient and lesion characteristics of patients randomised to treatment with polymer-free sirolimus-eluting, biodegradable-polymer sirolimus-eluting and permanent-polymer zotarolimus- or everolimus-eluting stents. Endpoints of interest at 10 years were all-cause mortality, myocardial infarction (MI), target lesion revascularisation (TLR) and definite or probable stent thrombosis (ST) according to the degree of CAC (no, mild, moderate or severe) and coating strategy (polymer-free vs biodegradable-polymer vs permanent-polymer).. A total of 4,953 patients with 6,924 lesions were included. No, mild, moderate or severe CAC was present in 24.5%, 41.8%, 25.8% and 8.0% of patients, respectively. At 10-year follow-up, overall event rates were high, with an incremental increase according to the degree of CAC (all-cause mortality: no 25.3%, mild 32.1%, moderate 41.7%, severe CAC 46.5%; adjusted [adj.] p=0.004; TLR: no 17.4%, mild 16.5%, moderate 19.8%, severe CAC 28.7%; adj. p=0.001; MI: no 4.9%, mild 5.9%, moderate 6.0%, severe CAC 10.5%; adj. p=0.02; and ST: no 1.3%, mild 1.4%, moderate 1.8%, severe CAC 3.6%; adj. p=0.57). In patients with moderate-severe CAC, event rates were comparable, regardless of the DES polymer-coating strategy.. At 10 years after PCI with new-generation DES, there was an incremental increase in adverse events by degree of coronary calcification. These detrimental effects do not seem to be impacted by different polymer-coating strategies.

Topics: Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55).. The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Topics: Aged; Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Treatment Outcome

Tuberous sclerosis (TSC) is an autosomal dominant inherited disease caused by mutations in the TSC1 or TSC2 gene and results in the over-activation of the mammalian target of the rapamycin (mTOR) signaling pathway. Rapamycin, an mTOR inhibitor, is clinically used to treat hamartomatous lesionsas in TSC and its effect on controlling epilepsy is also reported in many studies. This study aims to evaluate the risk factors of pharmacoresistant epilepsy in patients with TSC receiving long-term rapamycin treatment.. A total of 108 patients with TSC taking rapamycin for over 1 year were enrolled in this study. Factors that might influence seizure control were statistically analyzed by multiple factor analysis. A subgroup analysis was also conducted to access the relationship between calcified epileptic foci and pharmacoresistant epilepsy. (Clinical trial registration number: ChiCTR-OOB-15006535(2015-05-29)).. Seizure was controlled in 53 patients but was not managed in 55 patients considered to be drug resistant. Logistic regression analysis showed that calcification in the cerebral parenchyma was a risk factor of pharmacoresistant epilepsy [P = 0.006, odds ratio (OR) = 4.831 (1.577, 14.795)]. Fifteen of 17 patients with calcified epileptic foci suffered from pharmacoresistant epilepsy (88.2%). Seizures in patients with calcified epileptic foci were probably pharmacoresistant (P = 0.010).. Calcification in epileptic foci strongly indicates pharmacoresistant epilepsy in patients with TSC even when treated with appropriate anti-epilepsy drugs (AEDs) and rapamycin. Calcification can be used to evaluate pharmacoresistant epilepsy in patients with TSC.

Topics: Anticonvulsants; Brain; Calcinosis; Child, Preschool; Drug Resistant Epilepsy; Factor Analysis, Statistical; Female; Humans; Infant; Logistic Models; Male; Parenchymal Tissue; Risk Factors; Sirolimus; TOR Serine-Threonine Kinases; Tuberous Sclerosis

Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.

