Bare Metal Stents For Treatment Research Articles

Abstract 19047: Comparison of Drug-Eluting Stent With Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis

Introduction: Trials comparing drug eluting stent (DES) versus bare metal stents (BMS) in patients undergoing endovascular therapy for femoropopliteal artery disease (FPAD) have shown variable results. Data indicating clear patency benefit of DES has not been definitively demonstrated. Methods: Medline, Embase, & Cochrane Central databases were searched to identify previous studies comparing efficacy of drug eluting stent versus bare metal stents in treatment of FPAD. The primary outcome of interest was risk of restenosis. Secondary outcomes included all-cause mortality, stent fracture, target vessel revascularization and primary patency. Odds ratios (OR) were pooled using a random-effect model while heterogeneity among studies was assessed using the Higgins I 2 value. Results: A total of 7 studies (5 RCTs and 2 retrospective cohorts) with 1786 patients were included in our analyses. The risk of target vessel revascularization was significantly reduced with the use of DES (OR: 0.69, 95% CI: 0.49-0.98, I 2 = 0) as compared with BMS. However, there was no significant difference observed in risk of restenosis (OR: 0.83, 95% CI 0.59-1.16), primary patency (OR: 1.09, 95% CI 0.91-1.29), stent fracture (OR: 0.84, 95% CI 0.27-2.67) and all-cause mortality (OR: 1.65, 95% CI 0.71-3.85). Conclusion: The risk of target vessel revascularization was significantly reduced with the use of DES implantation in patients with FPAD. However, DES does not seem to provide much benefit in terms of clinical outcomes. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.

Hypoechoic Halo Imaging Findings Following Femoropopliteal Artery Stent Implantation: Risk Factors and Clinical Outcomes

BackgroundHypoechoic peri-stent areas in duplex ultrasonography (DUS) (ie, “halo”) have been noted following femoropopliteal artery stenting. ObjectivesThis study sought to investigate the prevalence, risk factors, and potential safety implications of hypoechoic halos identified with DUS following stent implantation in the IMPERIAL (ELUVIA Drug-Eluting Stent Versus Zilver PTX Stent) and EMINENT (Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) trials. MethodsThe IMPERIAL and EMINENT studies of femoropopliteal artery stenting included polymer-based drug-eluting stent, nonpolymer drug-coated stent, and bare metal stent treatment arms. A dedicated DUS protocol was implemented for core laboratory assessment of halo presence at study follow-up visits. Logistic regressions were used to investigate risk factors for a halo sign and its impact on clinically driven target lesion revascularization and primary patency. ResultsDiagnostic DUS imaging from 659 patients was obtained at time points ranging from 6 months to 5 years post–stent implantation. Halo prevalence ranged from 20% to 35% of patients with diagnostic DUS and was present at all time intervals. Halos were identified surrounding all stent types. In analyses of patients with diagnostic imaging from at least 2 visits, halo presence typically persisted, with occasional cases of regression and development at later times. No statistically significant association was found for halo status (ie, halo vs no halo) on 1-year clinically driven target lesion revascularization (OR: 1.27; 95% CI: 0.70-2.30; P = 0.4240) or primary patency (OR: 0.68; 95% CI: 0.43-1.07; P = 0.0927). ConclusionsA hypoechoic halo following a femoropopliteal stent procedure is a common occurrence associated with all studied stent types. The presence of a halo appears to be benign with no associated clinical sequelae or effect on target vessel revascularization rates within 1 year of stent implantation.

Drug-coated balloons versus bare metal stent for treatment of femoropopliteal lesions:36 month follow-up results of single center

