Drug-Eluting Versus Bare-Metal Stents in Older Patients: A Meta-Analysis of Randomized Controlled Trials

BackgroundDespite the high prevalence of ischemic heart disease in older patients, there is a substantial lack of evidence to guide clinical decision-making in this population. Hence, we performed a meta-analysis to determine the safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus bare-metal stents (BMS).MethodsElectronic databases were searched for randomized trials comparing DES with BMS in patients ≥70 years-old. The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes included different ischemic and bleeding events. Subgroup analyses for dual-antiplatelet therapy (DAPT) duration were conducted.ResultsWe included 7 trials with a total of 5449 patients. The use of DES compared with BMS was associated with a significant reduction in MACE (odds ratio [OR]:0.76; 95% confidence interval [CI]:0.62–0.93; P = 0.007) with no increased risk of bleeding events (OR: 1.07; 95% CI: 0.89–1.27; P = 0.48). However, longer duration of DAPT (>6 months) for the DES group increased bleeding events (OR: 1.52; 95% CI: 1.05–2.20; P = 0.03). In contrast, shorter DAPT showed persistent efficacy in reducing MACE in DES-treated patients with no increased bleeding events (OR: 0.72; 95% CI: 0.60–0.87; P < 0.01 and OR: 1.01; 95% CI: 0.84–1.22; P = 0.89, respectively).ConclusionsIn older patients who had undergone PCI, DES showed superior efficacy in reducing MACE with no increased risk of bleeding compared with BMS. Persistent MACE reduction was evident with shorter DAPT durations in DES-treated patients.SummaryThis meta-analysis of randomized clinical trials demonstrated that drug-eluting stents were associated with a significant reduction in major adverse cardiovascular events with no increased risk of bleeding compared with bare-metal stents. The risk of bleeding was high with longer dual antiplatelet therapy duration for patients who underwent DES placement. However, short duration of dual antiplatelet therapy substantially reduced major adverse cardiovascular events with no increased bleeding risk.     

Risk of Long‐Term Dual Antiplatelet Therapy Following Drug‐Eluting Stent Implantation in Octogenarians

Objectives

To evaluate the risk of long‐term dual antiplatelet therapy (DAT) following drug‐eluting stent (DES) implantation in octogenarians.

Background

DES implantation requires DAT; however, DAT‐associated risk in octogenarians remains unclear.

Methods

Two‐hundred and six consecutive octogenarians (130 men, 83.3 ± 3.4 years) underwent stent implantation (104 bare metal stents [BMSs] and 102 DESs) and 38.0 ± 13.2 months of follow‐up.

Results

Significantly more DES patients received DAT. The incidence of bleeding events was similar in the DES and BMS groups for 1 year (total: 10.8% vs 5.8%, P = 0.19; major: 4.9% vs 2.9%, P = 0.70). However, after 2 years, significantly more bleeding events occurred in the DES group than the BMS group (total: 2 years, 21.6% vs 9.6%, P = 0.02; 3 years, 29.4% vs 11.5%, P = 0.001; 4 years, 31.4% vs 15.4%, P = 0.007; major: 2 years, 12.7% vs 3.8%, P = 0.04; 3 years, 18.6% vs 5.8%, P = 0.005; 4 years, 19.6% vs 6.7%, P = 0.006). Overall, significantly more total bleeding events (31.4% vs 15.4%, P = 0.007) and major bleeding events (19.2% vs 6.7%, P = 0.006) were observed in the DES group than in the BMS group. The adjusted hazard ratios and 95% confidence intervals (CI) were as follows: total bleeding events, 2.203 (95% CI: 1.065–4.556; P = 0.033); major bleeding events, 4.324 (1.506–12.414; P = 0.007).

