Outcomes of patients with acute coronary syndromes and prior percutaneous coronary intervention: a pooled analysis of three randomized clinical trials.

AIMS: We sought to characterize the outcomes of patients with a prior percutaneous coronary intervention (PCI) who presented with a non-ST-segment elevation acute coronary syndrome (ACS). METHODS AND RESULTS: We analysed the 30 and 180 day outcomes of 3012 patients with prior PCI and 21 154 patients without prior PCI enrolled in three randomized ACS trials (GUSTO IIb, PURSUIT, and PARAGON-B). The median (25th, 75th percentile) interval between the prior PCI and randomization was 647 (123, 1585) days. Patients with prior PCI had significantly more adverse baseline clinical characteristics, left ventricular dysfunction, and multi-vessel coronary artery disease. After adjusting for baseline characteristics and treatment, we found that patients with prior PCI had a significantly lower mortality rate at 30 days [hazard ratio (HR), 0.60; 95% confidence interval (CI), 0.45-0.80; P=0.0006] and 180 days (HR, 0.81; 95% CI, 0.66-0.98; P=0.029). However, no difference was observed in the composite of death or myocardial infarction (MI) at 30 days (HR, 0.95; 95% CI, 0.83-1.08; P=0.42) or 180 days (HR, 1.01; 95% CI, 0.90-1.13; P=0.90). Patients with prior PCI had a higher rate of MI at 180 days (13.3 vs. 12.0%; P=0.045). Prior-PCI patients had lower incidences of in-hospital cardiogenic shock, congestive heart failure (CHF), and atrial fibrillation. CONCLUSION: Patients with prior PCI who present with non-ST-segment elevation ACS have a lower mortality rate than those without prior PCI.     

Impact of gender on in-hospital outcomes following contemporary percutaneous intervention for peripheral arterial disease

BACKGROUND: Percutaneous peripheral arterial intervention (PPAI) has emerged as an effective and less invasive alternative to surgery for peripheral arterial disease (PAD), however, data on gender differences in outcome of PPAI, especially in the stent era, are limited. The purpose of this study was to assess the gender differences on in-hospital outcomes of patients undergoing PPAI. METHODS: We analyzed data on 268 consecutive patients (women: 122; men: 146) who underwent PPAI for PAD between October 2001 and January 2004. A total of 405 lesions (women: 184; men: 221) were treated. RESULTS: Background characteristics were similar except for less prevalent prior coronary intervention in women (18.0% versus 28.8%; p = 0.04), and more prevalent current smokers in women (22.1% versus 12.3%; p = 0.03). Upper extremities interventions were performed more often in women (9.2% versus 3.2%; p = 0.01). Procedure success was achieved in 89.3% of women and 89.7% of men (p = NS). In-hospital mortality was similar between women and men (1.6% versus 0.7%; p = NS). However, hemorrhagic complications occurred more frequently in women (7.4% versus 0.7%; p = 0.006). The blood transfusion rate was significantly higher in women (6.6% versus 0.7%; p = 0.013). Female gender was the only independent predictor of hemorrhagic complications (OR = 12.2; 95% CI = 1.39-111.1; p = 0.024). CONCLUSIONS: Percutaneous intervention for PAD can be performed in women with similar success rates as in men, albeit with a greater than 10-fold higher risk of hemorrhagic complications.     

Meta-analysis of four randomized controlled trials on long-term outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with stenting for multivessel coronary artery disease

To provide a quantitative analysis of long-term clinical outcomes, a meta-analysis of 4 randomized controlled trials of percutaneous coronary intervention (PCI) with stenting versus coronary artery bypass grafting (CABG) for multivessel coronary artery disease was conducted. The search identified 4 randomized controlled trials of PCI with stenting versus CABG that enrolled patients with multivessel coronary artery disease. In conclusion, pooled analysis demonstrated no statistically significant differences in death, cardiac death, Q-wave myocardial infarction, cerebrovascular accidents, and angina pectoris between PCI with stenting and CABG. However, PCI with stenting was associated with a statistically significant increase in subsequent PCI, subsequent CABG, subsequent revascularization (PCI or CABG), and major adverse cardiovascular events relative to CABG.     

