Small Vessel Stenting Research Articles

Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study

BackgroundImmediate and long-term functional outcomes after percutaneous treatment of small vessel disease (SVD) with drug-coated balloon (DCB) versus drug-eluting stent (DES) remain unknown. The study sought to investigate whether treatment of de novo SVD with DCB yields similar functional results compared with DES, as judged with angiography-based quantitative flow ratio (QFR).Methods and resultsQFR was measured at pre-procedural, post-procedural and 9-month angiography in all available subjects from the non-inferiority RESTORE SVD China trial, in which patients were randomized to Restore DCB (n = 116) or Resolute DES (n = 114) study arms. Primary outcome of this analysis was 9-month QFR. Pre-procedural, post-procedural and 9-month QFR was performed in 84.8% (195/230), 83.0% (191/230) and 93.8% (181/193) cases, respectively. At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12). Both 9-month QFR and the QFR difference between post-procedure and 9-month follow-up were correlated with angiographic percentage of diameter stenosis and late loss, and predictive of 2-year clinical outcome.ConclusionsTreatment of coronary SVD with DCB resulted in similar 9-month functional results compared with DES. This study provides evidences to the value of QFR as a mean of evaluating device performance after coronary revascularization.Clinical trial registrationURL: https://www.clinicaltrials.gov; ClinicalTrial.gov: Identifier: NCT02946307.

Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study

Percutaneous coronary intervention (PCI) in coronary artery disease (CAD) with very small vessels remains challenging. The aim of this study is to evaluate the safety and effectiveness of the 2.25-mm diameter Ultimaster sirolimus-eluting stent in the treatment of Japanese patients with CAD due to lesions in very small vessels. The CENTURY JSV study is a prospective, multicentre, single-arm study. Seventy patients with lesions deemed suitable for implantation of a 2.25-mm diameter stent were enrolled at seven hospitals in Japan. Patients underwent clinical follow-up at 1-, 9-month, 1-, and 2-year after the PCI procedure. The primary endpoint was the major adverse cardiac event (MACE), a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) free rate at 9-month following the procedure. The MACE-free rate was 97.1%, and the lower limit of the two-sided 95% confidence interval (CI) was 90.1%, which exceeded the threshold of 80% set as the performance goal. Angiographic in-stent and in-segment late loss at 9-month were 0.22 ± 0.31 and − 0.02 ± 0.34 mm, respectively. Between 9 months and 2 years, two additional TLRs occurred. Stent thrombosis, bleeding and vascular complication did not occur throughout 2 years. The 2.25-mm diameter Ultimaster® bioresorbable-polymer sirolimus-eluting stent is safe and effective for treating lesions in very small coronary arteries throughout 2 years after stent implantation.Clinical trial registration: UMIN000012928.

Impact of mean platelet aggregation degree on long-term clinical outcomes among patients undergoing a complex percutaneous coronary intervention.

The aim of this study was to evaluate the association between the mean platelet aggregation degree and long-term clinical outcomes in patients receiving a complex percutaneous coronary intervention (CPCI). We screened 2141 patients after a percutaneous coronary intervention (PCI) treated with aspirin and clopidogrel. CPCI was defined as a procedure targeted to at least one of the following: left main disease, bifurcation lesion, ostial lesion, chronic total occlusion, and small-vessel stenting. ADP-induced platelet aggregation was serially measured by light transmission aggregometry at least three times after PCI and the mean value was calculated. The population was categorized on the basis of the mean ADP degree and the presence of CPCI. The primary endpoint measured was a major adverse cardiovascular and cerebral event (MACCE). A total of 1245 patients enrolled in the study were divided into four groups: group A (CPCI and ADP≥40%), group B (CPCI and ADP<40%), group C (non-CPCI and ADP≥40%), and group D (non-CPCI and ADP<40%). The median follow-up was 29.9 months. The Cox multivariate analysis suggested that group A was an independent risk factor for MACCE (hazard ratio: 2.70, 95% confidence interval: 1.25-5.81; P<0.001). Compared with group A, the remaining groups (groups B, C, and D) had a lower rate of MACCE. When group C was set as the reference, groups B and D had similar risks for primary endpoints. Patients undergoing CPCI with a high mean ADP degree are at a high risk for MACCE. Serial platelet function testing is therefore important in patients receiving CPCI.