Conclusions

DAT was associated with an increased risk of bleeding events in octogenarians after 2 years. DAT discontinuation should be considered for octogenarians 1‐year post‐DES implantation. (J Interven Cardiol 2013;26:114–122)

     

Clinical Outcome of First‐ vs Second‐Generation DES According to DAPT Duration: Results of ARCTIC‐Generation

There is an apparent benefit with extension of dual antiplatelet therapy (DAPT) beyond 1 year after implantation of drug‐eluting stents (DES). Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs a Monitoring‐Guided Strategy for Drug‐Eluting Stent Implantation, and of Treatment Interruption vs Continuation One Year After Stenting (ARCTIC)‐Generation assessed whether there is a difference of outcome between first‐ vs second‐generation DES and if there is an interaction with DAPT duration in the ARCTIC‐Interruption study. ARCTIC‐Interruption randomly allocated 1259 patients 1 year after stent implantation to a strategy of interruption of DAPT (n = 624), in which aspirin antiplatelet treatment only was maintained, or DAPT continuation (n = 635) for 6 to 18 additional months. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization. A total of 520 and 722 patients received a first‐ and a second‐generation DES, respectively. After a median follow‐up of 17 months (interquartile range, 15–18 months) after randomization, the primary endpoint occurred in 32 (6.2%) and 19 (2.6%) patients with first‐ and second‐generation DES, respectively (hazard ratio: 2.31, 95% confidence interval: 1.31‐4.07, P = 0.004). This was observed irrespective of the strategy of interruption or continuation of DAPT and timing of study recruitment. Major bleeding events occurred in 4 (0.8%) and 3 patients (0.4%) with first‐ and second‐generation DES, respectively (hazard ratio: 1.79, 95% confidence interval: 0.40‐8.02, P = 0.44). Results did not change after multiple adjustments for potential confounding variables. ARCTIC‐Generation showed worse clinical outcome with first‐ vs second‐generation DES, a difference that appeared to persist even with prolonged DAPT.     

Meta-Analysis of the Efficacy and Safety of P2Y12 Inhibitor Monotherapy After Short Course of Dual-Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention

BackgroundGuidelines recommend dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) placement for ≥12 months in acute coronary syndrome or 6 months in stable coronary artery disease. However, with the advent of newer-generation stents, the optimal duration of DAPT to balance bleeding and thrombotic risks has been debated.ObjectivesWe aimed to perform a meta-analysis of randomized controlled trials (RCT) comparing P2Y₁₂ monotherapy in short-duration group (SDG) vs. standard treatment group (STG) course of DAPT in patients undergoing PCI.MethodsElectronic databases were searched for RCTs of patients undergoing percutaneous coronary intervention (PCI) with DES placement who received short (≤ 3 months) vs. standard DAPT course (≥12 months) and were followed for ≥12-months. Rates of major adverse cardiovascular events (a composite of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke) were the primary outcome. Study-specific odds ratios (OR) and corresponding 95% confidence intervals were calculated using random-effects model.ResultsA total of 20,706 patients (10,344 in the SDG and 10,362 in the STG) were analysed from four studies. There was no significant difference observed for MACE (OR = 0.95, 95% CI: 0.81–1.08, P = .92, I² = 0%) myocardial infarction or stent thrombosis. However, lower rates of major bleeding were noted in the SDG (1.20 vs. 1.80%; OR: 0.61; 95% CI: 0.37–0.99; P = .04; I² = 71%) albeit with increased heterogeneity.ConclusionA short duration of DAPT followed by P2Y₁₂ inhibitor monotherapy was comparable to 12 months of DAPT with respect to MACE and thrombotic events, with lower rates of major bleeding events in select group of patients undergoing PCI. More data is needed to assess efficacy in patients with complex lesions and high risk ACS population including those with STEMI presentation.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

Comparison of three-year clinical outcomes with nonextended versus extended dual antiplatelet therapy between first- and second-generation drug-eluting stent implantation in patients with acute myocardial infarction: data from the infarct prognosis study registry