Objective: To examine the therapeutic effects of drug-coated balloon (DCB) and bare metal stent (BMS) on primary femoropopliteal disease (FPAD) in the real world. Methods: This was a retrospective analysis of single-center follow-up results at 12,24,and 36 months of patients with FPAD lesions that were treated with DCB and BMS at Department of Aortic and Vascular Surgery, Fu Wai Hospital.One-to-one propensity score matching(PSM) was performed to balance the covariance between DCB group (137 cases) and BMS group (100 cases). Freedom from clinically driven target lesion reintervention rate(fCD-TLR) was determined by Kaplan-Meier curve.Log-rank test was used to compare the rates of fCD-TLR between DCB and BMS groups at 12,24,36 months post-operation. Results: After PSM, there were both 71 patients in each group,aged (68.0±9.6) years(range: 46 to 90 years) and (68.8±7.3) years(range: 48 to 87 years),lesion lengths were (119.6±14.2)mm(range:40 to 380 mm) and (110.8±13.1)mm(range:40 to 400 mm). The median follow-up period were 24.3 months (range:5.8 to 55.1 months).There was no death,amputation or reintervention within the 30 days after operation.The rates of fCD-TLR for DCB group at 12,24 and 36 months were 97.2%,85.9%,69.1%, and 95.8%,83.1%,59.2% for BMS group.There was no statistical difference between the two groups by Log-rank test (P=0.551). Conclusion: DCB and BMS can both maintain favorable clinical effects in FPAD patients at 12,24,36 months post-operation.

Covered vs Uncovered Stents for Aortoiliac and Femoropopliteal Arterial Disease

Purpose: To evaluate outcomes of covered vs bare metal stents for the treatment of lower limb peripheral artery disease. Methods: A search of electronic databases was performed to identify all studies comparing outcomes of covered vs bare metal stents for treatment of aortoiliac and femoropopliteal arterial disease. The Cochrane tool and the Newcastle-Ottawa scale were used to assess the risk of bias in randomized controlled trials (RCTs) and observational studies, respectively. Fixed or random effects models were applied to analyze pooled outcome data. The results for dichotomous outcome variables are presented as the odds ratio (OR) and 95% confidence interval (CI); intergroup comparisons of continuous clinical variables are reported as the mean difference (MD) and 95% CI. Results: Two RCTs and 4 retrospective cohort studies, enrolling 744 patients (mean age 67 years; 477 men) and 918 diseased arteries, were identified. For aortoiliac disease, treatment with a covered stent showed no significant improvement in primary patency (OR 2.10, 95% CI 0.48 to 9.11, p=0.32), but it was associated with higher ankle-brachial index (ABI) (MD 0.08, 95% CI 0.07 to 0.09, p<0.001) and a lower reintervention rate (OR 0.19, 95% CI 0.09 to 0.42, p<0.001). For femoropopliteal disease, use of covered stents was associated with increased primary patency (OR 1.84, 95% CI 1.11 to 3.06, p=0.02), higher ABI (MD 0.08, 95% CI 0.00 to 0.16, p=0.04), and a lower reintervention rate (OR 0.51, 95% CI 0.30 to 0.87, p=0.01). No significant differences in technical success, complications, limb salvage, or survival were identified between the groups in either segment. Conclusion: Theoretically, the use of covered stents may increase the patency rate due to decreased restenosis after stent placement. This analysis found that the primary patency was improved with the use of a covered stent in femoropopliteal lesions but not in aortoiliac disease. Improved outcomes were seen with covered stents compared with bare metal stents as indicated by a lower need for reintervention and an improved ABI. It remains to be investigated whether such beneficial effects can be translated into improved clinical outcomes, such as limb salvage and amputation-free survival. Long-term results of the comparative efficacy of covered stents over bare metal stents are not currently available.

Atypical “vacuum” inside of neoatherosclerosis long term after DES implantation: Insights from optical coherence tomography

