Drug-Eluting Versus Bare Metal Stents in Saphenous Vein Graft Intervention: An Updated Comprehensive Meta-Analysis of Randomized Trials

BackgroundDrug eluting stents (DES) are preferred over bare metal stents (BMS) for native coronary artery revascularization unless contraindicated. However, the preferred stent choice for saphenous venous graft (SVG) percutaneous coronary interventions (PCI) is unclear due to conflicting results.MethodsPubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through June 2018. Seven studies (n = 1639) comparing DES versus BMS in SVG-PCI were included. Endpoints were major adverse cardiac events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), in-stent thrombosis, binary in-stent restenosis, and late lumen loss (LLL).ResultsOverall, during a mean follow up of 32.1 months, there was no significant difference in the risk of MACE, cardiovascular mortality, all-cause mortality, MI, stent thrombosis, TVR and TLR between DES and BMS. However, short-term follow up (mean 11 months) showed lower rate of MACE (OR 0.66 [0.51, 0.85]; p = 0.002), TVR (OR 0.47 [0.23, 0.97]; p = 0.04) and binary in-stent restenosis (OR 0.14 [0.06, 0.37]; p < 0.0001) in DES as compared with BMS. This benefit was lost on long-term follow up with a mean follow up 35.5 months.ConclusionIn this meta-analysis of SVG-PCI, DES use was associated with similar MACE, cardiovascular mortality, all-cause mortality, MI, in-stent thrombosis, TVR and TLR compared with BMS during long-term follow up. There was high incidence of MACE noted in both DES and BMS suggesting a need for exploring novel strategies to treat SVG disease to improve clinical outcomes.     

Sex Differences in Clinical Outcomes Following Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery: A Systematic Review and Meta-Analysis

IntroductionPercutaneous coronary intervention (PCI) has emerged as a reasonable alternative to coronary artery bypass graft (CABG) surgery in well-selected patients with unprotected left main coronary disease (LMCD). We conducted a systematic review and meta-analysis with the aim of assessing the impact of sex on outcomes of PCI in patients with unprotected LMCD.MethodsA systematic search of PUBMED, EMBASE, Cochrane, and Google Scholar databases was performed to identify studies comparing the outcomes of men vs. women among patients undergoing PCI for unprotected LMCD. The primary outcome of interest was study defined major adverse cardiac events (MACE) and secondary outcomes were all-cause mortality, cardiac mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and stroke. For all outcomes, pooled odds ratios (OR) with their corresponding 95% confidence intervals (CIs) were calculated using the DerSimonian-Laird random-effects model.ResultsSix studies with a total of 6515 individuals (4954 men, 1561women) with a mean follow up of 36 months were included in the analysis. MACE and MI were significantly higher in women with OR of 1.17 (95% CI 1.01–1.36; p = 0.03) and 1.42 (95% CI 1.07–1.87; p = 0.01) respectively. All-cause mortality, cardiac mortality, and TLR were similar among men and women.ConclusionOur meta-analysis suggests that women undergoing PCI for unprotected LMCD have higher rates of MACE and MI compared to men.     

Efficacy and safety of zotarolimus-eluting stents compared with sirolimus-eluting stents in patients undergoing percutaneous coronary interventions — A meta-analysis of randomized controlled trials

Background

Whether ZES can further improve angiographic and clinical outcomes compared to SES still remains uncertain.

Objectives

The aim of this study was to assess the efficacy and safety of zotarolimus-eluting stents (ZES) compared with sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary interventions (PCI).

Methods

Major electronic information sources were explored for randomized controlled trials comparing ZES with SES among patients undergoing PCI during at least 9 months follow-up. The primary efficacy outcomes were target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE); safety outcomes were stent thrombosis (ST), myocardial infarction (MI), and cardiac death.

