Platinum Chromium Everolimus-eluting Stent Research Articles

Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries)

There is limited data on new-generation stent outcomes in patients with previous coronary artery bypass graft (CABG) and the associated risk of gender and race/ethnicity is unclear. We investigated 1-year outcomes after platinum chromium everolimus-eluting stent implantation in a diverse population of men, women, and minorities with previous CABG pooled from the PLATINUM Diversity (NCT02240810) and PROMUS Element Plus (NCT01589978) registries. Our primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1-year post percutaneous coronary intervention (PCI). Secondary end points included all-cause death, MI, TVR, target vessel failure, and stent thrombosis. A total of 4,175 patients were included in the analysis, including 1,858 women (44.5%), 1,057 minorities (25.3%), and 662 (15.9%) with previous CABG. Patients with previous CABG were older, included more men and White patients, and had more co-morbidities compared with patients without previous CABG. At 1 year, patients with previous CABG had a higher risk of MACE (12.6% vs 7.5%, hazard ratio 1.70, 95% confidence interval 1.32 to 2.19, p<0.001) and end points, including death/MI, TVR, and target vessel failure. After multivariate adjustment, no differences were observed in MACE (adjusted hazard ratio 1.11, 95% confidence interval 0.82 to 1.49, p=0.506) or any secondary end points. No interaction was observed between previous CABG and gender or minority status. In conclusion, in a contemporary PCI population, patients with previous CABG remain at high risk for PCI because of their elevated risk profile. Previous CABG status was however not independently associated with worse outcomes after adjustment, nor was any interaction observed with gender or race/ethnicity.

Prasugrel Monotherapy After Percutaneous Coronary Intervention With Biodegradable-Polymer Platinum-Chromium Everolimus Eluting Stent for Japanese Patients With Chronic Coronary Syndrome (ASET-JAPAN).

P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).Methods and Results: ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis. This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This "aspirin-free" strategy may be a safe alternative to traditional DAPT following PCI.

Clinical outcomes of percutaneous coronary intervention and rotational atherectomy using second generation drug eluting stents: a Korean multicentre analysis

Abstract Background The aim of this study was to compare the clinical outcomes of different second generation drug-eluting stents (DES) in patients with calcified coronary lesions who underwent percutaneous coronary intervention using rotational atherectomy. Methods This study was based on a multicentre registry which enrolled patients with calcified coronary artery disease who received RA during between January 2010 and October 2019 from 9 tertiary centres in Korea. The primary outcome was target-vessel failure (TVF), defined as the compositae of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularisation (TVR). The secondary outcomes were all-cause death, cardiac death, target vessel MI, TVR, cardiovascular accident, stent thrombosis, and total bleeding. Results 540 patients who underwent PCI after RA were enrolled and followed up for a median period of 16.1 months. From this registry, 439 patients who were treated using second generation DES were selected for further analysis. They were divided into four groups based on the characteristics of the stents used during the procedure. [Group I cobalt-chromium sirolimus eluting stent (CoCr-SES): Ultimaster 48 &amp; Orsiro 30, Group II platinum-chromium everolimus eluting stent (PtCr-EES): Synergy 93 &amp; Promus 70, Group III cobalt-chromium everolimus eluting stent (CoCr-EES): Xience 105, Group IV zotarolimus eluting stent (ZES): Resolute 93] There was no inter-group difference in procedural success rates, and the primary outcome of TVF showed no difference across the four groups (I: 10.3%, II: 13.5%, III: 13.3%, IV: 15.1%, log-rank p=0.922). Even after multivariate Cox regression analysis, there was no significant difference in TVF, or the secondary outcomes of all-cause death, cardiac death, target vessel MI, TVR, cardiovascular accident, stent thrombosis, and total bleeding. Conclusions There was no difference in procedural success rates and clinical outcomes between four different types of second-generation DES (CoCr-SES, PtCr-EES, CoCr-EES, ZES) in patients who underwent PCI using RA. Funding Acknowledgement Type of funding sources: None.

Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions.

Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. This study sought to compare the relative performance of different types of DES for de novo long (≥25mm) coronary artery lesions. Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9months. The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

Platinum chromium everolimus-eluting stent versus cobalt chromium zotarolimus-eluting stent in very late stent thrombosis: a meta-analysis of randomized controlled trials

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Very late stent thrombosis is a rare but potentially lethal outcome for drug-eluting stents used in percutaneous coronary intervention. There is limited research currently on the occurrence of very late stent thrombosis as a complication of two most used second-generation drug-eluting stents, i.e. platinum chromium everolimus-eluting stent (PtCR-EES) and cobalt chromium zotarolimus-eluting stent (CoCr-ZES). Purpose The study provides comparative information on the formation of very late stent thrombosis as a long-term outcome of PtCr-EES and CoCr-ZES. Results of this study may guide interventional cardiologists in decision-making regarding the choice of stent. Methods Randomized controlled trials (RCTs) which compared stent thrombosis end point of PtCr-EES and CoCr-ZES were identified through Pubmed. Results Data from three RCTs analyzed a total of 7,911 participants, with 4,574 in the PtCr-EES and 3,324 in the CoCr-ZES. Treatment with either stent showed no significant difference in the incidence of very late stent thrombosis. Conclusion Both stents showed comparable incidence of very late stent thrombosis. Additional RCTs are recommended to further establish the results for very late stent thrombosis. Longer follow-up is also suggested to discover more long-term outcomes.

Comparison of neointimal coverage between biodegradable-polymer everolimus-eluting stent and durable-polymer everolimus-eluting stent using angioscopy for the patients with acute coronary syndrome

Abstract Background New-generation biodegradable-polymer platinum chromium everolimus-eluting stent (BP-PtCr-EES) is available, which has different polymer and alloy compare to more established stent design, a durable-polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES). Purpose To compare neointimal coverage (NIC) between BP-PtCr-EES and DP-CoCr-EES by using coronary angioscopy (CAS). Methods A total of 36 patients (44 stents) with BP-PtCr-EES or DP-CoCr-EES who underwent CAS at 1 year after stenting were investigated. We compared angioscopic findings assessed by angioscopy between BP-PtCr-EES (n=18) and DP-CoCr-EES (n=26). NIC grade and yellow plaque grade (YPG) was adopted from earlier reports from grade 0 to 3. We determined maximum (max-) and minimum (min-) NIC grade and heterogeneity score (HGS = max NIC grade minus min NIC grade). We also assessed YPG and the presence of thrombus (TH). Results Six lesions (33.3%) in BP-PtCr-EES group and 7 (26.9%) lesions in DP-CoCr-EES group were culprit lesions of acute coronary syndrome, which did not statistically differ between the two groups (p=0.74). And there were no significant differences in stent diameter (BP-PtCr-EES: 2.97±0.39 mm vs DP-CoCr-EES: 3.14±0.45 mm, p=0.22) and length (BP-PtCr-EES: 26.9±7.9 mm vs DP-CoCr-EES: 28.4±8.0 mm, p=0.54). In terms of CAS findings, BP-PtCr-EES group has better neointimal coverage than DP-CoCr-EES group (max NIC grade: 2.6±0.7 vs 2.0±0.9, p=0.01. min NIC grade: 1.1±0.8 vs 0.5±0.5, p&amp;lt;0.01), but HGS was almost same (1.6±0.7 vs 1.5±0.9, p=0.70). YPG of BP-PtCr-EES group showed significantly lower than DP-CoCr-EES group (1.0±1.0 vs 1.7±1.0, p=0.02). The rate of TH was significantly lower in BP-PtCr-EES group than DP-CoCr-EES group (25%, n=6, vs 75%, n=18, p=0.03). There were no clinical events such as stent thrombosis or restenosis during the observation period in both stent groups. Conclusion Superior neointimal coverage and less YPG or TH were observed by CAS in the BP-PtCr-EES group at 1 year after stenting. Clinical significance was still unknown because of no clinical events in both groups. Prospective and large populations studies may be required. Funding Acknowledgement Type of funding source: None

Impact of stent designs of second-generation drug-eluting stents on long-term outcomes in coronary bifurcation lesions.