Percutaneous coronary intervention (PCI) with stenting is the most widely performed procedure for the treatment of symptomatic coronary artery disease [ [1] Serruys P.W. et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N. Engl. J. Med. 1994; 331: 489-495 Crossref PubMed Scopus (4365) Google Scholar ], and the technological developments of drug-eluting stents (DES) have reduced the rates of in-stent restenosis and target lesion revascularization of bare-metal stent [ 2 Morice M.C. et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 2002; 346: 1773-1780 Crossref PubMed Scopus (3859) Google Scholar , 3 Fajadet J. et al. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation. 2005; 111: 1040-1044 Crossref PubMed Scopus (216) Google Scholar , 4 Moses J. et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 2003; 349: 1315-1323 Crossref PubMed Scopus (4060) Google Scholar , 5 Weiz G. et al. Five-year follow-up after sirolimus-eluting stent implantation: results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial. J. Am. Coll. Cardiol. 2009; 53: 1488-1497 Abstract Full Text Full Text PDF PubMed Scopus (183) Google Scholar ]. Clinical and histological studies of DES have confirmed evidence that restenosis is the result of arterial damage with subsequent neointimal tissue proliferation, which was named as “late catch-up” phenomenon [ 6 Grube et al. TAXUS VI final 5-year results: a multicentre, randomised trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions. EuroIntervention. 2009; 4: 572-577 Crossref PubMed Scopus (58) Google Scholar , 7 Nakazawa et al. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J. Am. Coll. Cardiol. 2011; 57: 390-398 Abstract Full Text Full Text PDF PubMed Scopus (257) Google Scholar ]. The mechanisms behind this DES failure remain complex and multi-factorial. The atherosclerotic changes (neoatherosclerosis) of neointimal layer inside of a restenosis are now thought to be potential mechanisms of DES failure [ [8] Park S.J. et al. In-stent neoatherosclerosis: a final common pathway of late stent failure. J. Am. Coll. Cardiol. 2012; 59: 2051-2057 Abstract Full Text Full Text PDF PubMed Scopus (301) Google Scholar ]. The exact pathogenesis of neoatherosclerosis remains partially unknown, however Yonetsu et al. have shown that the risk factors such as stent >48 months old, DES, cigarette smoking and chronic kidney disease are strongly associated with the formation of neoatherosclerosis, whereas the use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers appears to be protective [ [9] Yonetsu et al. Predictors for neoatherosclerosis: a retrospective observational study from the optical coherence tomography registry. Circ. Cardiovasc. Imaging. 2012; 5: 660-666 Crossref PubMed Scopus (126) Google Scholar ]. We present a case of atypical “vacuum” inside neoatherosclerotic pattern of restenosis after DES implantation where the OCT was used to describe this new report of neoatherosclerosis and to demonstrate probable causes of it.

Bare Metal Stents for Treatment of Extracranial Internal Carotid Artery Aneurysms

Purpose: To examine the long-term outcomes of bare metal stent placement for exclusion of extracranial internal carotid artery (ICA) aneurysms. Methods: From 2006 to 2011, 7 consecutive symptomatic patients (4 men; mean age 52 years) with surgically inaccessible extracranial ICA aneurysms were treated with a bare stent at a single center. Patients received clopidogrel for 3 months after the procedure and aspirin for life. Clinical follow-up with duplex ultrasound and/or computed tomographic angiography was performed at 3, 6, and 12 months and yearly thereafter. Results: All procedures were technically successful; no neurological complications occurred. After 6 months, there was complete thrombosis of the aneurysm in all except one case. In this asymptomatic patient, the residual active flow was successfully obliterated by additional coil embolization. Over a mean follow-up of 57±22 months, all patients were alive and free of local or central neurological symptoms. All stents were patent, and thrombosis of the aneurysms was complete. Conclusion: In this small series, treatment of extracranial ICA aneurysms with a bare stent seems technically feasible and safe. All treated extracranial ICA aneurysms were excluded by primary intervention or secondary coil embolization.

Midterm Outcomes of Covered Versus Bare-Metal Balloon-Expandable Stents for Aortoiliac Occlusive Disease