Meta-analysis of randomized controlled trials on effect of cilostazol on restenosis rates and outcomes after percutaneous coronary intervention

Cilostazol is a generic drug with antiplatelet and antiproliferative effects. It is unclear whether adding cilostazol to standard dual antiplatelet therapy (aspirin and clopidogrel) after percutaneous coronary intervention reduces restenosis and improves the outcomes. We, therefore, conducted a systematic review and meta-analysis. We systematically searched the Cochrane Library, EMBASE, and MEDLINE databases for randomized controlled trials comparing dual antiplatelet therapy with and without cilostazol after percutaneous coronary intervention. The data were pooled using random-effects models and stratified into short-term (1-month), midterm (1- to 12-month), and long-term (≥12-month) follow-up durations. Twelve randomized controlled trials involving 5,655 patients met our inclusion criteria. The addition of cilostazol to dual antiplatelet therapy was not associated with a significant change in target lesion revascularization (TLR) and target vessel revascularization (TVR) at short-term follow-up. However, TLR and TVR were significantly reduced at midterm follow-up (relative risk 0.57, 95% confidence interval 0.39 to 0.84, and relative risk 0.62, 95% confidence interval 0.47 to 0.83, respectively). Data regarding TLR and TVR at long-term follow-up were limited and inconclusive. We did not find a difference in myocardial infarction, mortality, or major bleeding at any follow-up duration. In conclusion, the addition of cilostazol to dual antiplatelet therapy after percutaneous coronary intervention has favorable effects on TLR and TVR at 1 to 12 months, with no differences in adverse outcomes at any follow-up duration.     

Cangrelor for patients undergoing percutaneous coronary intervention: evidence from a meta-analysis of randomized trials

Cangrelor is a new parenteral adenosine diphosphate P2Y12 receptor inhibitor with rapid, profound and reversible inhibition of platelet activity. The aim of this meta-analysis was to evaluate efficacy and safety of this new agent in patients undergoing percutaneous coronary intervention (PCI). We searched PubMed, Cochrane Library, EMBASE, Web of Science and CINAHL databases from the inception through April 2013. Randomized controlled trials (RCTs) comparing cangrelor with control (clopidogrel/placebo) were selected. We used the random-effects models to calculate the risk ratio. The primary efficacy outcome was risk of myocardial infarction, and the primary safety outcome was TIMI major bleeding at 48 h. Three RCTs included a total of 25,107 participants. Effects of Cangrelor were not different against comparators for myocardial infarction (MI) (Risk ratio [RR] 0.94, 95 % confidence interval [CI] 0.78–1.13) and all-cause mortality (RR 0.72, 95 % CI 0.36–1.43). However, cangrelor significantly reduced the risk of ischemia-driven revascularization (RR 0.72, 95 % CI 0.52–0.98), stent thrombosis (RR 0.60, 95 % CI 0.44–0.82) and Q wave MI (RR 0.53, 95 % CI 0.30–0.92) without causing extra major bleeding (Thrombolysis in Myocardial infarction criteria) and severe or life-threatening bleeding (Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries criteria). Separate analysis against only clopidogrel also showed similar findings except Q wave MI outcome. Use of cangrelor during PCI might reduce the risk of ischemia-driven revascularization and stent thrombosis, without causing extra major bleeding.     

Female gender and mortality after percutaneous coronary intervention: Results from a large registry