Results

Seven comparative studies were identified (a total of 5983 patients). When compared with ZES at 12-month follow‐up, SES significantly reduced risk of MACE (relative risk [RR]: 0.74, 95% confidence interval [CI]: 0.61 to 0.89, p = 0.002), and TLR (RR:0.39; 95% CI: 0.29 to 0.52; p < 0.00001), without significant differences in terms of TVR (RR:0.68, 95% CI: 0.38 to 1.20; p = 0.18), ST (RR:0.71; 95% CI: 0.39 to 1.31; p = 0.28), cardiac death (RR:0.83; 95% CI: 0.49–1.42, p = 0.50) or MI (RR:1.08; 95%CI: 0.80 to 1.45; p = 0.62).

Conclusions

At 12-month follow-up, SES are superior to ZES in reducing the incidences of TLR and MACE in patients undergoing PCI, without significant differences in terms of TVR, ST, cardiac death, and MI.     

Meta-Analysis of Provisional Versus Systematic Double-Stenting Strategy for Left Main Bifurcation Lesions

ObjectiveWe sought to compare the clinical outcomes with provisional versus double-stenting strategy for left main (LM) bifurcation percutaneous coronary intervention (PCI).BackgroundDespite two recent randomized controlled trials (RCTs) and several observational reports, the optimal LM bifurcation PCI technique remains controversial.MethodsPubMed, Cochrane Central Register of Controlled-Trials (CENTRAL), Clinicaltrials.gov, International Clinical Trial Registry Platform were leveraged for studies comparing PCI bifurcation techniques for LM coronary lesions using second-generation drug eluting stents (DES). The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes of interest were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), target vessel or lesion revascularization, and stent thrombosis.ResultsTwo RCTs and 10 observational studies with 7105 patients were included. Median follow-up duration was 42 months (IQR: 25.7). Double stenting was associated with a trend towards higher incidence of MACE (odds ratio [OR] 1.20; 95 % confidence interval [CI] 0.94 to 1.53) compared with provisional stenting. This was mainly driven by higher rates of target lesion revascularization (TLR) (OR 1.50; 95 % CI 1.07 to 2.11). There were no statistically significant differences in the incidence of all-cause mortality, cardiovascular mortality, MI, or stent thrombosis. On subgroup analysis according to the study type, provisional stenting was associated with lower MACE and TLR in observational studies, but not in RCTs.ConclusionFor LM bifurcation PCI using second-generation DES, a provisional stenting strategy was associated with a trend towards lower incidence of MACE driven by statistically significant lower rates of TLR, compared with systematic double stenting. These differences were primarily driven by observational studies. Further RCTs are warranted to confirm these findings.     

Drug-Eluting Stents Versus Bare-Metal Stents in Large Coronary Artery Revascularization: Systematic Review and Meta-Analysis

ObjectivesWe aim to determine if drug eluting stents (DES) are better than bare-metal stents (BMS) in large coronary artery (diameter ≥ 3 mm) percutaneous coronary intervention (PCI).BackgroundDES have become the standard of care for PCI in coronary artery disease (CAD). However, the superiority of DES over BMS in large vessel CAD is not clear and previous studies have shown conflicting results.MethodsRandomized controlled trials (RCTs) comparing outcomes of PCI with BMS and DES for large vessel CAD were identified from the year 2000 to August 2019. The outcomes were studied individually and included all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. Aggregated odds ratio and 95% CI were calculated using a random-effects model.ResultsEight RCTs were included (4 with data for first-generation DES, 3 with data for second-generation DES, and 1 with data for both first- and second-generation DES). Compared to BMS, second generation DES had a significantly lower rate of all-cause mortality (2.4% vs. 3.9%, OR 0.74, 95% CI 0.56–0.98, P 0.04), TLR (3.5% vs. 8.6% OR 0.38 95% CI 0.28–0.53, P < 0.001), and MI (2.1% vs. 2.9% OR 0.73 95% CI 0.53–1.0, P 0.05). The difference in all-cause mortality was not seen with first-generation DES.ConclusionNewer DES are associated with a lower mortality, TLR, and MI and thus should be preferred over BMS for large coronary artery PCI.     