Background: The difference of the clinical outcomes between nonextended (≤12 months) and extended (>12 months) dual antiplatelet therapy (DAPT) remains unclear in patients with acute myocardial infarction (AMI) implanted by different generations of drug‐eluting stent (DES). Methods: We identified 790 consecutive patients with AMI who were free from major adverse cardiac events for 12 months after first‐generation (n = 537) or second‐generation DES (n = 253) implantation; each DES generation group was further divided into nonextended and extended DAPT. Results: During follow‐up (median: 40 months), nonextended DAPT in the first‐generation DES group showed a higher rate of cardiac death or MI than was observed in the extended DAPT group (14% vs 2%, P < 0.001). However, in the second‐generation DES group, there was no difference in the occurrence of cardiac death and MI between the extended and nonextended groups (4% vs 3%, P = 0.809). Nonextended DAPT was the most significant predictor of cardiac death and MI for first‐generation DES implantation [hazard ratio (HR) = 5.47, 95% confidence interval (CI) = 1.53–19.59, P = 0.009] but not for second‐generation DES implantation [HR = 3.21, 95% CI = 0.21–50.65, P = 0.401]. Conclusion: This study suggested that the clinical outcomes between nonextended and extended DAPT might be different depending on the generation of implanted DESs in patients with AMI. (J Interven Cardiol 2012;25:245–252)     

Antithrombotic Regimens for Patients Taking Oral Anticoagulation After Coronary Intervention: A Meta‐analysis of 16 Clinical Trials and 9185 Patients

The optimal antithrombotic regimen remains controversial in patients taking oral anticoagulation (OAC) undergoing coronary stenting. This study sought to compare efficacy and safety outcomes of triple therapy (OAC, aspirin, and clopidogrel) vs dual therapy (clopidogrel with aspirin or OAC) in these patients. We hypothesize OAC plus clopidogrel could be the optimal regimen for patients with indications for OAC receiving stent implantation. Medline, the Cochrane Library, and other Internet sources were searched for clinical trials comparing the efficacy and safety of triple vs dual therapy for patients taking OAC after coronary stenting. Sixteen eligible trials including 9185 patients were identified. The risks of major adverse cardiac events (odds ratio [OR]: 1.06, 95% confidence interval [CI]: 0.82‐1.39, P = 0.65), all‐cause mortality (OR: 0.98, 95% CI: 0.76‐1.27, P = 0.89), myocardial infarction (OR: 1.01, 95% CI: 0.77‐1.31, P = 0.97), and stent thrombosis (OR: 0.91, 95% CI: 0.49‐1.69, P = 0.75) were similar between triple and dual therapy. Compared with dual therapy, triple therapy was associated with a reduced risk of ischemic stroke (OR: 0.57, 95% CI: 0.35‐0.94, P = 0.03) but with higher major bleeding (OR: 1.52, 95% CI: 1.11‐2.10, P = 0.01) and minor bleeding (OR: 1.59, 95% CI: 1.05‐2.42, P = 0.03). Subgroup analysis indicated there were similar ischemic stroke and major bleeding outcomes between triple therapy and therapy with OAC plus clopidogrel. Treatment with OAC and clopidogrel was associated with similar efficacy and safety outcomes compared with triple therapy. Triple therapy could be replaced by OAC plus clopidogrel without any concern about additional risk of thrombotic events.     

Prasugrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Trials

Purpose

Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor or prasugrel is the mainstay of treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We aimed to systematically perform a head-to-head comparison of ticagrelor vs prasugrel in terms of efficacy and safety.

Methods

We searched PubMed/Medline, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) for relevant published randomized controlled trials (RCTs). The primary outcome was adverse cardiovascular events and secondary outcome was bleeding events. A random-effects meta-analysis was used to obtain the pooled estimate of each outcome.

