Paclitaxel-eluting Coronary Stent Research Articles

Numerical analysis of paclitaxel-eluting coronary stents: Mechanics and drug release properties

Since theoretical models provide data that cannot be otherwise gathered, numerical methods applied to medical devices analysis have emerged as fundamental tool in preclinical development. Large efforts were done to study mechanical and drug-eluting properties in stents but often the coating modelling is neglected. This work presents a finite element framework to calculate mechanical loads and drug distribution in three commercial drug-eluting stents (Palmaz-Schatz, Palmaz Genesis and Multi Link Vision), to check coatings strength and drug distribution maps in biological tissues. The promising copolymer poly(methylmethacrylate-co-n-butylmethacrylate), loaded with paclitaxel, is analyzed. Results demonstrated that the coating undergoes localized plastic phenomena, and calculated stresses are lower than the ultimate stress, ensuring coating integrity. Computed drug concentration depends on stent geometry and its values are in all cases lower than the toxicity level for this drug.

Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial).

AimsTo describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs).Methods and ResultsA randomised controlled trial was performed in four hospitals in three European countries between December 2011 and December 2013. Patients with de novo lesions (>50% stenosis) in an SVG with a diameter between 2.5–6 mm were included. Primary endpoint was late lumen loss at 6 months. Secondary endpoints included procedural success and the occurrence of major adverse cardiac events (MACE) at 12 months. A total of 57 patients were randomised to STENTYS self-apposing BMS (n = 27) or PES (n = 30). Procedural success was obtained in 89.5%. No significant differences in late lumen loss were found between BMS and PES at 6 months (0.53 mm vs 0.47; p = 0.86). MACE rates at 12 months were comparable in both groups (BMS 22.2% vs. PES 26.7%; p = 0.70).ConclusionsTreatment of SVGs with STENTYS self-expandable stents is safe and effective. No significant differences were found in late lumen loss and MACE between BMS and PES.

Efficacy and safety of limus-eluting versus paclitaxel-eluting coronary artery stents in patients with diabetes mellitus: A meta-analysis

Background/objectivesThe relative efficacy and safety of limus-eluting stent (LES) versus paclitaxel-eluting stent (PES) in DM patients remain unclear. MethodsThe PubMed, EMBASE, and Cochrane Central Register of Controlled Trials electronic databases were searched from January 2001 to December 2013. Clinical trials that performed head-to-head comparisons of LES versus PES implantation in patients with DM were considered for inclusion. ResultsThis meta-analysis included 28 clinical trials involving 23,678 patients: 9953 who underwent sirolimus-eluting stent (SES) implantation, 4209 underwent everolimus-eluting stent (EES) or zotarolimus-eluting stent (ZES) implantation, and 9516 underwent PES implantation. The short-term target lesion revascularization (TLR) rate was significantly lower after SES implantation than after PES implantation (3.6% vs 6.3%; odds ratio (OR): 0.659; P=0.014), but there were no significant differences in the rates of target vessel revascularization (TVR), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality, or major adverse cardiac events (MACE). There were no differences in the longer-term rates of TLR, TVR, ST, MI, all-cause mortality, or MACE between SES versus PES. Second-generation LES (EES or ZES) implantation resulted in lower rates of ST (2.1% vs 3.3%; OR: 0.586; P<0.001), MI (2.3% vs 4.1%; OR: 0.527; P=0.001), and MACE (8.0% vs 10.3%; OR: 0.796; P=0.007) than PES implantation. ConclusionsIn patients with DM, short- and longer-term MACE rates were similar after first-generation LES and PES implantation. The second-generation LES may be better than PES implantation in rates of ST, MI, and MACE.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