Percutaneous coronary intervention of unprotected left main disease: Five-year outcome of a single-center registry

Introduction and AimsPercutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main coronary artery (ULMCA) lesions. We aimed to evaluate the long-term outcome of patients undergoing ULMCA PCI.Methods and ResultsWe retrospectively analyzed 95 consecutive patients (median EuroSCORE I 2.9 [IQR 1.4;6.1]) who underwent ULMCA PCI between 1999 and 2006, included in a single-center prospective registry. The primary outcome was major adverse cardiovascular events (MACE) defined as all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) at five years. Forty patients (42.1%) were treated in the setting of acute coronary syndrome and 81 patients (85%) had at least one additional significant lesion (SYNTAX score 24.2±11.8). Single ULMCA PCI was performed in 33% (81.1% with drug-eluting stents) and complete functional revascularization was achieved in 79% of the patients. During the observation period, 20 patients died (21.1%), 6 (6.3%) had MI and 11 (11.6%) had TLR (total combined MACE 28.4%). Independent predictors of MACE were previous MI (HR 2.9 95% CI 1.23–6.92; p=0.015), hypertension (HR 5.7 95% CI 1.86–17.47; p=0.002) and the EuroSCORE I (HR 1.1 95% CI 1.03–1.12; p=0.001). Drug-eluting stent implantation was associated with a significantly lower MACE rate, even after propensity score adjustment (AUC=0.84; HR [corrected] 0.1; 95% CI 0.04–0.26; p<0.001).ConclusionsUnprotected left main percutaneous coronary intervention, particularly using drug-eluting stents, can be considered a valid alternative to coronary artery bypass grafting, especially in high-risk surgical patients and with favorable anatomic features.     

Incidence and Predictors of Target Lesion Failure in Patients With Lesions in Small Vessels Undergoing PCI With Contemporary Drug-Eluting Stents: Insights From the BIONICS Study

Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI).We aimed to evaluate the outcomes of patients undergoing small-vessel PCI in the BIONICS trial and to identify predictors of stent failure. 1910 patients were randomized to treatment with the EluNIR™ ridaforolimus-eluting stent (RES) or Resolute™ zotarolimus-eluting stent (ZES). Small vessels were defined as reference vessel diameters (RVD) ≤2.5 mm. A Cox proportional hazards model was used to identify predictors of target lesion failure (TLF) through 2 years. Patients undergoing small vessel disease PCI had a higher frequency of diabetes, prior myocardial infarction (MI), and prior PCI. 2 year TLF was higher among patients with small vessels (9.7% vs. 5.9%, HR 1.7 [95% CI 1.22–2.37], p < 0.01), driven by increased rates of target vessel-MI and target lesion revascularization (TLR). Stent thrombosis at 2 years was higher among patients with small vessel disease (1.4% vs. 0.3%, HR 5.25 [95% CI 1.47–18.8], p < 0.01). 2 year TLF rates were similar in the RES and ZES patient groups (P_interaction 0.86). In conclusion, patients undergoing PCI in small vessels have significantly worse outcomes despite the use of contemporary stents.     

Impact of Diabetes Mellitus on Outcomes of Percutaneous Coronary Intervention in Chronic Total Occlusions: A Systematic Review and Meta-Analysis

BackgroundPatients with diabetes mellitus (DM) have a high prevalence of coronary chronic total occlusions (CTOs). We conducted a systematic review and meta-analysis to characterize outcomes after CTO percutaneous coronary intervention (PCI) in patients without or with DM.MethodsPubMed, EMBASE, Cochrane, and Google Scholar were queried for studies comparing non-DM vs. DM patients undergoing attempted CTO PCI. The primary outcome was all-cause mortality at longest follow-up (at least 6 months). Secondary outcomes were major adverse cardiovascular events (MACE) which is a composite endpoint including myocardial infarction, cardiac or all-cause mortality and any revascularization in patients after CTO PCI, target vessel revascularization (TVR), myocardial infarction (MI), Japanese chronic total occlusion (J-CTO) score and prevalence of multivessel (MV) CTO disease. We used a random effects model to calculate odds ratios (ORs) and 95% confidence intervals (CIs).ResultsSixteen studies, including 2 randomized control trials and 14 observational studies, met inclusion criteria. At longest follow-up, all-cause mortality (OR 0.54 [95% CI 0.37–0.80], p < 0.0001) and MACE (OR 0.82 [95% CI 0.72–0.93], p < 0.00001) were significantly lower in non-DM CTO patients. MV CTO disease was less prevalent in patients without DM (OR 0.80 [95% CI 0.69–0.93], p = 0.004). However, there were no differences in MI, TVR and J-CTO score.ConclusionsNon-diabetics undergoing CTO PCI have lower all-cause mortality and MACE than diabetics. Future research may determine if DM control improves diabetics' CTO PCI outcomes.     