Results

Nine RCTs with a total number of 6990 patients (3550 treated with prasugrel and 3481 treated with ticagrelor) were included. No significant difference between prasugrel and ticagrelor was observed in terms of mortality (OR 0.86, 95% CI 0.66 to 1.13, P?=?0.28), major adverse cardiovascular events (MACEs) (OR 0.85, 95% CI 0.70 to 1.03, P?=?0.10), non-fatal myocardial infarction (OR 0.78, 95% CI 0.57 to 1.06, P?=?0.11), stroke (OR 1.02, 95% CI 0.60 to 1.72, P?=?0.95), stent thrombosis (OR 0.76, 95% CI 0.47 to 1.21, P?=?0.25), thrombolysis in myocardial infarction (TIMI) defined major (OR 0.94, 95% CI 0.19 to 4.67, P?=?0.94), minor (OR 0.35, 95% CI 0.08 to 1.62, P?=?0.18) and minimal (OR 0.48, 95% CI 0.19 to 1.18, P?=?0.11) bleeding and Bleeding Academic Research Consortium (BARC) defined bleeding (OR 1.06, 95% CI 0.82 to 1.36, P?=?0.68).

Conclusion

In patients with ACS undergoing PCI, both prasugrel and ticagrelor were associated with similar cardiovascular outcomes and adverse bleeding events.

     

Increased bleeding events with the addition of apixaban to the dual anti-platelet regimen for the treatment of patients with acute coronary syndrome: A meta-analysis

Background:Dual anti-platelet therapy (DAPT) with aspirin and clopidogrel has been the mainstay of treatment for patients with acute coronary syndrome (ACS). However, the recurrence of thrombotic events, potential aspirin and clopidogrel hypo-responsiveness, and other limitations of DAPT have led to the development of newer oral anti-thrombotic drugs. Apixaban, a new non-vitamin K antagonist, has been approved for use. In this meta-analysis, we aimed to compare the bleeding outcomes observed with the addition of apixaban to DAPT for the treatment of patients with ACS.Methods:Online databases including EMBASE, Cochrane Central, http://www.ClinicalTrials.gov, MEDLINE and Web of Science were searched for English based publications comparing the use of apixaban added to DAPT for the treatment of patients with ACS. Different categories of bleeding events and cardiovascular outcomes were assessed. The analysis was carried out by the RevMan software version 5.4. Odds ratios (OR) with 95% confidence intervals (CI) were used to represent the data following analysis.Results:This research analysis consisted of 4 trials with a total number of 9010 participants. Thrombolysis in myocardial infarction (TIMI) defined major bleeding (OR: 2.45, 95% CI: 1.45–4.12; P = .0008), TIMI defined minor bleeding (OR: 3.12, 95% CI: 1.71–5.70; P = .0002), International society of thrombosis and hemostasis (ISTH) major bleeding (OR: 2.49, 95% CI: 1.80–3.45; P = .00001) and Global Use of Strategies to Open Occluded Arteries (GUSTO) defined severe bleeding (OR: 3.00, 95% CI: 1.56–5.78; P = .01) were significantly increased with the addition of apixaban to DAPT versus DAPT alone in these patients with ACS. However fatal bleeding (OR: 10.96, 95% CI: 0.61–198.3; P = .11) was not significantly different.Conclusions:Addition of the novel oral anticoagulant apixaban to the DAPT regimen significantly increased bleeding and therefore did not show any beneficial effect in these patients with ACS. However, due to the extremely limited data, we apparently have to rely on future larger studies to confirm this hypothesis.     

Comparison of single‐ versus two‐stent techniques in treatment of unprotected left main coronary bifurcation disease

Background : This study sought to compare 3‐year outcomes of single‐ versus two‐stent techniques in patients with distal unprotected left main coronary artery (LMCA) disease treated with drug‐eluting stents (DES). Methods and Results : A total of 392 patients with distal unprotected LMCA disease who underwent DES implantation with single‐ (n = 234) or two‐ (n = 158) stent techniques were evaluated. The primary end point was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). The two‐stent group was more likely to have extensive coronary artery stenosis. After adjustment with weighted Cox model using the inverse probability of treatment weighting, the 3‐year risk of death was similar in the single‐ and two‐stent groups (hazard ratio [HR], 0.77, 95% confidence interval [CI], 0.28–2.13, P = 0.62). However, the 3‐year risks of MI (HR, 0.38, 95% CI, 0.19–0.78, P = 0.008), TLR (HR, 0.16, 95% CI, 0.05–0.57, P = 0.005), and MACE (HR, 0.89, 95% CI, 0.22–0.67, P = 0.0007) were significantly lower in the single‐stent group. Conclusion : Compared with the two‐stent technique, the single‐stent technique showed more favorable long‐term clinical outcomes in patients with distal unprotected LMCA disease who received DES. © 2011 Wiley‐Liss, Inc.     

