Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry

Background: Multiple randomized trials and observational studies have shown drug‐eluting stents (DES) to be safe and effective at 3‐year follow‐up in stent thrombosis (ST)‐segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3–4 years after DES implantation are sparse. Methods: We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end‐points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end‐points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression. Results: There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow‐up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log‐rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31–0.76], P = 0.0007) than BMS implantation. Conclusion: In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long‐term follow‐up. (J Interven Cardiol 2012;25:118–125)     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

A comparison of transradial and transfemoral approaches for primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients in a high volume percutaneous coronary intervention center

Background Large percutaneous coronary intervention （PCI） centers have shown statistically better prognosis with transradial approach （TRA） compared with transfemoral approach （TFA）. So we tried to compare the outcomes between TRA and TFA in one high volume PCI center in ST-segment elevation myocardial infarction （STEMI） patients undergoing primary PCI. Method Six hundred and sixty two STEMI patients who underwent primary PCI with stents implantation were retrospectively included from June 1, 2006 to April 30, 2011 in our hospital and prospectively followed for one year. The primary endpoint was defined as in-hospital net adverse clinical events （NACE） which included death, myocardial infarction （MI）, stroke, target vessel revascularization （TVR） and major bleeding. The secondary endpoint was defined as 1 year major adverse cardiovascular events （MACE） which included death, MI and TVR. Results The occurrence rates of NACE （8.0% vs. 17.0%, P = 0.0018）, access site complications （4.0% vs. 10.7% P = 0.0027） and access site-related major bleeding （2.4% vs. 6.3%, P = 0.0254） were all higher in the TFA group than in the TRA group. The incidence rate of 1 year MACE was similar between TRA and TFA （8.5% vs. 13.2%, P = 0.0932）. The inverse probabilities weighting matched multivariable Cox regression analysis showed TRA was an independent predictor of lower rates of in-hospital NACE （HR： 0.58, 95% CI： 0.34-0.99, P = 0.0477）, in-hospital death （HR： 0.31, 95% CI： 0.10-0.73, P = 0.0499） and access site complications （HR： 0.37, 95% CI： 0.19-0.73, P = 0.0040）. Conclusions TRA showed great efficacy and safety for STEMI patients undergoing primar-y PCI in high volume PCI centers. It should be recommended as routine practice in future, and especially in those patients with high risk of bleeding.     

Long term efficacy of abciximab bolus‐only compared to abciximab bolus and infusion after transradial coronary stenting

Background: No data are available on the long term efficacy of abciximab bolus‐only with aspirin and clopidogrel pretreatment and systematic coronary stenting. Our objective was to evaluate the 3‐year clinical outcomes in the EASY trial. Methods: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same‐day home discharge and no infusion (bolus‐only group, n = 504) or to overnight hospitalization and 12 hours abciximab infusion (bolus + infusion group, n = 501). In contrast, 343 patients were not randomized after stenting for safety reasons and received abciximab bolus and infusion (not‐randomized group). The rate of major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) was evaluated. Results: Up to 3 years, the incidence of MACE remained similar in the two randomized groups, 14% in bolus‐only vs. 17% in bolus + infusion (P = 0.38). Similar efficacy was observed in subgroups analysis including higher‐risk patients such as those with diabetes, unstable angina or non‐ST elevation MI. Conversely, the incidence of MACE remained significantly higher in patients not‐randomized post‐PCI at all time intervals (P < 0.0001). The difference in outcomes between randomized and not‐randomized patients was mostly accounted by the higher rates of MI, TVR as survival rate remained similar. Conclusion: In patients pretreated with aspirin and clopidogrel and undergoing uncomplicated coronary artery stenting, abciximab bolus‐only was associated with similar outcomes compared with bolus followed by infusion, up to 3 years after PCI. Conversely, patients with suboptimal results or clinical complications during PCI remained at higher risk of late revascularization or MI. © 2009 Wiley‐Liss, Inc.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 Wiley‐Liss, Inc.     

Clinical impact of sirolimus‐eluting stent in ST‐segment elevation myocardial infarction: A meta‐analysis of randomized clinical trials

Objectives: To evaluate outcome of patients undergoing sirolimus‐eluting stent (SES) as compared to bare‐metal stent (BMS) implantation during primary angioplasty for ST‐segment elevation myocardial infarction (STEMI). Background: The role of SES in primary percutaneous coronary intervention setting is still debated. Methods: We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow‐up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target‐vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI). Results: Six trials were included in the meta‐analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12‐month follow‐up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24–0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52–1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52–1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45–1.11], P = 0.13) between the two groups. Conclusion: SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow‐up. Further studies with larger population and longer follow‐up time are needed to confirm our findings. © 2009 Wiley‐Liss, Inc.     