Topics: Acute Coronary Syndrome; Calcinosis; Creatine Kinase; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Off-Label Use; Patient Outcome Assessment; Percutaneous Coronary Intervention; Severity of Illness Index; Sirolimus

To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS).. IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10 ± 0.46 mm2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57 ± 1.3 mm2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external elastic membrane area (y=0.68x-0.1; r=0.58, p=0.03).. Based on 6-months IVUS-VH analysis, the BVS 1.1 appears to have a different backscattering signal compared to the BVS 1.0, which may reflect differences in the speed of chemical and structural alteration.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Image Interpretation, Computer-Assisted; Male; Middle Aged; Necrosis; New Zealand; Polyesters; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional

Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.. The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed.. The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12).. The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; New Zealand; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The main objective was to use IVUS-backscatter radiofrequency (IVUS-RF) to assess the degradation of a bioabsorbable stent by measuring serial changes in dense calcium (DC) and necrotic core (NC) as assessed by intravascular ultrasound-Virtual Histology (IVUS-VH) and in the strain as assessed by palpography.. In the ABSORB trial, 27 patients treated with a single bioabsorbable everolimus-eluting stent (BVS, Abbott Vascular, Santa Clara, CA, USA) were all imaged with IVUS-RF post-stenting and at 6-month follow-up, and 13 and 12 patients were also investigated pre-stenting with IVUS-VH and palpography respectively. From pre- to post-stenting, with VH (n = 13), there was an increase in mean "DC" (9.8 vs. 25.4%, p = 0.0002) and "NC" (15.5 vs. 30.5%, p = 0.0002). In palpography (n = 12), the mean number of frames with Rotterdam Classification (ROC) III/IV per cm decreased from 1.22 +/- 1.91 to 0.12 +/- 0.31 (p = 0.0781) and the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.50 +/- 0.27 to 0.20 +/- 0.10% (p = 0.0034). Comparing post-stenting with follow-up (n = 27), VH showed a decrease in "DC" (29.7% vs. 21.1%, p = 0.0001). "NC" also decreased (26.9 vs. 21.5%, p = 0.0027). For palpography (n = 25 patients), an increase in the mean number of frames with ROC III/IV per cm was observed from 0.09 +/- 0.26 to 0.22 +/- 0.36 (p = -0.1563) while the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.15 +/- 0.10 to 0.26 +/- 0.12% (p < 0.0001).. IVUS-VH changes at 6 months suggest alteration of the BVS with reduction of RF backscattering by polymeric struts. Strained plaques on the palpograms were almost abolished following stent implantation. However, strain values reappeared within 6 months suggesting an increase in endoluminal deformability of the stented vessel.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Necrosis; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Stress, Mechanical; Time Factors; Treatment Outcome; Ultrasonography, Interventional; User-Computer Interface

Topics: Aged; Antineoplastic Agents; Calcinosis; Carcinoma, Renal Cell; Female; Humans; Kidney Neoplasms; Palliative Care; Protein Kinase Inhibitors; Sirolimus; Tomography, X-Ray Computed; Treatment Outcome

Drug-eluting stents (DES) are widely used for the treatment of coronary artery disease, and a sirolimus-eluting stent (SES; Cypher) was the first DES introduced into clinical practice. Although pathological reactions of coronary arteries to SES have been described in autopsy cases, there are few reports regarding calcification of the coronary arteries after SES implantation. The present report describes the findings of an autopsy conducted 16 months after SES implantation that showed remarkable persistent calcification. In addition, previously reported pertinent pathological findings are also described.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Autopsy; Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Fatal Outcome; Female; Heart Arrest; Humans; Percutaneous Coronary Intervention; Sirolimus; Time Factors

