How to perform a successful drug-coated balloon angioplasty? Tips and tricks.

Drug-coated balloons (DCB) offer an excellent alternative to stents as the antiproliferative drugs are delivered via balloons and hence there is no permanent implant of metal or polymer. This rationale applies perfectly in in-stent restenosis (ISR) as we want to avoid another layer of metal in a previously failed stent. However, their use has also been extended to de novo lesions especially in patients and lesion subsets where stents are not ideal. There is an increased desire toward expanding this further and studies are now being done which are testing DCB in large-caliber vessels. As the use of DCB is escalating, we felt the importance of writing this article whereby we aim to provide important tips and tricks when using DCB especially for the operators who are in the early phase or have the desire of embarking this technology. From our experience, the DCB-angioplasty substantially differs on several aspects from DES-angioplasty. We have provided several case bases examples including algorithm when using DCB in ISR and de novo lesions.

The evolution and revolution of drug coated balloons in coronary angioplasty: An up-to-date review of literature data.

European Society of Cardiology (ESC) guidelines gave class I A indication for use of DCB in in-stent restenosis. However, no indication exists for the usage of DCB in de novo lesions. Although the current generation DES offer excellent results, as we embark more complex lesions such as calcified lesion and chronic total occlusion, restenosis and stent thrombosis are higher and tend to increase within the years. There is increasing desire to leave nothing behind to abolish the risk of restenosis and stent thrombosis and hence the absorbable scaffolds were introduced, but with disappointing results. In addition, they take several years to be absorbed. Drug coated balloons offer an alternative to stents with no permanent implant of metal or polymer. They are already in use in in Europe and Asia and they have been approved for the first time in the United States for clinical trials specifically for restenotic lesions. There is emerging data in de novo lesions which have shown that DCB are noninferior and in some studies maybe even superior to current generation DES especially in small vessels. In this article, we provide a comprehensive review of the literature on this expanding technology focussing on the evidence in both re-stenotic and de novo lesions.

The estimation of coronary artery calcium thickness by computed tomography angiography based on optical coherence tomography measurements.

Optical coherence tomography (OCT) is recommended to be the most appropriate modality in assessing calcium thickness, however, it has limitations associated with infrared attenuation. Although coronary computed tomography angiography (CCTA) detects calcification, it has low resolution and hence not recommended to measure the calcium size. The aim of this study was to devise a simple algorithm to estimate calcium thickness based on the CCTA image. A total of 68 patients who had CCTA for suspected coronary artery disease and subsequently went on to have OCT were included in the study. 238 lesions of them divided into derivation and validation dataset at 2:1 ratio (47 patients with 159 lesions and 21 with 79, respectively) were analyzed. A new method was developed to estimate calcium thickness from the maximum CT density within the calcification and compared with calcium thickness measured by OCT. Maximum Calcium density and measured calcium-border CT density had a good correlation with a linear equation of y = 0.58x + 201 (r = 0.892, 95% CI 0.855-0.919, p < 0.001). The estimated calcium thickness derived from this equation showed strong agreement with measured calcium thickness in validation and derivation dataset (r2 = 0.481 and 0.527, 95% CI 0.609-0.842 and 0.497-0.782, p < 0.001 in both, respectively), more accurate than the estimation by full width at half maximum and inflection point method. In conclusion, this novel method provided the estimation of calcium thickness more accurately than conventional methods.

Long-term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real-World Multicenter European Study.

OBJECTIVES: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. BACKGROUND: IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients. METHODS: This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed. RESULTS: In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30). CONCLUSION: This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.

Is a high calcific burden an indication, or a contraindication for Drug Coated Balloon?

Drug coated balloons (DCB) are increasingly being used in coronary intervention. Most of their use is currently restricted to in stent restenosis, however, they are also being used to treat some de novo lesion subsets (especially small vessels) and in patients unable to take dual antiplatelet therapy beyond a month. Calcified lesions pose a significant challenge to coronary intervention from lesion preparation to the delivery of drug to the vessel wall. There are limited data on the use of DCB in calcified lesions. In this article, we have provided a detailed literature review on calcified lesions and the use of DCB including a case example.

Mid-term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population.