Safety and effectiveness of drug eluting stent in patients with ST elevation myocardial infarction undergoing primary angioplasty

Background : Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stents in elective procedures. Most early DES trials did not include patients undergoing primary percutaneous coronary intervention (PCI) for ST‐segment elevation MI, because these patients tend to have lower restenosis rates than other patient groups and delayed endothelization of these stents raises concern about a possible increase of thrombotic complications in the setting of STEMI. Aim : To confirm the safety and effectiveness of DES in patients with STEMI in a real‐world scenario. Methods : From January 2004 to December 2006, clinical and angiographic data of 370 patients with STEMI treated with primary PCI have been analyzed. Patients were retrospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). Results : Overall, 120 patients received DES (32%, DES group) and 250 received bare metal stents (68%, BMS group) in the infarct related artery. Compared with the BMS group, DES patients were younger, (mean age 56 ± 12 vs. 65 ± 10; P < 0.001) had more often diabetes mellitus (47% vs. 14% P < 0.001), anterior localization (65% vs. 45%; P < 0.0011) and less cardiogenic shock at admission (4% vs. 7%; P < 0.001). The angiographic characteristics in the DES group showed longer lesions (23 mm vs. 19 mm) and smaller diameter of vessels (2.5 mm vs. 3.0 mm). After a median follow‐up of 24 ± 9 months, there was no significant difference in the rate of stent thrombosis (1.6% in the DES group vs. 1.2% in the BMS group, P = ns). The incidence of MACE was significantly lower in the DES group compared with the BMS group (HR 0.56 [95% CI: 0.3–0.8]; P = 0.01), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2–0.85]; P = 0.01). Conclusions : Utilization of DES in the setting of primary PCI for STEMI, in our “real world,” was safe and improved the 3‐year clinical outcome compared with BMS reducing the need of TVR. © 2008 Wiley‐Liss, Inc.     

Clinical outcomes and predictors of unprotected left main stem culprit lesions in patients with acute ST segment elevation myocardial infarction

Objectives : We aimed at comparing the clinical outcomes of the patients who underwent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI) due to left main coronary arteries (LMCA) and non‐LMCA determining the predictors of mortality in the patients. Background : There are few data regarding the midterm prognosis of STEMI due to LMCA as compared with them due to non‐LMCA. Methods : A total of 4,697 patients with STEMI (61 patients with LMCA and 4,636 patients with non‐LMCA) were enrolled in a nationwide Korea Acute Myocardial Infarction (MI) Registry between November 2005 and September 2009. The primary endpoints was a composite of cardiac death, nonfatal MI, and target lesion and vessel revascularization (TLR/TVR) during a 12‐month clinical follow‐up. Results : The LMCA group had a higher incidence of total major adverse cardiac events (MACEs) (26.2% vs. 7.8%; P < 0.001) at 12 months, which was largely attributable to cardiac deaths at 1 month (21.3% vs. 3.8%; P < 0.001). Therefore, there was no statistical difference in cardiac deaths, nonfatal MI, TLR/TVR, and MACEs after 1 month between the two groups. Presenting in cardiogenic shock (HR, 4.25; 95% CI, 1.01–17.97; P = 0.049) and heart rate ≥100 bpm (HR, 4.97; 95% CI, 1.18–21.00; P = 0.029) were independent predictors of cardiac death due to LMCA. Conclusion : Patients with STEMI and a LMCA had poor clinical outcomes, which is attributable to hemodynamic deterioration during the periprocedural period. However, after that time, midterm MACEs of the survivors following the periprocedural period may not be different between STEMI due to LMCA and non‐LMCA. © 2011 Wiley Periodicals, Inc.     

Validating the EXCEL hypothesis: A propensity score matched 3‐year comparison of percutaneous coronary intervention versus coronary artery bypass graft in left main patients with SYNTAX score ≤32

