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Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

ABSTRACT: BACKGROUND:We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. METHODS:We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. RESULTS:In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P<.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P=.0035) and HL (63.72%, P<.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P<.0001) and smoking (38.41%, P=.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P<.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (?<0.02) statistically significant temporal trends over time, except for sex. CONCLUSIONS:There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.

SUBMITTER: Liu E

PROVIDER: S-EPMC5728179 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

Liu Eden E Hsueh Leon L Kim Hajwa H Vidovich Mladen I MI

American heart journal 20170908

<h4>Background</h4>We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents.<h4>Methods</h4>We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellit ...[more]

PMID: 29224645

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Project description:BackgroundPercutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI).MethodsWe searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model.ResultsSixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61-1.66; RR 0.88 95% CI 0.66-1.17), reinfarction (RR 0.89 95% CI 0.69-1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47-6.42), heart failure (HF) (RR 0.54 95% CI 0.11-2.66), repeat revascularization (RR 0.73 95% CI 0.25-2.10), embolization (RR 3.00 95% CI 0.13-71.61), or arrhythmia (RR 2.81 95% CI 0.30-26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71-1.29; RR 1.23 95% CI 0.88-1.72), reinfarction (RR 0.98 95% CI 0.68-1.42), stroke/TIA (RR 0.45 95% CI 0.1-1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38-1.80), or arrhythmia (RR 1.52 95% CI 0.71-3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08-0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72-4.73).ConclusionsNeither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.

Project description:Background Despite advances in devices and techniques, coronary bifurcation lesion remains a challenging lesion subset in the field of percutaneous coronary intervention (PCI). We evaluate 10-year trends in bifurcation PCI and their effects on patient outcomes. Methods and Results We analyzed 10-year trends in patient/lesion characteristics, devices, PCI strategy, stent optimization techniques, and clinical outcomes using data from 5498 patients who underwent bifurcation PCI from 2004 to 2015. Clinical outcomes 2 years after the index procedure were evaluated in terms of target vessel failure (a composite of cardiac death, myocardial infarction, and target vessel revascularization) and a patient-oriented composite outcome (a composite of all-cause death, myocardial infarction, and any revascularization). During the 10-year study period, patient and lesion complexity, such as multivessel disease, diabetes mellitus, chronic kidney disease, and left main bifurcation, increased continuously (all P<0.001). The risk of target vessel failure or patient-oriented composite outcome decreased continuously from 2004 to 2015 (target vessel failure: from 12.3% to 6.9%, log-rank P<0.001; patient-oriented composite outcome: from 13.6% to 9.3%, log-rank P<0.001). The use of a second-generation drug-eluting stent and decreased target vessel failure risk in true bifurcation lesions were the major contributors to improved patient prognosis (interaction P values were <0.001 and 0.013, respectively). Conclusions During the past decade of bifurcation PCI, patient and lesion characteristics, devices, PCI techniques, and patient prognosis have all significantly changed. Despite increased patient and lesion complexity, clinical outcomes after bifurcation PCI have improved, mainly because of better devices and more widespread adoption of procedural optimization techniques and appropriate treatment strategies. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01642992 and NCT03068494.

Project description:Inconsistent results exist regarding the treatment effectiveness of immediate versus deferred percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). This meta-analysis aimed to evaluate the efficacy and safety of immediate versus deferred PCI in ACS patients. PubMed, EMBASE, and Cochrane Library electronic databases were systematically searched from their inception up to August 2019. Random-effects models were employed to calculate pooled relative risks (RRs) and weight mean differences (WMDs) with 95% confidence intervals (CIs). A total of 10 randomized controlled trials (RCTs) that recruited 3350 patients were selected for inclusion in the final meta-analysis. Four trials included patients with non-ST elevation ACS (NSTEACS), whereas the remaining six trials included patients with ST elevation myocardial infarction (STEMI). There were no significant differences between immediate versus deferred PCI for the risk of major adverse cardiovascular events (NSTEACS patients: RR, 0.76, 95%CI, 0.33-1.75, P = 0.513; STEMI patients: RR, 1.24, 95%CI, 0.80-1.92, P = 0.335), myocardial infarction (NSTEACS patients: RR, 0.88, 95%CI, 0.27-2.81, P = 0.826; STEMI patients: RR, 0.86, 95%CI, 0.43-1.74, P = 0.678), all-cause mortality (NSTEACS patients: RR, 0.85, 95%CI, 0.38-1.88, P = 0.686; STEMI patients: RR, 1.16, 95%CI, 0.82-1.66, P = 0.407), target vessel revascularisation (NSTEACS patients: RR, 1.26, 95%CI, 0.29-5.43, P = 0.756; STEMI patients: RR, 1.01, 95%CI, 0.51-1.97, P = 0.988), or major bleeding (NSTEACS patients: RR, 0.99, 95%CI, 0.64-1.54, P = 0.972; STEMI patients: RR, 0.90, 95%CI, 0.45-1.77, P = 0.753). Although patients who underwent immediate PCI may experience increased incidences of cardiac death (RR, 1.19, 95%CI, 0.69-2.07, P = 0.525) and no or slow reflow (RR, 1.60, 95%CI, 0.91-2.84, P = 0.105), these increases were not statistically significant. We noted that immediate versus deferred PCI was associated with a reduced incidence of myocardial brush grade 3 (RR, 0.70, 95%CI, 0.56-0.88, P = 0.002); however, no significant differences were observed between immediate and deferred PCI for TIMI III flow (RR, 0.98, 95%CI, 0.93-1.03, P = 0.453), complete ST-segment resolution (RR, 0.93, 95%CI, 0.75-1.17, P = 0.548), and ejection fraction (WMD, -1.05, 95%CI, -2.58 to 0.49, P = 0.182). The findings of this study suggested that deferred PCI did not yield significant benefits for clinical endpoints. Further large-scale RCTs should be conducted to verify the findings of this study.

Project description:BackgroundTwenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches to treatment.MethodsTwo hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life-5 dimension-5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was performed to compare clinical and procedural characteristics among patients with and without post-PCI angina (defined by follow-up SAQ-angina frequency score <100).ResultsEighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, P<0.001) and EQ-5D-5L health index scores (0.84±0.15 versus 0.69±0.22, P<0.001). Pre-PCI fractional flow reserve (FFR) was lower among patients who had no post-PCI angina (0.56±0.15 versus 0.62±0.13, P=0.003). Percentage change in FFR after PCI had a moderate correlation with angina frequency score at follow-up (r=0.36, P<0.0001). Patients with post-PCI angina had less improvement in FFR (43.1±33.5% versus 67.0±50.7%, P<0.001). There were no between-group differences in post-PCI FFR, coronary flow reserve, or corrected index of microcirculatory resistance. Patients with post-PCI angina had lower SAQ-summary scores (64.01±22 versus 95.16±8.72, P≤0.001) and EQ-5D-5L index scores (0.69±0.26 versus 0.91±0.17, P≤0.001) at follow-up.ConclusionsLarger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriateness of PCI.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT03259815.

Project description:Percutaneous coronary intervention with bivalirudin plus bail-out glycoprotein IIb/IIIa inhibitors has been shown to be as effective as unfractionated heparin plus routine glycoprotein IIb/IIIa inhibitors in preventing cardiac ischemic events, but with a lower bleeding risk. It is unknown whether bivalirudin would have the same beneficial effects if compared with heparin when the use of glycoprotein IIb/IIIa inhibitors was similar between treatment arms. We searched the MEDLINE, Web of Science, and Cochrane databases from inception until March 2015 for randomized trials that compared bivalirudin to heparin in patients undergoing percutaneous coronary intervention. We required that the intended use of glycoprotein IIb/IIIa inhibitors was similar between the study groups. Summary estimates were principally constructed by the Peto method. Fifteen trials met our inclusion criteria, which yielded 25,824 patients. Bivalirudin versus heparin was associated with an increased hazard of stent thrombosis (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.15-1.92, P = .002, I2 = 16.9%), with a similar hazard of myocardial infarction (OR 1.09, 95% CI 0.98-1.22, P = .11, I2 = 35.8%), all-cause mortality (OR 0.88, 95% CI 0.72-1.08, P = .21, I2 = 31.5%) and major adverse cardiac events (OR 1.04, 95% CI 0.94-1.14, P = .46, I2 = 53.9%). Bivalirudin was associated with a reduced hazard of major bleeding (OR 0.80, 95% CI 0.70-0.92, P = .001, I2 = 63.5%). The dose of heparin in the control arm modified this association; when the dose of unfractionated heparin in the control arm was ≥ 100 units/kg, bivalirudin was associated with a reduction in major bleeding (OR 0.55, 95% CI 0.45-0.68, P < .0001), but when the dose of unfractionated heparin was ≤ 75 units/kg, bivalirudin was not associated with reduction in bleeding (OR 1.09, 95% CI 0.91-1.31, P = .36). Among patients undergoing PCI, bivalirudin was associated with an increased hazard of stent thrombosis. Bivalirudin may be associated with a reduced hazard of major bleeding; however, this benefit was no longer apparent when compared with a dose of unfractionated heparin ≤ 75 units/kg.

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Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

Publications

Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

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