Platelet reactivity-adjusted antiplatelet therapy in patients with percutaneous coronary intervention: a meta-analysis of randomized controlled trials

Numerous number of evidences show that high on-treatment platelet reactivity is a well-known risk factor for adverse events in patients after percutaneous coronary intervention (PCI). Controversial situations still exist regarding the effectiveness of tailoring antiplatelet therapy according to platelet function monitoring. The PubMed, Embase, and Cochrane Central databases were searched for randomized trials comparing platelet reactivity-adjusted antiplatelet therapy with conventional antiplatelet therapy in patients undergoing PCI. The primary end point was all-cause mortality, major adverse cardiac events (MACE) including cardiovascular (CV) death, nonfatal myocardial infarction (MI), definite/probable stent thrombosis (ST), revascularization, and stroke or transient ischemic attack (TIA). The safety end point was defined as major bleeding events. We derived pooled risk ratios (RRs) with fixed-effect models. Six studies enrolling 6347 patients were included. Compared with conventional treatment, tailoring antiplatelet failed to reduce all-cause mortality (RR: 0.89, 95% confidence interval [CI]: 0.63–1.24, P = 0.48), MACE (RR: 1.02, 95% CI: 0.92–1.14, P = 0.69), MI (RR: 1.07, 95% CI: 0.95–1.21, P = 0.24), CV death (RR: 0.69, 95% CI: 0.40–1.19, P = 0.09), ST (RR: 0.83, 95% CI: 0.50–1.38, P = 0.23), stroke or TIA (RR: 1.08, 95% CI: 0.55–2.12, P = 0.83), revascularization (RR: 0.96, 95% CI: 0.69–1.33, P = 0.79), and major bleeding events (RR: 0.79, 95% CI: 0.53–1.17, P = 0.24).

Compared with traditional antiplatelet treatment, tailoring antiplatelet therapy according to platelet reactivity testing failed to reduce all-cause mortality, MACE, and major bleeding events in patients undergoing PCI.     

Biodegradable-Polymer Versus Polymer-Free Drug-Eluting Stents for the Treatment of Coronary Artery Disease

Background/purposeBiodegradable-polymer (BP) and polymer-free (PF) drug eluting stents (DES) were developed to reduce the risk of delayed arterial healing observed with durable-polymer (DP) platforms. Although trials demonstrate BP-DES and PF-DES are non-inferior to DP-DES, there is limited data directly comparing these technologies. We performed a meta-analysis to assess the efficacy and safety of BP-DES versus PF-DES for the treatment of coronary artery disease.Methods/materialsElectronic searches were performed identifying randomized trials comparing BP-DES with PF-DES. Co-primary efficacy endpoints were target vessel revascularization (TVR), target lesion revascularization (TLR) and angiographic in-stent late lumen loss (LLL). Co-secondary safety endpoints were all-cause death, myocardial infarction (MI) and stent thrombosis (ST).ResultsOf 208 studies, 5 met inclusion criteria including 1975 patients. At mean follow-up (14 ± 5 months), BP-DES were associated with significantly reduced rates of TVR (OR 0.58, 95%CI 0.37–0.92, p = 0.02), TLR (4.7% vs 9.5%) (OR 0.48, 95%CI 0.31–0.75, p = 0.001) and in-stent LLL (pooled mean difference ?0.20 mm, 95%CI ?0.24 to ?0.16, p < 0.001). There was no difference in safety, including all-cause death (OR 1.24, 95%CI 0.68–2.28, p = 0.48), MI (OR 0.92, 95%CI 0.54–1.56, p = 0.75) or ST (OR 1.58, 95%CI 0.67–3.73, p = 0.30).ConclusionsThese data suggests that BP-DES are more efficacious when compared with PF-DES for the treatment of CAD.     