Preliminary Experience with Stent-Assisted Coiling of Aneurysms Arising from Small (

The Low-Profile Visualized Intraluminal Support (LVIS) stent is a new device recently introduced for the treatment of wide-neck intracranial aneurysms. This single-center study presents the authors' preliminary experience using the LVIS stent to treat saccular aneurysms with parent arteries smaller than 2.5 mm. Aneurysms with a LVIS stent used in a small parent vessel (<2.5 mm in diameter) between October 2014 and April 2016 were included. Procedure-related complications, angiographic results, clinical outcomes, and midterm follow-up data were analyzed retrospectively. A total of 22 patients was studied, including 5 ruptured and 17 unruptured aneurysms. Most of the aneurysms were located in the anterior circulation (90.9%). Stent placement in the parent arteries measuring 1.7-2.4 mm in diameter (mean, 2.1 mm) was successful in 100% of cases. Procedure-related complication developed in 1 patient (4.5%) who presented with aneurysm rupture. No permanent morbidity and mortality occurred. Immediate angiographic outcome showed complete occlusion in 8 aneurysms (36.4%), neck residual in 8 (36.4%), and residual aneurysm in 6 (27.3%). All patients underwent angiographic follow-up at a mean of 8.3 months, which revealed complete occlusion in 18 (81.8%) patients, neck remnant in 3 (13.6%), and residual sac in 1 (4.5%). No recanalization of the target aneurysm was observed. There was 1 case with asymptomatic in-stent stenosis. Our preliminary results show that the deployment of LVIS stents in small vessels is feasible, safe, and effective in the midterm. Larger studies with long-term follow-up are needed to validate our promising results.

Relationship between the Level of Circulating CD45+ Platelets and Development of Restenosis after Implantation of Drug-Eluting Stents to Patients with Coronary Heart Disease.

The study was carried out in 126 patients with stable angina pectoris, who underwent elective coronary artery stenting with drug-eluting stents and follow-up angiography within 6-12 months thereafter. Five significant risk factors of restenosis were identified by binary comparisons of different variables. The logistic regression equation that included the level of CD45-positive platelets, diabetes, small vessel stenting, number of simultaneously implanted stents in one patient, and lesion length demonstrates the highest level of prediction of in-stent restenosis (OR=22.8; p<0.001). ROC-analysis demonstrated high prognostic value of the logit model (area under ROC curve 0.87, p<0.001). The data suggest that a close relationship exists between the development of restenosis and the level of circulating CD45+ platelets.

TCT-581 Impact of Vessel Size on Clinical Outcomes of Revascularization With Biolimus A9TM-Eluting Stent in Patients with Acute Coronary Syndrome

Stenting of small vessels might be associated with higher rates of adverse events. The relationship between stent strut thickness and adverse clinical events remains particularly evident in smaller vessels. Recently published trial showed biolimus A9-eluting stent (BES) was non-inferior with

Long-term clinical outcomes of drug-eluting stents in diabetic patients with small vessels compared to larger vessel—7years clinical follow-up

The aim of this study was to analyze the effectiveness of drug-eluting stents (DES) in small vessels in patients with non-insulin-dependent (NIDDM) and insulin-dependent diabetes mellitus (IDDM). Several randomized trials have shown DES to significantly reduce the angiographic and clinical events in diabetic patients. However, there is insufficient data on similar outcomes in diabetics with small vessels. We studied 258 consecutive diabetic patients (173 NIDDM and 85 IDDM) who underwent coronary stenting with DES, divided into 2 cohorts: group A (vessels<2.7mm): 163 patients, and group B (vessels≥2.7mm): 95 patients. We analyzed the major adverse cardiac events (MACE) [death, nonfatal myocardial infarction MI, and target lesion revascularization (TVR)] over a mean follow-up of 78.4±14.8months. Group A patients had: smaller reference diameter (2.4±0.31 versus 3.14±0.2mm, p=0.0001), longer lesions (19.3±9.5 versus 16.7±7.1mm, p=0.023), more complex lesions: (B2/C) (80.7 versus 52.6%, p<0.033), bifurcation lesions (25.8 versus 11.6%, p=0.007), diffuse disease (42.9 versus 26.3%, p=0.008), multivessel (32.5 versus 18.9%, p=0.019), eccentric lesions (57.1 versus 43.2%, p=0.031), more stents implanted (1.99±1.6 versus 1.7±1.3, p<0.0001), more overlapping stents (29.4 versus 13.7%, p=0.004) and more stents length (25.7±4.9 versus 20.2±2.6, p<0.003). During the follow-up, both groups had overall similar MACE (10.4 versus 11.7%, p=0.9) with insignificant higher restenosis (9.2 versus 8.4%, p=0.832) and TVR (7.4 versus 6.4%, p=0.75) in group A. There was no difference in death (p=0.111) or MI (p=0.858). Both groups had similar stent thrombosis rate (1.2 versus 1.1%, p=0.899), angina events (10.4 versus 16.8%, p=0.137), abnormal stress thallium (14.1 versus 14.7%, p=0.890), and hospital days (2.91 versus 3.57, p=0.886). Despite complex angiographic characteristics, the use of DES in diabetic patients with small vessels showed favorable clinical outcomes and similar low TVR compared to those with large vessels.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study

Background/objectivesA prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. MethodsA total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. ResultsTwo-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6months, 1year and 2years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). ConclusionsOur results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Performance of the resolute zotarolimus‐eluting stent in small vessels

Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute zotarolimus-eluting stent (R-ZES) in small vessels was examined. Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.

Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions

BackgroundThis prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions...

Diff use coronary disease: short- and long-term outcome after percutaneous coronary intervention

Aim The aim of this study was to evaluate short- and long-term results of PCI (percutaneous coronary intervention) in patients with small vessel coronary artery disease and the prognostic impact of the extension and the length of coronary lesions.Methods and results All consecutive patients treated with PCI in our centre between July 2002 and December 2004 were included and divided into two groups according to the diameter of the implanted stents: small vessel disease was defi ned as requiring implantation of stents ≤ 2.75 mm in diameter. The primary end point was the long-term incidence of major adverse cardiac events (MACE), the composite of cardiac mortality, nonfatal myocardial reinfarction, and repeated percutaneous target vessel revascularization (re-PTCA TVR). 1599 patients were treated by PCI: 419 (26.2%) were implanted with 2.75 mm or smaller stents. At both 1 and 36 months as well as at 53 ± 20 months of follow-up small vessel stenting was associated with a higher rate of MACE (4.2% vs 2.1%, P= 0.028; 20.3% vs 17.9%, P< 0.001; 27.5% vs 22.4%, P= 0.04, respectively). Multivariate analysis showed higher rates of revascularization for patients with small vessel disease regardless of lesion length. Rates of death were higher in patients with small vessels and long lesions.Conclusion Atherosclerotic involvement of small vessels in patients with CAD confers a higher short- and long-term risk of adverse outcome after PCI.

A randomized multicentre study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: The BELLO (Balloon Elution and Late Loss Optimization) study

Objectives: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel eluting stents (PES) for the reduction of restenosis in small vessels. Background: DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de-novo disease. Methods: BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicentre trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary end-points were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. Results: Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter<2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference −0.21; 95% CI: −0.34 to −0.09; p noninferiority < 0.001; p superiority = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (8.9% vs. 14.1%; p = 0.25), target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (7.8% vs. 13.2%; p = 0.77). Conclusions: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES.

CRT-47 Two-Year Outcomes Following Platinum Chromium Everolimus-Eluting Stent Implantation in Small Vessel Lesions in Japan

Small vessel diameter is associated with increased restenosis rates and adverse outcomes following coronary stenting. The PLATINUM Japan Small Vessel multicenter study specifically assessed small vessel stenting in Japanese patients treated with the PROMUS Element everolimus-eluting stent (Boston

A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels: The BELLO (Balloon Elution and Late Loss Optimization) Study

The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

OUTCOMES AFTER REVASCULARIZATION WITH EVEROLIMUS AND SIROLIMUS ELUTING STENTS IN PATIENTS WITH SMALL AND LARGE CORONARY ARTERIES. A SUBSTUDY OF THE SORT OUT IV TRIAL

Randomized trials comparing outcomes after implantation of first generation drug-eluting stents (DES) versus second generation DES in small coronary arteries are limited. Stenting of small vessels might be associated with higher rates of adverse events. In a substudy of the SORT OUT IV trial, we

Safety and efficacy of the XIENCE V everolimus-eluting stent compared to the resolute zotarolimus-eluting stent in small vessels

BackgroundThe second generation drug-eluting stents have been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularisation, but its performance in small coronary arteries has not been investigated.ObjectivesTo evaluate...

Performance of Everolimus-Eluting versus Paclitaxel-Eluting Coronary Stents in Small Vessels: Results from the SPIRIT III and SPIRIT IV Clinical Trials