We compared the long-term clinical outcomes of four different types of second-generation drug-eluting stents (DESs) in coronary bifurcation lesions. Clinical outcomes of different designs of second-generation DESs are not well known in bifurcation lesions. Patients who underwent percutaneous coronary intervention with second-generation DESs for coronary bifurcation lesion were enrolled from 21 centers in South Korea. A total of 2,526 patients was evaluated and divided into four treatment groups according to DES type: bioabsorbable polymer biolimus-eluting stent (BP-BES group, n=514), platinum chromium everolimus-eluting stent (PtCr-EES group, n=473), cobalt nickel zotarolimus-eluting stent (CoNi-ZES group, n=736), or cobalt chromium everolimus-eluting stent (CoCr-EES group, n=803). Primary outcome was target lesion failure (TLF, defined as a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). Inverse probability of treatment weighting (IPTW) was performed to reduce selection bias and potential confounding factors. For 5 years of follow-up, the rates of TLF among the four DES groups were not significantly different (6.2% for BP-BES group, 8.2% for PtCr-EES group, 6.5% for CoNi-ZES group, and 8.6% for CoCr-EES group, p=.434). The results were consistent after IPTW adjustment (6.8, 8.4, 6.0, and 7.5%, respectively, p=.554). In subgroup analysis, the similarity of long-term outcomes among the four different types of second-generation DES was consistent across subgroups regardless of side branch treatment (p for interaction=.691). There seems to be no significant difference in long-term clinical outcomes among patients who received different types of second-generation DES for coronary bifurcation lesion.

Multivariable prediction model to estimate the probability of restenosis at proximal edge after 2nd-generation drug-eluting-stent implantation: development and internal validation using a quantitative coronary angiography from the post-marketing surveillance studies of everolimus-eluting stent in Japan

Edge restenosis has still been reported after second-generation drug-eluting stent (DES) implantation. It was more likely attributable to post-procedural angiographic results than to the patient's background. The aim of this study was to develop and internally validate a prediction model for restenosis in proximal edge after 2nd-generation DES stent implantation using angiographic data. Data were obtained from several post-marketing surveillance (PMS) studies of the cobalt-chromium everolimus-eluting stent (CoCr-EES) and platinum-chromium everolimus-eluting stent (PtCr-EES), second-generation DES, in Japan. Angiographic analysis was conducted at baseline and after 8 or 12months. We focused on the proximal edge of angiographic analysis. The main outcome was restenosis defined as ≥ 50% diameter stenosis at follow-up. The predictive performance of the prediction model based on multivariable logistic regression was assessed in terms of discrimination and calibration, which were internally validated by the bootstrap method. We also performed decision curve analysis to assess threshold of predicted probability of restenosis at which additional intervention was considered. Among 2053 lesions in 1860 patients, restenosis rates in proximal edge was 2.8%. The final model was constructed with % post-procedural diameter stenosis (DS) and post-procedural reference diameter (RD) as strong predictors for edge restenosis. Discrimination and calibration were satisfactory with optimism-corrected C-statistics 0.75. Predicted probability between 0.03 and 0.24 was preferable threshold for restenosis treatments. Our prediction model can be used to obtain valid prediction for restenosis in proximal edge, assisting to know complete stent coverage of lesion.

Impact of lesion angle on optical coherence tomography findings and clinical outcomes after drug-eluting stent implantation in curved vessels.