Objectives : To investigate if previously reported gender‐based outcome disparities following percutaneous coronary intervention (PCI) are applicable in a large and racially‐diverse cohort in the drug eluting stent (DES) era. Background : It is generally believed that women suffer inferior outcomes compared to men after PCI. However, various strategies have evolved that may have mitigated this imbalance, including improved medical therapy, attention to risk‐factors, and procedural advances of PCI including DES. Methods : We identified 13,752 patients (4,761 female, 34.6%) with complete follow‐up data who underwent de novo lesion PCI from 04/2003 to 04/2009. Relevant data were extracted from an IRB‐approved registry. Results : Compared to males, females were significantly older (69.0 vs. 64.8 years) and more frequently from a minority or non‐Caucasian background. Females smoked less, but more were hypertensive and/or diabetic. Women had higher HDL, but also higher LDL cholesterol levels. More women presented with an unstable coronary syndrome and required left anterior descending artery PCI. While unadjusted post‐PCI mortality rates were higher in females versus males (30 days, 1.3 vs. 0.8%, P = 0.009; 1 year, 6.1 vs. 4.8%, P = 0.001; 3 year, 10.4 vs. 8.4%, P < 0.0001), multivariable regression analyses failed to identify female gender as an independent predictor of mortality. Propensity‐adjusted modeling confirmed that females were not at intrinsically higher risk for mortality after PCI. Conclusions : Females undergoing PCI exhibit more comorbidities and adverse prognostic factors than males. However, risk‐adjusted analyses identified that gender is not an independent predictor of mortality after PCI in the DES era. © 2011 Wiley Periodicals, Inc.     

Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients

Aims Although outcomes after acute myocardial infarction (AMI)seemed to be superior with primary percutaneous coronary intervention(PPCI) relative to fibrinolysis (FL), the extent to which treatmentdelay modulates this treatment effect is unclear. Methods and results Twenty-five randomized trials (n=7743) testingthe efficacy of PPCI vs. FL were identified in journal articlesand abstract listings published between 1990 and 2002. Of these,individual patient data from 22 trials (n=6763) were pooled,and multi-level logistic regression assessed the relationshipamong treatment, treatment delay, and 30-day mortality. Treatmentdelay was divided into ‘presentation delay’ [symptomonset to randomization; FL: median 143 (IQR: 91–225) min;PPCI: 140 (91–220) min] and hospital-specific ‘PCI-relateddelay’ [median time from randomization to PPCI minus mediantime to FL per hospital; median 55 (IQR: 37–74) min].PPCI was associated with a significant 37% reduction in 30-daymortality [adjusted OR, 0.63; 95% CI (0.42–0.84)].Although, there was no heterogeneity in the treatment effectby presentation delay (pBreslow-Day=0.88), the absolute mortalityreduction by PPCI widened over time (1.3% 0–1 h to4.2% >6 h after symptom onset). When the PCI-relateddelay was <35 min, the relative (67 vs. 28% pBreslow-Day=0.004)and absolute (5.4 vs. 2.0%) mortality reduction was significantlyhigher than those with longer delays. Conclusion PPCI was associated with significantly lower 30-daymortality relative to FL, regardless of treatment delay. Althoughlogistic and economic constraints challenge the feasibilityof ‘PPCI-for-all’, the benefit of timely treatmentunderscores the importance of a comprehensive, unified approachto delivery of cardiac care in all AMI patients.     

Contrast use in relation to the arterial access site for percutaneous coronary intervention:A comprehensive meta-analysis of randomized trials

AIM To compare the amount of contrast used during percutaneous coronary intervention(PCI) via trans-radial access(TRA) vs trans-femoral access(TFA).METHODS Scientific databases and websites were searched for:randomizedcontrolledtrials(RCTs). Data were extracted by two independent reviewers and was summarized as the weighted mean difference(WMD) of contrast used with a 95%CI using a random-effects model. RESULTS The meta-analysis included 13 RCTs with a total of 3165 patients. There was no difference between the two strategies in the amount of contrast used(WMD =-0.65 mL,95%CI:-10.94-9.46 mL; P = 0.901). CONCLUSION This meta-analysis shows that in patients undergoing PCI,the amount of contrast volume used was not different between TRA and TFA.     

Metoprolol-induced reduction in postinfarction mortality: pooled results from five double-blind randomized trials.

