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In patients with ST-segment elevation myocardial infarction, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death and adverse cardiovascular events at 1 year.

Whether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear. We conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis. A total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients. In older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.).

In patients with coronary bifurcation lesions, optical coherence tomography–guided PCI was associated with a lower incidence of major adverse cardiac events at a median 2 years of follow-up than angiography-guided PCI.

In a randomized trial of imaging-guided or angiography-guided PCI for complex coronary lesion revascularization procedures, imaging-guided PCI led to a lower risk of target-vessel failure than angiography-guided PCI.

In a randomized trial, optical coherence tomography–guided PCI resulted in a larger minimum stent area than angiography-guided PCI, but there was no between-group difference in target-vessel failure at 2 years.

Treatment options for coronary chronic total occlusions (CTO) are limited, with low historical success rates from percutaneous coronary intervention (PCI). We report procedural outcomes of CTO PCI from 7 centres with dedicated CTO operators trained in hybrid approaches comprising antegrade/retrograde wire escalation (AWE/RWE) and dissection re-entry (ADR/RDR) techniques. Clinical and procedural data were collected from consecutive unselected patients with CTO between 2012 and 2014. Lesion complexity was graded by the Multicentre CTO Registry of Japan (J-CTO) score, with ≥2 defined as complex. Success was defined as thrombolysis in myocardial infarction 3 flow with <30% residual stenosis, subclassified as at first attempt or overall. Inhospital complications and 30-day major adverse cardiovascular events (MACEs, death/myocardial infarction/unplanned target vessel revascularisation) were recorded. 1156 patients were included. Despite high complexity (mean J-CTO score 2.5±1.3), success rates were 79% (first attempt) and 90% (overall) with 30-day MACE of 1.6%. AWE was highly effective in less complex lesions (J-CTO ≤1 94% success vs 79% in J-CTO score ≥2). ADR/RDR was used more commonly in complex lesions (J-CTO≤1 15% vs J-CTO ≥2 56%). Need for multiple approaches during each attempt increased with lesion complexity (17% J-CTO ≤1 vs 48% J-CTO ≥2). Lesion modification ('investment procedures') at the end of unsuccessful first attempts increased the chance of subsequent success (96% vs 71%). Hybrid-trained operators can achieve overall success rates of 90% in real world practice with acceptable MACE. Use of dissection re-entry and investment procedures maintains high success rates in complex lesions. The hybrid approach represents a significant advance in CTO treatment.

In this trial involving patients with three-vessel coronary artery disease, PCI guided by assessment of fractional flow reserve was not noninferior to CABG with respect to the composite end point of death, myocardial infarction, stroke, or repeat revascularization at 1 year. The incidence of this composite end point was higher among those assigned to FFR-guided PCI than among those assigned to CABG.

Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24–2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74–1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66–5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25–2·40]; p=0·0009). In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. Biosensors.

Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25–3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54–7·34) with OCT guidance, 5·89 mm2 (4·67–7·80) with IVUS guidance, and 5·49 mm2 (4·39–6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI −0·70 mm2; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. St Jude Medical.

The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear. In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37). Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).