Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).
The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154).
The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.
Context Observational studies have previously reported that elective intra-aortic balloon pump (IABP) insertion may improve outcomes following high-risk percutaneous coronary intervention (PCI). To date, this assertion has not been tested in a randomized trial. Objective To determine whether routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE) in patients with severe left ventricular dysfunction and extensive coronary disease. Design, Setting, and Patients The Balloon Pump-Assisted Coronary Intervention Study, a prospective, open, multicenter, randomized controlled trial conducted in 17 tertiary referral cardiac centers in the United Kingdom between December 2005 and January 2009. Patients (n=301) had severe left ventricular dysfunction (ejection fraction Յ30%) and extensive coronary disease (Jeopardy Score Ն8/12); those with contraindications to or class I indications for IABP therapy were excluded. Intervention Elective insertion of IABP before PCI. Main Outcome Measures Primary end point was MACCE, defined as death, acute myocardial infarction, cerebrovascular event, or further revascularization at hospital discharge (capped at 28 days). Secondary end points included all-cause mortality at 6 months, major procedural complications, bleeding, and access-site complications. Results MACCE at hospital discharge occurred in 15.2% (23/151) of the elective IABP and 16.0% (24/150) of the no planned IABP groups (P=.85; odds ratio [OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality at 6 months was 4.6% and 7.4% in the respective groups (P=.32; OR, 0.61 [95% CI, 0.24-1.62]). Fewer major procedural complications occurred with elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%, PϽ.001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in 19.2% and 11.3% (P=.06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site complications in 3.3% and 0% (P=.06) of the elective and no planned IABP groups, respectively. Conclusions Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease.
Successful CTO PCI was associated with improved long-term survival. The improvement was greatest in patients when complete revascularization was achieved. The identity of the successfully treated occluded vessel was not associated with differences in outcome.
Background New-generation drug-eluting stents (DES) have been mostly investigated by means of head-to-head non-inferiority trials, which typically showed comparable efficacy and greater safety as compared with early-generation DES. Evidence related to new-generation DES versus bare-metal stents (BMS) is more limited, and there remain uncertainties on their comparative safety profile. Methods We performed an individual patient data (IPD) meta-analysis of randomized trials comparing new-generation DES with BMS among patients undergoing percutaneous coronary intervention. The protocol of the study was registered in PROSPERO (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random effects metaanalysis and examined at maximum follow-up and with 1-year landmark. Risk estimates are reported as hazard ratio (HR) with 95% confidence intervals (95%CI). Findings We obtained IPD data from 20 randomized trials including a total of 26,616 patients, with 3•2±1•8 years mean follow-up. The primary outcome occurred in fewer patients in the DES group than in the BMS group (HR 0•84, 95%CI 0•78 to 0•90, P<0•001) owing to lower risk of myocardial infarction (HR 0•79, 95%CI 0•71 to 0•88, P<0•001) and weaker evidence for a possible cardiac mortality benefit (HR 0•89, 95%CI 0•78 to 1•01, P=0•075). All-cause death was unaffected (HR with DES, 0•96, 95%CI 0•88 to 1•05, P=0•358), but DES reduced the risk of definite stent thrombosis (HR 0•63, 95%CI 0•50 to 0•80, P<0•001) and targetvessel revascularization (HR 0•55, 95%CI 0•50 to 0•60, P<0•001). There was evidence for a time-dependent treatment effect, with DES being associated with lower risks of the primary outcome during the first year followed by a null effect in the subsequent years. Interpretation New-generation DES instead of BMS were associated with sustained reduction of cardiac death or myocardial infarction owing to lower event rates within the first year without offsetting effects thereafter.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.