Several postinfarction trials have evaluated the effect of secondary prophylaxis with different beta-blockers. Although so called meta-analysis of the results from all the trials have shown a beneficial effect of postinfarction beta-blockade, many of the individual studies have shown inconclusive results, mainly due to low statistical power. In order to obtain an evaluation of the merits of postinfarction therapy with metoprolol, data from the five available studies with metoprolol have been pooled into one database. In the total material 5474 patients (4353 men, 1121 women) have been studied during double-blind therapy with metoprolol 100 mg twice daily or matching placebo. The follow-up ranges from 3 months to 3 years. In total 4732 patient years of observation have been obtained. In total there were 223 deaths in the placebo-treated patients as compared to 188 deaths in the metoprolol-treated patients (P = 0.036), which corresponds to mortality rates of 97.0 and 78.3 per 1000 patient years, respectively. The mortality reduction was found both in men and women. As has been reported from individual postinfarction beta-blocker trials, the pooled results showed a marked reduction in sudden deaths (104 in the placebo group, 62 in the metoprolol group, P = 0.002). In a Cox regression model the influence of sex, age and smoking habits on the effect of metoprolol was evaluated. None of these factors influenced the metoprolol effect significantly. It is concluded that metoprolol therapy after acute myocardial infarction reduces the total number of deaths, and especially sudden cardiac deaths. The mortality reduction was independent of gender, age and smoking habits. Available data support a continuous beneficial effect.     

Complete versus culprit vessel percutaneous coronary intervention in multivessel disease: a randomized comparison

Background

The purpose of this study was to compare the safety, efficacy, and costs of complete versus “culprit” vessel revascularization in multivessel coronary artery disease treated with percutaneous coronary interventions (PCI).

Methods

Patients with multivessel disease and an identified culprit vessel were randomly assigned to complete revascularization of vessels ≥50% stenoses (n = 108) versus revascularization limited to the culprit vessel (n = 111). The primary end point, major adverse cardiac events (MACE), were defined as cardiac or noncardiac death, myocardial infarction, need for coronary artery bypass graft surgery, and repeat PCI up to 1 year.

Results

Despite equal MACE at 24 hours (6.3% vs 7.4%), strategy success was higher in the culprit vessel than in the complete revascularization group (93.7% vs 81.5%, P = .007). MACE rates at 1 month (14.4% vs 9.3%), 1 year (32.4% vs 26.9%), and 4.6 ± 1.2 years (40.4% vs 34.6%) were similar in both groups. Repeat PCI was performed more often in the culprit vessel group (31.2% vs 21.2%, P = .06). A lower consumption of medical material was associated with lower procedural costs in the culprit vessel group (5784 vs 7315 Euros; P < .001). However, between 1 year and the end of follow-up, costs had equalized in both groups.

Conclusions

Complete versus culprit vessel revascularization in multivessel coronary disease treated with PCI was associated with a lower strategy success rate, similar MACE rates, and initially higher costs. However, over the long term, more repeat PCIs were conducted in patients treated by culprit revascularization only, mostly because of the need to treat lesions initially left untreated. As a consequence, incremental costs had equalized within 1 year. The decision of whether to perform culprit vessel or complete revascularization can be made on an individual basis.     

Multi-vessel versus culprit-vessel and staged percutaneous coronary intervention in STEMI patients with multivessel disease: a meta-analysis of randomized controlled trials

IntroductionPercutaneous coronary intervention (PCI) is preferred in patients with acute ST-elevation myocardial infarction (STEMI). In patients with acute STEMI with multivessel disease (MVD), the guidelines recommend culprit vessel PCI (CV-PCI) in the absence of hemodynamic instability. We performed a meta-analysis of all randomized controlled trials (RCTs) comparing multi-vessel PCI (MV-PCI) with CV-PCI or staged PCI (S-PCI) in patients with acute STEMI and MVD.MethodsPubMed, EMBASE and CENTRAL were searched for publications since inception to December 2013. Random effects model was used to compute summary effects.ResultsFour RCTs (840 patients) were identified. MV-PCI compared to CV-PCI significantly reduced the risks of major adverse cardiac events (MACE)—a composite of MI, revascularization and all-cause mortality (RR: 0.46, 95% CI: 0.35–0.60, P < 0.00001) by reducing the risks of MI (0.35, 0.17–0.71, P = 0.004) and revascularization (0.35, 0.24–0.52, P < 0.00001). The risk of all-cause mortality was not different (0.69, 0.39–1.21, P = 0.19). S-PCI and MV-PCI had similar risks of MACE (0.96, 0.59–1.57, P = 0.87), MI (0.60, 0.20–1.78, P = 0.36), revascularization (0.86, 0.47–1.54, P = 0.60) and all-cause mortality (1.50, 0.44–5.07, P = 0.57).ConclusionsMV-PCI compared to CV-PCI resulted in lower risks of MACE driven by lower MI and revascularization in patients with STEMI and multi-vessel disease.     

