Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial.

BACKGROUND: In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers. METHODS: The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents, analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov, number NCT01674803. FINDINGS: From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of 3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%) of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%) of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting stents compared with zotarolimus-eluting stents was confirmed (both -0·7% absolute risk difference, 95% CI -2·4 to 1·1; upper limit of one sided 95% CI 0·8%, pnon-inferiority<0·0001). Definite stent thrombosis (defined by the Academic Research Consortium) occurred in four (0·3%) of 1172 patients who were allocated to everolimus-eluting stents, four (0·3%) of 1169 patients who were allocated to sirolimus-eluting stents, and three (0·3%) of 1173 patients who were allocated to zotarolimus-eluting stents (log-rank p=0·70 for both comparisons with zotarolimus-eluting stents). INTERPRETATION: At 12 month follow-up, both very thin strut drug-eluting stents with dissimilar biodegradable polymer coatings (eluting either everolimus or sirolimus) were non-inferior to the durable polymer stent (eluting zotarolimus) in treating allcomers with a high proportion of patients with acute coronary syndromes. The absence of a loss of 1 year safety and efficacy with the use of these two biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits. FUNDING: Biotronik, Boston Scientific, and Medtronic.

Computational analysis of the effects of geometric irregularities and post-processing steps on the mechanical behavior of additively manufactured 316L stainless steel stents.

Advances in additive manufacturing enable the production of tailored lattice structures and thus, in principle, coronary stents. This study investigates the effects of process-related irregularities, heat and surface treatment on the morphology, mechanical response, and expansion behavior of 316L stainless steel stents produced by laser powder bed fusion and provides a methodological approach for their numerical evaluation. A combined experimental and computational framework is used, based on both actual and computationally reconstructed laser powder bed fused stents. Process-related morphological deviations between the as-designed and actual laser powder bed fused stents were observed, resulting in a diameter increase by a factor of 2-2.6 for the stents without surface treatment and 1.3-2 for the electropolished stent compared to the as-designed stent. Thus, due to the increased geometrically induced stiffness, the laser powder bed fused stents in the as-built (7.11 ± 0.63 N) or the heat treated condition (5.87 ± 0.49 N) showed increased radial forces when compressed between two plates. After electropolishing, the heat treated stents exhibited radial forces (2.38 ± 0.23 N) comparable to conventional metallic stents. The laser powder bed fused stents were further affected by the size effect, resulting in a reduced yield strength by 41% in the as-built and by 59% in the heat treated condition compared to the bulk material obtained from tensile tests. The presented numerical approach was successful in predicting the macroscopic mechanical response of the stents under compression. During deformation, increased stiffness and local stress concentration were observed within the laser powder bed fused stents. Subsequent numerical expansion analysis of the derived stent models within a previously verified numerical model of stent expansion showed that electropolished and heat treated laser powder bed fused stents can exhibit comparable expansion behavior to conventional stents. The findings from this work motivate future experimental/numerical studies to quantify threshold values of critical geometric irregularities, which could be used to establish design guidelines for laser powder bed fused stents/lattice structures.

Immediate and long-term outcomes of drug-eluting stent implantation for unprotected left main coronary artery disease: comparison with bare-metal stent implantation.

BACKGROUND: The efficacy and safety of drug-eluting stent (DES) implantation for unprotected left main coronary artery (LMCA) disease remain to be established in different clinical settings. METHODS: Elective DES implantation for unprotected LMCA stenosis was performed in 220 patients at the Fu Wai Hospital, China, from April 2003 to February 2006. Data derived from the latter group were compared with those derived from 224 patients treated with bare-metal stents (BMSs) before March 2003 in a Chinese registry of unprotected LMCA stenting. RESULTS: Compared with the historical BMS control group, the DES group had more multivessel disease and underwent more bifurcation stenting. The inhospital major adverse cardiac events were significantly higher in the DES than in the BMS recipients (4.1% vs 0.9%, P = .030) because of more complex lesions and procedures in the DES group. During the 15-month mean follow-up period, cumulative cardiac death (0.5% vs 4.9%, P = .004), target-vessel revascularization (5.9% vs 11.6%, P = .034), and major adverse cardiac event (9.5% vs 16.5%, P = .029) rates were significantly lower in the DES than in the BMS group. There was no significant difference in clinical efficacy between sirolimus- and paclitaxel-eluting stents. Angiographic follow-up was performed in 46.4% of DES and 45.7% of BMS recipients, respectively; and the binary restenosis rate was significantly lower in the DES versus the BMS control group (16.7% vs 31.4%, P = .014). CONCLUSIONS: Based on this comparison with a historical control, DES implantation for unprotected LMCA appears safe in selected patients and might be more effective in preventing major adverse cardiac events compared with BMS implantation over a mean follow-up period of 15 months.

Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial).

Drug-eluting stent failures were associated with various clinical factors. However, the clinical impact of stent deployment technique was unknown. This study was designed to evaluate the frequency and impact of suboptimal percutaneous coronary intervention on long-term outcomes of 1,557 patients treated with sirolimus-eluting stents (SESs) in 41 US hospitals. All steps of the interventional procedure were scrutinized by an independent core laboratory to determine the occurrence of geographic miss (GM). GM included longitudinal (LGM; injured or diseased segment not covered by SES) or axial GM (balloon-artery size ratio <0.9 or >1.3) mismatches. Patients with and without GM were stratified (GM vs no-GM group). Patients, investigators, and the independent clinical event adjudication committee were blind to study group assignments. The primary end point was 1-year target-vessel revascularization (TVR) rate. Incidences and predictors of GM and safety outcomes were secondary end points. GM occurred in 943 patients (66.5%): 47.6% had LGM, 35.2% had axial GM, and 16.5% had both. One-year TVR rates were 5.1% in the GM group versus 2.5% in the no-GM group (p=0.025). TVR was 6.1% in the LGM versus 2.6% in the no-LGM subgroups (p=0.001). The association of GM with 1-year TVR was independent of clinical or anatomic factors (hazard ratio 2.0, 95% confidence interval 1.0 to 4.02, p=0.05). There was a 3-fold increase in myocardial infarction rates associated with GM (2.4% vs 0.8%; p=0.04). In conclusion, GM occurred frequently during SES implantation and was associated with increased risk of TVR and myocardial infarction at 1 year. These results emphasized the need for improvement in contemporary percutaneous coronary intervention practices and technologies.

Rates of stent thrombosis in bare-metal versus drug-eluting stents (from a large Australian multicenter registry).

Recent reports suggest that drug-eluting stents (DESs) may increase the risk of stent thrombosis (ST) relative to bare-metal stents (BMSs). Therefore, the aim of this study was to compare DES and BMS outcomes with a specific focus on ST. We analyzed 30-day and 1-year outcomes of 2,919 patients who underwent percutaneous coronary intervention with stent implantation from the Melbourne Interventional Group registry. Academic Research Consortium definitions of ST were used: (1) definite ST (confirmed using angiography in patients with an acute coronary syndrome), (2) probable ST (unexplained death <30 days or target-vessel myocardial infarction without angiographic confirmation), and (3) possible ST (unexplained death >30 days). Multivariate analysis was performed to identify predictors of ST. The incidence of ST (early or late) was similar between BMSs and DESs (1.6% vs 1.4%; p=0.66), and DES use was not predictive of ST. Independent predictors of ST included the absence of clopidogrel therapy at 30 days (odds ratio [OR] 2.58, 95% confidence interval [CI] 1.29 to 5.29, p<0.01), renal failure (OR 3.30, 95% CI 1.43 to 7.59, p<0.01), index procedure presentation with an acute coronary syndrome (OR 2.59, 95% CI 1.14 to 5.87, p=0.02), diabetes mellitus (OR 2.25, 95% CI 1.19 to 4.23, p=0.01), and total stent length >or=20 mm (OR 1.85, 95% CI 1.00 to 3.42, p=0.04). In conclusion, DESs were not associated with increased risk of ST compared with BMSs at 12 months in this large Australian registry that selectively used DESs for patients at high risk of restenosis.

Impact of body mass index on the one-year clinical outcome of patients undergoing multivessel revascularization with sirolimus-eluting stents (from the Arterial Revascularization Therapies Study Part II).

The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs (<25 kg/m(2)), 289 were overweight (> or =25 and < or =30 kg/m(2)), and 142 were obese (>30 kg/m(2)). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II.

Comparison of two antiplatelet regimens (aspirin alone versus aspirin + ticlopidine or clopidogrel) after intracoronary implantation of a carbofilm-coated stent.