Calcific aortic valve disease (CAVD) is an age-related and slowly progressive valvular disorder. We have previously found that the increased inflammatory and osteogenic responses to Toll-like receptor 4 (TLR4) stimulation is correlated with lower signal transducer and activator of transcription 3 (Stat3) activity in aortic valve interstitial cells (AVICs). Rapamycin, a drug used clinically, induces feedback activation of Akt. Akt in turn may upregulate Stat3. Therefore we hypothesized that rapamycin will decrease TLR4-induced osteogenic response in human AVICs through modulation of Stat3 activity.. AVICs were isolated from normal valves taken from the explanted hearts of patients undergoing transplantation. Cells were treated with TLR4 ligand lipopolysaccharide (LPS) or rapamycin, or both. The osteogenic markers runt-related transcription factor 2 (RUNX2), alkaline phosphatase (ALP), and bone morphogenetic protein 2 (BMP-2), as well as activation of Stat3 and its associated signaling molecules, were analyzed.. LPS induces the expression of RUNX2, ALP, and BMP-2. Rapamycin decreased both the baseline and LPS-induced expression of RUNX2, ALP, and BMP-2. Rapamycin also decreased calcium deposit formation. Rapamycin activated both Stat3 and Akt in AVICs. Suppression of Akt resulted in abolishment of Stat3 activation. Inhibition of Stat3 enhanced expression of RUNX2, ALP, and BMP-2 at baseline and in response to LPS.. Rapamycin inhibits TLR4-induced osteogenic responses in AVICs by activation of Stat3 through Akt. Rapamycin may alleviate inflammation-induced initiation and progression of CAVD.

Topics: Aortic Valve; Aortic Valve Stenosis; Calcinosis; Cells, Cultured; Humans; Immunoblotting; Osteogenesis; Sensitivity and Specificity; Signal Transduction; Sirolimus; STAT3 Transcription Factor; Toll-Like Receptor 4

We describe a case of very late stent thrombosis with documentation of highly calcific restenosis at optical coherence tomography without clear signs of stent malapposition, neoatherosclerosis disruption, or vascular toxicity to stent polymer. To the best of our knowledge, this is one of the first reports dealing with highly calcific restenosis as a potential background to very late stent thrombosis.

Topics: Calcinosis; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Tomography, Optical Coherence

The technology of bioabsorbable vascular scaffolds (BVSs) that disappears with minimal trace essentially eliminating the risk of very late stent thrombosis appears exciting. However, these scaffolds have only been tried in simple lesions in which the risk of late stent thrombosis is very low. We would like to report the use of everolimus-eluting BVS in calcified coronary lesions following debulking the lesions using scoring balloons and rotational atherectomy. With the use of intravascular ultrasound, we have confirmed the adequate expansion of these scaffolds. These cases demonstrate the feasibility of BVS in complex lesions, but appropriate lesion preparation remains the key to aid adequate expansion of these scaffolds.

Topics: Absorbable Implants; Aged, 80 and over; Antineoplastic Agents; Calcinosis; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus

Ostial right coronary artery (RCA) lesions are associated with a high restenosis rate after bare-metal stent implantation. However, long-term outcomes after drug-eluting stent (DES) implantation for ostial RCA lesions have not been adequately evaluated. Among 12824 patients enrolled in the j-Cypher registry, 5-year outcomes were compared between 397 patients with ostial RCA lesions, and 3716 patients with non-ostial RCA lesions treated with sirolimus-eluting stents (SES). Through 5-year follow-up, patients with ostial RCA lesions had a significantly higher cumulative incidence of target lesion revascularization (TLR) (28.2 versus 13.7 %, P < 0.0001) than those with non-ostial RCA lesions. After adjusting for confounders, excess TLR risk of the ostial group relative to the non-ostial group was significant for both early TLR within 1-year and late TLR beyond 1-year (HR 2.14 [95 % CI 1.59-2.84], P < 0.0001, and HR 1.58 [95 % CI 1.06-2.26], P = 0.02, respectively). Although the cumulative incidence of death was also significantly higher in the ostial group than in the non-ostial group (25.7 versus 14.4 %, P < 0.0001), the excess risk of the ostial group relative to the non-ostial group was no longer significant after adjusting for confounders (HR 1.25 [95 % CI 0.99-1.57], P = 0.07). SES implantation for ostial RCA lesions was associated with higher risk for TLR as compared with that for non-ostial RCA lesions. Restenosis, both early and late, remains an issue in coronary DES implantation for ostial RCA lesions.