Higher rates of adverse cardiac events have been observed in patients with small vessel disease. Therefore, we compared an everolimus-eluting stent (EES) to a paclitaxel-eluting stent (PES) for treatment of small (reference vessel diameter: RVD <2.5 mm) and larger vessels (≥2.5 mm) in a pooled analysis from the SPIRIT III (n = 1,002) and SPIRIT IV (n = 3,687) trials (randomized 2:1, EES vs. PES). Data of 4,689 total patients were pooled for a patient level analysis. Lesion length, RVD, and percent diabetics were matched between stent types. EES versus PES performance was evaluated at 1 year in patients with small (n = 1,019) and larger vessels (n = 2,586) who had a single lesion treated. Mean RVD assessed by quantitative coronary angiography in patients with small vessels was 2.24 ± 0.19 and 2.25 ± 0.20 mm in the EES and PES groups, respectively. At 1 year, EES compared to PES in small vessel patients significantly reduced major adverse cardiac events (4.5% vs. 7.9%, P = 0.04), target lesion failure (4.4% vs. 7.9%, P = 0.03), target lesion revascularization (2.4% vs. 5.5%, P = 0.02), and stent thrombosis (0.2% vs. 1.2%, P = 0.04). Relative benefits of EES versus PES were comparable in small and larger vessels (P interaction > 0.05), although the absolute benefits were greater in patients with small vessel disease. In high-risk patients requiring percutaneous coronary intervention in small coronary arteries, EES results in significantly improved 1-year rates of event-free survival compared to PES, with evidence present for both enhanced safety and efficacy.

Sex difference in long-term clinical outcome after sirolimus-eluting stent implantation

Coronary stenting in women has been associated with worse results in terms of morbidity, mortality, and restenosis rate in the bare-metal stent era, possibly due to higher risk profile and smaller coronary vessels. Although drug-eluting stents have equalized clinical results, no data are available on long-term outcomes between sexes. To evaluate the role of sex in acute, mid-term, and long-term clinical outcome after sirolimus-eluting stent (SES) implantation. We retrospectively evaluated 1186 patients, 970 (81.8%) male and 216 (18.2%) female, treated with SES implantation between April 2002 and December 2005. Women were older (P=0.049), more likely to have hypertension (43.5 vs. 33.7%, P=0.006), single-vessel disease (63.9 vs. 42.5%, P=0.03), and unstable angina (16.6% vs. 9.2%, P=0.001) and more frequently received small (≤ 2.75 mm) vessel stenting (39.3 vs. 28.2%, P=0.001). The two groups were similar for lesion and procedural characteristics. Overall, the stent thrombosis rate was 0.4% (0.5% in women vs. 0.3% in men, P=not significant). At 6-month follow-up, no significant difference in major adverse cardiac event was observed. Long-term follow-up (median time 33.2 months), available in 180 (83.3%) women and 720 (75%) men, showed higher angina recurrence rate (17.7 vs. 11%, P=0.013), percutaneous coronary re-intervention (16.1 vs. 8.7%, P=0.001) and target vessel revascularization (3.9 vs. 0.9%, P=0.001) in women compared with men. Late stent thrombosis, need for coronary artery bypass grafting, and mortality were similar in both groups. No sex difference was observed in acute and 6-month outcome after SES implantation despite older age, more unstable clinical presentation, and more frequent small vessel stenting in women. However, long-term clinical follow-up (up to 5 years) in women showed higher symptom recurrence and target vessel revascularization rate but no difference in overall major adverse cardiac events.

Drug-eluting stents perform better than bare metal stents in small coronary vessels: A meta-analysis of randomised and observational clinical studies with mid-term follow up

BackgroundWe tested drug-eluting stent (DES) and bare metal stent (BMS) performance in small coronary vessels by means of meta-analysis of all available clinical studies. MethodsThe analysis included randomised controlled trials (RCT), subgroups of RCT and observational studies with a follow-up of at least six months comparing the use of DES and BMS during percutaneous interventions involving small coronary arteries (diameter<3mm). The primary endpoint was target vessel failure (TVF); the others were pooled and isolated major adverse cardiovascular events (MACE), stent thrombosis (ST), binary restenosis and late lumen loss at the longest available follow-up. The effect of treatment was evaluated in terms of odds ratios (OR) and 95% confidence intervals (95% CI) for binary variables, and mean difference (MD)±standard deviation (SD) for continuous variables. Fixed- or random-effect models were used depending on the statistical heterogeneity of studies. The analyses of major endpoints were stratified by study type, length of follow-up, and type of DES. ResultsWe pooled 12 studies involving 3182 patients. Trial heterogeneity was a minor issue. TVF (OR: 0.35; CI: 0.24–0.51), MACE (OR: 0.36; CI: 0.29–0.45), binary restenosis (OR: 0.15; CI: 0.12–0.20) and late lumen loss (MD: −0.46; SD: −0.55 to −0.38) all significantly improved with DES treatment; ST (OR: 0.63; CI: 0.34–1.17) was not statistically different between studies. ConclusionsDES are superior to BMS in terms of their efficacy in managing small coronary arteries (diameter<3mm), and at least equivalent in terms of safety. The use of DES should be considered the treatment of choice in this setting.

A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial

Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.