An immediate or early invasive strategy in non-ST-elevation acute coronary syndrome: The OPTIMA-2 randomized controlled trial.

BACKGROUND: In intermediate- and high-risk non-ST elevated acute coronary syndrome (NSTE-ACS) patients, a routine invasive approach is recommended. The timing of coronary angiography remains controversial. To assess whether an immediate (<3 hours) invasive treatment strategy would reduce infarct size and is safe, compared with an early strategy (12-24 hours), for patients admitted with NSTE-ACS while preferably treated with ticagrelor. METHODS: In this single-center, prospective, randomized trial an immediate or early invasive strategy was randomly assigned to patients with NSTE-ACS. At admission, the patients were preferably treated with a combination of aspirin, ticagrelor and fondaparinux. The primary endpoint was the infarct size as measured by area under the curve (AUC) of CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major adverse cardiac events (MACE): composite of all-cause death, MI and unplanned revascularization. Interim analysis showed futility regarding the primary endpoint and trial inclusion was terminated. RESULTS: In total 249 patients (71% of planned) were included. The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group (IQR 112-618) and 201.3 ng/mL in the early group (IQR 119-479). Clinical follow-up was 1-year. The MACE-rate was 10% in the immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI: 0.52-2.49). CONCLUSIONS: In NSTE-ACS patients randomized to either an immediate or an early-invasive strategy the observed median difference in the primary endpoint was about half the magnitude of the expected difference. The trial was terminated early for futility after 71% of the projected enrollment had been randomized into the trial.

One-year mortality in NSTEMI patients is unaffected by timing of PCI within the first week of admission: Results of a real-world cohort analysis.

OBJECTIVES: We aimed to explore the impact of time to percutaneous coronary intervention (PCI) (T2P) on 1-year mortality in non-ST-elevation myocardial infarction (NSTEMI) patients. BACKGROUND: The current guidelines recommend an early invasive strategy for NSTEMI patients. However, impact of an early invasive strategy on mortality is a matter of debate. For that reason, real world data are of great value to determine the optimal treatment window. METHODS: This retrospective single center cohort study was performed in a high-volume PCI center in Amsterdam, The Netherlands. Intermediate- and high-risk NSTEMI patients undergoing PCI were included. The main discriminant was timing of PCI after admission (T2P), stratified according to different time windows (<24 h, 24-72 h, 72 h-7 days or >7 days). We analyzed 1-year mortality and the time distribution of overall survival. RESULTS: In total, 848 patients treated between January 1, 2016 and January 1, 2018 were included in the analysis. T2P was <24 h in 145 patients, 24-72 h in 192 patients, 72 h-7 days in 275 patients, and >7 days in 236 patients. The mean GRACE-risk score was 127.1 (SD 28.7), 130.0 (33.1), 133.8 (32.1), and 148.7 (34.6) respectively, p = <0.001. After adjusting for confounders, 1-year mortality in patients with T2P <24 h did not significantly differ when compared with T2P 24-72 h (OR = 1.08; 95% CI = 0.33-3.51) and T2P 72 h-7 days (OR 1.72; 95% CI = 0.57-5.21) but was significantly higher in T2P >7 days (OR = 3.20; 95% CI = 1.06-9.68). CONCLUSIONS: In an unselected cohort of patients with NSTEMI, treatment by PCI <24 h did not lead to improved survival as compared to aT2P <7 days strategy. Delay in PCI >7 days after admission resulted in worse outcome.

REVascularization with paclitaxEL-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarcTION-A randomized controlled trial: Rationale and design of the REVELATION trial.

AIM: In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI. STUDY DESIGN: The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR <0.85, we decided to accept an FFR value of ≥0.85 after DCB only at follow-up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5-year follow-up. CONCLUSION: Our trial will address the efficacy and safety of DCB angioplasty versus DES in the setting of PPCI for STEMI. The REVELATION trial will introduce the recognized prognostic significance of physiologic assessment of the infarct-related lesion by FFR at 9 months follow-up as primary end point. © 2015 Wiley Periodicals, Inc.

A prospective, postmarket study with the Mguard Prime Embolic Protection Stent in ST-segment elevation myocardial infarction: the International MGuard Prime Observational Study (IMOS Prime).

AIMS: We sought to evaluate the procedural and clinical performances of the MGuard Prime Embolic Protection Stent (EPS) in a "real-world" population with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS: Consecutive STEMI patients meeting the inclusion criteria and undergoing PPCI were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave) or target lesion revascularization (PCI or coronary artery bypass graft). Secondary endpoints included device success, lesion success, and postprocedural reperfusion outcomes: thrombolysis in myocardial infarction (TIMI) flow and ST-segment elevation resolution (STR). A total of 97 patients (62 years, 77% men) were included. Symptom to cathlab time was 238 min. Device and lesion success were 100%. Final TIMI-3 flow was achieved in 91.8%, and STR > 50% in 87% of the patients. MACE at 30 days was 2.2%, which consisted of one case each of target vessel (TV)-myocardial infarction (MI), and non-TV-MI. CONCLUSIONS: The use of the MGuard Prime EPS stent is feasible and safe and could be also effective in achieving myocardial reperfusion in STEMI patients undergoing PPCI.

Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure: Post-Hoc Analysis of the PASSION Trial.

OBJECTIVES: Our aim was to investigate the risk of events related to non-culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD). BACKGROUND: In patients undergoing primary PCI for ST-elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non-culprit lesions when compared with culprit-lesion PCI only. METHODS: We performed a post-hoc analysis of 279 patients with MVD included in the Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis. RESULTS: After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1-vessel disease (HR 1.06, 95%CI 0.52-2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment. CONCLUSIONS: In this post-hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non-culprit coronary artery.

EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries.

BACKGROUND: Coronary artery calcification is a strong predictor for procedural failure and is independently associated with adverse events after percutaneous coronary intervention (PCI). An important contributor to the impaired outcome is the inability to achieve optimal results due to stent underexpansion or stent deformation/fracture. Intravascular lithotripsy (IVL) has emerged as an alternative technique to change the integrity of calcified plaques. AIMS: Our aim was to investigate if pre-treatment with IVL in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (OCT), when compared to predilatation with conventional and/or specialty balloon strategy. METHODS: EXIT-CALC was a prospective, single-centre, randomised controlled study. Patients with an indication for PCI and severe calcification of the target lesion were allocated to predilatation with conventional angioplasty balloons or pre-treatment with IVL, followed by drug-eluting stenting and mandatory postdilatation. Primary endpoint was stent expansion assessed by OCT. Secondary endpoints were the occurrence of peri-procedural events and major adverse cardiac events (MACE) in hospital and during follow-up. RESULTS: A total of 40 patients were included. The minimal stent expansion in the IVL-group (n = 19) was 83.9 ± 10.3% and 82.2 ± 11.5% in the conventional group (n = 21) (p = 0.630). Minimal stent area was 6.6 ± 1.5 mm2 and 6.2 ± 1.8 mm2, respectively (p = 0.406). No peri-procedural, in-hospital and 30-day follow-up MACE were reported. CONCLUSIONS: In severely calcified coronary lesions we found no significant difference in stent expansion measured by OCT when comparing IVL, as plaque modification, with conventional and/or specialty angioplasty balloons.

Lack of long-term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel-eluting stents or bare-metal stents: post-hoc analysis of the PASSION-trial.

BACKGROUND: Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents. METHODS: We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA. RESULTS: Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups. CONCLUSIONS: In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPCI.

Primary percutaneous coronary intervention by magnetic navigation compared with conventional wire technique.

Aims Comparison of magnetic guidewire navigation in percutaneous coronary intervention (MPCI) vs. conventional percutaneous coronary intervention (CPCI) for the treatment of acute myocardial infarction. Methods and results We compared 65 sequential patients (mean age 61 ± 15 years) undergoing primary MPCI with those of 405 patients undergoing CPCI (mean age 61 ± 13 years). The major endpoint was contrast media use. Technical success and procedural outcomes were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for fewer patients with previous coronary artery bypass grafting (CABG) and hypertension in the CPCI group and fewer patients with diabetes in the MPCI group. The technical success rate was high in both the MPCI and CPCI groups (95.4 vs. 98%). There was significantly less contrast media usage in the MPCI compared with the CPCI group, median reduction of contrast media of 30 mL with an OR = 0.41 (0.21-0.81). Fluoroscopy times were significantly reduced for MPCI compared with CPCI, median reduction of 7.2 min with an OR = 0.42 (0.20-0.79). Conclusion This comparison indicates the feasibility and non-inferiority of magnetic navigation in performing primary PCI and suggests the possibility of reductions in contrast media use and fluoroscopy time compared with CPCI.

Cardiac arrest resulting from an unidentified foreign object, later identified as a balloon cover, within the left anterior descending coronary artery.

A 31-year-old man with a history of hypertrophic cardiomyopathy and alcohol septal ablation one week before was presented after an out of hospital cardiac arrest in the setting of an anterior wall ST-elevation myocardial infarction. Immediate coronary angiography showed an unidentified foreign object within the left anterior descending coronary artery (LAD), later identified as the cover of a balloon that had been unintentionally inserted and abandoned within the LAD during the alcohol septum ablation one week earlier. Intracoronary imaging confirmed the presence of endothelial damage and thrombus formation within the LAD explaining acute myocardial infarction. The patient was treated by surgical retrieval of the balloon cover, extended septal myectomy and coronary artery bypass grafting (CABG) of the LAD. This case is both an example of unintentional neglect of unexpected objects, and the importance of multimodality imaging and multidisciplinary teamwork to get to a correct diagnosis and treatment.