Randomized trials and registries suggest that covered balloon expandable stents have better short-term patency than bare metal (BM) balloon expandable stents in the treatment of common iliac artery disease. This study was performed to evaluate midterm outcomes of bare metal vs covered balloon expandable stents for treatment of aortoiliac (AI) occlusive disease. All AI endovascular interventions for symptomatic peripheral arterial occlusive disease performed at a single institution from 2006-2012 were reviewed. Patients that underwent stent placement in the common iliac arterial segment were included in the analysis. Demographic data, TransAtlantic Inter-Societal Classification (TASC), stent type, patency, and all reinterventions for each limb were compared. 188 procedures in 124 patients were performed for treatment of de novo distal aorta and/or common iliac artery stenosis. Bare metal balloon expandable stents were used in 135 arteries, and covered balloon expandable stents were used in 53 arteries. There was no difference in age, gender, or TASC classification between the two groups. Table I. Median follow up was 1.7 years (IQR, 0.6-3.0). There was no difference in overall primary or primary assisted patency between the two groups. Table II. Secondary patency was significantly better in the covered stent group, however, common Iliac arteries treated with covered stents were more likely at 1 year and beyond to require repeat aortoiliac intervention (HR, 2.6; 95% CI, 1.13-6.0; P = .02; Fig). TASC classification did not predict need for reintervention in either group. In the current study, covered stents have improved secondary patency over bare metal stents for treatment of AI occlusive disease, at the expense of increased reinterventions. The difference in secondary patency may be due to more focal, edge restenosis in covered stents vs diffuse restenosis in bare metal stents.Table IDemographic characteristics of treated lesionsOverallBare metalCoveredP valueAge (mean ± SD)64 ± 1164 ± 1265 ± 11.5TASC A (%)54 (45)39 (43)15 (52).57TASC B56 (30)41 (30)15 (28).99TASC C41 (22)30 (22)11 (21).98TASC D36 (19)24 (18)12 (23).58 Open table in a new tab Table IIPatency of treated lesionsn = 188OverallBare metalCoveredP valuePrimary patency (%)121 (75)86 (75)35 (74).99Primary assisted patency136 (84)93 (82)43 (91).18Secondary patency140 (87)94 (82)46 (98).02 Open table in a new tab

Comparison of covered stents versus bare metal stents for treatment of chronic atherosclerotic mesenteric arterial disease

To compare outcomes of mesenteric angioplasty and stenting using iCAST covered stents (CS; Atrium, Hudson, NH) or bare metal stents (BMS) in patients with chronic mesenteric ischemia (CMI). We reviewed the clinical data of 225 patients (65 male and 160 female; mean age, 72 ± 12 years) treated for CMI at two academic centers (2000-2010). Outcomes were analyzed in patients who had primary intervention or reintervention using BMS (n = 164 patients/197 vessels) or CS (n = 61 patients/67 vessels). End points were freedom from restenosis, symptom recurrence, reinterventions, and patency rates. Patients in both groups had similar demographics, cardiovascular risk factors, and extent of disease. In the primary intervention group (mean follow-up, 29 ± 12 months), patients treated by CS had higher freedom from restenosis (92% ± 6% vs 53% ± 4%; P = .003), symptom recurrence (92 ± 4% vs 50 ± 5%; P = .003), reintervention (91% ± 6% vs 56% ± 5%; P = .005), and better primary patency at 3 years (92% ± 6% vs 52% ± 5%; P < .003) than for BMS. In the reintervention group (mean follow-up, 24 ± 9 months), patients treated by CS had higher freedom from restenosis (89% ± 10% vs 49% ± 14%; P < .04), symptom recurrence (100% vs 64%± 9%; P = .001), and reintervention (100% vs 72% ± 9%; P = .03) at 1 year, and a trend toward improved primary patency at 1 year (100% vs 63% ± 9%; P = .054). Secondary patency rates were similar in both groups. In this nonrandomized study, CS were associated with less restenosis, recurrences, and reinterventions than BMS in patients undergoing primary interventions or reinterventions for CMI.

Abstract WMP44: A Meta-Analysis of Drug Eluting Stents vs Bare Metal Stents for Treatment of Extracranial Vertebral Artery Disease

A Meta-Analysis of Drug Eluting Stents vs. Bare Metal Stents for Treatment of Extracranial Vertebral Artery Disease Background: —Although a growing number of reports offer evidence for the potential of drug eluting stents (DES) in treating atherosclerotic stenosis of the extracranial vertebral artery, their efficacy when compared to bare metal stents (BMS) is uncertain due to the lack of a large prospective randomized trial. Methods: —A search strategy was used using the terms "stents," "drug-eluting stents," "atherosclerosis," "vertebral artery," and "vertebrobasilar insufficiency" through Medline. Five studies met the criteria for a comparative meta-analysis. The technical and clinical success, periprocedural complications, target vessel revascularization (TVR), rates of restenosis and recurrent symptoms and overall survival were compared between the DES and BMS groups using the Mantel-Haenszel method with fixed and random effect models. Results: —The mean pretreatment stenosis was 83.8±4.2% in the DES group (n = 156) and 80.12±2.7% in the BMS group (n = 148). There was no significant difference in the technical success (OR = 1.528, p = 0.622), clinical success (OR = 1.917, p = 0.274) and periprocedural complications (OR = 0.741, p = 0.614) between the two groups. The rates of technical success, clinical success and periprocedural complications were 98.78%, 95.77% and 1.94% for the DES group vs. 100%, 97.96% and 2.96% for the BMS group. There was no periprocedural mortality, stroke or TIA. The mean clinical and radiological follow-up times were 19.1±6.9 and 14.23±1.5 months respectively, for the DES arm and 26±7.6 and 20.5±3.3 months, respectively, for the BMS group. A 0.388 odds ratio of no-restenosis in the BMS to DES arms (p = 0.001) indicated a significantly higher restenosis rate in the BMS group relative to the DES group (33.57% vs. 15.49%, respectively). When compared with the DES group, the BMS group had a significantly higher rate of recurrent symptoms (2.76% vs. 11.26%; OR = 3.319, p = 0.011) and TVR (4.83% vs. 19.21%; OR = 4.099, p = 0.001). There was no significant difference between overall survival (OR = 0.655, p = 0.32). Conclusion: —A lower rate of restenosis, recurrent symptoms and target vessel revascularization was noted in the DES group.