BACKGROUND: Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel-DCB. However, when it comes of stents, Limus-drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch-SCB (Concept Medical, FL) elutes Sirolimus via nano-technology and have been used in our centers since March 2018. We report a mid-term follow-up with this relatively novel-technology. METHODS AND RESULTS: We retrospectively analyzed all patients treated with MagicTouch-SCB between March-2018 and February-2019. Results are reported as cardiac-death, target-vessel myocardial-infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288-patients (373-lesions) with a mean age of 65.8 were treated with MagicTouch-SCB. 84% (n = 241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n = 110) had diabetes and 62% (n = 233) were in de-novo lesions. Most lesions treated were in the LAD/diagonal-system (n = 170; 46%). Pre-dilatation was performed in 92% (n = 345) of cases. Bailout stenting was required in 9% lesions (n = 35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow-up of 363 days (IQR: 278-435), cardiac death and TVMI occurred in 5-patients (1.7%) and 10-patients (3.4%) respectively, TLR per-lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure. CONCLUSIONS: The results from mid-term follow-up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

Intravascular lithotripsy in calcified-coronary lesions: A real-world observational, European multicenter study.

BACKGROUND: The recently introduced intravascular lithotripsy (IVL) appears promising and relatively safer than conventional approaches when dealing with calcified lesions. Although there are published reports on this novel technology, data from the real world are limited. In this study, we aim to report on the experience of IVL from a real-world population derived from six European centers that undertake high-volume complex coronary interventions. METHODS AND RESULTS: We enrolled all patients treated with IVL between November 2018 and February 2020 at six centers. Procedural success and complications were assessed along with clinical outcomes, which included: cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TLR). Hundred and ninety patients (200 lesions) with a mean age of 72 years were treated using IVL. Diabetes and chronic kidney disease were present in 50% (n = 95) and 16% (n = 30) of cases, respectively. Acute-coronary syndromes accounted for 91 (48%) of the cases. Most were de-novo lesions (77%; n = 154). Upfront use of IVL occurred in 26% of cases, while the rest were bail-out procedures due to inadequate predilatation with conventional balloons. Adjuvant rotational atherectomy was needed in 17% of cases. Procedural success was achieved in 99% of cases with a complication rate of 3%. During the median follow-up of 222 days, there was two cardiac deaths (1%), one case of TVMI (0.5%), 3 TLR (1.5%) taking the MACE rate to 2.6%. CONCLUSION: Use of IVL appears to be safe and effective in dealing with calcified-coronary lesions. A high success rate was observed with low procedural complications and event rates.

Treatment of drug-eluting stent restenosis: Comparison between drug-eluting balloon versus second-generation drug-eluting stents from a retrospective observational study.

OBJECTIVES: To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). BACKGROUND: The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. METHODS: We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. RESULTS: Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46-1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group. CONCLUSION: There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc.

Can bioabsorbable scaffolds be used in calcified lesions?

The technology of bioabsorbable vascular scaffolds (BVSs) that disappears with minimal trace essentially eliminating the risk of very late stent thrombosis appears exciting. However, these scaffolds have only been tried in simple lesions in which the risk of late stent thrombosis is very low. We would like to report the use of everolimus-eluting BVS in calcified coronary lesions following debulking the lesions using scoring balloons and rotational atherectomy. With the use of intravascular ultrasound, we have confirmed the adequate expansion of these scaffolds. These cases demonstrate the feasibility of BVS in complex lesions, but appropriate lesion preparation remains the key to aid adequate expansion of these scaffolds.

Extended follow-up following "full-metal jacket" percutaneous coronary interventions with drug-eluting stents.