Topics: Aged; Aged, 80 and over; Calcinosis; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Registries; Risk Factors; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Sirolimus

The aim of the present study was to investigate the long-term outcome of sirolimus-eluting stent (SES) implantation in lesions with severe calcification that may disturb adequate stent expansion and increase the risk of restenosis and target lesion revascularization (TLR).. The Cypher Post-Marketing Surveillance Registry study has been conducted since August 2004 in Japan to evaluate the efficacy and safety of SES in a real-world setting. Data on 2,458 lesions in 2,050 patients were reviewed, and the angiographical outcomes at 240 days and clinical outcomes at 1,080 days after implantation compared between calcified lesions and non-calcified lesions in dialysis patients and non-dialysis patients. In non-dialysis patients, the rates of major adverse cardiac events (MACE; 16.0% vs. 12.8%; P=0.144) including TLR (4.9% vs. 6.0%; P=0.457), and restenosis (10.1% vs. 7.8%; P=0.207) were similar in calcified lesions and non-calcified lesions. In dialysis patients, the rate of MACE was similar in calcified lesions and non-calcified lesions (51.1% vs. 43.1%; P=0.544), but the rates of TLR (29.8% vs. 9.8%; P=0.020), and restenosis (39.5% vs. 17.0%; P=0.029) were significantly higher in calcified lesions than in non-calcified lesions.. There is a differential impact of calcification on the long-term outcome of SES implantation in dialysis and non-dialysis patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Calcinosis; Coronary Angiography; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Registries; Renal Dialysis; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

There has been no detailed intravascular ultrasound (IVUS) analysis to evaluate the degree to which stent underexpansion or reference vessel/stent size mismatch contributes to the occurrence of post-procedural incomplete stent apposition (post-ISA).. We evaluated 238 lesions treated with everolimus-eluting stents (n = 110) or paclitaxel-eluting stents (n = 128). Reference lumen/stent area ratio was defined as the ratio of lumen area adjacent to the stent edge in the reference segment to stent area at the stent edge or at stent body ISA site.. Post-ISA was observed in 36 of the 238 cases (15%) at the proximal stent edge, 15 of the 238 cases (6%) at the distal stent edge and 14 of the 238 cases (6%) at stent body. Reference lumen/stent area ratio was significantly greater in the ISA group compared with non-ISA in proximal edge (127 ± 20 vs. 99 ± 10%; P<.001), and greater reference lumen/stent area ratio (118 ± 18 vs. 94 ± 11%; P<.001) and higher presence of calcification (60 vs. 29%; P<0.001) were observed in distal edge ISA group compared with non-ISA. At the stent body, presence of calcification was more frequently observed in the ISA compared with the non-ISA group (86 vs. 42%; P=.002).. Post-ISA at the stent edge was significantly associated with vessel/stent mismatch rather than stent underexpansion. IVUS-guided appropriate stent or balloon sizing might be useful to prevent post-ISA and optimize initial stent deployment.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Middle Aged; Paclitaxel; Randomized Controlled Trials as Topic; Retrospective Studies; Sirolimus; Ultrasonography, Interventional

Long-term outcomes of patients with bifurcated lesions and the restenotic response of the side branches after sirolimus-eluting stent (SES) implantation, comparing 1-stent with 2-stent treatment, are still under discussion.. Japan Post-Marketing Surveillance Registry (J-PMS) is a prospective registry designed to evaluate the safety and efficacy of the SES in routine clinical practice. Angiograms of 1,063 patients with 1,250 lesions were analyzed at the independent core lab. Of these, 324 patients with bifurcation lesions were enrolled. Clinical endpoints were assessed at 3 years. Both main and side branches were evaluated by quantitative coronary angiography at post-procedure (n=349) and 8-month follow up (n=293). Two-stent treatment was performed in 12% of the cases. In-segment restenosis rates at 8 months were 25.6% in the side branch, but newly developed restenosis was seen in only 6.8%. Late loss at the carina of the side branch was -0.11mm in the 1-stent group. Major adverse cardiovascular events rate was 18.3% at 3 years. Target-lesion revascularization rate up to 3 years was 21.6% in the 2-stent group and 8.7% in the 1-stent group (P=0.037). Stent thrombosis occurred in 6 cases (2.0%) until 3 years. Of these, 4 cases were treated with 2-stent (10.81% vs. 0.76% in 1-stent, P=0.003, respectively).. In a real-world setting, treatment of coronary bifurcation lesions using SES demonstrated favorable long-term outcomes as long as the side branch was not stented.