Two-Year Clinical Outcomes of the REVELATION Study: Sustained Safety and Feasibility of Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction.

OBJECTIVES: The randomized REVELATION (REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION) trial showed that in the setting of ST-segment elevation myocardial infarction (STEMI), a drug-coated balloon (DCB) strategy was non-inferior to a drug-eluting stent (DES) strategy in terms of fractional flow reserve assessed at 9 months. The aim of the present study is to evaluate the long-term clinical outcome of this treatment strategy. METHODS: Between October 2014 and November 2017, a total of 120 patients with a non-severely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after predilation were randomized to treatment with DCB or DES. Primary clinical endpoint was the occurrence of major adverse cardiac events, defined as death, recurrent myocardial infarction, or target-lesion revascularization, the occurrence of definite ST, and non-coronary artery bypass grafting (CABG) major bleeding. RESULTS: Complete clinical follow-up at 2 years was available for 109 patients (91%). A major adverse cardiac event occurred in 3 patients (5.4%) in the DCB group and 1 patient (1.9%) in the DES group (hazard ratio, 2.86; 95% confidence interval, 0.30-27.53; P=.34). Between 9 months and 2 years, only 1 additional event occurred (target-lesion revascularization in a patient randomized to DCB). CONCLUSION: In this randomized study of DCB vs DES in selected patients presenting with STEMI, 2-year clinical outcome was excellent and comparable between the DCB and DES groups.

A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST-segment elevation myocardial infarction (TREAT-MI).

OBJECTIVES: The objective of this study was to compare the efficacy and long-term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X-sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI). BACKGROUND: In PPCI for acute ST-segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short-term clinical outcome. In current literature, no direct comparison is available. METHODS: We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X-sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST-segment resolution were examined. The primary endpoint of the follow-up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target-vessel revascularization (TVR) at 3 years. RESULTS: Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST-segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X-sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65-2.22; P = 0.35). CONCLUSION: Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3-year clinical follow-up were similar with the use of the Export catheter as compared to the X-sizer system.

Magnetic wire lock: prevention and correction to avoid wire fracture.

This report illustrates an undescribed mechanism causing magnetic angioplasty wire fracture and describes how to avoid its occurrence and how to correct it, if it occurs. The cause is the transition point in the wire between a flexible wire shaft and the inflexible magnetic tip of a magnetically enabled wire. In the first stage of the problem, the wire becomes trapped in a doubled-back position. Subsequently, traction causes the second stage that kinks the wire and hooks behind a structure, in this case, a stent, causing magnetic wire lock. Further traction has a high chance of wire fracture. Correction, although challenging, remains possible before wire fracture occurs. Although there is no intrinsic problem with the technology, attention to this problem by the operator will reduce its occurrence and therefore its sequelae.

Comparison of magnetically navigated and conventional wire percutaneous coronary intervention of a single discrete stenosis.

OBJECTIVE: The objective of this study is to compare magnetic guidewire navigation in percutaneous coronary intervention (MPCI) to conventional percutaneous coronary intervention (CPCI) for the elective treatment of a single discrete stenosis. BACKGROUND: Magnetic navigation actively steers an angioplasty wire-tip and may improve PCI procedures, but it is not known whether the intricacy and increased preparation necessary for using the system negatively influences the performance of simple procedures in terms of time and contrast use. METHODS: The procedures of 44 patients (mean age 65 +/- 10 year) undergoing elective single vessel MPCI of a single discrete stenosis were matched for age, gender, and lesion location with 44 concurrent patients (mean age 65 +/- 10 year) undergoing CPCI. The major endpoint was procedural time. RESULTS: Technical success was defined as an intraluminal wire position distal to the stenosis. Procedural outcome, contrast use, and costs were evaluated. Clinical demographics and angiographic characteristics of the two groups were similar, except for a higher incidence of previous MI and class III angina pectoris in the conventional group. The technical success rate was high and identical in both groups (97.7%). Procedural and fluoroscopy times were not significantly different for MPCI compared to CPCI (21.0 +/- 14.5 min vs. 24.7 +/- 14.0 min; 4.9 +/- 4.8 min vs. 7.3 +/- 10.3 min, P = NS). There was a significant reduction in median contrast use [60 ml/patient (41-100) vs. 100 ml/patient (64-130); P = 0.006]. CONCLUSION: Magnetic navigation does not increase procedural time, irradiation, equipment use, or cost compared to conventional PCI of a single discrete stenosis. It proved feasible, yielding high rates of procedural success with less contrast use.

Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.