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.     

Long‐term outcomes with aspiration thrombectomy for patients undergoing primary percutaneous coronary intervention: A meta‐analysis of randomized trials

Randomized clinical trials that examined long‐term clinical outcomes of routine aspiration thrombectomy prior to primary percutaneous coronary intervention (PCI ) in patients with acute ST ‐segment elevation myocardial infarction have yielded different results. We hypothesized that the routine use of manual thrombus aspiration prior to primary PCI lacks long‐term clinical benefits. Electronic databases were searched for randomized trials comparing routine aspiration thrombectomy and conventional PCI . We included only trials that reported clinical outcomes beyond 6 months. The primary outcome was all‐cause mortality, and the secondary outcomes included major adverse cardiovascular events, re‐infarction, cardiovascular mortality, and stent thrombosis (ST) . A DerSimonian ‐Laird model was used to construct the summary estimates risk ratio (RR ). We retrieved 18 trials with 20 641 ST ‐segment elevation myocardial infarction patients, of whom 10 331 patients underwent routine aspiration thrombectomy prior to primary PCI . At a mean follow‐up of 12 months, there was no significant decrease in the risk of all‐cause mortality (RR : 0.93, 95% confidence interval [CI ]: 0.82‐1.05, P = 0.22), major adverse cardiac events (RR : 0.95, 95% CI : 0.87‐1.03, P = 0.18), re‐infarction (RR : 0.95, 95% CI : 0.80‐1.13, P = 0.59), cardiovascular mortality (RR : 0.80, 95% CI : 0.47‐1.36, P = 0.40), or ST (RR : 0.80, 95% CI : 0.63‐1.01, P = 0.06) with routine aspiration thrombectomy. Routine aspiration thrombectomy prior to primary PCI was not associated with a reduction in long‐term mortality or clinical outcomes. Future randomized trials are warranted to further evaluate the role of aspiration thrombectomy in select patients and coronary lesions.     

A meta-analysis of randomized trials of rescue percutaneous coronary intervention after failed fibrinolysis

Previous trials have suggested clinical benefit with rescue percutaneous coronary intervention (PCI) after failed fibrinolysis, but more recent, larger studies are conflicting. Therefore, we designed a meta-analysis to determine whether rescue PCI improves outcomes compared with conservative therapy in the setting of early failure of fibrinolysis. We searched MEDLINE for randomized trials by using the Medical Subject Heading terms "angioplasty," "myocardial infarction," "thrombolytic therapy," and "fibrinolysis." The inclusion criteria were (1) acute ST-elevation myocardial infarction initially treated with fibrinolytics, (2) randomization of patients with failed fibrinolysis to immediate PCI or conservative therapy, and (3) available short-term clinical outcome data. The primary end point was short-term mortality and secondary end points were thromboembolic stroke and heart failure. Numbers of events were tabulated for each trial and risk ratios (RRs) were computed. Five trials were included for analysis. The pooled RR estimates showed a 36% decrease in the risk of death in the rescue arm (RR 0.64, 95% confidence interval 0.41 to 1.00, p=0.048) and a marginally significant 28% decrease in the risk of heart failure (RR 0.72, 95% confidence interval 0.51 to 1.01, p=0.06). We also found a marginally increased risk of thromboembolic stroke in the rescue arm (RR 3.61, 95% confidence interval 0.91 to 14.27, p=0.07). In conclusion, rescue PCI in the setting of early fibrinolytic failure improves mortality, but this is tempered by a possible increase in the risk of thromboembolic stroke.