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration

BackgroundSmall vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.ObjectiveWe examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.MethodsThe COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.ResultsThe study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74–1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93–5.00, p = 0.07.ConclusionsOne-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.     

Percutaneous Coronary Intervention using a Full Metal Jacket with Drug-eluting Stents: Major Adverse Cardiac Events at One Year

Background

The clinical benefit of percutaneous coronary intervention (PCI) for long coronary lesions is unclear; furthermore, concerns have been raised about its safety.

Objectives

To evaluate the predictors of major adverse cardiac events (MACE) associated with PCI using a full metal jacket (FMJ), defined as overlapping drug-eluting stents (DES) measuring > 60 mm in length, for very long lesions.

Methods

We enrolled 136 consecutive patients with long coronary lesions requiring FMJ in our single-center registry. The primary endpoint included the combined occurrence of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Demographic, clinical, angiographic, and procedural variables were evaluated using stepwise Cox regression analysis to determine independent predictors of outcome.

Results

The mean length of stent per lesion was 73.2 ± 12.3 mm and the mean reference vessel diameter was 2.9 ± 0.6 mm. Angiographic success was 96.3%. Freedom from MACE was 94.9% at 30 days and 85.3% at one year. At the one-year follow-up, the all-cause mortality rate was 3.7% (1.5% cardiac deaths), the MI rate was 3.7%, and the incidence of definite or probable stent thrombosis (ST) was 2.9%. Female gender [hazard ratio (HR), 4.40; 95% confidence interval (CI), 1.81-10.66; p = 0.001) and non-right coronary artery PCI (HR, 3.49; 95%CI, 1.42-8.59; p = 0,006) were independent predictors of MACE at one year. Freedom from adverse events at one year was higher in patients with stable angina who underwent PCI (HR, 0.33; 95%CI, 0.13-0.80; p = 0.014).

Conclusions

PCI using FMJ with DES for very long lesions was efficacious but associated with a high rate of ST at the one-year follow-up. However, the rate of cardiac mortality, nonprocedure-related MI, and MACE was relatively low. Target coronary vessel PCI, clinical presentation, and female gender are new contemporary clinical factors that appear to have adverse effects on the outcome of PCI using FMJ for long lesions.     

Bioactive or Drug-Eluting Stents in 75 Years or Older Patients: The BIODES-75 Registry

BackgroundTiNO-coated BAS have demonstrated competitive outcomes compared to drug-eluting stents (DES). These devices allow short antiplatelet regimens and may be a good option for the growing elderly population undergoing percutaneous coronary intervention (PCI).MethodsMulticenter observational trial in routine clinical practice. A propensity-score matched analysis compared a prospective cohort of patients ≥ 75 years undergoing PCI with BAS, with a contemporary and retrospective cohort treated with last-generation DES. The co-primary endpoints of the study were the Target-Lesion-Failure (Cardiac death, non-fatal myocardial infarction, or target lesion revascularization) and Major Adverse Cardiovascular Events (total death, non-fatal myocardial infarction, stroke, or new revascularization) at 1 year.ResultsWhole population included 1000 patients, and 326 patients in each group were matched for analysis. No differences in primary endpoints were found: TLF 10.4% vs. 11% (HR 0.96 (Confidence Interval 95%, 0.36–1.7; p = 0.87)) and MACE 16.3% vs. 17.2% (HR 0.98 (Confidence Interval 95%; 0.3–1.5, p = 0.93)). Patients treated with BAS received shorter antiplatelets regimens (dual antiplatelet therapy at 1 year, 25.7% vs. 70.6%, p = 0.0001), and they presented lower incidence of bleeding (3.7% vs. 11.7%, HR 0.3 (IC 95% 0.16–0.6, p = 0.001)).ConclusionIn this real-life registry of patients ≥ 75 years, BAS were similar to the latest-generation DES in terms of efficacy and reduced the duration of the antithrombotic therapy, lowering bleeding events.     