Topics: Angioplasty; Aspirin; Calcinosis; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Japan; Myocardial Infarction; Platelet Aggregation Inhibitors; Product Surveillance, Postmarketing; Sirolimus; Survival Analysis; Thrombophilia; Ticlopidine; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Microscopy, Electron, Scanning; Polymers; Prosthesis Design; Prosthesis Failure; Sirolimus; Surface Properties; Treatment Outcome

Calcified coronary lesions have commonly been considered as a challenge for interventional cardiologists, and few previous studies of sirolimus-eluting stent (SES) for calcified lesion have been limited by small sample size. Therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified lesions in a large Chinese cohort of real world practice.. A total of 956 consecutive patients who successfully received SES placement were enrolled in this study, and were divided into the two groups according to whether the mild-moderate calcified lesion treated with SES exists or not: noncalcified group (n = 637) and calcified group (n = 319). Lesions treated with SES were subjected to quantitative coronary angiography immediately and 8 months after stenting.. Baseline characteristics including clinical, demographic or angiographic data were well balanced between the noncalcified and calcified groups. In the angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were similar in both the groups (in-stent restenosis: 3.8 vs. 4.0%, P>0.05; in-segment restenosis: 8.5 vs. 9.7%, P>0.05). The target lesion revascularization was not different between the two groups (5.2 vs. 6.8%; P>0.05). In addition, the in-stent late loss and overall thrombosis rate were also similar in both the groups (0.17+/-0.41 vs. 0.18+/-0.35 mm and 1.8 vs. 1.8%, P>0.05, respectively).. Although stenting of the calcified lesion was hard, successful treatment with SES for mild-moderate calcified lesions was conferred to similar favorable results compared with noncalcified lesions in patients with coronary artery disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period >/=4 years.. Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology.. All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model.. A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis.. The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Calcinosis; Cardiovascular Agents; Coronary Restenosis; Disease-Free Survival; Drug Therapy, Combination; Drug-Eluting Stents; Female; Heart Diseases; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Sirolimus-eluting stent (SES) has revolutionized interventional cardiology. Its application is spreading to complex, high-risk subsets of patients and lesions. Therefore, it is important to determine the factors associated with post-SES restenosis.. The study investigated 341 patients with angina pectoris, in whom SES was implanted. The coronary artery calcification (CAC) degree was assessed using the angiographic scoring system as follows: 0, none; 1, blocky or spotty calcification; 2, linear calcification compromising 1 side of the arterial lumen; 3, linear calcification found unidirectionally compromising both sides of the arterial lumen; 4, linear calcification found bidirectionally compromising both sides of the arterial lumen; and 5, blanket/circumferential and dense calcification. Restenosis was observed in 23 patients (7.3%). The target lesion (1.8 +/-1.7 vs 0.7 +/-1.1 [mean +/- SD]) and stent delivery route CAC scores (3.1 +/-2.5 vs 1.4 +/-2.0) were significantly higher in patients with restenosis than in those without it (P<0.0001). In multivariate analysis, the CAC score of the stent delivery route was independently associated with restenosis (odds ratio of 6.804, P<0.05), although CAC score of the target lesion was not.. CAC in the stent delivery route is an important determinant of post-SES restenosis.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Microscopy, Electron; Middle Aged; Odds Ratio; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Treatment Outcome

