Promus Element Stent Research Articles

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.

Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography.

Stent failure is more likely in the lipid rich and thrombus laden culprit lesions underlying ST-segment elevation myocardial infarction (STEMI). This study assessed the effectiveness of post-dilatation in primary percutaneous coronary intervention (pPCI) for acute STEMI. The multi-center POST-STEMI trial enrolled 41 consecutive STEMI patients with symptom onset <12 hours undergoing manual thrombus aspiration and Promus Element stent implantation. Patients were randomly assigned to control group (n=20) or post-dilatation group (n=21) in which a non-compliant balloon was inflated to >16 atm pressure. Strut apposition and coverage were evaluated by optical coherence tomography (OCT) after intracoronary verapamil administration via thrombus aspiration catheter, post pPCI and at 7-month follow-up. The primary endpoint was rate of incomplete strut apposition (ISA) at 7 months after pPCI. There were similar baseline characteristics except for stent length (21.9 [SD 6.5] mm vs. 26.0 [SD 5.8] mm, respectively, P=0.03). In post-dilatation vs. control group, ISA rate was lower (2.5% vs. 4.5%, P=0.04) immediately after pPCI without affecting final TIMI flow 3 rate (95.2% vs. 95.0%, P>0.05) or corrected TIMI frame counts (22.6±9.4 vs. 22.0±9.7, P>0.05); and at 7-month follow-up (0.7% vs. 1.8%, P<0.0001), the primary study endpoint, with similar strut coverage (98.5% vs. 98.4%, P=0.63) and 1-year rate of major adverse cardiovascular events (MACE). In STEMI patients, post-dilatation after stent implantation and thrombus aspiration improved strut apposition up to 7 months without affecting coronary blood flow or 1-year MACE rate. Larger and longer term studies are warranted to further assess safety (ClinicalTrials.gov identifier: NCT02121223).

Case Report: Case of Coronary Stent Longitudinal Deformation

AbstractThe foreshortening of a stent also known as longitudinal stent deformation (LSD) is a potential complication of present generation drug-eluting stents (DES) that had thin struts design, and it was most commonly reported in the everolimus-eluting Promus Element stent. However, there are limited reports of migration and dislodgement of a DES shortly after its deployment. So, we describe a case of a DES foreshortening 1 and half months after its deployment. While performing complex interventions, careful handling and gentle manipulation of procedure-related devices and use of imaging modalities such as optical coherence tomography, intravascular ultrasound, and adjunctive balloons for complete lesion cover and optimal stent apposition may significantly reduce the occurrence of LSD and related complications.

Clinical outcomes in unselected patients treated with the PROMUS Element platinum-chromium, everolimus-eluting stent: Final five-year results from the PE PROVE Study.

The goal of this analysis was to evaluate the final 5-year safety and effectiveness of the PROMUS Element platinum-chromium everolimus-eluting stent in unselected patients treated in routine clinical practice. The prospective, open-label PROMUS Element™ European Post-Approval Surveillance Study (PE-PROVE) enrolled 1,010 "real-world" patients who received the PROMUS Element stent. Adverse event rates were low at 1-year, and the incidence of stent thrombosis was 0.6%. The primary endpoint was target vessel failure (TVF; overall and PE stent-related), a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target vessel revascularization (TVR) at 1-year post-implantation. Five-year clinical outcomes were evaluated in overall as well as high-risk patient subgroups. The overall 5-year TVF rate was 14.9%, with 7.0% being related to the study stent. Cardiac death, MI and TVR related to the study stent occurred in 0.5%, 3.2%, and 5.7%, respectively. Stent thrombosis through 5-year follow-up was 1.0%. The rates of overall and study stent related TVF were numerically higher in patients with medically treated diabetes, long lesions (≥28 mm), and small diameter vessels (≤2.5 mm) compared to the overall study population. Additionally, favorable stent thrombosis rates through 5 years were reported for the PROMUS Element stent in these high-risk subgroups. The final 5-year data from the PE-PROVE study demonstrate favorable outcomes and low rates of adverse events with the PE stent when used in "real-world" patients with coronary artery disease.

Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial

ObjectivesThe authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102). BackgroundIn the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention. MethodsPatients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. ResultsIn the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions. ConclusionsPtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434)

Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents: a propensity-matched analysis.

The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort. Patients from the REMEDEE registry (COMBO, n=1,000) were matched with patients from the DUTCH PEERS trial (PROMUS Element/Resolute Integrity, n=1,811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79). In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

Longitudinal deformation bench testing using a coronary artery model: a new standard?

ObjectivesTo compare susceptibility of five different stent platforms with longitudinal stent deformation (LSD) using a clinically relevant bench testing model simulating both short and long malapposed lengths.BackgroundRecent data suggest that...

Clinical and angiographic outcomes of axial stent deformations in unrestricted real world patient population.