SS14. Comparison of Covered Stents versus Bare Metal Stents for Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease

SS14. Comparison of Covered Stents versus Bare Metal Stents for Treatment of Chronic Atherosclerotic Mesenteric Arterial Disease

Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial

Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial

Paclitaxel-coated balloon in combination with bare metal stent for treatment of de novo coronary lesions: an optical coherence tomography first-in-human randomised trial, balloon first vs. stent first

To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first vs. BMS first). In a multicentre pilot trial, 26 patients with de novo coronary lesions were randomised to receive a paclitaxel-coated balloon application followed by BMS implantation (DCB first) or vice versa (BMS first). Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed post-procedure and at six months, with OCT % neointimal volume obstruction as primary endpoint. Longitudinal geographical miss was only observed in DCB first (23.1 vs. 0.0%, p=0.220). Implantation of BMS first resulted in fewer malapposed struts (p=0.013) but similar coverage at six months. No significant difference was found regarding the primary endpoint (25.5 vs. 24.9%, p=0.922), mean thickness of coverage (261 vs. 225 µm, p=0.763), late loss (0.53 vs. 0.45 mm, p=0.833), binary restenosis (27.3 vs. 16.7% in-segment, p=0.640) or clinical endpoints. Sequential application of DCB and not pre-mounted BMS for treatment of de novo coronary lesions results in efficient inhibition of neointimal hyperplasia. The sequence of application (DCB first vs. BMS first) does not seem to influence the outcome, except for better apposition in BMS first.

Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial

Percutaneous coronary intervention with bare metal stent (BMS) in chronic total coronary occlusions (CTOs) is associated with a higher rate of angiographic restenosis and reocclusion than that observed in subtotal stenoses. Preliminary reports have suggested a better performance of drug-eluting stents in CTO. In this multicentre, randomized trial, we compared the mid-term angiographic and clinical outcome of sirolimus-eluting stent (SES) or BMS implantation after successful recanalization of CTO. Patients with CTO older than 1 month, after successful recanalization, were randomized to implantation of SES (78 patients) or BMS (74 patients) in 13 Italian centres. Clopidogrel therapy was prescribed for 6 months. The primary endpoint was in-segment minimal luminal diameter (MLD) at 8-month follow-up. Secondary clinical endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) at 24 months. Patients treated with SES showed, at in-segment analysis, a larger MLD (1.98 +/- 0.57 vs. 0.98 +/- 0.80 mm, P < 0.001), a lower late luminal loss (-0.06 +/- 0.49 vs. 1.11 +/- 0.79 mm, P < 0.001), and lower restenosis (9.8 vs. 67.7%, P < 0.001) and reocclusion (0 vs. 17%, P = 0.001) rates. At 24-month follow-up, patients in the SES group experienced fewer major adverse cardiac events (50.0 vs. 17.6%, P < 0.001) mainly due to a lower rate of both TLR (44.9 vs. 8.1%, P < 0.001) and TVR (44.9 vs. 14.9%, P < 0.001). In CTO, SES is markedly superior to BMS in terms of restenosis and reocclusion rate, and incidence of repeat revascularization at 24 months. Clinicaltrials.gov identifier: NCT00220558.

