Predictors of Favorable Angiographic Outcomes After Drug-Coated Balloon Use for de novo Small Vessel Coronary Disease (DCB-ONLY)

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was −0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and % diameter stenosis (DS ) <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.

A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

Objective We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. Methods A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. Results EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001). Conclusion Among those three types of stents, EES should be the first recommended stent for DM patients.

Effects of high-intensity interval training in patients with coronary artery disease after percutaneous coronary intervention: a systematic review and meta-analysis

BackgroundHigh-intensity interval training, for its characteristic of short-time high oxygen-consumption exercise interphase with periods of low-intensity training or rest for recovery, is easier to persist and execute in cardiac rehabilitation. However, it is little known whether HIIT program has an advantageous effect on patients after percutaneous coronary intervention or not.MethodsRandomized controlled trials (RCTs) focusing on HIIT program in patients after PCI were searched in Cochrane Library, Web of Science Core Collection, EMbase, PubMed, China National Knowledge Infrastructure (CNKI) and SinoMed from the inception to March 24, 2020. Two reviewers conducted the literature retrieval, data extraction, and quality assessment independently. Standard Mean difference (SMD) and 95% confidence intervals (CI) were performed to summarize the effect sizes.Results6 RCTs (247 patients) met the criteria. HIIT program had a statistically significant effect on raising left ventricular ejection function (LVEF) (SMD=0.38, 95%CI[0.03, 0.73], p=0.03), VO2peak (SMD=0.94, 95%CI[0.61, 1.28], p<0.01), as well as improving the serum level of high-density lipoprotein (SMD=0.55, 95%CI[0.06, 1.03], p=0.03) and late luminal loss (SMD=−0.65, 95%CI[−1.07, −0.23], p<0.01). But HIIT had no prominent effect on improving heart rate (SMD=−0.04, 95%CI[-0.29, 0.21], p=0.73).ConclusionsHIIT program might be favorable for CAD patients after PCI by improving cardiopulmonary function, such as LVEF and VO2peak, as well as reducing late luminal loss in per stented arteries. Nevertheless, HIIT had no advantage for adjusting heart rate. More researches with rigorous methods are warranted to explore the controversy about lipid profiles.

Ongoing Late Lumen Loss with the CYPHER and TAXUS Drug-eluting Stents Supports a Theory of Catch-up Restenosis

Luminal loss and restenosis are critical problems in coronary artery drug-eluting stents (DES). These implants need to minimise long-term neointimal coverage and maximise blood flow. Two studies compared the effects of different types of DES on lumen loss after surgical implantation. The first study included 2,030 patients and showed that over two years late luminal loss (termed ‘late luminal creep’) progressed for two types of commercially prepared permanent polymer stents containing rapamycin or paclitaxel (CYPHER and TAXUS), but not for a polymer-free in-house coated stent containing rapamycin (YUKON). In a smaller study, luminal coverage was lower with the CYPHER than with the YUKON stent, but struts of the stent structure were better covered with the YUKON stent and less likely to cause an obstruction. Stents should ideally limit luminal loss but also allow for sufficient coverage to prevent thrombotic hazards.

Abstract 5998: Final Results of the HEALING 2B Trial to Evaluate a Bioengineered CD34 Antibody Coated Stent (Genous ™ Stent) Designed to Promote Vascular Healing by Capture of Circulating Endothelial Progenitor Cells in CAD Patients

Background: In contrast to a cytotoxic or cytostatic pharmacotherapy, promoting the vascular healing response by capturing and sequestering circulating endothelial progenitor cells (EPC) to the stent surface by a CD34 antibody coating (Genous ™ stent) may accelerate stent reendo-thelialization and prevent restenosis formation, as well as stent thrombosis (ST) Methods: The HEALING IIB study was a multi-center, prospective trial designed to assess the safety and efficacy of the Genous ™ bio-engineered stent in conjunction with HmG CoA reductase inhibitors (statins) to stimulate EPC recruitment, in the treatment of patients with de novo coronary artery lesions (n=100 pts). The primary safety endpoint was major adverse cardiac events (MACE) at 30 days, whereas the primary efficacy endpoint was late luminal loss by QCA at 6 months follow-up. Results: At interim analysis of the first 45 patients that completed the 6-month angiographic follow-up, the composite MACE rate was 11.1%, whereas 6.6% clinically justified target lesion revascularizations were observed. 2 Patients died within the first 30 days after stent implantation due to angiographically verified stent thrombosis. Low circulating EPC titers were previously associated with a poor response to the EPC capture stent with TLR events and high late loss. Therefore, patients were pre-treated with Atorvastatin 80 mg qd prior to the PCI in order to augment EPC levels. Statin therapy stimulated the levels of committed EPCs by +294%, but failed to increase the titer of CD34+cells (+25%). Although statin pretreatment stimulated EPC levels, the angiographic outcome of the EPC capture stent was not improved in these patients: in-stent late luminal loss was 0.77±0.46 mm. We anticipate to complete analysis of the 6 month angiographic follow-up of all 100 patients by the time of the AHA2008. Conclusions: The HEALING-IIB study suggests that the EPC capture coronary stent in combination with statin therapy does not sufficiently impede stent restenosis formation for the treatment of de novo coronary artery disease. Although concomitant statin therapy was able to stimulate EPC recruitment, it failed to stimulate CD34+ stem cell levels and did not improve the angiographic outcome of the bioengineered EPC capture stent.

Current status of infrapopliteal artery stenting in patients with critical limb ischemia

Due to the fear that early thrombosis and late luminal loss resulting from intimal hyperplasia might impede sustained patency of small-caliber arteries, such as those of the infrapopliteal bed, stent implantation in below-knee vessels remains controversial and is generally reserved for cases with a suboptimal outcome after percutaneous transluminal angioplasty (i.e. > 50% residual stenosis, flow-limiting dissection). Although evidence starts to build, favoring the use of stenting in the tibial area, results of well-conducted randomized controlled trials have to be awaited to change this strategy. Because of diameter similarities with coronary arteries, the first stents applied in the infrapopliteal vessels were all coronary devices. Once the feasibility of the stenting approach with these coronary products was shown, device manufacturers started to develop a dedicated infrapopliteal product range. To date, a broad spectrum of stent types has been used and investigated for the given indication. This article overviews the available literature and results of different balloon-expandable (bare metal, passive coated, drug eluting), self-expanding and absorbable stent types available for below-the-knee application and gives recommendations for future device technology advancements.