Prior reports have suggested that the design of the Promus Element stent is prone to longitudinal stent deformation (LSD). However, little is known about the clinical and angiographic outcomes of Promus Element stent axial deformations when implanted in unrestricted coronary lesions. Two independent reviewers retrospectively evaluated the procedure steps of 961 Promus Element stent (833 de novo lesions in 494 consecutive patients) implanted in unrestricted coronary lesions, between February 2012 and March 2013, and compared the prevalence, predictors, and the mid-term clinical and angiographic outcomes between lesions with and without stent deformation. Fifteen stents (1.56%) with LSD were observed (95% confidence interval [CI]: 0.78-2.34%). The proximal edge of the stent was deformed in 13 stents (86.6%). Ostial stenting (Adjusted Odds ratio [OR]: 9; 95%CI: 2.27-33.3; P = 0.002), and bifurcation lesions (Adjusted OR: 3; 95%CI: 1.03-8.8; P = 0.04) were independently associated with the occurrence of stent deformation. LSD led to unplanned stenting in (53%, 8 of 15) of the deformed stents, which consumed larger contrast volume and longer fluoroscopy time. At 8-month follow-up, there was no significant difference in binary restenosis rate and target lesions revascularization between both groups (P = 0.98, and P = 0.56, respectively), while death occurred in six patients of the non-LSD group (1.36%, 6 of 440) and none in the LSD group. All patients of the LSD group had no major adverse clinical events at 8-month follow-up. Axial stent deformation in Promus Element platform is an infrequent event, occurs following manipulation of the interventional tools. Other than unplanned stenting, the LSD was not associated with any adverse clinical events at 8-month follow-up.

Coronary stent concertina in proximal left anterior descending artery: An unusual case

Since the emergence of stents, there has been persistent improvement in flexibility and deliverability of stents with modifications in its design and number of connectors. This has unfortunately created negative effect on longitudinal strength of stent resulting into a recently recognized and unaccustomed complication, longitudinal stent deformation (LSD). It is an abrupt shortening of the stent along its longitudinal axis, usually after deployment, due to various reasons. We present a case of LSD in Promus Element stent implanted at proximal left anterior descending artery. The stent shortening was about 25%–30% of its actual length. As this led to exposure of a part of lesion, it was successfully managed by overlapping another stent.

Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial

Objective: Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). Methods: We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). Results: At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00). Conclusions: The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

TCT-170 Clinical Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From DUTCH PEERS (TWENTE II) Randomized Trial

TCT-170 Clinical Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From DUTCH PEERS (TWENTE II) Randomized Trial

Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial

Introduction and objectivesIn acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. MethodsThe prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. ResultsOf all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). ConclusionsResolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.

Resultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: análisis del ensayo aleatorizado DUTCH PEERS (TWENTE II)

Introduction and objectivesIn acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. MethodsThe prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. ResultsOf all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF: 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF: 9.0% vs 7.5%; P = .56). ConclusionsResolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.Full English text available from:www.revespcardiol.org/en

TCT-561 Final Five-Year Outcomes Following Implantation of the Promus Element® Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions in Small Vessels (SV) and Long Lesions (LL): Results of the PLATINUM Small Vessel and Long Lesion Trials

The thin-strut, everolimus-eluting, platinum chromium PROMUS Element stent (Boston Scientific, Marlborough MA) has shown favorable early outcomes up to 4 years post-implantation for the treatment of de novo long lesions or lesions in small-caliber vessels, but long-term follow-up has not been

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

TCT-15 Results of the Primary Endpoint of the PLATINUM PLUS Trial: A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients

A drug-eluting stent consists of 3 components of equal importance: a metallic platform, a polymer and a drug, all influencing acute and long term results both in safety and efficacy. The PLATINUM PLUS trial was designed to compare the PROMUS Element(tm) stent (Boston Scientific; Natick, MA, US) to

In vitro evaluation of second-generation drug-eluting coronary stents with 256-slice computed tomography

Background: Multi-slice computed tomography (MSCT) with improved resolution has been used for detecting coronary artery disease as an alternative to invasive coronary angiography. Since MSCT has the advantage of low cost and its non-invasiveness, assessment of coronary in-stent restenosis (ISR) with MSCT is clinically useful. Purpose: We evaluated the difference of stent lumen visibility and lumen attenuation in various stents using coronary phantoms on MSCT. Methods: Six different types of drug-eluting stent with a diameter 3.0mm (Xience V/Promus and Xience Prime [cobalt-chromium], Endeavor and Resolute Integrity [cobalt-nickel], Promus Element [platinum-chromium], Nobori [stainless steel]) were examined. The stents were placed on a diluted iodine-filled (370HU) plastic tube. Those phantoms in water-filled tank were scanned on 256-MSCT (Phillips Corporation). Multi-planar reformation (MPR) images of each stent were reconstructed and profile curves were obtained by MPR images. As an index of stent lumen, the full width at half maximum (FWHM) was calculated using profile curve. We assessed the stent lumen visually by the normalized-rank approach and physically using profile curves. Results: The least degree of visualization was found in the Promus Element stent (p<0.05). Profile curves showed both peak CT value (stent strut) and valley CT value (stent lumen) were highest in the Promus Element stent (2,327HU and 713HU, respectively) (Figure 1). In the FWHM, the Promus Element stent was 0.96 mm at the minimum and the Xience V/Promus stent was 1.40 mm at the maximum. ![Figure][1] Figure 1 Conclusions: Stent lumen visibility largely varies depending on the stent type of the material and design. These data suggest that the platinum alloy stent is unsuitable in the examination of coronary stents for ISR using MSCT. [1]: pending:yes

Drug-eluting Stents: Will the transformation to bioabsorption make durable polymers obsolete?