The efficacy of drug-eluting stents after rotational atherectomy (ROTA) has not been clarified.. The 704 consecutive patients who underwent percutaneous coronary intervention (PCI) with a sirolimus-eluting stent (SES) (79 with and 625 without ROTA) were enrolled. The 2-year clinical outcome of these patients was compared with that of a group of 1,123 consecutive patients treated with bare-metal stents (BMS) (144 with and 979 without ROTA). At 2 years after index PCI, the use of SES after ROTA was associated with a lower crude incidence of major adverse cardiac events (MACE) than were BMS after ROTA (30.1% vs 43.1%, P=0.024). The difference was mainly derived from the reduction in target lesion revascularization (TLR) (25.0% vs 39.1%, P=0.022). After adjusting for confounders, ROTA-SES was associated with a reduction in MACE and TLR, with a similar hazard ratio to the non-ROTA group only with SES implantation. In a subgroup of dialysis patients, the incidence of TLR after ROTA with SES and BMS was similarly high.. The use of SES after ROTA is an appropriate method for selected hard lesions, but has a limited effect in dialysis patients, even after lesion preparation with ROTA.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Renal Dialysis; Sirolimus; Stents; Treatment Outcome

We have occasionally encountered restenosis due to the crushing of drug-eluting stents (DES) implanted in severely calcified lesions. We aimed to establish the role of rotational atherectomy (RA) in its treatment. At first, we conducted an experimental study and found that the size of the metallic particles generated during RA of stent struts was 5.6 +/- 3.6 mum. We performed RA on the restenosis of the sirolimus-eluting stents implanted in the severely calcified lesions of a 66-year-old male who had received hemodialysis for 13 years. He had restenosis in the proximal and mid-segments of the right coronary artery, and intravascular ultrasound images documented that these stents were crushed by calcified plaque behind them. RA ablated both crushed stent struts and the calcified lesions behind them, and there was no hemodynamic derangement during the procedure. Maximum dilatation of the lesions was achieved with balloon angioplasty, followed by stent implantation. RA is an effective strategy to treat restenotic lesions resulting from the crushing of DES in severely calcified lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Sirolimus; Treatment Outcome

Although previously reported studies on coronary calcification mainly focused on its presence or absence in discrete focal target lesions, calcified coronary lesions (CCL) angiographically present as diffuse long lesions in some patients. The aim of our study was to evaluate the long-term efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) on long CCL.. A total of 122 patients with 134 lesions (77 patients with 88 lesions for SES and 45 patients with 46 lesions for PES) were enrolled from 3 centers. Long CCL was defined visually as a culprit lesion with type B or C that was mainly due to coronary calcification with > 20 mm in total length by coronary angiography. Clinical follow-up was performed at 1 year and angiographic follow-up at 6 to 9 months after procedure. Major adverse coronary events (MACE) were defined as all-cause death, myocardial infarction (MI), and repeat target-lesion revascularization (TLR).. There were no statistically significant differences in baseline, procedural, or angiographic characteristics and in 1-year rates of all-cause death, MI, and TLR between the 2 groups (all P = NS [not significant]). Likewise, the cumulative incidence of MACE at 1 year was similar between the 2 groups (7.8% of patients in the SES group vs 4.4% of patients in the PES group, respectively, P = NS). In patients who underwent follow-up angiography, the angiographic binary restenosis rate was 6.2% in the SES group vs 12.1% in the PES group, respectively (P = NS).. In patients with long CCL, both SES and PES were comparably effective in either angiographic or clinical long-term outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Republic of Korea; Retrospective Studies; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Accelerated atherosclerosis is a major risk for long-term survivors receiving hemodialysis (HD), with coronary events being the leading cause of mortality.. A total of 88 consecutive patients on HD (121 lesions) who underwent percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) were compared with 78 patients on HD (95 lesions) who received bare metal stents (BMS) in the preceding 1 year. The primary endpoint was angiographic restenosis defined as > or =50% diameter stenosis at 6-8 months follow-up after PCI. The angiographic restenosis rate at follow-up was 22.2% in the SES group and 24.4% in the BMS group. No difference was detected in the restenosis rate between the 2 groups (p=0.73). When including both HD and non-HD patients, the independent predictors for restenosis after SES implantation were treatment with HD (hazard ratio (HR) 3.12; 95% confidence interval (CI) 1.23-7.95; p=0.016), incidence of hyperlipidemia (HR 3.93; 95%CI 1.12-13.7; p=0.032), coronary calcification (HR 2.78; 95%CI 1.12-6.91; p=0.027), and implantation of multi-stents (HR 4.14; 95%CI 1.70-10.1; p=0.0017).. Even if treated with SES, patients with end-stage renal failure on HD are at high risk of restenosis after PCI.