Long-Term Clinical Outcomes of Biodegradable-Polymer Drug-Eluting Stents Versus Second-Generation Durable-Polymer Drug-Eluting Stents for ST-Segment Elevation Myocardial Infarction

BackgroundBiodegradable polymer drug eluting stents (BP-DES) may offer the advantage of vascular healing in ST-segment elevation myocardial infarction (STEMI). Long-term outcome data comparing BP-DES and second-generation durable polymer drug eluting stents (DP-DES) in STEMI is lacking. This study aims to compare the long-term clinical outcomes of BP-DES versus second-generation DP-DES in STEMI.MethodsThis is an observational study of consecutive patients with STEMI who received either BP-DES (n = 854) or DP-DES (n = 708) during primary percutaneous coronary intervention (PCI) from 1st February 2007 to 31st December 2016. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization with follow up till 30th November 2019.ResultsThe baseline demographics, lesion and procedural characteristic were similar between the two groups except for more prior MI and chronic obstructive pulmonary disease in the BP-DES group. At a median follow up of 4.2 years (interquartile range: 2.6–6.2 years), the incidence of TLF was similar between BP-DES and DP-DES (adjusted hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.70–1.26). Likewise, incidence of major adverse cardiovascular events (MACE: all-cause death, any MI or target vessel revascularization) and definite stent thrombosis were similar in both groups (MACE: adjusted HR 1.04, 95% CI 0.82–1.32; definite stent thrombosis: adjusted HR 1.06, 95% CI 0.31–3.64).ConclusionAmong patients with STEMI who underwent primary PCI, BP-DES and DP-DES implantation was associated with similar long-term clinical outcomes.     

Eventos cardiovasculares major após intervenção coronária percutânea com balão eluidor de fármaco: Resultados a um ano de um registo prospetivo multicêntrico

Introduction and objectivesPercutaneous coronary intervention (PCI) with paclitaxel drug-eluting balloons (DEBs) is used mainly for treatment of in-stent restenosis (ISR) and small vessel disease. Our objective was to evaluate the clinical efficacy of this strategy in a multicenter registry.MethodsBetween 2009 and 2010 a prospective registry from two centers enrolled 156 consecutive patients undergoing PCI with at least one DEB. A primary composite endpoint of major adverse cardiac events (MACE) (all-cause death, myocardial infarction [MI] and target lesion revascularization [TLR]) was assessed at one-year follow-up. Stepwise Cox regression was used to determine independent predictors of outcome.ResultsDEBs (n=206) were used to treat 184 lesions. Procedural success was obtained in 98% of patients (n=150). At one-year follow-up, 86% (n=134) were free of the primary endpoint (6% death, 6% non-procedure related MI and 5% TLR). The independent predictors of MACE at one year were index PCI in the left anterior descending artery (HR 2.81, 95% CI 1.21-6.51; p=0.02) and a history of MI (HR 3.46, 95% CI 1.35-8.84; p=0.01). ISR and DEB diameter or length were not predictors of events.ConclusionsPCI with DEBs in real-world patients with complex lesions is effective, with a low rate of MACE, including TLR, at one-year follow-up. The results are equally good whether the intervention is for ISR or for native coronary disease.     