OBJECTIVES: This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. METHODS: In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion. RESULTS: A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group). CONCLUSIONS: In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).

Percutaneous treatment of an iatrogenic cardiac fistula.

Coronary fistulae, defined as communications between coronary arteries and cardiac chambers or veins, are uncommon. We present a case where a fistula was inadvertently caused by the surgical anastomosis of an arterial coronary artery bypass graft to a coronary vein. This produced two coronary problems, the unrevascularized Cx territory and a coronary arteriovenous fistula, and left the patient with symptoms. Each of these problems was addressed in a tailored percutaneous intervention by deploying ostial and distal stents to revascularize the Cx, followed by coils to block the distal section of the graft.

Use of the Stereotaxis Niobe magnetic navigation system for percutaneous coronary intervention: results from 350 consecutive patients.

INTRODUCTION: The Stereotaxis Niobe magnetic navigation system (MNS; Stereotaxis, St. Louis, MO) facilitates precise vector based navigation of magnetically-enabled guidewires for percutaneous coronary intervention (PCI) by using two permanent magnets located on opposite sides of the patient table to produce a controllable magnetic field. The objective of this study is to describe the results of a large patient series using this system, to compare the results with a historical control group, and to detail the MNS learning curve. METHODS: We prospectively collected data on 439 lesions in 350 consecutive PCI patients using the MNS predominantly using the radial approach. All data were entered into a customized database to capture the key parameters and then compared with a previously collected stent registry from the same center. RESULTS: In 410/439 lesions (93%) the wire crossed the lesion successfully using the MNS. Twenty-five of the 35 failures were chronic total occlusions. No wire perforations or dissections occurred in this population. Lesion crossing time was 81 +/- 168 sec (mean +/- SD), and fluoroscopy time was 64 +/- 123 sec. A clear learning curve was evident after the first 80 patients. Contrast use was reduced when compared with a historical control group. Procedural and fluoroscopy times were similar. CONCLUSIONS: Use of the MNS may enable the successful performance of more complex procedures in the cardiac catheterization laboratory with an improvement in time efficiency.

Prehospital Prasugrel Versus Ticagrelor in Real-World Patients With ST-Elevation Myocardial Infarction Referred for Primary PCI: Procedural and 30-Day Outcomes.

OBJECTIVES: Pretreatment with P2Y12 inhibitors before primary percutaneous coronary intervention (PPCI) can reduce the incidence of major adverse cardiovascular event (MACE) rate in ST-segment elevation myocardial infarction (STEMI) patients. We investigated differences in coronary reperfusion and clinical outcomes between prehospital administration of prasugrel vs ticagrelor in a historical cohort analysis. METHODS AND RESULTS: We conducted a retrospective analysis of prospectively collected data of 533 STEMI patients, directly referred by the ambulance for PPCI, and pretreated with either prasugrel (2013-2014) or ticagrelor (2015-2016). The primary outcome measurement was coronary and myocardial reperfusion prior to and after intervention. Secondary outcome measurements included MACE and stent thrombosis (ST) at 30 days. The median time from first medical contact to balloon was 82 minutes. There was no significant difference in preprocedural and postprocedural coronary reperfusion (TIMI flow grade 3) and postprocedural ST-segment elevation resolution between the prasugrel and ticagrelor groups. No significant differences in MACE and ST rates were found between the groups. No fatal or intracranial bleedings were reported up to 30-day follow-up. CONCLUSIONS: Prehospital administration of both prasugrel and ticagrelor in STEMI patients is safe, without differences in preprocedural and postprocedural reperfusion and short-term clinical outcomes.

Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study.

AIMS: In primary percutaneous coronary intervention (PPCI), stenting has been shown to reduce the need for repeat target lesion revascularisation (TLR) compared to balloon angioplasty alone, but did not result in a reduction of recurrent myocardial infarction (MI) or cardiac death. Meanwhile, stent-related adverse events such as stent thrombosis continue to be of concern. Our aim was to evaluate the safety and feasibility of drug- coated balloon (DCB) angioplasty without stenting in PPCI. METHODS AND RESULTS: One hundred patients presenting with ST-elevation MI were prospectively enrolled in this pilot study. They underwent PPCI with DCB angioplasty; additional stenting was allowed only in case of type C to F coronary dissection or residual stenosis >50%. All patients were treated with i.v. bivalirudin. The primary endpoint was the composite of cardiac death, recurrent MI and TLR. A total of 59 patients received treatment with DCB angioplasty alone, whereas additional stenting was required in 41 patients. One-year clinical follow-up was completed in 98 patients. A total of five major adverse cardiac events were reported (5%). Cardiac death was seen in two patients, while three patients underwent TLR. CONCLUSIONS: This first study of a DCB angioplasty-only strategy in the setting of PPCI showed good one-year clinical results.