Clinical Outcomes of Biodegradable Polymer Drug‐Eluting Stents for Percutaneous Coronary Intervention: An Updated Meta‐analysis of Randomized Controlled Trials

Biodegradable polymer drug‐eluting stents (DES) are innovative concepts in the era of percutaneous coronary intervention. We systematically reviewed the latest randomized evidence on the efficacy and safety of biodegradable polymer DES as compared to durable polymer DES. MEDLINE, Embase, and the Cochrane database were searched in August 2013 for eligible randomized controlled trials (RCTs) comparing biodegradable polymer DES with durable polymer DES. Clinical outcomes of interest were mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis. A total of 20 RCTs randomizing 20 021 participants were included, of whom 11 045 were allocated to biodegradable polymer DES and 8976 to durable polymer DES. Treatment of biodegradable polymer DES was not associated with a significant reduction of any of the clinical outcomes (all‐cause mortality, odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.80 to 1.10, P = 0.42; cardiovascular mortality, OR: 0.97, 95% CI: 0.79 to 1.19, P = 0.74; MI, OR: 1.07, 95% CI: 0.91 to 1.26, P = 0.41; TLR, OR: 0.87, 95% CI: 0.69 to 1.08, P = 0.20; TVR, OR: 1.05, 95% CI: 0.85 to 1.28, P = 0.67; definite/probable stent thrombosis, OR: 0.80, 95% CI: 0.59 to 1.07, P = 0.14). Current randomized data indicate that clinical efficacy and safety profiles of biodegradable polymer DES are comparable to those of durable polymer DES. Findings from large‐scale studies with rigorous methodology and long follow‐up duration are needed.     

Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis

Objective Uncertainty exists regarding the relative performance of drug-eluting stents (DES) versus bare-metal stents (BMS) in octogenarians undergoing percutaneous coronary intervention (PCI). We undertook a meta-analysis to assess outcomes for DES and BMS in octogenarians undergoing PCI. Methods Electronic data bases of PubMed, Cochrane, and EMBASE were searched. We included randomized, controlled clinical trials (RCT) and observational studies comparing DES and BMS in octogenarians receiving PCI. The methodological qualities of eligible trials were assessed using a “risk of bias” tool. The endpoints included all-cause death, major adverse cardiac events (MACE), myocardial infarction (MI), target vessel revascularization (TVR), major bleeding, and stent thrombosis (ST). Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated for each endpoint. Results A total of one RCT and six observational studies were included and analyzed in this meta-analysis. All trials were of acceptable quality. At 30 days, compared with DES-treated patients, BMS-treated patients had a higher incidence of mortality (OR: 3.91, 95% CI: 1.10–13.91; P = 0.03). The OR for MACE (1.52, 95% CI: 0.56–4.17; P = 0.13), MI (0.81, 95% CI: 0.37–2.17; P = 0.23), TVR (0.75, 95% CI: 0.17–3.41; P = 0.41), major bleeding (0.77, 95% CI: 0.35–1.68; P = 0.43), and ST (1.44, 95% CI: 0.32–6.45; P = 0.33) did not reach statistical significance. At one year follow-up, the OR did not favor BMS over MACE (MACE, defined as the composite of death, myocardial infarction, and TVR) (1.87; 95% CI: 1.22–2.87; P < 0.01), MI (1.91, 95% CI: 1.22–2.99; P < 0.01), TVR (3.08, 95% CI: 1.80–5.26; P < 0.01) and ST (3.37, 95% CI: 1.12–10.13; P < 0.01). The OR for mortality (1.51; 95% CI: 0.92–2.47; P = 0.10) and major bleeding (0.85, 95% CI: 0.47–1.55; P = 0.60) did not reach statistical significance. At > 1 year follow-up, the OR for all endpoints, including mortality, MACE, MI, TVR, major bleeding, and ST, did not reach statistical significance. Conclusions Our meta-analysis suggests that DES is associated with favorable outcomes as compared with BMS in octogenarians receiving PCI.     