Late-Breaking Clinical Trial Abstracts

### Late-Breaking Clinical Trials: Risk and Benefit of Dual Antiplatelet Therapy #### Increased Risk of Ischemic Events Upon Discontinuation of Prasugrel After 12 or 30 Months of Therapy Following Placement of the Taxus Liberte Paclitaxel-Eluting Coronary Stent Kirk N Garratt1, Ronald D Jenkins2, Thomas K Pow3, W. Douglas Weaver4, Laura Mauri5, De J Kereiakes6, Kenneth J Winters7, Thomas Christen8, Dominic J Allocco8, David P Lee9; 1Cardiac Interventions, Lenox Hill Heart and Vascular Institute, New York, NY; 2Cardiac Interventions, Heart Clinics Northwest, Coeur d'Alene, ID; 3Cardiac Interventions, Great Lakes Heart Institute, St Joseph, MI; 4Cardiology, Henry Ford Hosp, Detroit, MI; 5Div of Cardiovascular Medicine, Brigham and Women's Hosp, Boston, MA; 6Cardiology, The Christ Hosp Heart and Vascular Cntr/The Lindner Rsch Cntr, Cincinnati, OH; 7Lilly Rsch Laboratories, Eli Lily and Company, Indianapolis, IN; 8Clinical Sciences, Boston Scientific, Marlborough, MA; 9Cardiovascular Medicine Clinic, Standford, Stanford, CA Introduction : The TAXUS Liberte Post-approval Study (TL-PAS) studied long-term clinical outcomes for the TL stent in conjunction with the use of prasugrel and aspirin. A portion of patients from TL-PAS contributed to the Dual Anti-Platelet Therapy (DAPT) trial. Methods : Eligible and consecutive patients in the United States treated with TL stents were enrolled into TL-PAS (N=4199). Those meeting inclusion and exclusion criteria were recruited for participation in the DAPT trial (N=3904). Patients received open-label prasugrel plus aspirin for 12 months after stent placement. At 12 months, patients without ischemic or bleeding events continued aspirin therapy and were randomized 1:1 to continued blinded treatment with either prasugrel or placebo for an additional 18 months (N=2202). At 30 months, study drugs were discontinued, and aspirin was continued through at least 33 months after stent placement. Events were adjudicated by a clinical events committee and monitored by the TL-PAS Data Monitoring Committee (DMC). Results : Nearly 3 years following randomization, the DMC noted a significant increase …

Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberté paclitaxel-eluting coronary stent placement.

The TAXUS Liberté Post Approval Study (TL-PAS) contributed patients treated with TAXUS Liberté paclitaxel-eluting stent and prasugrel to the Dual Antiplatelet Therapy Study (DAPT) that compared 12 and 30 months thienopyridine plus aspirin therapy after drug-eluting stents. Outcomes for 2191 TL-PAS patients enrolled into DAPT were assessed. The DAPT coprimary composite end point (death, myocardial infarction [MI], or stroke) was lower with 30 compared with 12 months prasugrel treatment (3.7% versus 8.8%; hazard ratio [HR], 0.407; P<0.001). Rates of death and stroke were similar between groups, but MI was significantly reduced with prolonged prasugrel treatment (1.9% versus 7.1%; HR, 0.255; P<0.001). The DAPT coprimary end point, stent thrombosis, was also lower with longer therapy (0.2% versus 2.9%; HR, 0.063; P<0.001). MI related to stent thrombosis (0% versus 2.6%; P<0.001) and occurring spontaneously (1.9% versus 4.5%; HR, 0.407; P=0.007) were both reduced with prolonged prasugrel. MI rates increased within 90 days of prasugrel cessation after both 12 and 30 months treatment. Composite Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) moderate or severe bleeds were modestly increased (2.4% versus 1.7%; HR, 1.438; P=0.234) but severe bleeds were not more frequent (0.3% versus 0.5%; HR, 0.549; P=0.471) in the prolonged treatment group. Prasugrel and aspirin continued for 30 months reduced ischemic events for the TAXUS Liberté paclitaxel-eluting stent patient subset from DAPT through reductions in MI and stent thrombosis. Withdrawal of prasugrel was followed by an increase in MI after both 12 and 30 months therapy. The optimal duration of dual antiplatelet therapy with prasugrel after TAXUS Liberté paclitaxel-eluting stent remains unknown, but appears to be >30 months. http://www.clinicaltrials.gov. Unique identifier: NCT00997503.

TCT-589 Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in diabetic patients: 5 year follow up from the COMPARE I trial

Long-term comparison data of the current generation everolimus-eluting stent (Xience™ V; EES) with the first generation paclitaxel-eluting stent (Taxus™ Liberte; PES) in an all-comers diabetic cohort undergoing percutaneous coronary intervention (PCI) are scarce. Initial results at 2 year

TCT-26 Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing primary percutaneous coronary intervention: 5 year follow-up from the COMPARE I trial

TCT-26 Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing primary percutaneous coronary intervention: 5 year follow-up from the COMPARE I trial

Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents

Objective. Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late-occurring increase in event rates. Therefore, the long-term outcome follow-up is of major clinical interest. Design. In total, 2.098 unselected patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years. Results. The primary end-point; the composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE), occurred in 467 patients (22.3%); Cypher™ n = 222 (20.8%), Taxus™ n = 245 (23.7%), ns. Definite and probable stent thrombosis occurred in 107 patients (5.1%); Cypher™ n = 51 (4.8%), Taxus™ n = 56 (5.4%), ns. No statistically significant differences were found in the elements of the primary end-point or in other secondary end-points between the two stent groups. After one year, the annual rates of stent thrombosis and MACE remained constant. Conclusions. During 5-year follow-up, the Cypher™ and the Taxus™ coronary stents had similar clinical outcome with no signs of increasing rates of adverse events over time.

Abstract T P97: A Swine Model of Restenosis after Intracranial Stent Deployment

Purpose: Although various types of stents have been used to treat symptomatic intracranial stenosis, how stents interact with atherosclerotic plaques has not been evaluated. In this study, we demonstrate the utility of a swine carotid atherosclerotic model for the preclinical evaluation of intracranial stenting therapies. Methods: Advanced atherosclerotic plaques were induced in 28 carotid arteries of 14 Chinese miniswines using partial ligation and high cholesterol diet to create &gt;70% stenosis. The plaques were characterized with three-dimensional rotational angiography, Doppler ultrasonography, MR scan and 18F-FDG PET/CT scans at three months and correlated with histopathological examination in 20 carotid arteries. Five Wingspan stents and one Paclitaxel-eluting balloon-mounted coronary stent were implanted into six diseased vessels. Two contralateral carotid arteries were used as controls. Dual-antiplatelet regimen with clopidogrel and aspirin was administrated 1 day prior to stenting and continued for 1 month. Stent and plaque interaction was evaluated with angiography, MR scan and 18F-FDG PET/CT scans at one month after stenting. Results: The diameter of proximal and distal segments of carotid arteries were 3.6±0.1 mm and 3.8±0.1 mm at post-ligation, and 3.6±0.1 mm and 3.7±0.1 mm at 3 months, respectively, similar to that of middle cerebral arteries in human (2.7-4.9 mm, average 3.7mm). Doppler waveforms showed features of low resistant vessels. Plaque rupture and distal embolism were observed, mimicking the mechanisms of stroke in human intracranial atherosclerosis. All stents were patent at one month but 25% restenosis was observed. Wingspan stents expanded beyond the arterial lumen whereas the coronary stent stayed in the intima. Conclusion: This swine model is suitable for the testing of devices for the endovascular treatment of intracranial atherosclerosis. It can be a useful tool for the study of mechanisms of in-stent restenosis.

A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus‐ vs. Paclitaxel‐eluting stents in de novo occlusive lesions in coronary arteries: Five‐year results from the ZOMAXX I trial

The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years. In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28). After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

The “Final” 5-Year Follow-Up From the ENDEAVOR IV Trial Comparing a Zotarolimus-Eluting Stent With a Paclitaxel-Eluting Stent

This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Evaluation of XIENCE V Everolimus-Eluting and Taxus Express2 Paclitaxel-Eluting Coronary Stents in Patients With Jailed Side Branches From the SPIRIT IV Trial at 2 Years

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p= 0.001), major adverse cardiac events (6.6% vs 12.2%, p= 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p= 0.004), and stent thrombosis (0.6% vs 2.8%, p= 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial.

Circulation: Cardiovascular Interventions Editors’ Picks

<i>Circulation: Cardiovascular Interventions</i> Editors’ Picks

Racial Differences in Long‐Term Outcomes after Percutaneous Coronary Intervention with Paclitaxel‐Eluting Coronary Stents

To assess the influence of race on long-term outcomes following percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES). Data on the influence of race on long-term outcomes following PCI with drug-eluting stents are limited because of severe underrepresentation of minority populations in randomized trials. We compared 5-year outcomes of 2,301 whites, 127 blacks, and 169 Asians treated with PES in the TAXUS IV, V, and ATLAS trials. Outcomes were adjusted using a propensity score logistic regression model with 1:4 matching. Blacks were more likely than whites to be female, have a history of hypertension, diabetes mellitus, congestive heart failure, and stroke, but were less likely to have prior coronary artery disease. Compared with whites, Asians were younger, more likely to be male, have stable angina, and left anterior descending disease, and less likely to have silent ischemia, previous coronary artery bypass surgery, prior coronary artery disease, diabetes mellitus, peripheral vascular disease, and to receive glycoprotein IIb/IIIa inhibitors. Despite higher antiplatelet compliance, the adjusted 5-year rates of myocardial infarction (15.4% vs. 5.4%, P < 0.001) and stent thrombosis (5.6% vs. 1.1%, P = 0.002) were higher in blacks than whites. Despite lower antiplatelet compliance, Asians had no differences in myocardial infarction and stent thrombosis compared with whites. Mortality and revascularization rates were similar between the three groups. The long-term risk of major thrombotic events after PCI with PES was higher in blacks, but not Asians, compared with whites. The mechanisms underlying these racial differences warrant further investigation.

Periprocedural Myocardial Infarction in a Randomized Trial of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents

A consensus definition for periprocedural myocardial infarction (MI) in coronary stent trials has not been established. Differences between a historic definition, based on modified World Health Organization (WHO) criteria, and a proposed universal definition have not been compared in a prospective clinical trial. We randomly assigned 3687 patients with stable coronary artery disease to undergo stenting with either everolimus-eluting stents (2458 patients) or paclitaxel-eluting stents (1229 patients). Serial creatine kinase (CK) and CKMB or troponin measurements were obtained before and after stenting. MI was classified by protocol according to the WHO definition (total CK >2× normal with elevated CKMB) and post hoc according to the Universal/Academic Research Consortium (ARC) definition (CKMB or troponin >3× normal). Protocol MI was determined in 58 (1.6%) and universal/ARC MI in 287 (7.8%) patients within 48 hours post index procedure. There were substantial differences in frequency of universal/ARC MI if only CKMB (5.4%) or troponin (18.7%) data were included for evaluation. Total stent length was a strong predictor of both protocol and universal/ARC MI. Mortality at 2 years was low (2.3%) and was not different for either MI definition. The mortality rates did not increase with elevations of CKMB or troponin to >10× normal. There was a marked difference in periprocedural MI rates according to protocol or universal/ARC MI definitions. No association was present between periprocedural MI and mortality up to 2 years by either definition. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00307047.

Predictors of early and late outcomes after everolimus and paclitaxel-eluting coronary stents

To evaluate whether the improved outcomes with newer generation drug-eluting stents (DES) utilising thin-strut stents are consistent among different patient and angiographic subgroups. Clinical outcomes over three years were collected in the SPIRIT III trial comparing the XIENCE V® everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, CA, USA) to the TAXUS® paclitaxel-eluting stents (PES) (Boston Scientific, Natick, MA, USA). Potential predictors of adverse clinical outcomes were assessed using demographic, clinical, and procedural variables by logistic and Cox regression analyses. For three-year target vessel failure, the independent predictors identified by Cox regression were number of vessels treated (HR=2.19 [1.50, 3.19], p<0.0001), HbA1c (%) (HR=1.17 [1.05, 1.29], p=0.004), total cholesterol (>200 mg/dl) (HR=1.63 [1.13, 2.36], p=0.009), and female gender (HR=1.42 [1.01, 2.01], p=0.05). Logistic regression analysis identified the same predictors except for the female gender. The clinical results with EES compared to PES were consistent among the multiple subgroups examined with the possible exception of patients with diabetes. Clinical factors and stent type were the most important multivariable predictors of adverse clinical outcomes in this contemporary trial of first versus second generation DES. The benefit of the EES compared to the PES was consistent across a wide range of patient and angiographic subgroups with the possible exception of patients with diabetes.

Drug-eluting Stents at a Crossroads: the good, the Bad and the Ugly

Drug-eluting Stents at a Crossroads: the good, the Bad and the Ugly

TAXUS®Element™ stent system

The TAXUS® Element™ stent system is the latest paclitaxel-eluting coronary stent by Boston Scientific. It uses a novel platinum–chromium alloy that enables low strut thickness, while maintaining high radial strength and radio-opacity. This new alloy has been coated with the established drug–polymer combination used in previous generations of TAXUS stents. This drug–polymer matrix has been extensively studied and has been shown to possess excellent efficacy compared with bare-metal stents. Subgroup analyses have demonstrated the TAXUS stent to be particularly efficacious in patients with diabetes. The new TAXUS Element stent has been further enhanced by a new low-profile stent delivery system, based on the Apex™ balloon catheter. This has been incorporated to improve deliverability, flexibility and pushability. The TAXUS Element has been carefully studied in a large randomized controlled trial that found it to be non-inferior to the previous generation TAXUS Express® stent in terms of both efficacy and safety.

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.