Objectives : The aim of this study is to verify the study hypothesis of the EXCEL trial by comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in an EXCEL‐like population of patients. Background : The upcoming EXCEL trial will test the hypothesis that left main patients with SYNTAX score ≤32 experience similar rates of 3‐year death, myocardial infarction (MI), or cerebrovascular accidents (CVA) following revascularization by PCI or CABG. Methods : We compared the 3‐year rates of death/MI/CVA and death/MI/CVA/target vessel revascularization (MACCE) in 556 patients with left main disease and SYNTAX score ≤32 undergoing PCI (n = 285) or CABG (n = 271). To account for confounders, outcome parameters underwent extensive statistical adjustment. Results : The unadjusted incidence of death/MI/CVA was similar between PCI and CABG (12.7% vs. 8.4%, P = 0.892), while MACCE were higher in the PCI group compared to the CABG group (27.0% vs. 11.8%, P < 0.001). After propensity score matching, PCI was not associated with a significant increase in the rate of death/MI/CVA (11.8% vs. 10.7%, P = 0.948), while MACCE were more frequently noted among patients treated with PCI (28.8% vs. 14.1%, P = 0.002). Adjustment by means of SYNTAX score and EUROSCORE, covariates with and without propensity score, and propensity score alone did not change significantly these findings. Conclusions : In an EXCEL‐like cohort of patients with left main disease, there seems to be a clinical equipoise between PCI and CABG in terms of death/MI/CVA. However, even in patients with SYNTAX score ≤32, CABG is superior to PCI when target vessel revascularization is included in the combined endpoint. © 2011 Wiley‐Liss, Inc.     

A Randomized Trial of Complete Versus Culprit‐Only Revascularization During Primary Percutaneous Coronary Intervention in Diabetic Patients With Acute ST Elevation Myocardial Infarction and Multi Vessel Disease

Background

Recent randomized trials and meta‐analyses demonstrated that a complete revascularization of significant non culprit lesions in patients with ST elevation myocardial infarction (STEMI) is superior to a culprit only revascularization approach in reducing major adverse cardiac events (MACE), however the proportion of diabetic patients was low in these trials.

Objectives

To investigate whether a complete revascularization approach is associated with better outcomes in diabetic patients with STEMI and multi‐vessel disease.

Methods

One hundred diabetic patients with acute STEMI with at least one non‐culprit lesion were randomized to either complete revascularization (n = 50) or culprit‐only treatment (n = 50). Complete revascularization was performed either at the time of primary percutaneous coronary intervention (PCI) or within 72 hours during hospitalization. The primary endpoint was the composite of all‐cause mortality, recurrent MI, and ischemia‐driven revascularization at 6 months.

Results

A complete revascularization approach was significantly associated with a reduction in the primary outcome (6% vs. 24%, P = 0.01), primarily due to reduction in ischemia driven revascularization in the complete revascularization group (2% vs. 12%; P = 0.047). There was no significant reduction in death or MI (2% vs. 8%; P = 0.17) and (2% vs. 4%; P = 0.56) respectively, or in the safety endpoints of major or minor bleeding, contrast‐induced nephropathy, or stroke between the groups.

Conclusions

In diabetic patients with multi‐vessel coronary artery disease undergoing PPCI, complete revascularization is associated with significantly reduced risk of adverse cardiovascular events, as compared with culprit vessel only PCI. (J Interven Cardiol 2016;29:241–247)

     

Early angio-guided complete revascularization versus culprit vessel PCI followed by ischemia-guided staged PCI in STEMI patients with multivessel disease

Background: Optimal management of multivessel disease (MVD) in ST‐segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PCI) is still unclear. Objectives: To compare short‐ and long‐term clinical outcomes of early‐staged, angio‐guided approach and delayed, ischemia‐guided treatment of non‐infarct‐related arteries (IRAs). Methods: Consecutive patients with STEMI and MVD treated with primary PCI in 6 tertiary care centers were retrospectively selected and analyzed. Major adverse cardiac events (MACE) were defined as the composite end‐point of death, MI, and repeat revascularization. All the events were adjudicated according to the Academic Research Consortium (ARC) definitions. Results: In the time period 2004–2008, 800 primary PCIs in STEMI patients with MVD were performed. Four hundred and seventeen were addressed to early‐staged, angio‐guided PCI of non‐IRAs (CR group) and 383 to an incomplete revascularization (IncR group). During the hospital stay, no difference in terms of death and repeat revascularization was found between groups but the incidence of periprocedural MI/reinfarction and MACE was significantly higher in the CR group (13.9% vs. 3.1%, P = 0.01 and 14.1% vs. 9.1%, P = 0.017, respectively). At a mean follow‐up of 642 ± 545 days, no difference in terms of death and MI was found between the CR and IncR group. The MACE‐free survival was significantly higher in the IncR group (73.8% vs. 57%, log rank 0.05), mainly driven by the lower incidence of re‐PCI. Conclusions: Early complete revascularization based only on angiographic findings in patients with STEMI and MVD is associated with an excess of periprocedural/re‐MI and with a significantly higher incidence of MACE at follow‐up. (J Interven Cardiol 2011;24:535–541)     

Two‐year outcomes after deployment of XIENCE V everolimus‐eluting stents in patients undergoing percutaneous coronary intervention of bifurcation lesions: A report from the SPIRIT V single arm study