OBJECTIVES: To report very long-term follow-up of "Full-Metal Jacket" (FMJ) percutaneous coronary interventions (PCI) in long-diffuse coronary lesions with drug-eluting stents (DES). BACKGROUND: PCI for long-diffuse lesions may result in FMJ, which is not preferred by some operators due to long-term risk of restenosis and stent thrombosis. The data on long-term follow-up of patients with FMJ are limited and would be useful in understanding the safety and feasibility of such a strategy. METHODS: Between April 2002 and March 2007, 274 patients (297 lesions in native coronary arteries) underwent PCI utilizing DES. FMJ was described as lesions requiring ≥ 60 mm of continuous stent. The measured endpoints were cardiac death, target-vessel myocardial infarction (MI), target lesion revascularization (TLR), target-vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as composite of cardiac death, target-vessel MI, and TVR. RESULTS: The mean age of patients was 62.1 ± 11 years. The mean length of total stents used was 75.1 ± 16.4 mm (60-150). During the median follow-up of 74.7 months (interquartile range: 58-96), the rates of cardiac death, MI, TLR, and TVR were: 5.8% (n = 16), 6.2% (n = 17), 27.3% (n = 81), and 30% (n = 89), respectively. The MACE rate was 34%. Definite and probable stent thrombosis occurred in 10 patients (3.6%). CONCLUSION: The long-term follow-up of patients with FMJ is acceptable especially in regards to hard endpoints (death and MI) given the complexity of lesions treated. The high MACE rate was driven mainly by TVR. The availability of newer-generation DES and bioabsorbable scaffolds may improve these results. © 2014 Wiley Periodicals, Inc.

Long-term clinical outcomes following drug-eluting stent implantation for unprotected distal trifurcation left main disease: the Milan-New Tokyo (MITO) registry.

BACKGROUND: Unprotected distal left main trifurcation (ULMT) lesion represents a challenge for interventional cardiologists with the potential for peri-procedural complications and adverse events at follow-up especially when the main branch and the side branches are concomitantly diseased. METHODS: A retrospective cohort analysis was performed on consecutive patients with ULMT stenosis who electively underwent percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation in order to assess the technical feasibility and long-term outcomes according to the disease distribution in the trifurcation branches (true vs. non-true ULMT). Primary endpoint of the study was a composite of major adverse cardiovascular events (MACE) defined as cardiac-death, myocardial infarction (MI), and target lesion revascularization (TLR) during follow-up. RESULTS: Eighty-four patients underwent PCI with DES for ULMT disease during the study period (40 true trifurcation and 44 non-true trifurcation). Angiographic and procedural success were obtained in 94% and 92.8% of cases. At 3-years follow-up, the occurrence of MACE was significantly higher in patients with true ULMT than in those with non-true ULMT (HR 2.801 [confidence interval; CI 1.164-7.896], P = 0.025) due to a higher TLR rate (HR 3.032 [CI 1.164-7.896], P = 0.023). No episodes of late and very late definite/probable stent thrombosis (ST) occurred. On multivariable analysis, a true-ULMT lesion was the only independent predictor of MACE (HR 2.344 [C.I. 1.006-5.461], P = 0.049). CONCLUSIONS: PCI with DES for ULMT stenosis is feasible with a high procedural success rate and no definite/probable ST reported at follow-up. A true trifurcation lesion is associated with enhanced risk of MACE mainly driven by TLR.

The impact of main branch restenosis on long term mortality following drug-eluting stent implantation in patients with de novo unprotected distal left main bifurcation coronary lesions: the Milan and New-Tokyo (MITO) Registry.

BACKGROUND: In-stent restenosis (ISR) remains one of the main limitations for percutaneous coronary intervention of unprotected distal left main (UDLM). This study aims to demonstrate the impact of main-branch ISR (MB-ISR) on mortality and to clarify the optimal strategy. METHODS: Between 2002 and 2008, 482 consecutive UDLM patients treated with drug eluting stent (sirolimus and paclitaxel) were evaluated. RESULTS: During follow-up period (median 52.6 months), MB-ISR occurred in 29, SB-ISR in 65, and MB/SB-ISR in 24. Multivariable analysis demonstrated that the independent predictors of MB-ISR were calcification (HR 2.284, p = 0.016), true-bifurcation (HR 2.331, p = 0.024), insulin-dependent diabetes mellitus (insulin-DM) (HR 2.259, p = 0.048). Furthermore, final proximal postdilatation (FPPD) (HR 0.548, p = 0.077), full LM cover approach (FCA) (HR 0.605, p = 0.093) and greater MLD (HR 0.611, p = 0.062) had a tendency to reduce MB-ISR. Furthermore, the occurrence of MB-ISR within 1-year was associated with cardiac-death (HR 2.734, p = 0.017). CONCLUSIONS: The patients with MB-ISR had more comorbidities and complex lesions, resulting in higher risk of cardiac mortality as compared to the patients without MB-ISR. Presence of calcification, true-bifurcation and insulin-DM were associated with MB-ISR following UDLM intervention, while FCA, FPPD, and greater MLD seemed to be associated with the low occurrence of MB-ISR.

Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world experience from our registry.

OBJECTIVES: To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease. BACKGROUND: DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking. METHODS: Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR. RESULTS: A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1). CONCLUSION: Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.

Differences in the clinical and angiographic characteristics of chronic total occlusion lesions in the three major coronary arteries.

OBJECTIVES: The purpose of this study was to evaluate the differences in the clinical and angiographic characteristics of chronic total occlusion (CTO) lesions among the 3 major coronary arteries (LAD, LCx, and RCA). BACKGROUND: The success rate of percutaneous coronary intervention (PCI) of CTO lesions is not uniform among the 3 major coronary arteries and this may be influenced by the differences in angiographic and clinical characteristics that may exists between them. METHODS: We retrospectively evaluated clinical and angiographic characteristics of patients who underwent PCI of CTO lesions at our 2 centers between 2003 and 2010. RESULTS: We analyzed 708 CTO-PCI procedures between 2003 and 2010. The CTO lesions were located in LAD: 222 (31.4%), LCx: 167 (23.6%), and RCA: 319 (45.0%). Patients with CTO in LAD had lower incidence of previous history of PCI and CABG compared to those with CTO lesions in LCx or RCA. In regard to angiographic findings, LAD lesions tended to have more side branches and blunt occlusion stump. The LCx lesions presented more frequently as a part of multivessel disease. RCA lesions were significantly longer, more severely angulated, and calcified. Good collateral circulations were more often encountered in the RCA. In regard to success rates, RCA showed lower procedural success rates (71.8%) followed by LAD (74.8%) and LCx (79.0%). CONCLUSIONS: There were several differences in the clinical and angiographic characteristics of CTO lesions among the 3 major coronary arteries. These differences can explain the discrepancy in procedure success rates.

Chronic total occlusion in non-ST elevation myocardial infarction - A multi-centre observational study.

OBJECTIVES: To evaluate the characteristics and outcomes of patients with a chronic total occlusion (CTO) in a Non-ST Elevation Myocardial Infarction (NSTEMI) cohort. BACKGROUND: There is limited data on the clinical characteristics, revascularisation strategies and outcomes of patients presenting with a NSTEMI and a CTO. METHODS: Retrospective analysis of a six-centre percutaneous coronary intervention (PCI) registry in the UK between January 2015 and December 2020 was performed. Patients with a NSTEMI with and without a CTO were compared for baseline characteristics and outcomes. RESULTS: There were 17,355 NSTEMI patients in total of whom 1813 patients had a CTO (10.4 %). Patients with a CTO were more likely to be older (CTO: 67.8 (±11.5) years vs. no CTO: 67.2 (±12) years, p = 0.04), male (CTO: 81.1 % vs.71.9 %, p < 0.0001) with a greater prevalence of cardiovascular risk factors. All-cause mortality at 30 days: HR 2.63, 95 % CI 1.42-4.84, p = 0.002 and at 1 year: HR: 1.87, 95 % CI 1.25-2.81, p = 0.003 was higher in the CTO cohort. CTO patients who underwent revascularisation were younger (Revascularisation 66.4 [±11.7] years vs. no revascularisation 68.4 [±11.4] years, p = 0.001). Patients with failed CTO revascularisation had lower survival (HR 0.21, 95 % CI 0.10-0.42, p < 0.0001). The mean time to revascularisation was 13.4 days. There was variation in attempt at CTO revascularisation between the 6 centres for (16 % to 100 %) with success rates ranging from 65 to 100 %. CONCLUSIONS: In conclusion, the presence of a CTO in NSTEMI patients undergoing PCI was associated with worse in-hospital and long-term outcomes.

Editorial: Is the axiom of balloon angioplasty, "the more you gain the more you lose", still true in the era of DCB with paclitaxel?

