The year in cardiology 2017: coronary interventions

The first balloon coronary angioplasty was performed in Zurich by Andreas Grüntzig in 1977. The patient, a 38-year-old man with severe angina and a tight stenosis on the left anterior descending artery, is still alive, is doing well, and he celebrated the 40-year anniversary of his percutaneous coronary interventions (PCI) in 2017 (Figure 1). During the last decades, PCI techniques have undergone major improvements with the first real game changer being the introduction of bare metal stents, which made PCI safer and improved longer-term outcomes. Later on, drug-eluting stents (DESs) were introduced, which resulted in a major reduction in restenosis and also—with the newer generation DES—a low rate of stent thrombosis. Further, the introduction of intracoronary pressure measurements for assessment of severity of coronary stenoses [fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR)] and intracoronary imaging [intravascular ultrasound (IVUS) and optical coherence tomography (OCT)] for lesion assessment has refined lesion and procedure assessment. Improved outcomes were also fostered by development of better and safer adjunctive antithrombotic drugs and secondary prevention, optimizing drug-device synergy. Still, 40 years later the research in the coronary interventional field is very intense, and we aim here to summarize major developments in PCI published in 2017. The first patient (left) to receive balloon angioplasty by Andreas Grüntzig in 1977 standing next to the President of EAPCI, Professor Michael Haude (middle), and Professor Bernhard Meier (right). The SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) II study investigated the impact of a contemporary PCI strategy on clinical outcomes of 454 patients with three-vessel disease.1 Characteristics of the SYNTAX II strategy that captures all components of today’s ‘best of PCI practice’ are summarized in Figure 2. Following this approach systematically, the authors demonstrated major adverse cardiac and cerebrovascular events (MACCE) at 1 year to be much improved with respect to a matched historical PCI cohort from the SYNTAX I trial (10.6% vs. 17.4%; P = 0.006). The better result of the contemporary PCI strategy compared with the procedural technique followed at the time of the SYNTAX I trial was driven by a lower risk of myocardial infarction (MI) and revascularization, with a parallel reduction in stent thrombosis. Overall, the SYNTAX II study suggests that the combination of best practice components in PCI technique portends improved patient outcomes beyond what can be achieved by introducing one single new element. Because these results outperform PCI results obtained in the earlier SYNTAX I trial, the hypothesis was generated that a new randomized study of modern best PCI practice in patients with three-vessel disease might show non-inferiority vs. coronary artery bypass grafting (CABG).1 Combined advances in percutaneous coronary intervention performance defining the ‘Best of PCI Practice’ applied in the SYNTAX-II study, as described by Escaned et al. 1 reproduced with permission from the European Heart Journal. Glimpsing to the future, the feasibility and technical success of robotically-assisted PCI for complex coronary lesions were investigated in 334 procedures from 315 patients included in the Complex Robotically Assisted Percutaneous Coronary Intervention (CORA-PCI) study.2 In 108 procedures of robotically-assisted PCI, technical success was 91.7% and clinical success was 99.1%. A propensity-matched analysis of 82 pairs showed that the procedures were longer in patients undergoing robotically-assisted PCI compared with patients undergoing standard PCI, but clinical success rates were similar.2 Robotically-assisted PCI might find its niche sooner than expected, boosted by the opportunity to further reduce radiation burden to the operator and team. The impact of different strategies for prevention of contrast-induced nephropathy is still a matter of debate. The effect of intravenous saline for patients undergoing an elective procedure requiring iodinated contrast material administration was tested in the single-centre, open-label A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial, where 660 consecutive subjects with an estimated glomerular filtration rate of 30–59 mL per min/1.73 m2 were randomized to receive intravenous isotonic saline or no prophylaxis.3 Contrast-induced nephropathy occurred in 2.6% of non-hydrated patients and in 2.7% of hydrated patients, meeting the criteria for non-inferiority of no prophylaxis. Notably, intravenous hydration was associated with higher costs and rates of clinical sequelae, including symptomatic heart failure and arrhythmias. A network meta-analysis of 28 240 patients undergoing PCI from 124 randomized trials compared 10 different strategies for preventing contrast-induced nephropathy.4 Statin administration was associated with a marked and consistent reduction in the risk of contrast-induced nephropathy compared with saline, while the evidence for the benefit of other treatment strategies (i.e. xanthine, N-acetylcysteine, sodium bicarbonate, ischaemic preconditioning, and natriuretic peptide) was less robust by sensitivity analyses.4 After publication of the Evaluation of XIENCE vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) and Nordic-Baltic-British left main revascularisation study (NOBLE) trials in 2016, a plethora of updated meta-analyses of PCI