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi‐vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30‐day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non‐bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare‐metal stents in a large consecutive patient cohort

Objectives : To ascertain the long‐term safety, efficacy, and pattern of use of drug‐eluting stents (DES) in routine clinical practice. Methods : We analyzed a registry of 6,583 consecutive patients undergoing percutaneous coronary intervention (PCI), of whom 2,633 were treated using DES (DES group) and 3,950 were treated using bare‐metal stents (BMS group). Propensity score was used for stratified analysis of outcomes and for matching. Outcomes were total mortality, myocardial infarction (MI), repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Results : Follow‐up time was 6 months to 5.18 years (mean: 3 years). Patients in the DES group were more likely to be diabetic and had use of longer or more stents, treatment of more lesions and of more proximal main vessels. After propensity score matching, the cumulative mortality was 12.85% in the DES group versus 14.14% in the BMS group (P = 0.001). Use of DES reduced the occurrence of MI (5.17% vs.5.83%, P = 0.046), of clinically driven TVR (9.76% vs. 12.28%, P < 0.001) and of the composite endpoint of death/MI/TVR (23.38% vs. 26.07%; P < 0.001). Conclusions : Our risk‐adjusted event‐free survival analysis indicates a prognostic benefit for DES utilization that sustains up to 5 years following PCI. © 2010 Wiley‐Liss, Inc.     

Culprit Vessel Only vs Immediate Complete Revascularization in Patients With Acute ST‐Segment Elevation Myocardial Infarction: Systematic Review and Meta‐Analysis

Although multivessel coronary artery disease has been associated with poor health outcomes in patients with acute ST‐segment elevation myocardial infarction (STEMI), the optimal approach to revascularization remains uncertain. The objective of this review was to determine the benefits and harms of culprit vessel only vs immediate complete percutaneous coronary intervention (PCI) in patients with acute STEMI. We searched MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for randomized controlled trials (RCTs). Teams of 2 reviewers, independently and in duplicate, screened titles and abstracts, completed full‐text reviews, and abstracted data. We calculated pooled risk ratios (RRs) and associated 95% confidence intervals (CIs) using random‐effect models for nonfatal myocardial infarction (MI), revascularization, cardiovascular mortality, all‐cause mortality, and adverse events, and used the GRADE approach to rate confidence in estimates of effect. Of 341 patients randomized to complete revascularization and followed to study conclusion, 31 experienced revascularization, as did 80 of 324 randomized to culprit vessel only revascularization (RR: 0.35, 95% CI: 0.24‐0.53). Ten patients in the complete revascularization group and 28 patients in the culprit vessel only revascularization group experienced nonfatal MI (RR: 0.35, 95% CI: 0.17‐0.72). All‐cause mortality and cardiac deaths did not differ between groups (RR: 0.69, 95% CI: 0.40‐1.21 for all‐cause mortality; RR: 0.48, 95% CI: 0.22‐1.04 for cardiac deaths). Pooled data from 3 RCTs suggest that immediate complete revascularization probably reduces revascularization in patients with acute STEMI; although results suggest possible benefits on MI and death, confidence in estimates is low.     

Initial culprit-only versus initial multivessel percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: results from the Ibaraki Cardiovascular Assessment Study registry

We investigated clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) treated for initial culprit-only or by initial simultaneous treatment of nonculprit lesion with culprit lesion. Optimal management of multivessel disease in STEMI patients treated by primary percutaneous coronary intervention (PCI) is still unclear in the drug-eluting stent era. We compared clinical outcomes of 274 STEMI patients (69.3 ± 11.8 years, 77 % men) in the Ibaraki Cardiovascular Assessment Study registry who underwent initial culprit-only (OCL, n = 220) or initial multivessel PCI of nonculprit lesion with culprit lesion (NCL, n = 54) from April 2007 to August 2010. Major adverse cardiac and cerebrovascular events (MACCE) included all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), and cerebrovascular accident (CVA). Patients in the NCL group were older and had higher Killip class and lower estimated glomerular filtration rate than those in the OCL group. MI, TVR, CVA, and stent thrombosis were not significantly different between the two groups. Incidences of all-cause death and MACCE were lower in the OCL than in the NCL group (all-cause death: 10.9 % vs 31.5 %, P < 0.05; MACCE: 27.7 % vs 46.2 %, P < 0.05). After adjusting for patient characteristics, NCL remained at significantly higher risk compared with OCL for in-hospital and all-cause death (P = 0.001, respectively), and MACCE were not significantly different (odds ratio 1.95, 95 % confidence interval 0.94–4.08; P = 0.07) between groups. Initial multivessel PCI was associated with significantly increased risk of in-hospital death, all-cause death, and MACCE, which was somewhat attenuated in a multivariable model, but the numerically excessive risk with NCL still persisted.     