Topics: Aged; Calcinosis; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperlipidemias; Japan; Kidney Failure, Chronic; Male; Middle Aged; Recurrence; Renal Dialysis; Sirolimus; Stents

Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents (SES) for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.. A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group (n = 264) and calcification group (n = 189). Lesions treated with SES were subjected to quantitative coronary angiography (QCA) immediately and 8 months following stenting.. Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; in-stent restenosis: 3.8% vs 4.2%; P = 0.081; in-segment restenosis: 8.7% vs 10.6%, P = 0.503. The target lesion revascularization (TLR) was also not significantly different between the two groups; 4.9% vs 6.9%, P = 0.378. In addition, the in-stent late loss was similar in both groups; (0.16 +/- 0.40) mm vs (0.17 +/- 0.33) mm, P > 0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P > 0.05.. Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.

Topics: Adult; Aged; Calcinosis; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus

The aim of this study was to compare the initial and long-term outcomes of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with calcified lesions without performing rotational atherectomy. The subjects were 79 consecutive lesions (38 in the SES group and 41 in the BMS group) which were confirmed to have superficially calcified lesions by intravascular ultrasound. In all lesions, the stent was implanted after predilatation with a balloon. The patient characteristics were not different between the 2 groups. All procedures were successfully performed in both groups. Vessel area was significantly smaller in the SES group than in the BMS group (11.01 +/- 3.88 mm(2) versus 13.08 +/- 3.49 mm(2), P < 0.005), as was the lumen area (5.41 +/- 2.31mm(2) versus 6.48 +/- 2.04 mm(2), P < 0.005). Minimum stent area was significantly smaller in the SES group than in the BMS group (5.61 +/- 1.54 mm(2) versus 6.69 +/- 1.74 mm(2), P < 0.01). In cases in whom angiographic follow-ups were performed, the late loss was significantly smaller in the SES group than in the BMS group (0.19 +/- 0.49 mm versus 0.76 +/- 0.48 mm, P < 0.001). The restenosis rate was significantly lower in the SES group than in the BMS group (8.8% versus 33.3%, P < 0.05) and the TLR rate tended to be lower in the SES group (7.9% versus 19.5%). Stent thrombosis was not observed in either group. The results suggest that SES are more effective than BMS and can be used safely when treating calcified lesions if predilatation with a balloon is possible.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Calcinosis; Coronary Disease; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Radiography; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography

The use of bare metal stents to treat symptomatic intracranial stenosis may be associated with significant restenosis rates. The advent of drug-eluting stents (DESs) in the coronary circulation has resulted in a reduction of restenosis rates. We report our technical success rate and short-term restenosis rates after stenting with DESs in the intracranial and extracranial circulation.. This study was a retrospective review of the period between April 1, 2004, and April 15, 2006, of 59 patients with 62 symptomatic intracranial or extracranial atherosclerotic lesions at 2 medical centers (University of Pittsburgh and Borgess Medical Center).. The mean age of our cohort was 61+/-12 years. The location of the 62 lesions was as follows: extracranial vertebral artery 31 (50%), intracranial vertebral artery or basilar artery 18 (29%), extracranial internal carotid artery (ICA) near the petrous bone 5 (8%), and intracranial ICA 8 (13%). There were 2 (3%) periprocedural complications: 1 non-flow-limiting dissection and 1 disabling stroke. Fifty vessels were available for follow-up angiography or computed tomography angiography at a median time of 4.0+/-2 months. A total of 2 of 36 extracranial stents (7%) and 1 of 26 intracranial stents (5%) were found to have restenosis > or = 50% at follow-up.. This report demonstrates that DES delivery in the intracranial and extracranial circulation is technically feasible. A small percentage of patients developed short-term in-stent restenosis. Longer-term follow-up is required in the setting of a prospective study to determine the late restenosis rates for DESs in comparison with bare metal stents.