Tortuous coronary lesions are associated with adverse outcomes after implantation of bare metal or first-generation drug-eluting stents (DESs). We investigated the impact of lesion angle on vessel wall injuries and stent apposition as assessed by optical coherence tomography (OCT) after second- and newer-generation DES implantation. We investigated 95 de novo lesions treated with a single DES (62 platinum-chromium everolimus-eluting stents and 33 bioresorbable-polymer sirolimus-eluting stents). Post-intervention OCT findings were compared between angled lesions (≥ 45°; n = 33) and non-angled lesions (< 45°; n = 62). The 12-month clinical outcomes were also compared between the groups. Cross-sectional OCT analysis revealed that compared to non-angled lesions, angled ones had a significantly higher incidence of intra-stent dissection around the centre of the angle (19.7% vs. 10.8%, p = 0.01) and incomplete stent apposition (ISA) in the distal and proximal sub-segments (10.0% vs. 4.1%, p = 0.002; 15.3% vs. 7.9%, p < 0.001, respectively). Strut-based analysis also showed that angled lesions demonstrated a higher rate of malapposed strut in the distal and proximal sub-segments (3.0% vs. 0.9%, p < 0.001; 4.3% vs. 1.8%, p < 0.001, respectively). The 12month clinical outcomes were comparable between the groups. Compared to non-angled lesions, angled coronary lesions were associated with a higher incidence of intra-stent dissection and ISA on post-intervention OCT after implantation of second- and newer-generation DESs.

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)

ObjectivesThe aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). BackgroundCurrently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. MethodsThis randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. ResultsA total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). ConclusionsAt 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

Final 5-Year Results in Unselected Patients Implanted With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study)

PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-comers study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 "real-world" patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11% were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11%). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of "real-world" clinical practice.

Assessment of strut coverage of everolimus-eluting platinum chromium stent 2 weeks after implantation by optical coherence tomography.

The SYNERGY coronary stent is new-generation drug-eluting stents, which has a thin-strut platinum-chromium platform with everolimus in a biodegradable polymer applied to the abluminal surface. It would be speculated that favorable arterial healing with early strut coverage could be achieved. The present study investigated the degree of strut coverage using optical coherence tomography (OCT) 2weeks after SYNERGY implantation and clinical factors contributing to strut coverage. A total of 29 patients who underwent staged percutaneous coronary intervention (PCI) to residual lesions 2weeks after the index PCI with SYNERGY stent implantation were enrolled. At the time of staged PCI, OCT examinations of the SYNERGY stent were performed for conventional OCT analysis on both cross-sectional and strut level. SYNERGY stent showed a high level of strut coverage and apposition, and the percentage was 82.4 ± 12.4% and 96.2 ± 5.0%, respectively. The lesion complexity was significantly related to greater strut coverage on univariate analysis; however, it was found to be insignificant in multivariate analysis. Our findings suggest early arterial healing after SYNERGY stent implantation.

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.

Suboptimal Bifurcation Stenting: A Case When the Check Comes Late

A 69-year-old man underwent percutaneous coronary intervention of a left anterior descending coronary artery (LAD) diagonal bifurcation lesion with 2 platinum-chromium everolimus-eluting stents with the culotte technique in September 2014. Dual-antiplatelet therapy was maintained for 1 year. In

Rationale and design of the comparison between a P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients undergoing implantation of coronary drug-eluting stents (SMART-CHOICE): A prospective multicenter randomized trial

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients undergoing percutaneous coronary intervention (PCI), but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. It is unclear whether P2Y12 inhibitor monotherapy might maintain anti-ischemic efficacy while reducing the bleeding risk compared with DAPT after implantation of the current generation of drug-eluting stents (DES). The SMART-CHOICE trial is a prospective, open-label, multi-center, and randomized study designed to test the non-inferiority of P2Y12 inhibitor monotherapy compared with aspirin plus a P2Y12 inhibitor after mandatory 3-month DAPT in patients undergoing PCI with current-generation DES. A total of 3000 patients will be randomized to 1 of the 2 antiplatelet treatment strategy groups. Randomization will be stratified by stent type (cobalt-chromium everolimus-eluting stents, platinum-chromium everolimus-eluting stents, and sirolimus-eluting stents with bioresorbable polymer), P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), clinical presentation (acute coronary syndrome and stable ischemic heart disease), and investigational centers. The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 12 months after the index procedure. The key secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium, and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-CHOICE trial aims to examine the non-inferiority of monotherapy with one of any available oral P2Y12 inhibitors versus conventional DAPT of an identical P2Y12 inhibitor plus aspirin in a broad spectrum of patients receiving representative current-generation DES.