Cancer Patients Have a Higher Risk of Thrombotic and Ischemic Events After Percutaneous Coronary Intervention

ObjectivesThis study sought to define the risk of stent thrombosis (ST) and myocardial infarction (MI) in cancer patients compared with noncancer patients after percutaneous coronary intervention (PCI).BackgroundCancer patients are considered to be at high thrombotic risk, but data on whether this is the case after PCI remain inconclusive.MethodsCancer patients undergoing PCI at Mayo Clinic Rochester from January 1, 2003, to December 31, 2013, were identified by cross-linking institutional cancer and PCI databases and by propensity score matching to noncancer patients. The combined primary endpoint was all-cause mortality, MI, and revascularization rate at 5-year follow-up. Secondary endpoints were the individual primary endpoint components, cause of mortality, ST, and Bleeding Academic Research Consortium 2+ bleeding.ResultsThe primary endpoint occurred in 48.6% of 416 cancer and in 33.0% of 768 noncancer patients (p < 0.001). In competing risk analyses, cancer patients had a higher rate of noncardiac death (24.0% vs. 10.5%; p < 0.001) and a lower rate of cardiac death (5.0% vs. 11.7%; p < 0.001). Cancer patients had a higher rate of MI (16.1% vs. 8.0%; p < 0.001), ST (6.0% vs. 2.3%; p < 0.001), repeat revascularization (21.2% vs. 10.0%; p < 0.001), and bleeding (6.7% vs. 3.9%; p = 0.03). The most critical period for ST in cancer patients was in the first year after PCI. The dual antiplatelet therapy score was predictive of thrombotic and ischemic events in both groups.ConclusionsCancer patients have a higher risk of thrombotic and ischemic events after PCI, identifiable by a high dual antiplatelet therapy score. These findings have important implications for antiplatelet therapy decisions.     

The efficacy and safety of CYP2C19 genotype-guided antiplatelet therapy compared with conventional antiplatelet therapy in patients with acute coronary syndrome or undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials

Abstract

Cytochrome P450 (CYP) 2C19 genotype is closely associated with the metabolism and efficacy of clopidogrel, thereby having an important impact on clinical outcomes of patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). This study aimed to evaluate the efficacy and safety of CYP2C19 genotype-guided antiplatelet therapy in patients with ACS or undergoing PCI. PubMed, EMBASE, the Cochrane Library and clinicaltrials.gov were searched to identify randomized controlled trials (RCTs) comparing CYP2C19 genotype-guided antiplatelet therapy with conventional therapy in patients with ACS or undergoing PCI. Eight RCTs involving 6708 patients were included in this meta-analysis. CYP2C19 genotype-guided antiplatelet therapy was slightly superior to the conventional antiplatelet therapy in reducing the risk of MACE [RR(95%CI): 0.71(0.51–0.98), p = .04]. Meanwhile, the genotype-guided therapy group had significantly lower incidence of myocardial infarction [RR(95%CI): 0.56(0.40–0.78), p < .01], but similar risk of all-cause mortality, cardiovascular mortality, stent thrombosis, urgent revascularization and stroke compared to the conventional therapy group. Incidences of major/minor bleeding and major bleeding were comparable between the two groups. In patients with ACS or undergoing PCI, CYP2C19 genotype-guided antiplatelet therapy displayed benefit over conventional antiplatelet therapy in reducing the risk of MACE and myocardial infarction, without increasing bleeding risk. Further RCTs are needed to provide more evidences for CYP2C19 genotype-guided antiplatelet therapy.     

Dedicated Tryton Side Branch Stents used in the treatment of coronary bifurcation lesions

IntroductionCoronary bifurcation lesions account for 15–20% of all percutaneous coronary interventions.Dedicated bifurcation stents have recently been introduced with the aim to simplify treatment and improve early and late outcomes following stenting of bifurcation lesions.The purpose of our study was to assess the safety and effectiveness of the Tryton dedicated side branch stent at a 6-month clinical and angiography follow-up.MethodsForty-two patients with bifurcation lesions were included in our study. The primary endpoint was a 6-month MACE and angiographic stent patency was also evaluated by MS-CT coronarography.ResultsTwenty-two patients (52.38%) were treated for acute coronary syndromes, 39 (92.85%) lesions were “true bifurcations”. The 6-month clinical follow-up was performed in all patients. The 6-month MACE rate (cardiac death, myocardial infarction and target lesion revascularization) was 9.52% (95% CI: 2.66–22.62%); of these one patient (2.38%; 95% CI: 0.06–12.57%) died due to cardiogenic shock caused by early stent thrombosis and three patients (7.14%; 95% CI: 1.50–19.48%) required repeated revascularization (TVR) due to in-stent restenosis, all of them in bare metal stents. Tryton stent implantation was successful in 100% lesions.6-Month MS-CT coronarography was performed in 39 (92.85%) patients. The implanted bifurcation Tryton stents were satisfactorily visualized in 97.43% of them and a satisfactory 6-month angiographic patency was demonstrated in 37 patients (88.1%).ConclusionThe usage of a dedicated bifurcation Tryton Side Branch Stent for PCI of the bifurcation lesions is technically feasible with satisfactory long-term results.     