Stent thrombosis (ST) is an infrequent (0.5% to 1.5%) complication of intracoronary stenting, with severe clinical consequences. This multicenter, randomized study evaluated the clinical outcome in 479 patients (598 lesions treated) who underwent elective coronary stenting with a Carbofilm-coated stent (CarboStent) who met prespecified eligibility criteria and were randomly assigned to receive aspirin alone (n = 235) or aspirin plus a thienopyridine antiplatelet regimen (n = 244). Clinical, angiographic, and procedural characteristics were similar between groups. The primary end point was the incidence of 30-day ST; secondary end points included major vascular or bleeding complications within 30 days and death, acute myocardial infarction, and target vessel revascularization at 6 months. ST occurred in 4 patients (1.4%) in the aspirin-only group and in 1 patient (0.3%) in the aspirin-plus-thienopyridine group (relative risk 0.23, 95% confidence interval 0.03 to 2.08, p = NS). After careful review of cases, 89 patients (19%) with protocol deviations were identified. When they were excluded from the analysis, no ST was observed in either group. Secondary end points were reached by 4% of the aspirin-alone group and 8% of the aspirin-plus-thienopyridine group (relative risk 2.35, 95% confidence interval 0.94 to 5.85, p = NS). In conclusion, after optimal intracoronary implantation of the CarboStent, antiplatelet therapy with aspirin alone was safe and provided efficacy comparable to aspirin plus a thienopyridine in the prevention of ST.

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death.

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

Fibrin glue in coronary artery bypass grafting operations: casting out the Devil with Beelzebub?

OBJECTIVE: Fibrin sealants are frequently used in aortocoronary bypass operations. Although they are considered to be clinically safe, we performed a retrospective analysis of our data to examine the possible side effects of Tissucol fibrin sealant, namely the acute thrombosis of grafts and native coronary arteries resulting in severe myocardial damage and patient deaths. METHODS: The data of 2716 patients (2001 male, 715 female) who received an aortocoronary bypass operation from November 1995 to December 1999 were studied retrospectively. Two groups (group 1: received Tissucol, group 2: no sealant used) were compared with respect to an a priori selected set of demographic and clinical variables and with respect to their effect on the outcome using bivariate tabulation. Multiple exploratory assessments of factors possibly related to fatal outcome were done by multiple logistic regression. RESULTS: Nine hundred ninety patients (group 1) received Tissucol, 1726 patients (group 2) did not receive it. Mean patient age was 64+/-9.1 years. Group 1 had a higher risk of death (7.8% vs 2.8%, p<0.001). The peak values of creatine kinase >500 and creatine kinase-myocardial band >50 were higher in group 1 than in group 2, p<0.001. Adjusted odds ratios for the risk of fatal outcome were: 2.01 for the use of Tissucol, 2.71 for patient age >70 years, 2.02 for aortic cross clamp time >90 min, 3.95 for postoperative ventricular fibrillation, 6.35 for postoperative cardiopulmonary resuscitation, 4.55 for postoperative aortocoronary reoperation. CONCLUSION: In our analysis an increased risk of myocardial injury or even death was found in coronary artery bypass grafting patients when Tissucol fibrin sealant was used intraoperatively.

Potential shift from coronary bypass surgery to percutaneous coronary intervention for multivessel disease and its economic impact in the drug-eluting stent era.

BACKGROUND: Drug-eluting stents (DES) may promote percutaneous coronary intervention (PCI) procedures in patients traditionally referred for coronary artery bypass graft (CABG) surgery and may save money. OBJECTIVES: The purpose of the present study was to quantify the potential shift from CABG surgery to multivessel PCI in the DES era and to model the economic consequences. METHODS: Based on predefined criteria, the feasibility of PCI was evaluated in patients with multivessel coronary artery disease who underwent CABG surgery before the availability of DES at the Centre Hospitalier de l'Université de Montréal's Notre-Dame Hospital (Montreal, Quebec). Modelling was used to evaluate the potential cost savings using multivessel PCI instead of CABG surgery. Equal one-year outcomes in both groups were assumed, with the exception of a 10% repeat revascularization (RR) rate in the DES group and a 4% RR rate in the CABG group. The impact of those assumptions was evaluated using 1000 Monte Carlo simulations. RESULTS: The authors retrospectively evaluated that, of 289 patients who underwent CABG without concomitant valve surgery between January and December 2003, only 22 patients (8%) were good candidates for multivessel DES implantation. The procedures would have involved an average of 3.6 DES per patient. The average cost per revascularization procedure was $14,402 with surgery and $11,220 for multivessel DES implantation (using $2,200 DES), leading to a savings of $3,182 per patient. However, after including RR procedures, PCI would only have been associated with savings of $812 per surgery avoided. Monte Carlo analysis revealed that surgery may be less expensive than PCI in 36% of patients. CONCLUSIONS: Most patients who underwent CABG surgery in 2003 were retrospectively judged to be ineligible for multivessel PCI with DES. In the rare eligible patient, multivessel PCI with DES is not expected to produce savings to health care costs in Canada unless the DES purchase cost continues to decrease.

Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians.

BACKGROUND: and Overview. Dual antiplatelet therapy with aspirin and a thienopyridine has been shown to reduce cardiac events after coronary stenting. However, many patients and health care providers prematurely discontinue dual antiplatelet therapy, which greatly increases the risk of stent thrombosis, myocardial infarction and death. CONCLUSIONS AND CLINICAL IMPLICATIONS: This advisory stresses the importance of 12 months of dual antiplatelet therapy after placement of a drug-eluting stent and educating patients and health care providers about hazards of premature discontinuation. It also recommends postponing elective surgery for one year, and if surgery cannot be deferred, considering the continuation of aspirin during the perioperative period in high-risk patients with drug-eluting stents.

Comparison of a Drug-Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3-Year Follow-Up.

BACKGROUND: Arterial Remodeling Technologies bioresorbable scaffold (ART-BRS), composed of l- and d-lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long-term performance remains unknown. The aim of this study was to evaluate the ART-BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years. METHODS AND RESULTS: Eighty-two ART-BRS and 66 BMS were implanted in 64 Yucatan swine, and animals were euthanatized at intervals of 1, 3, 6, 9, 12, 18, 24, and 36 months to determine the vascular response using quantitative coronary angiography, optical coherence tomography, light and scanning electron microscopy, and molecular weight analysis. Lumen enlargement was observed in ART-BRS as early as 3 months, which progressively increased up to 18 months, whereas BMS showed no significant difference over time. Percentage area stenosis by optical coherence tomography was greater in ART-BRS than in BMS at 1 and 3 months, but this relationship reversed beyond 3 months. Inflammation peaked at 6 months and thereafter continued to decrease up to 36 months. Complete re-endothelialization was observed at 1 month following implantation in both ART-BRS and BMS. Scaffold dismantling started at 3 months, which allowed early vessel enlargement, and bioresorption was complete by 24 months. CONCLUSIONS: ART-BRS has the unique quality of early programmed dismantling accompanied by vessel lumen enlargement with mild to moderate inflammation. The main distinguishing feature of the ART-BRS from other scaffolds made from poly-l-lactic acid may result in early and long-term vascular restoration.

Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

Sirolimus-eluting stents versus Paclitaxel-eluting stents in the treatment of coronary artery disease in patients with diabetes mellitus.

This study was performed to compare the safety and efficacy of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) on the outcomes of diabetic patients. Recent data with drug-eluting stents have shown improved clinical outcomes in diabetic patients. This study compared outcomes between the 2 available drug-eluting stents, SESs and PESs. From the prospective drug-eluting stent registries at the investigators' institution, 1,320 consecutive diabetic patients treated with SESs (n=873, 1,293 lesions) and PESs (n=447, 733 lesions) were identified and their in-hospital and 1- and 6-month clinical outcomes compared. Baseline characteristics showed more men, more patients with previous coronary bypass surgery, and smaller ejection fractions in the PES group and more obese patients in the SES group. Procedural characteristics were similar except for more left anterior descending artery and proximal lesions and the greater use of glycoprotein IIb/IIIa inhibitors in the SES group and more type C lesions, direct stenting, and stents per patient in the PES group. In-hospital complications were similar. Clinical follow-up at 1 month was also similar between the 2 groups, including subacute stent thrombosis. At 6 months, the 2 groups had similar mortality (7% vs 7%), myocardial infarctions (18% vs 21%), target lesion revascularization, target vessel revascularization, major adverse cardiac events (11% vs 12%), and late thrombosis (0.3% vs 0%). Subanalysis of insulin-treated diabetic patients showed no significant differences in outcomes in the 2 groups. No significant differences were found between SESs and PESs on Cox regression analysis for hazard ratios. In conclusion, SESs and PESs are associated with similar efficacy and safety with regard to repeat revascularization rates, major adverse cardiac events, and stent thrombosis up to 6 months for the treatment of coronary artery disease in patients with diabetes mellitus regardless of insulin therapy.