vs. CABG for unprotected left main coronary artery disease (CAD) has been published this year. Taking a cautious approach to these mid-term data, it seems that CABG may protect against further revascularization and that there is no significant difference with regard to all-cause mortality. A patient-centred strategy, based on a heart team conference decision taking patient preference and relevant comorbidities into consideration, seems to be the way forward based on the currently available data. Three trials of PCI for chronic total occlusion (CTO) plus guideline-directed medical therapy vs. guideline-directed medical therapy alone (DECISION-CTO, EuroCTO, REVASC) have been presented this year at major interventional cardiology meetings, but are currently unpublished. In view of their premature termination or small sample size, these trials do not address conclusively the debate on the benefit of CTO revascularization with PCI. Although there was no difference in mortality and MI, this may have been due to excessive cross-over rates and concomitant treatment of other non-occlusive lesions. Moreover, the only trial with a quality-of-life endpoint (EuroCTO) reached a difference in favour of PCI in CTO lesions, which may be all you can expect with short-term follow-up in patients with stable angina and primarily non-LAD lesions. Systematic two stent techniques are not necessary for the majority of bifurcation lesions. However, bifurcations with large side branches and significant ostial disease length are typically treated with a two-stent technique upfront. The validity of this concept has been challenged by the EBC (European Bifurcation Club) trial, which randomized 200 patients with large caliber true bifurcation lesions and significant ostial disease length (≥5 mm) to either a provisional T-stent strategy (resulting in the use of two stents in 16% of cases) or a dual stent culotte technique.5 The composite of all-cause death, MI, and target vessel revascularization at 1-year follow-up did not differ significantly between groups, while procedure time, radiation dose and cost considerations favoured the simpler strategy.5 In contrast with these results, the Double Kissing and Double Crush vs. Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions (DK-CRUSH) V trial, a study of a planned double kissing crush technique vs. provisional stenting for left main PCI of true bifurcation lesions (N = 482) found a significant reduction in target lesion failure (TLF) at 12 months with the two-stent strategy, driven by lower rates of target vessel MI with parallel reduction in stent thrombosis.6 Notably, the double kissing crush technique also showed favourable long-term outcomes compared with the culotte technique in left main PCI.7 Five-year outcomes of the double kissing crush technique from the DKCRUSH-II trial have also become available.8 In this study, a total of 370 patients with bifurcation lesions were randomly assigned to the double kissing crush or provisional stenting strategies (resulting in 28.6% of cases with double stent use). At 5 years, MACE occurred in 23.8% of patients in the provisional group and 15.7% of patients in the double kissing crush group, trending towards statistical significance (P = 0.051). Despite the above data, the debate on how to best approach bifurcations with large diseased side branches or left main bifurcation stenosis continues. In such lesions the DKCRUSH may be considered if an upfront two-stent technique is chosen. However, many operators favour a single-stent strategy, with use of provisional culotte or T-stenting strategies, in the majority of cases. Strategies for improving PCI for in-stent restenosis continue to be the object of ongoing investigation. In the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis (ISAR-DESIRE) 4 trial, modification of in-stent restenosis neointima with scoring balloon pre-dilatation before drug-coated balloon application proved significantly better than a drug-coated balloon standard therapy only with respect to percentage diameter stenosis and angiographic restenosis at 6- to 8-month follow-up angiography.9 A pooled analysis of individual patient data from three large randomized trials [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction (TAPAS), Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE), and Trial of Routine Aspiration Thrombectomy With PCI vs. PCI Alone in Patients With STEMI (TOTAL)] provided novel insights about thrombus aspiration for ST-elevation myocardial infarction (STEMI).10 By including 18 306 patients, the study did not show a significant reduction in cardiovascular death when thrombus aspiration was compared with standard therapy. There were also no differences between thrombus aspiration and no thrombus aspiration with respect to stroke or transient ischaemic attack, recurrent MI, stent thrombosis, heart failure, or target vessel revascularization.10 Although routine use of mechanical thrombus aspiration is no longer recommended, prior safety concerns regarding the risk of stroke could not be confirmed. Because a trend towards reduced cardiovascular death and increased stroke or transient ischaemic attack was found in the subgroup of patients with high thrombus burden, future studies may want to investigate improved thrombus aspiration technologies in this high-risk subgroup. Management of non-infarct-related coronary arteries after primary PCI for STEMI remains controversial. 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