A meta-analysis of randomized controlled trials appraising the efficacy and safety of cilostazol after coronary artery stent implantation

Objectives: To evaluate the impact of cilostazol on the angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with stents and treated with aspirin and thienopyridine. Methods: A total of 11 randomized controlled trials including 8,525 patients comparing triple antiplatelet therapy (aspirin, thienopyridine and cilostazol) with standard dual antiplatelet therapy were included in the analysis. The primary end points were in-segment late loss and angiographic restenosis at angiographic follow-up. Secondary end points included mortality, stent thrombosis, target lesion revascularization (TLR) and major adverse cardiac events (MACE). Results: Triple antiplatelet therapy was associated with a significant reduction in late loss [weighted mean difference 0.14, 95% confidence interval (CI) 0.08-0.20; p < 0.001] and angiographic restenosis [odds ratio (OR) 0.58, 95% CI 0.48-0.71; p < 0.001]. Addition of cilostazol to dual antiplatelet therapy was associated with a significant reduction in TLR (OR 0.56, 95% CI 0.41-0.77; p < 0.001) and MACE (OR 0.72, 95% CI 0.60-0.86; p < 0.001) with no differences in mortality (p = 0.29), stent thrombosis (p = 0.60) or bleeding episodes (p = 0.77). Conclusions: Cilostazol in addition to dual antiplatelet therapy appears to be effective in reducing the risk of restenosis and repeat revascularization after PCI without any significant benefits for mortality or stent thrombosis.     

To kiss or not to kiss? Impact of final kissing-balloon inflation on early and long-term results of percutaneous coronary intervention for bifurcation lesions

Final kissing-balloon inflation is often recommended for percutaneous coronary intervention (PCI) of bifurcation lesions. However, randomized trials focusing on kissing inflation have not confirmed its beneficial impact. We compared outcomes of kissing inflation for PCI of bifurcation lesions, explicitly stratifying results according to stenting strategy. Patients undergoing bifurcation PCI were retrospectively enrolled. Subjects receiving final kissing inflation were compared with those not undergoing kissing inflation, after stratification for a single-stent technique. The primary end point was the long-term rate of major adverse cardiac events (MACE, i.e., death, myocardial infarction, or target lesion revascularization (TLR)). A total of 4314 patients were included: 1176 (27.3 %) treated with a single stent and kissing inflation, 1637 (37.9 %) with a single stent but no kissing, 1072 (24.8 %) with two stents and kissing, and 429 (9.9 %) with two stents but no kissing. At unadjusted analyses kissing was associated with fewer short-term MACE and deaths in the two-stent group, and with fewer long-term MACE, cardiac deaths, and side-branch TLR in the two-stent group (all P < 0.05). Conversely, kissing appeared detrimental after single stenting. However, after multivariable analyses, kissing no longer significantly affected the risk of adverse events, with the exception of the risk of side-branch TLR, which was lower in those receiving two stents and final kissing inflation (hazard ratio = 0.52, 95 % confidence interval 0.30–0.90, P = 0.020). Kissing inflation can be avoided in bifurcation lesions uneventfully treated with single-stent PCI. However, final kissing-balloon inflation appears beneficial in reducing the risk of side-branch repeat revascularization after using a two-stent strategy.