Relation of C-reactive protein level and long-term risk of death or myocardial infarction following percutaneous coronary intervention with a sirolimus-eluting stent.

Previous observations in the bare metal stent (BMS) era have demonstrated an association between a high preprocedural C-reactive protein (CRP) level and an increased incidence of death or myocardial infarction after percutaneous coronary intervention (PCI). We hypothesized that PCI with sirolimus-eluting stents (SESs) would result in a smaller increase in CRP compared with BMSs and that a high CRP level before PCI would be associated with a higher incidence of death or myocardial infarction at 12 months, regardless of the type of stent implanted. We analyzed patients who underwent PCI with stenting at the Cleveland Clinic Foundation. Patients who received BMSs and SESs were analyzed separately by categorizing them into low and high CRP groups based on whether their CRP level before PCI was above or below the median for each group. The increase in CRP that occurred with PCI was termed DeltaCRP. In total, 652 patients were included in the analysis. Median DeltaCRP was smaller in the SES group than in the BMS group (1.5 vs 0.7 mg/L, p = 0.009). In the BMS group, patients with a CRP level above the median before PCI had a higher incidence of 12-month death or myocardial infarction compared with patients with a CRP level below the median (11.3% vs 1.6%, p = 0.002). The same relation was present in the SES group, i.e., patients with a higher CRP level had a higher incidence of 12-month death or myocardial infarction compared with patients with a low CRP level (6.3% vs 1.0%, p = 0.005) and a higher 12-month mortality (5.2% vs 0%, p = 0.001). Multivariate logistic regression analysis demonstrated that the CRP level above the median before PCI was associated with a higher 12-month incidence of death or myocardial infarction, independent of the type of stent used, or DeltaCRP. In conclusion, PCI in the SES era causes a smaller increase in CRP compared with the BMS era. A high CRP level before PCI is independently associated with a higher risk of long-term death or myocardial infarction. This finding was present in the BMS and SES groups and highlights the need for aggressive risk-factor modification after PCI.

Double jeopardy: balance between bleeding and stent thrombosis with prolonged dual antiplatelet therapy after drug-eluting stent implantation.

Prolonged dual antiplatelet therapy with aspirin and clopidogrel is mandatory after drug-eluting stent (DES) implantation because of potential increase risk of stent thrombosis compared to bare-metal stents. As more DES are being implanted, many of these patients will undergo non-cardiac surgery whilst on antiplatelet therapy. The optimal management of perioperative antiplatelet therapy is not well established. The risk of excessive bleeding associated with antiplatelet therapy needs to be balanced against the risk of stent thrombosis with interruption of antiplatelet therapy on a case-to-case basis.

Emergency polytetrafluoroethylene-covered stent implantation to treat coronary ruptures.

BACKGROUND: Coronary perforation is a life-threatening complication of percutaneous interventions. In the past few years, the implantation of covered stents has emerged as a strategy for treatment when the traditional conservative approach (ie, prolonged balloon inflation and reversal of anticoagulation) fails. METHODS AND RESULTS: Since May 1997 (when polytetrafluoroethylene [PTFE]-covered stents were available at our institutions), 11 of the 12 consecutive patients who had coronary ruptures that were unsuccessfully sealed with prolonged balloon inflation and reversal of anticoagulation were treated with 12 PTFE-covered stents (PTFE group). The efficacy of the PTFE-covered stent was compared with that of noncovered stents, which were used to treat 17 perforations (non-PTFE group). One patient sustained a very distal perforation that was not suitable for covered stent sealing and underwent emergency surgery. All vessel ruptures treated with PTFE-covered stent implantation were successfully sealed. The time necessary to deploy the stent was 10+/-3 minutes (range, 4 to 15 minutes). All patients but one were discharged from the hospital and had an optimal early clinical outcome. One patient underwent emergency bypass surgery and died in the intensive care unit. The occurrence of cardiac tamponade and the necessity for emergency surgery was significantly lower in the PTFE group than in the non-PTFE group. At 14+/-4 months, the 10 discharged patients had not experienced any major adverse cardiac events. CONCLUSIONS: This preliminary study supports the utility of the PTFE-covered stent for the nonsurgical treatment of vessel ruptures.