It's been over a decade since drug-eluting stents (DES) were introduced into the clinical practice of percutaneous coronary intervention for the treatment of coronary artery lesions. With significant reductions in restenosis rates and the need for repeat revascularizations, the technology was disseminated globally at an unprecedented rate [1]. Soon after, reports of early and late stent thrombosis curbed the enthusiasm and mandated selective DES uses and prolonged dual antiplatelet therapy (DAPT) for at least 12months [2]. This strategy significantly reduced stent thrombosis rates, albeit at the price of bleeding, which has often led to premature DAPT discontinuation [3]. Additionally, first-generation DES, Cypher and Taxus, reported a stent thrombosis increasing hazard of 0.6 per year up to 5 years and even higher rates of target lesion failure [4]. Firstgeneration DES were then replaced with second-generation DES that utilize a thinner cobalt chromium or platinum chromium alloy, sirolimus analogue drugs, such as everolimus and zotarolimus, and a thinner and more biocompatible polymer layer. Despite these iterations, the requirement for prolonged DAPT did not change. At the same time, the hazard ratios for stent thrombosis and target vessel failure were attenuated, but not eliminated, especially in the more complex patient and lesion subsets [5,6]. The question remains, “What factors contribute to the development of the late events seen in second-generation DES?” Is it the metal? The polymer? Or is it the drug? For BMS, target vessel failure occurs within the first 6–12 months, and events beyond that are rare. With second-generation DES, the drug is gone within the first 6 months and complete healing is usually attained at 12 months. This suggests that the culprit for these late events (N12 months) is most likely the polymer, which continues to irritate the vessel wall causing low grade inflammation and subsequently neoatherosclerosis. The polymers used in first-generation DES were associated with a high degree of inflammation, which often resulted in vessel wall toxicity, target lesion failure, and late stent thrombosis. Nevertheless, the polymers used in the second-generation DES, such as BioLinx and fluoropolymer, are proven to be more biocompatible. More specifically, the fluoropolymer used in Xience V (Abbott Vascular) and Promus Element stents (Boston Scientific) have further claimed to have antithrombotic properties and protection from stent thrombosis when compared to BMS [7]. However, the data to support this claim are rather weak and did not result in a change in the recommended duration of DAPT for such stents. Further, in the Prospective, Randomized, Multicenter Trial to Assess

“Procedural trauma risks longitudinal shortening of the promus element™ stent platform”

This case series raises further awareness of the potential for longitudinal shortening with the Promus Element™ (Boston Scientific, MN) drug-eluting stent (DES) platform. With safety at the forefront of DES development, newer generation systems are utilizing thinner platforms with little or no polymer. Although these contemporary, ultrathin platforms also improve conformability and deliverability, specific design characteristics might inadvertently reduce longitudinal strength. To date, there are no randomized data addressing this issue in vivo for any stent platform, with opinion based on individual experience and bench testing. We report five cases of longitudinal shortening with the Promus Element stent occurring in our institution over a 15-month period. During the same period, we experienced only isolated cases with other second generation DES platforms. Our experience supports recently published bench-top data correlating the two-link design of this platform with the risk of compression.

Longitudinal Deformation of Contemporary Coronary Stents: An Integrated Analysis of Clinical Experience and Observations from the Bench

To report clinical experience with longitudinal stent deformation (LSD) and observations from the bench. LSD was recently reported with thin-strut coronary stents. Whether it is related to a particular stent or constitutes a class-effect remains debatable. After 2 cases of LSD were reported, information was sent to operators to warn of this event and identify possible cases. All cases were reviewed to ensure LSD had occurred. Simultaneously, bench testing was conducted to identify the susceptibility of stents to longitudinal compression and whether LSD detection is influenced by fluoroscopic stent visibility. Between July 2010 and November 2011, 2,705 coronary interventions were performed with 4,588 stents (Promus Element = 41.6%, Xience Prime = 24.4%). Six patients with LSD were identified, all with Promus Element (0.31%). Wire bias was a predisposing factor in 4 cases. All patients were treated with postdilatation and/or additional stenting. No adverse events occurred (mean 5.8 months). In bench testing, LSD occured in all examined stents, but at different levels of applied force (weight). Most shortening at 50 g was observed with Promus Element (38.9%), as was the best visibility of LSD on x-ray images. With postdilatation all stents showed some re-elongation. In our practice LSD was a rare observation only seen with the Promus Element stent. When subjected to longitudinal compression in a bench test all contemporary stents can be compressed. Compression of Promus Element occurs at a lower force, but it is the only stent where deformations are detected with x ray. Postdilatation can partially improve LSD.