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)

Outcomes of patients treated with durable polymer platinum-chromium everolimus-eluting stents: a meta-analysis of randomised trials.

The durable polymer platinum-chromium everolimus-eluting stent (PtCr-EES) is a new-generation drug-eluting stent (DES) with a platinum-enriched metallic platform developed to improve the percutaneous treatment of patients with coronary artery disease. We sought to investigate the performance of durable polymer PtCr-EES versus other new-generation DES. We undertook a meta-analysis of trials in which patients receiving percutaneous coronary intervention (PCI) were randomly assigned to durable polymer PtCr-EES versus other new-generation DES (other DES). Primary efficacy and safety outcomes were target lesion revascularisation (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were myocardial infarction (MI), target vessel revascularisation (TVR), death, cardiac death and longitudinal stent deformation (LSD). A total of 11,036 patients in seven trials received a PCI with either durable polymer PtCr-EES (n=6,613) or other DES (n=4,423). This latter group comprised patients treated with biolimus- (n=325), cobalt-chromium everolimus- (n=1,940) or zotarolimus-eluting stents (n=2,158). After a median follow-up of 12 months (interquartile range 12-24), durable polymer PtCr-EES displayed a risk of TLR (odds ratio 0.98, 95% confidence interval [CI]: 0.75-1.29; p=0.90) and definite/probable ST (0.89 [0.55-1.45]; p=0.63) comparable to that of other DES. However, the durable polymer PtCr-EES was associated with a higher risk of LSD (12.05 [1.60-90.71], p=0.02) compared to other DES. There was no significant difference with regard to other secondary outcomes nor was there heterogeneity across trials. At one-year follow-up, the durable polymer PtCr-EES displays a performance comparable to that of other new-generation DES platforms.

Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

No previous studies have evaluated the performance of the Synergy stent in a large real-life population. To describe the initial real-life experience with a novel everolimus eluting platinum chromium stent with abluminal biodegradable polymer (SYNERGY) in unselected patients from a nationwide registry. All implanted Synergy stents were compared with other new generation drug eluting stents (n-DES) with >1,000 implantations in Sweden between March 2013 and October 2015. Restenosis, definite stent thrombosis (ST), myocardial infarction (MI) and death rates were assessed using propensity score and Cox regression analyses. A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N = 1,953; Orsiro, N = 4,946; Promus Element Plus, N= 2,543; Promus Premier, N= 20,414; Xience Xpedition, N= 7,971, Resolute/Resolute Integrity, N = 19,021; Ultimaster, N = 1,156; Resolute Onyx, N = 6,425) were implanted in 42,357 procedures. Restenosis and stent thrombosis occurred in 642 and 314 cases, respectively, in the overall population at 1 year. The cumulative rate of restenosis (1.1% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; P = 0.21) and ST (0.4% vs. 0.5%, adjusted HR: 0.97; 95% CI: 0.63-1.50; P = 0.17) up to 1 year was low in both the Synergy group and the other n-DES group. Death occurred in 5.2% versus 4.5% (adjusted HR: 1.14; 95% CI: 0.96-1.36; P = 0.11) and MI in 3.2% versus 3.5%, (adjusted HR: 1.11; 95% CI: 0.93-1.33; P = 0.24) up to 1 year. In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc.

The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry)

BackgroundA new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. MethodsA total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year. ResultsMean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77–1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively. ConclusionsIn all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS.