Mark W. Kennedy

A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the “DAPT-STEMI trial”

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. HYPOTHESIS Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. STUDY DESIGN The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. SUMMARY The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.

Factors associated with deferred lesion failure following fractional flow reserve assessment in patients with diabetes mellitus

To explore the predictors of deferred lesion failure (DLF) in patients with diabetes mellitus (DM) and lesions with a fractional flow reserve (FFR) >0.80 and to examine whether a predictive relationship between negative FFR values (>0.80–1.00) and DLF exists.

International Subspecialty Fellowship Training, the Path for Cardiologists of Tomorrow? : A European Perspective

Cardiology as a specialty continues to rapidly evolve, and continuous technological advancements have altered and improved the approach to both diagnosis and treatment of cardiac diseases. In response, numerous subspecialties have arisen, and advanced fellowship training has now become the de facto

Entrapment of dissection flap and intimal tissue cleavage during rotational atherectomy

A 57-year-old man with unstable angina was referred for rotational atherectomy (RA) percutaneous coronary intervention of a calcified right coronary artery (Fig. 1a). The RotablatorTM (Boston Scientific, Natick, MA, USA) was advanced over a 0.009′′ RotablatorTM Floppy wire to the catheter tip. With a rotational speed of 160,000 rpm, a pushforward/pull-back movement of the 1.5 mm burr was performed at less than 15 s per run (Fig. 1b); speed deceleration (> 5000 rpm) was not observed but a transient III degree atrio-ventricular-block occurred. After subsequent burr passage, the device was removed using dynaglide mode; however, an unusual sound was noted by the operator. Angiographic control revealed a severe dissection (Fig. 1c, arrows; online video) with associated flow limitation. Interestingly inspection of the burr revealed the presence of an entrapped dissection flap with intimal tissue (γ: one side of the burr, δ: opposite side of the burr). Subsequent successful deployment of 4 drug-eluting stents restored final TIMI III flow (Fig. 1d). We showed, for the first time, that the burr during rotational motion may cause entrapment of a dissection flap resulting in cleaving of the arterial intima. This highlights that the coronary dissections after RA may differ from those induced by typical balloon angioplasty. Moreover, according to expert consensus [1], the use of RA in dissection planes is not recommended due to the high risk of extending further the dissection. Indeed the burr preferentially ablates hard inelastic material (such as calcium, fibrous tissue), with sparing of healthy arterial wall, a concept known as differential cutting. However, this ability to cut one material while sparing another may fail when a significant damage of the vessel wall occurs, and in such cases the burr may entrap a dissection flap. Indeed our images clearly show the particular pathological anatomy of vessel dissection caused by the burr passage. Although this phenomenon can occur with a single passage of the burr resulting in a dissection plan, repeated burr passages have a great potential to disrupt a focal coronary dissection. However, in our case it was not possible to establish whether a focal dissection was present before the final burr passage. Coronary dissection is a well-known complication of RA, however the reasons of its occurrence, as in our case, often remain difficult to ascertain. Whether the guidewire sets the cutting vector when the burr advances, the stiff guidewire may be not centrally oriented also in case of short angulations and may bias preferentially to one side of the arterial wall coronary predisposing to dissection during RA. In conclusion, RA provides excellent plaque modification in calcified coronary lesions, however, burr passage may be complicated by coronary dissection which differs from that

Long-term mortality and prehospital tirofiban treatment in patients with ST elevation myocardial infarction

Objective We undertook a subgroup analysis of the On-TIME 2 (Ongoing Tirofiban In Myocardial infarction Evaluation 2), a placebo-controlled, double-blind, randomised trial, in order to evaluate the association between N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and long-term (5 years) mortality and to investigate the effect of prehospital tirofiban administration on mortality in relation to NT-proBNP levels. Methods A total of 984 patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) were randomised to either in ambulance tirofiban or placebo. NT-proBNP levels were evaluated on admission before angiography (baseline) and 18–96 hours thereafter (post PCI). Results There were 918 (93.3%) patients with NT-proBNP values available at baseline and 865 (87.9%) post PCI. Patients with baseline NT-proBNP values above the median (137 pg/mL) had higher 30-day (5.1% vs 0.2%, p<0.001), 1-year (7.0% vs 0.7%, p<0.001) and 5-year (20.3% vs 4.9%, p<0.001) mortality as compared with patients with values below the median. Using multivariate Cox analysis, NT-proBNP above the median was an independent predictor for 5-year mortality (HR 2.73, 95% CI 1.47 to 5.06; p=0.002). Patients with values above the median who received early tirofiban treatment had significant lower mortality compared with patients treated with placebo at 30 days (2.7% vs 7.5%, p=0.021) and 1 year (4.5% vs 9.4%, p=0.043). At 5 years, a lower but non-significant mortality rate was maintained in the treatment group (18% vs 22.4%, p=0.265). Conclusions In patients with STEMI, baseline NT-proBNP level independently predicts long-term mortality. In patients with baseline NT-proBNP levels above the median, early prehospital treatment with tirofiban significantly reduced 30-day and 1-year mortality, suggesting that high-risk patients may derive particular benefit. This finding should be confirmed in other studies. Trial registration number ISRCTN06195297.

TCT-94 Impact of Thin-Cap Fibroatheromas on Unanticipated Ischemic Events in Medically Treated Patients With Diabetes Mellitus: Insights From the PROSPECT Study.

nos: 93 96

TCT-512 Fractional Flow Reserve-Guided Deferred Versus Complete Revascularisation in Patients With Diabetes Mellitus

Whether Fractional Flow Reserve (FFR), the gold standard to detect ischemia, is equally safe in subpopulations with accelerated atherosclerosis progression, such as Diabetes Mellitus (DM) patients remains unknown. This study sought to assess the safety and efficacy of deferred versus complete

TCT-266 Impact of elevated glycosylated hemoglobin (HbA1c) on admission on long-term Mortality in Patients with Unknown Diabetes Mellitus Presenting with acute myocardial infarction (STEMI or NSTEMI)

Patients with diabetes mellitus (DM), who present with an acute myocardial infarction (AMI), have a worse outcome than patients without DM. However, outcome is less well known in non-diabetic patients who present with elevated HbA1c levels on admission. We therefore aimed to study the prognostic

TCT-262 Clinical Outcomes of Deferred Revascularisation Using Fractional Flow Reserve in Patients With and Without Diabetes Mellitus

METHODS In a 12-center prospective CTO PCI registry, patients were assessed for technical success, periprocedural complications, and health status using the Seattle Angina Questionnaire Summary, Angina Frequency and Quality of Life scores at baseline and 30-day follow-up. Hierarchical Poisson regression was used to examine the association between diabetes and technical success adjusting for patient and angiographic factors, while multivariable linear regression was used to assess the association between diabetes and 30day health status adjusting for baseline health status and patient factors.