Topics: Anticoagulants; Aortic Dissection; Calcinosis; Carotid Artery, External; Carotid Artery, Internal; Carotid Stenosis; Catheterization; Cohort Studies; Drug Evaluation; Drug Implants; Feasibility Studies; Female; Follow-Up Studies; Humans; Ischemic Attack, Transient; Male; Middle Aged; Organ Specificity; Paclitaxel; Recurrence; Retrospective Studies; Sirolimus; Stents; Stroke; Vertebrobasilar Insufficiency

This study examined the outcomes of patients who underwent sirolimus-eluting stent (SES) implantation for the treatment of heavily calcified coronary lesions (HCCL) with and without the use of rotational atherectomy (rotablator). We investigated 150 consecutive patients with angiographic evidence of HCCL who underwent SES implantation. Sixty-nine patients underwent SES implantation without the need of rotablator (SES), and 81 patients required rotational atherectomy to modify the plaque and facilitate the delivery of the stent (SES + rotational atherectomy). Clinical success was equivalent in both groups (>98%) and there were no in-hospital outcome differences. At 6 months, the target lesion revascularization rate was 4.9% in SES vs. 4.2% in SES + rotational atherectomy groups, respectively (P = NS). Mortality at 6 months was 7.9% in the SES group vs. 6.8% in the SES + rotational atherectomy group (P = NS). SES performs well in patients with complex HCCL, with a relative low event rate. Lesions requiring rotational atherectomy to facilitate dilation and stenting had similar outcomes after SES implantation to those that could be stented without the need for rotablator.

Topics: Aged; Anti-Inflammatory Agents; Atherectomy, Coronary; Calcinosis; Coronary Restenosis; Coronary Stenosis; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

The use of the immunosuppressant cyclosporine A (CsA) is limited by its adverse renal effects. Most recently, we reported that the drug markedly decreases the levels of the calcium-binding protein calbindin-D 28kDa in kidneys of male Wistar rats. In the present study, the potential relationship between drug-induced nephrotoxicity and the decrease in kidney calbindin-D 28kDa was investigated. Four groups of male Wistar rats were treated for 10 or 31 days with either the immunosuppressant CsA (50 mg/kg/day), FK-506 (5 mg/kg/day), rapamycin (5 mg/kg/day) or with the nonimmunosuppressive cyclosporine derivative 3'keto-[Bmt1]-[Val2]-CsA (SDZ PSC-833) (50 mg/kg/day), and the effects on calcium homeostasis, kidney histology and renal calbindin-D 28kDa were examined. Similar effects were found with CsA and FK-506; both drugs strongly reduced kidney calbindin-D 28kDa protein levels, increased urine calcium excretion, caused intratubular calcification, and induced basophilic tubules. In contrast, rapamycin and SDZ PSC-833 caused no decrease in renal calbindin-D 28kDa levels, no noticeable alterations in calcium metabolism, and no renal calcification. The results provide evidence for a link between decreased renal calbindin, increased calcium urine excretion, and intratubular kidney calcification. The present data show no correlation between the decrease in renal calbindin and the induction of basophilic tubules; however, it needs to be investigated if these apparently independent kidney effects may have a common origin upstream of calbindin expression.

Topics: Animals; Calbindins; Calcinosis; Calcium; Cyclosporine; Immunosuppressive Agents; Kidney; Kidney Tubules; Male; Polyenes; Rats; Rats, Wistar; S100 Calcium Binding Protein G; Sirolimus; Tacrolimus