Intracoronary compared to intravenous bolus abciximab during primary percutaneous coronary intervention in ST-segment Elevation Myocardial Infarction (STEMI) patients reduces 30-day mortality and target vessel revascularization: a randomized trial

Background: Abciximab is beneficial in patients with ST‐segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). However, the optimal administration route of the initial bolus of abciximab, that is, intravenous (IV) versus intracoronary (IC), has been questioned. Preliminary studies suggest that IC‐bolus is superior, probably due to high local concentration. In this study, we assess the short‐term efficacy and safety of IC compared to IV bolus of abciximab in patients with STEMI during pPCI. Methods: In 2006–2008, we randomized 355 STEMI patients who underwent pPCI and had indication for abciximab to either IV or IC bolus followed by a 12‐hour IV infusion. Primary end‐points at 30 days were target vessel revascularization (TVR), recurrent myocardial infarction (MI) or death, and the composite of the three. Secondary end‐points were bleeding complications. Results: The two groups (IV n = 170;IC n = 185) were similar with respect to baseline characteristics. Mortality at 30 days was 5.3% in the IV group compared to only 1.1% in the IC group (P = 0.02). TVR was performed in 9.4% in the IV group compared to 3.8% in the IC group (P = 0.03). No significant difference in MI rates was seen (IV 4.7% vs. IC 2.7%; P = 0.32). We found a significant reduction in the composite end‐point (IV 19.4% vs. IC 7.6%; P = 0.001) in favor of IC use. Major bleeding complications were similar (IV 2.4% vs. IC 1.6%; P = 0.62). Neither difference was observed in minor bleedings (IV 14.1% vs. IC 9.7%; P = 0.20). Conclusion: IC administration of bolus abciximab in STEMI patients undergoing pPCI reduces 30‐day mortality and TVR and tends to reduce MI, compared to IV‐bolus. (J Interven Cardiol 2011;24:105–111)     

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Background

It has been reported that sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there might be differences between these two drug‐eluting stents in terms of efficacy and safety in the setting of acute ST‐segment elevation myocardial infarction (STEMI).

Hypothesis

The aim of the present study was to compare SES with PES in patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI).

Methods

The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. Internet‐based sources of information on the results of clinical trials in cardiology were also searched.

Results

A total of 4 randomized trials were included in the present meta‐analysis, involving 1105 patients (550 in the SES group, 555 in the PES group). SES were significantly more effective in the reduction of angiographic binary (≥50%) restenosis (4.0% vs 9.6%, odds ratio 0.38, 95% confidence interval 0.19 to 0.74, P = 0.004) compared to PES. The differences between SES and PES were not statistically significant with respect to target vessel revascularization (TVR), stent thrombosis, cardiac death, and myocardial infarction.

Conclusions

SES are superior to PES in reducing the incidence of restenosis in patients undergoing primary PCI for STEMI, with nonsignificant differences in terms of TVR, cardiac death, myocardial infarction, and stent thrombosis. Copyright © 2010 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Drug-eluting stents are associated with similar cardiovascular outcomes when compared to bare metal stents in the setting of acute myocardial infarction

BACKGROUND: Recent randomized trials have demonstrated conflicting results regarding the use of drug-eluting stents (DESs) as compared to bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI). We compared outcomes among patients presenting with acute ST-elevation myocardial infarction (STEMI) who received DES with those who received BMS. METHODS: In-hospital, 30-day, 6-month, and 1-year outcomes of a cohort of 122 patients who underwent primary or facilitated PCI and received a BMS were compared to 122 propensity-matched patients who received a DES. Seventy-two patients received sirolimus-eluting stents, and 50 received paclitaxel-eluting stents. RESULTS: Baseline demographics were similar among groups. One-, 6-, and 12-month outcomes, including reinfarction, death, stent thrombosis, and target vessel revascularization (TVR), were similar among groups. At 1 year, all-cause mortality was 13.3% in the BMS group and 9.2% in the DES group [P=not significant (ns)], recurrent MI was 5.3% in the BMS group vs. 4.4% in the DES group (P=ns), and TVR was 7% in the BMS group vs. 8.7% in the DES group (P=ns). CONCLUSIONS: Our data do not support the general use of DES in the setting of STEMI given similar cardiovascular outcomes among patients receiving BMS or DES, the need for long-term dual antiplatelet therapy with DES, and the possible repercussions of very late stent thrombosis.