Drug-Eluting Stents in Animals and Patients

Four legs good, two legs better. — —George Orwell, Animal Farm, 1945 Since the earliest use of coronary stents for treating symptomatic coronary stenosis, maintaining patent arteries after treatment has remained an elusive goal. Although the first bare metal stents opened stenotic arteries, they injured the arterial wall. The buildup of intimal scar tissue caused restenosis, a frustrating problem for prevention or treatment. After a dozen years of research, however, drug-eluting stents were developed; armed with polymer coating and paclitaxel or sirolimus, they prevented restenosis and were hailed as a major therapeutic breakthrough. Article see p 141 Not long afterward, however, questions about the safety and efficacy of drug-eluting stents surfaced as reports of late stent thrombosis began to appear.1,2 Cardiologists wondered if prevention of restenosis was always a good thing. If no protective cellular layer formed over the struts of the drug-eluting stent—even months or years after implantation—would thrombus develop on the exposed metal scaffolding or other damaged or inflamed areas on the blood vessel wall? Over months or years, would progressive inflammation or late “catchup” tissue growth cause drug-eluting stents to lose their early advantage over bare metal stents? The pendulum in this debate has swung back and forth as clinical trials first raised concern about increased thrombosis and then later quelled our fears as our understanding of how drug-eluting stents work in real life has matured. An important issue has been the increased use of stents in patients with more complex coronary and other disorders, raising the question of whether the established standards of safety and efficacy still apply. Answers for these challenging questions have come from 2 worlds: clinical studies of patients with stents …

TAXUS VI final 5-year results: a multicentre, randomised trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions

To assess the long-term safety and efficacy of the paclitaxel-eluting TAXUS moderate-release (MR) investigation-only stent for the treatment of long, complex coronary artery lesions. TAXUS VI was a prospective, double-blind, multicentre trial wherein 446 patients were randomised between a TAXUS Express MR stent and an uncoated Express Control stent. At 5-years, the overall rate of major adverse cardiac events (MACE) was similar in the two groups at 27.8% in control and 31.3% in TAXUS (P = 0.61), including similar rates for stent thrombosis. The target vessel revascularisation (TVR) rate was 23.7% in control and 22.2% in TAXUS (P = 0.45) with a non-target lesion revascularisation (non-TLR) rate of 5.1% in control and 10.9% in TAXUS (P = 0.0274) and a TLR rate of 21.4% in control and 14.6% in TAXUS (relative reduction, 32%; P = 0.0325). Furthermore, subgroup analysis revealed that the TLR benefit of TAXUS was preserved among study groups including small vessels, long lesions and patients receiving multiple overlapping stents. Treatment of complex coronary lesions with the TAXUS MR stent demonstrated similar MACE, similar TVR, and reduced TLR rates compared with control through five years. Based on these positive results, the aetiology of increased non-TLR TVR rate in TAXUS remains unclear.

Firebird and Cypher sirolimus-eluting stents and bare metal stents in treatment of very long coronary lesions

As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion (VLCL). The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion (> or = 30 mm) between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event (MACE) that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 (41 lesions) were treated with Firebird SES, 37 (39 lesions) with Cypher SES, and 37 (37 lesions) with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group (in-segment: 14.6% vs 12.8%, relative risk (RR) 1.14, P = 0.81; in-stent: 9.8% vs 10.3%, RR 0.95, P = 0.94), and significantly lower than those in the BMS group (in-segment: vs. 36.1%, RR 0.41 or 0.36, P = 0.04 or 0.03, respectively; in-stent: vs 30.6%, RR 0.32 or 0.34, P = 0.03 or 0.04, respectively). The total MACE rate up to 12 months was also similar in both SES groups (7.7% vs 5.4%, P = 1.000), and significantly lower than that in the BMS group (27.0%, P = 0.034 or 0.024, respectively). The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups (2.7% and 2.7%, respectively, P = 1.000). In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.

TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions

Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting TAXUS MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of TAXUS VI. TAXUS VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the TAXUS MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the TAXUS group (P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (TAXUS 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the TAXUS group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a TAXUS stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5. Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting TAXUS MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation.

Cause of death with bare metal and sirolimus-eluting stents

Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents. An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.