Impact of abciximab on mortality and reinfarction in patients with acute ST‐segment elevation myocardial infarction treated with primary stenting

Objectives: To combine data from all randomized trials of abciximab versus placebo or open‐label control in patients with STEMI treated with primary stenting to assess the short‐term and long‐term mortality, reinfarction, and bleeding complications. Background: Clinical trials of adjunctive abciximab therapy in patients with ST‐segment elevation myocardial infarction (STEMI) undergoing primary stenting have produced conflicting results. Methods: Formal searches of electronic databases (Medline, Cochrane) from January 1990 to April 2009 were performed. Five trials randomizing 2,937 patients (1,475 in the abciximab group, 1,462 in the placebo group) were included in the analysis. Results: When compared with placebo, abciximab was not associated with a significant reduction in the odds of 30‐day (OR 0.71, 95% CI: 0.45–1.14, P = 0.16) or long‐term (OR 0.85, 95% CI: 0.48–1.50, P = 0.57) mortality. Similarly, the rate of reinfarction was not statistically different at 30 days (OR 0.59, 95% CI: 0.30–1.17, P = 0.13) or at long‐term follow‐up (OR 0.67; 95% CI: 0.39–1.16, P = 0.16). However, when trials with upstream use of thienopyridines were excluded, abciximab was associated with a significant reduction in the composite of death or reinfarction at 30 days (OR 0.45; 95% CI: 0.26–0.77, P = 0.004) but not at long‐term follow‐up (OR 0.59; 95% CI: 0.27–1.28, P = 0.18). Conclusion: Routine use of abciximab in patients with STEMI treated with primary stenting may reduce short‐term rates of death or reinfarction in patients not administered preprocedural thienopyridine therapy, but does not appear to be beneficial in those who receive preprocedural thienopyridines. © 2009 Wiley‐Liss, Inc.     

A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis

Aims: Studies demonstrate that percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta‐analysis to compare outcomes between BMS and DES in SVG PCI. Methods and Results: A search (2004–2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta‐analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta‐analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53–0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51–0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43–0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41–0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. Conclusions: Our meta‐analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed. (J Interven Cardiol 2011;24:172–180)     

Efficacy and safety of ticagrelor monotherapy in patients following percutaneous coronary intervention: A systematic review and meta-analysis

Background:We aimed to systematically evaluate the efficacy and safety ticagrelor monotherapy following percutaneous coronary intervention.Methods:Online databases were searched for relevant studies (published between the years 2015 and 2020) comparing 1-month Dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy with 12-month DAPT followed by 12-month aspirin monotherapy following percutaneous coronary intervention. Primary outcomes assessed efficacy whereas secondary outcomes assessed safety. Odds ratios (OR) with 95% confidence intervals (CIs) based on a random effect model were calculated and the analysis was carried out by the RevMan 5.3 software.Results:Only 6 studies were selected for this meta-analytical research. The meta-analysis results: MI(OR:0.96, 95% CI:0.86–1.06, P = .40), stroke (OR:1.04, 95% CI: 0.87–1.25, P = .68), stent thrombosis (OR: 0.91,95% CI:0.76–1.10,P = .32),New-Q Wave (OR:0.85,95% CI: 0.72–1.00, P = .05), all cause death (OR:0.91, 95% CI: 0.87–0.96, P < .0001), death from cardiovascular (OR: 0.76, 95% CI: 0.58–0.99, P = .04), revascularization (OR: 0.93, 95% CI: 0.87–0.99, P = .03). Ticagrelor monotherapy was associated with a significantly lower rate of myocardial Infarction (MI), stroke, stent thrombosis, all cause death, death from cardiovascular and revascularization (OR:0.91,95% CI:0.87–0.96, P < .0001) when compared to DAPT. Besides, DAPT was associated with a significantly higher rate of BARC3 or 5 bleeding (OR:0.85, 95% CI: 0.68–1.06; P = .16) when compared to ticagrelor. When bleeding was further subdivided, minor or major bleeding was also significantly higher with DAPT (OR: 0.72, 95% CI: 0.41–1.27; P = .26). GUSTO moderate or severe bleeding was also significantly higher with DAPT (OR: 0.77, 95% CI: 0.39–1.52; P = .45).Conclusion:Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) can optimize ischemic and bleeding risks. And, it can reduce the occurrence of events outcome (MI, revascularization, stroke, stent thrombosis).     

Drug-eluting stents vs. intracoronary brachytherapy for in-stent restenosis: a meta-analysis

Background:

It has been reported that drug‐eluting stents (DES) were superior to intracoronary brachytherapy (ICBT) in patients with in‐stent restenosis (ISR). However, it is unknown whether there might be differences between DES and ICBT in terms of efficacy and safety in large sample size and long‐term follow‐up.

Hypothesis:

The aim of this study was to determine whether DES implantation remains favorable in large sample size and long‐term follow‐up when compared with ICBT among patients with ISR.

Methods:

We conducted a search in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials without language restrictions. A meta‐analysis of 1942 cases from 12 controlled trials of DES vs ICBT for ISR was performed.

Results:

Drug‐eluting stents were significantly more effective in reducing target‐vessel revascularization (TVR) (odds ratio [OR]: 0.44, 95% confidence interval [CI]: 0.23–0.81, P = 0.009) and binary restenosis (OR: 0.34, 95% CI: 0.26–0.46, P<0.00001) compared with ICBT at midterm follow‐up. There were no significant differences between DES and ICBT in cardiac death, myocardial infarction (MI), and late stent thrombosis at midterm follow‐up. A statistical significance has been found between the 2 groups in TVR (OR: 0.61, 95% CI: 0.43–0.86, P = 0.005) at long‐term follow‐up. There were no significant differences in cardiac death and MI between the 2 groups at long‐term follow‐up.

Conclusions:

These findings provide evidence that DES is superior to ICBT for the treatment of ISR in TVR and binary restenosis reduction, but not in cardiac death, MI, and late stent thrombosis reduction. © 2011 Wiley Periodicals, Inc. Yong‐Guang Lu, MD, and Yan‐Mei Chen, MD, contributed equally to this work. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Long‐term clinical outcomes of successful versus unsuccessful revascularization with drug‐eluting stents for true chronic total occlusion

Objectives: The aims of this study were to investigate the long‐term clinical outcomes of patients with successful versus unsuccessful revascularization with drug‐eluting stents (DES) for chronic total occlusion (CTO). Background: The benefits of successful revascularization of CTO remain unclear. Methods: Consecutive patients (n = 333) with “true” CTO, defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 on angiography and duration ≥3 months, were divided into two groups, those with successful (CTO success group, n = 251) and unsuccessful (CTO failure group, n = 82) revascularization with DES for CTO lesions. The primary endpoint was defined as major adverse cardiac events (MACE) the composite of death, Q‐wave myocardial infarction (MI), or target vessel revascularization (TVR). Results: The CTO success group was significantly younger, with a higher involvement of LAD, and lower incidences of renal failure, previous myocardial infarction, and previous coronary intervention than the CTO failure group. After a median follow up of 1,317 days (interquartile range, 1,059–1,590 days), there were no significant between‐group differences in rate of MACE, both after crude analysis (9.4% vs. 11.8%, log‐rank P = 0.16) and after adjustment (HR 1.17; 95% CI 0.47–2.88, P = 0.53). On multivariate analysis, major predictors of MACE were left ventricle ejection fraction (LVEF) <40% (HR 3.14; 95% CI 1.39–7.09, P = 0.005) and multiple CTO (HR 2.38; 95% CI 1.01–5.71, P = 0.049). Conclusions: Long‐term clinical outcomes were similar in the CTO success and failure groups. Multiple CTOs and LVEF <40% in CTO patients were independent predictors of MACE. © 2011 Wiley‐Liss, Inc.     