Polymeric stenting in the porcine coronary artery model: differential outcome of exogenous fibrin sleeves versus polyurethane-coated stents.

OBJECTIVES: In a porcine coronary model, fibrin film soaked for 3 h in heparin was used as a circumferential coating on a tantalum stent to assess the effect of this naturally occurring biopolymer on arterial healing. The results were compared with those obtained with medical grade polyurethane-coated stainless steel stents. BACKGROUND: Thrombus plays an important role in healing after arterial injury and may affect the development of neointimal hyperplasia. Manipulation of the initial thrombus may alter the healing response. To study this, we placed a template of fibrin in a porcine coronary artery restenosis model. METHODS: Thirty-four fibrin film stents were delivered in 20 swine. Oversizing was avoided, to prevent deep arterial injury, by placement of optimally sized stents. Initial patency of the stented vessel was confirmed by angiography. RESULTS: Three fibrin-stented swine died within 48 h; in each, the stent was occluded with a fibrin/red blood cell mass. In two of these three, a portion of the exogenous fibrin had become detached from the stent and partially occluded the lumen. Of the remaining 31 stents, all were patent at elective sacrifice at 28 days. Eighty-four percent had a diameter stenosis < 50%, and the mean (+/- SD) diameter stenosis was 32.3 +/- 13%. There was no evidence of significant foreign-body giant-cell reaction. These results contrasted with the medical grade polyurethane-coated stents placed according to the same protocol without oversizing. Twelve of these stents were placed; six swine died of thrombotic occlusion within the 1st 48 h. At elective sacrifice at 28 days, the remaining polyurethane-coated stents were occluded by marked neointimal hyperplasia. CONCLUSIONS: Fibrin film-coated stents seem promising as a template for modifying the local response to arterial injury and for potentially decreasing restenosis rates.

Coronary stent infection: a rare but severe complication of percutaneous coronary intervention.

During the last two decades, the number of percutaneous coronary interventions (PCI) has steadily increased in Switzerland, as has the use of coronary stents. However, reports of coronary stent infections are very rare. In the present article we review all published cases of coronary stent infections. All patients presented with symptoms of infection within the first four weeks after PCI. Clinical hallmarks of stent infection were fever and chest pain. Blood cultures were positive in all patients. Despite the use of intravenous antibiotics in all except one patient and surgical drainage of the infectious focus in the majority of affected individuals mortality was high (40%). Thus, coronary stent infection, although exceedingly rare, represents a life-threatening complication and should be considered in the differential diagnosis of patients presenting with fever during the first few weeks after PCI.

Will drug-eluting stents replace coronary artery bypass surgery?

Although coronary artery bypass grafting (CABG) remains the treatment of choice for certain types of coronary artery disease (CAD), percutaneous coronary intervention (PCI)--particularly coronary angioplasty with stenting--has become the most popular nonmedical treatment approach to CAD. Some have speculated that, with the advent of drug-eluting stents (DESs), PCI will replace CABG entirely. However, the complete disappearance of CABG is both unlikely and unwarranted, for several reasons. Published randomized trials of CABG, PCI, and medical approaches to CAD compared only highly selected subgroups of patients because of strict exclusion criteria that often favored the PCI cohorts. Therefore, their results do not constitute sufficient evidence for the superiority of PCI over CABG in all CAD patients requiring revascularization. As PCI indications broaden to include more complex lesions and more high-risk patients, outcomes will not remain as favorable. In addition, although PCI is less invasive than surgery, CABG offers more complete revascularization and better freedom from repeat revascularization. Furthermore, no long-term patency data on DESs yet exist, whereas excellent 10- and 20-year patency rates have been reported for the left internal mammary artery-to-left anterior descending artery graft used in most CABG procedures. While PCI has been changing, CABG has not been stagnant; recently, advances in many aspects of the CABG procedure have improved short- and long-term outcomes in CABG patients. Both CABG and PCI technologies will continue to advance, not necessarily exclusive of one another, but no data yet exist to suggest that DESs will render CABG obsolete any time soon.