Balloon angioplasty achieves luminal enlargement by fracturing the atherosclerotic intima at its point of least resistance, thereby creating a dissection plane and space with dehiscence of the intima from the media. This barotraumatic dissection triggers an inflammatory and proliferative reaction, resulting in a restenosis process at medium-term. In the era of plain old balloon angioplasty, quantitative angiographic studies at follow-up demonstrated that - the greater the acute luminal gain was after balloon angioplasty, the greater the late luminal loss was at follow-up. The interventional cardiologists coined the following motto "the more you gain, the more you lose". However, in the current era of drug coated balloon (DCB), it appears that this vexing conundrum could have been abrogated. A recently published DCB study in small de novo vessel has demonstrated that there was a slightly negative correlation between the volume of dissection assessed by optical coherence tomography and the angiographic late luminal loss (now gain) after Paclitaxel coated balloon treatment. In other words, the barotraumatic dissection does not necessarily herald a restenosis process in the era of DCB. This article revisits the mechanism of balloon angioplasty and explores how DCB with Paclitaxel may change the paradigm of balloon angioplasty as default treatment in CAD percutaneous treatment.

Single-stent crossover technique from distal unprotected left main coronary artery to the left circumflex artery.

OBJECTIVES: To report the clinical outcomes of single-stenting from distal unprotected left main coronary artery (LMCA) to the left circumflex artery (LCx). BACKGROUND: Percutaneous coronary intervention of distal LMCA is usually performed by stenting into the left anterior descending artery (LAD). In some cases, stenting from LMCA to LCx alone is performed. METHODS: Between April 2002 and April 2011, single-stenting with drug-eluting stents for distal unprotected LMCA disease was performed in 584 patients. Thirty-one patients underwent LMCA-LCx stenting, who were compared with the remaining 553 LMCA-LAD stented patients. RESULTS: At 3-year follow-up, there were no significant differences between LMCA-LCx and LMCA-LAD stenting groups in major adverse cardiac events (24.1% vs. 19.6%; P = 0.540), cardiac death, and myocardial infarction. A trend toward higher target lesion revascularization (TLR) in the LMCA-LCx stenting group was noted. This was significant when the stented branch was only considered (18.2% vs. 3.0%; P < 0.001). In both TLR subgroups, LCx ostium was frequently involved (83.3% in LMCA-LCx vs. 66.2% in LMCA-LAD TLR subgroups; P = 0.39). The LAD ostium was more frequently involved in LMCA-LCx TLR subgroup (83.3% vs. 21.0%; P < 0.001). On the multivariable Cox regression analysis, LMCA-LCx stenting was an independent predictor of TLR for restenosis at the ostium of the stented branch (HR 6.49; 95% CI 2.27-18.53; P < 0.001). CONCLUSIONS: TLR rate at the LCx ostium is high irrespective of LMCA-LCx or LMCA-LAD stenting. The former also seems to be associated with high TLR at the LAD ostium. It may therefore be important to evaluate alternative strategies for treating distal LMCA disease that extends into the LCx but not LAD.

Assessment of efficacy and safety of combining "paclitaxel" eluting balloon and "limus" eluting stent in the same lesion.

OBJECTIVES: To assess the safety and efficacy of combining drug-eluting balloon (DEB) and drug-eluting stents (DES) in the same coronary lesion. BACKGROUND: Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk-profile for restenosis. We have opted for DES over BMS in such situations and present our follow-up data. METHODS: Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second-generation DES. All patients had at-least one or more risk-factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in-stent restenosis [ISR], and/or long diffuse lesions ≥ 30 mm). RESULTS: Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI-3 flow post PCI with no in-lab complications. At median follow-up of 12.3 months (interquartile range [IQR]: 7.5-18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac-death, MI, and TVR occurred in 11% of patients. CONCLUSION: The results from this novel strategy of combining "Paclitaxel" eluting balloon and "Limus" eluting stent in a same lesion are encouraging. Dual drug-elution acting on two different pathways may provide potential synergy that may explain the favorable outcome.

Which predilatation balloons provide the best lesion preparation prior to use of drug coated balloons in de-novo lesions? Results from the PREPARE study.

BACKGROUND: There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of predilatation balloons: semi-compliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing de-novo lesions prior to the use of DCB. METHODS: We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were cardiac-death, TV-MI, TLR and MACE. RESULTS: During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Predilatation balloons were significantly larger in the ScB, and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; P<0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; P<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical endpoints, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; P=0.02). CONCLUSIONS: The PREPARE study results do not suggest routine use of ScB prior to DCB in de-novo lesions.