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

Aspirin and clopidogrel with or without phenprocoumon after drug eluting coronary stent placement in patients on chronic oral anticoagulation

Objectives. Optimal antithrombotic/anticoagulation therapy in patients on chronic oral anticoagulation (OAC) undergoing drug‐eluting stent (DES) implantation is unknown. We investigated the efficacy and safety of two regimens of antithrombotic/anticoagulation therapy in patients who present for DES implantation whilst on OAC. Methods. We included a series of 515 patients on OAC who underwent DES implantation between 2002 and 2007. Based on predefined clinical and echocardiographic criteria, 306 patients continued OAC (triple therapy) and 209 patients discontinued OAC (dual therapy) for the time they received antiplatelet therapy with clopidogrel and aspirin [stent‐related antithrombotic treatment (SRAT)]. The primary end point was a composite of death, myocardial infarction, stent thrombosis or stroke. Results. During SRAT the primary endpoint was observed in 13 patients in the group with triple therapy versus 15 patients in the group with dual therapy [Kaplan–Meier estimates 4.2% and 7.2%, odds ratio (OR) = 0.61, 95% confidence interval (CI) 0.29–1.28; P = 0.19]. At 2 years of follow‐up, the primary endpoint was observed in 35 patients in the group with triple therapy versus 36 patients in the group with dual therapy (Kaplan–Meier estimates 14.1% and 18.0%, OR = 0.76, 95% CI: 0.48–1.21; P = 0.25). Two‐year incidence of major bleeding was 1.4% (n = 4, triple therapy) versus 3.1% (n = 6, dual therapy) (P = 0.34). Conclusions. In patients on chronic OAC undergoing DES implantation, clinical and echocardiographic criteria help to define postprocedural antithrombotic/anticoagulation therapy. Based on these criteria, both a double antiplatelet therapy (clopidogrel plus aspirin) and a triple therapy (OAC plus clopidogrel plus aspirin) are associated with favourable safety and efficacy.     

Comparative long-term efficacy and safety of drug-eluting stent versus coronary artery bypass grafting in ostial left main coronary artery disease: analysis of the MAIN-COMPARE registry

Background : To date, drug‐eluting stent (DES) implantation has not been compared with coronary artery bypass grafting (CABG) for ostial left main coronary artery (LMCA) lesions. Methods : Of the 263 patients in the MAIN‐COMPARE registry with ostial LMCA stenosis, 123 were treated with percutaneous coronary intervention (PCI) with DES and 140 with CABG. We compared their 5‐year overall survival, composite outcomes of death, Q‐wave myocardial infarction (MI) or stroke, and target vessel revascularization (TVR) rates. Results : Unadjusted analysis showed no significant differences between CABG and DES in overall survival rates (95% confidence interval (CI) for hazard ratio (HR): 0.44 to 1.77, P = 0.71), composite outcomes (death, Q‐wave MI, or stroke)‐free survival rates (95% CI for HR: 0.41–1.63, P = 0.56), and TVR‐free survival rates (95% CI for HR: 0.79–5.03, P = 0.14). Multivariate adjusted Cox regression analysis also showed no significant between‐group differences in TVR (95% CI for HR: 0.52–3.79, P = 0.49), death (95% CI for HR: 0.79–2.82, P = 0.22) and the composite of death, Q‐wave MI, or stroke (95% CI for HR: 0.65–2.57, P = 0.46). These results were sustained after propensity score adjustment and propensity score matching analysis. Conclusions : DES implantation for ostial LMCA lesions showed similar 5‐year outcomes of death, major adverse events, and TVR compared with CABG. Although meticulous adjustments decreased baseline difference between the two treatments, the absence of statistical significance could be attributable to the size of the study sample and hidden bias. © 2012 Wiley Periodicals, Inc.